Biofilms in endoscopes - the role of cleaning

1. Biofilms in endoscopes:
the role of cleaning
Belgian Interdisciplinary Biofilm Research
BIBR – Sept 2016
Thomas Vanzieleghem –
R&D Manager @ OneLIFE
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2. Biofilms and medical devices
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3. Medical devices and biofilms
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Medical devices are prone to biofilm formation!
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4. Key factors are met: Surface/interface, Nutriments, Temperature and Water
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Biofilm development on medical devices
Source : Otto, Nature Reviews Microbiology, 2009
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5. Biofilms in Endoscopy :
Risk assessment
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6. There is an endoscope to be reprocessed it should be done as soon as possible :
“The sooner, the better”
Two good reasons not to leave an endoscope dirty :
- Creates the perfect environment for biofilm to develop
- Lets the soil dry in the endoscope channels, therefore making it harder to
clean and disinfect
If an endoscopes cannot be treated directly after a procedure, foresee a more
intensive cleaning before proceeding to high-level disinfection
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Reprocessing endoscopes – Time matters!
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7. 7
Reprocessing endoscopes – The protocol
According to guidelines published by national health councils, manufacturers
and associations (ESGE-ESGENA)
Leak Test
Manual
Cleaning
Rinsing
High Level
Disinfection
Channel
Flushing
Channel
Brushing
Automatic
(AER)
Storage
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8. 8
Reprocessing endoscopes – The protocol
Critical Steps
Leak Test
Manual
Cleaning
Rinsing
High Level
Disinfection
Channel
Flushing
Channel
Brushing
Automatic
(AER)
Storage
Risk of biofilm : Lack of proper
contact between the channels
and the detergent
Risk of biofilm : Lack of mechanical
action to remove organic matter
Risk of biofilm:
Contaminated final
rinse water
Risk of biofilm :
Wet storage!
Risk of biofilm : cross-contamination of
endoscopes if the detergent bath is not changed
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9. 9
Reprocessing endoscopes – A difficult job
Lack of visibility on the result of the cleaning process: is the endoscope clean?
?
Kovaleva et al., 2013
?
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Biofilms in endoscopes
Biofilm can form in endoscope channels and represent a persitent nest of
undesired microorganisms
« Buildup biofilm develops as a result of cyclical exposure to wet and dry
phases during usage and reprocessing » (Alfa, 2009)
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Pajkos et al., JHI, 2004

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Biofilms = High tolerance & persistance
Flemming et al., 2016
• Multiple barriers prevent disinfection from
working
• Oxidizing agents for high level disinfection
of endoscopes interact with EPS !
• Even when biocides penetrate biofilms,
germs can still tolerate them
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12. 12
Sampling of endoscopes after cleaning and high-level disinfection
Detection of germs in endoscopes
Source : Biotech Germande, 2012
OneLIFE Proprietary

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Risk of transmission to patients
The rate of transmission of germs from contaminated endoscopes to patients
is rather high and infection can occur!
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14. Biofilm in Endoscopy:
Prevention & Corrective Treatment
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15. Cleaning, cleaning, cleaning!
The cleaning step dictates the efficiency of the whole (endoscope)
decontamination process:
The most important step in the reduction of microorganisms is the
cleaning. It is impossible to disinfect or even sterilize an inadequately cleaning
instrument. Protein debris can become fixed by chemicals on the channel
surface of the scope if the cleaning and rinsing steps have not been carried out
correctly. In short, all disinfection processes, whether done manually or by
washer-disinfector, should be done only after appropriate manual cleaning .
(ESGE-ESGENA guideline: Cleaning and disinfection in gastrointestinal endoscope, update 2008)
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Sinner Cycle
Detergent should allow
to remove organic
matter and biofilms
Brushing and flushing
are key to a successful
cleaning
Proper cleaning
takes time!
Warm water improves the
cleaning process
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17. Cleaning, and not disinfection, is the most effective way to remove
Biofilm and its EPS matrix.
An established biofilm cannot be removed using routine procedure, it requires a
specific approach!
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Corrective treatment of biofilms
Specific solutions that degrade EPS
Weakened integrity of the biofilm
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Step 1 :
Routine cleaning & disinfection Step 2 :
Cleaning with specific detergents

18. Specific approach = the right choice of enzymes!
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OneLIFE enzymatic detergents
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Biofilm Action destructrice
sur la matrice du
biofilm
Détergent multi-
enzymatique
spécifique
Bactéries exposées
aux désinfectants

19. Comparative testing of detergents on biofilms of clinically relevant bacterial species.
Detergents were tested in standard tap water (2.5 mM CaCl2, 1.25 mM MgCl2 and 3.33 mM
NaHCO3). Results are expressed in % of removal compared to an untreated control
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OneLIFE enzymatic detergents
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Detergents
Biofilms
S. aureus P. aeruginosa K. pneumoniae E. coli E. faecalis
ATCC 33591 PAO1 ATCC700603 ATCC25922 ATCC29512
Garuda MD 85 80 51 56 65
Enzyscope MD 61 67 43 32 44
Cleaner 1 85 38 0 0 64
Cleaner 2 2 14 0 0 1
Cleaner 3 19 19 0 0 0
Cleaner 4 46 38 0 0 0
Cleaner 5 54 59 75 16 74
Cleaner 6 21 0 58 0 0
Cleaner 7 54 8 47 45 0
Cleaner 8 46 0 28 0 0
Cleaner 9 79 75 25 11 59
Cleaner 10 55 21 83 0 0

20. Tests in hospitals
Case of a contaminated duodenoscope
• 16/10/2015 > 10.000 CFU/sample (120 ml, all channels) including Pseudomonas
aeruginosa
• 17/10/2015 Treatment with Garuda MD + Desinfection with peracetic acid
• 18/10/2015 Microbiological sampling of the endoscope at the hospital
• 26/10/2015 Hospital confirms the absence of Pseudomonas aeruginosa and < 5
CFU/sample
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21. Tests in hospitals
Case of a contaminated gastroscope - loaned to the hospital early January 2016
• 26/01/2016 Endoscope contaminated with 5.000 CFU/sample (120 ml, all
channels) including Pseudomonas aeruginosa
 Corrective decontamination procedure was applied by the hospital
but contamination remained
• 09/02/2016 Endoscope contaminated with 15.000 CFU/sample (120 ml, all
channels) including Pseudomonas aeruginosa
 Corrective decontamination procedure was applied by the hospital
but contamination remained
• 20/02/2016 The endoscope was treated with Garuda MD and disinfected with
PAA and sampled
• 22/02/2016 Microbiological aerobic culture was negative, the endoscope is clean
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22. Biofilms …
• can form in endoscopes and may resist classical cleaning and disinfection
procedures
• cases of infections due to contaminated endoscopes can be linked to biofilm
dwelling in endoscopes
• tackling the biofilm issue in endoscopes requires solutions that can degrade
the EPS and breakdown the vicious cycle
What does not kill/remove biofilms makes them stronger!
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Take home messages
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23. OneLIFE SA
Parc Scientifique Einstein
15 avenue Albert Einstein
1348 Louvain-la-Neuve
Belgium
Tel : +32 (0)10 48 34 27
Fax: +32 (0)10 45 63 63
www.onelife-biofilmfree.com
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Thank you for your attention, any questions?
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