Medical Devices

Manual Cleaning?
SOBECC Round Table:
Manual and Automated Cleaning Methods
11.40-12.30
27th July 2012
Chirurgie-Instrumenten-Arbeitsgruppe Berlin
Dr. med. Dipl.-Ing. Thomas W. Fengler
Chirurgie-Instrumenten-AG Berlin – hands on !
Chronology of Surgical Instruments Workgroup (CLEANICAL)
1993
1994
1998
1999
2000
2001
2002
2005
Establishment of Chirurgie-Instrumenten-AG (Surgical Instruments Workgroup - CLEANICAL) at
Hospital Moabit Berlin
Secretary Dr. med. Dipl.-Ing. Thomas W. Fengler, Member of diverse scientific organisations:
German Society for Surgery, German Society for Visceral Surgery, European Association of
Endoscopic Surgery (E.A.E.S.), German Society for Sterile Goods Supply (DGSV)
Technical management Antje Hartwig, previously Helmut Pahlke (deceased on 9/30/10)
Quality of Instruments for Laparoscopy – retro- and prospective clinical studies on
medical devices for abdominal surgery at Hospital Moabit Berlin
Projekts with several manufacturers of medical devices for surgery (BODE, KARL STORZ
Miele PROFESSIONAL, ebro, Schuelke) concerning function and hygiene (design, functionality,
cleanability, residues, process-control)
Organisation of the first clinical multicenter study worldwide on residual contamination after
automated cleaning (no thermal disinfection) for varied instrument-designs in 6 different
hospitals (CSSD)
1st International FORUM Medical Devices & Processes, Kongress-Center MEDICA Düsseldorf.
Foundation of SMP GmbH in Tübingen – „Test, Validate, Research“; Managing partner Klaus Roth
Foundation of ZEHNACKER CLEANICAL® GmbH
2011
3rd International FORUM Medical Devices & Processes in Berlin
Business Support International: FORUM-Tour Argentina, Armenia, Brazil, China, Chile, Georgia,
Irland, Mexico, Norway, Russia
Foundation of two Firms: CMP (Process-Validation) und CLEANICAL ® GmbH (Consulting on
medical devices & processes)
Member of editors board of CENTRAL SERVICE / ZENTRALSTERILISATION
(Dr. Thomas W. Fengler)
Menber of the board (A. Hartwig) aseptica
2012
Series of Journals: International FORUM Medical Devices & Processes Vol. 14, 15, 16
2007
2010
What is so “manual“ about Cleaning?
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Medical devices enable new surgical approaches
Remanents are a fact after cleaning
(Re-)Processing cycle is a quality cycle
We move “manually“ from step to step through processing
Cleaning needs specific tools and considerable skills
Washing is not Cleaning/ is not „automatically“ happening
Process of cleaning has to be documented
Countable events have to be identified, verified and
validated – together with “ not countable“ events.
9. Validation is a spot check
10. Operator is responsible in the first place
Medical Devices enable new surgical Approaches
Environment and Hygiene in the
Operating Theatre:
The Medical Device is just a part of it!
Safe Function and adequate Usability
Adequate and intended Use
inspección con los ojos y manos
Verification and Validation of the safe Function
which includes Cleanliness and Cleanability
Defining Parameters for Cleanliness
6 Hospitals, 6 (Re-)Processing Departments,
6 different Instrument Designs 7 Samples each*
*Fengler TW, Pahlke H, Bisson S, Michels W: Are processed Surgical Instruments Free of Protein?
ZentrSteril 2001; 9(1):20-32
4 analytical Methods:
visual, modified Biuret, OPA for Protein Contamination,
Pseudoperoxidase Reaction for Detection of Hemoglobin
Practice of
Reprocessing
Operational Practice
Quality Management
Why „(oh so…) correct“ (Re-)Processing?
• The risks of reprocessing are considered to be „fully manageable“.
Correctness is the basic requirement in order to rule out at least one source of
infection!
• Incidence of nosocomial infections remains unclear, since they are difficult to
trace back. They might concern patients, resulting possibly in fatalities; some of
which (allegedly: 20-30%) could be prevented.
• „The hygiene- and sterilisation risk has to be kept to the inevitable residual
risk, according to the state of science and technology.“ (from a verdict of
German Federal Supreme Court [BGH])
• From a legal point of view, work in a CSSD is a task „of a higher degree“.
This implies an obligation for the staff, to be guided by the current state of
science and technology at all times and further their education „to the limits of
what can reasonably be expected“ (quotations from relevant verdicts).
15
A Quality Cycle?
What does (Re-)Processing of Medical Devices imply:
clean &
disinfect
dry
sterilize
inspect
waste
waste
traceability
use
wrap &
label
stock
sterilize
raw
material
(Re-)Processing needs time
Do we know their qualification?
Do we care?
Central de Equipos y Esterilización
( C E y E)
Todos los productos médicos reciben
un procedimiento descrito Parámetros físicos si
posible -> T, p, t
Lavado:
• Inspección visual
Desinfección: • Concentración, tiempo.
