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DR. MICHELLE ALFA

DEPT OF MEDICAL MICROBIOLOGY,

UNIVERSITY OF MANITOBA, WINNIPEG, MB

Biofilm: Wet & Dry Surfaces and

Instruments

CME Disclosure

Consultant & Advisory board: 3M, Olympus and J&J ASP. Consulting services: Ofstead Associates, KARL STORZ, Novaflux Royalties:University of Manitoba for patent license to Healthmark

Sponsored Speaker: 3M, Ruhof, Ambu, Olympus

Acknowledgement:

The research funding for some of the data in this presentation was provided by ASGE (American Society for Gastroenterology).

St Boniface Research Centre

Winnipeg, Manitoba Canada

Pat DeGagne Nancy Olson Michelle Alfa

Overview

yHow does biofilm form? yTraditional vs N0n-traditional biofilm yBiofilm in Healthcare; What are the issues? ySummary All images in this presentation are from Google Free images unless stated otherwise Comparison: Traditional to Non-traditional Biofilm

ZhongW, Alfa M, Howie R, Zelenitksy S.

Simulation of cyclic reprocessing buildup on reused medical devices. Comput Biol Med 2009 Jun; 39(6): 568-577.

Biofilm in Healthcare

Wounds, Implants. Taps & SinksHigh touch surfacesMedical devices Protection of S. aureus by Bacillus biofilm resistant to PAA Bridier et al Biofilms of a Bacillus subtilis Hospital Isolate Protect Staphylococcus aureus from Biocide Action. PLoS

ONE 2012 doi:10.1371/journal.pone.0044506

Bacillus subtilis 168:

Genetic Stock Centre

JOINT BIOFILM

S.aureus (RED) &

B. subtilis-ND (GREEN)

Bacillus subtilis ND:

Isolated from AER

Take Home Messages:

Once biofilm is present:

other bacteria can integrate into it and be protected from disinfectant activity yPREVENT Biofilm formation

Non-Traditional Biofilm in Healthcare

Alfa MJ et al A novel polytetrafluoroethylene-channel model, which simulates low levels of culturable bacteria in buildup biofilm after repeated endoscope reprocessing.

Gastrointest Endosc 2017;86:442-51

Almtroudi et al A new dry-surface biofilm model: An essential tool for efficacy testing of hospital surface decontamination procedures. J Microbiological Methods 2015;117:171-176

Build-up BiofilmDry-surface Biofilm

Build-up Biofilm in Endoscope Channels

yExpectation:

Biofilm SHOULD NOT form inside

dryendoscope channels yReality:

Build-up biofilm does form!

2004: Air/Water channel of GI

flexible endoscopes Pajkos et al

J Hosp Infect 2004;58:224-9

2014: SEM showed biofilm in:

-54.6% of 66 Biopsy channels -76.9% of 13 Air/water channels

Ren-Pei W AJIC 2014; 42:1203-6

FDA Mandated Clinical study of Duodenoscope

contamination; Preliminary report April 2019

FDA/CDC/ASM Duodenoscopeculture method: Feb 2018

(validated by manufacturers) yAssumption: rightafter HLD < 0.4% contamination yData to date (April 12, 21019 FDA report): -3.6% showed > 100 CFU low concern organisms -5.4% showed High concern organisms (E.coli, Pseudomonas etc) -BP to distal end; Flush-brush-flush -Elevator lever recess: Flush-brush-fllush -Neutralizer added -Concentration for culture (filtration method) instructions eliminate traditional biofilm?

Alfa MJ, et al Simulated-use polytetrafluorethylene biofilm model: repeated rounds of complete reprocessing lead

to accumulation of organic debris and viable bacteria. ICHE 2017 http://dx.doi.org/10.1016/j.gie.2017.05.014

PTFE Biofilm Model (ISO 15883-2005 AnnexF)

yBiofilm allowed to form overnight in PTFE channel cleaning combined with liquid chemical sterilization (SS1E) yProcess repeated for 5 times (i.e. 5 consecutive days) yOptimal culture method

Alfa MJ, et al Simulated-use polytetrafluorethylene biofilm model: repeated rounds of complete reprocessing lead

to accumulation of organic debris and viable bacteria. ICHE 2017 http://dx.doi.org/10.1016/j.gie.2017.05.014

Five Repeated Rounds of Reprocessing

Test ConditionE.faecalis

Log10CFU/cm2P.aeruginosa

Log10CFU/cm2Protein

ug/cm2

1.Positive control

No cleaning

No AER

7.72 (0.09)9.10 (0.09)172.31

(13.30)

