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

Area of Science:

• Gastroenterology
• Infectious Diseases
• Medical Device Technology

Background:

• Duodenoscope-related infections (DRIs) pose a significant risk during endoscopic retrograde cholangiopancreatography (ERCP) despite disinfection protocols.
• Reusable duodenoscopes require complex reprocessing, which can lead to inconsistent disinfection and patient-to-patient transmission.
• Single-use duodenoscopes offer a potential solution to mitigate DRIs by eliminating reprocessing needs.

Purpose of the Study:

• To evaluate the feasibility and technical success rate of a novel single-use duodenoscope.
• To assess the usability, performance, and safety of the single-use duodenoscope in ERCP procedures.
• To compare the performance of single-use duodenoscopes with traditional reusable duodenoscopes.

Main Methods:

• A prospective evaluation of a new single-use duodenoscope was conducted in 52 consecutive patients undergoing ERCP.
• Usability, performance metrics, and safety outcomes, including adverse events, were systematically assessed.
• The rate of crossover to a reusable duodenoscope was recorded.

Main Results:

• The ERCP completion rate was 90.4% with the single-use duodenoscope, increasing to 94.2% after crossover.
• Procedures included advanced complexity cases (ASGE grade 3 & 4), with 94% of therapeutic treatments comparable to reusable scopes.
• No major adverse events were linked to the single-use endoscope, and overall satisfaction was 80%.

Conclusions:

• Single-use duodenoscopes are a feasible and safe alternative for ERCP, addressing concerns with reprocessing reusable scopes.
• The evaluated first-generation single-use duodenoscope demonstrated adequate performance across various ERCP indications and complexities.
• This technology has the potential to significantly reduce the risk of duodenoscope-related infections.