Secado:
Control visual del secado
Mantenimiento: • Controles descritos
Empaque
• Manejo descrito
Esterilización
• prueba BD, protocolo
Parámetros del lavado (Círculo de Sinner)
Químico
Temperatura
Agua
Mecánico
Tiempo
Manual cleaning may waste water (rinsing from the tap) and
needs more time by cleaning one part after the other
¿Cuantos lavabos tiene?
Flexible Bone Drills
Washer disinfectors may reduce the waste of water
rinsing many instruments at the same time in the same process
Important parameters are
• Water pressure
• Volume of water
• Coverage of water
• Rotation
• Temperature
• Selected detergent
• Quality and quantity of operating means
• Velocidad
• Chosen load carriers
• Positioning of the chosen load
Water is moving the easiest way possible
Washer disinfector
Washer disinfector can possibly rinse inner lumina of medical devices with a
defined pressure
Beware of the load!
Charge it … correctly!
CEN ISO 15 883 Part 1-7
Correct cleaning dries the load ...
Efficient loads?
Miele
Steelco
Belimed
Getinge
Correct loading in specifically
constructed carriers with
sufficient pressure of
(tap or fully desalinated?)
water is necessary.
Spray arms must provide
enough pressure.
Mechanized (re-)processing
using different load carriers
does not „automatically“ lead
to clean results.
Cleaning is more than washing
Bañar, lavar – limpiar:
El resultado del lavado manual depende de la persona / del día:
Reproducibilidad limitada, temperatura < 40°C
Endoscopes are
complexe. During
reprocessing they
need a lot of care,
manually or by an
adequate washer
disinfector
Cleaning is brushing, is mechanical manual action
Brushing is helpful against remnants, microbes and biofilmes
Cepillos diferentes
Being ¨in touch¨, beware of penetration:
Manual steps may be infectious
Fault of concentration, poor performance, no discipline:
Damage in a hurry!
Personal Protective Equipment (PPE)
Space at the working place?
Ultrasound – bathing or cleaning?
Bathing instruments „in between“? Noisy, dirty, smelling –
or a well documented precleaning site for specific instruments?
Correct means,
Correct tools
at site?
Transporte en cestillos sin complicaciones
„One touch“ –
lo tocamos una sóla vez:
-> Transporte
-> Lavado
-> Esterilización
Módulos para soluciones técnicas
Mejorando ....
Instrumentenpflege
1. Inspección visual táctil
2. Mantenimiento
3. Pruebas de funcionamiento
Verify
Validated
Operational Practices:
Validation is verification of specified „predestined“ values
Documentation
Countable events:
Not countable events:
Defining parameters in the lab
Defining values for those
parameters in the lab
Measuring parameters in the
clinical environment
Quality Management with
standard operating procedures
(SOP)
Cleaning Process Control supported by Data Logger
Documentation is knowledge
Appropriate means?
Just do it!
Regulatory Affairs
Law for medical products / Guideline for operators of medical
products
Social law
RKI „Requirements for the hygiene in processing medical products“
DIN EN 285 Large sterilizers /
EN 13060 Small sterilizers (< 60 liters)
EN ISO 17665 Validation of sterilization processes
ISO EN 11140-4 Routine control (Bowie Dick Test)
Recommendation of DGKH for the validation and routine control of
sterilization processes with saturated steam for medical products
EN ISO 15883 Part 1-7 Routine control and validation of washer
disinfectors
Guidelines of DGKH, DGSV and A-K-I for the validation and routine
control of washer disinfectors
Medical Devices –
Product „Families“ regarding Reprocessing Properties
considering Permeability (to Steam or Water)
.
Medical Devices –
Product „Families“ regarding Reprocessing Properties
considering Permeability (to Steam or Water)
1. Massive goods (surgical instruments, e.g. hammer)
Free access of steam to all surfaces
Factors are steam quality and dimensions
2. Porous goods (Surgical covers, wound covers, pad)
Factors are air ejection
as well as steam quality.
.
Overdry cellulose fibers can re-hydrate (overheating)
3. Hollow „containers“
(surgical instruments, e.g. minimal invasive surgical instruments)
Factors are air ejection as well as steam quality
Problematic are: tubes, joints, threads etc.
Influences to Cleaning and Disinfection Processes
Design of Instruments
„Permeability“ of the inner lumen
Materials and coatings
Joints, Hinges
Hollows, Cavities
Shafts
Surface properties
Influences to Cleaning and Disinfection Processes
Process Chemicals
Cleaning agent
Disinfection agent
Neutralising agent
Rinse agent
Concentration of the agents
Are You using 2 baths?
One for cleaning, one for disinfection
… or rinsing under tap water?
Then disinfection bath?
What size is Your containment?
Documentation of the chemicals?
(name, frequency of change, concentration)
Conclusion
Medical devices are not always cleaned properly by washer disinfectors.
Staff is not always able to work consistently and regular.
Manual cleaning remains necessary as automated devices are limited in
capacity and capability. (Re-)Processors have limited access to washer
disinfectors as well.
Validated (re)processing is mandatory. It requires verification of
parameters that are predefined, in the case of manual cleaning mainly
standard operating procedures (SOP).
The specifications of validation must reflect the actual state of science
and technology. They are partly measurements, partly descriptions and
control of fulfillment (countable/ not countable events).
FORUM workshop CLEANICAL
Muito Obrigado