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

Abstract

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. Microbiological culturing of duodenoscopes and reprocessing with repeat high-level disinfection or liquid chemical sterilization have been offered as supplemental measures to enhance duodenoscope reprocessing by the U.S. Food and Drug Administration (FDA). This study aims to compare the efficacy of reprocessing duodenoscopes with double high-level disinfection (DHLD) versus liquid chemical sterilization (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 time period, there were 878 postreprocessing surveillance cultures (453 in the DHLD group and 425 in the LCS group). Of all of the 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%) to duodenoscopes undergoing LCS (9 positive cultures, 2.1%, p=0.8). Both groups had 2 cultures that grew high-concern organisms (0.5% vs. 0.5%, p=1.0). No multi-drug resistant organisms (MDRO), including carbapenem-resistant enterobacteriaceae (CRE), were detected. Conclusions DHLD and LCS both resulted in a low rate of positive cultures, both for all organisms and for high-concern organisms, but neither process completely eliminated positive cultures from duodenoscopes reprocessed with 2 different supplemental reprocessing strategies.