8826 Kendal Guide to Bed Safety

Transcription

Which Ways of Reducing
Risk are Best?
A process that requires ongoing patient evaluation and monitoring will result in optimizing
bed safety. Many patients go through a period
of adjustment to become comfortable with
new options. Patients and their families
should talk to their health care planning team
to find out which options are best for them.
If patients or family ask about using bed rails,
health care providers should:
• Reassure patients and their families that in
many cases the patient can sleep safely
without bed rails.
• Reassess the need for using bed rails on a
frequent, regular basis.
To report an adverse event or medical device problem, please call FDA’s MedWatch Reporting
Program at 1-800-FDA-1088.
For additional copies of this brochure, see the
FDA’s website at
http://www.fda.gov/cdrh/beds/
For more information about this brochure, contact
Beryl Goldman at 610-335-1280 or by e-mail at
[email protected]. She has volunteered to answer questions.
For information regarding a specific hospital
bed, contact the bed manufacturer directly.
• AARP
• ABA Tort and Insurance Practice Section
• American Association of Homes and Services for
the Aging
A Guide to
Bed Safety
• American Health Care Association
• American Medical Directors Association
• American Nurses Association
• American Society for Healthcare Engineering of
the American Hospital Association
• American Society for Healthcare Risk Management
• Basic American Metal Products
• Beverly Enterprises, Inc.
• Care Providers of Minnesota
• Carroll Healthcare
• DePaul College of Law
• ECRI
• Evangelical Lutheran Good Samaritan Society
• Hill-Rom Co., Inc.
• Joerns Healthcare, Inc.
• Joint Commission on Accreditation of Healthcare
Organizations
• Medical Devices Bureau, Health Canada
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• Encourage patients or family to talk to their
health care planning team to determine
whether or not bed rails are indicated.
Participating Organizations:
ry
ust
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Patient or Family Concerns
About Bed Rail Use
Developed by the Hospital
Bed Safety Workgroup
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• National Association for Home Care
• National Citizens’ Coalition for Nursing Home
Reform
• National Patient Safety Foundation
• RN+ Systems
• Stryker Medical
• The Jewish Home and Hospital
• Untie the Elderly, The Kendal Corporation
• U.S. Food and Drug Administration
October 2000
Brochure Revised January 2008
Bed Rails In Hospitals,
Nursing Homes and
Home Health Care:
The Facts
Bed Rail Entrapment
Statistics
Today there are about 2.5 million hospital
and nursing home beds in use in the United
States. Between 1985 and 2008, 772 incidents
of patients* caught, trapped, entangled, or
strangled in beds with rails were reported to
the U.S. Food and Drug Administration. Of
these reports, 460 people died, 136 had a
nonfatal injury, and 176 were not injured
because staff intervened. Most patients
were frail, elderly or confused.
Patient Safety
Patients who have problems with memory,
sleeping , incontinence, pain, uncontrolled
body movement, or who get out of bed and
walk unsafely without assistance, must be
carefully assessed for the best ways to keep
them from harm, such as falling. Assessment
by the patient’s health care team will help to
determine how best to keep the patient safe.
Historically, physical restraints (such as vests,
ankle or wrist restraints) were used to try to
keep patients safe in health care facilities. In
recent years, the health care community has
recognized that physically restraining patients
can be dangerous. Although not indicated for
this use, bed rails are sometimes used as
restraints. Regulatory agencies, health care
organizations, product manufacturers and
advocacy groups encourage hospitals, nursing
* In this brochure, the term patient refers to a resident
of a nursing home, any individual receiving services
in a home care setting, or patients in hospitals.
homes and home care providers to assess
patients’ needs and to provide safe care without restraints.
The Benef its and Risks
of Bed Rails
Potential benefits of bed rails include:
• Aiding in turning and repositioning within
the bed.
• Providing a hand-hold for getting into or out
of bed.
• Providing a feeling of comfort and security.
• Reducing the risk of patients falling out of
bed when being transported.
• Providing easy access to bed controls and
personal care items.
Potential risks of bed rails may include:
• Strangling, suffocating, bodily injury or
death when patients or part of their body are
caught between rails or between the bed
rails and mattress.
• More serious injuries from falls when
patients climb over rails.
• Skin bruising, cuts, and scrapes.
• Inducing agitated behavior when bed rails
are used as a restraint.
• Feeling isolated or unnecessarily restricted.
• Preventing patients, who are able to get out
of bed, from performing routine activities
such as going to the bathroom or retrieving
something from a closet.
Meeting Patients’ Needs
for Safety
Most patients can be in bed safely without bed
rails. Consider the following:
• Use beds that can be raised and lowered
close to the floor to accommodate both
patient and health care worker needs.
• Keep the bed in the lowest position with
wheels locked.
• When the patient is at risk of falling out of
bed, place mats next to the bed, as long as
this does not create a greater risk of accident.
• Use transfer or mobility aids.
• Monitor patients frequently.
• Anticipate the reasons patients get out of
bed such as hunger, thirst, going to the
bathroom, restlessness and pain; meet these
needs by offering food and fluids, scheduling ample toileting, and providing calming
interventions and pain relief.
When bed rails are used, perform an on-going
assessment of the patient’s physical and mental
status; closely monitor high-risk patients.
Consider the following:
• Lower one or more sections of the bed rail,
such as the foot rail.
• Use a proper size mattress or mattress with
raised foam edges to prevent patients from
being trapped between the mattress and rail.
• Reduce the gaps between the mattress and
side rails.
Restraint
Reduction
• Assessment and Alternatives
Help Guide
• Evaluation Trees
• Assessment Log/
Intervention Care Plan
Funding for this Skilled Nursing Facility Health Care Quality
Improvement Project was provided by the Health Care
Financing Administration, Contract #500-96-P611. These
materials were prepared and assembled by the Colorado
Foundation for Medical Care in collaboration with the
Colorado Department of Public Health and Environment,
Health Facilities Division, May 1998. The contents presented
do not necessarily reflect HCFA policy .
1
ASSESSMENT and ALTERNATIVES
HELP GUIDE
Table of Contents
Page
2
BASIC ASSESSMENT
5
ASSESSMENT TOOLS
7
FALLS
14
BEHAVIOR PROBLEMS
36
WANDERING
55
MEDICAL NECESSITY
61
ACKNOWLEDGMENTS
“One person can make a difference, and every person should try.”
John F. Kennedy
The Help Guide was prepared by the Colorado Foundation for Medical Care with funds
provided by the Health Care Financing Administration contract # 500-96-P611 and in
collaboration with organizations and individuals from throughout the state.
Partnership Members
Alzheimer's Association
Colorado Association of Homes and Services for the Aging
Colorado Department of Health Care Policy and Financing
Colorado Department of Public Health and Environment
Colorado Foundation for Medical Care
Colorado Health Care Association
Department of Preventative Medicine and Biometrics - UCHSC
Family Representation
Health Care Financing Administration
Long Term Care Staff
Colorado Medical Directors' Association
Nursing Home Administration
Office of the State Attorney General
Office of the State Ombudsman
Appreciation is expressed to the Colorado Health Care Association for permission to include excerpts from
Freeing A Half-Million People: Increasing Resident Independence Through Restraint Reduction, prepared by
Diane Carter, RN, MSN for the Colorado Health Care Association, 1991.
Special thanks to Diane Carter, RN, MSN, Susan Smith, RN, BSN C-GNP and Karyn P. Prochoda, MD for
their contributions to the development of this Help Guide along with the Assessment Log and Evaluation
Trees.
For information regarding the Help Guide, please call:
Communications Department
303-695-3300, Ext. 3332
3
This poem was found among the possessions of an elderly lady who died in the geriatric ward of a
hospital. No information is available concerning her -- who she was or when she died.
See Me
What do you see, nurses, what do you see?
Are you thinking, when you look at me -A crabby old woman, not very wise,
Uncertain of habit, with far-away eyes,
Who dribbles her food and makes no reply,
When you say in a loud voice -- "I do wish you'd try."
Who seems not to notice the things that you do,
And forever is losing a stocking or shoe,
Who unresisting or not, lets you do as you will,
With bathing and feeding, the long day to fill.
Is that what you're thinking, is that what you see?
Then open your eyes, nurse, you're looking at ME...
I'll tell you who I am, as I sit here so still;
As I rise at your bidding, as I eat at your will.
I'm a small child of ten with a father and mother,
Brothers and sisters, who love one another,
A young girl of sixteen with wings on her feet.
Dreaming that soon now a lover she'll meet;
A bride soon at twenty -- my heart gives a leap,
Remembering the vows that I promised to keep;
At twenty-five now I have young of my own,
Who need me to build a secure, happy home;
A woman of thirty, my young now grow fast,
Bound to each other with ties that should last;
At forty, my young sons have grown and are gone,
But my man's beside me to see I don't mourn;
At fifty once more babies play 'round my knee,
Again we know children, my loved one and me.
Dark days are upon me, my husband is dead,
I look at the future, I shudder with dread,
For my young are all rearing young of their own,
And I think of the years and the love that I've known;
I'm an old woman now and nature is cruel -'Tis her jest to make old age look like a fool.
The body is crumbled, grace and vigor depart,
There is now a stone where one I had a heart,
But inside this old carcass a young girl still dwells,
And now and again my battered heart swells.
I remember the joys, I remember the pain,
And I'm loving and living life over again,
I think of the years, all too few -- gone too fast,
And accept the stark fact that nothing can last -So I open your eyes, nurses, open and see,
Not a crabby old woman, look closer, nurses -- see ME!
4
Basic Assessment Tool
When a patient is not feeling well or is "just not right", it is important to do a basic assessment of his
or her current status. Some of the signs that indicate that something is wrong include:
The patient is:
- more confused than usual
- not eating
- incontinent
- experiencing increased swelling
This is the first diagnostic step. It is followed by basic data gathering and physical exam.
The most common acute geriatric problems:
1.
2.
3.
4.
5.
UTI (urinary tract infection)
impaction/obstruction
pneumonia
medications
confusion
These acute problems are superimposed on chronic disease. Example: patient is coughing more
and has existing diagnosis of COPD (chronic obstructive pulmonary disease) and CHF (congestive
heart failure). What is going on and how do you figure it out?
Gather history - most important. Diagnosis frequently made on history alone, with physical exam only
confirming.
Pain - how long, where, nature of pain (constant, intermittent, sharp, burning, aching, heavy,
stabbing, boring, cramping), does pain radiate?
Examples:
burning epigastric pain - ulcer vs. gastritis
burning back pain may indicate muscular/neuro pain
burning abdominal - UTI (Urinary Tract Infection)
heavy sternal pain - MI (Myocardial Infarction)
sharp, abdominal pain - stones
aching joint - arthritis
Pain is frequently denied in this population - “Grin and bear it” ethic
Decreased expectation for relief of pain
Inability to communicate, or stoicism
What makes pain better or worse, i.e.: food, rest, cold, heat, exercise.
Is there nausea? urinary burning? retention? vomiting? urinary frequency (most geriatric patients
are asymptomatic)? last bowel movement - nature of bowel movement (hard, soft, tarry, brown)?
Is patient coughing more than usual, does he have chest pain - nature of pain? rib fracture vs. wall
pain vs. cardiac vs. pneumonia. Are symptoms new or increased from baseline?
Be very specific but try not to guide patient.
5
Has patient been taking meds? sleeping? eating? Is patient sad/depressed looking? Ask him
directly - Are you sad, how long?
Chest -
nature of pain, difficulty breathing, SOB, pain radiating to arms, neck or face.
Check Meds - Digitalis, Theophylline, Dilantin ™, Tegretol ™, psychotropics require levels. When
was last level and was it noted by physician as being acceptable? Not all meds need
to be in therapeutic levels. Illness can alter normal levels. Anti-convulsants, even at
therapeutic levels, can cause dizziness and sedation.
If patient unable to give history, must rely on PE. Remember baseline.
Survey Patient - do they look acutely ill, dehydrated, in pain?
VS -
body temperature is least reliable measure of geriatric illness - Respiration, Heart
Rate, BP better - geriatric patients frequently don't run fevers.
Heent -
check ears, throat, palpate sinus - does patient have teeth, dentures - what condition?
Lungs -
decreased breath sounds? Are lung sounds even, any rales? Check progress notes
for baseline.
Heart -
fast, slow, regular, irregular, is there edema? Is BP increased over baseline?
Abdomen -
Bowel Sounds - listen for 2 minutes before deciding there are no bowel sounds. Is
patient tender to palpation? Where? Is abdomen soft, hard, distended?
Extremities - swollen, red, painful? Has Range of Motion changed from baseline?
Mental Status - is it different from baseline?
Labs -
Evaluate medication. Synthroid ™, digoxin ™, dilantin ™, Tegretol ™, psychotropics
require laboratory monitoring. Again check baseline.
UA very important.
SMA6 - elevated BUN and Creatinine may indicate renal failure or simple dehydration
Check baseline levels
May need chest x-ray
CBC
Abdominal X-ray - 3 way, KUB
6
Assessment Log/
Resident:
Intervention
Assessment of Intervention
What did staff do? How does this improve resident
function? Permits resident access to his/her own body?
Least restrictive and highest level of functioning?
How did intervention work?
If not, why?
If yes, why?
7
Document: Initial Assessment/Each Event/Actions & Results
Room #:
ID #:
Event #
When (Date/Time)
What/Where What behavior/event was observed? Where did it occur? (Be specific)
Who/Why Who else was present? What was happening? What may have caused
or triggered behavior?
Review & Comment by Charge Nurse/Restraint Committee:
Initials
INSTRUCTIONS FOR USE - ASSESSMENT LOG/INTERVENTION CARE PLAN
See other side for detailed instructions
WHEN DO I USE THIS FORM?
WHICH RESIDENTS NEED THIS FORM?
- for every event for each resident
- anyone currently using a device
- for injury and non-injury events
- anyone being considered for a device
- for every event until least restrictive device,
- anyone who has had an incident or event
allowing highest level of functioning is obtained
such as fall, wandered, behavior problem
REMEMBER: An intervention is anything you do that helps!
- Maintain a separate log for each patient
- Record all facility attempts to reduce
- Keep information specific and brief
restrictiveness of device, why it is least
- Look for patterns around time, place, furniture
restrictive, and resident outcome
other residents, staff or medication administration
- Document briefly all monitoring, changes,
- Try alternatives è document outcomes/results
and reactions to changes
VERY IMPORTANT to ASK YOURSELF THE FOLLOWING KEY QUESTIONS:
ý IS THIS LEAST RESTRICTIVE?
If yes: J
ý DOES THIS PERMIT RESIDENT ACCESS TO OWN BODY?
If yes: J
ý DOES THIS ACHIEVE HIGHEST LEVEL OF FUNCTIONING?
If yes: J
Form will service as documentation of restraint RAP ð Note location of RAP Summary ð attach to chart as Restraint Care Plan.
Use as Interdisciplinary Team approach. Talk with families to better understand resident’s needs.
Copy as necessary for supervisory review and Restraint Committee.
Funding provided by
7
HCFA Contract #500-96-P611
Event #: Indicate number. Keep numbers consecutive so events are easy to track.
When: Indicate date and time. Be specific. Use AM and PM indicators. Indicate if during shift
change.
Example: 7/4/97, 3:00 p.m., during evening shift change.
What/Where: Describe what happened to/with resident. Be specific as to where it occurred.
Example: Fell while leaving bathroom, at doorway. Resident found on floor, no
injury or cuts. Able to walk.
Who/Why: Indicate who else was present and what else was occurring at the time of event.
Document any possible causes that may have triggered the incident.
Example: No one else present. Attempting to leave bathroom. Floor was wet at
doorway. Resident's shoes smooth on bottom and slick when wet.
Initials: Indicate initials of person completing the what/where/who/why portion of form.
Intervention: What changes were made to help the resident or to keep the event from occurring
again.
Ask yourself and document when appropriate:
1. why intervention improves resident function
2. how intervention permits access to resident's own body
3. how intervention promotes highest level of resident functioning
Example: Non-skid tape added to floor at doorway. Resident's shoes evaluated for fit
and found acceptable. Might consider adding handle bar at doorway if
future incidences occur. Patient still able to safely toilet himself.
If intervention is for medical necessity, document what condition is present or treatment is
necessary.
Document any time frames when device is to be used or discontinued.
Assessment of Intervention: Clearly document whether intervention was successful. If
intervention was successful, state why. If intervention was not successful, state why it did not
work and what will be tried next. Go on to next block on the form if more space is needed.
Expect to try additional interventions until the least restrictive successful intervention is achieved.
Example: No falls in last 48 hours after non-skid tape placed on floor.
Review and Comment by Charge Nurse/Restraint Committee: Add initials and comments of
charge personnel. State agreement, what to consider, or future plans with patient.
Example: Reviewed and approved by J. Smith, RN 7/22/97
Funded through HCFA Contract #500-96-P611
8
POSSIBLE AREAS FOR EVALUATION:
CONSULT PRIMARY CARE PROVIDER, AS APPROPRIATE
Dosage - multiple dosages/multiple medications
uCheck drug substitution, interactions, side effects of psychotropics, diuretics, cardiovascular
uHave any new medications been added to regimen which may increase falls?
uTegretol level
uNeurological checks
uFrequent toileting assist if on diuretics
uDilantin level
uElectrolytes, BUN, creatinine
uLimit long-acting benzodiazapines
uDepakote level
uVoid before tranquilizers/sedatives
uAdminister pain meds before transfer & ROM
u
Medication
Unstable gait
FALLS
DO INTERDISCIPLINARY ASSESSMENT/SELECT BEST INTERVENTION
COMMON CAUSES
Cardiovascular insufficiency
Syncope - orthostatic, TIA,
arrhythmia, hypotension
Infection
Restorative nursing program
Evaluate clothing for size & length
uGait training, muscle strengthing for ADL training
uFracture, arthritis, TIAs, seizures, Parkinson’s, hypothyroidism, anemia
u
u
u
Auscultate sitting and walking
Teach to change position slowly
uUse elastic stockings
u
u
Upper respiratory infection
uUrinary tract infection
Fever - frequently afebrile, lung sounds, CBC, CXR, UA-C&S, O 2saturation
u
u
Dehydration
Constipation
u
Check blood sugar
Provide 1.5 to 2 qts. of water per day unless otherwise restricted
uCheck bowel sounds, abdominal distention, impaction
History of pain
Location
uIntensity
Quality
Onset, duration
uAbility to express pain
Family Environ- Psychomental social
Dementia/cognitive disorders
Denial of impairment/depression
Physical surroundings
Change in mental status
u
Medications - try pain medications
Transcutaneous nerve stimulation
uPhysical therapy
Massage
Heat
uCold
u
u
u
u
u
u
u
u
Sleep/wake patterns
uBedtime routines/rituals
uMedications
u
Sleep
EKG, 24 hr. Holter monitor, O 2saturation, CXR, electrolytes, BUN,
creatinine, orthostatic BP, heart rate, digitalis level
uCheck pacemaker
u
u
Hyperglycemia/Hypoglycemia
Pain
Evaluate hearing and vision
Physical therapy--weight bearing
uWalker, cane, merry walker
uShoe assessment
u
Diet effects
uPhysiologic
uIllness
u
Maintain regular schedule
uLimit caffeine, cigarettes, etc.
uAvoid hypnotics
uRoom - quiet, cool, no noise
u
Attitude/approach
uDistraction evaluation
uHearing/vision
Structured ADL schedules
uLocate near nurses’ station
u
u
u
u
Bedrails
uFurniture
u
Bathroom
uLighting
u
Noise
uFloor
u
TV-remote control
uStairs
u
Deep gentle exercise
uAvoid napping
uAvoid stimulating drugs
u
Verbal approaches
Geriatric Depression Scale
Accessible call light
u
9
Physiological
FACTORS
F A L L S
Involve family in care planning
uTeach about current condition and interventions
uTeach about predicted course of illness, as appropriate, behavior changes that result from cognitive loss
u
Adapted from Rehabilitation Nursing,
15 (1), 22-25, 1990, with permission from the Association of Rehabilitation Nurses.
Colorado Foundation for Medical Care - Funding provided by HCFA Contract #500-96-P611
9
Assessment Log/
Resident:
Document: Initial Assessment/Each Event/Actions & Results
ID #:
Room #:
Intervention
Assessment of Intervention
What did staff do? How does this improve resident
function? Permits resident access to his/her own body?
Least restrictive and highest level of functioning?
How did intervention work?
If not, why?
If yes, why?
Event #
When (Date/Time)
Initials
Event #
When (Date/Time)
Initials
When (Date/Time)
Event #
Initials
Assessment Log adapted in part from Strumpf, N., et al. (1992),
Reducing Restraints: Individualized Approaches to Behavior.
Huntingdon Valley, PA: The Whitman Group.”
THINK ALTERNATIVES
before restraints
This form may be duplicated
Need Ideas?
See Evaluation Trees and Help Guide
10
FACTORS
BEHAVIOR PROBLEMS
DO INTERDISCIPLINARY ASSESSMENT/SELECT BEST INTERVEN-
COMMON CAUSES
CONSULT PRIMARY CARE PROVIDER, AS APPROPRI-
Dosage - multiple dosages/multiple medications
uCheck drug substitution, interactions, side effects of psychotropics, diuretics, cardiovascular
uHave any new medications been added to regimen which may increase falls?
uFrequent toileting assist if on diuretics
uTegretol level
uNeurological checks
uLimit long-acting benzodiazapines
uDilantin level
uElectrolytes, BUN, creatinine
uAdminister pain meds before transfer & ROM
uDepakote level
uVoid before tranquilizers/sedatives
Medication
Physical
Cardiovascular insufficiency
Syncope - orthostatic, TIA,
arrhythmia, hypotension
Infection
Hyperglycemia/Hypoglycemia
Dehydration
Constipation
Pain
Auscultate sitting and walking
uTeach to change position slowly
uUse elastic stockings
u
Psychosocial
Sleep
Delusions
Hallucinations
Depression
EKG, 24 hr. Holter monitor, O saturation,
CXR, electrolytes, BUN,
2
creatinine, orthostatic BP, heart rate, digitalis level
uCheck pacemaker
u
Upper respiratory infection
uUrinary tract infection
uFever - frequently afebrile, lung sounds, CBC, CXR, UA-C&S,2O saturation
u
Check blood sugar
u
Provide 1.5 to 2 qts. of water per day unless otherwise restricted
uCheck bowel sounds, abdominal distention, impaction
u
History of pain
Location
uIntensity
Quality
Onset, duration
uAbility to express pain
u
u
u
u
Sleep/wake patterns
uBedtime routines/rituals
u
Environmental
BEHAVIOR PROBLEMS
u
Medications - try pain medications
uTranscutaneous nerve stimulation
uPhysical therapy
Maintain regular schedule
uLimit caffeine, cigarettes, etc.
uAvoid hypnotics
uRoom - quiet, cool, no noise
Contract with patient
Cognitive therapy
u
u
u
u
Massage
uHeat
uCold
u
u
Diet effects
uPhysiologic
u
Assess agressive behavior
Assess psychoactive medications
Change in mental status
u
u
Deep gentle exercise
uAvoid napping
uAvoid stimulating drugs
u
Behavior modification
u
Attitude/approach - calm, flexible, guiding (not controlling)
Verbal approaches - concrete, validate feeling, task segmentation, avoid excess disability
uNon-verbal approaches - attitude contagious, equal/lower position, therapeutic touch
uMusic therapy
uDistraction therapy
uRecreation
uExercise
uRemotivation
u
Dementia
Alzheimer’s Disease
u
Call light
uRocking chair
uNight-time activities
uAvoid sensory overload
uRoommate
uPersonalize room
uAssess interpersonal preferences
uStaff: street clothes, decrease turnover, resident chooses caregiver, permanent assignments, use non-nursing
as much as possible, consistent scheduling
u
Adapted from Rehabilitation Nursing,
15 (1), 22-25, 1990, with permission from the Association of Rehabilitation Nurses.
Colorado Foundation for Medical Care - Funding provided by HCFA Contract
#500-96-P611
11
W A N D E R I N G
FACTORS
Medication
COMMON CAUSES
Physical
Dementia
Psychosocial
Environmental
Adapted from Rehabilitation Nursing, 15 (1), 22-25, 1990,
with permission from the Association of Rehabilitation Nurses.
WANDERING
DO INTERDISCIPLINARY ASSESSMENT/
SELECT BEST INTERVENTION
If new behavior--do a physical workup - see Falls Evaluation Guide
Medications may increase restlessness/agitation
u
u
uExit seekers
uRestless
uDistraction
uWay to stimulate self
uWanders because someone else does
uNon-verbal approaches
uAssess for personal agenda and validate - agenda behaviors
Attitude/approaches - approach from side or front
Verbal approaches - gently redirect, use your body to show direction
u
u
uMusic
uRecreation
uExercise
uAsk family to record reassuring messages on tape
uProvide indoor/outdoor space for wandering
uLimit number of exits and people exiting
uMake doors and elevators look like something else
uPersonalize room with familiar objects and pictures
Distract by visual barriers - stop sign, ribbons, curtains, wall paper door,
cover door knobs, mirrors at exits, distraction alarms, secure unit
u
Funding provided by HCFA Contract #500-96-P611
12
Pharmacological
DO INTERDISCIPLINARY ASSESSMENT/
SELECT BEST INTERVENTION
COMMON
CAUSES
IV
Evaluate to eliminate risk, if possible
uCover with Kerlix
uAir splints on arms
uSoft sponges in hands
uFoam mitts
uBath blanket wrapped around arms to prevent bending arms
Gastrotomy
u
Catheter
u
Oversedation/
Undersedation
NECESSITY
Abdominal binder/band
Sweat pants
u
Foam mitts
Foam mitts uSupra-pubic abdominal binder
u
Evaluate for medical necessity rather than control
Adapted from Rehabilitation Nursing, 15 (1), 22-25, 1990,
with permission from the Association of Rehabilitation Nurses.
Funding provided by HCFA Contract #500-96-P611
13
NECESSITY
FACTORS
Physical
MEDICAL
MEDICAL
FALLS
FIRST COMPLETE BASIC ASSESSMENT TO RULE OUT MEDICAL ILLNESS BEFORE
PROCEEDING WITH THIS SECTION.
Medications
DOSAGE - MULTIPLE DOSAGES/MULTIPLE MEDICATIONS
•
Seniors usually require 1/2 - 2/3 of the normal dose especially there is a hepatic/renal
disease, low body weight, and malnutrition.
CHECK DRUG SUBSTITUTIONS, INTERACTION, SIDE EFFECTS - psychotropics, diuretics,
cardiovascular
•
•
•
•
•
•
Be aware that for institutionalized individuals the greater risk of falls is in the first six
weeks, however, the risk remains somewhat higher for the first six months.
Evaluate medications for drug toxicity
Some residents may be toxic at therapeutic levels, while other residents may be at
therapeutic levels when medication is below usual accepted range.
Psychotropics
- Recommend to physician avoidance of long-acting barbiturates and benzodiazepines
and limit other sedatives/tranquilizers if indicated, for example PRN.
- Have residents void before receiving tranquilizers/sedatives
- Do not hold back medication if physician feels it is indicated. Depression and psychosis
are as real as physically observed disabilities.
Diuretics
- Offer frequent toileting assistance if diuretics are used
- Minimize use of diuretics at bedtime
- May cause hypotension
- Will require electrolytes, BUN, and creatinine at least every 6 months to monitor renal
status
Cardiovascular
- Monitor residents for orthostatic dizziness
- Watch for signs of weakness or fatigue - taking anti-hypertensives?
- Many cardiac medications after Heart Rate.
- Teach resident to rise slowly from a sitting or lying position
HAVE ANY MEDICATIONS BEEN ADDED TO REGIMEN WHICH MAY INCREASE FALLS?
•
14
Benzodiazepine, psychotropics, anti-convulsants/mood stabilizers, cardiovascular meds
DIGITALIS LEVELS
•
Heart rate that is dramatically fast or slow decreases the efficiency of the heart resulting in
hypoxia to vital organs including the brain.
DILANTIN™ LEVEL
•
VPA(VALPROIC ACID)
TEGRETOL ™
May cause sedation and dizziness even at therapeutic levels. Disorientation may be
experienced as well as nausea. These medications require CBC and liver function tests
every 6 months.
SMA 6 (BLOOD CHEMISTRY PANEL)
•
Elevated BUN with creatinine may indicate renal failure or dehydration. Electrolytes (Na,
K, Cl) are important in muscle contractibility - includes the cardiac muscle
VOID BEFORE GIVING TRANQUILIZERS / SEDATIVES
FREQUENT TOILETING ASSIST IF ON DIURETICS
LIMIT LONG-ACTING BENZODIAZEPINES
•
When possible, Ativan ™ is a popular short-acting benzodiazepine.
ADMINISTER PAIN MEDICATIONS BEFORE ROM AND TRANSFER
•
Non-Steroidal Anti-Inflammatory drugs are useful, but these drugs continue to have a
higher incidence of gastrointestinal, hepatic and renal side effects. An acetaminophen may
be a better choice for osteoarthritis. Use adequate pain meds to include narcotics in
proper dose. Addiction is not an issue in this population. Be watchful for sedation and
CONSTIPATION.
Unstable Gait
RESTORATIVE NURSING PROGRAM
•
•
•
•
•
•
•
Gait training including small steps and broad base stance
Balance exercises, including standing on one foot, reaching and turning while sitting and
picking up objects
Talk with resident about limitations related to mobility
Teach difference in transfer with right vs. left sided stroke, difference in ambulation with a
resident with Parkinson's vs. resident who has had a stroke
Work with physical therapist to design good restorative nursing program
Devices which assist with reaching or placing items within reach
Extra pillows for positioning
EVALUATE CLOTHING SIZE AND LENGTH
• Clothing
- Proper fitting clothing
- No long robes
- Clothing which slips on instead of over the head or step in
- Hemmed trousers, with belts to prevent drooping
- Is clothing appropriate for weather?
15
•
Cognitively disabled (psychosis) frequently have an altered sense of body temperature
resulting in their wearing winter coats in 90° weather.
GAIT TRAINING, MUSCLE STRENGTHENING FOR ACTIVITIES OF DAILY LIVING TRAINING
FRACTURE
•
•
•
•
•
•
•
Residents with osteoporosis may fracture bones while turning over in bed. Suspect
fracture whenever there is a trauma or if there are any new complaints of sever pain in a
boney area, especially if they cannot bear weight.
Arthritis
- Usually of the Degenerative Joint Disease, Osteoarthritis type - Acetaminophen or mild
narcotic that is effective.
Transient Ischemic Attacks
- Results in neuro deficits that usually resolve in a few hours - days
Seizures
- Check level of seizure med and for infections. If this is a new onset, deserves physical
work up to include EEG and brain scan if appropriate
Parkinson's Disease
- Results in motor neural dysfunction. Extremities may become very rigid, gait; short and
shuffling. Sense of balance is effected. Disease or medication may cause dementia
and/or hallucinations.
Hypothyroidism
- Can dramatically slow body processes, to include motor and cognitive
Anemia
- If RBCs are low, O2 may not be adequately reaching cells. An O2 sat may read normal
even when hypoxia exits. A pulse Ox measures what percentage of RBCs are saturated
with O2. If there is an inadequate amount of RBCs, they can be 100% saturated but there
is still inadequate oxygen.
EVALUATE HEARING AND VISION
•
Assessment of hearing and vision - Residents with impaired hearing and/or vision may
appear to have mental status problems when this is not the case
- Hearing - Has hearing been checked recently? Does the resident need a hearing aid? If
the resident has a hearing aid, does it function properly? Does the resident have a
problem with excessive ear wax?
- Vision - Does the resident have history of cataracts? Have glasses been checked in the
past year? Are glasses in good repair? Are they cleaned daily?
PHYSICAL THERAPY - WEIGHT BEARING
•
16
Evaluation by P.T. and O.T.
