Advertisement

Position statement: Multi-society guideline for reprocessing flexible gastrointestinal endoscopes

  • Prevention of Infection During Gastrointestinal Endoscopy Consensus Conference

      Introduction

      The beneficial role of gastrointestinal endoscopy for the prevention, diagnosis, and treatment of many digestive diseases and cancer is well established. Like many sophisticated medical devices, the endoscope is a complex, reusable instrument that requires reprocessing before being used on subsequent patients. The most commonly used methods for reprocessing endoscopes result in high-level disinfection. To date, all published episodes of pathogen transmission related to GI endoscopy have been associated with failure to follow established cleaning and disinfection/sterilization guidelines or with the use of defective equipment. Despite the strong published data regarding the safety of endoscope reprocessing, concern over the potential for pathogen transmission during endoscopy has raised questions about the best methods for disinfection or sterilization of these devices between patient uses. To this end, The American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Healthcare Epidemiology of America (SHEA) convened a conference at which representatives from physician and nursing organizations, infection control organizations, federal and state agencies, and industry leaders presented and discussed the latest information on this subject. A consensus panel on the second day reviewed the data presented at the conference to recommend evidence-based guidelines for reprocessing GI endoscopes.

      Spaulding classification for medical devices and level of disinfection

      The classification system first proposed by Dr. E. H. Spaulding divides medical devices into categories based on the risk of infection involved with their use.
      • Favero MS
      • Bond WW
      Disinfection of medical and surgical materials.
      This classification system is widely accepted and is used by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), epidemiologists, microbiologists, and professional medical organizations to help determine the degree of disinfection or sterilization required for various medical devices. Three categories of medical devices and their associated level of disinfection are recognized:
      • Critical: A device that enters normally sterile tissue or the vascular system. Such devices should be sterilized, defined as the destruction of all microbial life. Examples of endoscopic instruments that require sterilization are biopsy forceps and papillotomes.
      • Semicritical: A device that comes into contact with intact mucous membranes and does not ordinarily penetrate sterile tissue. These devices (e.g., endoscopes) should receive at least high-level disinfection, defined as the destruction of all vegetative microorganisms, mycobacteria, small or nonlipid viruses, medium or lipid viruses, fungal spores, and some but not all bacterial spores.
      • Noncritical: Devices that do not ordinarily touch the patient or touch only intact skin, such as stethoscopes or patient carts. These items may be cleaned by low-level disinfection.

      Pathogen transmission

      Over 10 million GI endoscopic procedures are performed annually in the United States. However, reports of pathogen transmission resulting from these procedures are rare. In the largest review to date, comprising 265 scientific articles published between 1966 and 1992, 281 episodes of pathogen transmission were attributed to GI endoscopy.
      • Spach DH
      • Silverstein FE
      • Stamm WE
      Transmission of infection by gastrointestinal endoscopy and bronchoscopy.
      In each instance, pathogen transmission was associated with a breach in currently accepted cleaning and disinfection guidelines, use of an unacceptable liquid chemical germicide for disinfection, improper drying, or defective equipment. When the ASGE Technology Assessment Committee reviewed the 28 cases in that series that had occurred since the adoption of specific guidelines for cleaning and disinfection between 1988 and 1992, they concluded that the incidence of pathogen transmission was approximately 1 in 1.8 million procedures.
      • Kimmey MB
      • Burnett DA
      • Carr-Locke DL
      • DiMarino AJ
      • Jensen DM
      • Katon R
      • et al.
      Transmission of infection by gastrointestinal endoscopy.
      Since 1993, there have only been 5 additional reported cases of pathogen transmission during GI endoscopy, all occurring outside of the United States. One instance of trichosporon esophagitis was caused by failure to sterilize biopsy forceps between patients.
      • Lo Passo C
      • Pernice I
      • Celeste A
      • Perdichizzi G
      • Todaro-Luck F
      Transmission of Trichosporon asahii esophagitis by a contaminated endoscope.
      There have been 4 episodes of transmission of hepatitis C virus (HCV), and each has been associated with a breach in accepted endoscope reprocessing protocols or a lapse in general infection control practices (inappropriate use of multi-dose vials/bottles and/or reuse of syringes).
      • Bronowicki J-P
      • Venard V
      • Botté C
      • Monhoven N
      • Gastin I
      • Choné L
      • et al.
      Patient-to-patient transmission of hepatitis C virus during colonoscopy.
      • Le Pogam S
      • Gondeau A
      • Bacq Y
      Nosocomial transmission of hepatitis C virus [letter].
      • Tennenbaum R
      • Colardelle P
      • Chochon M
      • Maisonneuve P
      • Jean F
      • Andrieu J
      Hépatite C après cholangiographie rétrograde [French].
      The importance of good general infection control practices is highlighted by a recent outbreak of HCV at a New York endoscopy center. Although initially attributed to endoscopic transmission in the lay press, investigation by the New York City Department of Health revealed the cause was not the endoscopy itself, but related to improper handling of intravenous sedation tubing, multidose vials, and/or reuse of needles (letter on file, New York City Department of Health; unpublished data presented at conference). This aspect of standard infection control practice must also be addressed when future reports of pathogen transmission are published. When the Centers for Disease Control and Prevention (CDC) Division of Healthcare Quality Promotion (formerly the Hospital Infection Program) reviewed its log of investigations between 1980 and 2002, no outbreaks of infection associated with GI endoscopy were found. Since 1990, healthcare facilities and manufacturers are required to report to the Food and Drug Administration (FDA) any information that reasonably suggests that a device (such as an endoscope, accessory, or an automated endoscope washer-disinfector) has caused or contributed to a death, injury, or serious illness of a patient. Review of the FDA Manufacturer And User-Facility Device Experience (MAUDE) database from 1990 to 2002 revealed 7 possible episodes of pathogen transmission during GI endoscopy. Although there are no well-designed prospective studies on the incidence of pathogen transmission during GI endoscopy, and estimates of pathogen transmission based on case reports may underestimate the true incidence of infection, available evidence suggests that this is an extremely rare event.

