1 Double High-Level Disinfection vs. Sterilization for Reprocessing of Duodenoscopes Used for ERCP: A Prospective Study

Abstract

INTRODUCTION: The potential for transmission of pathogenic organisms is a problem inherent to the current duodenoscope design. Recent outbreaks of multi-drug 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 US 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. METHODS: We prospectively evaluated two different modalities of duodenoscope reprocessing from 10/23/17 to 9/24/18. All operable duodenoscopes were segregated to be reprocessed by either DHLD (i.e., complete manual cleaning followed by automated reprocessing, repeated for two total cycles) or manual cleaning followed by liquid chemical sterilization. Duodenoscopes were randomly cultured post-reprocessing for surveillance based on an internal protocol. RESULTS: During the study time period, there were 878 post-reprocessing surveillance cultures (453 in the DHLD group and 425 in the sterilization group). Of all of the cultures, 17 were positive (1.9%). There was no significant difference of positive cultures when comparing the duodenoscopes undergoing DHLD (8 positive cultures, 1.8%) to duodenoscopes undergoing sterilization (9 positive cultures, 2.1%, P > 0.05). Both groups had two cultures that grew high-concern organisms. No multi-drug resistant organisms (MDRO), including carbapenem-resistant enterobacteriaceae (CRE), were detected. Organisms from positive cultures are presented in Table 1. CONCLUSION: DHLD and liquid chemical sterilization both resulted in a low rate of positive cultures, both for all organisms and for high-concern organisms, but neither process eliminated positive cultures from reprocessed duodenoscopes. A liquid chemical sterilization protocol did not improve the growth of organisms on surveillance cultures compared to DHLD.