- Exercised aimed at increasing muscle strength, coordination, or dexterity
- Get occupational therapy to evaluate for Activities of Daily Living training
•
Have P.T. evaluate how resident can move in least painful way to increase strength and
mobility
WALKER, CANE, MERRY WALKER ™
•
•
•
•
•
Are walker, wheelchair, etc. appropriate for problem
Non-skid tips on canes and walkers
Instruction in use of devices
Teach the resident how to use wheelchairs, crutches, walkers and canes safely, teach
frequently if the resident is forgetful.
Use reflective tape on cane and walker handles.
SHOE ASSESSMENT
• Educate resident and family about proper footwear
• Non-skid shoes for residents likely to slip
• Shoes with a smoother surface for residents with Parkinson's Disease due to shuffling gait
• Make certain shoes fit well
• Podiatry referral if special shoes required
• Shoes require an adequate back and toe box
CARDIOVASCULAR INSUFFICIENCY
Arrhythmia, Hypertension
-
Syncope,
Orthostatic,
TIA,
AUSCULTATE SITTING AND WALKING
•
A resident may have a normal sinus rhythm when sitting yet go into an arrhythmia with
movement resulting in hypoxia
TEACH TO CHANGE POSITION SLOWLY
USE OF ELASTIC STOCKINGS
•
Use when lack of patency of lower extremity circulatory system exists. Are their pedal
pulses, sensation intact?
EKG
•
Gives a cardiac reading at time of test
24 HOUR HALTER - MONITOR
•
Can show cardiac reaction to 24° of activity and stimulus
O2 SATURATION
•
Important to check with any change in mental or physical condition. Increased frequency
of respiration can cause a misleading reading as can anemia.
CXR (Chest X-Ray)
•
17
May be indicated in change of mental of physical condition. Pneumonia is very common in
LTC population. If CHF is noted on X-ray, it is probably advanced. There may be no
rales, rhonchi accompanying an infiltrate.
SMA6 (Blood Chemistry Panel)
•
Measures renal status and may indicate dehydration. Electrolytes (Na, K, Cl) are
necessary for muscle contractibility, including the heart muscle.
ORTHOSTATIC BP
•
•
May check by doing blood pressure and heart rate while lying, sitting and standing. This
must be done in this order and with a 1 minute wait period between each reading.
Gradually increase mobility after confinement to bed or chair to prevent falls due to
orthostatic hypotension
HEART RATE
•
CHECK PACEMAKER
•
Yearly evaluation
Infection
UPPER RESPIRATORY INFECTION
•
Seniors have fewer colds, sinusitis and otitis media than the young, yet they do occur.
Suggest that facility have at least one ophthalmoscope with staff trained to assess using
this tool.
FEVER - FREQUENTLY AFEBRILE
•
•
•
•
•
18
Least reliable of vital signs when assessing the elderly. They can be septic while afebrile.
Lung Sounds
- Many elderly have decreased breath sounds due to lung disease, smoking, etc. This
may be their baseline. It is wise to compare what you are hearing with what has been
heard in the past. A senior may have no rales - cough or wheezing and still have
pneumonia.
CBC
- These are important in assessing the immune system and in checking for anemia.
CXR ( Chest X-Ray)
- May show infiltrates, CHF and other pulmonary disease. Portable x-ray is not as reliable
as large x-ray, particularly when x-raying areas of greater density
UA - C&S (URINE ANALYSIS - CULTURE AND SENSITIVITY)
- FIRST TEST TO DO WHEN THERE IS A CHANGE OF MENTAL PHYSICAL
CONDITION OF UNKNOWN ETIOLOGY. ELDERLY MAY HAVE NO PHYSICAL
SYMPTOMS.
BACTERIA IN URINE WITHOUT WBCs ARE NOT USUALLY
SIGNIFICANT - RESULT OF CONTAMINATION.
•
O2 Saturation
- As previously, may be false positive if resident is hyperventilating or anemic. This is a
very useful tool in assessing cardiac/pulmonary status.
URINARY TRACT INFECTION
•
Most common cause of physical or mental change. Usually caused by urinary retention,
catheters, poor hygiene.
Hypoglycemia
CHECK BLOOD SUGAR
•
Hypoglycemia can cause deterioration in motor/neural/cognition - may become lethargic
and confused because brain is receiving inadequate glucose
Dehydration
NEEDS 1.5 TO 2 QUARTS OF WATER PER DAY unless otherwise restricted
•
Common problem in LTC. Thirst mechanisms may be impaired by disease. Resident
may have impaired motor abilities and be unable to reach water in his environment. High
use of diuretics, while necessary, contribute to dehydration, as does swallowing
dysfunction.
Constipation
CHECK BOWEL SOUNDS
•
Listen for at least 2 minutes in each quadrant before deciding there are no bowel sounds
ABDOMINAL DISTENTION - Coffee Ground Emesis
•
Distention may indicate an obstruction, renal, hepatic or biliary disease. Coffee ground
emesis indicates a GI bleed.
IMPACTION
•
If low, may be removed manually with care. Higher up impactions are only identified by xray and require laxatives and fluids.
CHANGE IN MENTAL STATUS
•
19
May be caused by meds or illness - UTI and pneumonia most common medical problem.
Pain
INITIAL PAIN ASSESSMENT
•
Pain is whatever the experiencing person says it is. The individual's perception of pain is a
unique experience that includes the variables of the patient's culture, gender, past pain
experience, meaning attached to pain, and physiologic alterations, including those due to
aging.
- Studies have found nurses and doctors do not ask patients "Are you in pain?" Even very
demented residents may respond to simple straight forward questions. This should be a
routine question in any assessment. Cognitively disabled may not be able to express pain
in accepted ways. Agitation, yelling may be the only clue.
- The fear of addiction remains common among patients, family members, physicians,
and nurses despite large studies indicating the risk is less than 1%. Concerns should be
sedation interfering with activities of daily living (most people develop tolerance) and
constipation.
•
•
Intractable pain
- Assess the patient's pain and believe his assessment of the pain. Pain is a subjective
experience rather than an objective experience.
- Give analgesics (pain medication) in doses high enough and frequent enough to control
the pain.
- Treat the pain before it returns. This involves maintaining constant blood levels of the
analgesic at all times and is achieved by giving the medication around the clock rather
than "PRN". (Cushing, 1992)
Demographics and General Information on Pain in Nursing Home Residents: (Fried,
1993)
- Pain is frequently associated with depression. Depression is most common in residents
who have physical disorders which cause pain. Chronic pain is sometimes relieved by
addition of low dose anti-depressants in conjunction with analgesic.
- Only 40 to 45% of residents who reported pain in studies have it noted on their charts.
- For resident who are severely demented, there is even less documenation of or
treatment for pain. Care providers are forced to rely on pain behaviors such as fidgeting,
facial grimacing and irritability. However, the accuracy of pain rating based on these
observations is unknown.
Behaviors Associated with Pain:
Type of Behavior
Examples
Facial expression
Grimacing, clenching teeth, tightly shutting lips, gazing/staring, wrinkling
forehead, tearing
Moaning, groaning, grunting, sighing, gasping, crying, screaming
Praying, counting, swearing or cursing, repeating nonsensical phrases
Thrashing, pounding, biting, rocking, rubbing
Massaging, immobilizing, guarding, bracing, eating/drinking, applying
pressure/heat/cold, assuming special position/posture, reading, watching
television, listening to music
Vocalization
Verbalization
Body action
Behaviors
From Puntillo, K., & Wilkie, D. (1991). Assessment of pain in the critically ill. In K. Puntillo (Ed.), Pain in the
critically ill: Assessment and management. Gaithersburg, MD: Aspen. Reprinted by permission.
20
Sleep
ASSESSMENT OF SLEEP
•
•
•
•
•
•
•
•
•
21
Nature of sleep problem including characteristics, clinical course, its duration, the
circumstances under which it developed, any precipitating or accentuating factors, any
previous treatment and results, and the impact of the sleep problem on resident's life.
Usual sleep-wake pattern for 24 hours - as we age, our sleep pattern changes. Seniors
typically do not sleep as long, wake sooner and more frequently, than when they were
younger. Assure them this may be normal.
Bedtime rituals/routines and environmental factors - noise, temperature
Diet and drug use (both prescription and over the counter) - including usual intake of
caffeine (coffee or cola) or alcohol. Excessive use of alcohol leads to difficulty in staying
asleep.
Withdrawal of relatively low doses of short or intermediate-acting
benzodiazepines produce rebound insomnia and abrupt withdrawal of long acting
benzodiazepine hypnotics may cause both insomnia and nightmares. Insomnia is
aggravated by stimulant drugs, steroids, energizing anti-depressants or beta-adrenergic
blockers. These drugs cause sleep problems if taken at bedtime.
Illness factors - Changes in health, including Alzheimer's disease, cardiovascular disease,
pulmonary disease, arthritis, pain, prostatic disease, endocrinopathies, and other illnesses.
Objective Data - Family and significant others may provide insight into usual patterns and
certain aspects of sleep. Resident may have a diagnosis of being a "night" person who
sleeps during the day.
Subjective - Many short sleepers who do not complain of insomnia actually sleep much
less than most insomniacs, but while short sleepers feel rested and alert on awakening in
the morning, most insomniacs feel tired and sluggish. The patient's complaint of
insomnia, rather than the actual amount of sleep, is the criterion for diagnosis. Health care
providers should not be biased by own sleep habits.
- Listen to verbal comments of not sleeping well, of not feeling rested, of being tired, of
being awakened earlier than usual, or of having interrupted sleep or being more irritable,
restless, lethargic, a greater sensitivity to pain, an increase in accidents and falls.
Changes in emotional life - stressors such as retirement, hospitalization or the death of a
loved one.
Chronic insomniacs generally show high levels of psychopathology and a tendency to
internalize emotional conflicts, which leads to psychophysiologic activation and a state of
hyperarousal. Acute insomnia is also common in many psychiatric conditions, including
depression, anxiety disorder, mania, acute schizophrenia and organic brain syndrome or
other psychiatric illness. The insomniac patient may use his symptoms for considerable
secondary gain. It is not unusual for insomniacs to avoid family and social interactions by
insisting they are too tired or by protesting that a certain activity will adversely affect their
sleep. May be used to avoid sexual relations.
•
•
•
Treatment depends on type of sleep difficulty and its etiology. If the difficulty is in falling
asleep, the focus should be on pre-sleep routine and his mental activity while attempting to
fall asleep. If the complain is difficulty staying asleep, the possibility of medical problems
or unsatisfactory environmental conditions should be investigated. Early final awakenings
are often symptomatic of endogenous depression and warrant inquiry about other
depressive symptoms.
Assessment of pain - If pain predominates, analgesic agents should be used to their
maximum therapeutic benefit.
Fear of death: Patients who are seriously ill have a greater fear of death at bedtime, and
frequently have severe difficulty getting to sleep. Patients with asthma, COPD or CHF
often experience disrupted sleep because they fear the recurrence of symptoms during
sleep.
TREATMENT OF COMMON DISORDERS:
•
Adjustment Sleep Disorder:
- It arises in fair to good sleepers who are coping with recent stressors such as retirement,
hospitalization, or death of a loved one. Usually will resolve with time as person adapts to
stress-related event.
- Problems with onset or maintenance of sleep result in daytime irritability, anxiety,
lethargy, slowed cognition, and tearfulness.
Often, worry and concern about
sleeplessness create a level of arousal that is incompatible with sleep.
- Treatment is more often needed in individuals with few sources of emotional support.
Behavioral treatment is preferred. Treatment seeks to restore normal sleep. Relaxation
tapes, proper sleep hygiene, self-help books such as No More Sleepless Nights.
- Hypnotics are indicated if the patient is overwhelmed by the situation. However, they
should only be administered for a few days or weeks.
- Psychophysiologic Insomnia:
Usually develops after an adjustment disorder has
developed and is combined with poor sleep hygiene.
Older adults with
psychophysiologically insomnia associate their bed and bedtime rituals with frustration and
increased mental and physical arousal. The sleep disturbance continues as a result of
conditioned, learned arousal, even after normal coping and sleep habits are reestablished. Two behavioral therapies are effective:
a. Stimulus Control Therapy: Used when sleep onset is the problem. If the patient
does not go to sleep in 10 minutes or less, he is instructed to get up and then return to
bed only when feeling sleepy again, repeating this pattern until sleep onset occurs
quickly. This establishes a new habit of good sleep.
b. Sleep Restriction Therapy: Recommended when sleep maintenance is presenting
problem. Average number of hours of sleep is determined. Then the patient is
allowed to spend only this amount of time in bed. As sleep improves, the patient is
allowed to retire 15 minutes earlier. This method consolidated the amount of sleep,
leading to deeper sleep, faster onset, and fewer awakenings.
22
•
Inadequate Sleep Hygiene: Irregular or poor sleep habits and sleep-incompatible
behaviors constitute inadequate sleep hygiene.
- Maintain a regular sleep schedule with a regular arising time. Irregular habits around the
time they go to bed and rise can lead to sleep problems. Patients with poor sleep hygiene
often spend excessive time in bed trying to sleep or follow highly irregular schedules for
going to sleep and arising. Such practices deprive them of strong behavioral cues for
deep, refreshing sleep.
- Factors that heighten arousal include caffeine, cigarettes, alcohol withdrawal, working
until bedtime, and clock watching may forestall sleep. They are preoccupied with their
inability to sleep.
- Hypnotics are best avoided because patients have increased risk of tolerance and
continued sleep disruption from sleep-disruptive behaviors.
- Make certain bedroom is quiet, comfortable, cool and secure. Decrease noise, the
appropriate strategy would be to reduce the frequency of interruptions to sleep. Avoid
caffeine after 12 o'clock noon.
- Avoid napping during the day.
- Get regular and gentle exercise around midday. Patients with insomnia often report low
or inconsistent levels of physical activity during the day. Increase exercise, however, limit
physical exercise or stimulating mental activity close to bedtime. This may also contribute
to difficulty falling asleep.
- Bed partner can often give useful information in assessing difficulties related to
disordered schedules and routines. Especially myoclonus nocturnus (jerking movement of
legs) and “restless legs syndrome”.
- Abstain from stimulating drugs (caffeine or decongestants) in the evening. Many over
the counter sleep remedies contain anti-histamines which will actually worsen the sleep
condition over time.
- Avoid heavy meals or hunger at bedtime.
- Get out of bed if awake. Limit time in bed to intimacy or sleep. Do not watch TV and
read in bed. Restrict total time I bed to 6.5 to 7.5 hours. per day.
- Avoid worry or frustration in bed. Schedule time to wind down and relax before going to
bed.
- Habitual pre-sleep activity that is comforting to the individual and enhances sleep. Presleep activity for men tended to include food, drink, television, and walking. Pre-sleep
activity for women tends to include hygienic activities, prayer, reading, and listening to
music and watching TV. Sleep was more satisfying for those who followed a routine.
23
•
Mood Disorders:
- Alteration in sleep is the hallmark symptom of such psychiatric disorders as major
depression, mania, dysthymic disorder, and cyclothymic disorder. Major depression, in
particular, may disrupt an elderly person’s ability to fall asleep, stay asleep, or both.
Manics may not sleep for days at a time.
- Often difficult, but important, to determine which came first insomnia or depression.
- Treatment is warranted when depression is suspected.
- Before antidepressants are prescribed, all depressed elderly should be screened for
other causes of insomnia, particularly restless leg syndrome and myoclonus because
antidepressants may worsen these syndromes, further disrupting the patients’ sleep and
mood.
- Medical Illness and Treatment: One study found that 12 of 26 standing orders in a
hospital included doses of hypnotic that are twice the recommended dosage for the elderly
and often provide inappropriate repeat doses.
- Physician’s efforts to medicate underlying disease processes may result in sleep
disruption. The most significant offenders are steroids, thyroxine, theophylline, and many
centrally active antihypertensives.
- Insomnia secondary to symptoms of medical illness is best managed by treating the
underlying medical disorder. If pain predominates, narcotics and NSAIDS for bone pain or
inflammatory conditions should be administered to their maximum therapeutic benefit.
•
Dementia/Delirium:
- Sleep disturbances in patients with dementing illness range from increased awakenings
and nocturnal wanderings to agitation and confusion. “Sundowning” frequently leads to
placement in an institution.
- The changes in sleep in patients with dementia arise from degeneration of cortical and
brain stem structures, resulting in poor accommodation to the transitions from sleep to
wake and lighter, more broken sleep.
- Treatment: Management of underlying metabolic, neurologic, or infectious processes.
Behavioral management includes proper sleep hygiene, particularly exposure to morning
light. Safety at night includes a night light and putting the mattress on the floor and
removing glass objects.
- When dementia is accompanied by agitation, low-dose antipsychotic medications may
work. However, antipsychotics carry the risk of bradykinesia, rigidity, and tardive
dyskinesias. Short acting Benzodiazepine or antidepressants such as trazodone should
be tried and tilracted to optimal dose; if not affective, then a trial of low dose antipsychotics may be tried.
24
•
Sundowning
- Occurs in patients with organic brain dysfunction. The classic symptoms are daytime
drowsiness combined with nighttime confusion, agitation, and anxiety. At night residents
tend to wander, exhibit speech and behavior that are not of character. Patients have a
strong need to maintain contact with a familiar environment. They feel that their fading
cognitive abilities are enhanced during the daytime. At night, however, they feel less safe
and confident, and staying awake makes them feel more secure.
Underlying
environmental or organic factors that could cause sundown syndrome should first be ruled
out. Such causes are easily treated. Simple environmental orientation procedures may
help - keeping a light on in the bathroom. Medications include Haldol or Trazodone to
reduce agitation, anxiety, and wandering and allow them to sleep. Hypnotics are
contraindicated because they may cause patients to become more disoriented and
confused. Paradoxically, these medications will excite already disinhibited patients. The
patient’s drug regimen should be evaluated for its potential to produce some or all of the
symptoms of sundown syndrome. Medications that have an anticholinergic component,
such as antidepressants, antihistamines, antiparkinsonism drugs, and antispasmodics, are
particularly likely to have this effect. Non-essential drugs should be reduced or stopped.
•
Prescribing Guidelines for Hypnotic:
- Should be the intervention of last resort, use the lowest effective dose. Use half of the
adult dose in patients over age 65.
- Monitor for side effects. Check interaction of hypnotic with alcohol or drugs, and other
interactions with lung or heart disease, Central Nervous System disease. Check for
interaction with other medications such as Tagamet ™, phenobarbital and Dilantin ™.
- Dispense a limited number of doses (#20) and follow for cognitive or behavioral changes.
- If the medication is needed for more than two weeks, consider a maximum of three
doses per week to lessen the chance of tolerance.
- Selection of an appropriate hypnotic depends on the target symptoms, whether related to
sleep onset, sleep maintenance, daytime anxiety, or possible depression.
- Consider adverse effects on the patient with lung or heart disease, Central Nervous
System disease, or a history of alcohol abuse.
25
Denial of Impairment/Depression:
•
•
•
•
Demented patients may deny or no longer realize that they cannot walk independently.
They may refuse or forget to use their ambulatory device (wheelchair, walker), resulting in
falls.
In early to moderate dementia, residents may avoid answering questions or change the
subject to disguise the fact that they cannot retrieve the information requested. “How old
are you Mrs. Greene?” -- “As old as the hills,” followed by smiles and laughter.
It is very depressing to realize that you are losing your cognitive skills, your independence,
your privacy, indeed your life.
In view of he effective therapies available for depression, it is especially crucial to make
the diagnosis and proceed with treatment.
Drugs that can cause symptoms of depression
Antihypertensives
Reserpine
Methyldopa
Propranolol
Clonidine
Hydralazine
Guanethidine
Analgesics
Narcotic
Morphine
Codeine
Meperidine
Pentazocine
Propoxyphene
Nonnarcotic
Indomethacin
Antiparkinsonism drugs
Levodopa
Antimicrobials
Sulfonamides
Isoniazid
Predisposition
26
Cardiovascular preparations
Digitalis
Diuretics
Lidocaine
Hypoglycemic agents
Psychotropic agents
Sedatives
Barbiturates
Benzodiazepines
Meprobamate
Antipsychotics
Chlorpromazine
Haloperidol
Thiothixene
Hypnotics
Chloral hydrate
Flurazepam
Steroids
Corticosteroids
Estrogens
Others
Cimetidine
Cancer chemotherapeutic agents
Alcohol
1.
2.
3.
4.
Biological
- family history of depression
- prior episodes of depression
- aging changes in neurotransmission
Physical
- Many diseases can directly cause major depression or elicit a depressive reaction.
This is particularly true of conditions that cause fear, produce chronic pain, disability or
dependence, e.g., Dementia’s, Parkinson’s, suspected or possible MI, suspected or
possible CVA - (right hemisphere infarcts more than left hemisphere) CHF,
neoplasms, thyroid, adrenal cancers, diabetes, anemia, hypoxia and dehydration.
- Drugs used to treat medical conditions can cause symptoms of depression
- Some disease can result in a physical appearance of depression when depression
does not exist, e.g., Parkinson.
Psychological
- unresolved conflicts and guilt; symptomology more common in younger populations.
Social
- loss of family, friends, independence, health, dignity, control and on and on; isolation,
environmental factors that promote isolation, sensory deprivation and forced
dependency.
Recognition/Diagnosis
1.
Classic neuro-vegetative signs - this is a general statement; the elderly have increased
physical complaints and a decreased incidence of guilt or self worth issues. An explanation of
this may be that the elderly are more comfortable with physical complaints than they are with
psychological issues. Geriatric patients may expect a moralistic judgment regarding psych
complaints and may not be familiar with the existence of treatment modalities.
- Helpful mnemonic is Sig: E Caps
- Sleep - c/o of insomnia with frequent early a.m. awakenings
Hypersomnia
- Interest - loss of interest in social connections
isolation in room
apathy
- Guilt -feelings of self reproach - less common in elderly
- Energy - no energy; fatigued - this ma be due to chronic illness
- Concentration - inability to concentrate or slowed, mixed up thought
- Appetite - poor appetite, weight loss; sometimes present with overeating
- Psychomotor - usually slowed, but agitation is very common and may be the only clear
cut symptom in the elderly demented patient
- Somatic complaints rather than psychological symptoms often predominate the clinical
picture. Chronic pain is an important clue.
2.
Major depression vs. depressive symptoms.
- Depressive symptoms which is a gray area may also deserve chemical therapy.
Differential Diagnosis
1.
Rule out physical illness or treat existing illness.
2.
Dementia vs. depression
- frequently coexist. Depression is the main treatable cause of dementia in the elderly.
Diagnostic criteria for major depressive episode
27
A.
At least five of the following symptoms have been present during the same two-week period
and represent a change from previous functioning; at least one of the symptoms is either (1)
depressed mood or (2) loss of interest or pleasure. (Do not include symptoms that are clearly
due to a physical condition, mood-incongruent delusions or hallucinations, incoherence, or
marked loosening of associations)
1.
Depressed mood most of the day, nearly every day, as indicated either by subjective account
or observation by others
2.
Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly
every day (as indicated either by subjective account or observation by others of apathy most
of the time)
3.
Significant weight loss or weight gain when not dieting (e.g., >5% of body weight in a month),
or decrease or increase in appetite nearly every day
4.
Insomnia or hypersomnia nearly every day
5.
Psychomotor agitation or retardation nearly every day (observable by others, not merely
subjective feelings of restlessness or being slowed down)
6.
Fatigue or loss of energy nearly every day
7.
Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly
every day (not merely self-reproach or guilt about being sick)
8.
Diminished ability to think or concentrate, or indecisiveness, nearly every day (either by
subjective account or as observed by others)
9.
Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a
specific plan, or a suicide attempt or a specific plan for committing suicide
B.1.
2.
Cannot be established that an organic factor initiated and maintained the disturbance.
1
Disturbance not a normal reaction to the death of a loved one (uncomplicated bereavement)
C.
At no time during the disturbance have there been delusions or hallucinations for as long as
two weeks in the absence of prominent mood symptoms (i.e., before the mood symptoms
developed or after they have remitted).
D.
Not superimposed on schizophrenia, schizophreniform disorder, delusional disorder, or
psychotic disorder.
1
28
Morbid preoccupation with worthlessness, suicidal ideation, marked functional impairment of psychomotor
retardation, or prolonged duration suggest bereavement complicated by major depression.
Source: After American Psychiatric Association, 1987.
Table 5-15 Characteristics of selected antidepressant drugs
Drug
Level of
sedation
Anticholinergic
Usual young-adult
activity
dosage, mg/day
Tricyclic teriary amines
Recommended geriatric
a
dosages, mg/day
Elimination
b
half-life
Very high
High
Very high
High
25-150
25-150
Intermediate
Intermediate
Middle
Middle
25-150
Long
None
None
Low
Middle
25-150
5-30
Long
Very long
Low
Middle
10-35
Long
Amoxapine (Asendin)
Maprotiline (Ludiomil)
Middle
Middle
Middle
Middle
100-300
100-300
Other drugs
25-150
25-150
Intermediate
Very long
Trazodone (Desyrel)
Fluoxetine (Prozac)
Sertraline (Zoloft)
Middle
Very low
Very low
Very low
Very low
Very low
150-400
20-80
50-200
50-200
10-40
25-100
Short
Very long
Very long
Amitriptyline (Elavil, Endep,
Amitril, etc.)
Doxepine (Sinequan, Adapin)
Irnipramine (Tofranil, SKPramine)
Desipramine (Norpramin,
Pertofrane)
Prolriplytyline (Vivactil)
Nortripyline (Aventyl,
Parnelor)
100-300
100-300
100-300
Tricyclic secondary amines
100-300
20-70
25-100
Other amines
29
Note: Other antidepressant drugs are disclosed in the text.
a
Some elderly patients may require higher dosages than those recommended (see text).
b
May be longer and more variable in the elderly; Short = <8 hrs.; Intermediate = 8-20 hrs; Long = 20-30 hrs; Very long >30 hrs.
Source: Based on Richelson, 1984.
Depression is a common, debilitating, and sometimes life threatening illness in the elderly. Dementia
does not include as its normal course frequent tearfulness, agitation, fear or hallucination. Dementia
is a cognitive disorder best managed by behavioral interventions. Dementia with complications such
as depression and paranoid ideation cannot be treated with behavioral management alone but
requires appropriate medical management as in other physical disorders such as diabetes and
hypertension.
Right diagnosis
Right drug
Right amount
Dementia/Cognitive Disorders
ATTITUDE / APPROACH
•
•
General attitude and approach
- calm
- flexible
- non-resistive
- guiding
Non-verbal approaches
- Know that your attitude/mood is contagious and felt by all, - practice smiling, looking
open and friendly and listening
- Assume an equal or lower position especially if the resident feels powerless
- Move slowly
- Avoid overwhelming the resident physically or verbally - approaching an anxious resident
with three or more people may lead to a catastrophic reaction
- Use lots of touch and allow time for the resident to touch you. Ask permission to touch.
- Identify symbolic behaviors and their meaning - Assess cultural and ethnic background
and incorporate this information into care plan.
VERBAL APPROACHES
•
•
•
30
Use concrete, exact, positive phrases and repetition of the same phrase to trigger an
automatic response - anchor response to words, gestures, or colors, and ask resident to
repeat command.
Use one step commands which are simple
Need to assess whether to offer the resident a choice. Give a suggestion or a command if
unable to offer a choice. When possible, offer choices of where to eat, when to do
grooming, bathing, etc. If the resident feels a lack of control he or she may become
aggressive. At times, too many choices may be confusing so limit choices. For example,
"Would you like cereal or toast?"
•
Use calm, soft, slow voice pattern. Say one question at a time and wait for a response.
•
Avoid arguing or reasoning
•
Eliminate distractions
•
Keep your promises, so make promises that you will be able to follow through with
•
•
•
Identify resident's vocabulary and use it.
Give directions within attention span - if resident is too confused or combative always
come back later
•
Verbal and non-verbal messages should match
•
Stand in front of person and make eye contact
•
•
•
•
•
•
31
When the resident is present, include in conversation. Treat resident as an elder, not as a
child. Validate resident's feelings. Use the resident's name frequently.
Assess whether the resident responds better to verbal or non-verbal messages. For
example, a resident who might become combative when told verbally to use the walker
may accept assistance if shown non-verbally how to use walker.
Verbal excess disability - the resident is already impaired but how staff communicate with
the resident may increase his/her disability - For example, the staff say "don't go outside,"
which may be confusing to a demented resident. It is far more effective and skillful to tell
the resident exactly what you want them to do in slow, concise, and concrete sentences like "Stay in the building." or "Walk with me." A nurse aide told a resident to "Hop in bed."
and the resident tried to do it and said "I can't." The reason why confused residents pull
the fire alarm is because "Pull" is clear and concise while "In case of an emergency" does
not register.
Residents with short term memory problems may confuse current requests with requests
and occasions from their past. For example, mother never let me do that or I have told
you children not to mess with that door, etc. With some residents, you can observe a
transfer in personality traits. They will speak as if they were their parents, children, or
teachers. You may improve communication wit them if you find out who you are talking to
and what the agenda is for that person.
Make sure to speak in primary language. Seek help of translator if primary language is
other than English or language in which you are not proficient. If a relative is the
translator, schedule care planning around when relative may be present to explain care
and procedures.
Do not use words such as on, below, beside, between. These words are difficult for
dementia patients to understand.
If the person is having difficulty finding the right work, supply the word for him. This helps
limit his or her frustration.
•
•
•
When you do not know what the individual means, ask him or her to point to it, describe it,
or to show you how it works.
Use other signals besides words to convey what you mean - point, touch or demonstrate.
Talk to the impaired individual and make a point of telling him or her what you are doing
and why.
REALITY ORIENTATION
•
Of limited usefulness but assess to see if appropriate because of memory problems, it is
not appropriate with all cognitively impaired individuals. It is helpful to orient residents to
who you are, what task you will be helping them with, and what the next task will be. For
example, "Helen, I'm your nurse and I'm here to help you get dressed." - The alternative
reality of some confused individuals may serve as a coping mechanism and improve their
quality of life. Therefore, in the severely demented, reality orientation may only increase
their anxiety, exaggerate separation from what they love and trust, and increase their
emotional pain by making them wrong in comparison to their perceived reality.
STRUCTURAL ADL SCHEDULES TASK SEGMENTATION
•
•
•
Mid-morning naps if fatigued
Stick to toileting schedules
Structured ADL schedules - Identify routines for rising, toileting to provide supervision
adapted to individual needs.
DISTRACTION THERAPY
•
Distraction therapy
- Use of mobiles
- Use of family videos
- Picture collages, scrapbooks
HEARING/ VISION EVALUATION
Environmental
CHECK BEDS
•
•
•
•
•
No siderails or only partial siderails unless indicated
Low beds for easy access
Padding or mattress on the floor beside the bed - Inflatable air mattress works well and
can be easily cleared and stored.
- Put beds in the low position.
Non-rolling/working brakes or stabilizers
Remove wheels from overbed tables
FURNITURE
•
•
32
Is furniture arranged poorly so resident may fall?
Cover edges of furniture with foam to prevent bruising.
•
Provide drawers with interesting, safe objects in them so the resident can go through
these drawers as a substitute for going through drawers which belong to other residents or
staff and which may contain items which are unsafe.
CHECK BATHROOMS
•
•
•
•
•
•
Are handrails and grab bars available, the appropriate height and secure in bathrooms?
Raised toilet seats
Bedside commode -place on rubber backed rug to prevent slipping
Rubber backed area rugs in front of sinks and toilets
If the resident is weak on one side, is the grab bar on his strong side?
Is the toilet a high contrast color so it is easily visible, e.g.; toilet is white and floor is a
darker color?
CHECK LIGHTING
•
•
•
•
•
Night lights available in all resident rooms and hallways.
Is facility lighting appropriate for activities likely to be performed in area?
Is lighting good on stairs and landings?
- Use adequate non-glare lighting for daytime
Do you have floor level lighting to reduce glare?
Are light switches accessible/reachable from bed?
DO AN ENVIRONMENTAL ASSESSMENT FACILITY-WIDE
CHECK FLOORS
•
•
•
•
•
•
•
•
Are there areas where patterned carpeting may cause a resident to fall?