      GI Endoscope Reprocessing

      Flexible GI endoscopes should first be cleaned and subjected to at least high-level disinfection; this standard has been recommended by federal agencies such as the FDA
      • Food and Drug Administration
      Draft guidance for the content of premarket notifications for endoscopes used in gastroenterology and urology.
      and CDC
      • Garner JS
      • Favero MS
      CDC guideline for handwashing and hospital environmental control, 1985.
      ; professional organizations such as the American Society for Gastrointestinal Endoscopy (ASGE), the American College of Gastroenterology (ACG), the American Gastroenterology Association (AGA), the Society of Gastroenterology Nurses and Associates (SGNA), the Association of Perioperative Registered Nurses (AORN), the Association for Professionals in Infection Control and Epidemiology (APIC); and the American Society for Testing and Materials (ASTM).
      • DiMarino Jr, AJ
      • Leung J
      • Ravich W
      • Wolf D
      • Zuckerman G
      • Walters V
      • et al.
      Reprocessing of flexible gastrointestinal endoscopes.
      • Alvarado CJ
      • Reichelderfer M
      APIC guidelines for infection prevention and control in flexible endoscopy.
      • American Society for Testing and Materials
      Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
      Guidelines are available from these organizations that discuss, in a step-by-step fashion, the elements of appropriate endoscope reprocessing.
      • DiMarino Jr, AJ
      • Leung J
      • Ravich W
      • Wolf D
      • Zuckerman G
      • Walters V
      • et al.
      Reprocessing of flexible gastrointestinal endoscopes.
      • Alvarado CJ
      • Reichelderfer M
      APIC guidelines for infection prevention and control in flexible endoscopy.
      • American Society for Testing and Materials
      Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
      • SGNA
      Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.
      There are no published reports of transmission of infection when these guidelines have been followed.
      However, compliance with reprocessing guidelines can be improved. In 1991, Gorse and Messner
      • Gorse GJ
      • Messner RL
      Infection control practices in gastrointestinal endoscopy in the United States: a national survey.
      surveyed 2030 SGNA members and found that compliance with various aspects of existing guidelines ranged from 67% to 93%. That same year, a collaborative study by the FDA and 3 state health departments investigating endoscope reprocessing at 26 health care facilities reported that 24% of patient-ready endoscopes (GI endoscopes and bronchoscopes) were culture positive, and these were associated with “a number of fundamental errors in the disinfection process.”
      • Kaczmarek RG
      • Moore Jr, RM
      • John M
      • Goldman DA
      • Reynolds C
      • Caquelin C
      • et al.
      Multi-state investigation of the actual disinfection/sterilization of endoscopes in health care facilities.
      • Reynolds CD
      • Rhinehart E
      • Dreyer P
      • Goldman DA
      Variability in reprocessing policies and procedures for flexible fiberoptic endoscopes in Massachusetts hospitals.
      Of more concern, Jackson and Ball
      • Jackson FW
      • Ball MD
      Correction of deficiencies in flexible fiberoptic sigmoidoscope cleaning and disinfection technique in family practice and internal medicine offices.
      surveyed 19 family practice and internal medicine offices performing flexible sigmoidoscopy and found that all were deficient in following reprocessing guidelines in at least one area. Although two more recent studies suggest that compliance with reprocessing guidelines has improved,
      • Cheung RJ
      • Ortiz D
      • DiMarino Jr, AJ
      GI endoscopic reprocessing practices in the United States.
      • Muscarella LF
      Current instrument reprocessing practices: results of a national survey.
      a minority of endoscopy centers still did not conform completely to accepted guidelines. Future efforts should be aimed at improving compliance with accepted guidelines in all venues in which endoscopy is performed.

      Recommendations

      Professional organizations vary in recommended practices. The present document is not intended to replace these guidelines, but to complement them, emphasizing those areas in which a broad range of professionals have reached consensus based on the available evidence. Endoscopes that use disposable components (e.g., protective barrier devices, sheaths, or valves) can provide an alternative to conventional liquid chemical disinfection. Users should refer to manufacturer's instructions for appropriate reprocessing. (See appendix for description of categories.)
      • 1.
        All healthcare personnel in the endoscopy suite should be trained in and adhere to standard infection control recommendations (e.g., standard precautions), including those to protect both patients and healthcare workers. Category IA
        • Garner JS
        • Favero MS
        CDC guideline for handwashing and hospital environmental control, 1985.
      • 2.
        Perform pressure/leak testing after each use according to manufacturer guidelines. Category IB
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

      • 3.
        Disconnect and disassemble endoscope components (e.g., air/water and suction valves) as far as possible and completely immerse the endoscope and components in the enzymatic detergent. Category 1B

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Merritt K
        • Hitchins VM
        • Brown SA
        Safety and cleaning of medical materials and devices.
        • Babb JR
        • Bradley CR
        Endoscope reprocessing: where do we go from here?.
      • 4.
        Cleaning is essential before manual or automated disinfection. Meticulously clean the entire endoscope, including valves, channels, connectors, and all detachable parts with an enzymatic detergent compatible with the endoscope immediately after use, according to the manufacturer's instructions. Flush and brush all accessible channels to remove all organic (e.g., blood, tissue) and other residues. Repeatedly actuate the valves during cleaning to facilitate access to all surfaces. Clean the external surfaces and components of the endoscope with a soft cloth, sponge, or brushes. Category IA
        • Spach DH
        • Silverstein FE
        • Stamm WE
        Transmission of infection by gastrointestinal endoscopy and bronchoscopy.
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Hanson PJV
        • Gor D
        • Clarke JR
        • Chadwick MV
        • Nicholson G
        • Shah N
        • et al.
        Contamination of endoscopes used in AIDS patients.
        • Vesley D
        • Norlien KG
        • Nelson B
        • Ott B
        • Streifel AJ
        Signficant factors in the disinfection and sterilization of flexible endoscopes.
        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • Urayama S
        • Kozarek RA
        • Sumida S
        • Raltz S
        • Merriam L
        • Pethigal P
        Mycobacteria and glutaraldehye: is high-level disinfection of endoscopes possible?.
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        • Chu NS
        • McAlister D
        • Antonoplos PA
        Natural bioburden levels detected on flexible gastrointestinal endoscopes after clinical use and manual cleaning.
        • Cronmiller JR
        • Nelson DK
        • Salman G
        • Jackson DK
        • Dean RS
        • Hsu JJ
        • et al.
        Antimicrobial efficacy of endoscopic disinfection procedures: a controlled, multifactorial investigation.
        • Kovacs BJ
        • Chen YK
        • Kettering JD
        • Aprecio RM
        • Roy I
        High-level disinfection of gastrointestinal endoscopes: are current guidelines adequate?.
        • Vesley D
        • Melson J
        • Patricia S
        Microbial bioburden in endoscope reprocessing and an in-use evaluation of the high-level disinfection capabilities of Cidex PA.
        • ESGE
        Guidelines on cleaning and disinfection in GI endoscopy.
      • 5.
        Use brushes appropriate for the size of the endoscope channel, parts, connectors, and orifices (e.g., bristles should contact all surfaces) for cleaning. Cleaning items should be disposable or thoroughly cleaned and disinfected/sterilized between uses. Category II
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        • ESGE
        Guidelines on cleaning and disinfection in GI endoscopy.
      • 6.
        Discard enzymatic detergents after each use because these products are not microbicidal and will not retard microbial growth. Category IB
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Babb JR
        • Bradley CR
        Endoscope reprocessing: where do we go from here?.
      • 7.
        Reusable endoscopic accessories (e.g., biopsy forceps or other cutting instruments) that break the mucosal barrier should be mechanically cleaned as described above and then sterilized between each patient use (high-level disinfection is not appropriate). Category IA
        • Spach DH
        • Silverstein FE
        • Stamm WE
        Transmission of infection by gastrointestinal endoscopy and bronchoscopy.
        • Bronowicki J-P
        • Venard V
        • Botté C
        • Monhoven N
        • Gastin I
        • Choné L
        • et al.
        Patient-to-patient transmission of hepatitis C virus during colonoscopy.
        • Garner JS
        • Favero MS
        CDC guideline for handwashing and hospital environmental control, 1985.
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        • ESGE
        Guidelines on cleaning and disinfection in GI endoscopy.
        • Graham DY
        • Osato MS
        Disinfection of biopsy forceps and culture of Helicobacter pylori from gastric mucosal biopsies [letter].
      • 8.
        Ultrasonic cleaning of reusable endoscopic accessories and endoscope components may be used to remove soil and organic material from hard-to-clean areas. Category II

