Flexible Endoscopes.pdf Risks associated with reprocessing flexible endoscopes
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The presentation by Talal Albudayri focuses on the reprocessing of flexible endoscopes, outlining the risks of contamination and infection during their use, particularly emphasizing the significance of high-level disinfection processes. It highlights the need for stringent reprocessing standards, effective cleaning techniques, and timely procedures to minimize the risk of nosocomial infections and cross-transmission. Additionally, it discusses the role of automated endoscope reprocessors in enhancing the reliability of infection control while identifying existing gaps in current practices and the importance of ongoing research in this field.
![Disinfection and Sterilization
EH Spaulding believed that how an object will be
disinfected depended on the object’s intended use.
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 .](https://image.slidesharecdn.com/flexibleendoscopes-240324190346-ce40e557/85/Flexible-Endoscopes-pdf-Risks-associated-with-reprocessing-flexible-endoscopes-7-320.jpg)
Flexible Endoscopes.pdf Risks associated with reprocessing flexible endoscopes
- 1. ALL YOU NEED TO KNOW ABOUT CENTRAL STERILE SUPPLY DEPARTMENT
- 2. Presentation 2024 Talal Albudayri FLEXIBLE ENDOSCOPES: INFO, WAYS TO CLEAN.
- 3. Reprocessing Flexible Endoscopes Objectives Risks associated with reprocessing flexible endoscopes Causes of contamination and infection Gaps in current reprocessing standards Establish scientific rationale and evidence requirements for enhancing safe practices
- 5. ENDOSCOPES Widely used diagnostic and therapeutic procedure GI endoscope contamination during use Semicritical items require high-level disinfection minimally Inappropriate cleaning and disinfection has lead to cross-transmission In the inanimate environment, although the incidence remains very low, endoscopes represent a significant risk of disease transmission
- 7. Disinfection and Sterilization EH Spaulding believed that how an object will be disinfected depended on the object’s intended use. 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 .
- 8. Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2011 Transmission categorized as: Non-endoscopic and related to care of intravenous lines and administration of anesthesia or other medications Multidose vials Reuse of needles and syringes Intravenous sedation tubing Endoscopic and related to endoscope and accessories Failure to sterilize biopsy forceps between patients Lapses in reprocessing tubing used in channel irrigation
- 9. Nosocomial Infections via GI Endoscopes Infections traced to deficient practices Inadequate cleaning (clean all channels) Inappropriate/ineffective disinfection (time exposure, perfuse channels, test concentration, ineffective disinfectant, inappropriate disinfectant) Failure to follow recommended disinfection practices (tapwater rinse) Flaws and complexity in design of endoscopes or AERs
- 10. DECREASING ORDER OF RESISTANCE OF MICROORGANISMS TO DISINFECTANTS/STERILANTS Prions Spores (C. difficile) Mycobacteria Non-Enveloped Viruses (norovirus, polio, HPV, parvo) Fungi Bacteria (MRSA, VRE, Acinetobacter) Enveloped Viruses Most Susceptible Most Resistant
- 11. C. difficile: MICROBIOLOGY AND EPIDEMIOLOGY Gram-positive bacillus: Strict anaerobe, spore-former Colonizes human GI tract.. Increasing prevalence and incidence New epidemic strain that hyper-produces toxins A and B Causes virtually all cases of antibiotic-associated pseudomembranous colitis. Introduction of CDI from the community into hospitals High morbidity and mortality in elderly Inability to effectively treat fulminant CDI Absence of a treatment that will prevent recurrence of CDI
- 12. BIOFILMS (Multi-Layered Bacteria Plus Exopolysaccharides That Cement Cell to Surface; Develop in Wet Environments)
- 13. BIOFILMS Bacteria residing within biofilms are many times more resistant to chemical inactivation than bacteria is suspension.. Does formation of biofilms within endoscopic channels contribute to failure of decontamination process.. Not known Could be a reason for failure of adequate HLD processes but if reprocessing performed promptly after use and endoscope dry the opportunity for biofilm formation is minimal
