Sterilization Issues Solutions

Sterilization Issues & Solutions - 2013
Presented by SPSmedical
Sterilization Issues
and
Solutions
• Largest sterilizer testing Lab
in North America and now a
part of Crosstex International,
a Cantel Medical Company
• Develop and market sterility
assurance products that offer
advanced technologies
• Provide full day sterilization
Seminars and on-site Facility
sterilization audits
• Corporate member: CSA and
AAMI, serving on numerous
sterilization working groups
2013
Cantel Medical Corp.
Objectives
At the end of this program, participants will be able to…
• identify the issues discussed at the end of last year,
such as IUSS, loaner tray checklist, TJC training on
AAMI Standards and the AAMI/FDA Summit on
instrument reprocessing.
• discuss the importance of having and following
MFG’s IFUs for reprocessing complex instruments,
• explain best practice for early release of implants,
• understand where to find best practices for HLD of
flexible endoscopes.
Multi-society statement endorses process
for immediate-use steam sterilization
(formerly flash sterilization)
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Sterilization Issues & Solutions - 2013
IAHCSMM Loaner instrumentation checklist:
• CS/SPD notified of loaners prior to receiving them.
• Received in facility (decontamination) at least 2 working days
(48 hours) for existing loaner sets and 3 working days (72 hours)
for new sets before scheduled case.
• Inventory list provided/available.
• FDA- cleared manufacturer written instructions for cleaning,
packaging, and sterilization available.
• Inventory and quality check completed.
• Multiple trays numbered and labeled (patient name, Surgeon).
• Trays do not exceed 25 pounds.
• All instruments in good condition, with no rusting or pitting.
• Container in good condition - no rusting, tape, residue, etc.
JC surveyors will, among other activities:
• Observe instruments from the time they leave one
OR to when they are returned to the next.
• Ask HCWs to provide the Mfg's’ instructions for
instrument sterilization, and to describe and
demonstrate how instruments are being cleaned and
decontaminated according to those written
instructions.
• Observe the cleaning of instruments. Rinsing is
rarely enough to properly remove soil from
instruments; meticulous cleaning is needed.
www.iahcsmm.org
It is important to know…
• Verify that staff members are wearing appropriate
personal protective equipment.
• Observe the sterilization process. The surveyor will
ask for the manufacturer’s instructions for the
following items: the sterilizer, wrapping or packing,
and the instruments.
• Review sterilization logs. Surveyors will ask about
physical, chemical and biological indicators.
• Observe the return of instruments to the sterile field
and verify that they are being protected from
recontamination.
All national survey organizations now audit healthcare
facilities for strict compliance with standards, guidelines,
and MFG’s instructions for use (IFU).
AAMI/FDA Medical Device
Reprocessing Summit
AAMI/FDA Medical Device
Reprocessing Summit
Nearly 250 healthcare professionals attended an October
Summit held at FDA headquarters in Silver Spring, MD.
The focus was on cleaning reusable medical devices and
SPSmedical was asked to speak on how to define clean
and the importance of complying with MFG’s IFU.
Sterile processing managers, technicians, regulatory
affairs professionals, clinicians, nurses, clinical engineers,
industry representatives, and regulators prioritized the
challenges to safe reprocessing.
The challenges included: high technician turnover, poorly
designed devices, and what many described as complicated
instructions for use (IFU) from manufacturers regarding
cleaning.
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Sterilization Issues & Solutions - 2013
AAMI/FDA Medical Device
Reprocessing Summit
Reflections of the Summit from some of the attendees
is captured on YouTube at:
http://www.youtube.com/watch?v=SxVg7Il4pFw
Instructions For Use (IFU)
It is best practice for healthcare facilities to have all of
the reusable medical device MFG’s IFUs and to place
them in locations where they are readily accessible to
those needing access; and to keep them updated.
Is this being done?
Copies of the presentations, priorities identified
and summary notes are available at:
http://www.aami.org/reprocessing/materials.html
Securing the MFG’s IFU?
