Flexibele endoscopen en CSA


Flexibele endoscopen en CSA
Infection Prevention
INLEIDING Flexibele endoscopen en CSA?
2013 VSZ Kwaliteitsgroepen
Transforming Health
Dirk Eraly
Professional Services Infection Prevention
Sterilization, Ioban, Clipper and Respirators
3M Infection Prevention Division
Endoscopie afdelingen (ook buiten ziekenhuis)
Device and Controll Station
Procedures: Colonoscopy, Gastroscopy, Bronchioscpy
Reprocessing (Cleaning and Disinfection)
Special storage cupboard
for flex. endoscopes
Decontamination via pre-cleaning and
Automatic Endoscope Reprocessing (AER)
Rigide endoscopen
Flexible endoscopen
Endoscopie afdel/privé-poli kliniek
- Minimal invasive surgical procedures
-Vele gescheiden afdelingen in
verschillende disciplines autonoom van
CSA, meestal ook zonder inspraak apoth
-Trend naar 1 centrale unit zoals NL
- Meer focus op diagnostiek en
therapeutische procedures i.p.v.
- Thermisch gevoelige optische en
technologische systemen
- Reprocessing (reiniging en desinfection) is
verantwoordelijkheid van Endoscopie
afdeling en plaatselijk gereprocessed
- Rigide Endoscopen
- zelfs camera kan autoclaveerbaar
- Endoscopen meestal gereprocessed met
andere intrumenten in speciale trays
- Decontaminatie and sterilisatie
uitgevoerd in CSA of outsourced service
•Goed gekende richtlijnen, aanvaarde
normen, vereisten en processen.
•- verantwoordelijkheden meestal bij 2
personen (apotheek, hoofd CSA)
• Endoscopie technologie ontwikkelt sneller
dan reprocessing mogelijkheden.
• Standaarden staan nog lang niet op punt –
missing links
•ISO 15883-4 published in 2008
•First reprocessing guideline in 2003
•Publicaties en infectiemeldingen na
Endoscope Reprocessing according to guidelines
cleaning at
Transport to
Leak testing
Manual cleaning:
a. Immerse
b. Wipe
c. Brush
d. Flush
e. Rinse
f. Dry
Monitoring? Is
het proper
Zal de
Als het
niet goed
, correcte
HLD niet
High Level
a. Manual
b. Automated
Is het
Endoscope Reprocessing according to guidelines
cleaning at
Transport to
Leak testing
Manual cleaning:
a. Immerse
b. Wipe
c. Brush
d. Flush
e. Rinse
f. Dry
for Clean
Trace ATP
for efficacy
monitoring of
process and
clean testing
High Level
a. Manual
b. Automated
Chain of Arguments
Every single guideline identifies manual cleaning
of flexible endoscopes as critical for effective
endoscope reprocessing
“Meticulous cleaning must precede any sterilization or high-level disinfection of
these instruments. Failure to perform good cleaning can result in sterilization or
disinfection failure, and outbreaks of infection can occur “
“The most important step in the reduction of microorganisms is the manual
cleaning. It is impossible to disinfect or even sterilize an inadequately cleaned
“The objective of cleaning endoscopes and additional endoscopic instrumentation
is to remove organic matter and pharmaceutical drugs, thereby leaving as little
residue as possible, because disinfection or sterilisation results can be adversely
affected by residues”
“Effective cleaning is an essential pre-requisite to disinfection and
sterilization and is vital to ensure removal of debris.”
Manual cleaning is one of the most challenging
parts of flexible endoscope decontamination, is
prone to human error and shows low compliance
„Practice audits showed that manual cleaning and drying before storage were
insufficient. Strict adherence to reprocessing procedures ended the outbreak.“
Aumeran et al Multidrug-resistant Klebsiella pneumoniae outbreak after
endoscopic retrograde cholangiopancreatography. Endoscopy 2010;42:957-9
„This multisite study documented extensive nonadherence with reprocessing
guidelines when manual reprocessing methods were useed.“
• 57% Did not brush all channels & components
• 55% Did not dry with forced air
• 22% Tested for leaks using sudy water
• 16% Skipped air purge after detergent flush
• 14% Did not flush with alcohol
• 10% Skipped final wipe down
Ofstead et al Endoscope reprocessing methods: a prospective study on the
impact of human factors and automation. Gastroenterol Nurs 2010;33:304-11
Monitoring of the cleaning efficacy of the
manual cleaning improves the process quality of
the endoscope reprocessing
„ Increased efforts and resources should be directed to improve
compliance with these guidelines.”