- 14. Transmission of Infection by Endoscopy Kovaleva et al. Clin Microbiol Rev 2013. 26:231-254 Scope Outbreaks Micro (primary) Pts Contaminated Pts Infected Cause (primary) Upper GI 19 Pa, H. pylori, Salmonella 169 56 Cleaning/Dis- infection (C/D) Sigmoid/Colo noscopy 5 Salmonella, HCV 14 6 Cleaning/Dis- infection ERCP 23 Pa 152 89 C/D, water bottle, AER Bronchoscopy 51 Pa, Mtb, Mycobacteria 778 98 C/D, AER, water Totals 98 1113 249 Based on outbreak data, if eliminated deficiencies associated with cleaning, disinfection, AER , contaminated water and drying would eliminate about 85% of the outbreaks. https://journals.asm.org/doi/10.1128/CMR.00085-12?cookieSet=1
- 17. Audit Manual Cleaning of Endoscopes Issues for consideration What is the clinical importance of <6.4µg/cm² for protein and <4 log₁₀ CFU/cm² bioburden: that is, has it been related epidemiologically or clinically to decrease or increase risk of infection? ATP may be related to markers (e.g., protein) but markers may have no relationship to microbes/disease and providing patient safe instrument. Ideally, validation of benchmarks should include correlation with patients’ clinical outcome. The CDC has suggested that sampling be done when there are epidemiological data that demonstrate risk (e.g., endotoxin testing and microbial testing of water used in dialysis correlated to increased risk of pyrogenic reactions in
- 18. Endoscope Reprocessing: Current Status of Cleaning and Disinfection Guidelines Multi-Society Guideline, 12 professional organizations, 2011 Centers for Disease Control and Prevention, 2008 Society of Gastroenterology Nurses and Associates, 2010 AAMI Technical Information Report, Endoscope Reprocessing, In preparation Food and Drug Administration, 2009 Endoscope Reprocessing, Health Canada, 2010 Association for Professional in Infection Control and Epidemiology, 2000
- 19. FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES Require low temperature disinfection Long narrow lumens Right angle turns Blind lumens May be heavily contaminated with pathogens, 10⁹ Cleaning (4-6 log₁₀ reduction) and HLD (4-6 log₁₀ reduction) essential for patient safe instrument
- 20. Endoscope Cleaning Endoscope must be cleaned using water with detergents or enzymatic cleaners before processing. Cleaning reduces the bioburden and removes foreign material (organic residue and inorganic salts) that interferes with the HLD or sterilization process. Cleaning and decontamination should be done as soon as possible after the items have been used as soiled materials become dried onto the endoscopes.
- 21. ENDOSCOPE REPROCESSING Multi-Society Guideline on Endoscope Reprocessing, 2011 PRECLEAN-point-of-use (bedside) remove debris by wiping exterior and aspiration of detergent through air/water and biopsy channels; leak test CLEAN-mechanically cleaned with water and enzymatic cleaner HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels for exposure time (>2% glut at 20m at 20ᵒC). If AER used, review model- specific reprocessing protocols from both the endoscope and AER manufacturer RINSE-scope and channels rinsed with sterile water, filtered water, or tap water. Flush channels with alcohol and dry DRY-use forced air to dry insertion tube and channels STORE-hang in vertical position to facilitate drying; stored in a manner to protect from contamination
- 23. Automated Endoscope Reprocessors Gastro Endoscopy 2010;72:675 All AERs have disinfection and rinsing cycles; some detergent cleaning; alcohol flush and/or forced-air drying Additional features may include: variable cycle times; printed documentation; HLD vapor recovery systems; heating; automated leak testing; automated detection of channel obstruction, MEC Not all AERs compatible with all HLDs or endoscopes; some models designed with specific HLDs Some AERs consume and dispose of HLD and other reuse HLD Some AERs have an FDA-cleared cleaning claim (eliminates soil and microbes equivalent to optimal manual cleaning- <6.4µg/cm² protein)
- 24. Automated Endoscope Reprocessors (AER) Manual cleaning of endoscopes is prone to error. AERs can enhance efficiency and reliability of HLD by replacing some manual reprocessing steps AER Advantages: automate and standardize reprocessing steps, reduce personnel exposure to chemicals, filtered tap water, reduce likelihood that essential steps will be skipped AER Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning BMC Infect Dis 2010;10:200 Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector MMWR 1999;48:557 Must ensure exposure of internal surfaces with HLD/sterilant
