Background and Aims
Worldwide, an increasing number of duodenoscope-associated outbreaks are reported.
The high prevalence rate of contaminated duodenoscopes puts patients undergoing ERCP
at risk of exogenous transmission of microorganisms. The contributing factors of the
duodenoscope design to contamination are not well understood. This article reports
on the investigation after the outbreak of a multidrug-resistant Klebsiella pneumoniae (MRKP) related to 2 Olympus TJF-Q180V duodenoscopes.
Methods
We conducted a contact patient screening and microbiologic laboratory database search.
Reprocessing procedures were audited, and both duodenoscopes were fully dismantled
to evaluate all potential contamination factors. Outcomes were reviewed by an experienced
independent expert.
Results
In total, 102 patients who had undergone an ERCP procedure from January to August
2015 were invited for screening. Cultures were available of 81 patients, yielding
27 MRKP-infected or -colonized patients. Ten patients developed an MRKP-related active
infection. The 2 duodenoscopes had attack rates (the number of infected or colonized
cases/number of exposed persons) of 35% (17/49) and 29% (7/24), respectively. Identical
MRKP isolates were cultured from channel flushes of both duodenoscopes. The review
revealed 4 major abnormalities: miscommunication about reprocessing, undetected damaged
parts, inadequate repair of duodenoscope damage, and duodenoscope design abnormalities,
including the forceps elevator, elevator lever, and instrumentation port sealing.
Conclusions
Outbreaks are associated with a combination of factors, including duodenoscope design
issues, repair issues, improper cleaning, and systemic monitoring of contamination.
To eliminate future duodenoscope-associated infections, a multipronged approach is
required, including clear communication by all parties involved, a reliable servicing
market, stringent surveillance measures, and eventually new duodenoscope designs and
reprocessing procedures with a larger margin of safety.
Abbreviations:
ESBL (extended-spectrum β-lactamase), IFU (instructions for use), ISO (independent service organization), MRKP (multidrug-resistant Klebsiella pneumoniae), UMCU (University Medical Center Utrecht)To read this article in full you will need to make a payment
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References
- Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.([updated 13-01-2016]. Available at:)https://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdfDate: 2016Date accessed: January 21, 2016
- Safely reprocessing duodenoscopes: current evidence and future directions.Lancet Gastroenterol Hepatol. 2018; 3: 499-508
- Infection using ERCP endoscopes.Gastroenterology. 2016; 151: 46-50
- Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy.Clin Microbiol Rev. 2013; 26: 231-254
- Adverse events associated with ERCP.Gastrointest Endosc. 2017; 85: 32-47
- Risk of infection following colonoscopy and sigmoidoscopy in symptomatic patients.Endoscopy. 2017; 49: 754-764
- Rates of infection after colonoscopy and osophagogastroduodenoscopy in ambulatory surgery centres in the USA.Gut. 2018; 67: 1626-1636
- Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data 2018 [updated 10-12-2018].(Available at:)https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628096.htmDate accessed: December 10, 2018
- High-quality endoscope reprocessing decreases endoscope contamination.Clin Microbiol Infect. 2018; 24: 1101
- Randomized comparison of 3 high-level disinfection and sterilization procedures for duodenoscopes.Gastroenterology. 2017; 153: 1018-1025
- Surveillance of guideline practices for duodenoscope and linear echoendoscope reprocessing in a large healthcare system.Gastrointest Endosc. 2016; 84: 392-399
- A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli.Gastrointest Endosc. 2015; 82: 477-483
- A survey of reprocessing methods, residual viable bioburden, and soil levels in patient-ready endoscopic retrograde choliangiopancreatography duodenoscopes used in Canadian centers.Infect Control Hosp Epidemiol. 2002; 23: 198-206
- Measures to improve microbial quality surveillance of gastrointestinal endoscopes.Endoscopy. 2016; 48: 704-710
- High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study.Gut. 2018; 67: 1637-1645