Multisociety guideline on reprocessing flexible gastrointestinal
endoscopes: 2011
„Strict adherence to reprocessing procedures ended the outbreak. [...] Regular
audits to ensure rigorous application of cleaning, high-level disinfection, and
drying steps are crucial to avoid contamination.”
Aumeran et al Multidrug-resistant Klebsiella pneumoniae outbreak after
endoscopic retrograde cholangiopancreatography. Endoscopy 2010;42:957-9
„ There is need for a rapid audit tool for ongoing quality assurance monitoring that
would allow facilities to proactively assess compliance with the manual cleaning
phase of flexible endoscope reprocessing
Alfa et al The adenosin triphosphate test is a rapid an reliable audit tool to
assess manual cleaning adequacy of flexible endoscope channels. AJIC 2012
„ As soon as simple practicable methods to check the effectiveness of the cleaning
process are available, they should be included in the guideline.“
Heeg P Reprocessing endoscopes: national recommendations with a special
emphasis on cleaning-the German perspective. J. of Hospital Infection 2004;
Meest geraadpleegde bronnen in
• Hoge Gezondheidsraad HGR.8355 mei 2010
– Aanbevelingen inzake het onderhoud van flexibel
warmtegevoelig endoscopisch materiaal en de preventie
van infecties
• ESGE-ESGANA (Euro Soc Gastrointest endosc)
– Cleaning and disinfecting in gastrointestinal endoscopy
• SFERD (NL Stuurgroep flex endosc Reinig en Desinfect)
– kwaliteitshandboek
• ISO 15883- 4 (met link naar ISO 15883-1 en 5)
Enkele belangrijke uitreksels:
Vlaams Agentschap Zorg en
• Eisenkader met nalevingstoezicht waarvan flexibele
endoscopen als 1 van de 6 focussen internistisch
zorgtraject kritische diensten
• Basis : juridische erkenningsnormen en Internationale
guidelines of gevalideerde en haalbare standaarden
• Vertaling eisenkader naar inspectie instrument
• Opgesteld in samenwerking met professionals
• Probleem: financiering Federaal, audit & toezicht
Multisociety guideline (2011) / Robert Koch Institute
11 professional organizations (ASGE)
Classification of instruments and recommendation on reprocessing requirements and essential steps.
Classification (Spaulding):
CRITICAL-objects which enter normally
sterile tissue or the vascular system or
through which blood flows should be sterile.
SEMICRITICAL-objects that touch mucous
membranes or skin that is not intact require
a disinfection process
(high-level disinfection[HLD]) that kills all
microorganisms but high numbers of
bacterial spores.
NONCRITICAL-objects that touch only
intact skin require low-level disinfection.
1.Pre-cleaning: at the point of use
2. Leak Test
3.Cleaning: meticulously clean
the entire endoscope and
brushing and flushing of all
channels. Use enzymatic
4.High level disinfection- manual
or automatic at decontamination
5. Drying
6. Storage
2.Leakl Test
3.Cleaning: Immerse endoscope
in detergent, brush and flush all
channels. Use enzymatic
4. Automated Endoscopy
Reprocess or: includes cleaning
and high level disinfection stage,
rinsing and drying .
5. Storage
Weak points
- does not distinguish between observational and therapeutically use of an endoscope.
- therapeutically used endoscopes are evaluated as semi-critical which is wrong by definition. ~1/3 of
all procedures use therapeutically applied instruments.
The recommended processes are not based on well-designed studies, but on available technology
status and industry input. The evidence is only based on the absence of case reports. It is confirmed
that this may underestimate the true incidence of pathogen transmission.
Microbiologic surveillance testing after reprocessing; Detection of non-environmental pathogens;
Indicator of faulty in reprocessing equipment, inadequate solution, or failed human process.
ISO 15883-4
Part of the 15883 Series - 7 parts (frequently refers to other parts especially 1 & 5)
In scope
• Part of the decontamination process that takes part in the Washer-Disinfector
(WD) / Automatic Endoscope Reprocessor (AER) / High Level Disinfector (HLD)
Out of scope
• Manual cleaning – some minor references
• Storage cabinets
• Endoscopes that can be steam sterilised – covered in 15883:2
ISO 15883-4
Standard Broken down into following broad sections
Performance requirements
Mechanical and process requirements
Testing for conformity
Documentation and inspection
Information to be supplied by the manufacturer
Summary of activities covered
Summary of test programmes
Methods for microbiological evaluation
ISO 15883-4
General observations
• Much emphasis on qualification and installation of WD – WD
manufacturers responsibility
• Recommended routine tests after installation described in detail - incl
cleaning efficacy and disinfection performance
– Frequency not recommended
– Apart from input water quality – at least annual micro test
– Chemical concentration testing (if not automatic)
• Process control very important
– Time / temperature / chemical concentration
ISO 15883-4 (2008)
Requirements and tests for washer disinfector employing chemical disinfection for thermolabile endoscopes.
