Multisociety Guideline on Reprocessing Flexible GI ...

1 Multisociety Guideline on Reprocessing Flexible GI endoscopes : 2011 Author(s): Bret T. Petersen, Jennifer Chennat, Jonathan Cohen, Peter B. Cotton, David , Thomas E. Kowalski, Mary L. Krinsky, Walter G. Park, Irving M. Pike, JosephRomagnuolo, William A. RutalaSource: Infection Control and Hospital Epidemiology, Vol. 32, No. 6 (June 2011 ), pp. 527-537 Published by: The University of Chicago Press on behalf of The Society for Healthcare Epidemiology ofAmericaStable URL: .Accessed: 11/05/ 2011 22:17 Your use of the JSTOR archive indicates your acceptance of JSTOR's Terms and Conditions of Use, available at . JSTOR's Terms and Conditions of Use provides, in part, that unlessyou have obtained prior permission, you may not download an entire issue of a journal or multiple copies of articles, and youmay use content in the JSTOR archive only for your personal, non-commercial contact the publisher regarding any further use of this work. Publisher contact information may be obtained at.

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3 Kowalski, MD; Mary L. Krinsky, DO; Walter G. Park, MD;Irving M. Pike, MD, FASGE; Joseph Romagnuolo, MD, FASGE;for the ASGE Quality Assurance in Endoscopy Committee; and William A. Rutala, PhD, MPH;for the Society for Healthcare Epidemiology of AmericaReceived April 5, 2011 ; accepted April 6, 2011 ; electronically published May 2, 2011 . 2011 by The Society for Healthcare Epidemiology of America and American Society of Gastrointestinal Endoscopy. All rights reserved. 0899-823X/ 2011 /3206-0001$ DOI: beneficial role of GI endoscopy for the prevention, di-agnosis, and treatment of many digestive diseases and canceris well established. Like many sophisticated medical devices,the endoscope is a complex, reusable instrument that requiresreprocessing before being used on subsequent patients. Themost commonly used methods for Reprocessing endoscopesresult in high-level disinfection.

4 To date, all published oc-currences of pathogen transmission related to GI endoscopyhave been associated with failure to follow established clean-ing and disinfection/sterilization guidelines or use of defectiveequipment. Despite the strong published data regarding thesafety of endoscope Reprocessing , concern over the potentialfor pathogen transmission during endoscopy has raised ques-tions about the best methods for disinfection or sterilizationof these devices between patient this end, in 2003, the American Society for Gastroin-testinal Endoscopy (ASGE) and the Society for HealthcareEpidemiology of America collaborated with multiple physi-cian and nursing organizations, infection prevention and con-trol organizations, federal and state agencies, and industryleaders to develop evidence-based guidelines for reprocessingGI ,2 Since that time, high-level disinfectants, au-tomated Reprocessing machines, endoscopes , and endoscopicaccessories have all , the efficacy of de-contamination and high-level disinfection is unchanged, andthe principles guiding both remain outbreaks of infection related to suboptimalinfection prevention practices during endoscopy or lapses inendoscope Reprocessing have been well publicized.

5 A clusterof hepatitis C cases was attributed to grossly inappropriateintravenous medication and sedation numerousother instances, risk of infection transmission has been linkedto less willful, but incorrect, Reprocessing as a result of un-familiarity with endoscope channels, accessories, and the spe-cific steps required for Reprocessing of ambulatory surgery center surveys confirm wide-spread gaps in infection prevention the on-going occurrences of endoscopy-associated infections attrib-uted to lapses in infection prevention, an update of themultisociety Guideline is document provides an update of the previous guide-line, with additional discussion of new or evolving repro-cessing issues and updated literature citations, where appro-priate. Specific additions or changes include review ofexpanded details related to critical Reprocessing steps (in-cluding cleaning and drying), Reprocessing issues for variousendoscope attachments such as flushing catheters, discussionof risks related to selected periprocedural practices includingmedication administration, and mention of newly recognizedissues for which there are incomplete data with which to guidepractice.

6 They include endoscope shelf life or hang time (the interval of storage after which endoscopes should bereprocessed before use), the role of microbiological surveil-lance testing of endoscopes after Reprocessing , and questionsregarding endoscope durability and longevity from the stand-point of infection classification of medicaldevices and level of disinfectionThe classification system first proposed by Dr. Spauldingdivides medical devices into categories based on the risk ofinfection involved with their classification systemis widely accepted and is used by the Food and DrugAdministration (FDA), the Centers for Disease Control andPrevention (CDC), epidemiologists, microbiologists, and pro-fessional medical organizations to help determine the degreeof disinfection or sterilization required for various medicaldevices. Three categories of medical devices and their asso-ciated level of disinfection are recognized: Critical: A device that enters normally sterile tissue or thevascular system.

