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

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 single-use duodenoscope over a broad range of ERCP procedures, in terms of both indication and complexity.