Opinion Statement
Physicians depend on the use of flexible endoscopes for delivery of vital care that is morbidity sparing compared to surgical alternatives. Iatrogenic infection is a well-documented complication of therapeutic endoscopy. Recent emergence of unique antimicrobial resistance patterns and molecular “fingerprinting” of bacteria harken a new era in duodenoscope-related infections which occur in spite of compliance with device manufacturer-recommended protocols for high-level disinfection (HLD). Further studies suggest that these protocols are likely inadequate. Endoscopic retrograde cholangiopancreatography (ERCP) remains critical in the provision of minimally invasive diagnostic, therapeutic, and palliative care for patients with pancreaticobiliary disease. This manuscript reviews the history of duodenoscope-related infections, current challenges to scope reprocessing, and recommendations from regulatory agencies.
Similar content being viewed by others
References and Recommended Reading
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
Epstein L, Hunter JC, Arwady MA, Tsai V, Stein L, Gribogiannis M, et al. New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA. 2014;312(14):1447–55. First documented U.S. outbreak of duodenoscope-related MDRO/CRE infection with patient cohort and enviromental relatedness confirmed using pulsed-field gel electrophoresis. Ultimately infections attributed to problem with AER.
Wendorf KA, Kay M, Baliga C, Weissman SJ, Gluck M, Verma P, et al. Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak. Infect Control Hosp Epidemiol. 2015;36(6):634–42. Publication of Seattle-based, duodenoscope-related MDRO outbreak and 1.9% HLD defect rate.
Dirlam Langlay AM, Ofstead CL, Mueller NJ, Tosh PK, Baron TH, Wetzler HP. Reported gastrointestinal endoscope reprocessing lapses: the tip of the iceberg. Am J Infect Control. 2013;41(12):1188–94.
Alrabaa SF, Nguyen P, Sanderson R, Baluch A, Sandin RL, Kelker D, et al. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control. 2013;41(6):562–4.
Cedars-Sinai. Media Statement regading CRE and duodenoscope. 2015.
Eisler P. Deadly infections from medical scopes go unreported, raising health risks. USA Today. 2015.
Petersen M, Terhune C. How a medical device maker kept U.S. hospitals in the dark about deadly infections. LA Times. December 19, 2015. Accessed January 16, 2016.
Gastmeier P, Vonberg RP. Klebsiella spp. in endoscopy-associated infections: we may only be seeing the tip of the iceberg. Infection. 2014;42(1):15–21.
Aumeran C, Poincloux L, Souweine B, Robin F, Laurichesse H, Baud O, et al. Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy. 2010;42(11):895–9.
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(3B):272S–80S.
Struelens 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(5):489–98.
Schaefer MK, Jhung M, Dahl M, Schillie S, Simpson C, Llata E, et al. Infection control assessment of ambulatory surgical centers. JAMA. 2010;303(22):2273–9.
Tennenbaum R, Colardelle P, Chochon M, Maisonneuve P, Jean F, Andrieu J. Hepatitis C after retrograde cholangiography. Gastroenterol Clin Biol. 1993;17(10):763–4.
Birnie GG, Quigley EM, Clements GB, Follet EA, Watkinson G. Endoscopic transmission of hepatitis B virus. Gut. 1983;24(2):171–4.
Humphries RM, McDonnell G. Superbugs on Duodenoscopes: the challenge of cleaning and disinfection of reusable devices. J Clin Microbiol. 2015;53(10):3118–25.
Verfaillie CJ, Bruno MJ, Voor in ‘t Holt AF, Buijs JG, Poley JW, Loeve AJ, et al. Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Endoscopy. 2015;47(6):493–502.
Van der Bij AK, Van der Zwan D, Peirano G, Severin JA, Pitout JD, Van Westreenen M, et al. Metallo-beta-lactamase-producing Pseudomonas aeruginosa in the Netherlands: the nationwide emergence of a single sequence type. Clin Microbiol Infect. 2012;18(9):E369–372. First documented outbreak of duodenoscope transmitted MDRO/CRE infection occurring without lapse in reprocessing.
Smith ZL, Oh YS, Saeian K, Edmiston Jr CE, Khan AH, Massey BT, et al. Transmission of carbapenem-resistant Enterobacteriaceae during ERCP: time to revisit the current reprocessing guidelines. Gastrointest Endosc. 2015;81(4):1041–5.
McCool S, Clarke L, Querry A, Pasculle A, Rack L, Neilsen C, et al. Carbapenem-resistant enterobacteriaceae (CRE) Klebsiella pneumoniae (KP) cluster analysis associated with GI scopes with elevator channel. ID Week. October 2–6, 2013. Abstract #1619.
ASGE Quality Assurance in Endoscopy Committee, Petersen BT, Chennat J, Cohen J, Cotton PB, Greenwald DA, et al. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. Gastrointest Endosc. 2011;73(6):1075–84.