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • ESGE
        Guidelines on cleaning and disinfection in GI endoscopy.
      • 9.
        Endoscopes (and accessories) that come in contact with mucous membranes are classified as semicritical items and should receive at least high-level disinfection after each patient use. Category IA
        • Spach DH
        • Silverstein FE
        • Stamm WE
        Transmission of infection by gastrointestinal endoscopy and bronchoscopy.
        • Garner JS
        • Favero MS
        CDC guideline for handwashing and hospital environmental control, 1985.
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        • ESGE
        Guidelines on cleaning and disinfection in GI endoscopy.
      • 10.
        Use a high-level disinfectant/sterilant cleared by the Food and Drug Administration (FDA) for high-level disinfection/sterilization (www.fda.gov/cdrh/ode/germlab.html ). Category IA
        • Spach DH
        • Silverstein FE
        • Stamm WE
        Transmission of infection by gastrointestinal endoscopy and bronchoscopy.
        • Garner JS
        • Favero MS
        CDC guideline for handwashing and hospital environmental control, 1985.
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.

        FDA. FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices 1/30/02. Available at: http://www.fda.gov/cdrh/ode/germlab.html. Accessed 12-9-02.

      • 11.
        The exposure time and temperature for disinfecting semicritical patient care equipment varies among the FDA-cleared high-level disinfectants. Follow the FDA-cleared label claim for high-level disinfection unless several well-designed experimental scientific studies, endorsed by professional societies, demonstrate an alternative exposure time is effective for disinfecting semicritical items. The FDA label claim for high-level disinfection with >2% glutaraldehyde at 25°C ranges from 20 to 90 minutes depending on the product. However, multiple scientific studies and professional organizations support the efficacy of >2% glutaraldehyde at 20 minutes at 20°C. Category IA
        • Favero MS
        • Bond WW
        Disinfection of medical and surgical materials.
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • Urayama S
        • Kozarek RA
        • Sumida S
        • Raltz S
        • Merriam L
        • Pethigal P
        Mycobacteria and glutaraldehye: is high-level disinfection of endoscopes possible?.
        • Vesley D
        • Melson J
        • Patricia S
        Microbial bioburden in endoscope reprocessing and an in-use evaluation of the high-level disinfection capabilities of Cidex PA.
        • Collins FM
        Kinetics of tuberculocidal response by alkaline glutaraldehye in solution and on an inert surface.
        • Collins FM
        Bactericidal activity of alkaline glutaraldehyde solution against a number of atypical mycobacterial species.
        • Ascenzi JM
        • Ezzell RJ
        • Wendt TM
        A more accurate method for measurement of tuberculocidal activity of disinfectants.
        • Collins FM
        Use of membrane filters for measurement of mycobacterial activity of alkaline glutaraldehyde solution.
        • Best M
        • Sattar SA
        • Springthorpe VS
        • Kennedy ME
        Efficacies of selected disinfectants against Mycobacterium tuberculosis.
        • Cole EC
        • Rutala WA
        • Nessen L
        • Wannamaker NS
        • Weber DJ
        Effect of methodology, dilution, and exposure time on the tuberculocidal activity of glutaraldehyde-based disinfectants.
        • Hanson PJV
        • Gor D
        • Jeffries DJ
        • Collins JV
        Elimination of high titre HIV from fiberoptic endoscopes.
        • Hanson PJ
        • Jeffries DJ
        • Collins JV
        Viral transmission and fibreoptic endoscopy.
        • Rutala WA
        • Cole EC
        • Wannamaker NS
        • Weber DJ
        Inactivation of Mycobacterium tuberculosis and Mycobacterium bovis by 14 hospital disinfectants.
        • Hanson PJ
        • Chadwick MV
        • Gaya H
        • Collins JV
        A study of glutaraldehyde disinfection of fibreoptic bronchoscopes experimentally contaminated with Mycobacterium tuberculosis.
        • Best M
        • Springthorpe VS
        • Sattar SA
        Feasibility of a combined carrier test for disinfectants: studies with a mixture of five types of microorganisms.
        • Jackson J
        • Leggett JE
        • Wilson D
        • Gilbert DN
        Mycobacterium gordonae in fiberoptic bronchoscopes.
        • Chanzy B
        • Duc-Bin DL
        • Rousset B
        • Morand P
        • Morel-Baccard C
        • Marchetti B
        • et al.
        Effectiveness of a manual disinfection procedure in eliminating hepatitis C virus from experimentally contaminated endoscopes.
      • 12.
        Select a disinfectant/sterilant that is compatible with the endoscope. The use of specific high-level disinfectants/sterilants on an endoscope should be avoided if the endoscope manufacturer warns against use because of functional damage (with or without cosmetic damage). Category IB

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Fuselier Jr, HA
        • Mason C
        Liquid sterilization versus high level disinfection in the urologic office.
        • Rutala WA
        • Weber DJ
        Disinfection of endoscopes: review of new chemical sterilants used for high-level disinfection.
      • 13.
        The selection and use of disinfectants in the healthcare field is dynamic, and products may become available that were not in existence when this guideline was written. As newer disinfectants become available, persons or committees responsible for selecting disinfectants for GI endoscope reprocessing should be guided by products cleared by the FDA and information in the scientific literature. Category II

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.

