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.


      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.


      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.


      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.


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

      • Enhanced reprocessing of duodenoscopes: A glass half full or half empty?
        Gastrointestinal EndoscopyVol. 93Issue 4
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          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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