Non-skid wax surfaces
Rugs/mats with edges that do not curl
Spills mopped up immediately
Clutter-free and no extension cords
No thresholds in doorways
Pets out of resident area at night
Non-reflective floors and surfaces - Do floors shine and glare is painful and impairs vision?
CHECK STAIRS
•
•
•
•
•
Handrails with extra support at top and bottom of stairs on both sides
Painted or marked top and bottom stair
Risers painted in highly visible colors and not too high
No skid treads
Stairs well maintained
ACCESSIBLE CALL LIGHTS
•
•
33
Call light attached to the resident’s clothing. When resident moves, the call light goes off.
Use cord of bright color so easily visible. Use reflective tape.
•
•
•
Respond to call lights promptly
Locate within resident’s reach
Orient resident regularly to use of the call light
CHECK CHAIRS
•
•
•
•
•
•
•
•
•
Wedge cushion for chair
Bean bag seating to prevent sliding and to prevent resident from rising
Saddle cushion
Contour cushion
Residents should be sitting in comfortable lounge chairs or winged chairs, not in
wheelchairs all day
Sturdy rocking chairs for anxious residents
Recliner chairs
Chairs of the appropriate height and size (P.T./O.T. consult)
Wheelchairs in good repair
DECREASE NOISE
•
•
•
Noise can add to confusion for the confused resident as well as with hearing impaired
residents.
Use public address system as little as possible and have times of day with no P.A. system
Use chimes instead of alarm for fire system.
VISUAL BARRIERS
•
Stop signs, yellow ribbons, curtains, distract wanderers by wall papering over exits, cover
door knobs, bookcase to cover doorway, fabric over door handles, mirrors at exits to
distract resident from leaving (Check with Fire Marshall).
USE ALARM SYSTEMS AND DOOR ALARMS, WANDERGUARD ™ BANDS
SECURED AREA OUTSIDE - INCLUDE THE OVER 90 NON-TOXIC PLANTS
USE OF CUEING FOR RECOGNITION OF ROOM, APPETITE, AND TOILETING
•
Use symbols, signs, photos to direct resident to room. For example, one facility set up a
contiguous loop for exercise with cueing such as showcases outside each residents’ room
which contains articles that are familiar to the resident so s/he knows his own room. For
appetite cueing the course took residents by the kitchen so they would smell food cooking
and had a refrigerator accessible to residents so they could get food when they wanted it,
served meals family style with staff and residents eating together. Bathroom doors were
left open on the walking course to cue residents to use the bathroom.
BARRIERS WHERE WANDERING RESIDENTS SHOULD NOT GO
•
Try to blend things into wall when you do not want the resident to focus on them; e.g.;
exits. Door Guards: Vinyl Door Barrier for Wanderers.
THE PROS AND CONS OF SPECIALIZED UNIT
•
34
Is a secured area available for people who may wander from the facility?
DEVICES WHICH ASSIST WITH REACHING OR PLACING ITEMS WITHIN REACH
USE A PRESSURE CHANGE ALARM BED CHECK SYSTEM OR POSITION CHANGE ALARM
•
Assess the use of an Ambularm ™
CLUTTER-FREE ENVIRONMENT
OUTDOOR ACCESS
•
•
•
Level and even walkways
Curbs and steps clearly marked
Rest areas /benches strategically placed in the shade
HALLWAYS
•
•
•
Chair/benches placed so residents can rest along the way in the long hallway
Handrails available and firmly secured to the wall
Avoid dead ends in walking areas or at least provide enough space so the resident can get
turned around. Persons with Alzheimer’s Disease. have difficulty turning due to brain
changes and tend to go in a straight line, so provide a safe walking track for them to walk
which is a safe, circular course.
INITIALLY ORIENT THE RESIDENT TO THE ROOM, FURNITURE, BATHROOM, AND REPEAT
FREQUENTLY IF RESIDENT HAS MEMORY PROBLEMS.
LOCATE THE RESIDENTS AT HIGH RISK FOR FALLING NEAR THE NURSES’ STATION.
ENLIST THE HELP OF ORIENTED RESIDENTS TO LET YOU KNOW WHEN A CONFUSED
RESIDENT WANDERS INTO THEIR ROOM AND ENCOURAGE EMPATHY WHERE POSSIBLE
FROM OTHER RESIDENTS.
Family
FAMILY FREQUENTLY DOES NOT UNDERSTAND LOVED ONES HEALTH PROBLEMS OR THE
CHANGE IN PERSONALITY.
•
35
Nursing can be most helpful in educating family about the diseases and how family can
play a positive role in their senior’s life. Family also needs to know that LTC facilities
operate under different regulations than hospitals. It is helpful if social services can
explain the Medicare/Medicaid Insurance maze to them. Families, like their loved ones,
need to keep a sense of control. Allow them choices, decision making opportunities. This
is a very chaotic, upsetting time for most families. There are times when dysfunctional
families can intentionally or unintentionally harm the resident. In these cases, after
appropriate intervention by nursing, social services and the primary care provider, Adult
Protective Services may be involved. The safety and well being of the patient is the
primary responsibility of the health care team, especially if the patient is unable to protect
himself/herself.
BEHAVIOR PROBLEMS
Medications
•
cardiovascular
•
•
•
•
•
•
Psychotropics
Diuretics
status
Cardiovascular
•
DIGITALIS LEVELS
•
36
DILANTIN ™ LEVEL
•
VPA(VALPROIC ACID)
TEGRETOL ™
every 6 months.
•
•
•
CONSTIPATION.
CARDIOVASCULAR INSUFFICIENCY
Arrhythmia, Hypertension
-
Syncope,
Orthostatic,
TIA,
AUSCULTATE SITTING AND WALKING
•
A resident may have a normal sinus rhythm when sitting yet go into an arrhythmia with
movement resulting in hypoxia
TEACH TO CHANGE POSITION SLOWLY
USE OF ELASTIC STOCKINGS
•
Use when lack of potency of lower extremity circulatory system exists. Are their pedal
pulse, sensory intact?
EKG
•
Gives a cardiac reading at time of test
24 HOUR HALTER - MONITOR
•
Can show cardiac reaction to 24° of activity and stimulus
O2 SATURATION
•
37
Important to check with any change in mental or physical condition. Increased frequency
of respiration can cause a misleading reading as can anemia.
CXR (Chest X-Ray)
•
May be indicated in change of mental of physical condition. Pneumonia is very common in
LTC population. If CHF is noted on X-ray, it is probably advanced. There may be no
rales, rhonchi accompanying an infiltrate.
SMA6 (Blood Chemistry Panel)
•
Measures renal status and may indicate dehydration. Electrolytes (Na, K, Cl) are
necessary for muscle contractibility, including the heart muscle.
ORTHOSTATIC BP
•
•
May check by doing blood pressure and heart rate while lying, sitting and standing. This
must be done in this order and with a 1 minute wait period between each reading.
Gradually increase mobility after confinement to bed or chair to prevent falls due to
orthostatic hypertension
HEART RATE
•
CHECK PACEMAKER
•
Yearly evaluation
Infection
UPPER RESPIRATORY INFECTION
•
Seniors have fewer colds, sinusitis and otitis media than the young, yet they do occur.
Suggest that facility have at least one ophthalmoscope with staff trained to assess using
this tool.
FEVER - FREQUENTLY AFEBRILE
•
•
•
•
38
Least reliable of vital signs when assessing the elderly. They can be septic while afebrile.
Lung Sounds
- Many elderly have decreased breath sounds due to lung disease, smoking, etc. This
may be their baseline. It is wise to compare what you are hearing with what has been
heard in the past. A senior may have no rales - cough or wheezing and still have
pneumonia.
CBC
- These are important in assessing the immune system and in checking for anemia.
CXR ( Chest X-Ray)
- May show infiltrates, CHF and other pulmonary disease. Portable x-ray is not as reliable
as large x-ray, particularly when x-raying areas of greater density
•
•
UA - C&S (URINE ANALYSIS - CULTURE AND SENSITIVITY)
- FIRST TEST TO DO WHEN THERE IS A CHANGE OF MENTAL PHYSICAL
CONDITION OF UNKNOWN ETIOLOGY. ELDERLY MAY HAVE NO PHYSICAL
SYMPTOMS.
BACTERIA IN URINE WITHOUT WBCs ARE NOT USUALLY
SIGNIFICANT - RESULT OF CONTAMINATION.
O2 Saturation
- As previously, may be false positive if resident is hyperventilating or anemic. This is a
very useful tool in assessing cardiac/pulmonary status.
URINARY TRACT INFECTION
•
Most common cause of physical or mental change. Usually caused by urinary retention,
catheters, poor hygiene.
Hyperglycemia / Hypoglycemia
CHECK BLOOD SUGAR
•
Hypoglycemia can cause deterioration in motor/neural/cognition - may become lethargic
and confused because brain is receiving inadequate glucose
Dehydration
NEEDS 1.5 TO 2 QUARTS OF WATER PER DAY unless otherwise restricted
•
Common problem in LTC. Thirst mechanisms may be impaired by disease. Resident
may have impaired motor abilities and be unable to reach water in his environment. High
use of diuretics, while necessary, contribute to dehydration, as does swallowing
dysfunction
Constipation
CHECK BOWEL SOUNDS
•
Listen for at least 2 minutes in each quadrant before deciding there are no bowel sounds.
CHANGE IN MENTAL STATUS
•
May be caused by meds or illness - UTI and pneumonia most common medical problem.
ABDOMINAL DISTENTION - Coffee Ground Emesis
•
Distention may indicate an obstruction, renal, hepatic or biliary disease. Coffee ground
emesis indicates a GI bleed.
IMPACTION
•
39
If low, may be removed manually with care. Higher up impactions are only identified by xray, scan and require laxatives and fluids.
Pain
INITIAL PAIN ASSESSMENT
•
Pain is whatever the experiencing person says it is. The individual's perception of pain is a
unique experience that includes the variables of the patient's culture, gender, past pain
experience, meaning attached to pain, and physiologic alterations, including those due to
aging.
- Studies have found nurses and doctors do not ask patients "Are you in pain?" Even very
demented residents may respond to simple straight forward questions. This should be a
routine question in any assessment. Cognitively disabled may not be able to express pain
in accepted ways. Agitation, yelling may be the only clue.
- The fear of addiction remains common among patients, family members, physicians,
and nurses despite large studies indicating the risk is less than 1%. Concerns should be
sedation interfering with activities of daily living (most people develop tolerance) and
constipation.
•
•
Intractable pain
- Assess the patient's pain and believe his assessment of the pain. Pain is a subjective
experience rather than an objective experience.
- Give analgesics (pain medication) in doses high enough and frequent enough to control
the pain.
- Treat the pain before it returns. This involves maintaining constant blood levels of the
analgesic at all times and is achieved by giving the medication around the clock rather
than "PRN". (Cushing, 1992)
Demographics and General Information on Pain in Nursing Home Residents: (Fried,
1993)
- Pain is frequently associated with depression. Depression is most common in residents
who have physical disorders which cause pain. Chronic pain is sometimes relieved by
addition of low dose anti-depressants in conjunction with analgesic.
- Only 40 to 45% of residents who reported pain in studies have it noted on their charts.
- For resident who are severely demented, there is even less documenation of or
treatment for pain. Care providers are forced to rely on pain behaviors such as fidgeting,
facial grimacing and irritability. However, the accuracy of pain rating based on these
observations is unknown.
Behaviors Associated with Pain:
Type of Behavior
Examples
Facial expression
Grimacing, clenching teeth, tightly shutting lips, gazing/staring, wrinkling
forehead, tearing
Moaning, groaning, grunting, sighing, gasping, crying, screaming
Praying, counting, swearing or cursing, repeating nonsensical phrases
Thrashing, pounding, biting, rocking, rubbing
Massaging, immobilizing, guarding, bracing, eating/drinking, applying
pressure/heat/cold, assuming special position/posture, reading, watching
television, listening to music
Vocalization
Verbalization
Body action
Behaviors
From Puntillo, K., & Wilkie, D. (1991). Assessment of pain in the critically ill. In K. Puntillo (Ed.), Pain in the
critically ill: Assessment and management. Gaithersburg, MD: Aspen. Reprinted by permission.
40
Sleep
ASSESSMENT OF SLEEP
•
•
•
•
•
•
•
•
•
41
Nature of sleep problem including characteristics, clinical course, its duration, the
circumstances under which it developed, any precipitating or accentuating factors, any
previous treatment and results, and the impact of the sleep problem on resident's life.
Usual sleep-wake pattern for 24 hours - as we age, our sleep pattern changes. Seniors
typically do not sleep as long, wake sooner and more frequently, than when they were
younger. Assure them this may be normal.
Bedtime rituals/routines and environmental factors - noise, temperature
Diet and drug use (both prescription and over the counter) - including usual intake of
caffeine (coffee or cola) or alcohol. Excessive use of alcohol leads to difficulty in staying
asleep.
Withdrawal of relatively low doses of short or intermediate-acting
benzodiazepines produce rebound insomnia and abrupt withdrawal of long acting
benzodiazepine hypnotics may cause both insomnia and nightmares. Insomnia is
aggravated by stimulant drugs, steroids, energizing anti-depressants or beta-adrenergic
blockers. These drugs cause sleep problems if taken at bedtime.
Illness factors - Changes in health, including Alzheimer's disease, cardiovascular disease,
pulmonary disease, arthritis, pain, prostatic disease, endocrinopathies, and other illnesses.
Objective Data - Family and significant others may provide insight into usual patterns and
certain aspects of sleep. Resident may have a diagnosis of being a "night" person who
sleeps during the day.
Subjective - Many short sleepers who do not complain of insomnia actually sleep much
less than most insomniacs, but while short sleepers feel rested and alert on awakening in
the morning, most insomniacs feel tired and sluggish. The patient's complaint of
insomnia, rather than the actual amount of sleep, is the criterion for diagnosis. Health care
providers should not be biased by own sleep habits.
- Listen to verbal comments of not sleeping well, of not feeling rested, of being tired, of
being awakened earlier than usual, or of having interrupted sleep or being more irritable,
restless, lethargic, a greater sensitivity to pain, an increase in accidents and falls.
Changes in emotional life - stressors such as retirement, hospitalization or the death of a
loved one.
Chronic insomniacs generally show high levels of psychopathology and a tendency to
internalize emotional conflicts, which leads to psychophysiologic activation and a state of
hyperarousal. Acute insomnia is also common in many psychiatric conditions, including
depression, anxiety disorder, mania, acute schizophrenia and organic brain syndrome or
other psychiatric illness. The insomniac patient may use his symptoms for considerable
secondary gain. It is not unusual for insomniacs to avoid family and social interactions by
insisting they are too tired or by protesting that a certain activity will adversely affect their
sleep. May be used to avoid sexual relations.
•
•
•
Treatment depends on type of sleep difficulty and its etiology. If the difficulty is in falling
asleep, the focus should be on pre-sleep routine and his mental activity while attempting to
fall asleep. If the complain is difficulty staying asleep, the possibility of medical problems
or unsatisfactory environmental conditions should be investigated. Early final awakenings
are often symptomatic of endogenous depression and warrant inquiry about other
depressive symptoms.
Assessment of pain - If pain predominates, analgesic agents should be used to their
maximum therapeutic benefit.
Fear of death: Patients who are seriously ill have a greater fear of death at bedtime, and
frequently have severe difficulty getting to sleep. Patients with asthma, COPD or CHF
often experience disrupted sleep because they fear the recurrence of symptoms during
sleep.
TREATMENT OF COMMON DISORDERS:
•
Adjustment Sleep Disorder:
- It arises in fair to good sleepers who are coping with recent stressors such as retirement,
hospitalization, or death of a loved one. Usually will resolve with time as person adapts to
stress-related event.
- Problems with onset or maintenance of sleep result in daytime irritability, anxiety,
lethargy, slowed cognition, and tearfulness.
Often, worry and concern about
sleeplessness create a level of arousal that is incompatible with sleep.
- Treatment is more often needed in individuals with few sources of emotional support.
Behavioral treatment is preferred. Treatment seeks to restore normal sleep. Relaxation
tapes, proper sleep hygiene, self-help books such as No More Sleepless Nights.
- Hypnotics are indicated if the patient is overwhelmed by the situation. However, they
should only be administered for a few days or weeks.
- Psychophysiologic Insomnia:
Usually develops after an adjustment disorder has
developed and is combined with poor sleep hygiene.
Older adults with
psychophysiologically insomnia associate their bed and bedtime rituals with frustration and
increased mental and physical arousal. The sleep disturbance continues as a result of
conditioned, learned arousal, even after normal coping and sleep habits are reestablished. Two behavioral therapies are effective:
a. Stimulus Control Therapy: Used when sleep onset is the problem. If the patient
does not go to sleep in 10 minutes or less, he is instructed to get up and then return to
bed only when feeling sleepy again, repeating this pattern until sleep onset occurs
quickly. This establishes a new habit of good sleep.
b. Sleep Restriction Therapy: Recommended when sleep maintenance is presenting
problem. Average number of hours of sleep is determined. Then the patient is
allowed to spend only this amount of time in bed. As sleep improves, the patient is
allowed to retire 15 minutes earlier. This method consolidated the amount of sleep,
leading to deeper sleep, faster onset, and fewer awakenings.
42
•
nadequate Sleep Hygiene: Irregular or poor sleep habits and sleep-incompatible
behaviors constitute inadequate sleep hygiene.
- Maintain a regular sleep schedule with a regular arising time. Irregular habits around the
time they go to bed and rise can lead to sleep problems. Patients with poor sleep hygiene
often spend excessive time in bed trying to sleep or follow highly irregular schedules for
going to sleep and arising. Such practices deprive them of strong behavioral cues for
deep, refreshing sleep.
- Factors that heighten arousal include caffeine, cigarettes, alcohol withdrawal, working
until bedtime, and clock watching may forestall sleep. They are preoccupied with their
inability to sleep.
- Hypnotics are best avoided because patients have increased risk of tolerance and
continued sleep disruption from sleep-disruptive behaviors.
- Make certain bedroom is quiet, comfortable, cool and secure. Decrease noise, the
appropriate strategy would be to reduce the frequency of interruptions to sleep. Avoid
caffeine after 12 o'clock noon.
- Avoid napping during the day.
- Get regular and gentle exercise around midday. Patients with insomnia often report low
or inconsistent levels of physical activity during the day. Increase exercise, however, limit
physical exercise or stimulating mental activity close to bedtime. This may also contribute
to difficulty falling asleep.
- Bed partner can often give useful information in assessing difficulties related to
disordered schedules and routines. Especially myoclonus nocturnus (jerking movement of
legs) and “restless legs syndrome”.
- Abstain from stimulating drugs (caffeine or decongestants) in the evening. Many over
the counter sleep remedies contain anti-histamines which will actually worsen the sleep
condition over time.
- Avoid heavy meals or hunger at bedtime.
- Get out of bed if awake. Limit time in bed to intimacy or sleep. Do not watch TV and
read in bed. Restrict total time I bed to 6.5 to 7.5 hours. per day.
- Avoid worry or frustration in bed. Schedule time to wind down and relax before going to
bed.
- Habitual pre-sleep activity that is comforting to the individual and enhances sleep. Presleep activity for men tended to include food, drink, television, and walking. Pre-sleep
activity for women tends to include hygienic activities, prayer, reading, and listening to
music and watching TV. Sleep was more satisfying for those who followed a routine.
•
Mood Disorders:
- Alteration in sleep is the hallmark symptom of such psychiatric disorders as major
depression, mania, dysthymic disorder, and cyclothymic disorder. Major depression, in
43
particular, may disrupt an elderly person’s ability to fall asleep, stay asleep, or both.
Manics may not sleep for days at a time.
- Often difficult, but important, to determine which came first insomnia or depression.
- Treatment is warranted when depression is suspected.
- Before antidepressants are prescribed, all depressed elderly should be screened for
other causes of insomnia, particularly restless leg syndrome and myoclonus because
antidepressants may worsen these syndromes, further disrupting the patients’ sleep and
mood.
- Medical Illness and Treatment: One study found that 12 of 26 standing orders in a
hospital included doses of hypnotic that are twice the recommended dosage for the elderly
and often provide inappropriate repeat doses.
- Physician’s efforts to medicate underlying disease processes may result in sleep
disruption. The most significant offenders are steroids, thyroxine, theophylline, and many
centrally active antihypertensives.
- Insomnia secondary to symptoms of medical illness is best managed by treating the
underlying medical disorder. If pain predominates, narcotics and NSAIDS for bone pain or
inflammatory conditions should be administered to their maximum therapeutic benefit.
•
Dementia/Delirium:
- Sleep disturbances in patients with dementing illness range from increased awakenings
and nocturnal wanderings to agitation and confusion. “Sundowning” frequently leads to
placement in an institution.
- The changes in sleep in patients with dementia arise from degeneration of cortical and
brain stem structures, resulting in poor accommodation to the transitions from sleep to
wake and lighter, more broken sleep.
- Treatment: Management of underlying metabolic, neurologic, or infectious processes.
Behavioral management includes proper sleep hygiene, particularly exposure to morning
light. Safety at night includes a night light and putting the mattress on the floor and
removing glass objects.
- When dementia is accompanied by agitation, low-dose antipsychotic medications may
work. However, antipsychotics carry the risk of bradykinesia, rigidity, and tardive
dyskinesias. Short acting Benzodiazepine or antidepressants such as trazodone should
be tried and tilracted to optimal dose; if not affective, then a trial of low dose antipsychotics may be tried.
•
Sundowning
- Occurs in patients with organic brain dysfunction. The classic symptoms are daytime
drowsiness combined with nighttime confusion, agitation, and anxiety. At night residents
tend to wander, exhibit speech and behavior that are not of character. Patients have a
strong need to maintain contact with a familiar environment. They feel that their fading
44
cognitive abilities are enhanced during the daytime. At night, however, they feel less safe
and confident, and staying awake makes them feel more secure.
Underlying
environmental or organic factors that could cause sundown syndrome should first be ruled
out. Such causes are easily treated. Simple environmental orientation procedures may
help - keeping a light on in the bathroom. Medications include Haldol or Trazodone to
reduce agitation, anxiety, and wandering and allow them to sleep. Hypnotics are
contraindicated because they may cause patients to become more disoriented and
confused. Paradoxically, these medications will excite already disinhibited patients. The
patient’s drug regimen should be evaluated for its potential to produce some or all of the
symptoms of sundown syndrome. Medications that have an anticholinergic component,
such as antidepressants, antihistamines, antiparkinsonism drugs, and antispasmodics, are
particularly likely to have this effect. Non-essential drugs should be reduced or stopped.
•
Prescribing Guidelines for Hypnotic:
- Should be the intervention of last resort, use the lowest effective dose. Use half of the
adult dose in patients over age 65.
- Monitor for side effects. Check interaction of hypnotic with alcohol or drugs, and other
interactions with lung or heart disease, Central Nervous System disease. Check for
interaction with other medications such as Tagamet ™, phenobarbital and Dilantin ™.
- Dispense a limited number of doses (#20) and follow for cognitive or behavioral changes.
- If the medication is needed for more than two weeks, consider a maximum of three
doses per week to lessen the chance of tolerance.
- Selection of an appropriate hypnotic depends on the target symptoms, whether related to
sleep onset, sleep maintenance, daytime anxiety, or possible depression.
- Consider adverse effects on the patient with lung or heart disease, Central Nervous
System disease, or a history of alcohol abuse.
Delusions, Hallucinations, Depression
ASSESS AGGRESSIVE BEHAVIOR
•
•
•
•
•
•
•
45
Identify the pattern of behavior, e.g., time , triggers.
Assess resident response to verbal/non-verbal messages. Use non-threatening positives.
Offer choices of when to eat, when to do grooming, bathing when possible.
Identify early signs of aggression or increased agitation and intervene at that point, by
distracting or removing them from the situation to prevent escalation.
Reduce or eliminate noise.
Learn sources of comfort or discomfort and communicate to all staff.
Do not argue with resident. If resident refuses treatment, return at another time. Never try
to talk a psychotic resident out of his hallucination.
ASSESS PSYCHOACTIVE MEDICATIONS (this does not include anti-depressants)
•
•
According to OBRA, may be used if the behavior:
- Is dangerous to resident or other
- Interferes with staff’s ability to deliver care
- Impairs function of resident
Steps to Use
- Chart behavior problems
- Obtain a physician’s order
- Begin with lowest dose
- Observe for side effects
- Chart behaviors for 48 hours
- Re-evaluate at later date. The effects of an antipsychotic which has been lowered or
stopped may not be seen for many weeks.
- Withdraw - “not to be a permanent order” except when patient has diagnosis supporting
chronic therapy such as schizophrenia, Bipolar, chronic depression. A slow, careful,
tapering off may be tried to evaluate patient’s current need.
CONTRACTING
•
•
Give rewards when behavior is appropriate.
•
Eliminate behavior modification. Not useful with dementia.
•
•
•
46
Depending on the mental status of the resident, make clear the relationship between
behavior and consequences.
Actively listening to the resident will give important clues to behavior. For example, one
resident who was fine during the day stayed up all night. When staff listened to her she
conveyed that she was afraid to become old and senile or go to sleep because she was
afraid she would lose her mind or die. In care planning, when she was involved, she said
she wanted a digital clock so she could see what time it was during the night. Also, her
family decided to come and help her get ready for bed. The clock and the family
assistance helped her sleep at night. Now she gets up less frequently, but she still gets
up. However, no one minds because they understand why she is up.
Use interview techniques with open ended question centering on five senses and feelings.
Remember, the nursing home population is not usually educated in communication skills.
It is helpful to find out why they exhibit a given behavior. For example, are they angry
about nursing home placement, do they have a history of combative behavior, are there
other family problems, or a dysfunctional family system. It is very unlikely that you will see
great changes in behavior because they are comfortable with their behavior even if it is not
in their best interest. A dysfunctional young person often becomes a dysfunctional senior.
Reality orientation - of limited usefulness but assess to see if appropriate. Because of
memory problems, it is not appropriate with all cognitively impaired individuals. It is helpful
to orient residents to who you are, what task you will be helping them with, and what the
next task will be. For example, “Helen, I’m your nurse, and I’m here to help you get
dressed.” The alternative reality of some confused individuals may serve as a coping
mechanism and improve their quality of life. Therefore, in the severely demented, reality
orientation may only increase their anxiety, exaggerate separation from what they love and
•
trust, and increase their emotional pain by making them wrong in comparison to their
perceived reality. Reality orientation with psychotic patients must be done skillfully. Never
try to argue them out of their reality.
Dementia/Alzheimer’s Disease
ATTITUDE/APPROACH
•
General attitude and approach
- Remain calm. Do not overreact to behavior.
- Stay flexible and non-resistive.
- Guiding (not controlling)
- Be patient and stay neutral.
VERBAL APPROACHES
•
•
•
Use one step commands which are simple.
Need to assess whether to offer the resident a choice. Give a suggestion or a command
if unable to offer a choice. When possible, offer choices of where to eat, when to do
grooming, bathing, etc. If the resident feels a lack of control, he or she may become
aggressive. At times, too many choices may be confusing, so limit choices.
For
example, “Would you like cereal or toast?”
•
•
Avoid arguing or reasoning.
•
Eliminate distractions.
•
Keep your promises, so only make promises that you will be able to follow through.
•
•
•
•
47
repeat command.
When the resident is present, include them in the conversation. Use the resident’s name
frequently.
Identify resident’s vocabulary and use it. Use language and expressions that are within
the life experience of the resident. A very old, demented person is unlikely to understand
explanations of HMO’s, current new medical practices, or slang expressions. A
demented person does not acquire new information well. Rely on their experiences as a
younger adult.
Treat resident as an elder, not as a child. Validate resident's feelings.
Give directions within attention span. If resident is too confused or combative, always
come back later.
•
•
•
•
•
•
•
•
•
•
•
•
48
Verbal and non-verbal messages should match. Stand in front of person and make eye
contact.
The resident is already impaired, but how staff communicate with the resident may
increase his/her disability. For example, the staff say “don’t go outside,” which may be
confusing to a demented resident. It is far more effective and skillful to tell the resident
exactly what you want them to do in slow, concise, and concrete sentences, such as:
“Stay in the building” or “Walk with me.” A nurse aide told a resident to “Hop in bed” and
the resident tried to do it, and said, “I can’t.” The reason why confused residents pull the
fire alarm is because “Pull” is clear and concise, while “In case of emergency” does not
register.
and occasions from their past. For example, “Mother never let me do that,” or “I have told
you children not to mess with that door,“ etc. With some residents, you can observe a
teachers. You may improve communication with them if you find out who you are talking
to and what the agenda is for that person.
other than English or a language in which you are not proficient. If a relative is the
translator, schedule care planing around when relative may be present to explain care
and procedures.
Do not use words such as “on,” “below,” “beside,” or “between.” These words are difficult
for dementia patients to understand.
If the person is having difficulty finding the right word, supply the word for him. This helps
When you do not know what the individual means, ask him or her to point to it, describe
it, or to show you how it works.
Use other signals besides words to convey what you mean - point, touch, or demonstrate.
and why.
Break down complex tasks into single steps. Show the resident how to begin.
Make sure the person’s clothing and articles of toileting do not require motor skills the
resident no longer has.
•
•
Provide opportunities for the resident to succeed in activities that she can still do.
Signs of Increasing Anxiety:
- Head: loss of eye contact
- Arms and hands: repetitive movements, wringing hands, clenched fists.
- Legs and body: repetitive movements, increase in motor activity, such as frequent
changes in position or pacing.
- Voice and speech: change in tone of voice, repetitive sounds, crying, complaining.
- When these signs observed, delay care or take steps to comfort, reassure or distract the
resident.
- Re-assess the correctness of approach.
•
Behavior Management Plan
- Four Steps for Dealing with Problem Behaviors:
1. Immediate action to control a threatening or dangerous behavior problem.
2. Medical evaluation to look for medical or other causes of the problem that need
treatment.
3. Behavior assessment to observe and describe the behavior.
4. Care plan development to describe realistic goals for behavior change.
- Immediate Action Techniques:
- Stay calm and use a firm tone of voice.
- If it is necessary to protect yourself, use a pillow or padding in the chest and shoulder
area.
- Do not use gestures that startle or frighten the resident.
- Stay at a safe distance from the resident.
- Do not confront or accuse the resident of wrongdoing.
- Do not argue or try to reason with the resident.
- Whenever possible, move the resident away from the triggering event.
- If restraint is needed, keep the resident safe and use the least amount possible for
the shortest period of time.
- Offer reassurance through gentle touching and express support when the resident is
able to hear you. Be selective about use of touch, especially with angry, depressed
and/or paranoid schizophrenic residents. Some residents will find touch comforting;
others will feel threatened.
NON-VERBAL APPROACHES
•
•
Assume an equal or lower position, especially if the resident feels powerless.
•
Move and speak slowly. Be respectful.
•
49
Know that your attitude/mood is contagious and felt by all - practice smiling, looking open
and friendly and listening. Show a positive attitude
Avoid overwhelming the resident physically or verbally - approaching an anxious resident
with three or more people may lead to a catastrophic reaction. Do not call out or surprise
resident from the rear where they cannot see.
•
•
Make sure that your actions match your verbal message. Exaggerate your expressions if
they are helpful in getting a message across.
Learn likes and dislikes, family situation, communication style, past behavior problems,
preferred routines and habits. Learn sources of comfort or discomfort.
•
Learn three things that give the resident comfort.
•
Do not force the resident to do anything when she will not cooperate.
•
Anticipate the resident’s needs during care.
MUSIC THERAPY
•
Music can assist with de-escalating a resident
- For example, one resident loved classical music. The staff discovered that if they turned
her radio to a classical music station just as she begins to escalate, she will relax and take
a nap instead of trying to leave the building.
DISTRACTION THERAPY
•
•
•
Limit distractions in the room while giving care.
Use distraction to keep the resident interested in something else during an activity that
causes behavior problems.