        FDA. FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices 1/30/02. Available at: http://www.fda.gov/cdrh/ode/germlab.html. Accessed 12-9-02.

      • 14.
        Completely immerse the endoscope and endoscope components in the high-level disinfectant/sterilant and ensure all channels are perfused. Nonimmersible GI endoscopes should be phased out immediately. Category IB
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        • Rutala WA
        • Weber DJ
        Importance of lumen flow in liquid chemical sterilization.
        • Sorin M
        • Segal-Maurer S
        • Urban C
        • Combest A
        • Rahal JJ
        Nosocomial tranmission of imipenem-resistant Pseudomonas aeruginosa following bronchoscopy associated with improper connection to the STERIS System 1 processor.
        • CDC
        Bronchoscopy-related infections and pseudoinfections—New York, 1996 and 1998.
      • 15.
        If an automated endoscope washer-disinfector (AEWD) is used, ensure that the endoscope and endoscope components can be effectively reprocessed in the AEWD (e.g., the elevator wire channel of duodenoscopes is not effectively disinfected by most AEWDs, and this step must be performed manually). Users should obtain and review model-specific reprocessing protocols from both the endoscope and AEWD manufacturers and check for compatibility. Category IB
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        • Rutala WA
        • Weber DJ
        Importance of lumen flow in liquid chemical sterilization.
        • Sorin M
        • Segal-Maurer S
        • Urban C
        • Combest A
        • Rahal JJ
        Nosocomial tranmission of imipenem-resistant Pseudomonas aeruginosa following bronchoscopy associated with improper connection to the STERIS System 1 processor.
        • CDC
        Bronchoscopy-related infections and pseudoinfections—New York, 1996 and 1998.
        • Allen JI
        Pseudomonas aeruginosa infection during endoscopy: reply [letter].
        • Streulens MJ
        • Rost F
        • Deplano A
        • Maas A
        • Schwam V
        • Serruys E
        • et al.
        Pseudomonas aeruginosa and Enterobacteriaceae bacteremia after biliary endoscopy: an outbreak investigation using DNA macrorestriction analysis.
      • 16.
        If an AEWD is used, place the endoscope and endoscope components in the reprocessor and attach all channel connectors according to the AEWD and endoscope manufacturers' instructions to ensure exposure of all internal surfaces with the high-level disinfectant/chemical sterilant. Category IB
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        • Weber DJ
        Importance of lumen flow in liquid chemical sterilization.
        • Sorin M
        • Segal-Maurer S
        • Urban C
        • Combest A
        • Rahal JJ
        Nosocomial tranmission of imipenem-resistant Pseudomonas aeruginosa following bronchoscopy associated with improper connection to the STERIS System 1 processor.
        • CDC
        Bronchoscopy-related infections and pseudoinfections—New York, 1996 and 1998.
      • 17.
        If an AEWD cycle is interrupted, high-level disinfection or sterilization cannot be assured. Category II
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.
      • 18.
        Because design flaws have compromised the effectiveness of AEWDs, the infection control staff should routinely review FDA advisories and the scientific literature for reports of AEWD deficiencies that may lead to infection. Category II
        • Sorin M
        • Segal-Maurer S
        • Urban C
        • Combest A
        • Rahal JJ
        Nosocomial tranmission of imipenem-resistant Pseudomonas aeruginosa following bronchoscopy associated with improper connection to the STERIS System 1 processor.
        • O'Connor HJ
        • Babb JR
        • Ayliffe GAJ
        Pseudomonas aeruginosa infection during endoscopy [letter].
        • Alvarado CJ
        • Stolz SM
        • Maki DG
        Nosocomial infections from contaminated endoscopes: a flawed automated endoscope washer. An investigation using molecular epidemiology.
        • CDC
        Nosocomial infection and pseudoinfection from contaminated endoscopes and bronchoscopes—Wisconsin and Missouri.
        • Fraser VJ
        • Jones M
        • Murray PR
        • Medoff G
        • Zhang Y
        • Wallace Jr, RJ
        Contamination of flexible fiberoptic bronchoscopes with Mycobacterium chelonae linked to an automated bronchoscope disinfection machine.
      • 19.
        After high-level disinfection, rinse the endoscope and flush the channels with sterile, filtered, or tap water to remove the disinfectant/sterilant. Discard the rinse water after each use/cycle. Flush the channels with 70% to 90% ethyl or isopropyl alcohol and dry with forced-air. The final drying steps greatly reduce the possibility of recontamination of the endoscope by waterborne microorganisms. Category IA
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • Cronmiller JR
        • Nelson DK
        • Salman G
        • Jackson DK
        • Dean RS
        • Hsu JJ
        • et al.
        Antimicrobial efficacy of endoscopic disinfection procedures: a controlled, multifactorial investigation.
        • Alvarado CJ
        • Stolz SM
        • Maki DG
        Nosocomial infections from contaminated endoscopes: a flawed automated endoscope washer. An investigation using molecular epidemiology.
        • Gerding DN
        • Peterson LR
        • Vennes JA
        Cleaning and disinfection of fiberoptic endoscopes: evaluation of glutaraldehyde exposure time and forced-air drying.
        • Allen JI
        • Allen MOC
        • Olson MM
        • Gerding DN
        • Shanholtzer CJ
        • Meier PB
        • et al.
        Pseudomonas infection of the biliary system resulting from use of a contaminated endoscope.
        • Alfa MJ
        • Sitter DL
        In hospital evaluation of contamination of duodenoscopes: a quantitative assessment of the effects of drying.
      • 20.
        When storing the endoscope, hang it in a vertical position to facilitate drying (with caps, valves, and other detachable components removed as per manufacturer instructions). Category II
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        • Noy MF
        • Harrison L
        • Holmes GKT
        • Cockel R
        The significance of bacterial contamination of fiberoptic endoscopes.
      • 21.
        Endoscopes should be stored in a manner that will protect the endoscope from contamination. Category II
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
      • 22.
        High-level disinfect or sterilize the water bottle (used for cleaning the lens and irrigation during the procedure), and its connecting tube at least daily. Sterile water should be used to fill the water bottle. Category IB
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Meenhorst PL
        • Reingold AL
        • Groothuis D
        Water-related nosocomial pneumonia caused by Legionella pneumophila serogroups 1 and 10.
        • Wright EP
        • Collins CH
        • Yates MD
        Mycobacterium xenopi and Mycobacterium kansasii in a hospital water supply.
        • Rutala WA
        • Weber DJ
        Water as a reservoir of nosocomial pathogens.
        • Wallace Jr, RJ
        • Brown BA
        • Driffith DE
        Nosocomial outbreaks/pseudo-outbreaks caused by nontuberculous mycobacteria.
      • 23.
        Maintain a log indicating for each procedure the patient's name and medical record number (if available), the procedure, the endoscopist, and the serial number or other identifier of the endoscope (and AEWD, if used) to assist in an outbreak investigation. Category II
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