- Outbreaks of carbapenem-resistant Enterobacteriaceae infections associated with duodenoscopes: What can we do to prevent infections?.Am J Infect Control. 2016; 44: e47-e51
- Studies on the bioburden on medical devices and the importance of cleaning.in: Rutala W.A. Disinfection, sterilization and antisepsis: principles and practices in healthcare facilities. Association for Professional in Infection Control and Epidemiology, Washington, DC2001: 63-69
- Worst-case soiling levels for patient-used flexible endoscopes before and after cleaning.Am J Infect Control. 1999; 27: 392-401
- FDA labeling requirements for disinfection of endoscopes: a counterpoint.Infect Control Hosp Epidemiol. 1995; 16: 231-235
- Endoscope reprocessing methods: a prospective study on the impact of human factors and automation.Gastroenterol Nurs. 2010; 33: 304-311
- Reported gastrointestinal endoscope reprocessing lapses: the tip of the iceberg.Am J Infect Control. 2013; 41: 1188-1194
- Infection control assessment of ambulatory surgical centers.JAMA. 2010; 303: 2273-2279
- Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa.Endoscopy. 2015; 47: 493-502
- New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes.JAMA. 2014; 312: 1447-1455
- Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak.Infect Control Hosp Epidemiol. 2015; 36: 634-642
Loeve AJ. Investigational report on a TJF-Q180V duodenoscope following contamination after cleaning and disinfection. Available on request from the Dutch Healthcare Inspectorate/National Institute for Public Health and the Environment. Bilthoven. The Netherlands; 2012. Accessed October 1, 2015.
- Desinfection of the Olympus TJF-Q180V ERCP endoscope. RIVM Adviespunt Medische en Consumentenproducten. Projectnummer: V/080118/01/AH.National Institute for Public Health and the Environment/Rijksinstituut voor Volksgezondheid en Milieu RIVM, Bilthoven, the Nederlands2012
- FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk.([updated 15-01-2016]. Available at:)www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm481956.htmDate: 2016Date accessed: January 21, 2016
- Inspection of endoscope instrument channels after reprocessing using a prototype borescope.Gastrointest Endosc. 2018; 88: 612-619
- Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.Am J Infect Control. 2017; 45: e26-e33
- Borescope examination: Is there value in visual assessment of endoscope channels?.Gastrointest Endosc. 2018; 88: 620-623
- Professional standard handbook, version 3.0. Flexible endoscope—cleaning and disinfection.([updated 18-09-2013]. Available at:)https://www.infectiepreventieopleidingen.nl/downloads/SFERDHandbook3_1.pdfDate: 2013Date accessed: October 1, 2016
- Investigation of Olympus TJF-Q180V scopes at UMC Utrecht regarding contamination found after cleaning and disinfection: reporting, conclusions and suggestions. 2017; (Available at:) (Accessed: January 5, 2017)
- Risk factors associated with the transmission of carbapenem-resistant Enterobacteriaceae via contaminated duodenoscopes.Gastrointest Endosc. 2016; 83: 1121-1129
- Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment.Am J Infect Control. 2013; 41: 562-564
- Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography.Endoscopy. 2010; 42: 895-899
- Control of a multi-hospital outbreak of KPC-producing Klebsiella pneumoniae type 2 in France, September to October 2009.Eur Surveill. 2010; 15: 19734
- successful control of an endoscopic retrograde cholangiopancreatography–associated nosocomial outbreak caused by Klebsiella pneumoniae carbapenemase producing Klebsiella pneumoniae in a university hospital in Bogota, Colombia.Open Forum Infect Dis. 2016; 3: 1398
- An outbreak of carbapenem-resistant OXA-48-producing Klebsiella pneumonia associated to duodenoscopy.Antimicrob Resist Infect Control. 2015; 4: 8
- Prevention of multidrug-resistant infections from contaminated duodenoscopes: position statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA).Endoscopy. 2017; 49: 1098-1106
- Guideline: control of microbiological safety of thermolabile flexible high-risk gastrointestinal endoscopes [Richtlijn controle op microbiologische veiligheid van thermolabiele flexibele hoog-risico gastro-intestinale endoscopen].(Available at:)https://www.nvmm.nl/media/2222/180627-richtlijn-controle-op-microbiologische-veiligheid-van-thermolabiele-flexibele-gi-endoscopen-juiste-versie.pdfDate: 2018Date accessed: April 1, 2018
- Is bacteriologic surveillance in endoscope reprocessing stringent enough?.Endoscopy. 2009; 41: 913-916
