Performance and applicability of a first generation single-use duodenoscope: a single-center cohort study

Diederik Persyn; Hannah Van Malenstein; Emma Vanderschueren; Annette Schuermans; Mira Dreesen; Wouter Meert; kristof Buysschaert; Schalk Van Der Merwe; Wim Laleman

Authors Diederik Persyn, Hannah Van Malenstein, Emma Vanderschueren, Annette Schuermans, Mira Dreesen, Wouter Meert, kristof Buysschaert, Schalk Van Der Merwe, Wim Laleman.

Abstract

Background Despite the standardization and optimization of disinfection protocols, duodenoscope-related infections (DRIs) remain an emerging threat for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Single-use duodenoscopes could represent a potential alternative avenue to circumvent the problem of reprocessing and thus risk of exogenous patient-to-patient transmission. The aim of our study was to test the feasibility and technical success rate of a recently made available single-use duodenoscope.

Methods We carried out a thorough and standardized evaluation of the usability, performance and safety of a recently developed single-use duodenoscope in 52 consecutive patients scheduled for ERCP in a single center. Outcomes included performance ratings of the single-use duodenoscopes, adverse events (assessed at 3 days and 1 week), and crossover rate to a reusable duodenoscope.

Results The ERCP completion rate with a single-use duodenoscope was 90.4%, rising to 94.2% after crossover to reusable duodenoscope. The mean American Society for Gastrointestinal Endoscopy (ASGE) grade was 2.7, with 27 procedures (51.9%) considered as advanced level complexity (ASGE grade 3 & 4). Performance rating found that 94% of the therapeutic treatments were comparable to those using a traditional reusable duodenoscope. Overall satisfaction amounted to 80%. No major adverse events were attributable to the single-use endoscope.

Conclusions Single-use duodenoscopes can provide an alternative to avoid the intensive and often inconsistent results of cleaning and disinfection procedures. We confirmed the feasibility, adequate performance characteristics and safety of a recently developed first-generation singleuse duodenoscope over a broad range of ERCP procedures, in terms of both indication and complexity.

Keywords Single-use duodenoscope, ERCP, duodenoscope-related infection, performance

Ann Gastroenterol 2022; 35 (4): 368-375