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Biofilms in endoscopes:
the role of cleaning
Belgian Interdisciplinary Biofilm Research
BIBR – Sept 2016
Thomas Vanzieleghem –
R&D Manager @ OneLIFE
HELPING HEALTHCARE TO BE BIOFILM FREE 1
PROPRIETARY
Biofilms and medical devices
HELPING HEALTHCARE TO BE BIOFILM FREE 2
PROPRIETARY
Medical devices and biofilms
HELPING HEALTHCARE TO BE BIOFILM FREE 3
Medical devices are prone to biofilm formation!
PROPRIETARY
Key factors are met: Surface/interface, Nutriments, Temperature and Water
HELPING HEALTHCARE TO BE BIOFILM FREE 4
Biofilm development on medical devices
Source : Otto, Nature Reviews Microbiology, 2009
PROPRIETARY
Biofilms in Endoscopy :
Risk assessment
HELPING HEALTHCARE TO BE BIOFILM FREE 5
PROPRIETARY
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
HELPING HEALTHCARE TO BE BIOFILM FREE 6
Reprocessing endoscopes – Time matters!
PROPRIETARY
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
HELPING HEALTHCARE TO BE BIOFILM FREE
PROPRIETARY
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
HELPING HEALTHCARE TO BE BIOFILM FREE
PROPRIETARY
9
Reprocessing endoscopes – A difficult job
Lack of visibility on the result of the cleaning process: is the endoscope clean?
?
Kovaleva et al., 2013
?
PROPRIETARY
HELPING HEALTHCARE TO BE BIOFILM FREE 10
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)
PROPRIETARY
Pajkos et al., JHI, 2004
HELPING HEALTHCARE TO BE BIOFILM FREE 11
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
PROPRIETARY
12
Sampling of endoscopes after cleaning and high-level disinfection
Detection of germs in endoscopes
Source : Biotech Germande, 2012
OneLIFE Proprietary
HELPING HEALTHCARE TO BE BIOFILM FREE 13
Risk of transmission to patients
The rate of transmission of germs from contaminated endoscopes to patients
is rather high and infection can occur!
PROPRIETARY
Biofilm in Endoscopy:
Prevention & Corrective Treatment
HELPING HEALTHCARE TO BE BIOFILM FREE 14
PROPRIETARY
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)
HELPING HEALTHCARE TO BE BIOFILM FREE 15
PROPRIETARY
HELPING HEALTHCARE TO BE BIOFILM FREE 16
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
PROPRIETARY
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!
HELPING HEALTHCARE TO BE BIOFILM FREE 17
Corrective treatment of biofilms
Specific solutions that degrade EPS
Weakened integrity of the biofilm
PROPRIETARY
Step 1 :
Routine cleaning & disinfection Step 2 :
Cleaning with specific detergents
Specific approach = the right choice of enzymes!
HELPING HEALTHCARE TO BE BIOFILM FREE 18
OneLIFE enzymatic detergents
PROPRIETARY
Biofilm Action destructrice
sur la matrice du
biofilm
Détergent multi-
enzymatique
spécifique
Bactéries exposées
aux désinfectants
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
HELPING HEALTHCARE TO BE BIOFILM FREE 19
OneLIFE enzymatic detergents
PROPRIETARY
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
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
HELPING HEALTHCARE TO BE BIOFILM FREE 20OneLIFE Proprietary
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
HELPING HEALTHCARE TO BE BIOFILM FREE 21OneLIFE Proprietary
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!
HELPING HEALTHCARE TO BE BIOFILM FREE 22
Take home messages
PROPRIETARY
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
HELPING HEALTHCARE TO BE BIOFILM FREE 23
Thank you for your attention, any questions?
PROPRIETARY

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Belgian interdisciplinary biofilm research sept 2016

  • 1. Biofilms in endoscopes: the role of cleaning Belgian Interdisciplinary Biofilm Research BIBR – Sept 2016 Thomas Vanzieleghem – R&D Manager @ OneLIFE HELPING HEALTHCARE TO BE BIOFILM FREE 1 PROPRIETARY
  • 2. Biofilms and medical devices HELPING HEALTHCARE TO BE BIOFILM FREE 2 PROPRIETARY
  • 3. Medical devices and biofilms HELPING HEALTHCARE TO BE BIOFILM FREE 3 Medical devices are prone to biofilm formation! PROPRIETARY
  • 4. Key factors are met: Surface/interface, Nutriments, Temperature and Water HELPING HEALTHCARE TO BE BIOFILM FREE 4 Biofilm development on medical devices Source : Otto, Nature Reviews Microbiology, 2009 PROPRIETARY
  • 5. Biofilms in Endoscopy : Risk assessment HELPING HEALTHCARE TO BE BIOFILM FREE 5 PROPRIETARY
  • 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 HELPING HEALTHCARE TO BE BIOFILM FREE 6 Reprocessing endoscopes – Time matters! PROPRIETARY
  • 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 HELPING HEALTHCARE TO BE BIOFILM FREE PROPRIETARY
  • 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 HELPING HEALTHCARE TO BE BIOFILM FREE PROPRIETARY
  • 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 ? PROPRIETARY
  • 10. HELPING HEALTHCARE TO BE BIOFILM FREE 10 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) PROPRIETARY Pajkos et al., JHI, 2004
  • 11. HELPING HEALTHCARE TO BE BIOFILM FREE 11 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 PROPRIETARY
  • 12. 12 Sampling of endoscopes after cleaning and high-level disinfection Detection of germs in endoscopes Source : Biotech Germande, 2012 OneLIFE Proprietary
  • 13. HELPING HEALTHCARE TO BE BIOFILM FREE 13 Risk of transmission to patients The rate of transmission of germs from contaminated endoscopes to patients is rather high and infection can occur! PROPRIETARY
  • 14. Biofilm in Endoscopy: Prevention & Corrective Treatment HELPING HEALTHCARE TO BE BIOFILM FREE 14 PROPRIETARY
  • 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) HELPING HEALTHCARE TO BE BIOFILM FREE 15 PROPRIETARY
  • 16. HELPING HEALTHCARE TO BE BIOFILM FREE 16 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 PROPRIETARY
  • 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! HELPING HEALTHCARE TO BE BIOFILM FREE 17 Corrective treatment of biofilms Specific solutions that degrade EPS Weakened integrity of the biofilm PROPRIETARY Step 1 : Routine cleaning & disinfection Step 2 : Cleaning with specific detergents
  • 18. Specific approach = the right choice of enzymes! HELPING HEALTHCARE TO BE BIOFILM FREE 18 OneLIFE enzymatic detergents PROPRIETARY 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 HELPING HEALTHCARE TO BE BIOFILM FREE 19 OneLIFE enzymatic detergents PROPRIETARY 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 HELPING HEALTHCARE TO BE BIOFILM FREE 20OneLIFE Proprietary
  • 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 HELPING HEALTHCARE TO BE BIOFILM FREE 21OneLIFE Proprietary
  • 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! HELPING HEALTHCARE TO BE BIOFILM FREE 22 Take home messages PROPRIETARY
  • 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 HELPING HEALTHCARE TO BE BIOFILM FREE 23 Thank you for your attention, any questions? PROPRIETARY