Securing the MFG’s IFUs?
Asking the Sales Representative will work some of the
time; however, contacting the device MFG directly is
better. Ask for Quality Assurance or Regulatory Affairs,
as they deal directly with the FDA and understand your
need for having their validated IFU.
Alternatively, there is at least one Company out there
who will do the search for you and keep them updated.
For a monthly or annual fee, they provide you with an
internet-based library.
Best Practice Professionals, Inc.
1800 East 900 South
Salt Lake City, UT 84108
800.701.3560
www.oneSOURCEdocs.com
AAMI ST79
Considered the bible of sterilization, this comprehensive
guide to steam sterilization in healthcare facilities covers
all aspects of facility design, personnel and reprocessing
procedures.
“The written IFU of the device
manufacturer should always be
followed.”
Is this being done?
EXAMPLE - MFG’s Cleaning IFU
SYMMETRY Orthopedic Instruments
1.
2.
3.
4.
5.
6.
7.
Submerge in enzymatic detergent.
Flush port with 50 ml enzymatic detergent.
Soak for 10 min in protein soluble detergent.
Scrub with soft bristled brush (agitate instrument
while scrubbing).
Rinse with warm tap water (38-49°C)
Flush port with 50 ml warm tap water.
Place in bath of warm water (agitate by hand for at least
1 min). Repeat this process 2 additional times.
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Sterilization Issues & Solutions - 2013
EXAMPLE - MFG’s Cleaning IFU
SYMMETRY Orthopedic Instruments
8.
Ultrasonic for 10 min with neutral pH detergent (flush
port with 50 ml prepared detergent before sonication).
9.
Flush port with clean tap water (3 times).
10. Rinse for at least 1 min with tap water.
11. Dry with clean, lint free cloth.
12. Inspect.
13. Lubricate tip mechanism and finger slot (do not
lubricate flush port).
What about
Ophthalmic instruments?
Improper cleaning of eye instruments can cause toxic
anterior segment syndrome (TASS). TASS is an acute
inflammation of the anterior chamber, or segment, of the
eye that usually starts within 24 hrs. of cataract surgery.
Patients with TASS complain of blurred vision, mild
ocular pain and eye redness. Left untreated, TASS can
result in permanent iris damage.
EXAMPLE MFG’s Cleaning IFU
Zimmer Orthopedic Surgical Instruments
1. Completely submerge instruments in enzyme
solution and allow to soak for 20 min.
2. Rinse in tap water for minimum of 3 min.
3. Ultrasonic clean for 10 min.
4. Rinse in purified water for at least 3 min.
5. Repeat sonication and rinse steps.
6. Remove excess moisture from the instrument with
a clean, absorbent and non-shedding wipe.
EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
Bausch + Lomb is pleased to announce the availability of new cleaning
instructions for our surgical instruments marketed under the Storz Ophthalmic
Instrument and Bausch + Lomb Instrument brands.
Manual Cleaning
1. Disassemble the instrument as applicable and inspect the
instrument for damage or corrosion.
2. Pre-rinse the instrument by holding it under cold running water
for at least 30 seconds, rotating the instrument to expose all
surfaces and cavities to flowing water. Additional rinsing may be
necessary depending on the size and extent of soiling of the
instrument.
3. Place the instrument into a suitable clean basin filled with fresh
neutral pH cleaning solution prepared according to the directions
of the solution manufacturer. Use only cleaning solutions that are
labeled for use with medical devices or surgical instruments.
EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
Ensure that the instrument is fully immersed in the cleaning
solution. The following conditions were validated using a neutral
pH detergent (Steris ProKlenz NpH) and a severe organic soil
challenge (Biomedical Instrumentation and Technology
2007;41(4):324-331).
4. Using a soft cleaning brush gently scrub all surfaces of the
instrument while keeping the instrument submerged in the
cleaning solution for at least 5 minutes. Clean the instrument until
all visible soil has been removed.