      • 24.
        Perform routine testing of the liquid sterilant/high-level disinfectant to ensure minimal effective concentration (MEC) of the active ingredient. Check the solution at the beginning of each day of use (or more frequently) and document the results. If the chemical indicator shows that the concentration is less than the MEC, the solution should be discarded. Category IA
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • Cole EC
        • Rutala WA
        • Nessen L
        • Wannamaker NS
        • Weber DJ
        Effect of methodology, dilution, and exposure time on the tuberculocidal activity of glutaraldehyde-based disinfectants.
      • 25.
        Discard the liquid sterilant/high-level disinfectant at the end of its reuse life (which may be single-use) regardless of the MEC. If additional liquid sterilant/high-level disinfectant is added to an AEWD (or basin, if manually disinfected), the reuse life should be determined by the first use/activation of the original solution, that is, the practice of “topping off” of a liquid sterilant/high-level disinfectant pool does not extend the reuse life of the liquid sterilant/high-level disinfectant. Category IB
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.
        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        • Nelson DB
        • Barkun AN
        • Block KP
        • Burdick JS
        • Ginsberg GG
        • Greenwald DA
        • et al.
        Transmission of infection by gastrointestinal endoscopy.
      • 26.
        Facilities where endoscopes are used and disinfected should be designed to provide a safe environment for healthcare workers and patients. Air-exchange equipment (e.g., ventilation system, exhaust hoods) should be used to minimize the exposure of all persons to potentially toxic vapors (e.g., glutaraldehyde). The vapor concentration of the chemical sterilant used should not exceed allowable limits (e.g., those of the American Conference of Governmental Industrial Hygienists, Occupational Safety and Health Administration [OSHA]). Although organic vapor respirators appropriate for chemical exposures can provide respiratory protection (e.g., in the event of spills), they are not intended for routine use and are not a substitute for adequate ventilation, vapor recovery systems, and work practice controls. Category IB, IC
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Rutala WA
        • Hamory BH
        Expanding role of hospital epidemiology: employee health—chemical exposure in the health care setting.
        • OSHA
        Air contaminants final rule.
        • Weber DJ
        • Rutala WA
        Occupational risks associated with the use of selected disinfectants and sterilants.
        • American Conference of Governmental Industrial Hygienists ACGIH
      • 27.
        Personnel assigned to reprocess endoscopes should receive device-specific reprocessing instructions (i.e., endoscope and/or AEWD manufacturer, as needed) to ensure proper cleaning and high-level disinfection or sterilization. Competency testing of personnel reprocessing endoscopes should be done on a regular basis (e.g., commencement of employment, annually). Temporary personnel should not be allowed to reprocess endoscopes until competency has been established. Category IA
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

      • 28.
        All personnel who use chemicals should be educated about the biologic and chemical hazards present while performing procedures that use disinfectants. Category IC

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        OSHA. Hazard Communication Standard.29 CFR 1910.1200. Washington, D.C.

      • 29.
        Personal protective equipment (e.g., gloves, gowns, eyewear, respiratory protection devices) should be readily available and should be used, as appropriate, to protect workers from exposure to chemicals, blood, or other potentially infectious material (OPIM). Category IC

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        OSHA. Hazard Communication Standard.29 CFR 1910.1200. Washington, D.C.

        • OSHA
        Occupational exposure to bloodborne pathogens: final rule.
        • Carr-Locke DL
        • Conn MI
        • Faigel DO
        • Laing K
        • Leung JW
        • Mills MR
        • et al.
        Per msonal protective equipment.
      • 30.
        Healthcare facilities should develop protocols to ensure that users can readily identify whether an endoscope is contaminated or is ready for patient use. Category II
      • 31.
        The utility of routine environmental microbiologic testing of endoscopes for quality assurance has not been established. No recommendation.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

      • 32.
        If environmental microbiologic testing is performed, standard microbiologic techniques should be used. Category II

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Bond WW
        • Hedrick ER
        Microbiological culturing of environment and medical-device surfaces.
      • 33.
        In the setting of an outbreak caused by a suspected infectious or chemical etiology, the environmental sampling should be performed according to standard outbreak investigation. Category IA
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Dixon RE
        Investigation of endemic and epidemic nosocomial infection data.
      • 34.
        Endoscopy-related infections should be reported to:
      • 1.
        Persons responsible for infection control at the institution.
      • 2.
        The appropriate public health agency (state or local health department as required by state law or regulation).
      • 3.
        The Food and Drug Administration (www.fda.gov/medwatch ).
      • 4.
        The Centers for Disease Control and Prevention (CDC).
      • 5.
        The manufacturer(s) of the endoscope, disinfectant/sterilant, and AEWD (if used) Category IB, IC
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.

        Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • FDA
        Medical device reporting (MDR).

      Summary

      Flexible GI endoscopy is a valuable diagnostic and therapeutic tool for the care of patients with GI and pancreaticobiliary disorders. Compliance with accepted guidelines for the reprocessing of GI endoscopes between patients is critical to the safety and success of their use. When these guidelines are followed, pathogen transmission can effectively be prevented. Increased efforts and resources should be directed to improve compliance with these guidelines. Further research in the area of GI endoscopy reprocessing should be encouraged. This position statement has been endorsed by the American Society for Gastrointestinal Endoscopy (ASGE), the Society for Healthcare Epidemiology of America (SHEA), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA), the American Society of Colon and Rectal Surgeons (ASCRS), the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), the Society of Gastroenterology Nurses and Associates (SGNA), the Association of Perioperative Registered Nurses (AORN), the Association for Professionals in Infection Control (APIC), and the Federated Ambulatory Surgery Association (FASA). These organizations are committed to assisting the FDA and manufacturers in addressing critical infection control issues in GI device reprocessing.