Distraction Therapy
- Use of mobiles
- Use of family videos
- Picture collages, scrapbooks
- Use of mirror
RECREATION
•
Recreation Therapy
- Residents who are involved in activities will usually not try to get up, so this should be a
restraint-free time each day.
- Restructure activities so residents who are not confused or only slightly confused are in
one group and cognitively impaired are in small group activities or one-to-one activities.
- Use volunteers for one-to-one activities.
- Select specific sensory experiences geared for their enjoyment. For example, an angora
sock massage or blow dryer massage.
EXERCISE
•
•
•
50
Exercise - There should be a planned daily exercise program. Schedule periods of
physical activity.
Provide time for rest throughout the day.
Therapeutic touch: Some people like to be touched, and others do not. Need to assess
this before you touch the resident. Individuals who have been touched adequately are
more emotionally satisfied and less stressed. It is interesting to contemplate that if the frail
•
elderly return to infantile needs, does their need for touch increase. An infant cries to be
touched. Do the frail elderly cry to be touched and cared for in the same way? It could be
that their only form of communication is through touch. Do they reach out for us begging
for human contact and a gentle touch? Touching makes us equal. The resident can be
helped to feel her caregivers understand her needs more completely if touch is the bridge
to understanding. Touch is a learned behavior. The nursing home population may not
have experienced positive tactile experience in past relationships. A thorough social
history is beneficial in ascertaining the family’s history of touching. Avoid touching
paranoid schizophrenic residents or angry, depressed residents without permission.
- Opportunities for Touch:
- Contact with other people.
- Contact with animals, gardening, finger foods, and objects.
- Use lots of touch and allow time for the resident to touch you.
- Ask permission to touch.
- Identify symbolic behaviors and their meaning. Assess cultural and ethnic
background and incorporate this information into the care plan.
ASSESSMENT OF HEARING AND VISION
•
Residents with impaired hearing and/or vision may appear to have mental status problems
when this is not the case.
- Hearing - Has hearing been checked recently? Does the resident need a hearing aid? If
the resident has a hearing aid, does it function properly? Does the resident have a
problem with excessive ear wax?
- Vision - Does the resident have cataracts? Have glasses been checked in the past
year? Are glasses in good repair? Are they cleaned daily?
- Be aware of hearing, seeing, and speech problems and aids the resident should be
using.
REMINISCENCE
•
Reminiscence therapy - This enables residents to talk about life experiences and provides
you with important information about hobbies and interests and potential activities for the
resident . For example, in reminiscence therapy activities, staff found out one resident
was an ex-prize fighter. Therefore, facility staff arranged for a volunteer to take him to a
gym three times a week so he could work out. This has substantially decreased his
agitation. Also, ask residents about important anniversary dates. Mortality rates are very
high for important anniversary dates. For example, one resident was very anxious and
agitated one day. A staff member asked her about it, and she said her child had died on
that date ten years before.
BEHAVIOR MANAGEMENT AND BATHING - INTERVENTION
•
•
51
Environmental:
- Ensure warm water and comfortable bathroom temperature.
- Post privacy signs on bathroom doors.
- Decorate to resemble residential bathroom (colored paint and towels).
- Install gentle-spray shower heads.
Behavioral:
- Individualize care to the patient/resident:
a. Find out about and accommodate prior preferences for type of bathing and time.
b.
Use familiar objects (favorite bathrobe, powder, or bath oil).
- Decrease potential for distress related to care techniques:
a. Allow flexibility in scheduling when possible.
b. Allow choice of tub, shower, or sponge bath.
c. Provide for privacy; have resident disrobe in bathroom to avoid “public” appearance
in unclothed state. Avoid rapid transportation to the bathroom without cueing.
d. Explain the care process; use task segmentation to increase comprehension.
e. Keep patient warmly covered .
f. Use reassuring statements or touches as appropriate.
g. Allow patient to self-perform care in an unrushed fashion.
h. Give positive feedback and personal regard during and after interaction. Defer or
cancel bathing if patient is unable to cope.
ANTI PSYCHOTIC DRUG USE
•
•
•
According to OBRA, may be used when:
- Resident is dangerous to self or others
- Resident interferes with staff’s ability to deliver care for resident
- Resident is not able to function
Steps to Use
- Chart behavior problems
- Obtain a physician’s order
- Begin with lowest dose
- Observe for side effects
- Chart behaviors for 48 hours
- Re-evaluate
- Withdraw - “not to be a permanent order”
Antipsychotic drugs may be permanent if resident has a supporting disease of
schizophrenia, bipolar, schizo affective or depression. Sometimes a slow, careful taper
may be tried to assess for a highest functioning with lowest dose. Remember, it may take
many weeks for the effects of lowering antipsychotic drugs to become apparent.
Environmental Therapy
AVOID SENSORY OVERLOAD
•
•
•
52
Avoid sensory overload - Decrease or eliminate noise and high activity level. It can be
very confusing to the frail elderly, as with residents with brain trauma or psychosis.
Decrease noise - Noise can add to confusion for the confused resident as well as with
hearing impaired residents.
- Use public address system as little as possible and have times of day with no P.A.
- Use chimes instead of alarm for fire system.
Reduce Distractions
- Reduce intercoms, TV’s, buzzers, and background noise.
- Put residents who are confused by large groups in small groups.
- Remove mirrors, confusing signs, wall coverings or slipcovers with busy patterns.
- Put residents who are sensitive to noise in rooms with quiet locations.
PERSONALIZE ROOM
•
•
Strongly encourage the use of personal possessions in rooms. This provides a great deal
of security and comfort to residents, particularly confused residents.
Personalize Living Areas
- Personal items and remembrances in resident’s room.
- Encourage expression of different cultures and ethnic backgrounds.
NIGHT TIME ACTIVITIES
•
Have night time programs for those residents who cannot sleep at night. The elderly
generally need less sleep.
STAFFING
•
Consider allowing staff to wear ordinary clothing rather than nursing uniforms.
Deinstitutionalize your facility and get away from the medical model of care to create a
more homelike environment. This helps to reduce stress for residents. Consistent staff
schedule. Permanent staff assignments will increase rapport.
•
Reduce turnover in staff.
•
Allow resident to choose caregivers. Use non-nursing personnel as much as possible.
•
•
•
Use a picture taken before the dementia developed to help staff think of the resident as a
person, not a problem.
Accessible Call Lights
- Can be attached to the resident’s clothing. When resident moves, the call light goes off.
- Use cord of bright color to make it easily visible.
Respond to call lights promptly.
- Locate within resident’s reach.
- Orient resident regularly to use of the call light.
TV, RADIO
•
Television, radio - consider a remote control for the resident likely to fall if they get up
unassisted.
INTERPERSONAL PREFERENCES
•
•
53
Preference in terms of care provider: For example, there were several examples of male
residents not wanting a male to provide care. When a male did provide care, the resident
became combative. When asked, the male resident explained he did not want a male to
see him being dependent.
Identify people near the resident when the disruptive behavior occurs. Another resident or
staff person may set off the behavior.
Family
•
Tell the family about resident’s current condition.
•
Teach the family about behavior changes that result from cognitive loss.
•
Help the family be realistic about the resident’s abilities.
•
Involve the family in the behavior management plan.
•
Inform the family of nursing home policy.
•
54
Assist family to understand state and federal regulations affecting LTC, hospitals, and the
differences.
WANDERING
Medications
•
cardiovascular
•
•
•
•
•
•
Psychotropics
Diuretics
status
Cardiovascular
•
DIGITALIS LEVELS
•
55
DILANTIN ™ LEVEL
•
VPA(VALPROIC ACID)
TEGRETOL ™
every 6 months.
•
•
•
CONSTIPATION.
Dementia / Alzheimer's Disease
•
•
Exit Seekers
- Barriers where wandering residents should not go - Try to blend things into wall when
you do not want the resident to focus on them, e.g.; exits.
- Visual barriers - Stop signs, yellow ribbons curtains, distract wanderers by wall papering
over exits, cover door knobs, use a bookcase to cover doorway, fabric over door handles,
mirrors at exits to distract resident from leaving. (Check with Fire Marshall)
- Use alarm systems and door alarms, wanderguard bands.
- Secured area outside - include the over 90 non-toxic plants.
- Use of cueing for recognition of room, appetite, and toileting
- use symbols, signs, photos to direct.
- If patient is not agitated, unhappy, a danger to themselves or other residents, use above
suggestions to provide a safe environment and allow them to wander. This behavior is
characteristic of Alzheimer type dementia; it may cause more agitation to resident if
behavior is not tolerated.
- If wandering interferes with nutrition, use finger foods that resident can eat while walking.
Cognitively disabled residents may express depression by anxiety and excessive pacing.
ATTITUDE/APPROACH
•
•
•
•
56
Remain calm. Do not overreact to behavior.
Stay flexible and non-resistive.
Guiding (not controlling)
Be patient and stay neutral.
VERBAL APPROACHES
•
•
•
Use one step commands which are simple.
Need to assess whether to offer the resident a choice. Give a suggestion or a command if
unable to offer a choice. When possible, offer choices of where to eat, when to do
grooming, bathing, etc. If the resident feels a lack of control, he or she may become
aggressive. At times, too many choices may be confusing, so limit choices. For example,
“Would you like cereal or toast?”
•
•
Avoid arguing or reasoning.
•
Eliminate distractions.
•
Keep your promises, so only make promises that you will be able to follow through.
•
When the resident is present, include them in the conversation.
•
Identify resident’s vocabulary and use it. A very old, demented person is unlikely to
understand explanations of HMO’s, current new medical practices, or slang expressions.
A demented person does not acquire new information well. Rely on their experiences as a
younger adult.
•
Treat resident as an elder, not as a child.
•
Validate resident’s feelings.
•
•
•
•
•
57
repeat command.
Give directions within attention span. If resident is too confused or combative, always
come back later.
Verbal and non-verbal messages should match. Stand in front of person and make eye
contact.
Use the resident’s name frequently.
The resident is already impaired, but how staff communicate with the resident may
increase his/her disability. For example, the staff say “don’t go outside,” which may be
confusing to a demented resident. It is far more effective and skillful to tell the resident
exactly what you want them to do in slow, concise, and concrete sentences, such as:
“Stay in the building” or “Walk with me.” A nurse aide told a resident to “Hop in bed” and
the resident tried to do it, and said, “I can’t.” The reason why confused residents pull the
fire alarm is because “Pull” is clear and concise, while “In case of emergency” does not
register.
•
•
•
•
•
•
•
•
•
•
and occasions from their past. For example, “Mother never let me do that,” or “I have told
you children not to mess with that door,“ etc. With some residents, you can observe a
teachers. You may improve communication with them if you find out who you are talking
to and what the agenda is for that person.
other than English or a language in which you are not proficient. If a relative is the
translator, schedule care planing around when relative may be present to explain care and
procedures.
Do not use words such as “on,” “below,” “beside,” or “between.” These words are difficult
for dementia patients to understand.
If the person is having difficulty finding the right word, supply the word for him. This helps
When you do not know what the individual means, ask him or her to point to it, describe it,
or to show you how it works.
Use other signals besides words to convey what you mean - point, touch, or demonstrate.
and why.
Break down complex tasks into single steps. Show the resident how to begin.
Make sure the person’s clothing and articles of toileting do not require motor skills the
resident no longer has.
Provide opportunities for the resident to succeed in activities that she can still do.
NON-VERBAL APPROACHES
58
•
Know that your attitude/mood is contagious and felt by all - practice smiling, looking
•
open and friendly and listening. Show a positive attitude.
•
Assume an equal or lower position, especially if the resident feels powerless.
•
•
Move and speak slowly.
Avoid overwhelming the resident physically or verbally - approaching an anxious resident
with three or more people may lead to a catastrophic reaction. Do not call out or surprise
resident from the rear where they cannot see.
•
Be respectful.
•
Make sure that your actions match your verbal message.
•
Exaggerate your expressions if they are helpful in getting a message across.
•
Learn likes and dislikes, family situation, communication style, past behavior problems,
preferred routines and habits.
•
Learn sources of comfort or discomfort.
•
Learn three things that give the resident comfort.
•
Do not force the resident to do anything when she will not cooperate.
•
Anticipate the resident’s needs during care.
DISTRACTION THERAPY
•
•
Look for possible reasons for behavior - overstimulated, need to exercise, looking for
something, hungry, or need to go to the bathroom.
•
Structured walked indoors or outdoors.
•
Buddy system.
•
Develop activities to provide freedom from restraints.
•
•
•
•
59
Get them to talk about where they are going and ask questions about home, family, etc.
Need for companionship and supervision
- Use the buddy system - have staff other than nursing go for a daily walk with resident.
- Get volunteers involved in walking with residents.
- Encourage relationships between residents who may have compatible interests.
Is a secured area available for people who may wander from the facility?
Limit distractions in the room while giving care
Use distraction to keep the resident interested in something else during an activity that
causes behavior problems.
•
Distraction Therapy
- Use of mobiles
- Use of family videos, picture collages, scrapbooks
- Use of Mirror
Environment
MUSIC THERAPY
•
Music can assist with de-escalating a resident
- For example, one resident loved classical music. The staff discovered that if they turned
her radio to a classical music station just as she begins to escalate, she will relax and take
a nap instead of trying to leave the building.
RECREATION
•
Recreation Therapy
- Residents who are involved in activities will usually not try to get up, so this should be a
restraint-free time each day.
- Restructure activities so residents who are not confused or only slightly confused are in
one group and cognitively impaired are in small group activities or one-to-one activities.
- Use volunteers for one-to-one activities.
- Sensory stimulation - Select specific sensory experiences geared for their enjoyment.
For example, an angora sock massage or blow dryer massage.
EXERCISE
•
•
•
There should be a planned daily exercise program.
Schedule periods of physical activity.
Provide time for rest throughout the day.
LABELING
•
•
•
•
60
Use high contrast black and white pictures.
Repeat labels often to remind residents of the location of rooms.
Place all labels at a level that can be seen from a wheelchair or in a lower posture.
Develop an emergency plan to retrieve residents found missing from the unit
MEDICAL NECESSITY
To prevent interference with Tubing/Life Support
•
I.V.:
- Cover site with Kerlix
- Soft sponges in hands
•
Evaluate for elimination of bothersome treatment - remove catheter or change from
an I.V. to gastrostomy tube or spoon feeding. However, do not remove catheter
without a primary care provider order. A patient may need a catheter because of
urinary retention or obstruction.
•
Ask the resident what is going on - For example, one resident was pulling out his
tubes. When asked about what was bothering him, he replied that he was
experiencing hallucinations. When the medication was discontinued, he stopped
pulling at his tubes.
•
Gastrostomy: Abdominal Binder/Band
•
Foley: Sweat Pants
•
NG: Air splints on arms
Pharmacological
•
61
Oversedation/Undersedation: evaluate for excessive dose, excessive duration,
adequate monitoring, indications for use and presence of adverse consequences.
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66
AGENCY RESOURCE LIST
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69
Case Study
Nursing Home Alarm Elimination Program:
It’s Possible to Reduce Falls by Eliminating Resident Alarms
I.
Case Study Objective
This case study summarizes the elimination of resident pressure
alarms and the relationship to fall prevention. The intervention occurred within a Massachusetts nursing home’s 45-bed unit.
II.
Facility Overview
Jewish Rehabilitation Center for the North Shore (Jewish Rehab) is
a Massachusetts-based 180 bed, Joint Commission on Accreditation
of Healthcare Organizations (JCAHO) accredited, freestanding,
not-for-profit facility providing sub-acute, long-term, and dementia
care. For years, it has been an active participant in Masspro’s quality improvement initiatives, and is currently part of the Centers
for Medicare & Medicaid Services (CMS), an agency of the U.S.
Department of Health and Human Services, 8th Scope of Work
Nursing Home Identified Participant Group (IPG).
III. Problem Statement
The Assistant Director of Nursing (ADON) who was the chairperson of the Falls Committee was concerned that resident falls
remained high, despite the work of two committees and multiple
individualized interventions.
IV.
Consequently, the ADON presented to the Falls Committee, the
idea of eliminating resident pressure alarms to actually prevent falls.
Her rationale focused on one 45-bed unit where over half of the
residents had either a bed or chair pressure alarm or both, yet the
number of falls continued to be high. She observed the following:
• Alarms were reactive rather than proactive because they only indicated to staff that the resident had moved or had already fallen.
• The noise produced by the alarms agitated residents so much
that residents fitted with alarms did not move at all to avoid
activating the alarm. This put them at risk for ADL decline.
• Residents not fitted with alarms were often heard calling to staff
to turn off the alarms and telling residents fitted with alarms to
remain still.
• Residents with dementia experienced increased agitation.
• CNAs were often distracted from other important duties, including ADL care and communication with residents.
Jewish Rehab’s leadership team is experienced, and the results of
their resident and staff satisfaction surveys, and certified nursing
assistant (CNA) turnover rate rank them in the top tier of their IPG
peers. The average score of their Resident Satisfaction Survey was
2% higher than the average score of all the participating IPG’s. In
particular, the residents felt that the staff cared about them, made
them feel safe, and allowed them to participate in decision making.
The average score of their Staff Satisfaction Survey was 10% higher
than the average score of all participating IPG’s. In particular, staff
felt that there was good communication, they understood the goals
of the facility, and felt pride being a member of the team. Not surprisingly, their CNA turnover rate was less than approximately 58%
of the other participating IPG’s turnover rate.
V.
Their Falls Committee consists of an interdisciplinary team of department heads, staff nurses, and CNAs, that meets every one-to-two
weeks to review falls and evaluate intervention successes. In addition to the weekly Falls Committee meeting, a separate Falls Review
Committee meets every morning for 15 minutes to discuss falls
that have occurred in the prior 24-hour period, and identifies the
root causes and the appropriateness of any related intervention(s).
This Committee is composed of department heads and nursing
management.
Of note: The unit on which this case study is based has CNAs and
nursing team leaders with consistent assignments.
Steps to Problem Identification
Although the facility held a facility-wide “Falls Fair” to educate staff
about the common causes of resident falls and appropriate interventions, and demonstrate the facility’s pressure alarms, the fall rates for
three subsequent months remained high.
The Pilot Test
Alarms were removed from several residents who had not had any falls
for a significant period of time because the causative factor for their
previous falls had resolved (e.g., urinary tract infection). Surprisingly,
the residents remained fall free upon removal of the alarms.
Drawing from this success, the ADON and the Falls Committee
selected additional residents for alarm removal. The criteria for
resident selection remained the same as for the previous group of
residents: the root cause of previous falls had been determined to
be episodic and the acute condition had resolved. Again, the effort
was successful.
masspro 245 Winter Street Waltham, MA 02451
tel 781.890.0011 fax 781.487.0083 www.masspro.org
VI.
Implementation Plan
Based upon the success of the two prior interventions, the team
developed a plan to progressively eliminate all 25 alarms on the
unit over a four-week period. Prior to implementation, all staff
received education on the falls prevention strategies to be used once
the alarms were removed. The Falls Committee made it clear that
the success of the intervention depended on the involvement of staff
throughout the facility.
Alarm removal began on the unit where residents tended to have
mild-to-moderate dementia and poor safety insight, but, were still
relatively mobile. The choice of this unit was based on the fact that
it had an excellent chance to be successful due to its consistent staff
and consistent assignments. Additionally, a success on this type of
unit would support the ADON’s position that alarm elimination
was an appropriate goal, as this unit had a high fall rate.
CNAs were very receptive to the program. Licensed nurses were
initially a bit hesitant. The basis for this hesitancy was because
they understood their responsibility as licensed staff to maintain
resident safety and felt that the alarms assisted them in accomplishing this. However, they recognized the success of the pilot and came
to support the plan, actively participating in its implementation
by talking to families about the program and the resident specific
intervention that would be utilized in place of the alarms.
A central part of the intervention was that nursing staff would need
to anticipate the needs of the residents, rather than respond to an
alarm. In other words, they would need to change their mindset
from being reactive to being proactive. Due to the facility’s workflow
style of consistent staff assignments, the CNAs and licensed nurses
knew the residents well and were able to develop individualized
care plans to anticipate needs. Alarm assessments had typically
been completed on a quarterly basis and were used to document
the continued appropriateness of alarm use. Now it became a tool
to document the resident’s participation in the alarm elimination
program.
VII. Program Design
A hall monitoring system, comprised of an interdisciplinary team
including department heads, therapists, and the administrator, was
initiated. Hall monitors were educated about patient safety, falls,
and resident specific safety risks. Three times per week, each hall
monitor took a 15-minue block, during which they would be in the
unit monitoring for resident safety and taking direct action when
necessary.
This monitoring program was in place from 7:45am −3:15pm, five
days per week. Monitors shared their observations and actions at
daily review meetings designed for plan modification. In addition,
on the 6:45am – 2:45pm shift, a non-clinical unit aid monitored the
unit for resident safety. The monitoring program remained in effect
for two months. Alarm use was reduced during the first month, with
the second month serving as an extra period of resident supervision
while the system was evaluated and modified as needed.
The 2:45pm – 10:45pm shift developed its own monitoring program using a resource aide whose function was to focus on agitated
residents and those who were at high risk for falls. The 10:45pm
– 6:45am shift developed its own plan as well, increasing level of
surveillance, adjusting book times, and increasing rounds.
Staff used activities to help reduce falls. The rationale was to decrease
the amount of resident agitation experienced by providing additional
activities, and thus decreasing the risk of falls.
On weekends, the nursing staff implemented a hall-monitoring
program, including increased visibility of the weekend supervisor
on the target unit, and heightened awareness by the housekeeping staff to be hyper-vigilant about resident safety. Since the same
CNA staff worked both on the weekend and during the week, they
had a good understanding of the safety needs of the residents. The
weekend plan worked well, with falls that had already been low
remaining low.
VIII. Program Implementation
During Week One, the 6:45am – 2:45pm shift disengaged the
resident alarms on the target unit. These interventions were implemented as part of their reorganized thinking of proactive approaches.
At 2:45pm (the end of shift), staff turned the alarms on again.
During Week Two, the alarms were turned off at 7:00am and remained off until the end of the 2:45pm – 10:45pm shift.
During Week Three, the alarms were turned off at 7:00am, and
remained off for all three shifts.
During Week Four, the alarms remained off during all three shifts
and residents continued to be monitored for safety.
The Falls Committee evaluated the plan both daily and weekly
during the first and second months of implementation, making
modifications as needed.
IX. The Results
Impact on quality of life was evidenced by less agitation of residents
due to decreased noise of alarms. Staff also experienced less anxiety
and a better workplace environment within the unit.
As a result of the implementation of this program, the proactive
approaches outlined above were identified as successful fall preventive strategies.
Using real-time information provided by falls incident reports the
ADON tracked and trended data on a monthly, quarterly, and annual basis. During the final quarter of 2005, that encompassed the
months of alarm reduction and increased resident monitoring on
the target unit, there was a 32% reduction in the quarterly average
of falls for this unit, when compared to the average number of falls
for the first three quarters of 2005.
Incidentally, this unit also experienced a reduction in the number
of pressure ulcers identified for the final quarter 2005, as compared
with the first three quarters of 2005. This could be the result of
residents’ toileting in advance of need, and more frequent ambulation and positioning, which were a part of residents’ individualized
fall prevention plans.
In addition, there was a 21% decrease in the CMS “Prevalence of
Falls” quality measure when comparing July 2005 – December 2005
to October 2005 through March 2006. Both six-month periods
shared the two-month intervention interval and subsequent evaluation. Additionally, the Director of Nursing has reported that the
increase in activities on the unit has had an impact on the “depression” quality measure.
X.
XI. In Summary
As the alarm elimination program continues to be implemented
throughout the facility, the Director of Nursing will utilize quality
measure reports to correlate alarm elimination with changes in quality measures other than just the prevalence of falls, including:
• Depression
• Behaviors
• Incontinence
• Pain
• ADL decline
• Little or no activity
• Pressure ulcers
Preliminary anecdotal data suggests that a relationship does exist.
However, with the increase of MDS data available over time, the
Director of Nursing hopes to be able to make a direct correlation
between the intervention and positive outcomes.
Moving Forward
In late 2005, the ADON assumed the role of Director of Nursing,
after having been with the facility for nine years. She is continuing
to lead the facility in its progressive implementation of the alarm
elimination program on each of the facility’s three other units. The
basic implementation plan has remained the same with some modification to accommodate for the varying resident population and
characteristics that exist on each of the three units, including:
• Sub-acute
• Long-term care
• End-stage dementia
As the facility has continued its work, it has identified the need to
change the starting time of Falls Committee meetings in order to
allow for greater and more consistent participation by CNAs, who
are recognized as a valuable and integral part of the process.
This material was prepared by Masspro, the Medicare Quality Improvement Organization for Massachusetts, under
contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and
Human Services. The contents presented do not necessarily represent CMS policy. 8sow-ma-nhqi-06-31 casestudy-aug
Clinical Guidance
For the Assessment and Implementation of
Bed Rails
In Hospitals, Long Term Care Facilities, and
Home Care Settings
Developed by the
Hospital Bed Safety Workgroup
April 2003
Table of Contents
Preface…………………………………………………………………………….
ii
Introduction………………………………………………………………………..
1
Guiding Principles…………………………………………………...……………
3
Policy Considerations…………………………………………………………….
4
Process/Procedure Considerations……………………………………………..
5
Risk Intervention…………………………………………………………………..
9
Individualized Environmental Changes…………………………………………
10
Patient Choice……………………………………………………………………..
10
Bed Rails as Restraints…………………………………………………………..
10
Education /Training……………………………………………………………….
10
Bed Rail Safety Guidelines………………………………………………………
11
Appendix 1: Glossary…………………………………………………………….
12
Appendix 2: Bed Rails - Intended Purpose and Potential Risks…………….
14
Appendix 3: Bed Side Rail Types……………………………………………….
15
Appendix 4: Hospital Bed Safety Workgroup Member Organizations
that Signed on to the Clinical Guidance….………………………………….…
17
Appendix 5: Authors…………………………………..………………………….
18
i
April 2003
In April 1999, the Food and Drug Administration (FDA) in
partnership with representatives from the hospital bed industry,
national healthcare organizations, patient advocacy groups and
other federal agencies formed the Hospital Bed Safety
Workgroup. The workgroup’s goal is to improve the safety of
hospital beds for patients in all health care settings who are
most vulnerable to the risk of entrapment. The workgroup is
developing additional resources including dimensional
guidelines, measurement tools, and educational materials to
assist manufacturers, caregivers and consumers.
This clinical guidance is provided for discussion and educational
purposes only and should not be used or in any way relied upon
without consultation with and supervision of a qualified
practitioner based on the case history and medical condition of a
particular patient. The Hospital Bed Safety Workgroup, their
heirs, executors, administrators, successors, and assigns hereby
disclaim any and all liability for damages of whatever kind
resulting from the use, negligent or otherwise, of this clinical
guidance.
The contents of this publication may be reproduced without permission. Credit to the
Hospital Bed Safety Workgroup as the source is appreciated but not required.
For information about the Hospital Bed Safety Workgroup, see the FDA’s website at http://www.fda.gov/cdrh/beds/
ii
April 2003
Clinical Guidance
For The Assessment and Implementation of Bed Rails
In Hospitals, Long Term Care Facilities, and Home Care Settings
Introduction
Every patient, regardless of care setting, deserves a safe and comfortable sleeping and bed
environment. The goal of this clinical guidance is the provision of such an environment to
patients in hospitals, long term care facilities, and home care settings. (Note: The term patient as
used in this document refers to patients in hospitals, residents in long term care facilities, and
clients in home care settings.) The purpose of this guidance is to provide a uniform set of
recommendations for caregivers in hospitals, long term care facilities, and home care settings to
use when assessing their patients’ need for and possible use of bed rails. The guidance is
deliberately basic in design and content to allow each setting to adapt it to meet the unique needs
of their respective patients and environments.
The guidance that follows is intended to assist caregivers in making decisions about the care for
their patients. Its components are not intended to serve as clinical standards or requirements for
care. They are not intended to serve as applicable federal, state or local regulations or guidelines
governing care in respective settings. Likewise the recommendations should not be interpreted
as the best or only options, professional standards of care, or legal protection for the users.
The term bed rails is used in this document. Commonly used synonymous terms are side rails,
bed side rails, and safety rails. Bed rails are adjustable metal or rigid plastic bars that attach to
the bed and are available in a variety of shapes and sizes from full to half, one-quarter, and oneeighth in lengths.1 In the spectrum of care including hospital, long term care and home care
settings, bed rails serve a variety of purposes, some of which are in the best interest of the
patient’s health and safety. Bed rails:
• are used on stretchers or beds while transporting patients following surgery or when
relocating a patient to a new room or unit;
• can facilitate turning and repositioning within the bed or transferring in or out of a bed;
• may provide a feeling of comfort and security, or facilitate access to bed controls; and
• may be used as a physical barrier to remind the patient of the bed perimeters, to ask for
nursing assistance, or to restrict voluntary movement out of bed.2,3
Achieving the goal of a safe and comfortable bed and sleeping environment may necessitate the
reduction or elimination of bed rail use in cases in which the bed rail is not in the best interests of
the patient’s health and safety.
1
Capezuti, E. & Lawson, WT III (1999). Falls and restraint liability issues. In P. Iyer (Ed.) Nursing Home
Litigation: Investigation and Case Preparation. Tucson, AZ: Lawyers and Judges Publishing Company.
2
Braun, J.A. & Capezuti, E. (2000). The legal and medical aspects of physical restraints and bed side rails and their
relationships to falls and fall-related injuries in nursing homes. DePaul Journal of Healthcare Law, 3 (1) 1-72.
3
Capezuti, E., Talerico, K.A., Cochran, I., Becker, H., Strumpf, N., & Evans, L. (1999). Individualized
interventions to prevent bed-related falls and reduce side rail use. Journal of Gerontological Nursing, 25, 26-34.
Clinical Guidance For the Assessment and Implementation of Bed Rails In Hospital, Long Term Care Facilities, and Home Care Settings
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April 2003
Although various types may be used depending on a patient’s medical and functional needs, bed
rails may pose increased risk to patient safety. Clinical research suggests that bed rails may not
be benign safety devices. For example, evidence indicates that half-rails pose a risk of
entrapment and full rails pose a risk of entrapment as well as falls that occur when patients climb
over the rails or footboards when the rails are in use.4,5 Recognizing this risk, the U.S. Food and
Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS), formerly
known as the Health Care Financing Administration (HCFA), have taken action aimed at
reducing the likelihood of injuries related to bed rails. The FDA MedWatch Reporting Program
receives reports of entrapment hazards.6 In 1995 the FDA issued a Safety Alert entitled,
“Entrapment Hazards with Hospital Bed Side Rails.”7 In 1997, the FDA authored an article,
based on the reported hospital bed adverse events, that identified potential risk factors and
entrapment locations about the hospital bed. The FDA continues to receive reports of patient
deaths and injury that provide documentation of patient entrapment.8
CMS has imposed performance expectations on hospitals and nursing facilities. For example, in
implementing federal regulations that apply to the use of physical restraints, CMS issued
guidance in June 2000 for surveyors to determine hospitals’ compliance with these regulations.
One section of the guidance states, “It is important to note that side rails present an inherent
safety risk, particularly when the patient is elderly or disoriented. Even when a side rail is not
intentionally used as a restraint, patients may become trapped between the mattress or bed
frame and the side rail. Disoriented patients may view a raised side rail as a barrier to climb
over, may slide between raised, segmented side rails, or may scoot to the end of the bed to get
around a raised side rail. When attempting to exit the bed by any of these routes, the patient is
at risk for entrapment, entanglement, or falling from a greater height posed by the raised side
rail, with a possibility for sustaining greater injury or death than if he/she had fallen from the
height of a lowered bed without raised siderails.”9
In September 2000 CMS (then HCFA) issued revisions to surveyor guidance for determining
nursing facilities’ compliance with federal Medicare and Medicaid regulations governing the use
of restraints, which similarly describes the potential risks of using bed rails.10 For example, the
guidance states, “The same device may have the effect of restraining one individual, but not
another, depending on the individual resident’s condition and circumstances. For example,
partial rails may assist one resident to enter and exit the bed independently while acting as a
restraint for another.”