5. Rinse the instrument by holding it under cold running water for
at least 30 seconds, rotating the instrument to expose all surfaces
and cavities to flowing water. Additional rinsing may be
necessary depending on the size of the instrument and the amount
of soil.
6. Place the instrument in an ultrasonic bath filled with fresh
neutral pH cleaning solution and sonicate for 5 minutes. Use only
cleaning solutions that are labeled for use with medical devices or
surgical instruments. Ensure that the instrument is fully immersed
in the cleaning solution. Do not overload the ultrasonic bath or
allow instruments to contact one another during cleaning. Do not
process dissimilar metals in the same ultrasonic cleaning cycle.
7. WARNING: Do not process powered instruments in an
ultrasonic cleaner.
8. The cleaning solution should be changed before it becomes
visibly soiled. The ultrasonic bath should be drained and cleaned
each day it is in use or more frequently if visible soiling is
evident.
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Sterilization Issues & Solutions - 2013
EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
EXAMPLE - MFG’s Cleaning IFU
BAUSCH + LOMB Storz Ophthalmic Instruments
Follow the instructions of the manufacturer for the cleaning and
draining of the ultrasonic bath.
9. Repeat steps 4-6 as necessary if visible soil remains on the
instrument.
10. Rinse the instrument by holding it under warm (27˚C – 44˚C;
80˚F – 100˚F) running water for at least 30 seconds, rotating the
instrument to expose all surfaces and cavities to flowing water.
Additional rinsing may be necessary depending on the size of the
instrument.
11. If the instrument has lumens the lumens should be flushed
using a syringe filled with 50cc of warm distilled or deionized
water using a stopcock as follows:
a. Place syringe tip into a beaker of warm (30˚C – 40˚C/85˚F –
105˚F) distilled or deionized water and fill to the 50cc mark.
b. Connect the end of the syringe to the center stopcock fitting.
c. Rotate the stopcock lever to the male Luer fitting (irrigation) or
to the female Luer fitting (aspiration) to allow fluid flow to the
appropriate Luer fitting.
d. Connect the stopcock to the appropriate Luer connector on the
instrument.
e. Push on the syringe plunger to force fluid through the lumen
into another beaker for proper disposal. Do not draw flushing
fluid back through the lumen. Disconnect the syringe. Disconnect
the syringe/stopcock from the instrument.
f. Repeat steps A-E at least three times, for each lumen.
g. Fill the syringe with 50cc of air, reattach the stopcock, and
push on the plunger to force air through each lumen. Disconnect
the syringe/stopcock from the instrument.
NOTE: The CX7120 Universal Maintenance Kit contains a syringe and
stopcock suitable for cleaning instrument lumens.
12. Immerse the instrument in clean basin containing fresh
deionized or distilled water and soak for at least three minutes.
13. Immerse the instrument in second clean basin containing
fresh deionized or distilled water and soak for at least 3 minutes.
14. Perform a final rinse of the instrument with sterile distilled or
deionized water for at least 30 seconds, rotating the instrument to
expose all surfaces and cavities to flowing water.
What about Rigid
Sterilization Containers?
Rigid sterilization container systems must also be cleaned
between uses. Per OSHA regulations, cleaning should be
performed in an appropriate decontamination area with
personnel wearing appropriate PPE.
Each container should be disassembled
(i.e. retention plate) and cleaned to the
MFG’s validated IFU.
Let’s take a look at a leading rigid
container MFG’s IFU for cleaning:
Example – MFG’s Cleaning IFU
Example – MFG’s Cleaning IFU
Aesculap
Aesculap
Manual Cleaning:
1. Use a soft sponge and a mild detergent (see recommended cleaners
section) and clean the STERILCONTAINER and all the components
(including PrimeLine lid with reusable filter) under water.
2. Rinse thoroughly under running water to remove all detergent residue,
as residues can affect the container system.
3. To remove sterilization adhesive tape remnant of surface abrasions, we
recommend the use of Aesculap-Eloxal Cleaner (Catalog number JG601).