      Consensus Panel Members and Conference Participants

      AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY SOCIETY FOR HEALTHCARE EPIDEMIOLOGY OF AMERICA Prevention of Infection During Gastrointestinal Endoscopy Consensus Conference
      CONSENSUS PANEL MEMBERS
      Douglas B. Nelson, MD, Chair American Society for Gastrointestinal Endoscopy
      William R. Jarvis, MD, Chair Society for Healthcare Epidemiology of America
      William A. Rutala, PhD University of North Carolina Health Care System
      Amy E. Foxx-Orenstein, DO American College of Gastroenterology
      Gerald Isenberg, MD American Society of Colon and Rectal Surgeons
      Georgia P. Dash, RN, MS, CIC Association for Professionals in Infection Control and Epidemiology
      Carla J. Alvarado, MS, CIC Association for Professionals in Infection Control and Epidemiology
      Marilee Ball, RN, MHA, CGRN Society of Gastroenterology Nurses and Associates, Inc.
      Joyce Griffin-Sobel, RN, PhD, ADCN, APN Society of Gastroenterology Nurses and Associates, Inc.
      Carol Petersen, RN, BSN, MAOM, CNOR Association of Perioperative Registered Nurses
      Kay A. Ball, RN, BSN, MSA, CNOR, FAAN Association of Perioperative Registered Nurses
      Jerry Henderson Federated Ambulatory Surgery Association
      Rachel L. Stricof, MPH New York State Department of Health
      CONFERENCE PARTICIPANTS
      Mary J. Cornelius, RN, BSN, CGRN Food and Drug Administration
      Cathy D. Nutter Food and Drug Administration
      Lynne Sehulster, PhD Centers for Disease Control and Prevention
      Martin S. Favero, PhD Advanced Sterilization Products
      Mike McFerson Advanced Sterilization Products
      Steve Lau Advanced Sterilization Products
      Cynthia Winker, PhD Amsurg Corp.
      John Winker Amsurg Corp.
      Walter Bond, MS (Independent consultant representing) Custom Ultrasonics
      Lawrence Muscarella, PhD Custom Ultrasonics
      Kim Smith Fujinon
      R. C. Kippenhan, PhD Medivators
      Terry Mistalski Medivators
      Roy Malkin Medivators
      Paul Harding Medivators
      Steve Goldstine, PhD Olympus America
      David Barlow, PhD Olympus America
      Keith Nelson Pentax Precision Instrument Corporation
      Gerald McDonnell, PhD Steris
      Daniel Subach, PhD, PhD Steris
      Terri Antonucci Steris
      Gerald B. Lichtenberger, PhD Vision Sciences
      Patrick Mach 3M

      Disclaimer

      The participation of employees of the federal government agencies should not be interpreted as endorsement or support of this position statement.

      Appendix

      Tabled 1
      The CDC system for categorizing recommendations is as follows:
      Category IA: Strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies.
      Category IB: Strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale.
      Category IC: Required by state or federal regulations. Because of state differences, readers should not assume that the absence of an IC recommendation implies the absence of state regulations.
      Category II: Recommended for implementation and supported by suggestive clinical or epidemiologic studies or theoretical rationale.
      No recommendation : Unresolved issue. Practices for which insufficient evidence or no consensus regarding efficacy exists.

      References

        • Favero MS
        • Bond WW
        Disinfection of medical and surgical materials.
        in: Disinfection, sterilization, and preservation. Lippincott Williams & Wilkins, Philadelphia2001: 881-917
        • Spach DH
        • Silverstein FE
        • Stamm WE
        Transmission of infection by gastrointestinal endoscopy and bronchoscopy.
        Ann Intern Med. 1993; 118: 117-128
        • Kimmey MB
        • Burnett DA
        • Carr-Locke DL
        • DiMarino AJ
        • Jensen DM
        • Katon R
        • et al.
        Transmission of infection by gastrointestinal endoscopy.
        Gastrointest Endosc. 1993; 36: 885-888
        • Lo Passo C
        • Pernice I
        • Celeste A
        • Perdichizzi G
        • Todaro-Luck F
        Transmission of Trichosporon asahii esophagitis by a contaminated endoscope.
        Mycoses. 2001; 44: 13-21
        • Bronowicki J-P
        • Venard V
        • Botté C
        • Monhoven N
        • Gastin I
        • Choné L
        • et al.
        Patient-to-patient transmission of hepatitis C virus during colonoscopy.
        N Engl J Med. 1997; 337: 237-240
        • Le Pogam S
        • Gondeau A
        • Bacq Y
        Nosocomial transmission of hepatitis C virus [letter].
        Ann Intern Med. 1999; 131: 794
        • Tennenbaum R
        • Colardelle P
        • Chochon M
        • Maisonneuve P
        • Jean F
        • Andrieu J
        Hépatite C après cholangiographie rétrograde [French].
        Gastroenterol Clin Biol. 1993; 17: 763-775
        • Food and Drug Administration
        Draft guidance for the content of premarket notifications for endoscopes used in gastroenterology and urology.
        FDA, Rockville1995
        • Garner JS
        • Favero MS
        CDC guideline for handwashing and hospital environmental control, 1985.
        Infect Control Hosp Epidemiol. 1986; 7: 231-243
        • DiMarino Jr, AJ
        • Leung J
        • Ravich W
        • Wolf D
        • Zuckerman G
        • Walters V
        • et al.
        Reprocessing of flexible gastrointestinal endoscopes.
        Gastrointest Endosc. 1996; 43: 540-546
        • Alvarado CJ
        • Reichelderfer M
        APIC guidelines for infection prevention and control in flexible endoscopy.
        Am J Infect Control. 2000; 28: 138-155
        • American Society for Testing and Materials
        Standard practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera.
        West Conshohocken. 2000; : F1518-F1600
      1. Recommended practices for use and care of endoscopes. 2002 Standards, recommended practices, and guidelines. AORN, Denver2002: 229-232
        • SGNA
        Standards of infection control in reprocessing of flexible gastrointestinal endoscopes.
        Gastroenterol Nurs. 2000; 23: 172-187
        • Gorse GJ
        • Messner RL
        Infection control practices in gastrointestinal endoscopy in the United States: a national survey.
        Infect Control Hosp Epidemiol. 1991; 12: 289-296
        • Kaczmarek RG
        • Moore Jr, RM
        • John M
        • Goldman DA
        • Reynolds C
        • Caquelin C
        • et al.
        Multi-state investigation of the actual disinfection/sterilization of endoscopes in health care facilities.
        Am J Med. 1992; 92: 257-261
        • Reynolds CD
        • Rhinehart E
        • Dreyer P
        • Goldman DA
        Variability in reprocessing policies and procedures for flexible fiberoptic endoscopes in Massachusetts hospitals.
        Am J Infect Control. 1992; 20: 283-290
        • Jackson FW
        • Ball MD
        Correction of deficiencies in flexible fiberoptic sigmoidoscope cleaning and disinfection technique in family practice and internal medicine offices.
        Arch Fam Med. 1997; 6: 578-582
        • Cheung RJ
        • Ortiz D
        • DiMarino Jr, AJ
        GI endoscopic reprocessing practices in the United States.
        Gastrointest Endosc. 1999; 50: 362-368
        • Muscarella LF
        Current instrument reprocessing practices: results of a national survey.
        Gastroenterol Nurs. 2001; 24: 253-260
      2. Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. Am J Infect Control. In Press.