- Multidrug-resistant Pseudomonas aeruginosa cholangitis after endoscopic retrograde cholangiopancreatography: failure of routine endoscope cultures to prevent an outbreak.Infect Control Hosp Epidemiol. 2004; 25: 856-859
- Transmission of carbapenem-resistant Enterobacteriaceae during ERCP: time to revisit the current reprocessing guidelines.Gastrointest Endosc. 2015; 81: 1041-1045
- Duodenoscopy: an amplifier of cross-transmission during a carbapenemase-producing Enterobacteriaceae outbreak in a gastroenterology pathway.J Hosp Infect. 2018; 99: 422-426
- Professional standard handbook, version 4.0. Flexible endoscopes—cleaning and disinfection.([updated 01-09-2016]. Available at:)https://www.infectiepreventieopleidingen.nl/downloads/SFERDHandbook4_1.pdfDate: 2016Date accessed: October 1, 2016
- Control measures for the use of endoscope disinfectors: progress of the implementation of the SFERD quality manual. 2018; (Available at:) (Accessed: November 7, 2018)
- Customer letter: Urgent medical device removal and corrective action. Elevator mechanism replacement, updated operation manual, and new reprocessing instructions for the Olympus TJF-Q180V duodenoscope 2016 [updated 15-01-2016].(Available at:)http://medical.olympusamerica.com/sites/us/files/pdf/160115-Olympus-TJF-Q180V-Customer-Letter.pdfDate accessed: January 21, 2016
- Urgent medical device correction and removal.([updated 21-07-2017]. Available at:) (Accessed February 11, 2018)
- ED34-i10T traditional 510(k) submission 2017.([updated 18-09-2017]. Available at:) (Accessed February 11, 2018)
- Increasing potential risks of contamination from repetitive use of endoscope.Am J Infect Control. 2015; 43: e13-e17
- Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update.Gastrointest Endosc. 2017; 85: 282-294
U.S. Food and Drug Administration. FDA report on the quality, safety, and effectiveness of servicing of medical devices. In accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) 2018 [updated 01-05-2018]. Available at: https://www.fda.gov/media/113431/download. Accessed August 3, 2018.
- Endoscope repair by original equipment manufacturers and independent service organizations.Gastrointest Endosc. 2003; 57: 639-642
- Transmission of Salmonella enteritidis after endoscopic retrograde cholangiopancreatography because of inadequate endoscope decontamination.Am J Infect Control. 2017; 45: 440-442
- Important safety advice.Safe reprocessing of TJF-Q180V. 2013; (Available at:) (Accessed January 10, 2015)
- Transmission of mobile colistin resistance (mcr-1) by duodenoscope.Clin Infect Dis. 2018; 68: 1327-1334
Article Info
Publication History
Published online: May 15, 2019
Accepted:
May 5,
2019
Received:
December 27,
2018
Footnotes
DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: F. P. Vleggaar: Consultant for and research grant recipient from Boston Scientific. M. J. Bruno: Consultant for 3M, Boston Scientific, and Cook Medical; speaker for Boston Scientific and Cook Medical; grant recipient from 3M, Boston Scientific, Cook Medical, and Pentax Medical. M. C. Vos: Grant recipient from 3M, Pentax Medical, and IMS Innovations. All other authors disclosed no financial relationships relevant to this publication.
If you would like to chat with an author of this article, you may contact Dr Monkelbaan at [email protected] .
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© 2019 by the American Society for Gastrointestinal Endoscopy
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Access this article on ScienceDirectLinked Article
- Dissecting an outbreak one scope at a time: Is this the new reality?Gastrointestinal EndoscopyVol. 90Issue 5
- PreviewThe infectious risk of ERCP has historically been ascribed to biliary stasis and obstructive physiology from stones, strictures, or stents. Recent outbreaks, many of them from multidrug-resistant organisms (MDROs), have been attributed to the infectious carriage of the duodenoscope itself: so-called exogenous infection. This has drawn considerable attention and research efforts intended to better characterize the contributory risk of each of the following factors: instrument design, reprocessing measures (eg, manual and automated cleaning), surveillance strategies for detecting instrument contamination, and other quality metrics.
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