Should we be testing endoscopes? One life - Central Sterilising Club (csc) 2016

The use of contaminated endoscopes can lead to patient-to-patient transmission of pathogens and infections. Studies evaluated cleanliness of patient-ready scopes after reprocessing and revealed between 10% and 30% of residual contamination.

Should therefore surveillance be standardized?

1. Should we be testing endoscopes?
PhDThomas Vanzieleghem
R&D Manager atOneLIFE S.A.
CSC Conference
11 April 2016
HELPING HEALTHCARE TO BE BIOFILM FREE
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2. Agenda
•Introduction to OneLIFE
•Risksassociatedwithendoscope reprocessing
•Guidelines and regulations
•Resultsof microbiologicalaudits by OneLIFE :
▪Summary
▪French UniversityHospital
▪Christie Hospital(Manchester, UK)
•Pros and cons of testingendoscopes
HELPING HEALTHCARE TO BE BIOFILM FREE 2

3. OneLIFES.A.
OneLIFES.A. is a Belgian biomedical company specialisedin
enzymatic biofilm cleaning products for Medical Devices:
HELPING HEALTHCARE TO BE BIOFILM FREE 3
MISSION
OneLIFE’smissionistoaccompanyhealthcareprofessionalsintheirconstantpursuit
ofoptimallevelsofcleanlinessfortheirMedicalDevices.
SOLUTIONS
OneLIFEprovidesinnovativeproducts,protocolsandservicesthatsupporthigh-
leveldecontamination,includingdetectionandtreatmentofbiofilm.
OneLIFEProprietaryLa propreté sans biofilm réduit les cas de non-
conformité des endoscopes ainsi que les coûts induits
HELPING
HEALTHCARE
TO BE
BIOFILM FREE
1. Elimination du biofilm
2. Détergence enzymatique de haut niveau
3. Prévention continue contre la réapparition des biofilms
4. Diagnostic du parc d’endoscopes: Evaluation du taux de biofilm et de la contamination
5. Monitoring de la propreté du parc d’endoscopes HELPING
HEALTHCARE
TO BE
BIOFILM FREE
For clean, biofilm free
surgical instruments
1. Detection of biofilm and residual protein on surgical instruments
2. In-depth enzymatic cleaning
3. Biofilm treatment; degrades biofilm matrix to expose bacteria
4. Routine use impedes biofilm formation
5. Quick and simple quality control of surgical instrument cleaning

4. 4
Endoscope reprocessing
Accordingto guidelines publishedby national healthcouncils(CFPP),
manufacturersand associations (ESGE-ESGENA)
LeakTest
Manual
Cleaning
Rinsing
High Level
Disinfection
Channel
Flushing
Channel
Brushing
Automatic
(AER)
Storage
PROPRIETARY

5. 5
Riskof residualcontamination
CriticalSteps
LeakTest
Manual
Cleaning
Rinsing
High Level
Disinfection
Channel
Flushing
Channel
Brushing
Automatic
(AER)
Storage
Risk: Lackof
propercontact
betweenthe
channelsand the
detergent
Risk: Lackof mechanicalaction
to removeorganicmatter
Risk: Contaminated
final rinsewater
Risk: Wetstorage!
Risk: cross-contamination of endoscopes if
the detergentbath isnot changed
PROPRIETARY

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Riskof residualcontamination
The keyroleof staff :
•Studyby Osteadin 2013 :
Only1 endoscope out of 69 had
undergoneall stepsof the procedure
Brushing and dryingweremost
oftenneglected!
PROPRIETARY

7. 7
Riskof residualcontamination
The roleplayedby staff iskey:
Lackof visibilityon the resultof the cleaningprocess: isthe endoscope clean?
?
Kovalevaet al., 2013
?
PROPRIETARY

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Consequencesof incompletereprocessing
Organicmatterremainingin endoscope channelsaftercleaningwill
preventHigh LevelDisinfection(HLD) frombeingfullyeffective!
As a result, (build-up) biofilm canformin endoscope channels:
And biofilms favourbacterialtolerancetowardsdisinfectants!
PROPRIETARY
Pajkoset al., JHI, 2004

