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Original article Clinical endoscopy| Volume 93, ISSUE 4, P927-931, April 01, 2021

Double high-level disinfection versus liquid chemical sterilization for reprocessing of duodenoscopes used for ERCP: a prospective randomized study

Published:July 30, 2020DOI:https://doi.org/10.1016/j.gie.2020.07.057
Double high-level disinfection versus liquid chemical sterilization for reprocessing of duodenoscopes used for ERCP: a prospective randomized study
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      Background and Aims

      The potential for transmission of pathogenic organisms is a problem inherent to the current reusable duodenoscope design. Recent outbreaks of multidrug-resistant pathogenic organisms transmitted via duodenoscopes has brought to light the urgency of this problem. Microbiologic culturing of duodenoscopes and reprocessing with repeat high-level disinfection (HLD) or liquid chemical sterilization (LCS) have been offered as supplemental measures to enhance duodenoscope reprocessing by the U.S. Food and Drug Administration. This study aims to compare the efficacy of reprocessing duodenoscopes with double HLD (DHLD) versus LCS.

      Methods

      We prospectively evaluated 2 different modalities of duodenoscope reprocessing from October 23, 2017 to September 24, 2018. Eligible duodenoscopes were randomly segregated to be reprocessed by either DHLD or LCS. Duodenoscopes were randomly cultured after reprocessing for surveillance based on an internal protocol.

      Results

      During the study period, there were 878 post-reprocessing surveillance cultures (453 in the DHLD group and 425 in the LCS group). Of all cultures, 17 were positive for any organism (1.9%). There was no significant difference of positive cultures when comparing the duodenoscopes undergoing DHLD (8 positive cultures, 1.8%) with duodenoscopes undergoing LCS (9 positive cultures, 2.1%; P = .8). Both groups had 2 cultures that grew high-concern organisms (.5% vs .5%, P=1.0). No multidrug-resistant organisms, including carbapenem-resistant enterobacteriaceae, were detected.

      Conclusions

      DHLD and LCS both resulted in a low rate of positive cultures, for all organisms and for high-concern organisms. However, neither process completely eliminated positive cultures from duodenoscopes reprocessed with 2 different supplemental reprocessing strategies.

      Abbreviations:

      DHLD (double high-level disinfection), FDA (U.S. Food and Drug Administration), HLD (high-level disinfection), LCS (liquid chemical sterilization)
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      Article Info

      Publication History

      Published online: July 30, 2020
      Accepted: July 26, 2020
      Received: May 11, 2020

      Footnotes

      DISCLOSURE: The following authors disclosed financial relationships: M. A. Gromski: Consultant for Boston Scientific. S. Sherman: Consultant for Olympus America, Boston Scientific, Ambu, Inc, and Cook Endoscopy. D. K. Rex: Consultant for Olympus Corporation, Boston Scientific, Medtronic, Aries Pharmaceutical, Braintree Laboratories, Lumendi Ltd, Norgine, Endokey, GI Supply, and Covidian/Medtronic; research support from EndoAid, Olympus Corporation, Medivators, and ERBE USA Inc; ownership interest in Satisfai Health. All other authors disclosed no financial relationships.

      If you would like to chat with an author of this article, you may contact Dr Gromski at [email protected] .

      Identification

      DOI: https://doi.org/10.1016/j.gie.2020.07.057

      Copyright

      © 2020 by the American Society for Gastrointestinal Endoscopy

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      Linked Article

      • Enhanced reprocessing of duodenoscopes: A glass half full or half empty?
        Gastrointestinal EndoscopyVol. 93Issue 4
        • Preview
          Reports of duodenoscope-transmitted infections date back to at least 1987, when Allen et al1 detailed an outbreak of Pseudomonas aeruginosa among 10 patients. Since this event, there have been many reports of duodenoscope-transmitted infections, often with multidrug-resistant organisms. To date, there have been at least 350 affected patients at 41 facilities since 2010.2 Initially, outbreaks were attributed to nonadherence with guidelines from the U.S. Food and Drug Administration (FDA) and from manufacturers for endoscope inspection, manual cleaning, high-level disinfection (HLD), or storage.
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