This is a non-abrasive cleaner. Apply the cream with a soft dry cloth and
rub to polish the surface. Thoroughly rinse under running water to remove
all residual cleaning cream.
4. Thoroughly dry all components with a soft dry cloth.
Wear proper protective personal attire when cleaning.
Mechanical Cleaning:
1. Place the STERILCONTAINER bottom in the washer with the inside
surface facing down to avoid water collection.
2. Fold the handles towards the inside of the PRIMELINE LID. Place the
lid with the inside surface facing down to avoid water collection.
3. Retention plates inside the PRIMELINE LID should be placed away from
the direct force of pressurized washer jets to avoid damage during the
washing cycle. Reusable filters can be cleaned mechanically inside the
retention plate.
4. Thoroughly dry (either with a soft, dry cloth or air dry) the
STERILCONTAINER and PRIMELINE LID before final assembly.
Ensure that the cleaning equipment has been properly maintained and
that the cleaning cycle has been adequately validated prior to use.
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Sterilization Issues & Solutions - 2013
IMPLANTS
IMPLANTS
AORN RP: Sterilization
Immediate-use steam sterilization should not be used
for implantable devices except in cases of defined
emergency when no other option is available.
AORN RP: Sterilization
Documentation of cycle information and monitoring
results should be maintained. A record describing what
could have been done to prevent IUSS of the implant
should be completed and used as part of a quality
monitoring system
When IUSS of an implant is unavoidable, cycle selection
should be determined by the manufacturer’s IFU, and a
biological indicator and a Class 5 chemical integrating
indicator should be run with the load.
SPSmedical can help you with
a SAMPLE early release form
and a Class 5 Tray Record card.
IMPLANTS
Certified for use with all steam
processes (gravity, prevacuum
and flash), the STEAMPlus has
documented performance
equivalent to a biological
indicator.
AAMI ST79 (Terminal Sterilization)
A Class 5 integrating CI within a PCD (that also
contains a BI) should be used to monitor each load
containing implants and may be used as the basis for
early release in documented
emergency situations only;
however, loads containing
implants should always be
biologically monitored.
For the last issue, let’s discuss
the processing of Flexible Endoscopes
Flexible endoscopes are some of the most challenging
devices for HCWs to reprocess due to their unique
design and complex reprocessing steps.
According to the CDC,
“more healthcare-associated
outbreaks have been linked to
contaminated endoscopes than
to any other medical device”.
So where do healthcare facilities find “best practices” for reprocessing
flexible endoscopes?
Association of periOperative Registered Nurses
“Recommended Practices for Cleaning and Processing
Flexible Endoscopes and Endoscopic Accessories”.
Flexible endoscopes and accessories contact mucous
membranes and/or nonintact skin during use and
require a minimum of high-level disinfection.
Sterilization is only required if the flexible
endoscope is to be used on a sterile field.
www.aorn.org
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Sterilization Issues & Solutions - 2013
Special Note:
Association for the Advancement of Medical Instrumentation
AAMI recently started a Working Group to write a
Technical Information Report (TIR) on reprocessing
flexible endoscopes. AAMI documents are usually
adopted by ANSI as our country’s national standard.
Nancy Chobin is also the Executive Director of CBSPD
which offers a GI Scope Certification program. Vendors
with 1 year experience in GI/Endoscopy qualify to take
the exam.
Nancy Chobin from St. Barnabas Health Care System
is a co-chair for this Working Group. I encourage each
of you to come to the AAMI meetings and participate
along with us in this important new Working Group.
Initial certification costs $125 and
is good for 5 years. $100 fee for
re-certification with accumulation
of 100 CE points.
www.aami.org
SGNA Standards of Infection Control in
Reprocessing of Flexible Gastrointestinal
Endoscopes
www.sterileprocessing.org
Common errors in the
reprocessing of Flexible Endoscopes
They complement the 2009
www.sgna.org
SGNA document titled “Guideline
for the Use of High Level Disinfectants and Sterilants for
Reprocessing of Flexible Gastrointestinal Endoscopes”.
