Advertisement
Original article Clinical endoscopy| Volume 88, ISSUE 2, P223-229, August 2018

Download started.

Ok

Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol

Published:February 21, 2018DOI:https://doi.org/10.1016/j.gie.2018.02.015
Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol
Previous ArticleNew technologies improve adenoma detection rate, adenoma miss rate, and polyp detection rate: a systematic review and meta-analysis
Next ArticleCombination of albumin-bilirubin grade and platelets to predict a compensated patient with hepatocellular carcinoma who does not require endoscopic screening for esophageal varices

      Background and Aims

      Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assessed the long-term results and impact of key interventions in the optimization of a rigorous “culture and quarantine” program for duodenoscope reprocessing.

      Methods

      We reviewed a prospectively collected, quality assurance database of all duodenoscope cultures (n = 4307) obtained for the initial 3-year duration of culture and quarantine from 2014 to 2017 in a single U.S.-based, high-volume endoscopy center. All duodenoscopes were subject to manual cleaning and automated reprocessing and drying, followed by sampling using a modified protocol developed by the Centers for Disease Control and Prevention. Duodenoscopes were cultured per-use.

      Results

      A total of 4307 duodenoscope cultures were obtained during the study period. High-concern organisms were isolated from 33 of these cultures, resulting in a .697% high-level disinfection defect rate. Statistically significant interventions included withdrawal of a high-frequency culture-positive duodenoscope (scope A) from clinical service in addition to implementation of new manufacturer-recommended cleaning protocols. Withdrawal of a second high-frequency culture-positive duodenoscope (scope B) and a mandatory device retrofit had no effect on the observed rate of positive duodenoscope cultures.

      Conclusions

      Withdrawal of duodenoscopes with a high rate of culture positivity and optimizing manual cleaning practices have contributed to an overall decline in the high-level disinfection defect rate. A stringent culture and quarantine protocol allowed identification of the culprit endoscopes. There remains a much-needed role for an inexpensive and highly reliable method to check on the adequacy of reprocessing given the inherent complexity of these tasks.

      Abbreviations:

      CDC (Centers for Disease Control and Prevention), FDA (U.S. Food and Drug Administration), HAC (hyperproduction of AmpC), HLD (high-level disinfection), MDRO (multidrug-resistant organisms)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Register: Create an account
      Institutional Access: Sign in to ScienceDirect

      References

        • Van der Bij A.K.
        • Van der Zwan D.
        • Peirano G.
        • et al.
        Metallo-beta-lactamase-producing Pseudomonas aeruginosa in the Netherlands: the nationwide emergence of a single sequence type.
        Clin Microbiol Infect. 2012; 18: E369-E372
        View in Article
        • Epstein L.
        • Hunter J.C.
        • Arwady M.A.
        • et al.
        New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes.
        JAMA. 2014; 312: 1447-1455
        View in Article
        • Verfaillie C.J.
        • Bruno M.J.
        • Voor in ‘t Holt A.F.
        • et al.
        Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa.
        Endoscopy. 2015; 47: 493-502
        View in Article
        • Wendorf K.A.
        • Kay M.
        • Baliga C.
        • et al.
        Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak.
        Infect Control Hosp Epidemiol. 2015; 36: 634-642
        View in Article

      5. U.S. Food and Drug Administration. Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning: FDA safety communication. Issued February 19th, 2015. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm. Accessed November 6, 2017.

        View in Article

      6. U.S. Food and Drug Administration. Materials of the Gastroenterology-Urology Devices Panel. May 14-15, 2015. Available at: https://wayback.archive-it.org/7993/20170112002249/http:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/ucm445590.htm. Accessed November 6, 2017.

        View in Article

      7. U.S. Food and Drug Administration. Supplemental measures to enhance duodenoscope reprocessing: FDA Safety Communication. August 4, 2015. Available at: http://wayback.archive-it.org/7993/20170722150658/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm. Accessed November 6, 2017.

        View in Article

      8. Olympus Corporation. Urgent safety notification important updated labeling information: new reprocessing instructions for the Olympus TJF-Q180V duodenoscope. March 26, 2015. Available at: http://medical.olympusamerica.com/sites/default/files/pdf/150326_TJF-Q180V_Customer_letter.pdf. Accessed November 6, 2017.