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Consequencesof incompletereprocessing
Ultimately, the use of contaminatedendoscopes canlead to
patient-to-patient transmission of pathogensand infections
PROPRIETARY

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Authoritiesgetinvolved
PROPRIETARY
The Netherlands
Specialattention shouldbe
paidto cleaningand
disinfectionof ERCP
endoscopes

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The needfor guidelines & qualitycontrol
PROPRIETARY

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The needfor guidelines & qualitycontrol
PROPRIETARY
ESGENA-ESGA, 2008

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OneLIFE microbiologicalaudits
PROPRIETARY
OneLIFEconductedaudits on endoscopes in 8 hospitals in the UK, Belgiumand France
•Endoscopes wereall in a patient-readystate (storedfor 72 hoursor less)
•Samplinginvolvedflushing120 ml of liquidin all endoscope channels
•Bufferedsolution usedfor samplingwasDiluent Neutralizingsolution (Pharmacopeia) :
▪Neutralizesresiduesof Peraceticacid
▪Containstensio-active principlesfor increasedrecovery
•Microbiologicalanalysis: Membrane filtration of 50 ml of sampleculturedfor TVC
•OneLIFE’sGaruda MD detergentwasusedto release biofilm contamination
•Contamination threshold: 20 CFU/sampleaccordingto ESGENA-ESGE Guidelines

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PROPRIETARY
Resultsof microbiologicalaudits
Hospital /
Country
Endoscopes testedResults on patient-ready scopes Comments
France (1) 3 ureteroscopes
1 cystoscope
3out of 4 scopescontaminated Over 3-month test period, OneLIFE EnzyscopeMD enabledconsistently
lower contamination levels compared to the control
Zero non-conformities since use of EnzyscopeMD (12 months).
France (2)
University
hospital
2 duodenoscopes
2 colonoscopes
2 fibroscopes
1 cystoscope
1 gastroscope
4 out of8 scopes contaminated
Further 3 contaminated after LDE
N/A
UK (1) 4 colonoscopes 2out of 4 scopes high contamination
2 out of 4 scopes low contamination
Over 3-month test period, OneLIFEEnzyscopeMD enabledconsistently
lower contamination levels compared to control group.
UK (2) 2 bronchoscopes
1 gastroscope
3 out of 3 scopes contaminated N/A
Belgium (1) 8 gastroscopes
1 fibroscope
7 out of 9 scopes contaminated Suspected CRE issue
Belgium (2) 4 fibroscopes 1 scope contaminated N/A
Belgium (3) 2gastroscopes
1 duodenoscope
1 colonoscope
2 scopescontaminated N/A
Belgium (4)
University
hospital
2 gastroscopes
2 colonoscopes
1 scope contaminated N/A
Belgium (5)
University
hospital
1 echoendoscope
1 duodenoscope
1 gastroscope
1 colonoscope
1 scopeslightlycontaminated N/A

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Resultsata French UniversityHospital
PROPRIETARY
DetailedprotocolSteps Parameters
1 - Sample all endoscope channels with DNP solution
100 ml of DNP
solution
Prepare Garuda MD bath (45°C - 1% dosage)
CTRL GARUDA - Sample 100 ml of detergent bath
Flush channels to remove trapped air
Brush each channel 3 times
2 - Sample all endoscope channels
100 ml of DNP
solution
Rinse Sterile water
Automatic disinfection in AER
Peracetic acid or
Glutaraldehyde
Final Rinse Sterile Water
3 - Sample all endoscope channels with DNP solution
100 ml of DNP
solution
Soak in Garuda MD
(1% - 45°C - 60 min)