2. Enzymatic Det.

Bristle brush,

AER: SS1E

< LD< LD4.60 (0.58)

3. Enzymatic Det

Pull-through

AER: SS1E

< LD < LD2.13 (2.07)

4.Non Enzymatic

Bristle brush

AER: SS1E

2.24 (0.00) 2.24 (0.00) 5.18 (1.50)

5.Non Enzymatic

Pull-through

AER: SS1E

0.008 (0.08) 0.026 (0.44) 4.31 (3.14)

Bristle brush

Pull-through cleaner

Enzymatic detergent

Non -Enzymatic detergent

Positive ControlNo cleaning

Bristle brush Pull-through cleaner

Bristle brush Pull-through cleaner

Positive Control

Biofilm Removal: PTFE channels

yMIFU Cleaning:

Friction and detergent affect ability of biofilm

bacteria to survive full reprocessing yChannel surface contact:

Bristle brush not as effective as pull-through

cleaner. Debris in fully reprocessed patient-used Endoscope channels

Ofstead et al AJIC 2017

Gradual accumulation of residual material

? Inadequate friction during cleaning on inner

PTFE channel surface

Alfa et al GIE 2017

PTFE-BBF; Bristle brush

& flush with waterPatient-used Instrument channels

PTFE-BBF channel stored at room temperature

E.faecalis

P.aeruginosa

Alfa et al GIE 2017 http://dx.doi.org/10.1016/j.gie.2017.05.014

Viable but non-culturable (VBNC) bacteria

Li et al Frontiers Microbiol2014

yVBNC bacteria: physical and chemical resistance due to reduced metabolic rate & strengthened cell wall yRevivability: varies for different bacteria yVariability of clinical culture results: -immediately after HLD AEno growth -after storage AEMicrobes grow on culture

Take Home Messages:

yEffective Cleaning is still an UNMET NEED for Endoscope channels: -Bristle brushes may leave traces of debris -No friction to clean smaller channels [ e.g. Air-water channel] yProlonged survival of VBNC in

Build-up Biofilm

Drying Endoscope channels for Storage

-all state endoscopes MUST be dried prior to storage. -ALL channels: alcohol flush & forced air drying

2.Automated Endoscope Reprocessors (AER)

-many have alcohol flush and drying cycle (1 to 3 mins) -they do NOTclaim this sufficiently dries all channels sufficiently

3.Endoscopy clinic staff:

-Widespread believe that AER cycle adequately dries endoscopes for storage. (SGNA 2015; AER cycle ±alcohol & drying)

Inspect inner channel of endoscopes

Borescope use for endoscopes recommended by:

AAMI ST91 2015, AORN 2017, IAHCSSM 2017

Large Hospital system:

Visible fluid in 49%

channels site 1: 0% site 2: 85% site 3: 85% [Ofsteadet al AJIC 2018;45:e26-e33 doi.org/10.1016/j.ajic.2018.03.002]

GastroscopeColonoscopeCystoscope

GastroscopeDuodenoscopeEUS Radial endoscope

Ambulatory Clinics: Visible Fluid in 95% Channels

[Ofsteadet al AJIC 2017;45:e26-e33 doi.org/10.1016/j.ajic.2016.10.017] After AER; alcohol flush, 6 min air flush & storage ON

Automated Air flush of channels

Channel-purge storage cabinets

Air-Time Channel dryer

Tri-Core Systems Inc

Automated vs Manual Drying:

Barakat et al GIE 2018, doi: 10.1016/j.gie.2018.08.033

After AER alcohol flush

and 1 min air dry

After AER alcohol flush

and 1 min air dry and;

10 min manual dry

with forced air

After AER alcohol flush

and 1 min air dry and;

5 min DriScope drying

Virtually no retained fluid after 10 min DriScope drying Impact of Simethicone on fluid residuals AFTER full reprocessing & manual drying 10 mins

Barakat et al GIE 2018.

DOI:10.1016/j.gie.2018.08.012

Conclusions:

Simethicone is not removed

by MIFU cleaning

Simethicone at 1% & 3%

impedes drying efficacy vs

0.5% & water only

Impact on HLD or

sterilization is not known

Injected; working channel

not via water bottle

Take Home Message:

Fluid & Simethicone residuals:

in instrument & Water jet channels (Ofstead 2016, 2018, van Stiphout 2016, Barakat 2018

Moisture in channels:

allows bacterial replication AEBIOFILM

Dry channels:

NO bacterial replication

What can you do???

yWhat is the situation in your facility?? ySpecific Audit with Data: -Test: compliance of manual cleaning -Test: Dry Storage -Test: Culture of endoscopesquotesdbs_dbs48.pdfusesText_48

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