4
Parker, K., Miles, SH. (1997). Deaths caused by bed rails. Journal of the American Geriatrics Society 45:797-802.
Feinsod, F.M., Moore, M., Levenson, S. (1997). Eliminating full-length bed rails from long term care facilities.
Nursing Home Medicine 5:257-263.
6
MedWatch, the U.S. Food and Drug Administration’s medical products reporting program.
7
Food and Drug Administration. FDA Safety Alert: Entrapment Hazards with Hospital Bed Side Rails (Aug 23,
1995). U.S. Department of Health and Human Services.
8
Todd, J., Ruhl, C., & Gross, T. (1997). Injury and Death Associated with Hospital Bed Side-Rails: Reports to the
U.S. Food and Drug Administration from 1985 to 1995. American Journal of Public Health 87 (10): 1675-1677.
9
Health Care Financing Administration guidance to surveyors in the implementation of 42 CFR Part 482 Medicare
and Medicaid Programs. State Operations Manual Provider Certification Transmittal 17. June 2000. A-182-183.
10
Health Care Financing Administration guidance to surveyors in the implementation of 42 CFR Part 483.13(a).
Medicare and Medicaid Programs. State Operations Manual Provider Certification Transmittal 20. September 7,
2000. PP-45.
5
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April 2003
Guiding Principles
National surveys of patient deaths occurring in the bed environment demonstrate the risk of
entrapment when a patient slips between the mattress and bed rail or when the patient becomes
entrapped in the bed rail itself. The population at risk for entrapment are patients who are frail or
elderly or those who have conditions such as agitation, delirium, confusion, pain, uncontrolled
body movement, hypoxia, fecal impaction, and acute urinary retention that cause them to move
about the bed or try to exit from the bed. The absence of timely toileting, position change, and
nursing care are factors that may also contribute to the risk of entrapment. The risk may also
increase due to technical issues such as the mis-sizing of mattresses, bed rails with winged edges,
loose bed rails, or design elements such as wide spaces between vertical bars in the rails
themselves.
The principles that follow are intended to guide the development of patients’ care plans.
1. The automatic use of bed rails may pose unwarranted hazards to patient safety.
When planning patient care the following should be considered:
• The potential for serious injury is more likely to be related to a fall from a bed with raised
bed rails when the patient attempts to climb over, around, between, or through the rails,
or over the foot board, than from a bed without rails in use.
• Evaluation is needed to assess the relative risk of using the bed rail compared with not
using it for an individual patient.
• Bed rails sometimes restrain patients. When used as restraints, bed rails can pose the
same risk to patient safety as other types of physical restraints.
• Patient safety is paramount. In an emergent situation the caregiver needs to do whatever
is necessary in his or her professional judgment to secure the patient’s safety. Consider
that using a bed rail or other device to restrain the patient could place the patient’s safety
at risk.
• Physical restraints such as vest/chest, waist, or leg/arm restraints used simultaneously
with raised bed rails may be medically indicated in certain limited circumstances in the
acute care environment. Consider that when physical restraints and bed rails are used
simultaneously:
- the risk to patient safety, e.g., suffocation or accidental suspension, may increase;
- patients should be monitored closely;
- appropriate care such as toileting should be provided; and
- reassessment for medical necessity and removal is needed on a regular basis.
• Strangling, suffocating, bodily injury, or death can occur when patients or parts of their
bodies are caught between rails or between the bed rails and mattresses.
2. Decisions to use or to discontinue the use of a bed rail should be made in the context of an
individualized patient assessment using an interdisciplinary team with input from the patient
and family or the patient’s legal guardian.
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April 2003
3. The patient’s right to participate in care planning and make choices should be balanced with
caregivers’ responsibility to provide care according to an individual assessment, professional
standards of care, and any applicable state and federal laws and regulations.
Policy Considerations
1. Regardless of the purpose for which bed rails are being used or considered, a decision to
utilize or remove those in current use should occur within the framework of an individual
patient assessment.
2. Because individuals may differ in their sleeping and nighttime habits, creation of a safe bed
environment that takes into account patients’ medical needs, comfort, and freedom of
movement should be based on individualized patient assessment by an interdisciplinary team.
• The composition of the interdisciplinary team may vary depending upon the nature of the
care and service setting and the patient’s individual needs. Team members for
consideration should include, but are not limited to: nursing, social services, and dietary
personnel; physicians (or their designees); medical director; rehabilitation and
occupational therapists; patient; family (or authorized representative); and medical
equipment suppliers.
• The patient and family (or authorized representative) play a key role in the creation of a
safe and comfortable bed and sleeping environment. These individuals can provide
information about the patient’s previous sleeping habits and bed environment that
caregivers need to design the bed environment. Their participation in discussions
facilitates creation of a bed and sleeping environment that meets patients’ needs.
3. Use of bed rails should be based on patients’ assessed medical needs and should be
documented clearly and approved by the interdisciplinary team.
• Bed rail effectiveness should be reviewed on a regular basis.
• The patient’s chart should include a risk-benefit assessment that identifies why other care
interventions are not appropriate or not effective if they were previously attempted and
determined not to be the treatment of choice for the patient. (See Appendix 1: Glossary
for patient/caregiver assist items.)
4. Bed rail use for treatment of a medical symptom or condition should be accompanied by a
care plan (treatment program) designed for that symptom or condition.
• The plan should present clear directions for further investigation of less restrictive care
interventions.
• The documentation should describe the attempts to use less restrictive care interventions
and, if indicated, their failure to meet patients’ assessed needs.
5. Bed rail use for patient’s mobility and/or transferring, for example turning and positioning
within the bed and providing a hand-hold for getting into or out of bed, should be
accompanied by a care plan.
• The patient should be encouraged to participate in care planning to help design a safe and
comfortable bed environment.
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April 2003
The care plan should:
- include educating the patient about possible bed rail danger to enable the patient to
make an informed decision; and
- address options for reducing the risks of the rail use.
6. The process of reducing and/or eliminating existing use of bed rails should be undertaken
incrementally using an individualized, systematic, and documented approach.
7. Creating a safe bed environment does not necessarily preclude the use of bed rails. However,
a decision to use them should be based on a comprehensive assessment and identification of
the patient’s needs, which include comparing the potential for injury or death associated with
use or non-use of bed rails to the benefits for an individual patient. In creating a safe bed
environment, the following general principles should be applied:
• Avoid the automatic use of bed rails of any size or shape.
• Restrict the use of physical restraints, including chest, abdominal, wrist, or ankle
restraints of any kind on individuals in bed.
• Inspect, evaluate, maintain, and upgrade equipment (beds/mattresses/bed rails) to identify
and remove potential fall and entrapment hazards and appropriately match the equipment
to patient needs, considering all relevant risk factors.
• Re-assess the patient’s needs and re-evaluate the equipment if an episode of entrapment
or near-entrapment occurs, with or without serious injury. This should be done
immediately because fatal “repeat” events can occur within minutes of the first episode.
Process/Procedure Considerations
The items listed below are not meant to be all-inclusive. Caregivers may identify other concerns
that need to be addressed.
1. Individualized Patient Assessment
Any decision regarding bed rail use or removal from use should be made within the
framework of an individual patient assessment. If a bed rail has been determined to be
necessary, steps should be taken to reduce the known risks associated with its use. The
individual patient assessment includes11,12,13,14,15,16,17,18
11
Capezuti, E., Talerico, K.A., Strumpf, N., & Evans, L. (1998). Individualized assessment and intervention in
bilateral side rail use. Geriatric Nursing, 25, 26-34.
12
See Capezuti et al., supra note 1.
13
Donius, M. & Rader, J. (1994) Use of Side rails: Rethinking a Standard of Practice, Journal of Gerontological
Nursing 23, 23-27.
14
Rader, J. (1995). Creating a supportive environment for eliminating restraints. In Rader, J. & Tornquist, E.M.
(Eds.) Individualized Dementia Care, New York: Springer Publishing Company.
15
Donius, M., & Rader, J. (1996). Side rails: Rethinking a Standard Practice. In Burggraf, V. & Barry, R. (Eds.),
Gerontological Nursing Current Practice and Research. Thorofare, NJ: Slack, Inc.
16
O’Keeffe, S., Jack, C.I.A., & Lye, M. (1996). Use of restraints and bed rails in a British hospital. Journal of the
American Geriatrics Society, 44, 1086-1088.
17
Frengley, J.D. (1999), Bedrails: Do They Have A Benefit?, Journal of the American Geriatrics Society, 47(5):
627-628.
18
Hammond, M., Levine, J.M. Bedrails: Choosing the Best Alternative. Geriatric Nursing. 20(6):297-300. 1999
Nov. – Dec.
5
•
•
•
•
•
•
•
•
•
•
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Medical diagnosis, conditions, symptoms, and/or behavioral symptoms
Sleep habits
Medication
Acute medical or surgical interventions
Underlying medical conditions
Existence of delirium
Ability to toilet self safely
Cognition
Communication
Mobility (in and out of bed)
Risk of falling
2. Sleeping environment assessment
This assessment includes elements or conditions that may affect the patient’s ability to sleep
and may be considered in evaluating areas to address in a patient’s care plan.
• Comfort
− pain
− hypoxia
− grieving
− loneliness
− hunger, thirst
− hydration
− calorie intake and protein calories
− boredom
− amount of time spent in bed
− light levels
− temperature
•
Understanding of self and family
− hobbies, interests, religion
− pictures of family
•
Proximity to toilet
− toilet within view
− toilet accessible
− strategy (patient with or without help from caregiver) for toileting
•
Appropriate bed
− comfortable
− safe
− height
− mattress/overlay
− mattress edge definition (if necessary)
− support for turning (if necessary)
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April 2003
− strategy for safe egress
− elevation for head of bed
•
Support by Caregivers
− individualized toileting schedule
− routine comfort assessment
− skin care and hygiene
− emotional and physical support
•
Medical Stabilization
− treatment of underlying acute medical problems
− dosages and types of medication
− effects of long-term use of hypnotics
− pain treatment strategy
− caution with orthostatic medications (diuretics, short-acting antihypertensives)
− diuretics (if indicated) not given at night
− diabetic snack given at night
− treatment for nocturnal esophageal reflux
− bowel elimination plan for regularity
3. Treatment Programs/Care Plans
• Address diagnoses, symptoms, conditions, and/or behavioral symptoms for which the
use of a bed rail is being considered.
• Identify nursing/medical and environmental interventions (e.g., for a patient with a
life-long habit of staying up at night, provide nighttime activity).
• If clinical and environmental interventions have proven to be unsuccessful in meeting
the patient’s assessed needs or a determination has been made that the risk of bed rail
use is lower than that of other interventions or of not using them, bed rails may be
used. Documentation of the risk-benefit assessment should be in the patient’s
medical chart.
• The team should review the treatment program and determine its effects on the
patient through an ongoing cycle of evaluation that includes assessment of outcomes
and adverse effects.
• When planning care for the patient for whom a low bed is selected, consideration
should be given to potential effects on the patient such as restraining desired
voluntary movement or creating an unwanted psychological effect by being placed
close to the floor. The individualized care plan and risk benefit considerations should
address these issues and the plan modified accordingly.
• General guidance:
a. A patient is assessed to be at low risk for injury, as defined by these factors:
transfers safely to and from the bed to a wheelchair without assistance;
ambulates without assistance to and from the toilet without falling;
has not fallen, or is unlikely to fall, out of bed; and
notifies staff appropriately using call system.
Consider using a bed for this patient without a bed rail.
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b. A patient is assessed to be unsafe in bed, or at high risk for injury, as defined
by these factors:
inability to transfer safely to and from the bed to a wheelchair;
previous entrapment or near-entrapment episode;
inability to ambulate to and from the toilet without falling;
history of bed-related serious injury;
episodes of falling out of bed, or likelihood that such episodes will occur; or
inconsistent in notifying staff of needs or unable to access the call system.
Consider placing this patient in an adjustable height bed that can go very low to the
floor for sleeping and raised for transfers and activities of daily living care, or an
alternative such as a concave mattress as determined by the interdisciplinary care
team. Use a high-impact mat next to the bed.
c. A patient is assessed to require a bed in a low position but has difficulty
getting into the low bed from the standing position:
Consider an adjustable-height bed. If this is not available, consider adding a quarter
rail or transfer device (See Appendix 1: Glossary) to a low bed for the patient to hold
for support while entering the low bed. When selecting a support hold, consider:
Such rails should contain cross bars close enough to prevent the passage of the
patient’s head or body part through the rail and fit closely enough to the mattress
to prevent entrapment.
Other interventions exist, such as secured vertical poles used for transferring in
and out of bed. These poles, which are secured into the ceiling and floor, have
weight limits. Tape applied to the pole may increase traction. They are generally
used with more cognitively functional individuals.
d. A patient is assessed to need a low bed, but an assessment determines that the
patient is in danger of hurting him/herself while exiting from the low bed or is
in danger of an unstable transfer after standing up by grabbing onto a bed side
table or sink:
Consider using a bed alarm to alert nursing staff when patient is leaving the bed.
Base the decision on the individual patient’s clinical condition and assessment.
Carefully consider the use of bed alarms for the patient who is agitated or
confused.
e. Steps should be taken to reduce risk of injury to patients and caregivers. Keep
the bed in the lowest position with the wheels locked when occupied,
adjusting the level for activities such as administering care or for patient
transfers in/out of bed:
Place a high impact mat next to the low bed to cushion falls from the low bed as
long as this does not create a greater risk of accident to the patient or caregivers.
Raise the bed to give care and lower it when finished. If the bed is not
adjustable, utilize body mechanics techniques such as kneeling on one or both
knees on the high impact mat rather than bending over.
Store the high impact mat when it is not in use.
Assess area for objects that may cause injury.
Move furniture far enough away from the bed to avoid risk of injury.
Train caregivers on the proper use of low beds and proper body mechanics.
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Risk Intervention
Assessment of risk should be part of the individual patient’s assessment, and steps to address the
risk should be incorporated into the patient’s care plan. The following are examples of risk
intervention approaches.
1. Nursing
• Provide individually scheduled toileting.
• Develop a schedule for turning and positioning.
• Clean urine and/or feces promptly.
• Elevate head of bed for patients with congestive heart failure (CHF), chronic obstructive
pulmonary disease (COPD), reflux, and actively infusing enteral fluids.
• Position patients to maximize comfort and change positions in a timely manner,
maintaining comfort and reducing risk for skin breakdown.
• Accommodate patients’ preferred bedtime habits whenever possible.
• Restrict use of physical restraints on patients in bed.
• When medically indicated, use padded bed rails for individuals with an active seizure
disorder or active movement disorder.
• Provide distractions such as music, television, or food and fluids for patients who do not
sleep through the night.
• Provide calming interventions and pain relief.
• Plan time during the day to provide periods of physical activity that help promote a
restful sleep.
• Re-evaluate and revise patient’s treatment program as needed if an episode of entrapment
or near-entrapment occurs with or without serious injury.
2. Medical
• Minimize use of medications that alter mental status.
• Use alternatives to sleeping medications.
• Dispense diuretics before the late afternoon/evening.
• Treat pain.
• Screen and treat for hypoxia.
• Assess the clinical status of delirious patients to rule out reversible etiologies.
• Promote mobility and fitness, e.g., restorative care to enhance abilities to stand safely and
to walk.
3. Patient and Family
• Seek and utilize input about the patient from the patient and family (or authorized
representative) to assist in identifying nursing and medical risk interventions.
• If patients or family members ask about using bed rails, encourage them to talk to the
health care team about whether bed rails are indicated.
• Since the patient and family are integral members of the team, they should be encouraged
to learn about bed safety and appropriate care options.
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April 2003
Individualized Environmental Changes
The environmental changes listed below are suggestions for consideration. Whether they will be
used for an individual patient depends on the patient’s assessment.
1. Use of low beds with adjacent mat on the floor (with consideration given to using
mechanical lifts and proper lift technique training for caregiver staff).
2. Use of low beds that can be elevated electronically for transfer and activities of daily
living (ADL) care.
3. Placement of the patient’s call bell within easy reach and provision of visual and
verbal reminders to use the call bell when necessary.
4. Use of bed alarms to warn of patients’ attempts to exit from bed.
5. Use of “perimeter reminders” or “border definers” such as body pillow/cushions or
mattresses with lipped/raised edges.
6. Use of a trapeze affixed to bed to increase patient’s bed mobility. (For patients with
shoulder conditions, trapeze use should be carefully scrutinized.)
7. Placement of inconspicuous signs, without patients’ names, to inform caregivers of
interdisciplinary care team recommendations.
Patient Choice
As with any other device that may be used as a restraint, if a patient, family member, or
authorized representative requests the inappropriate use of side rails, then the interdisciplinary
care team has a responsibility to discuss the risks involved, as well as the benefits of any clinical
and/or environmental interventions that may be safer in meeting the patient’s assessed needs,
individual circumstances, and environment. The patient’s right to participate in care planning
and make choices should be balanced with caregivers’ responsibility to provide care according to
an individual assessment, professional standards of care, and any applicable state and federal
laws and regulations.
Bed Rails as Restraints
When bed rails have the effect of keeping a patient from voluntarily getting out of bed, they fall
under the definition of a physical restraint. If they are not necessary to treat medical symptoms,
and less restrictive interventions have not been attempted and determined to be ineffective, bed
rails used as restraints should be avoided.19,20 Bed rails used on the bed of a patient who is
completely immobile do not serve as restraints, but may not be medically necessary. It is
recommended that they be avoided.
Education /Training
Hospitals, long term care facilities, and home health care providers should provide education and
training about bed rail use to assist in creating and implementing a safe and comfortable sleeping
environment for their patients. It is recommended that the education and training be directed
toward the following groups:
19
20
See Health Care Financing Administration supra note 10.
See Health Care Financing Administration supra note 7 at A-182.
10
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•
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April 2003
Staff
Patient/family
Physicians, including medical directors and physician extenders such as physician assistants
and nurse practitioners
Long term care ombudsman
Regulatory agencies or representatives
Bed Rail Safety Guidelines
If it is determined that bed rails are required and that other environmental or treatment
considerations may not meet the individual patient’s assessed needs, or have been tried and were
unsuccessful in meeting the patient’s assessed needs, then close attention must be given to the
design of the rails and the relationship between rails and other parts of the bed.
1.
2.
3.
4.
5.
6.
7.
8.
9.
The bars within the bed rails should be closely spaced to prevent a patient’s head from
passing through the openings and becoming entrapped.
The mattress to bed rail interface should prevent an individual from falling between the
mattress and bed rails and possibly smothering.
Care should be taken that the mattress does not shrink over time or after cleaning. Such
shrinkage increases the potential space between the rails and the mattress.
Check for compression of the mattress’ outside perimeter. Easily compressed perimeters
can increase the gaps between the mattress and the bed rail.
Ensure that the mattress is appropriately sized for the selected bed frame, as not all beds
and mattresses are interchangeable.
The space between the bed rails and the mattress and the headboard and the mattress
should be filled either by an added firm inlay or a mattress that creates an interface with
the bed rail that prevents an individual from falling between the mattress and bed rails.
Latches securing bed rails should be stable so that the bed rails will not fall when shaken.
Older bed rail designs that have tapered or winged ends are not appropriate for use with
patients assessed to be at risk for entrapment.
Maintenance and monitoring of the bed, mattress, and accessories such as
patient/caregiver assist items (See Appendix 1: Glossary) should be ongoing.
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April 2003
Appendix 1: Glossary
Adjustable height bed – A bed with “hi-low” function such that the height of the sleep surface can be
adjusted.
Automatic contour - A feature of a bed where the thigh section of the sleep surface articulates upward as
the head section travels upward thereby reducing the likelihood of patient/resident mattress from
migrating toward the foot end of the bed.
Bed alarms – Alarms intended to notify caregivers of either an unwanted patient/resident egress or that
the patient/resident is near the edge of the mattress.
Bed rail extender – A detachable device intended to bridge the space between the head and foot bed rail.
Bed rails –Adjustable metal or rigid plastic bars that attach to the bed. They are available in a variety of
types, shapes, and sizes ranging from full to one-half, one-quarter, or one-eighth lengths. Synonymous
terms are side rails, bed side rails, and safety rails. (See attached Bed Side Rail Types for illustrated
definitions.)
Control bed rail – A bed rail that incorporates bed function controls for patient/staff activation.
Fireman’s pole – A pole secured (floor and ceiling mooring) next to the bed that acts as a support for the
patient to get into and out of the bed.
Handgrips – Devices attached to either side of the bed to provide the patient/resident the ability to
reposition themselves while in bed as well as an aid to enter and leave the bed.
High-impact mat (bed-side mat) – A mat placed next to the bed that absorbs the shock if the patient
falls from the bed.
Entrapment – An event in which a patient is caught, trapped, or entangled in the spaces in or about the
bed rail, mattress, or hospital bed frame. Entrapment can result in serious injury or death.
Interdisciplinary team -- The interdisciplinary team may vary in constituency depending upon the nature
of the care and service setting and the individual patients’ needs. Members may include, but are not
limited to: patient; family member (or patient’s legal representative); nursing, social services, and dietary
personnel; attending physician (or designee); medical director; rehabilitation and occupational therapists;
and medical equipment suppliers.
Lifting pole – A device suspended above the bed intended to allow the patient to change position by
gripping it.
Low bed – This bed is defined according to the patient: The bed is considered “low” if, when the patient
is sitting on the side of the bed with feet on the floor, the angle of the patient’s bent knees is 90 degrees or
less.
Mattress with raised edges – A mattress that has a perimeter configured in a manner to allow the
patient/resident to be “cradled” in the center of the mattress and reduces the likelihood of unwanted
patient egress. It has a central area on either side of the mattress that is not raised and is used for egress.
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April 2003
Patient assessment – The assessment provides ongoing information necessary to develop a care plan, to
provide the appropriate care and services for each patient, and to modify the care plan and care/services
based on the patient’s status. Details about the components of the assessment are found on pages 5 and 6
of this document.
Pediatric rail – A rail in which the bar spacing is no larger than two and three-eighths inches.
Pendant control – A means used by either the patient or the operator to control the drives that activate
various bed functions and is attached to the bed by a cord.
Physical restraint – Any manual method or physical or mechanical device, material, or equipment
attached or adjacent to the resident’s [patient’s] body that the individual cannot remove easily that
restricts freedom of movement or normal access to one’s body. (Source: Health Care Financing
Administration State Operations Manual, Rev. 274, Guidance to Surveyors at 42 CFR Subpart B,
Requirements for Long Term Care Facilities, 483.13(a).)
Sleeping environment – Includes physical components such as the bed size and height and mattress, the
accessibility of personal items and accessories such as a call bell, and the room temperature and noise or
light levels. The environment also includes nonphysical aspects such as comfort and security. These
aspects may be related to the physical features of the bed such as the degree of mattress firmness, or
features that facilitate freedom from physical pain, or a feeling of safety and privacy.
Transfer device - Support for transfers such as half - or quarter-length upper bed rails, bed grab bars, bed
handles attached to the bed frame, or fireman’s transfer pole.
Treatment program (care plan) – The treatment program includes measurable objectives and timetables
to meet the patient’s medical, nursing, and mental and psychosocial needs that are identified through the
assessment process. The effectiveness of the treatment program is evaluated and modified as necessary.
The interdisciplinary team reviews, revises, and initiates changes to the program as needed in accordance
with professional standards of practice after each assessment.
Seizure pads - Padded covers for bed rails that may be used to prevent unwanted patient/resident cuts and
bruising from repeated contact with the bed rails. Also used to cover openings within the perimeter of the
side rails and space between the head and foot rails.
Side rails – See Bed rails.
Stuff pads – Plastic covered pads used to obliterate open spaces between bed rails and mattresses,
mattresses and head/foot boards.
Transfer bar – A one-piece device, attached to the bed frame on one or both sides of the bed, that is
grasped to aid in bed entry and exit.
13
April 2003
Appendix 2: Bed Rails - Intended Purpose and Potential Risks
Intended Purpose of Bed Rails
1. One of several methods utilized to prevent patient from falling out of bed.
• Reminds patient not to get out of bed when medically contraindicated and/or medical equipment
is attached to the patient.
• Defines the bed edge.
• Helps to protect patient from falling out of bed during transport.
2. May assist patient with movement.
• Moving within the bed.
• Getting in and out of bed.
3. One of several methods to provide the patient with easy access to bed controls.
4. One of several methods to provide a feeling of comfort and security.
Potential Risks of Bed Rails
1. Create a source of known morbidity and mortality such as:
• Strangling, suffocation, serious bodily injury,* or death when patients or parts of their bodies are
caught between rails, the openings of the rails, or between the bed rails and mattress.
2. Impede patients from safely getting out of bed:
• Patients crawl over rails and fall from greater heights increasing the risk for serious injury.
• Patients attempt to get out of bed over the foot board.
3. Restrain patients in many circumstances:
• Hinder patients from independently getting out of bed thereby confining them to their beds.
• Create a barrier to performing routine activities such as going to the bathroom.
4. Can create negative psychological effects:
• Create undignified personal image.
• Alter patient self-esteem.
• Contribute to patient isolation.
• Confinement can cause patients to be incontinent.
The potential risks can be exacerbated by:
• Improper match of the bed rail to bed frame.
• Improper installation.
• Objects such as holders or supports that remain when the bed rail is removed.
* May include head trauma; bruising, contusions, and/or skin lacerations; and
fractures and/or dislocations.
14
April 2003
Appendix 3: Bed Side Rail Types
The drawings below are intended only to illustrate the design of bed rails. They are not intended
to represent actual or recommended dimensions.
Full-Length Rail: A onepiece rail that extends along
the side of the bed from the
head to the foot section.
¾-Length Rail: A onepiece rail that extends along
the side of the bed threequarters of the way down
from the head of the bed.
Half-Length Rail: A onepiece rail that extends
along the side of the bed
one-half the length of the
bed from the head of the
bed.
15
April 2003
Quarter-Length Rail: A
one-piece rail that extends
along the side of the bed
approximately ¼ the length
of the bed from the head of
the bed.
Split Rails: A pair of half
rails. One set extends along
the side of the bed from the
head of the bed to the midsection of the bed. The other
set extends from the midsection of the bed to the foot
of the bed. Generally, there
is a space between the two
sets of rails.
Transfer Bar: A one-piece
device, attached to the bed
frame on one or both sides
of the bed, that is grasped to
aid in bed entry and exit.
16
April 2003
Appendix 4: Hospital Bed Safety Workgroup Member
Organizations that Signed on to the Clinical Guidance
AARP
American Association of Homes and Services for the Aging
American Health Care Association
American Medical Directors Association
American Nurses Association
American Society of Healthcare Risk Management
Basic American Metal Products
Care Providers of Minnesota
Carroll Health Care
ECRI
Evangelical Lutheran Good Samaritan Society
Hard Manufacturing
Health Safe, Incorporated
Iona Senior Services
Kinetic Concepts Incorporated
Law Offices of Julie A. Braun
MC Healthcare
Medical Devices Bureau, Health Canada
National Association of Home Care
National Patient Safety Foundation
National Citizens Coalition for Nursing Home Reform
Orange Grove Habilitation Center
RN Systems +
Span American
Sunrise Medical
Tactilics, Inc.
Untie the Elderly, The Kendal Corporation
U.S. Food and Drug Administration
Vail Products, Incorporated
Veterans Administration National Center for Patient Safety
HBSW member, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has
determined that the Clinical Guidance does not conflict with current standards in the JCAHO
Comprehensive Accreditation Manual for Hospitals 2002, 2002 Standards Manuals for Home Care, or
the 2002-2003 Comprehensive Accreditation Manual for Long Term Care.
17
April 2003
Appendix 5: Authors
Doug Beardsley
Administrator/CEO
Valley Hospital at Hidden Lakes
Golden Valley, Minnesota
Mary Bias
Vice President
Hard Manufacturing Company
Buffalo, New York
Sarah Greene Burger, RNC, MPH
National Citizens’ Coalition for Nursing Home Reform
Washington, DC
Elizabeth Capezuti, PhD, RN, CS, FAAN
Associate Professor
Independence Foundation Wesley Woods Chair in Gerontologic Nursing
Nell Hodgson Woodruff School of Nursing
Emory University
Atlanta, Georgia
Fred M. Feinsod, MD, MPH, CMD
American Medical Directors’ Association
Colorado Springs, Colorado
Rita Munley Gallagher, PhD, RN, C
Senior Policy Fellow
Department of Nursing Practice and Policy
Washington, DC
Beryl Goldman, RN, MS, NHA
Director for Health Services
The Kendal Corporation
Kennett Square, Pennsylvania
Doni Haas, RN, LHRM
National Patient Safety Foundation
Stuart, Florida
18
April 2003
Stephanie B. Hoffman, PhD
Director, Interprofessional Team Training and Development
Department of Veterans Affairs
James A. Haley Veterans Hospital
Tampa, Florida
Bill Kubat, MA
Vice President for Care Management, Clinical and Quality Affairs
Sioux Falls, South Dakota
Evvie Munley
Senior Health Policy Analyst
American Association of Homes & Services for the Aging
Washington, DC
Janet Myder, MPA
Director of Regulatory Systems
Washington, DC
Mary Lou Pijar
Public Health Advisor
Office of Health and Industry Programs
Center for Devices and Radiological Health
Rockville, Maryland
Georgene Saliba (through 2001)
Lehigh Valley Hospital
Allentown, Pennsylvania
Paul English Smith, JD, CPHRM, ASHRM
Vice President and General Counsel
Cabell Huntington Hospital, Inc.
Huntington, West Virginia
Joan Ferlo Todd
Senior Nurse Analyst
Office of Surveillance and Biometrics
Rockville, Maryland
19
Making the Right Choice
What you need to know about restraints in nursing homes
Myths about restraints
Myth: Restraints prevent falls and injuries.
Fact: Often restraints are actually the cause of injuries or even death.
Myth: It is a nursing home’s moral responsibility to safeguard people by using restraints.
Fact: Nursing homes are responsible for caring for people and helping them stay as healthy and happy as
possible. Restraints may or may not help reach those goals.
Myth: Residents do not mind being restrained. It makes them feel secure.
Fact: No one likes to feel helpless or trapped. A restraint can cause your loved one to become depressed,
confused, agitated, angry or withdrawn.
Myth: There are not any other options to protect my loved one.
Fact: This may be true in a very few cases, but most nursing home residents can be safely cared for
without using restraints.
What is a restraint?
A restraint is anything used to keep a person from moving around, moving a part of the body, like the arms
or hands, or having normal access to one’s body. Restraints must never be used to punish a person or to make
a person easier to handle. Two kinds of restraints may be used: physical and chemical. The use of any type of
restraint is a medical decision and must be ordered by a physician.
A physical restraint is anything that can keep a resident from getting out of a bed or chair, such as trays, bars,
belts, vests and lap cushions. Some other examples of physical restraints include:
• Wrist bindings
• Mittens
• Ankle bindings
• Special chairs, such as geriatric chairs, chairs with trays
A chemical restraint is a drug given to keep a person from striking out or acting in a way that could be
harmful. These drugs are helpful when they are used for the right reasons. But they shouldn’t be used just to
keep a person from pacing or wandering or to get them to do what you want. Chemical restraints can include:
• Sedatives: make a person relaxed or drowsy • Antipsychotics: calm a person with mental problems
Remember…
Everyone deserves as much freedom and dignity as possible. Restraints should only be used as a last resort. If
people are able to move around on their own, it helps them:
• Keep their dignity.
• Interact with others and the world around them.
• Feel more content and independent.
• Keep their muscles working and keep their strength.
To compare local nursing homes’ use of restraints, visit www.medicare.gov, then select Compare Nursing Homes
in Your Area.
This document is available at www.primaris.org
Frequently Asked Questions
Q: Do restraints have risks?