7 Such devices should be sterilized, defined528infection control and hospital epidemiologyjune 2011 , vol. 32, no. 6as the destruction of all microbial life. Examples of endo-scopic instruments that require sterilization are biopsy for-ceps and sphincterotomes. Semicritical: A device that comes in contact with intactmucous membranes and does not ordinarily penetrate ster-ile tissue. These devices (eg, endoscopes ) should receive atleast high-level disinfection, defined as the destruction ofall vegetative microorganisms, mycobacteria, small or non-lipid viruses, medium or lipid viruses, fungal spores, andsome, but not all, bacterial spores. Noncritical: Devices that do not ordinarily touch the patientor touch only intact skin, such as stethoscopes or patientcarts. These items may be cleaned by low-level transmissionMore than 20 million GI endoscopic procedures are per-formed annually in the United outcomes arenot routinely tracked; however, reports of pathogen trans-mission resulting from these procedures are rare.

8 In the largestreview to date, comprising 265 scientific articles publishedbetween 1966 and 1992, 281 instances of pathogen trans-mission were attributed to GI ,14In each instance,pathogen transmission was associated with a breach in cur-rently accepted cleaning and disinfection guidelines , use ofan unacceptable liquid chemical germicide for disinfection,improper drying, or defective equipment. When the ASGET echnology Assessment Committee reviewed the 28 cases inthat series that had occurred since the adoption of specificguidelines for cleaning and disinfection between 1988 and1992, it concluded that the incidence of pathogen transmis-sion was approximately 1 in million 1993, there have been very few additional reportedoccurrences of pathogen transmission during GI endoscopy,and essentially all have been associated with clear lapses ineither infection prevention practices or Reprocessing of theendoscope and accessories.

9 Hence, transmission can be cat-egorized as nonendoscopic and related to care of intravenouslines and administration of anesthesia or other medicationsor endoscopic and related to transmission by the endoscopeand Transmission of InfectionThe importance of good general infection prevention prac-tices is highlighted by several outbreaks of hepatitis C virusincluding one at a New York endoscopy center related toimproper handling of intravenous sedation tubing, multidosevials, and/or reuse of similar, more recent clusterof 6 cases of hepatitis C occurred among patients at a LasVegas endoscopy cases were caused by cross-contamination from syringes reused to draw additional dosesof anesthetic from single-use vials, which were then used formultiple patients undergoing endoscopy. Surveillance testingwas offered to more than 40,000 patients of several affiliatedendoscopy centers that used these unsafe practices, the resultsof which have not been formally Transmission of InfectionOne instance ofTrichosporonesophagitis was caused by failureto sterilize biopsy forceps among Taiwanese caseofAcinetobacterprosthetic valve endocarditis after polymi-crobial bacteremia was, in the absence of other apparentsources, attributed to upper endoscopy performed 11 daysearlier for esophagitis with associated esophageal authors presumed that transmission occurred by handsof staff contaminated after direct contact with the hospitalenvironment.

10 Several occurrences of hepatitis C virus trans-mission have been associated with breaches in accepted en-doscope Reprocessing recently, lapses inthe use of appropriate tubing with attached 1-way valves andlapses in Reprocessing of the tubing used to attach waterpumps to endoscope irrigation channels have been recognizedin numerous centers around the United States, including sev-eral Veterans Administration risk ofpotentialtransmission of infectious agents in these settings promptedwidespread patient notification and screening, with the sub-sequent discovery of numerous cases of previously unknownhepatitis and HIV. Whether the identified cases were relatedto previous endoscopy remains ,22To date,there is no epidemiologic or microbiological evidence linkingthe potential endoscopic exposure to the identified , this demonstrates that multiple endoscopic de-vices and accessories, in addition to the endoscope, may besubject to lapses in Reprocessing and subsequently put patientsat risk of exposure and possibly the Centers for Disease Control and Prevention(CDC) Division of Healthcare Quality Promotion (formerlythe Hospital Infection Program) reviewed its log of investi-gations between 1980 and 2002, no outbreaks of infectionassociated with GI endoscopy were ,2 Since 1990,health care facilities and manufacturers have been requiredto report to the FDA s MAUDE (Manufacturer and User-Facility Device Experience)