        • Merritt K
        • Hitchins VM
        • Brown SA
        Safety and cleaning of medical materials and devices.
        J Biomed Mater Res. 2000; 53: 131-136
        • Babb JR
        • Bradley CR
        Endoscope reprocessing: where do we go from here?.
        J Hosp Infect. 1995; 30: 543-551
        • Hanson PJV
        • Gor D
        • Clarke JR
        • Chadwick MV
        • Nicholson G
        • Shah N
        • et al.
        Contamination of endoscopes used in AIDS patients.
        Lancet. 1989; 2: 86-88
        • Vesley D
        • Norlien KG
        • Nelson B
        • Ott B
        • Streifel AJ
        Signficant factors in the disinfection and sterilization of flexible endoscopes.
        Am J Infect Control. 1992; 20: 291-300
        • Rutala WA
        APIC guideline for selection and use of disinfectants.
        Am J Infect Control. 1996; 24: 313-342
        • Urayama S
        • Kozarek RA
        • Sumida S
        • Raltz S
        • Merriam L
        • Pethigal P
        Mycobacteria and glutaraldehye: is high-level disinfection of endoscopes possible?.
        Gastrointest Endosc. 1996; 43: 451-456
        • BSG
        Cleaning and disinfection of equipment for gastrointestinal endoscopy. Report of a Working party of the British Society of Gastroenterology Endoscopy Committee.
        Gut. 1998; 42: 585-593
        • Chu NS
        • McAlister D
        • Antonoplos PA
        Natural bioburden levels detected on flexible gastrointestinal endoscopes after clinical use and manual cleaning.
        Gastrointest Endosc. 1998; 48: 137-142
        • Cronmiller JR
        • Nelson DK
        • Salman G
        • Jackson DK
        • Dean RS
        • Hsu JJ
        • et al.
        Antimicrobial efficacy of endoscopic disinfection procedures: a controlled, multifactorial investigation.
        Gastrointest Endosc. 1999; 50: 152-158
        • Kovacs BJ
        • Chen YK
        • Kettering JD
        • Aprecio RM
        • Roy I
        High-level disinfection of gastrointestinal endoscopes: are current guidelines adequate?.
        Am J Gastroenterol. 1999; 94: 1546-1550
        • Vesley D
        • Melson J
        • Patricia S
        Microbial bioburden in endoscope reprocessing and an in-use evaluation of the high-level disinfection capabilities of Cidex PA.
        Gastroenterology Nursing. 1999; 22: 63-68
        • ESGE
        Guidelines on cleaning and disinfection in GI endoscopy.
        Endoscopy. 2000; 32: 77-83
        • Graham DY
        • Osato MS
        Disinfection of biopsy forceps and culture of Helicobacter pylori from gastric mucosal biopsies [letter].
        Am J Gastroenterol. 1999; 94: 1422-1423
      3. Recommended practices for high-level disinfection. 2002 Standards, recommended practices, and guideline. AORN, Denver2002: 211-216
      4. FDA. FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices 1/30/02. Available at: http://www.fda.gov/cdrh/ode/germlab.html. Accessed 12-9-02.