Point of Use (Procedure Room)
• Not wearing proper PPE
• Not having MFG’s IFUs
• Reprocessing delay (multiple procedures and/or with
procedures performed at night or on the weekend)
• Failure to clean all channels (even if unused, fluid and
debris can enter channels at the distal tip)
• Transporting without using a closed container
and/or not labeled with biohazard id
Common errors in the
reprocessing of Flexible Endoscopes
Common errors in the
reprocessing of Flexible Endoscopes
These updated (2012) Standards
are for use in all settings where
gastrointestinal endoscopy is
practiced.
Leak Testing
• Not having the MFG’s IFU available
• Use of damaged water resistant cap
• Overlooking pressurization of scope prior to immersion
• Incomplete angulation of the distal tip in all directions
during leak test
• Not following the MFG’s IFUs for reprocessing a
damaged scope
Manual Cleaning
• Failure to fully submerge endoscope
• Failure to submerge for the required length of time
• Neglecting to dilute the detergent per the MFG’s IFU
• Using worn, damaged or improper brushes
• Failure to use MFG’s validated cleaning adapters
• Damaged/improperly reprocessed cleaning adapters
• Failure to thoroughly rinse
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Sterilization Issues & Solutions - 2013
Common errors in the
reprocessing of Flexible Endoscopes
Manual HLD
• Using a sink or basin of insufficient dimensions
• Using a solution after it’s expiration date
• Not MRC testing the HLD solution before use
• Not QC testing the test strips for each lot
Documentation!
The lack of proper documentation really came to our
attention this year, as we launched the industry’s fastest
and longest lasting OPA solution.
AER
• Failure to manually clean and/or rinse before using
the AER
Common errors in the
reprocessing of Flexible Endoscopes
Storage
• Oversight in removing all valves
and water resistant cap when
storing the endoscope
• Neglecting to ensure that scopes
are hung with all locks in the free
position
• Crowded and unsecured scope
storage areas
Thank You!
Chuck Hughes
VP, Infection Prevention Consulting Services
Cantel Medical Corp. c/o SPSmedical Supply Corp.
6789 W. Henrietta Road · Rush, NY 14543 USA
(800) 722-1529 · E-mail: [email protected]
Certified as a Health Education teacher, Chuck has worked for over 25 years in the
manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology
and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA
and numerous other organizations, including AAMI and CSA where he contributes to
sterilization standards. A popular speaker at regional, national and international
healthcare conferences, Chuck has visited thousands of healthcare facilities during
his career providing sterilization consulting services that include fee based and
complementary audits of instrument reprocessing areas.
Conclusion
In this program, we have discussed several sterilization
(and HLD) issues we experienced this calendar year, as
well as a quick review of those from last year.
Hopefully, the solutions discussed will assist each of
you in complying with best practices, as only through
strict compliance – you can be assured patient safety,
maintaining your accreditation and for positive media
attention.
References & Resources
Accreditation Association for Ambulatory Health Care (AAAHC). 5250 Old Orchard
Road, Suite 200 · Skokie, IL 60007 www.aaahc.org
Association for the Advancement of Medical Instrumentation (AAMI). (2012).
ANSI/AAMI ST 79 Comprehensive guide to steam sterilization and sterility assurance in
healthcare facilities, Amendment 2. Arlington, VA: AAMI. www.aami.org
Association of Perioperative Nurses (AORN). (2013). Perioperative Standards and
Recommended Practices. Denver: AORN, Inc. www.aorn.org
Centers for Medicare & Medicaid Services (CMS). CMS Infection Control Surveyor
Worksheet, Exhibit 351, 2009.
The Joint Commission (TJC). Steam Sterilization Update on The Joint Commission’s
Position. June 15, 2009. The Joint Commission Online. July 20, 2010.
The Joint Commission Accreditation program. (2010). Hospital National Patient Safety
Goals (NPSGs). www.jointcommission.org
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