A: When a person’s freedom is restricted, health problems or serious complications can occur, such as:
• Death
• Poor nutrition
• Falls
• Loss of appetite
• Pneumonia
• Weak bones and muscles
• Bed sores or bruises
• Stiff joints
• Dehydration (not getting enough to drink)
• Anxiety
• Bladder infections (cannot get to bathroom)
• Lack of sleep
• Incontinence (lack of bladder control)
• Depression
• Constipation
• Loss of dignity
Q: As a family member, can I ask a nursing home to use restraints on my loved one?
A: No. Only a physician can order a restraint for a patient. Staff members may not use restraints when they are
not medically needed, even if the person’s family members request or approve their use. A restraint is like
any other medical treatment. You need to know what medical symptoms are being treated. If there is not a
medical reason for the restraint, it should not be used.
Q: My loved one is in restraints, what can I do as a family member?
A: Know the dangers of using restraints. Each restraint has its own risk. To get a better understanding, you can:
• Discuss the current restraint use with the medical professional and staff, especially if you don’t think
they are needed.
• Ask about the different things that were tried before restraints were used.
• Ask the medical professional and staff about the plan for the restraint. How long will it be used?
When will it be taken off?
• Ask if the restraint has more benefits than side effects or risks.
• Talk to the staff about your loved one’s habits and routines.
• Bring items from home to comfort your loved one.
Q: How can nursing homes avoid using restraints?
A: It’s important to know how to care for people without using restraints. Some of the ways nursing homes
might work to avoid restraints are listed. This list does not contain all possible interventions.
• Help them get to the bathroom regularly, so they won’t fall trying to go on their own.
• Provide a bedside toilet.
• Provide a low watt nightlight.
• Select the right size chair or wheelchair.
• Keep personal items in reach.
• Make sure shoes fit and have non-skid soles.
• Provide your loved one opportunities to be around people who enjoy the same activities and hobbies.
• Focus on the person’s needs and try to provide for them.
• Try to find out why a restraint seems necessary to the staff.
• Use automatic wheelchair locks, if indicated by assessment.
MO-05-04-NHR May 2005 This material was prepared by Primaris, the Medicare Quality Improvement Organization for Missouri, under contract with the Centers for
Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy.
This document is available at www.primaris.org
Issue 27: Bed rail-related entrapment deaths | Joint Commission
Page 1 of 3
Sentinel Event Alert
September 06, 2002
Issue 27 - September 6, 2002
Bed rail-related entrapment deaths
On March 9, 2006, the Food & Drug Administration published final guidance designed to reduce
the occurrence of hospital bed entrapments. The guidance, entitled “Hospital Bed System
Dimensional and Assessment Guidance to Reduce Entrapment," identifies special issues
associated with hospital bed systems and provides design recommendations for manufacturers
of new hospital beds and suggestions for health care facilities on ways to assess existing beds.
The guidelines and supporting materials are available on the FDA website at
http://www.fda.gov/.
Since 1995, the Joint Commission has received reports of seven deaths or injuries related to bed rails;
three of these reports were from hospitals, two were from long term care facilities, one was from a
behavioral health care facility, and one involved a patient receiving home care services. JCAHO has root
cause analysis information only for the five incidents that occurred in hospitals and long term care
facilities, and this Alert will report information derived from those five cases.
All five cases involved patients/residents who were 65 years of age or older and all resulted in death by
asphyxiation. Of the patients/residents, four were mentally or behaviorally impaired; three were at risk for
falling; two had limited mobility in bed; one was on psychoactive or sedative medications; and one had a
physical deformity. Asphyxiation was caused by one of the following: being caught between the mattress
and the bed rail; being caught between the headboard and the bed rail; getting his or her head stuck in
the bed rail; or being strangulated by a vest restraint between the rails. No particular bed rail
configuration was implicated in these cases, which included upper rails only, upper and lower rails, both
upper rails and one lower rail, or continuous full-length rails. None of the cases involved the use of only
lower rails.
Root causes and risk reduction strategies
Recognizing the limitations of the small sample of cases, certain findings were recurrent in the root cause
analyses. All five organizations cited a breakdown in communication, most often among staff (two cases)
or with or between physicians (two cases), as well as with administration (one case). Four of the five
organizations cited equipment factors, including side rail protector pads not being used (four cases) and
problems with the bed/mattress/side rail configuration (one case). Other problems cited were
patient/resident assessment (three cases), including adequacy of assessment, scope and timing of
reassessment, and patient/resident observation; human factors (three cases), including staff orientation
and use of an agency nurse; and leadership (one case).
The risk reduction strategies implemented at these health care organizations included:
Orientation and retraining of staff.
Equipment redesign, including the use of bed rail protector pads, re-evaluation of beds for entrapment
potential, replacing beds, replacing or modifying side rails with gaps greater than five inches, removing
side rails from the bed, installing a positioning bar, or using "low" beds.
Process redesign, including patient assessment for risk of entrapment (e.g. confusion, sedation,
restlessness, lack of muscle control, size), patient observation, resident/family education about bed
rails, and improving communication policies.
Expert advice on bed rail safety
Elizabeth Capezuti, Ph.D., R.N., F.A.A.N., associate director for nursing science at the Center for Health in
Aging at Emory University, is an expert on restraints and bed rail safety. "Health care organizations need
to look at these devices like any restraint and evaluate the rationale for using them," says Capezuti.
"Don't pull up the siderail and walk away. Both split and full rails have the potential to cause fall-related
injuries as well as entrapment. Health care organizations need to look at bed rails as potentially restrictive
devices, or restraints, and ask themselves what kind of surveillance needs to be in place to assure safety."
"Health care
organizations need to
The Safe Medical Devices Act of 1990 requires hospitals and other
facilities to report to the Food and Drug Administration (FDA) any
deaths, serious illnesses and injuries associated with the use of medical
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_27.htm?print=yes
9/20/2010
look at these devices
like any restraint and
evaluate the rationale
for using them. Don't
pull up the siderail and
walk away. Both split
and full rails have the
potential to cause fallrelated injuries as well
as entrapment. Health
care organizations need
to look on bed rails as
potentially restrictive
devices, or restraints,
and ask themselves
what kind of
surveillance needs to be
in place to assure
safety."
-- Elizabeth Capezuti,
Ph.D., R.N., F.A.A.N.,
associate director for
nursing science at the
Center for Health in Aging
at Emory University
Page 2 of 3
devices, including bed rails. In 1995, the FDA issued its FDA Safety
Alert: Entrapment Hazards with Hospital Bed Side Rails (1), a report
that includes actions to prevent deaths and injuries from entrapment,
including evaluating the bed, mattress and bed rails and taking
additional safety measures for patients at risk for entrapment. From
1995 through 2001, the FDA received 381 entrapment reports of
deaths, injuries or near misses involving bed rails; of these reports,
237 were of deaths, 73 were of injuries, and 71 were of near misses.
More than half—53 percent—of the reports to the FDA occurred in
nursing homes, and 20 percent occurred in hospitals.
Of the 381 reports to the FDA, 35 of the deaths involved air pressure
mattresses (either overlay air mattresses placed on top of a regular
mattress or beds with built-in air mattresses.) A recent Journal of the
American Geriatrics Society (2) article reports that "the high
compressibility of air pressure mattresses distinguishes these deaths
from similar events involving conventional mattresses. As a person
moves to one side of an air mattress, that side compresses. This raises
the center of the mattress and lowers the side, making a ramp that
'pours' the patient off the bed or against the bed rail. Mattress
compression also widens the space between the mattress and the rail."
The article states that while foam blocks can be used to occlude the
space between the bed rail and a conventional mattress, highly
compressible air mattresses make this option less feasible. The article
concludes that "healthcare providers should manage this risk rather
than abandoning the beneficial use of pressurized mattresses for
treating or preventing decubitus ulcers."
In July 2001, the Department of Veterans Affairs' (VA) National Center
for Patient Safety issued guidance addressing bed rail entrapment and
requiring that beds used for patients at risk for entrapment be assessed
for excessive gaps and openings. Guidance was provided to use bed rail
retrofit kits, bed rail netting, clear padding or other suitable materials that would not obstruct staff's
visibility of the patient to fill gaps and openings. The VA suggested positioning the mattress on the bed
frame with Velcro or anti-skid mats to prevent the mattress from being pushed to one side creating a
large gap on one side of the bed.
Currently, the FDA, in partnership with the VA, Health Canada, representatives from the hospital bed
industry, national health care organizations and patient advocacy groups, formed the Hospital Bed Safety
Workgroup. This group is specifically concerned with preventing patient entrapment in hospital beds. In
early 2003, this group is scheduled to issue clinical guidance to assist caregivers in their assessment and
implementation of bed rail use. Dimensional guidance that includes entrapment zones measurements and
a tool for caregivers to measure openings in a bed will follow. (While devices to measure entrapment
zones may be helpful in identifying risk to patient safety, Joint Commission standards do not require the
measurement of entrapment zones.) Joint Commission standards require that organizations have a patient
safety program that encompasses performance improvement, environmental safety and risk
management; however, the standards do not prescribe how these activities should be structured.
Joint Commission recommendations
To help prevent entrapment deaths associated with bed rails, Joint Commission recommends that health
care organizations take these precautions:
1.
Provide orientation and training to staff about entrapment dangers with bed rails and assessment of
patients/residents for entrapment risk, as appropriate to the patient population and the care
environment.
2.
Assess patients/residents for risk of entrapment, including physical, mental, behavioral or medication
impairment.
3.
Re-evaluate beds for entrapment potential, including "gap" measurement and appropriate sizing of
mattresses for bed frames.
4.
For individual patients/residents at risk for entrapment, implement appropriate changes to beds (for
example, the use of retrofit kits, bed rail netting, clear padding, Velcro or anti-skid mats) to reduce
the risk of entrapment.
5.
When possible, keep patients/residents with risk factors for entrapment under more frequent
observation.
6.
Educate the patient/resident and/or his or her family about the purpose and potential dangers of bed
rails.
9/20/2010
Page 3 of 3
Resources
1.
FDA Safety Alert: Entrapment Hazards is available at the United States Food and Drug
Administration website, http://www.fda.gov/. A Guide to Bed Safety brochure is also available at
www.fda.gov/.
2.
"Deaths Between Bedrails and Air Pressure Mattresses," by Steven H. Miles, Journal of the American
Geriatrics Society, June 2002, p. 1124-5.
Please route this issue to appropriate staff within your organization. Sentinel Event Alert may
only be reproduced in its entirety and credited to The Joint Commission.
9/20/2010
Guidance for Industry and FDA
Staff
Hospital Bed System Dimensional
and Assessment Guidance to
Reduce Entrapment
Document issued on: March 10, 2006
The draft of this document was issued on August 30, 2004.
For questions regarding this document contact Jay A. Rachlin, Office of Communication,
Education, and Radiation Programs, 301-796-5722, [email protected] or Joan Ferlo
Todd, Office of Surveillance and Biometrics, 301-796-6079, [email protected].
U.S. Department of Health and Human Services
Food and Drug Administration
Division of Device User Programs and Systems Analysis (HFZ-230)
Office of Communication, Education, and Radiation Programs
Division of Postmarket Surveillance (HFZ-520)
Office of Surveillance and Biometrics
Contains Nonbinding Recommendations
Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane,
Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be
submitted to http://www.fda.gov/dockets/ecomments. When submitting comments, please
refer to Docket No. 2004D-0343. Comments may not be acted upon by the Agency until the
document is next revised or updated.
Additional Copies
Additional copies are available from the Internet at http://www.fda.gov/cdrh/beds, or you
may either send a fax request to 301-847-8149 to receive a hard copy of the document, or
send an e-mail request to [email protected] to request hard or electronic copy.
Please use the document number 1537 to identify the guidance you are requesting.
Table of Contents
Introduction ..........................................................................................................................................................1
The Least Burdensome Approach.......................................................................................................................2
Background...........................................................................................................................................................2
Standards and Future Harmonization.................................................................................................................4
Organization of this Guidance.............................................................................................................................5
Scope......................................................................................................................................................................5
Articulation........................................................................................................................................................7
Legacy Beds ......................................................................................................................................................7
Exclusions..........................................................................................................................................................8
Reporting an Entrapment Adverse Event ..........................................................................................................9
Key Body Parts at Risk ......................................................................................................................................10
Head.................................................................................................................................................................10
Neck.................................................................................................................................................................11
Chest ................................................................................................................................................................12
Potential Zones of Entrapment .........................................................................................................................13
A Retrospective Study of Entrapment Reports to FDA ..................................................................................14
Dimensional Limits for Identified Entrapment Zones 1-4..............................................................................15
Zone 1 – Within the Rail .................................................................................................................................15
Zone 2 – Under the Rail, Between the Rail Supports or Next to a Single Rail Support ..................................16
Zone 3 – Between the Rail and the Mattress ...................................................................................................17
Zone 4 – Under the Rail at the Ends of the Rail ..............................................................................................18
Zone 5 – Between Split Bed Rails ...................................................................................................................19
Zone 6 – Between the End of the Rail and the Side Edge of the Head or Foot Board.....................................19
Zone 7 – Between the Head or Foot Board and the End of the Mattress.........................................................20
APPENDIX A: List of Hospital Bed Safety Workgroup (HBSW) Participating Organizations ...............22
APPENDIX B: Additional Information and Kit Information .......................................................................23
APPENDIX C: References for National and International Entrapment Standards ...................................24
APPENDIX D: Anthropometric References ...................................................................................................25
APPENDIX E: Drawings of Potential Entrapment in Hospital Beds ...........................................................27
APPENDIX F: HBSW Dimensional Test Methods for Bed Systems ............................................................28
Guidance for Industry and FDA Staff
Hospital Bed System Dimensional
and Assessment Guidance to
Reduce Entrapment
This guidance represents the Food and Drug Administration's (FDA's) current thinking
on this topic. It does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations. If you want to discuss
an alternative approach, contact the FDA staff responsible for implementing this
guidance. If you cannot identify the appropriate FDA staff, call the appropriate number
listed on the title page of this guidance.
Introduction
This guidance provides recommendations relating to hospital beds1 and hospital bed
accessories. The guidance provides recommendations intended to reduce life-threatening
entrapments associated with hospital bed systems.2 It characterizes the body parts at risk for
entrapment, identifies the locations of hospital bed openings that are potential entrapment
areas, and recommends dimensional criteria for these devices.
Manufacturers may use this guidance when designing new beds to help ensure compliance
with applicable FDA regulations such as the Quality System regulation3, to provide adequate
labeling and instructions for use, and to assist in ensuring that their devices are safe when
used as labeled. FDA encourages manufacturers to provide information to medical device
1
The terms “medical bed” and “hospital bed” are used interchangeably throughout this
document and include adult medical beds with siderails. See discussion in Scope, page 5.
2
As used in this guidance, “hospital bed system” encompasses the bed frame and its
components, including the mattress, bed side rails, head and foot board, and any accessories
added to the bed.
3
Title 21, Code of Federal Regulations, Part 820 – Quality System regulation.
1
distributors, clinicians, patients and families regarding mattress dimensions, compatible
components, and issues of entrapment. In addition, the recommendations in this guidance
may be useful in evaluating and reducing the entrapment risk presented by hospital beds that
have been placed into use, also known as legacy beds.
Not all patients are at risk for an entrapment, and not all hospital beds pose a risk of
entrapment. We suggest that facilities and manufacturers determine the level of risk for
entrapment and take steps to mitigate the risk. Evaluating the dimensional limits of the gaps
in hospital beds is one component of an overall assessment and mitigation strategy to reduce
entrapment. As a result, healthcare facilities may use this guidance as part of a bed safety
program to help identify entrapment risks that may exist with current hospital bed systems.
Other educational documents are available to assist health care facilities in making decisions
towards the goal of achieving a safe and comfortable sleeping environment for their patients.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidances means that
something is suggested or recommended, but not required.
The Least Burdensome Approach
We believe we should consider the least burdensome approach in all areas of medical device
regulation. This guidance reflects our careful review of the relevant scientific and legal
requirements and what we believe is the least burdensome way for you to comply with those
requirements. However, if you believe that an alternative approach would be less
burdensome, please contact us so we can consider your point of view. You may send your
written comments to the contact person listed in the preface to this guidance or to the CDRH
Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to
contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.
Background
For 20 years, FDA has received reports4,5 in which vulnerable patients6,7 have become
entrapped in hospital beds while undergoing care and treatment in health care facilities. The
4
Ferlo Todd J, Ruhl C, Gross T P, “Injury and Death Associated with Hospital Bed Side
Rails: Reports to the U.S. Food and Drug Administration from 1985 to 1995.” American
Journal of Public Health 1997; 87:1675-1677.
5
Hospital Bed Safety Workgroup “A Guide to Bed Safety,” http://www.fda.gov/cdrh/beds/.
6
U. S. Food and Drug Administration. FDA Safety Alert: Entrapment Hazards with Hospital
Bed Side Rails (August 23, 1995), U.S. Department of Health and Human Services.
2
term "entrapment" describes an event in which a patient/resident is caught, trapped, or
entangled in the space in or about the bed rail8, mattress, or hospital bed frame. Patient
entrapments may result in deaths and serious injuries.
FDA received approximately 691 entrapment reports over a period of 21 years from January
1, 1985, to January 1, 20069. In these reports, 413 people died, 120 were injured, and 158
were near-miss events with no serious injury as a result of intervention. These entrapment
events have occurred in openings within the bed rails, between the bed rails and mattresses,
under bed rails, between split rails, and between the bed rails and head or foot boards. The
population most vulnerable to entrapment are elderly patients and residents, especially those
who are frail, confused, restless, or who have uncontrolled body movement. Entrapments
have occurred in a variety of patient care settings, including hospitals, nursing homes, and
private homes. Long-term care facilities reported the majority of the entrapments.
In response to continued reports of patient entrapment, the FDA, in partnership with the U.S.
Department of Veterans Affairs, Health Canada’s Medical Devices Bureau and
representatives from national health care organizations and provider groups, patient advocacy
groups, and medical bed and equipment manufacturers, formed a working group in 1999
known as the Hospital Bed Safety Workgroup (HBSW). Appendix A contains a list of
HBSW participating organizations. The HBSW also worked in cooperation with the Joint
Commission on Accreditation of Healthcare Organizations, the U.S. Centers for Medicare
7
“Vulnerable patients” are defined in “A Guide to Bed Safety,” developed by the Hospital
Bed Safety Workgroup (described on pages 3-4), as: “Patients who have problems with
memory, sleeping, incontinence, pain, uncontrolled body movement or who get out of bed
and walk unsafely without assistance. These patients most often have been frail, elderly or
confused."
8
FDA uses the term “bed rails” frequently throughout this document. Commonly used
synonymous terms are side rails, bed side rails, grab bars and safety rails. Bed rails are rigid
bars that are attached to the bed and are available in a variety of sizes and configurations
from full length to half, one-quarter, and one-eighth length and are used as restraints,
reminders, or as assistive devices. An historical review can be found in Braun & Capezuti,
"The Legal and Medial Aspects of Physical Restraints and Bed Side rails and Their
Relationship to Falls and Fall-Related Injuries in Nursing Homes,” DePaul Journal of Health
Care Law, vol. 4, Fall 2000.
9
FDA acknowledges several limitations of these adverse event report data. First, many
adverse events may not be reported to the FDA, thus the true number of adverse events may
be unknown. Second, the number of reported events does not represent incident rates for a
given problem in the absence of a defined denominator—the number of individuals at risk for
a given adverse event. Finally, many reports lack a complete and detailed description of the
adverse event or are not verified. Despite these limitations, adverse event reports can suggest
a profile of the areas or locations on a hospital bed that present a risk of entrapment, as well
as the parts of the body that are at risk of entrapment.
3
and Medicaid Services, and the U.S. Consumer Product Safety Commission to improve
patient safety associated with the use of hospital beds.
The HBSW identified 7 potential entrapment zones (See Potential Zones of Entrapment,
Page 13) in hospital beds. The workgroup then developed (1) educational materials regarding
entrapment associated with hospital beds, (2) clinical practice guidelines to reduce the
occurrence of patient entrapment, (3) evidence-based dimensional guidelines for hospital
beds, (4) test tools and methods to assess gaps in hospital bed systems, and (5) information to
assist in mitigating entrapment risks in currently used hospital beds. See Appendix B for
information on the availability of these materials.
Consistent with 21 CFR 10.115(f), the HBSW submitted to FDA recommendations for
hospital bed dimensional criteria for consideration as an FDA guidance document. Members
of the HBSW have developed procedures for measuring and assessing gaps in hospital bed
systems in accordance with these criteria. Healthcare personnel, through participation in
HBSW testing, validated the test methods and tool. The FDA has considered these HBSW
recommendations in preparing this guidance.
Standards and Future Harmonization
The International Electrotechnical Commission (IEC) issued an internationally recognized
standard that applies to a certain segment of the products addressed in this guidance, products
labeled as “powered hospital beds.” This standard is the IEC 60601-2-38, Amendment 110.
The current IEC standard recognizes that the bed frame, deck, and rails are the major
elements involved in entrapment, but does not include the mattress as a contributor or
mitigator and sets dimensions for new beds only. The standard also does not address safety
issues associated with the use of non-electric hospital beds or the use of hospital beds in the
home or in long-term care settings. The IEC standard is currently undergoing revision and
will likely undergo significant change prior to its expected publication in 2007/2008. The
recommendations in this FDA Guidance are similar to the IEC standard for some entrapment
zones, but differ in other zones to include consideration of the mattress as part of the
entrapment risk. The IEC test methods are not readily applicable for use by health care
providers and are written primarily for test labs. Upon completion of the revised
international bed standard, FDA will consider whether harmonization of the FDA guidance
and the IEC standard is appropriate. See Appendix C for a list of National and International
Entrapment Standards.
10
International Electrotechnical Commission (IEC) 60601-2-38, Amendment 1, 1999
Medical Electrical Equipment – Part 2-38: Particular Requirements for the Safety of
Electrically-Operated Hospital Beds.
4
Organization of this Guidance
This guidance:
•
identifies key parts of the body at risk for entrapment
•
describes potential entrapment areas or zones
•
recommends maximum and minimum dimensional limits of gaps or openings in
hospital bed systems
•
provides a scientific basis for the dimensional limits derived from a review of
international anthropometric data, a review of historical entrapment data, and a
retrospective study to verify the proposed dimensional limits
•
provides information about reporting entrapment adverse events
•
provides a copy of the HBSW test methods for assessing gaps or openings in hospital
bed systems
•
provides information about obtaining other HBSW documents and instructional
materials
Scope
The goal of the FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce
Entrapment is to reduce potential life-threatening entrapments associated with hospital bed
systems. Because hospital bed systems that are primarily intended for one type of care setting
can be moved into other care settings, the recommendations in this guidance may be
appropriate for hospital beds regardless of the healthcare setting. The dimensional limits in
this guidance may not reduce entrapments in all populations, e.g. pediatrics and
developmentally disabled people. See the narrative below in the exclusions section.
FDA uses the term “hospital bed” in this guidance to refer to a variety of medical devices
that are classified as beds. FDA regulations classify hospital beds as Class I and Class II
devices (see Table 1). These devices are used for patients in acute care, long-term care, or
home care settings. FDA considers stretchers that are used for extended stay in health care
facilities (because they are used like hospital beds) as hospital beds for purposes of this
guidance. As stated above, the term “hospital bed system” used throughout this document
encompasses the bed frame and its components, including the mattress, bed side rails, head
and foot board, and any accessories added to the bed. Bed rails (see footnote 8), also called
“side rails,” may be an integral part of the bed frame or they may be removable and at times
are used either as a restraint, a reminder or an assistive device. Bed rails may consist of one
5
full-length rail per side or one or more, shorter rails per side, may be a fixed height or
adjustable in height, and may move as the head or foot sections of the bed are raised or
lowered.
This guidance provides recommendations related to devices in the following table (Table 1).
Class II devices are subject to design controls under the Quality System regulation. For those
beds in class II, we recommend that manufacturers consider the recommendations in this
guidance when developing their design controls. The recommendations in this guidance may
also assist manufacturers of all devices listed in Table 1 below in manufacturing hospital
beds that will minimize the risk for patient entrapment.
Table 1: Bed Systems Covered under this Guidance
Product Code CFR Section Classification Name
Class
FMR
880.6785
Manual patient transfer device
I
FNJ
880.5120
Manual adjustable hospital bed
I
FNK
880.5110
Hydraulic adjustable hospital bed
I
FNL
880.5100
AC-powered adjustable hospital bed II
FPO
880.6910
Wheeled stretcher*
II
IKZ
890.5225
Powered patient rotation bed
II
ILK
890.5150
Powered patient transport*
II
INK
890.3690
Powered wheeled stretcher*
II
INY
890.5180
Manual patient rotation bed
I
IOQ
890.5170
Powered flotation therapy bed
II
*When labeled for extended-stay use
510(k) Exempt
Yes
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
The recommendations in this guidance may also be useful in evaluating and reducing the risk
of entrapment presented by the devices listed in Table 1 that have already been manufactured
and installed (legacy beds). FDA recognizes that legacy beds have the potential for
dimensional change over time through wear and tear or substitution of new mattresses and
other components not contemplated in the original bed system. Because of these factors,
FDA does not intend to take enforcement actions for failure to submit reports of corrections
and removals under 21 CFR Part 806 for actions taken in response to this guidance that
correct or improve hospital beds currently in use or held as inventory. However,
manufacturers and importers should create and maintain records of these corrections and
removals in accordance with 21 CFR Part 806.
Some states may have adopted special requirements for the design of hospital beds. For
example, New York has adopted more stringent dimensional limits for hospital beds and twin
beds used for developmentally disabled people.11 The dimensions used in the FDA guidance
are not intended to replace state law requirements that may exist. Moreover, some hospital
beds excluded from the scope of the recommendations in this guidance may still be subject to
dimensional limits under state laws.
11
Schatz, William M., PT, Bed Safety Consulting, Inc., Comment #C2 to Docket #2004 D0343, Draft Guidance for Industry and FDA Staff; Hospital Bed System Dimensional
Guidance to Reduce Entrapment, November 10, 2004.
6
Articulation
The movement of the bed deck is known as articulation. FDA recognizes that articulation of
the bed introduces complex geometries that make applying the dimensional criteria to reduce
entrapment difficult. Presently, the dimensional recommendations in this guidance apply to
hospital beds in the flat deck position and rails in the fully raised position, except where
noted. FDA recognizes that patient care also occurs while the bed is articulated and some
articulated positions may pose a risk of entrapment. The Agency will continue to gather data
and consider other approaches for assessing gaps in articulated beds in the future. We
recommend that patient assessment procedures be used to assess the risk of entrapment when
clinical care is provided in an articulated position.
Legacy Beds
The issue of patient entrapment in hospital beds is complex and affects manufacturers,
healthcare practitioners and facilities, medical equipment suppliers, home health agencies,
patients, and caregivers. Many beds currently in use may no longer have the original
mattress or bed rails, and may present an entrapment hazard by increasing or creating gaps or
spaces between various components of the bed system. The recommendations in this
guidance therefore apply to most hospital beds, including legacy beds in various settings
where health care is provided. As described above, a new hospital bed becomes a “legacy
bed” as soon as it is placed into use.
Reducing the risk of entrapment involves a multi-faceted approach that includes bed design,
clinical assessment and monitoring, as well as meeting patient, resident, and family needs for
vulnerable patients in most health care settings - hospitals, long term care facilities, and at
home. Therefore, comprehensive bed safety programs in these settings will likely involve
input from manufacturers as well as facility staff. Recognizing that not all hospital beds
present a risk of entrapment, and that this risk may vary depending on the patient, FDA
encourages manufacturers and facilities to work together to develop bed safety programs to
evaluate and, if needed, mitigate entrapment risk.
When evaluating the safe use of a hospital bed, component or accessory, manufacturers and
caregivers should recognize that the risk for entrapment may increase if a hospital bed system
is used for purposes, or used in a care setting, not intended by the manufacturer. Evaluating
the dimensional limits of gaps in hospital beds may be one component of a bed safety
program which includes a comprehensive plan for patient and bed assessment. Bed safety
programs may also include plans for the reassessment of hospital bed systems. Reassessment
may be appropriate when (1) there is reason to believe that some components are worn (e.g.,
rails wobble, rails have been damaged, mattresses are softer) and could cause increased
spaces within the bed system, (2) when accessories such as mattress overlays or positioning
poles are added or removed, or (3) when components of the bed system are changed or
replaced (e.g., new bed rails or mattresses).
7
FDA recommends that healthcare facilities conduct a risk-benefit analysis to ensure that steps
taken to mitigate the risk of entrapment do not create different, unintended risks or reduce
clinical benefits available to patients using legacy beds. Such steps may include checking
with bed system manufacturers to identify compatible mattresses, rails, and accessories.
Likewise, healthcare facilities may contact their equipment suppliers for entrapment
mitigating solutions that may already be available. Manufacturers should follow the
appropriate FDA regulations regarding risk assessment, design controls, and documentation
when developing mitigation components, attachments and other accessories to address
entrapment risks in legacy hospital beds.
Additional resources are available to help caregivers and health care providers assess the
individual patient’s needs, consider and address entrapment risks, and recommend mitigation
strategies. See Appendix B for examples of additional resources.
Exclusions
The dimensional criteria described on pages 15-21 are recommended for a number of
products, but not all types of hospital beds. We are listing those products below for which
some, or all, of the dimensional criteria are not recommended. You can find more detailed
descriptions of these products in 21 CFR Parts 880 and 890. Please note that the products
listed below are not free from risk of entrapment. We continue to suggest that users identify
and address areas of potential entrapment for each patient or resident through a
comprehensive bed safety program.
Total exclusion from the scope of this guidance:
• Air fluidized therapy beds are excluded because the nature of the therapy does not
allow the patient to exit the bed easily. When these products are used, we
recommend that steps are taken to ensure that the therapeutic benefit outweighs the
risk of entrapment.
•
Bariatric (obesity) beds, pediatric beds and infant cribs are excluded because we did
not use anthropometric data for these groups in determining the recommended
dimensional limits of the entrapment zones in this guidance.
•
Stretchers not used for extended-stay, examination tables, operating room tables,
radiology tables, proning tables, exercise and range of motion tables, bathing units,
and mechanical lifting devices are excluded from the scope of this guidance because
they are not ordinarily used as hospital beds.
Partial Exclusion from the scope of this guidance:
• Kinetic treatment tables and rotation beds are excluded from the dimensional limits
except for those spaces within the perimeter of the rail due to the special design
requirements of these beds. See Zone 1 description on page 15. When these products
are used, we recommend that steps are taken to ensure that the therapeutic benefit
outweighs the risk of entrapment.
8
•
Labor, delivery, recovery, and postpartum (LDRP) specialty beds are excluded from
the dimensional limits for the area under the rail at the end of the rail due to the
special design requirements for obstetric care. See Zone 4 description on page 18.
•
Pressure Reduction Therapeutic Products
Framed flotation therapy beds, powered air mattress replacements, and similar
pressure reduction products that have therapeutic benefits such as reducing pressure
on skin are easily compressed by the weight of a patient and may pose an additional
risk of entrapment when used with conventional hospital bed systems. When these
types of mattresses compress, the space between the mattress and the bed rail may
increase and pose an additional risk of entrapment. While entrapments have occurred
with the use of framed flotation therapy beds (specialty air beds built into a hospital
bed frame) and air mattress replacements,12, 13 these products are excluded from the
dimensional limit recommendations, except for those spaces within the perimeter of
the rail. See Zone 1 description on page 15. This partial exemption is due to the
highly compressible nature of these mattresses, which poses technical difficulties
with measuring certain dimensional gaps in these types of products. We will continue
to work with the IEC to develop and refine test methods to address the risk of
entrapment in bed systems using these products.
Additional caution should be taken when using these products to ensure a tight fit of
the mattress to the bed system. If a powered air mattress is replacing a mattress on a
bed system that meets the recommendations in the guidance with the original
mattress, the resulting bed system with the new air mattress may still pose a risk of
entrapment. When these products are used, we recommend that steps are taken to
ensure that the therapeutic benefit outweighs the risk of entrapment.