        • Collins FM
        Kinetics of tuberculocidal response by alkaline glutaraldehye in solution and on an inert surface.
        J Appl Bacteriol. 1986; 61: 87-93
        • Collins FM
        Bactericidal activity of alkaline glutaraldehyde solution against a number of atypical mycobacterial species.
        J Appl Bacteriol. 1986; 61: 247-251
        • Ascenzi JM
        • Ezzell RJ
        • Wendt TM
        A more accurate method for measurement of tuberculocidal activity of disinfectants.
        Appl Environ Microbiol. 1987; 53: 2189-2192
        • Collins FM
        Use of membrane filters for measurement of mycobacterial activity of alkaline glutaraldehyde solution.
        Appl Environ Microbiol. 1987; 53: 737-739
        • Best M
        • Sattar SA
        • Springthorpe VS
        • Kennedy ME
        Efficacies of selected disinfectants against Mycobacterium tuberculosis.
        J Clin Microbiol. 1990; 28: 2234-2239
        • Cole EC
        • Rutala WA
        • Nessen L
        • Wannamaker NS
        • Weber DJ
        Effect of methodology, dilution, and exposure time on the tuberculocidal activity of glutaraldehyde-based disinfectants.
        Appl Environ Microbiol. 1990; 56: 1813-1817
        • Hanson PJV
        • Gor D
        • Jeffries DJ
        • Collins JV
        Elimination of high titre HIV from fiberoptic endoscopes.
        Gut. 1990; 31: 657-659
        • Hanson PJ
        • Jeffries DJ
        • Collins JV
        Viral transmission and fibreoptic endoscopy.
        J Hosp Infect. 1991; 18: 136-140
        • Rutala WA
        • Cole EC
        • Wannamaker NS
        • Weber DJ
        Inactivation of Mycobacterium tuberculosis and Mycobacterium bovis by 14 hospital disinfectants.
        Am J Med. 1991; 91: 267S-271S
        • Hanson PJ
        • Chadwick MV
        • Gaya H
        • Collins JV
        A study of glutaraldehyde disinfection of fibreoptic bronchoscopes experimentally contaminated with Mycobacterium tuberculosis.
        J Hosp Infect. 1992; 22: 137-142
        • Best M
        • Springthorpe VS
        • Sattar SA
        Feasibility of a combined carrier test for disinfectants: studies with a mixture of five types of microorganisms.
        Am J Infect Control. 1994; 22: 152-162
        • Jackson J
        • Leggett JE
        • Wilson D
        • Gilbert DN
        Mycobacterium gordonae in fiberoptic bronchoscopes.
        Am J Infect Control. 1996; 24: 19-23
        • Chanzy B
        • Duc-Bin DL
        • Rousset B
        • Morand P
        • Morel-Baccard C
        • Marchetti B
        • et al.
        Effectiveness of a manual disinfection procedure in eliminating hepatitis C virus from experimentally contaminated endoscopes.
        Gastrointest Endosc. 1999; 50: 147-151
        • Fuselier Jr, HA
        • Mason C
        Liquid sterilization versus high level disinfection in the urologic office.
        Urology. 1997; 50: 337-340
        • Rutala WA
        • Weber DJ
        Disinfection of endoscopes: review of new chemical sterilants used for high-level disinfection.
        Infect Control Hosp Epidemiol. 1999; 20: 69-76
        • Rutala WA
        • Weber DJ
        Importance of lumen flow in liquid chemical sterilization.
        Am J Infect Control. 1999; 20: 458-459
        • Sorin M
        • Segal-Maurer S
        • Urban C
        • Combest A
        • Rahal JJ
        Nosocomial tranmission of imipenem-resistant Pseudomonas aeruginosa following bronchoscopy associated with improper connection to the STERIS System 1 processor.
        Infect Control Hosp Epidemiol. 2001; 20: 514-516
        • CDC
        Bronchoscopy-related infections and pseudoinfections—New York, 1996 and 1998.
        MMWR. 1999; 48: 557-560
        • Allen JI
        Pseudomonas aeruginosa infection during endoscopy: reply [letter].
        Gastroenterology. 1987; 93: 1451
        • Streulens MJ
        • Rost F
        • Deplano A
        • Maas A
        • Schwam V
        • Serruys E
        • et al.
        Pseudomonas aeruginosa and Enterobacteriaceae bacteremia after biliary endoscopy: an outbreak investigation using DNA macrorestriction analysis.
        Am J Med. 1993; 95: 489-498
        • O'Connor HJ
        • Babb JR
        • Ayliffe GAJ
        Pseudomonas aeruginosa infection during endoscopy [letter].
        Gastroenterology. 1987; 93: 1451
        • Alvarado CJ
        • Stolz SM
        • Maki DG
        Nosocomial infections from contaminated endoscopes: a flawed automated endoscope washer. An investigation using molecular epidemiology.
        Am J Med. 1991; 91: 272S-280S
        • CDC
        Nosocomial infection and pseudoinfection from contaminated endoscopes and bronchoscopes—Wisconsin and Missouri.
        MMWR. 1991; 40: 675-678
        • Fraser VJ
        • Jones M
        • Murray PR
        • Medoff G
        • Zhang Y
        • Wallace Jr, RJ
        Contamination of flexible fiberoptic bronchoscopes with Mycobacterium chelonae linked to an automated bronchoscope disinfection machine.
        Am Rev Respir Dis. 1992; 145: 853-855
        • Gerding DN
        • Peterson LR
        • Vennes JA
        Cleaning and disinfection of fiberoptic endoscopes: evaluation of glutaraldehyde exposure time and forced-air drying.
        Gastroenterology. 1982; 83: 613-618
        • Allen JI
        • Allen MOC
        • Olson MM
        • Gerding DN
        • Shanholtzer CJ
        • Meier PB
        • et al.
        Pseudomonas infection of the biliary system resulting from use of a contaminated endoscope.
        Gastroenterology. 1987; 92: 759-763
        • Alfa MJ
        • Sitter DL
        In hospital evaluation of contamination of duodenoscopes: a quantitative assessment of the effects of drying.
        J Hosp Infect. 1991; 19: 89-98
        • Noy MF
        • Harrison L
        • Holmes GKT
        • Cockel R
        The significance of bacterial contamination of fiberoptic endoscopes.
        J Hosp Infect. 1980; 1: 53-61
        • Meenhorst PL
        • Reingold AL
        • Groothuis D
        Water-related nosocomial pneumonia caused by Legionella pneumophila serogroups 1 and 10.
        J Infect Dis. 1985; 152: 356-364
        • Wright EP
        • Collins CH
        • Yates MD
        Mycobacterium xenopi and Mycobacterium kansasii in a hospital water supply.
        J Hosp Infect. 1985; 6: 175-178
        • Rutala WA
        • Weber DJ
        Water as a reservoir of nosocomial pathogens.
        Infect Control Hosp Epidemiol. 1997; 18: 609-616
        • Wallace Jr, RJ
        • Brown BA
        • Driffith DE
        Nosocomial outbreaks/pseudo-outbreaks caused by nontuberculous mycobacteria.
        Annu Rev Microbiol. 1998; 52: 453-490
        • Nelson DB
        • Barkun AN
        • Block KP
        • Burdick JS
        • Ginsberg GG
        • Greenwald DA
        • et al.
        Transmission of infection by gastrointestinal endoscopy.
        Gastrointest Endosc. 2001; 54: 824-828
        • Rutala WA
        • Hamory BH
        Expanding role of hospital epidemiology: employee health—chemical exposure in the health care setting.
        Infect Control Hosp Epidemiol. 1989; 10: 261-266
        • OSHA
        Air contaminants final rule.
        Federal Register. 1993; 58: 35338-35351
        • Weber DJ
        • Rutala WA
        Occupational risks associated with the use of selected disinfectants and sterilants.
        in: Disinfection, sterilization, and antisepsis in healthcare. Polyscience Publications, Champlain1998: 211-226
        • American Conference of Governmental Industrial Hygienists ACGIH
        Threshold limit values for chemical substances and physical agents and biologic exposure indices. Cincinnati, 2001
      5. OSHA. Hazard Communication Standard.29 CFR 1910.1200. Washington, D.C.

        • OSHA
        Occupational exposure to bloodborne pathogens: final rule.
        Federal Register. 1991; 56: 64003-64182
        • Carr-Locke DL
        • Conn MI
        • Faigel DO
        • Laing K
        • Leung JW
        • Mills MR
        • et al.
        Per msonal protective equipment.
        Gastrointest Endosc. 1999; 49: 854-857
        • Bond WW
        • Hedrick ER
        Microbiological culturing of environment and medical-device surfaces.
        in: Clinical microbiology procedures handbook. American Society for Microbiology, Washington (DC)1992: 11.0.1-1109
        • Dixon RE
        Investigation of endemic and epidemic nosocomial infection data.
        in: 3rd ed. Hospital infection. Little Brown, Boston1992: 109-135
        • FDA
        Medical device reporting (MDR).
        (Available at)
        http://www.fda.gov/cdrh/mdr/
        Date: November 20, 2002
        (Accessed)