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

      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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      References

        • Centers for Disease Control and Prevention
        Notes from the field: New Delhi metallo-beta-lactamase-producing Escherichia coli associated with endoscopic retrograde cholangiopancreatography—Illinois, 2013.
        MMWR Morb Mortal Wkly Rep. 2014; 62: 1051
        • 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
        • 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
      1. U.S. Food and Drug Administration. The FDA is recommending transition to duodenoscopes with innovative designs to enhance safety: FDA safety communication. Available at: https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication#:~:text=The%20FDA%20is%20Recommending%20Transition%20to%20Duodenoscopes%20with,in%20the%20assessment%20and%20treatment%20of%20diseases%20. Accessed October 4, 2020.

        • Becq A.
        • Snyder G.M.
        • Heroux R.
        • et al.
        Prospective assessment of the effectiveness of standard high-level disinfection for echoendoscopes.
        Gastrointest Endosc. 2019; 89: 984-989
        • Kim S.
        • Russell D.
        • Mohamadnejad M.
        • et al.
        Risk factors associated with the transmission of carbapenem-resistant enterobacteriaceae via contaminated duodenoscopes.
        Gastrointest Endosc. 2016; 83: 1121-1129
        • Snyder G.M.
        • Wright S.B.
        • Smithey A.
        • et al.
        Randomized comparison of 3 high-level disinfection and sterilization procedures for duodenoscopes.
        Gastroenterology. 2017; 153: 1018-1025
        • Bartles R.L.
        • Leggett J.E.
        • Hove S.
        • et al.
        A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing.
        Gastrointest Endosc. 2018; 88: 306-313
        • Rex D.K.
        • Sieber M.
        • Lehman G.A.
        • et al.
        A double-reprocessing high-level disinfection protocol does not eliminate positive cultures from the elevators of duodenoscopes.
        Endoscopy. 2018; 50: 588-596
        • Rauwers A.W.
        • Troelstra A.
        • Fluit A.C.
        • et al.
        Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae.
        Gastrointest Endosc. 2019; 90: 793-804
      2. U.S. Food and Drug Administration. Supplemental measures to enhance duodenoscope reprocessing: FDA safety communication. Available at: https://www.fdanews.com/ext/resources/files/08-15/081015-duodenoscopes-fda.pdf?1520541508. Accessed December 18, 2019.

        • Department of Health and Human Services Collaboration
        Duodenoscope surveillance sampling and culturing: reducing the risks of infection.
        (Available at:)
        https://www.fda.gov/media/111081/download
        Date accessed: December 18, 2019
        • Muthusamy V.R.
        • Bruno M.J.
        • Kozarek R.A.
        • et al.
        Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography.
        Clin Gastroenterol Hepatol. 2020; 18: 2108-2117.e3
        • Ross A.S.
        • Bruno M.J.
        • Kozarek R.A.
        • et al.
        Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison.
        Gastrointest Endosc. 2020; 91: 396-403

      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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