        View in Article

      9. 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. Available at: http://medical.olympusamerica.com/sites/us/files/pdf/160118-Olympus-TJF-Q180V-Customer-Letter.pdf. Accessed November 6, 2017.

        View in Article

      10. Olympus Corporation. Urgent safety notification important updated labeling information: new reprocessing instructions for the Olympus TJF-160F/VF duodenoscope. March 14, 2016. Available at: http://medical.olympusamerica.com/sites/us/files/pdf/Urgent-Safety-Notification-TJF-Q160F-VF-Duodenoscope.pdf. Accessed November 6, 2017.

        View in Article
        • Ross A.S.
        • Baliga C.
        • Verma P.
        • et al.
        A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli.
        Gastrointest Endosc. 2015; 82: 477-483
        View in Article
        • Centers for Disease Control and Prevention
        Interim protocol for healthcare facilities regarding surveillance for bacterial contamination of duodenoscopes after reprocessing.
        March 2015 (Available at: https://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html. Accessed November 6, 2017)
        View in Article
        • Tokar J.L.
        • Allen J.I.
        • Kochman M.L.
        Getting to zero: reducing the risk for duodenoscope-related infections.
        Ann Intern Med. 2015; 163: 873-874
        View in Article
        • Almario C.V.
        • May F.P.
        • Shaheen N.J.
        • et al.
        Cost utility of competing strategies to prevent endoscopic transmission of carbapenem-resistant enterobacteriaceae.
        Am J Gastroenterol. 2015; 110: 1666-1674
        View in Article

      Article info

      Publication history

      Published online: February 21, 2018
      Accepted: February 7, 2018
      Received: November 28, 2017

      Footnotes

      DISCLOSURE: All 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 Ross at [email protected]

      Identification

      DOI: https://doi.org/10.1016/j.gie.2018.02.015

      Copyright

      © 2018 by the American Society for Gastrointestinal Endoscopy

      ScienceDirect

      Access this article on ScienceDirect

      Linked Article

      • Reprint of: Comments on duodenoscope reprocessing study
        Gastrointestinal EndoscopyVol. 89Issue 4
        • Preview
          As experts retained by the duodenoscope manufacturer in litigation involving both the manufacturer and the medical center, we obtained access to the study data produced in the litigation. Although we applaud the authors’ communication of important information regarding the challenges of duodenoscope reprocessing, and their successful efforts to control contamination in their facility (including the implementation of a culture and quarantine protocol), we believe that the authors neglected to consider possible trends over time.
        • Full-Text
        • PDF
      • Comments on duodenoscope reprocessing study
        Gastrointestinal EndoscopyVol. 89Issue 2
        • Preview
          As experts retained by the duodenoscope manufacturer in litigation involving both the manufacturer and the medical center, we obtained access to the study data produced in the litigation. Although we applaud the authors’ communication of important information regarding the challenges of duodenoscope reprocessing, and their successful efforts to control contamination in their facility (including the implementation of a culture and quarantine protocol), we believe that the authors neglected to consider possible trends over time.
        • Full-Text
        • PDF
      • Duodenoscope-related and echoendoscope-related infections: Is “never” possible?
        Gastrointestinal EndoscopyVol. 88Issue 2
        • Preview
          In 1999, the term “never event” was introduced by the National Quality Forum (NQF) to refer to particularly egregious and entirely preventable errors such as wrong-site surgery.1 The NQF more recently transitioned toward using the slightly more flexible term “serious reportable events” to describe events that are “unambiguous, usually preventable, serious,” “indicative of a problem in a health care facility's safety systems,” and/or “important for public credibility or…accountability.”2 The widely reported duodenoscope-related outbreaks in the past several years, which have been associated with equipment from all 3 major endoscope manufacturers, meet the NQF criteria for “serious reportable events.”
        • Full-Text
        • PDF

      The content on this site is intended for healthcare professionals.


      We use cookies to help provide and enhance our service and tailor content. To update your cookie settings, please visit the Cookie Preference Center for this site.
      Copyright © 2023 Elsevier Inc. except certain content provided by third parties.


      RELX