Chu NS, Favero M. The microbial flora of the gastrointestinal tract and the cleaning of flexible endoscopes. Gastrointest Endosc Clin N Am. 2000;10(2):233–44.
Kovaleva J, Peters FT, van der Mei HC, Degener JE. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev. 2013;26(2):231–54.
Rutala WA, Weber DJ. ERCP scopes: what can we do to prevent infections? Infect Control Hosp Epidemiol. 2015;36(6):643–8.
Ross AS, Baliga C, Verma P, Duchin J, Gluck M. A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli. Gastrointest Endosc. 2015;82(3):477–83. First publication regarding efficacy of culture and quarantine method.
Rutala WA, Weber DJ. Gastrointestinal endoscopes: a need to shift from disinfection to sterilization? JAMA. 2014;312(14):1405–6.
Rutala WA, Weber DJ. Sterilization of endoscopic instruments—reply. JAMA. 2015;313(5):524.
Haney PE, Raymond BA, Lewis LC. Ethylene oxide. An occupational health hazard for hospital workers. AORN J. 1990;51(2):480. –481, 483, 485–486.
Foliente RL, Kovacs BJ, Aprecio RM, Bains HJ, Kettering JD, Chen YK. Efficacy of high-level disinfectants for reprocessing GI endoscopes in simulated-use testing. Gastrointest Endosc. 2001;53(4):456–62.
Cloutman-Green E, Canales M, Zhou Q, Ciric L, Hartley JC, McDonnell G. Biochemical and microbial contamination of surgical devices: a quantitative analysis. Am J Infect Control. 2015;43(6):659–61.
Hansen D, Benner D, Hilgenhoner M, Leisebein T, Brauksiepe A, Popp W. ATP measurement as method to monitor the quality of reprocessing flexible endoscopes. Ger Med Sci. 2004;2:Doc04.
Centers for Disease C. Interim protocol for healthcare facilities regarding surveillance for bacterial contamination of duodenoscopes after reprocessing. CDC. March 11, 2015. Accessed January 16, 2016.
Olympus Corporation. Urgent medical device removal and corrective action: elevator mechanism replacement, updated operation manual, and new reprocessing instructions for the Olympus TJF-Q180V Duodenoscope. January 15, 2016. Accessed January 16, 2016.
Aumeran C, Thibert E, Chapelle FA, Hennequin C, Lesens O, Traore O. Assessment on experimental bacterial biofilms and in clinical practice of the efficacy of sampling solutions for microbiological testing of endoscopes. J Clin Microbiol. 2012;50(3):938–42.
Beilenhoff U, Neumann CS, Biering H, Blum R, Schmidt V, Rey JF, et al. ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5. Endoscopy. 2007;39(1):85–94.
Beilenhoff U, Neumann CS, Rey JF, Biering H, Blum R, Schmidt V, et al. ESGE-ESGENA guideline for quality assurance in reprocessing: microbiological surveillance testing in endoscopy. Endoscopy. 2007;39(2):175–81.
Shin SP, Kim WH. Recent update on microbiological monitoring of gastrointestinal endoscopes after high-level disinfection. Clin Endosc. 2015;48(5):369–73.
Gazdik MA, Coombs J, Burke J, Lopansri B. Comparison of two culture methods for use in assessing microbial contamination of duodenoscopes. J Clin Microbiol. 2015.
Petersen BT. Duodenoscope reprocessing: risk and options coming into view. Gastrointest Endosc. 2015;82(3):484–7.
Almario CV, May FP, Shaheen NJ, Murthy R, Gupta K, Jamil LH, et al. Cost utility of competing strategies to prevent endoscopic transmission of carbapenem-resistant enterobacteriaceae. Am J Gastroenterol. 2015;110(12):1666–74.
Food and Drug Administration. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. March 17, 2015. Accessed January 16, 2016.
Olympus Corporation. Urgent safety notification important updated labeling information: new reprocessing instructions for the Olympus TJF-Q180V duodenoscope. March 26, 2015. Accessed January 16, 2016.
Food and Drug Administration. Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication. August 4, 2015. Accessed January 16, 2016. Most recent regulatory body guidelines for duodenoscope reprocessing, incorporating consensus from expert-led panel.
Food and Drug Administration. 2015 Materials of the Gastroenterology-Urology Devices Panel. June 15, 2015. Accessed January 16, 2016.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of Interest
Jennifer T. Higa, Michael Gluck, and Andrew Ross declare that they have no conflict of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Additional information
This article is part of the Topical Collection on Endoscopy
Rights and permissions
About this article
Cite this article
Higa, J.T., Gluck, M. & Ross, A.S. Duodenoscope-Associated Bacterial Infections: A Review and Update. Curr Treat Options Gastro 14, 185–193 (2016). https://doi.org/10.1007/s11938-016-0088-9
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11938-016-0088-9