- 25. Automated Endoscope Reprocessors with Cleaning Claim (requires procedure room pre-cleaning) Medivator Advantage Plus Endoscope Reprocessing System Evo-Tech (eliminates soil and microbes equivalent to optimal manual cleaning. BMC ID 2010;10:200)
- 27. ENDOSCOPE REPROCESSING: CHALLENGES NDM-Producing E. coli Associated ERCP MMWR 2014;62:1051 NDM-producing E.coli recovered from elevator channel
- 28. ResertTM HLD High Level Disinfectant - Chemosterilant 2% hydrogen peroxide, in formulation pH stabilizers Chelating agents Corrosion inhibitors Efficacy (claims need verification) Sporicidal, virucidal, bactericidal, tuberculocidal, fungicidal HLD: 8 mins at 20ᵒC Odorless, non-staining, ready-to-use No special shipping or venting requirements Manual or automated applications 12-month shelf life, 21 days reuse Material compatibility/organic material resistance (Fe, Cu)? *The Accelerated Hydrogen Peroxide technology and logo are the property of Virox Technologies, Inc. Modified from G MacDonald. AJIC 2006;34:571
- 29. Endoscopes: Delayed Reprocessing and Drying Delayed Reprocessing (GI Endoscopy 2011;73;853) Reprocess immediately after use; do not allow to sit idle and soiled for hours before being processed. If precleaning not initiated within an hour, soak in detergent before cleaning. Endoscope Drying (J Hosp Infect 2008;68:59) Microbial contamination lower when stored in drying and storage cabinet.
- 30. Endoscopes Reprocessed If Unused 5 Days AORN, 2010 Investigat or Shelf Life Contaminatio n Rate Recommenda tion Osborne, Endosco py 2007 18.8h medi an 15.5% CONS, Micrococcus, Bacillus Environmental /process contamination Rejchrt, Gastro Endosc 2004 5 days 3.0% (4/135), skin bacteria (CONS, diphteroids) Reprocessing before use not necessary Vergis, Endosco py 2007 7 days 8.6% (6/70), all CONS Reprocessing not necessary for at least 7d Riley, GI Nursing, 2002 24,1 68h 50% (5/10), <3 CFU CONS, S. aureus, P. Left for up to 1 week Provided all channels thoroughly reprocessed and dried, reuse within 10- 14 appears safe. Data are insufficient to offer maximum duration for use.
- 31. IS THERE A STANDARD TO DEFINE WHEN A DEVICE IS CLEAN? There is currently no standard to define when a device is “clean”, cleanliness controlled by visual Potential methods: level of detectable bacteria; protein (6µg/cm²); endotoxin; ATP; lipid This is due in part to the fact that no universally accepted test soils to evaluate cleaning efficiency and no standard procedure for measuring cleaning efficiency
- 32. Conclusions Endoscopes represent a nosocomial hazard. Narrow margin of safety associated with high-level disinfection of semicritical items. Guidelines must be strictly followed. AERs can enhance efficiency and reliability of HLD of endoscopes by replacing some manual reprocessing steps and reducing the likelihood that essential steps are not skipped Urgent need to better understand the gaps in endoscope reprocessing-CRE, C. difficile spores, HPV, biofilms, etc. Industry must support research to answer questions. Data are insufficient to recommend ATP monitoring Data suggest that contamination during storage for 7-14 days is negligible.
- 34. MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011 Petersen et al. ICHE. 2011;32:527
- 35. Audit Manual Cleaning of Endoscopes Establishing Benchmarks Lack of consensus regarding the clinical value of routine microbiological monitoring of endoscopes. We perform to assess the efficacy of reprocessing. Alfa et al. Am J Infect Control 2012;40:233. Recommends a bioburden residual of <100 CFU/ml. Beilenhoff et al. Endoscopy; 2007;39: 175. ESGE-ESGENA allows bioburden count of <20 CFU/ channel. Heeg et al. J Hosp Infect; 2004;56:23. Contamination should not exceed 1 CFU/ml. Certain organisms should not be detected in any amount (e.g., P. aeruginosa, E. coli, S. aureus)
- 36. MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011 Petersen et al. ICHE. 2011;32:527
- 37. Endoscope Reprocessing Methods Ofstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204
- 39. BIOFILMS Pajkos, Vickery, Cossart. J Hosp Infect 2004;58:224
- 40. Sans Standardization: Effective Endoscope Reprocessing https://oce.ovid.com/article/00006976-202100120-00009?sequence=1&clickthrough=y