Main focus:
- Perfomance requirements
- Mechanical and process requirements
- Testing for conformity
Performance requirements:
1) leak testing (where appropriate)
2) cleaning (which may include several stages)
3) disinfecting
4) final rinsing
5) purging of rinse water
6) drying (when appropriate)
Weak points - few or no guidance on essential process steps like manual cleaning or storage
-7 different test soils are listed to prove the efficacy of the process
-only a surrogate and 2 representative devices have to be tested to demonstrate cleaning
-disinfection performance qualification and routine testing are mentioned but not
specifically described
It is obvious that the standard is based on input from manufacturers and lacks in
reference to profound data. The efficacy of processes is not evidence based.
Leverage Clinical Research for Guideline Influence
•Vele professionele groepen
• betrokken
Meer studies nodig ,
data infecties,
wat zijn de risico‘s
veiligheid patient
Clean Trace for Endoscopy
Surface test
Monitors the exterior
of bending section of
the distal end.
Water test
Data Transfer and Analysis
Monitors the interior
of the suction biopsy
channel via validated
flushing method.
Defined threshold is
200 RLUs
Downloads Endoscope
specific data and
generates a trend
analysis. Validate the
process. Web based or
CD-Rom based.
3M™ Clean-Trace™
ATP swabs
ATP waterswabs
Surface ATP Swabs
ATP proteïnetest
Water ATP Swabs
Controle Omgeving
NGi Luminometer
Heat Block
Controle was-en desinfectiefase
En flexibele endoscopen
Surgical Instruments
Online Software
PC Based Software
Gevalideerde levels na
manuele cleaning
Gevalideerde levels na
manuele cleaning
Protein Test
Gebaseerd op ISO
15883 ninhydrinetest
3M Clean Trace does allow fast real time
monitoring of the manual cleaning process to
ensure appropiate manual cleaning before
automatic processing of the endosope
„ The results of our simulated-use study support the application of the ATP method
[ 3M CT] as a reliable means of monitoring manual cleaning efficacy on a “realtime” basis for channels of flexible endoscopes.“
Alfa et al Validation of adenosine triphosphate to audit manual cleaning of
flexible endoscope channels. AJIC 2012, in press
„ We recommend that the ATP test [3M CT] be used after manual cleaning as an
audit tool to confirm adequacy of cleaning (ie, removal of both patient-derived
organic materials and bioburden). Alfa et al The adenosin triphosphate test is a rapid an reliable audit tool to
assess manual cleaning adequacy of flexible endoscope channels. AJIC 2012 in
„ ATP [3M CT] is likely to be the superior
routine monitoring system for its practical,
real-time and quantitative evaluation
capabilities in clinical settings.
Fushimi et al Comparison of adenosin triphosphate, microbiological load, and
residual protein as inbdicators for assessing the cleanliness of flexible
gastrointestinal endoscopes. AJIC 2012, in press
Vragen - discussie
• Wie is verantwoordelijk voor de reprocessing
van flex.endoscopen en hoe worden deze
• Zijn er geschreven procedures die in
Com.Ziekenhuishygiëne worden goedgekeurd
en hoe dikwijls worden die herzien?
Vragen - discussie
• Worden er nog flex.scopen volledig manueel
geprocessed en waarom? Plan om dit te
• Welke zijn de werkpunten op vlak van
structurele indicatoren (lokalen,
veiligheidsmiddelen, autom reproc,
transportkar, compartimentering lokalen,
Vragen - discussie
• Welke controles worden er uitgevoerd bij de
behandeling van flex scopen en wie voert ze
uit? Frekwentie? Wat bij positief resultaat?
• Is er zicht op de training en opleiding van het
personeel – welke opleiding (intern, extern)
Vragen - discussie
• Welke aspecten van de reprocessing zouden
onder toezicht van de CSA idealiter moeten
komen. (nu opleiding bij endoscopie
verplegenden) – hoe best samenwerken?

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