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PROPRIETARYCY D 1 D 2 F FN G C 1 C 2
CY Cytoscope CYF-5
D Duodenoscopes TJF 180V
F Fibroscope GIF ITQ 160
FN Nasal FibroscopeN180
G Gastroscope GIF-H185
C Colonoscopes CF-H1901
* Threshold was set at 20 CFU/sample
Not Contaminated *
Contaminated *
Legend
Endoscopes References
2 - Sample of the treatment solution after 1 h (Garuda MD)
=> Enables release of "hidden" contamination
3 - Sampling of endoscopes after disinfection in AER
1 - Sampling of patient-ready endoscopes (<72 h storage)
Samples
Resultsata French UniversityHospital
•2 patient-readyduodenoscopeswerefoundto becontaminated
•1 gastroscope and 1 colonoscopemostlikelycontaminatedby microbialbiofilm
•3 endoscopes wereclean beforebut contaminatedaftera cycle in the AER

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PROPRIETARY
ResultsatChristie Hospital
First test –4 colonoscopes
All four patient-readyendoscopes werecontaminated. Twowithmore than1.000 CFU,
twowithmore than100 CFU (threshold= 20 CFU/sample)
Second test –3 endoscopes
•Gastroscope :
1.First sampleisclean (0 CFU)
1.«Hidden» contamination was
releasedby Garuda cleaning(> 100 CFU)

18. HELPING HEALTHCARE TO BE BIOFILM FREE 18PROPRIETARY
ResultsatChristie Hospital
Bronchoscope 1
Patient-ready Recoverywithcleaningsolution AfterAER
Control DNP
Control Garuda MD

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ResultsatChristie Hospital
Bronchoscope 2
Patient-ready Recoverywithcleaningsolution AfterAER
Control DNP Control Garuda MD

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Conclusions of OneLIFE audits
PROPRIETARY
•In all hospitals, atleast 1 endoscope wasfoundcontaminatedabovethe permissible
leveldefinedby ESGENA-ESGE guidelines (and CFPP 01-06)
•Microbialcontamination wasfoundin severaltypes of endoscopes:
oGastroscopes
oDuodenoscopes
oColonoscopes
oBronchoscopes
oUreteroscopes
•Severalendoscopes presentedcontamination in the formof a biofilm (not detected
in regularliquidsampling) as revealedwitha Garuda MD treatment
•Despiteroutine microbiologicalsurveillance of water, someendoscopes werefound
contaminatedaftera cycle in AERs

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Microbiologicalsurveillance : Pros and Cons
PROPRIETARY
Investment:
•5 minutes to samplean endoscope by asepticallyflushingliquidin all channels
•Sampledendoscope shouldbetreatedin the AER beforeitcanbesafelystoredagain
Type of analysis:
•Culture (in the laboratory) : -Membrane filtration and TVConce per sample
-Resultsin 48 to 72 hours(endoscopes in quarantine?)
•ATP quantification (on site) : -Immediateresults(5 min)
-Lowersensitivityfor microorganisms
-Detectsorganicsoilsas well

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Microbiologicalsurveillance : Pros and Cons
PROPRIETARY
How frequently?
Once per month?Once every3 months? Once every6 months?Once a year?
Coulddependon the endoscope modelsand type of procedures(ERCP)
ESGENA-ESGA, 2008

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Microbiologicalsurveillance : Pros and Cons
PROPRIETARY
Benefits:
•Identifycontaminatedendoscopes and preventtheirusage on patients
•Avoidaccumulation of biofilm resultingfromlapses in reprocessingprocedures
•Gain feedback on the efficiencyof the reprocessingprocedure:
✓Takeintoaccountthe humanfactor (manualcleaning)
✓Assessthe robustnessof cleaningand disinfectionmethodsused
✓Validateyourprocessbasedon the actualoutput of endoscope reprocessing

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Test your endoscopes, reveal the full picture
PROPRIETARY

25. Thank you for your attention
Any questions?
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26. OneLIFESA
Parc Scientifique Einstein
15 avenue Albert Einstein
1348 Louvain-la-Neuve
Belgium
Tel : [phone]
Fax: [phone]
www.onelife-biofilmfree.com
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Thank you for your attention, any questions?
PROPRIETARY