Skip to main content
Log in

Duodenoscope-Associated Bacterial Infections: A Review and Update

  • Endoscopy (I Waxman, Section Editor)
  • Published:
Current Treatment Options in Gastroenterology Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

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

  1. 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.

    Article  PubMed  Google Scholar 

  2. 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.

    Article  PubMed  Google Scholar 

  3. 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.

    Article  PubMed  Google Scholar 

  4. 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.

    Article  PubMed  Google Scholar 

  5. Cedars-Sinai. Media Statement regading CRE and duodenoscope. 2015.

  6. Eisler P. Deadly infections from medical scopes go unreported, raising health risks. USA Today. 2015.

  7. 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.

  8. 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.

    Article  CAS  PubMed  Google Scholar 

  9. 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.

    Article  CAS  PubMed  Google Scholar 

  10. 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.

    Article  CAS  PubMed  Google Scholar 

  11. 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.

    Article  CAS  PubMed  Google Scholar 

  12. 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.

    Article  CAS  PubMed  Google Scholar 

  13. 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.

    CAS  PubMed  Google Scholar 

  14. Birnie GG, Quigley EM, Clements GB, Follet EA, Watkinson G. Endoscopic transmission of hepatitis B virus. Gut. 1983;24(2):171–4.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Humphries RM, McDonnell G. Superbugs on Duodenoscopes: the challenge of cleaning and disinfection of reusable devices. J Clin Microbiol. 2015;53(10):3118–25.

    Article  PubMed  PubMed Central  Google Scholar 

  16. 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.

    Article  PubMed  Google Scholar 

  17. 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.

    Article  PubMed  Google Scholar 

  18. 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.

    Article  PubMed  Google Scholar 

  19. 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.

  20. 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.

    Article  Google Scholar 

  21. 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.

    CAS  PubMed  Google Scholar 

  22. 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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. Rutala WA, Weber DJ. ERCP scopes: what can we do to prevent infections? Infect Control Hosp Epidemiol. 2015;36(6):643–8.

    Article  PubMed  Google Scholar 

  24. 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.

    Article  PubMed  Google Scholar 

  25. Rutala WA, Weber DJ. Gastrointestinal endoscopes: a need to shift from disinfection to sterilization? JAMA. 2014;312(14):1405–6.

    Article  CAS  PubMed  Google Scholar 

  26. Rutala WA, Weber DJ. Sterilization of endoscopic instruments—reply. JAMA. 2015;313(5):524.

    Article  PubMed  Google Scholar 

  27. 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.

    Article  CAS  PubMed  Google Scholar 

  28. 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.

    Article  CAS  PubMed  Google Scholar 

  29. 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.

    Article  CAS  PubMed  Google Scholar 

  30. 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.

    PubMed  PubMed Central  Google Scholar 

  31. 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.

  32. 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.

  33. 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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  34. 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.

    Article  CAS  PubMed  Google Scholar 

  35. 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.

    Article  CAS  PubMed  Google Scholar 

  36. Shin SP, Kim WH. Recent update on microbiological monitoring of gastrointestinal endoscopes after high-level disinfection. Clin Endosc. 2015;48(5):369–73.

    Article  PubMed  PubMed Central  Google Scholar 

  37. 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.

  38. Petersen BT. Duodenoscope reprocessing: risk and options coming into view. Gastrointest Endosc. 2015;82(3):484–7.

    Article  PubMed  Google Scholar 

  39. 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.

    Article  PubMed  Google Scholar 

  40. 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.

  41. 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.

  42. 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.

  43. Food and Drug Administration. 2015 Materials of the Gastroenterology-Urology Devices Panel. June 15, 2015. Accessed January 16, 2016.

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Andrew S. Ross M.D..

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

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

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

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11938-016-0088-9

Keywords

Navigation