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

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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

      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)
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      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