NOTE: FDA continues to recommend the dimensional limits in this guidance for bed
systems using mattress overlays. We recommend that steps be taken to assess the
therapeutic benefit to the patient when applying a mattress overlay to a bed system
that does not meet the recommended dimensional limits. The clinical benefit should
outweigh the risk of entrapment presented by use of such a system.
Reporting an Entrapment Adverse Event
FDA will continue to monitor adverse event data on entrapments in hospital beds. Your
complete and descriptive reports of each entrapment or near-entrapment adverse event will
help FDA to monitor the safety of hospital beds. When reporting an entrapment event,
manufacturers and users often leave out details of the entrapment event that can be useful in
12
Miles SH. Deaths between Bedrails and Air Pressure Mattresses, Journal of the American
Geriatrics Society 2002; 50:1124-5.
13
Joint Commission on Accreditation of Healthcare Organizations, Issue 17 Sentinel Event
Alert: Bed Rail-Related Entrapment Deaths (Sept. 6, 2002).
9
identifying the factors or conditions that led to the event. Consequently, these reports only
tell FDA that an adverse event took place. To improve the quality of entrapment adverse
event reports, the following information is important and helpful to include:
1. the exact location or zone of entrapment (the zones described in this document and
Appendix D can be used to help describe entrapment events)
2. the body part that was entrapped, and, if possible, the size of the entrapped body part
(i.e., head breadth, neck diameter, chest depth)
3. the position of the rails (fully raised, intermediate, or lowered)
4. type of rails in use (full length, ¾ length, ½ length, split rails or ¼ length), and the
number of side rails raised a the time of the event
5. the articulation of the bed deck (which sections of the deck were raised, and the
approximate degree of elevation for each deck section)
6. mattress type, mattress height, and height of the rail from the top of the mattress, and
7. information on the size of the gap that contributed to the entrapment.
More information on reporting adverse events to the FDA can be found at:
http://www.fda.gov/cdrh/mdr/.
Key Body Parts at Risk
Three key body parts at risk for life-threatening entrapment in the seven zones of a hospital
bed system discussed in this guidance are the head, neck, and chest. International
anthropometric data references have been used to determine the relative sizes of these body
parts for the population at greatest risk for entrapment and to provide a guide for the
dimensional limits that would reduce their risk of entrapment. See Appendix D.
Head
To reduce the risk of head entrapment, openings in the bed system should not allow
the widest part of a small head (head breadth measured across the face from ear to
ear) to be trapped. Country-specific anthropometric data show that a 1st percentile
female head breadth may be as small as 95 mm (3 ¾ inches). A dimension of 120
mm (4 ¾ inches) encompasses the 5th percentile female head breadth in all data
sources used to develop these recommendations, and includes 1st percentile female
head breadth as reported in some data sources.
FDA is therefore using a head breadth dimension of 120 mm (4 ¾ inches) as the basis
for its dimensional limit recommendations. This dimension is consistent with the
dimensions recommended by the HBSW and the IEC.
10
Rail
Neck
Mattress Deck
To reduce the risk of neck entrapment,
openings in the bed system should not
allow a small neck to become trapped.
Data show a 1st percentile female neck
diameter of 79 mm (3 1/8 inches) [5th
percentile = 83 mm (3 1/4 inches)].
Several factors, such as neck
compressibility, loss of muscle mass in the
Wedging
neck when people age, and the
asymmetrical shape of the neck, support the use of a reduced measurement. For
example, one published estimate for compressibility of neck tissue is 25% of the
uncompressed measure.14 Reducing the 79 mm measure by approximately 25% to
account for tissue compression gives a measure of 60 mm (2 3/8 inches). Both the
IEC and the HBSW recommend a dimensional limit of 60 mm (2 3/8 inches) to
prevent neck entrapment. Consistent with these recommendations, FDA is
recommending 60 mm (2 3/8 inches) as an appropriate dimension for neck diameter.
The concept of a wedging effect, which occurs when the neck is trapped in a Vshaped opening, recurs throughout many national and international entrapmentprevention standards (See Appendix C); however, the standards differ with respect to
what is considered to be the critical angle for wedging. Some standards specify
minimum angles to prevent neck entrapment based on a theoretical analysis of the
forces on a cylindrical object (representing the cross-section of a neck) in an angled
space. Depending on whether the wedging is considered to be caused by the total
resultant forces on the neck or the horizontal components of the forces, the critical
angles are identified as either 60 (See Appendix C, References 5 and 6) or 53 degrees
(rounded up to 55) (See Appendix C, References 1,4 and 9), respectively.
When developing its recommendations for preventing neck entrapment, HBSW
consulted a published international standard for swimming pool equipment [see EN
13451], which includes dimensional limits to prevent entrapment of various body
parts of adults and children. This standard specifies that V-shaped openings should
be of angles greater than 60 degrees. HBSW members performed analyses that
support this limit, and the HBSW has recommended that V-shaped openings be
greater than 60 degrees to avoid neck entrapment.
Given the adult population at risk for wedging entrapments in hospital beds, FDA is
recommending a dimension of 60 mm (2 3/8 inches) to represent neck diameter.
14
ASTM International. “Standard Consumer Safety Specification for Expansion Gates and
Expandable Enclosures.” Annual Book of ASTM Standards, Vol. 15.07, Appendix X2,
Designation F 1004.
11
Additionally, to prevent wedging, a limit of greater than 60 degrees is recommended
for V-shaped openings that a neck could enter. These dimensions are consistent with
the dimensions recommended by the HBSW and the IEC (see IEC 60601-2-38-1).
Chest
The openings in a bed system should be wide enough not to trap a large chest through
the opening between split rails. For purposes of the recommendations in this
guidance, a 95th percentile male chest depth is used to represent the largest chest
measure. Although one would assume that the largest chest size belongs to women,
breast tissue is compressible and diminishes in size as aging occurs. Male chests,
however, have less compressible tissue and do not diminish as significantly in size
with aging. A 95th percentile male chest depth of 318 mm (12 ½ inches), measured
from the nipple to the back, including the pectoral muscles, is used to represent the
largest chest measure.
The IEC is proposing to adopt a dimension to reduce chest entrapment of greater than
318 mm (12 ½ inches). FDA concurs with the dimension of 318 mm (12 ½ inches)
to represent chest depth for the population vulnerable to entrapment, and has used this
dimension as the basis for its recommended dimensional limits.
The body part dimensions used to develop FDA's dimensional limit recommendations
are summarized in Table 2 below.
Table 2
Key Body Part Dimensions
Key Body Part
Dimension
Head
120 mm (4 ¾ inches)
Neck
60 mm (2 3/8 inches) and
an angle > 60 degree
Chest
318 mm (12 ½ inches)
12
Potential Zones of Entrapment
This guidance describes seven zones in the hospital bed system where there is a potential for
patient entrapment. Entrapment may occur in flat or articulated bed positions, with the rails
fully raised or in intermediate positions. Descriptions of the seven entrapment zones appear
on pages 15-21 in this guidance. Summary drawings of entrapment for all of the zones
appear in Appendix E.
The seven areas in the bed system where there is a potential for entrapment are identified in
the drawing below.
Zone 1: Within the Rail
Zone 2: Under the Rail, Between the
Rail Supports or Next to a
Single Rail Support
Zone 3: Between the Rail and the
Mattress
Zone 4: Under the Rail, at the Ends of
the Rail
Zone 5: Between Split Bed Rails
Zone 6: Between the End of the Rail
and the Side Edge of the
Head or Foot Board
Zone 7: Between the Head or Foot
Board and the Mattress End
Entrapment at the Bed Deck or Frame
Many of the entrapment event reports FDA received involved entrapment between the rail
and the bed’s “frame.” It is unclear from the event descriptions whether this refers to the
mattress deck, the bed frame, or even the hardware attaching the bedrail to the bed system.
While this guidance does not recommend dimensional limits on the space at the deck or
frame locations, FDA believes that meeting the other recommended dimensional limits
would reduce the possibility of entrapment at the deck or frame locations.
13
A Retrospective Study of Entrapment Reports to FDA
FDA’s adverse event reporting system helps promote product safety by collecting information
on products that are currently on the market. FDA’s reporting system collects reports of adverse
events15 that caused or may have caused a death, a serious injury, or a malfunction. From
January 1985 to March 2000, FDA received 390 entrapment event reports to its adverse events
database from manufacturers, hospitals, nursing homes, and consumers. In 2000, HBSW
reviewed these adverse event reports and identified entrapment areas or zones in the bed system
and the body parts at risk. Based on its analysis of the reported adverse events, HBSW made
recommendations for dimensional limits.
A retrospective study conducted by members of HBSW compared the HBSW recommended
dimensions with dimensions of the bed models identified in the adverse events reports. For each of
the entrapment adverse events in the study where the model number of the bed was reported, a
participating bed manufacturer provided information on the dimensions of the identified area where
an entrapment was believed to have occurred16. Four manufacturers provided this information.
These data represented 215 (55%) of the 390 entrapment events. This information provided a
reference range typical of hospital beds currently available for use in acute, long term care, and
home settings.
The retrospective study compared the manufacturer-supplied information, in the aggregate, to
the dimensions recommended by the HBSW. If the size of the openings in the reported bed
models did not meet the HBSW recommended limits, i.e., the openings in the reported beds
were outside the limits of the recommended gap sizes, then the HBSW dimensional limits were
considered to be an appropriate limit to reduce entrapments at that area. We have considered
the information from this study in developing the dimensional limit recommendations described
in this guidance.
15
Note: Many reports lacked a complete and detailed description of the adverse event. The
beds involved in these adverse events may not have had compatible mattresses or bed rails
specifically designed for the particular bed model involved in the reported entrapments. Also,
information was limited regarding the condition of the beds, bed rails, and mattress at the time
of the entrapments. Specific details about the exact location of the entrapments within the beds
were sometimes lacking. Despite these limitations, adverse event reports can suggest a profile
of the areas or locations on a hospital bed where entrapment can occur, as well as the parts of
the body at risk for entrapment.
16
When manufacturers measured the gaps for the retrospective study, they used mattresses of
the size, type and thickness typically recommended for use with their bed models. Mattresses
involved in reporting entrapment events may have been different from the manufacturers’
recommended mattresses, which means actual gap sizes in entrapments involving the
mattresses may have been different from those identified by the manufacturers in the
retrospective study. The manufacturers’ measurements may have been representative of “best
case measurements.” We also note that spaces in a hospital bed system may vary in size when
the hospital bed system is articulated through the various ranges of motion. For the
retrospective study, manufacturers measured gap sizes with the beds in the flat position. This
means that if the bed was articulated in reported entrapments, the size of the gap may have
been different from that provided by the manufacturers in the retrospective study.
14
Dimensional Limits for Identified Entrapment Zones 1-4
FDA is recommending dimensional limits for zones 1 through 4 at this time because we
believe the majority of the entrapments reported to FDA have occurred in these zones. We
based these recommended limits upon the body parts entrapped in these individual zones
identified through adverse event reports and entrapment scenarios described in the reports. A
summary table (Table 3) of the hospital bed dimensional limit recommendations appears on
page 21 at the end of this section.
The Hospital Bed Safety Workgroup developed and validated test methods to measure and
assess gaps or openings in zones 1-4 of hospital bed systems, reprinted in Appendix F. As a
member of the HBSW, FDA participated in the development and validation of these test
methods. FDA recommends these test methods as an acceptable approach for assessing
hospital bed gap sizes in accordance with the dimensional limitations described below. The
test methods and tool used to conduct these tests are available through HBSW (see Appendix
B). If an alternate approach is used to assess gap sizes, FDA recommends that the
dimensional limits used in any alternative approach be at least as stringent as the ones
described below.
Zone 1 – Within the Rail
Zone 1 is any open space within the perimeter of the rail. Openings in the rail should be
small enough to prevent the head from entering. A loosened bar or rail can change the size of
the space. The HBSW and IEC recommend that the space be less than 120 mm (4 ¾ inches),
representing head breadth.
Data from the Retrospective Study
Adverse events identified as occurring within the rail were reported in bed models where
open spaces within the rail were greater than 120 mm (4 ¾ inches). Manufacturers’
measurements of bed models representative of those identified in these incidents had spacing
within the rail of between 177 mm (6.97 inches) and 190 mm (7.48 inches). The data suggest
that nearly all of these entrapment events may have been prevented if the spaces within the
rails had been less than 120 mm (4 ¾ inches), representing head breadth as described above.
Consistent with HBSW’s and the IEC’s recommendations and comments received on the
15
previously published draft FDA guidance, FDA is recommending a measure of less than 120
mm (4 ¾ inches) as the dimensional limit for any open space within the perimeter of a rail.
The space should not permit an object with a circular cross-section measuring less than 120
mm (4 ¾ inches) in diameter to enter or pass through.
Zone 2 – Under the Rail, Between the Rail Supports or Next to a Single
Rail Support
This space is the gap under the rail between a mattress compressed by the weight of a
patient’s head and the bottom edge of the rail at a location between the rail supports, or next
to a single rail support. If there is a single rail support, entrapment in Zone 2 can occur
anywhere along the bottom length of the rail beyond the support, up to the end of the rail.
(Entrapment at the end of the rail is explained in Zone 4.) Factors to consider are the
mattress compressibility17 which may change over time due to wear, the lateral shift of the
mattress or rail, and any degree of play from loosened rails or rail supports. A restless
patient may enlarge the space by compressing the mattress beyond the specified dimensional
limit. This space may also change with different rail height positions and as the head or foot
sections of the bed are raised and lowered. The space may increase, decrease, become less
accessible, or disappear entirely. In some positions, the potential for entrapment in this zone
may still exist when the deck is articulated.
Preventing the head from entering under the rail would most likely prevent neck entrapment
in this space. FDA recommends that this space be small enough to prevent head entrapment,
less than 120 mm (4 ¾ inches). IEC recommends the same dimensions but measures the
space without the mattress in place.
In the study, the manufacturers were instructed to measure diagonally from the top edge of the
compressed mattress to the lowest inside edge of the rail between the rail supports. This
17
"Mattress compressibility” refers to the extent to which a mattress changes in dimension as
a result of the weight of a patient’s body or body part moving on, across, or off of the
mattress surface. The mattress dimension may also change as a result of articulation of the
deck.
16
measurement ranged from between 76 mm (3 inches) and 191 mm (7.5 inches). If the reported
entrapments occurred at Zone 2, the data suggest that the HBSW recommended dimensional
limit of less than 120 mm (4 ¾ inches) would have prevented only about half of the reported
events at this zone. At times, the adverse event report information was not clear, and it was
difficult to determine the precise location of the entrapment and to determine whether it
occurred in Zone 2, 3, or 4. Most reports only stated that an entrapment occurred “between the
rail and the mattress.” However, given the scenarios in the reports, some of these events may
have occurred at the rail end, beyond the support (Zone 4) as neck entrapments when the head
entered under the rail first.17
Because the data for reported entrapments at Zone 2 are not definitive and the most likely
scenario for entrapment in this space would include a head-first entry, the dimensional limit
of 120mm (4 ¾ inches) is being recommended.
Zone 3 – Between the Rail and the Mattress
This area is the space between the inside surface of the rail and the mattress compressed by
the weight of a patient’s head. The space should be small enough to prevent head entrapment
when taking into account the mattress compressibility, any lateral shift of the mattress or rail,
and degree of play from loosened rails. HBSW and IEC recommend a dimension of less than
120 mm (4 ¾ inches) because the head is presumed to enter the space before the neck. FDA
is recommending a dimensional limit of less than 120 mm (4 ¾ inches) for the area between
the inside surface of the rail and the compressed mattress.
Data from the Retrospective study
A review of the manufacturers’ supplied measurements indicates that the horizontal gap
between the rail and the uncompressed mattress for bed models involved in entrapments
believed to have occurred at Zone 3 was between 38 mm (1 ½ inches) and 127 mm (5
inches). Theoretically, entrapment would involve compression of the mattress which would
have resulted in a larger gap than the manufacturer measurements without patients present
and, subsequently, a larger range of measures. Further, it could not be determined from the
description of entrapment events whether entrapments occurred at Zones 2, 3 or 4.
FDA recommends a 120mm (4 ¾ inch) dimensional limit for this zone based on the head
breadth dimension described above.
17
Zone 4 – Under the Rail at the Ends of the Rail
This space is the gap that forms between the mattress compressed by the patient, and the
lowermost portion of the rail, at the end of the rail. Factors that may increase the gap size
are: mattress compressibility, lateral shift of the mattress or rail, and degree of play from
loosened rails. The space poses a risk for entrapment of a patient’s neck. It may change with
different rail height positions and as the head or foot sections of the bed are raised and
lowered. The space may increase, decrease, become less accessible, or disappear entirely.
Thus, in some positions, the potential for entrapment in this zone may still exist when the
deck is articulated.
At the time of this publication, the IEC international standard recommends a dimensional
limit of less than 60 mm (2 3/8 inches) measured between the mattress support platform and
the lowest portion of the rail at the rail end to prevent neck entrapment. Based on the neck
diameter dimension described above, FDA recommends that the dimensional limit for this
space also be less than 60 mm (2 3/8 inches). To reduce the risk of neck entrapment at Zone
4, FDA recommends consideration of the combination of the gap size and the angle size
(created between the mattress and the rail). Thus, FDA recommends that the V-shaped
opening under the rail at its end be of an angle wide enough, i.e. greater than 60 degrees, to
prevent wedging entrapment (See Neck Section on pages 11 and 12 for a description and
diagram of wedging entrapments).
The retrospective study measures for Zone 4 ranged between 102 mm (4 inches) and 152 mm
(6 inches) for the diagonal measure between the inside bottom edge of the rail at the end of
the rail and the top of the compressed mattress. It could not be determined from the
entrapment event reports whether the entrapments occurred in Zone 4, or whether events
reported as neck entrapment occurred as a result of head-first entry. The HBSW
recommended that a 60 mm dimension be used to represent neck diameter. Later the HBSW
identified the importance of avoiding wedging of the neck at the end of the rail, and
concluded that a linear measure for the Zone 4 space would not adequately address mattress
compressibility and wedging forces in Zone 4. HBSW recommended that openings in Zone
4 measure both less than 60 mm in size and greater than 60 degrees in angle. FDA agrees
with this recommendation.
18
Zones 5, 6 and 7
Although seven potential zones of entrapment have been identified by HBSW, FDA is
recommending dimensional limits for zones 1-4 because these zones were most frequently
reported as having entrapments. The current international standard (IEC 60601-2-38)
addresses limits for zones 1, 2, 4, and 6. In addition, IEC intends to set or revise dimensional
limits, for areas comparable to HBSW’s zones 1-6 in their upcoming international standard
for hospital beds. FDA continues to receive entrapment reports for Zones 5 and 6, and Zone
7 remains a potential for entrapment. FDA will monitor entrapments in these zones and
consider harmonization with the IEC standard once it is available.
Zone 5 – Between Split Bed Rails
This zone occurs when partial length head and foot side rails (split rails) are used on the same
side of the bed. The space between the split rails may present a risk of either neck
entrapment or chest entrapment between the rails if a patient attempts to, or accidentally,
exits the bed at this location. In addition, any V-shaped opening between the rails may
present a risk of entrapment due to wedging. FDA recognizes this area as a potential for
entrapment and encourages facilities and manufacturers to report entrapment events at this
zone.
Zone 6 – Between the End of the Rail and the Side Edge of the Head or
Foot Board
Zone 6 is the space between the end of the rail and the side edge of the headboard or
footboard. This space may present a risk of either neck entrapment or chest entrapment. In
19
addition, any V-shaped opening between the end of the rail and the head or footboard may
present a risk of entrapment due to wedging. This space may change when raising or
lowering the head or foot sections of the bed. This space may increase, decrease, become
less accessible, or disappear entirely. Thus, in some positions, the potential for entrapment
may exist when the deck is articulated. FDA recognizes this area as a potential for
entrapment and encourages facilities and manufacturers to report entrapment events at this
zone.
Zone 7 – Between the Head or Foot Board and the End of the Mattress
Zone 7 is the space between the inside surface of the head board or foot board and the end of
the mattress. This space may present a risk of head entrapment when taking into account the
mattress compressibility, any shift of the mattress, and degree of play from loosened head or
foot boards. FDA recognizes this area as a potential for entrapment and encourages facilities
and manufacturers to report entrapment events at this zone.
20
Table 3 Summary of FDA Hospital Bed Dimensional Limit
Recommendations
Zone
Dimensional Limit
Recommendations
1
Within the rail
<120 mm (< 4 3/4 “)
2
Under the rail, between rail supports
or next to a single rail support
< 120 mm (< 4 3/4 “)
3
Between rail and mattress
<120 mm (< 4 3/4 “)
4
Under the rail, at the ends of the rail
<60 mm (< 2 3/8 “)
AND
>60° angle
21
APPENDIX A
List of Hospital Bed Safety Workgroup (HBSW) Participating Organizations
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
AARP
American Association of Homes and Services for the Aging
American Medical Directors Association
American Society for Healthcare Risk Management/American Hospital Association
Basic American Metal Products
Beverly Enterprises, Inc.
Bilanx Consulting LLC
Care Providers of Minnesota
Carroll Healthcare, Inc.
ECRI
ElderTech Solutions, LLC
Exceptional Parent Foundation For Education
Hard Manufacturing Co., Inc.
HealthSafe Inc.
Hill Rom, Inc.
Huntleigh Healthcare
Iona Senior Services
Kinetic Concepts, Inc.
Law Offices of Julie A. Braun
Lockwood Consulting, LLC
Medical Devices Bureau, Health Canada
M.C. Healthcare Products
National Association for Home Care
National Citizens Coalition for Nursing Home Reform
National Patient Safety Foundation/American Medical Association
Posey Company
RN+ Systems / Tactilitics, Inc.
Span-America Medical Systems, Inc.
Stryker Medical
Sunrise Medical, Inc.
The ROHO Group, Inc.
Untie the Elderly, The Kendal Corporation
U.S. Department of Veterans Affairs
Vail Products Inc.
Consulting Organizations to the Hospital Bed Safety Workgroup
• Joint Commission on Accreditation of Healthcare Organizations
• U.S. Centers for Medicare & Medicaid Services
• U.S. Consumer Product Safety Commission
22
APPENDIX B
Additional Information and Kit Information
Websites:
Food and Drug Administration:
http://www.fda.gov/cdrh/beds
Bureau of Medical Devices, Health Canada:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advisories_professionals_e.html
ECRI:
http://www.ecri.org/Patient_Information/Patient_Safety/BedSafetyClinicalGuidance.pdf
HealthSafe, Inc.:
http://www.healthsafe.org/
Untie the Elderly, Kendal Corporation:
http://www.ute.kendal.org
American Association of Homes and Services for the Aging:
http://www.aahsa.org
American Health Care Association:
http://www.ahca.org
Kit Information:
The HBSW Bed Safety Entrapment Kit will be available through National Safety
Technologies at http://www.nst-usa.com. The kit will include:
Documents
• A Guide to Bed Safety (a brochure) from the Hospital Bed Safety Workgroup
• Clinical Guidance and Decision Tree for the Assessment and Implementation
of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings
from the Hospital Bed Safety Workgroup
• Dimensional Test Methods for Bed Systems from the Hospital Bed Safety
Workgroup
• Instructional Video/DVD for bed measurement
• A Guide for Modifying Bed Systems and the Use of Accessories to Reduce the
Risk of Entrapment from the Hospital Bed Safety Workgroup
Test tool kit
Educational videotapes:
• An educational videotape, Do No Harm – Hospital Bed Safety, explaining
hospital bed and bed rail safety issues is produced by AARP.
The AARP video is available through The Kendal Corporation. Ordering
information can be obtained from http://www.ute.kendal.org/
23
APPENDIX C
References for National and International Entrapment Standards
1. ASTM International. “Standard Consumer Safety Performance Specification for
Playground Equipment for Public Use.” Annual Book of ASTM Standards, Vol. 15.07,
Designation F 1487.
2. ASTM International. “Standard Consumer Safety Specification for Expansion Gates and
Expandable Enclosures.” Annual Book of ASTM Standards, Vol. 15.07, Designation F 1004.
3. ASTM International. “Standard Consumer Safety Specification for Bunk Beds.” Annual
Book of ASTM Standards, Vol. 15.07, Designation F1427.
4. U.S. Department of the Army. “Child Development Center Play Area Inspection and
Maintenance Program.” Publication No. TM 5-663.
Public domain document available at www.army.mil
5. European Committee for Standardization. “Playground Equipment – Part 1: General
Safety Requirements and Test Methods.” Ref. No. EN 1176-1.
Adopted and published under various national designations by 28 member countries
of CEN, including France, Great Britain, Germany, and Sweden.
6. European Committee for Standardization. “Swimming Pool Equipment – Part 1: General
Safety Requirements and Test Methods.” Ref. No. EN 13451-1.
Adopted and published under various national designations by 25 member countries
of CEN, including France, Great Britain, Germany, and Sweden.
7. 16 CFR Part 1213, “Safety Standard for Entrapment Hazards in Bunk Beds.”
8. 16 CFR Part 1513, “Requirements for Bunk Beds.”
9. U.S. Consumer Product Safety Commission. “Handbook for Public Playground Safety.”
Publication No. 325.
Public domain document, available at www.cpsc.gov
24
APPENDIX D
Anthropometric References
Anthropometric References used:
Hall, Judith. Handbook of normal physical measurements. New York : Oxford University
Press, 1990.
[Note: Head width and neck circumference data for both sexes,-2SD (2.5th percentile), from
birth to age 16. Data visually extrapolated from graphs.]
Jurgens, H., Pieper, U. International data on anthropometry. Geneva, Switzerland :
International Labour Office, 1990. (Occupational safety and health series; no. 65).
[Note: This report reviewed data for North America, Latin America (Indian population),
Latin America (European and Negroid population, Northern Europe, Central Europe, Eastern
Europe, South-Eastern Europe, France, Iberian Peninsula, North Africa, West Africa, SouthEastern Africa, Near East, North India, South India, North Asia, South China, South-East
Asia, Australia (European Population), Japan.]
Peebles, Laura, Norris, Beverly J. Adultdata - The handbook of adult anthropometric and
strength measurements: data for design safety. London : Department of Trade and Industry,
1998.
[Note: This handbook contains data from various sources for the following countries: UK,
Brazil, France, Germany, Italy, Japan, Poland, Sri Lanka, Sweden, Netherlands, and USA.
Data were not available from ALL these countries for EACH measurement.]
Smith, Stuart, Norris, Beverly, Peebles, Laura. Older adult data – The handbook of
measurements and capabilities of the older adult: data for design safety. London :
Department of Trade and Industry, 2000.
[Note: This handbook contains data from various sources for the following countries: UK,
Brazil, France, Germany, Italy, Japan, Poland, Sri Lanka, Sweden, Netherlands, and USA.
Data were not available from ALL these countries for EACH measurement.]
Snyder, JRG. Anthropometry of infants, children and youths to age 18 for product safety
design: final report. Bethesda, MD : Consumer Product Safety Commission, 1977.
Others references consulted:
Association for the Advancement of Medical Instrumentation. Human factors engineering
guidelines and preferred practices for the design of medical devices. 2nd ed. Arlington, VA :
Association for the Advancement of Medical Instrumentation, 1993 ; AAMI HE-48 1993.
British Standards Institution. 1987 Ergonomics – standards and guidelines for designers.
United Kingdom : British Standards Institution, 1987 ; document no. PP 7317.
25
Damon, Albert, Stoudt, Howard W., McFarland, Ross A. The human body in equipment
design. Cambridge, MA : Harvard University Press, 1966.
Diffrient, Niels. Humanscale one-two-three. Cambridge, MA : MIT Press, 1974.
Human engineering design data digest. Washington, DC : U.S. Government Printing
Office, 1975.
National Center for Health Statistics. Weight, height, and selected body dimensions of adults,
United States, 1960-62. Hyattsville, MD: National Center for Health Statistics, 1980; DHHS
publication no. (PHS) 80-1301. Vital and health statistics; series 11, no. 8.
Salvendy, Gavriel, ed. Handbook of human factors. New York : John Wiley & Sons, 1987.
Woodson, Wesley E. Human factors design handbook : information and guidelines for the
design of systems, facilities, equipment and products for human use. New York : McGrawHill Book Company, 1981.
Woodson, Wesley E., Conover, Donald W. Human engineering guide for equipment
designers. 2nd ed. Berkeley, CA : University of California Press, 1970.
Woodson, Wesley E., Tillman, Peggy, Tillman, Barry. Human factors design handbook. 2nd
ed. New York : McGraw-Hill Professional, 1992.
26
APPENDIX E
Drawings of Potential Entrapment in Hospital Beds
Zone 1 – Entrapment within the rail
Zone 2 – Entrapment under the rail,
between the rail supports or next to a single
rail support
Zone 3 – Entrapment between the rail
and the mattress
Zone 4 – Entrapment under the rail,
at end of rail
Zone 5 – Entrapment between split
bed rails
Zone 6 – Entrapment between the
end of the rail and the side edge
of the head or foot board
Zone 7 – Entrapment between head or
foot board and the mattress end
27
APPENDIX F
Dimensional Test Methods for Bed Systems
28
Dimensional Test Methods for Bed Systems
July 2005
Introduction
The Hospital Bed Safety Workgroup (HBSW) and the U.S. Food and Drug Administration (FDA)
have defined seven numbered "zones" or spaces in and around hospital bed systems where patients
could potentially become trapped. Actual entrapments have been reported in six of these zones, with
Zones 1, 2, 3, and 4 accounting for approximately 80% of entrapment events reported to the FDA.
This appendix contains instructions for testing Zones 1, 2, 3, and 4, using tools and methods
developed by the HBSW.
Contents
Summary of Test Zones .......................................................................................................................................2
Description of Test Tools .....................................................................................................................................3
Cone and Cylinder Tool.....................................................................................................................................3
Tool Assembly and Disassembly.......................................................................................................................3
Using the spring scale........................................................................................................................................4
General Testing Considerations ..........................................................................................................................4
Test Methods
Zone 1 Test ........................................................................................................................................................5
Zone 2 Test ........................................................................................................................................................6
Zone 3 Test ........................................................................................................................................................8
Zone 4 Test ......................................................................................................................................................10
Appendix: Testing Tips and Frequent Questions ............................................................................................12
SAMPLE DATASHEETS..................................................................................................................................17
1
Summary of Test Zones
The four (4) tests in these instructions measure gaps within bed systems where a patient could
become trapped. Each test measures a different area, or zone, where entrapment can occur:
Zone 1: Within the rail
Zone 1
Figure 1. The Zone 1 test assesses the potential for head entrapment within the rail (shaded areas).
Zone 2: Under the rail between the rail supports or next to a single support
Zone 2
Figure 2. The Zone 2 test assesses the potential for head entrapment under the rail, between the rail supports (or
next to a single rail support) (shaded areas).
Zone 3: Between the rail and the mattress
Side rail
Zone 3
Zone 3
Mattress
Mattress
Side rail
Figure 3. The Zone 3 test assesses the potential for head entrapment between the edge of the mattress and the inside
of the rail (shaded areas).
Zone 4: Under the rail at the end of the rail
Zone 4
Figure 4. The Zone 4 test assesses the potential for neck entrapment between the top of the mattress compressed
by the patient and the lower-most portion of the rail at the end of the rail (shaded areas).
2
Description of Test Tools
Each test requires the use of simple tools, including a cone, a cylinder, and a spring scale. Your tools
may look slightly different from the tools in the figures, but they will work the same way.
Cone and Cylinder Tool
The cone and cylinder is a combination tool (see Figure 5). It can be easily taken apart so that the
cone and cylinder can be used separately. Tests 1, 2 and 3 use only the cone. Test 4 uses the
combined assembled tool.

The diameter of the large end of the cone represents
the width of a small adult head (120 mm, or
approximately 4 ¾ inches).
The diameter of the cylinder represents the size of a
small adult neck (60 mm, or approximately 2 3/8
inches).
The cone and cylinder together weigh 15 lbs. This
represents the combined weight of an adult head (12
lbs.) and neck (3 lbs.).
The red area of the cylinder defines contact angles in
which the neck could become wedged (60 degrees or
narrower),
The cone tool includes the following features:

A loop at the end for attaching a spring scale.

A safety strap.

A marked center line on the large face of the cone.
Figure 5. Cone and cylinder tool.
The cylinder includes the following features:

Red and green zones for identifying pass/fail at siderail ends.

A level to aid in tool positioning.
To prevent personal injury during the measurement process, attach the strap to a secure point on the
bed and shorten the length of the safety strap enough to keep the tool from dropping on your feet if it
should fall during a test. Make sure the strap is long enough to not interfere with the test
measurement.
Tool Assembly and Disassembly
Note: General procedures for tools with a screw-type connection are described here. (Your tool may
have a different type of connection.) Follow the instructions supplied with your tools for more
detailed information.
To take the cone and cylinder tool apart:
1. Turn the knob to loosen and remove the connection shaft.
2. Pull the cylinder from the cone.
To put the cone and cylinder tool together:
1. Align the red and green areas of the cone and cylinder.
2. Insert the pins of the cone into the cylinder.
3. Insert the connection shaft and turn the knob to tighten.
3
Figure 6. Disassembly and assembly of the cone and cylinder tool.
Using the spring scale
Use the spring scale to apply 12 lbs of force to the cone
when testing Zones 1 and 2. At the small end of the cone
tool, insert the scale hook into the metal loop. Pull the
scale slowly until the needle points to 12 lbs.
For other types of scales (sliders, digital, etc.), and for
information on scale calibration, consult the instructions
supplied with your toolkit.
Figure 7. Use of spring scale.
General Testing Considerations
• Bed Occupancy: For ease of mattress movement and measurement, and general safety, the patient
should not be in the bed during the measurement procedures.
• Bed Height: To avoid unnecessary bending or back strain, position the bed at a comfortable
working height.
• Bed Wheels: To prevent movement of the bed during testing, lock the wheels.
• Linens/Sheets: Perform the tests with sheets in place as is typical for patient care. Remove any
pillows and blankets.
• Infection Control: To avoid cross-contamination, disinfect the tools each time a different bed is
measured. Follow the supplier’s recommendations for tool disinfection.
• Personal Safety: To avoid injury, use care when pulling the tool through openings in the bed rails.
If the tool suddenly pulls through, you could lose your balance and fall. Always use
the safety strap to keep the tool from injuring your feet if it falls.
• Intermediate Rail Position: Some rails have an intermediate stopping position or a high and low
locking position. Follow the individual test instructions, which may require testing
the rails at both positions.
• Bed Position: Most tests should be done with the bed in the flat position. The exception is the test
for Zone 2. Follow the individual test instructions carefully.
• Testing Tips: Consult the Appendix for helpful information.
4
Zone 1 Test
This test assesses the potential for head entrapment within the perimeter of the rail.
The tools needed to do this test are the cone, the safety strap and the spring scale.
Prepare for the Zone 1 Test:
1. Lock the wheels.
2. Put the bed in the flat, horizontal position.
3. Fully raise all bed rails.
4. Position the bed at a comfortable working height.
Do the Zone 1 Test:
1. With the cone resting on mattress, attach the safety strap of the cone
to the rail being tested. Make sure the strap is short enough to keep
the tool from injuring your feet if it falls, and long enough so it does
not interfere with the test.
2. From inside the rail, insert the cone, small end first, into the largest
opening in the rail. Try to pull the tool through the space (figure 8).
3. If the tool does not pull through freely, attach the spring scale to the
loop on the small end of the cone. Try to pull the cone through the
rail by pulling on the attached spring scale using 12 lbs. of force.
Use care when pulling. If the tool suddenly pulls through the
opening, you may lose your balance and fall, or the tool may fall on
you.
4. Repeat steps 2 and 3 to check all other openings within the same rail.
Figure 8. Zone 1 test
(within the rail).
5. Interpret test result.
Interpret the Zone 1 Results:
If the large end of the cone does not enter any of the openings, this space passes the test (figure 9a).
If the large end of the cone does enter or pass through any of the openings, this space fails the test
(figure 9b).
Figure 9a. Zone 1 test: Pass, large end of cone
does not enter rail opening.
Figure 9b. Zone 1 test: Fail, large end of cone
does enter rail opening.
Repeat the Zone 1 Test:
On the other rails: Repeat the test for all other rails on the bed.
5
Zone 2 Test
This test assesses the potential for head entrapment under the rail, at a location between
the rail supports or next to a single support.
The tools needed to do this test are the cone, the safety strap and the spring scale.
1. Lock the wheels.
Do the Zone 2 Test:
1. Firmly push the mattress away from the rail
being measured until it stops.
2. Identify the space where the test will be done
(see Figure(s) 10a and 10b).
3. Determine whether the bed will be tested in the
flat position or a different position:
•
Raise and lower the head and foot sections of
the bed while you observe the space that will
be tested.
•
If the space(s) where the test will be done
becomes smaller or does not change as the
bed moves, do the test with the bed in the flat
position. (See the Appendix for examples.)
•
If the space(s) becomes larger as the bed
moves, find the bed position that creates the
largest space. Perform the test with the bed in
the position where the space is the largest.
(See the Appendix for an example.)
4. Attach the safety strap of the cone to the rail
being tested. Make sure the strap is short
enough to keep the tool from injuring your feet
if it falls, and long enough so it does not
interfere with the test.
Figure 10a. Zone 2 test between rail supports.
Figure 10b. Zone 2 test for a single rail
support.
5. From the inside of the rail, insert the cone, small end first, into the gap between the mattress
and the lower edge of the rail, between the rail supports. Let the cone compress the mattress.
Do not force the cone into the area.
6. Attach the spring scale to the loop on the cone.
7. Pull on the spring scale with 12 lbs of force at any angle that increases the chances of the cone
going through the space. Use care when pulling. If the tool suddenly pulls through the opening,
you may lose your balance and fall, or the tool may fall on you. Observe whether the large end
of the cone enters through the opening.
6
Interpret Zone 2 Test Results:
If the large end of the cone does not enter the space under the rail, or pass under the rail, this space
passes the test (figures 11a and 11b).
If the large end of the cone does enter the space under the rail, or if it passes under the rail, this space
fails the test (figures 11c and 11d).
Figure 11a. Zone 2 test: Pass.
Figure 11b. Zone 2 test: Pass.
Figure 11c. Zone 2 test: Fail.
Figure 11d. Zone 2 test: Fail.
On the same rail: If the rail has intermediate locking positions, perform the test for every intermediate
position.
On the other rails: Perform the test for all other rails on the bed, including intermediate and raised
positions.
7
Zone 3 Test
This test assesses the potential for head entrapment between the inside of the rail and the
surface of the mattress (compressed by the weight of a patient’s head).
The tools needed for this test are the cone and the safety strap.
1. Lock the wheels.
Do the Zone 3 Test:
1. Firmly push the mattress away from the rail being measured until it stops.
2. Put the cone near the rail being tested and attach the safety strap. Make sure the strap is short
enough to prevent the tool from injuring your feet if it falls, and long enough so it does not
3. Gently place the cone horizontally in the gap (figure 12a). Do not push the tool down into the
gap.
4. Turn the cone until the line on the face of the large end is horizontal (figure 12b).
5. Let the cone sink into the space by its own weight. If the cone is tilted, use one hand to gently
level it (figure 12c). Do not push the tool down into the gap.
Note: If a mattress stop, rail support, or other structure keeps the cone from sinking in the gap,
put the cone tool at a different location along the rail where there is no interference.
6. Determine whether the cone’s center line is above or below the surface of the mattress.
Figure 12a. Zone 3 test: between the mattress and the inside of the rail.
Figure 12b. Zone 3 test: turning the cone.
Figure 12c. Zone 3 test: tilting the cone.
8
If the line across the flat end of the cone is above the surface of the mattress, the space passes the test
(figure 13a).
If the line across the flat end of the cone is at or below the top surface of the mattress, the space fails
the test (figure 13b).
Figure 13a. Zone 3 test: Pass
(line above mattress surface).
Figure 13b. Zone 3 test: Fail
(line below mattress surface).
On the same rail: If the rail has any intermediate positions, perform the test at every intermediate
position.
On the other rails: Perform the test for all other rails on the bed, including the intermediate positions.
9
Zone 4 Test
This test assesses the potential for neck entrapment between the top of the mattress
(compressed by the patient) and the lower-most portion of the rail, at the end of the rail.
The tools needed for this test are the assembled cone and cylinder with safety strap.
1. Lock the wheels.
Do the Zone 4 Test:
1. Firmly push the mattress away from the rail being tested until it stops.
2. Attach the safety strap of the cone tool to the rail being tested. Make sure the strap is short
enough to prevent the tool from injuring your feet if it falls, and long enough so it does not
3. Just beyond the end of the rail, rest the cone
portion of the cone and cylinder tool on the
mattress. The test area is shown in Figure 14. (If
the bed has split rails, you may need to lower the
rail next to the one being measured to make room
for the tools.)
Note: If the cylinder tool cannot fit into an area
between the head or footboard and the end of a
rail, the space passes.
4. Position the tool so that the large face of the cone
is flush or even with the edge of the mattress
(figure 15a).
Figure 14. Zone 4 test area: under the rail
at the end of the rail.
5. Let the weight of the cone compress the mattress, but do not force the tool down onto the mattress
or under the rail. Slide the tool towards the rail until it touches the rail or support (figure 15b).
Figure 15a. Align cone with edge and rest on mattress.
Figure 15b. Slide the tool towards the
rail until it makes contact.
6. Hold the cylinder section and use the level on the end of the cylinder to keep the cone level.
10
7. If the cylinder slides completely under the rail, this space fails. If the cylinder touches the rail,
observe the color on the cylinder where it makes contact: Red fails; Green passes (figure 16).
If the cylinder touches the rail in the green area, the space passes (figure 16a).
If the cylinder touches the rail in the red area, the space fails (figure 16b).
If the cylinder passes completely under the rail, the space fails (figure 16c).
Reminder: If the cylinder tool cannot fit into an area between the head or footboard and the end of a
rail, the space passes.
contact
point
Figure 16a. Zone 4 test Pass
(contact in green).
contact
point
Figure 16b. Zone 4 test Fail
(contact in red).
Figure 16c. Zone 4 test Fail
(tool passes completely under rail).
On the same rail: If the rail has any intermediate positions, perform the test at every intermediate
position.
On the other rails: Perform the Zone 4 test at both ends of all other rails on the bed, including the
intermediate positions.
11
Appendix to HBSW Dimensional Test Methods for Bed Systems
Testing Tips and Frequent Questions
Do I have to do the tests in order?
No. You may do the tests in any order you wish. You may find it convenient to do all the tests on
one side of the bed, then the other (to keep from repeatedly pushing the mattress back and forth).
Or, you may wish to do all of the tests that use just the cone, then all of the tests that use the cone
and cylinder together (to avoid having to put the tool together and take it apart several times).
Do I have to use the safety strap?
The test tools are heavy, and the safety strap helps protect you if they fall or suddenly pull through
a gap. Not using the safety strap increases your risk of being injured.
How do I keep track of my test results?
You may use any method that meets the recordkeeping requirements of your institution. HBSW
has developed some sample data sheets that you may use or modify according to your needs.
Sample data sheets are attached at the end of this document.
What are the most common mistakes people make when doing the tests?
In field tests conducted to evaluate the test tools and instructions, some of the most common errors
made by the testers were:
• Not pushing the mattress away from the test location
• Pulling the mattress toward the test location (instead of pushing it away)
• Not articulating the bed enough to create the largest possible gap in Zone 2
• Not having the bed flat when testing Zones 1, 3, or 4
• Not aligning or leveling the tool properly
• Forcibly pushing the tool into gaps
When pushing the mattress, how hard do I need to push?
Some test instructions ask you to push the mattress "until it stops." Usually that means pushing
until either:
• the mattress retention system (such as mattress stops, straps, or Velcro®) engages and
keeps you from pushing the mattress any further, or
• the mattress stops against the opposite side rail(s).
Always make sure you push the mattress straight across; it should not be crooked on the bed.
When testing Zone 2, what position should the bed be in?
Unlike the other three tests, the Zone 2 test is not always done with the bed in the flat position.
Before you do the Zone 2 test, you first need to find the correct testing position. With the bed in
the flat position, identify the location of the Zone 2 space. Then, articulate the bed (adjust the head
and knee sections) while you watch the Zone 2 space. As you articulate the bed, the Zone 2 space
may get bigger, get smaller, or stay the same. Adjust the position of the bed until you find the
position that makes the largest opening in Zone 2. If the size of the opening gets smaller, or does
not change, return the bed to the flat position to do the test. Some examples of how Zone 2 might
change with articulation are shown below.
12
In this example, the opening in
Zone 2 gets larger when the
bed is articulated (because of
the bend in the mattress).
Zone 2 should be tested with
this bed in the position where
the space is largest.
In this example, the size of the
Zone 2 opening does not
change as the bed articulates
(the rail and the mattress stay
in the same relative position).
Zone 2 should be tested with
this bed in the flat position.
Zone 2
Zone 2
(Note: For the rail design shown
below, Zone 2 and Zone 1 are the
same. See the discussion of
unusual rail designs.)
Zone 2
Zone 2
Mattress
In this example, the Zone 2
openings get smaller when
the bed is articulated. Zone 2
should be tested with this bed
in the flat position.
Mattress
Mattress
Flat position
Flat position
Flat position
Zone 2
Zone 2
Zone 2
Articulated position
What if one of the Zones doesn't seem to exist on a particular bed system?
If a zone doesn't exist on a particular bed, then there is no risk of a patient becoming trapped
in that Zone. For example: if there are no openings in a rail, then a patient could not get his
or her head trapped in Zone 1 of that rail. Your facility's policy and method of recordkeeping
will determine how you should record data for Zones that do not exist. For example, your
facility may use customized data sheets that simply omit zones or rails that do not exist. If
you are using a generic form (such as a table or spreadsheet), it may be appropriate to record
a result of either “pass,” “not applicable,” or “not tested,” or to cross out entry spaces for
Zones that do not exist. (You should provide some indication that the Zone was not
accidentally omitted from testing.)
I need to test a bed with an unusual rail design. The rails don't look like any of the rails
shown in the instructions or video. How do I figure out where to do each test?
Occasionally, the most difficult part of a test may be figuring out where on the bed to
perform the test. For some beds or rail configurations, it may be difficult to identify the
locations of various Zones. The following hints and examples for each Zone may help.
Zone 1: The goal of the Zone 1 test is to see whether a patient could become trapped by
putting his or her head through an opening in the rail itself.
Example: No openings in the rail
If there are no openings in the rail, then there is no risk of entrapment in Zone 1.
Examples of cases where there may not be any openings in the rail are:
13
• The rail consists of a solid panel
• The rail has a cover on it, and the cover blocks all the openings in the rail (whether
you can see through the cover or not).
putting his or her head under the rail, head first, between the rail supports (or next to a
single support). (Note: Trapping the head by sliding the neck under the rail sideways is
addressed by the test for Zone 4.)
Example: Rail supports form part of the rail
In some designs, the rail supports also form
part of the body of the rail. Crib-style rails,
shown here, are common examples. Often,
when the rail supports form part of the rail,
Zones 1 and 2 overlap. Zone 1 should be
tested with the bed in the flat position; if the
size of the space changes with articulation,
the result for Zone 2 may be different.
Zones 1 and 2
Zone 3: The goal of the Zone 3 test is to see whether a patient could become trapped with
his or her head in the horizontal space between the rail and the mattress. Usually, the
gap in Zone 3 is easily identified, even if the rail design is unusual.
sliding or wedging his or her neck under the end of the rail.
Example: The rail end is very close to head/foot board (very little space in between)
When testing in Zone 4, do not try to force the cylinder down between the rail and the
end board or insert it under the rail from behind. If the cylinder’s diameter will not fit
between the end of the rail and the head or foot board, record a result of Pass for Zone
4.
Example: Full-length rail with horizontal supports at the ends
An example of this rail type is shown at the right. The
cylinder cannot pass between the end of the rail and the
head/foot board and then under the rail -- it would stop on the
support. The result for Zone 4 is Pass, because a patient
would not be able to get his or her neck under the rail without
the head or body going under first. The potential for headfirst entrapment under the rail should be evaluated using the
test for Zone 2.
End Board
Mattress
Rail Support
Rail
14
Example: The end of the rail is vertical
When the end of the rail is completely
vertical from top to bottom, there may be
no space "under" the end of the rail
where the cylinder (or a patient's neck)
could fit. In the example at right, the left
side of the rail is vertical, and there is no
space “under” the end of the rail. For the
left rail end in the figure, the rating for
Zone 4 should be either “pass” or “not
applicable,” depending on your facility’s
policy. The right end should be tested as
usual for Zone 4.
Note: If you are unsure about a particular
rail you are testing, you should go ahead
and perform the Zone 4 test to verify your
answer. The cone and cylinder would
give a result of Pass if they were used to
physically test the area shown on the left
side of the rail in the figure.
Test as usual for Zone
4 at this end of the rail.
There is no space "under" the
rail at this end; you can verify
by doing the Zone 4 test in the
shaded area if you are unsure.
Why did my co-worker and I get different results for the same test?
Different testers can get different test results for the same bed system. Or, the same tester
may get a different result when he or she repeats a test. Some reasons this can happen are:
• Different people may handle the tools slightly differently.
• An error or oversight can affect the test result (see common errors below).
• When a test is a very close call, some testers may be biased toward passing, and
others toward failing.
• A long time has elapsed between tests (mattresses vary in softness, and can compress
over time; rails or rail supports may loosen or bend over time).
What if a result is too close to call?
If you are faced with a borderline pass/fail decision, use your best judgment to decide on a
result. You can also try these suggestions:
• Repeat the test, and double-check that you did every step correctly.
• If possible, get a second opinion. Ask a co-worker for help.
Your facility may also have suggestions or procedures for handling close calls. For beds
with borderline passes that result from close calls, you may wish to consider mitigation (see
the next question below).
15
What should I do if a bed system fails one of the tests?
You should strongly consider mitigation of entrapment risks for bed systems that fail any of
the four tests. You may also wish to consider mitigation for bed systems that have borderline
passes. Mitigation may include patient assessment; some patients are at lower risk for
entrapment than others. For more information, consult the following, available at
http://www.fda.gov/cdrh/beds:
• Clinical Guidance for Assessment and Implementation of Bed Rails in Hospitals,
Long Term Care Facilities and Home Care Settings
• A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of
Entrapment
What if I have a question that wasn't answered here?
There are several resources available to help address questions. As a start, you may contact
the supplier of your beds, mattresses, or rails. Your tool kit supplier is another resource. In
addition, an advisory group is being established by the HBSW to address additional questions
that arise. You may submit questions to that committee via the Web at [URL to be
determined, www.xxx.yyy].
16
P
F
F
ZONE 4 :
P
If the bed has 4 rails, use these boxes to record your results for the
footrails. Leave them blank or cross them out if the bed does not have foot
ZONE 3:
ZONE 1:
P
P
F
F
F
ZONE 2:
P
F
ZONE 4 :
P
F
ZONE 3:
ZONE 2:
P
P
F
F
F
ZONE 4 :
P
If the bed only has 2 rails, use these boxes to record your results.
If the bed has 4 rails, use these boxes for the headrails.
P
ZONE 4 :
F
ZONE 2:
F
F
P
F
ZONE 4:
F
P
P
ZONE 1:
P
ZONE 1:
ZONE 2:
F
P
F
ZONE 4 :
P
If the bed has 4 rails, use these boxes to record your results for the footrails.
Leave them blank or cross them out if the bed does not have foot rails.
ZONE 3:
FOOT BOARD
ZONE 4 :
F
P
F
P
F
P
pillow
(removed)
ZONE 3:
Rails
Fully
Raised
P
HEAD BOARD
ZONE 4 :
SAMPLE DATASHEET
ZONE 1:
17
F
P
F
ZONE 3:
F
ZONE 4 :
P
If the bed has 4 rails, use these boxes to record your results for the
footrails. Leave them blank or cross them out if the bed does not have foot
P
F
ZONE 2:
P
ZONE 3:
ZONE 4:
F
ZONE 4 :
P
F
F
P
F
ZONE 3:
F
F
ZONE 4 :
P
P
P
F
ZONE 2:
P
F
ZONE 4 :
P
F
F
ZONE 4 :
P
If the bed has 4 rails, use these boxes to record your results for the footrails.
Leave them blank or cross them out if the bed does not have foot rails.
P
FOOT BOARD
P
F
F
ZONE 3:
P
Rails
Intermediate
Position
ZONE 2:
P
pillow
(removed)
ZONE 4 :
HEAD BOARD
ZONE 4 :
SAMPLE DATASHEET
ZONE 2:
18
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You Are Here: AHRQ Home > Research Findings > Research Activities > June 2007 > A fall
management program in nursing homes improves care and reduces use of physical restraints
Elderly/Long-term Care
A fall management program in nursing homes
improves care and reduces use of physical restraints
About half of the 1.6 million nursing home (NH) residents in the United States fall each year,
and 30 to 40 percent of them fall 2 or more times. These falls can result in painful and costly
injuries, fear of falling, less participation in activities, and lower quality of life. Implementing a fall
management program (FMP) can keep fall rates stable and substantially decrease restraint use
among nursing home residents, according to a new study. Emory University researcher
Kimberly Rask, M.D., Ph.D., and colleagues examined nursing homes in Georgia that were
owned and operated by a single nonprofit organization.
A convenience sample of 19 nursing homes implemented the FMP. The FMP falls assessment
targets five common risk factors: medications (for example, use of antianxiety drugs or
hypnotics), gait and mobility problems, vision problems, orthostatic hypotension (very low blood
pressure that can cause dizziness), and unsafe behavior. The assessment leads to a fall
intervention plan to minimize the risk of falling. A flow chart guides staff through the process,
from entering a resident into the FMP through followup assessments.
The researchers examined documentation of 24 process of care items related to fall prevention.
Successful implementation of the FMP was associated with improvements in the documentation
of recommended care processes for fall prevention. Restraint use decreased 44 percent from
7.9 to 4.4 percent in the FMP NHs, but only 30 percent from 7 to 4.9 percent in the non-FMP
NHs during the study period.
Fall rates remained stable in the FMP NHs during the study period (from 17.3 to 16.4 falls/100
residents per month). However, fall rates increased 26 percent in the NHs not implementing the
FMP (from 15 to 18.9 falls/100 residents per month). The study was supported in part by the
Agency for Healthcare Research and Quality (Contract No. 290-00-0011).
See "Implementation and evaluation of a nursing home fall management program," by Dr. Rask,
Patricia A. Parmelee, Ph.D., Jo A. Taylor, R.N., M.P.H., and others in the March 2007 Journal of
the American Geriatrics Society 55, pp. 342-349.
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Rethinking the Use of Position Change Alarms
By Joanne Rader, Barbara Frank, Cathie Brady
January 4, 2007
Personal alarms are alerting devices designed to emit a warning signal when a person moves in a
way perceived to put them at risk, usually for falls. The most common types of devices are:




A cord attached to the person’s clothing with a pin or clip and ending with a magnet or pullpin that activates when the person exceeds the length of the cord
Pressure sensitive pads for chairs, wheelchairs and beds that activate when there is
decreased pressure
Pressure sensitive mats for the floor that activates when pressure is increased
Light beams on the bed or door that activate when the person crosses the beam.
The Omnibus Reconciliation Act of 1987 (OBRA 87) implemented in 1990, resulted in a dramatic
shift in thinking and practice related to the use of physical restraints and falls. The Quality of Care
regulations to implement OBRA 87 require that there be no decline in a person’s physical, mental,
or psychosocial well-being, unless such a decline is an inevitable consequence of the person’s
disease or condition.
Restraints cause declines in a person’s physical, mental, and psychosocial well-being. By keeping
people from moving, restraints adversely affect people’s respiratory, digestive, circulatory, and
muscular systems, contribute to depression and isolation, and inhibit sleeping as well as
independent eating, drinking, toileting, and natural repositioning. As nursing home staff came to
understand the detrimental affects of restraints and changed practice, the use of position change
alarms became wide spread. However, just as restraints cause harm by keeping people from
moving, so do personal alarms. Meanwhile, there is no evidence to support alarms’ usefulness in
preventing falls or injuries. In fact, in most cases, falls continue to occur. In spite of that, staff, and
sometimes families, gravitated to the use of alarms, and surveyors in many states began looking
for them as part of the documented safety plan.
Quite often, staff respond to the alarm by directing a resident to sit back down instead of assisting
residents with whatever is generating their movement (discomfort with the current position, a need
for a drink, the bathroom, or simply a need to move). Often staff respond to the alarm and not to
the person.
In addition to the harm alarms cause by immobilizing residents, and having no evidence that they
prevent falls or injuries, they are difficult to utilize in a consistent way for a variety of reasons:



Many persons dislike them and repeatedly hide or remove them
The device can malfunction (cord breaks or detaches, battery dies, alarm fails to go off or is
slow to respond)
If too many are in use, the warning signal loses its effectiveness at alerting staff.
Page 2
For the person, there can be numerous negative consequences to his/her quality of life and
mobility:







Alarms create noise, fear and confusion for the person and those around them. For
example, one gentleman would duck down when he heard the alarm as he was interpreting
the sound to mean incoming missiles, bullets from his World War II experience
If staff tell the person to sit down when the alarm goes off, the underlying need causing
them to want to move is not being address
As the use of the alarm decreases the person’s overall mobility, he/she may be more at
risk for fracture when he/she falls since the person may have increased weakness and
osteoporosis and decreased balance and endurance
The alarms can be experienced as embarrassing and an infringement of freedom, dignity,
and privacy
Skin break down can occur from being immobilized, and afraid to shift position or body
weight while sitting for prolonged periods of time, or while lying in bed at night
Sleep may be interrupted, or even impossible when residents lie still for fear of setting off
the alarm if they shift their position or being awakened by the alarm
Loss of independent bowel and bladder function can occur.
Clearly there are many people in LTC who are at risk for falls and injury and who need to have a
safety plan in place. These plans need to be highly individualized and based on a thorough
assessment of the risk factors that exist within the person and her/his clinical condition, in the
physical environment and also the organizational environment. The alarms provide a clear
example of an intervention that by attempting to prevent the risk of falling may actually increase
the risk of serious injury from falling. They give a false sense of security and at the same time,
absorb an inordinate amount of staff time responding to the alarm. In most cases, the best way to
prevent the risk of falls with injury is to promote residents’ balance, endurance, and overall
mobility.
The residents’ wishes and preferences have to be considered. If persons do not have cognitive
impairment and are informed of the risks, they have a right to be mobile, even if that involves
falling. If the person is cognitively impaired, his or her expressed wishes must be factored in.
These wishes may well be expressed through behaviors that demonstrate any discomfort from the
person’s perspective. For people who are cognitively impaired, the alarms are particularly
upsetting. They have been found to induce agitation during the day and interrupt sleep at night.
Lack of deep sleep compounds agitation, and contributes to loss of appetite, and decreased
balance and endurance. The medications used to treat agitation and sleeplessness often pile on
to the problems.
Page 3
For people who have had a recent change in health and ambulatory status (e.g., amputation, hip
replacement, stroke or debilitating acute illness), there may be some value in using an alerting
device temporarily as a reminder of the need to call for assistance. In a sense it acts as a
substitute call light for at risk people who may not remember to use a call light. It might also be
helpful in assessing the needs and patterns of newly admitted residents. Given that there is no
clear evidence of the efficacy of the devices in reducing falls or injuries, any prolonged use should
be very carefully and routinely assessed against the multiple adverse consequences that can
inhibit healing. In some cases, premature and prolonged use of alarms contribute to such a severe
decline in a resident’s function that it may unnecessarily turn short-term residents into long-term
residents. People who came to the nursing home to recover may never go home.
Originally alarms were designed for very short-term use to learn a resident’s patterns. These
patterns can more easily be learned through individualized care. Staff would have time for
individualized care if they were not responding to so many alarms. However, when an alerting
device is documented as being part of the short-term safety plan, staff have a responsibility to
assure that they are being used as indicated in the plan (e.g., placed correctly on the person,
length of cord adjusted properly, in good working order). If this is not done or if the resident
consistently tries to remove it, the facility will be viewed as having not followed the person’s safety
plan and be at risk for deficiencies. So the reasonability of the plan has to be considered. It makes
no sense to create a plan that you know the resident will consistently foil.
Since our culture tends to be over-protective of elders and to seek solutions in technology, and our
traditional nursing home culture tends to focus on risk prevention instead of health promotion, it is
easy to over rely on these devices. Because there is potential for harm, we need instead to find the
underlying causes of falls and instability, and develop individualized approaches that take into
account the strengths, possibilities, wishes and needs of each person. So when considering using
personal alarms, it is important to ask, “Will this cause immobilization and isolation for this
person?” “Will this really increase the person’s safety or is it more to help the caregivers
(family and professionals) feel they are doing something?”
As a culture we need to come to terms with the fact that in our long-term care settings we are
working with the frailest of the frail much of the time. Some are going to fall, get injured and even
die as a part of normal life and risk taking. There is no way to prevent all falls and people coming
into new settings have an increased risk of falls. We certainly don’t want to contribute to their risk
of injury from falls by immobilizing them and causing their decline. The best we can do is work to
strengthen balance and endurance and know as much as we can about the person. By doing so,
we can respond to his/her needs and help him/her sleep, drink, shift, and move as safely, freely
and comfortably as possible with our assistance when needed. With this approach, we can try to
create plans of care that meet the unique needs of each person.
Page 4
As with any significant change in clinical practice, it is important to start slowly. In order to remove
position alarms, identify residents who can most easily have a decrease in the amount of time
alarms are in use for them. Remove the alarms a few hours at a time. Have all staff involved in
watching and learning together, identifying any possible concerns, as well as possible strategies.
Make sure to give staff the help and support they need as they proceed. Work together to mitigate
risks and put in place the necessary interventions to meet residents’ needs and build their capacity
to function without alarms. Each success will teach you more about how to take on the next
challenge.
You may want to start by putting an alarm on yourself, and having all who will be involved in an
alarm elimination effort do the same. Wear the alarm for 30 minutes and then discuss the
experience together. You’ll be surprised by how uncomfortable it is and how much it has the
psychological effect of restricting your movement. This kind of personal experience is a great
teacher.
Essential ingredients for a successful process include:








Consistent staffing so that staff know residents well and work well with each other
Daily meetings on the unit where you are changing practice to discuss what staff are doing,
learning, and needing
Consistent communication across shifts to share information, ideas, and experiences
Interdepartmental communication so that all who are on the floor can be knowledgeable
partners in the effort
Coordination with care planning processes
Inclusion of the physician
Review of factors contributing to risk of falls (e.g. medications, diet, activity, footwear, etc.)
On-going communication with resident and family throughout the process and full inclusion
of their input into decision-making.
For more information on how to eliminate alarms, see Nursing Home Alarm Elimination Program: It’s
Possible to Reduce Falls by Eliminating Resident Alarms by Brenda Davison, DON, Jewish Rehabilitation
Center of the North Shore, Swampscott, MA. The article is available at www.MassPRO.org. Brenda shares
her story on the CMS Surveyor Training web cast, From Institutional to Individualized Care, Part One:
Integrating Individualized Care and Quality Improvement, November 3, 2006, available from
http://cms.internetstreaming.com. Copies of this program, and the accompanying train-the-trainer manual
and handouts, can be obtained from the National Technical Information Services at 5285 Port Royal Road,
Rm. 1008, Sills Bldg. Springfield VA 22161. Phone number: (703) 605-6186.
This material was prepared by Quality Partners of Rhode Island, the Quality Improvement Organization Support Center for the Nursing Home
Quality Initiative, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human
Services. Publication number: 8SOW-RI-NHQIOSC-072208-1.