Assessment of the Learning Curve for a Single-Use Disposable Duodenoscope

Area of Science:

• Gastroenterology
• Medical Devices
• Infectious Disease Control

Background:

• Concerns over multidrug-resistant organism transmission from reusable duodenoscopes.
• FDA recommendations favor innovative duodenoscope designs, including disposable models.
• Need to evaluate the learning curve for new disposable duodenoscopes.

Purpose of the Study:

• To characterize the learning curve for a specific single-use disposable duodenoscope (EXALT Model D).
• To assess procedural proficiency in terms of cannulation attempts and time.
• To compare safety outcomes with traditional reusable duodenoscopes.

Main Methods:

• Retrospective analysis of prospectively collected data from 31 patients undergoing ERCP.
• Single, experienced endoscopist used the EXALT Model D disposable duodenoscope.
• Cumulative sum (CUSUM) analysis evaluated learning curve for cannulation attempts and time.

Main Results:

• Proficiency, indicated by CUSUM curve inflection, was achieved at 10 cases for both cannulation attempts and time.
• Successful completion with the disposable duodenoscope occurred in 87% of cases.
• Adverse events (pancreatitis, bleeding) were consistent with reusable duodenoscope use; no perforations.

Conclusions:

• Approximately 10 ERCP procedures represent the learning curve threshold for experienced endoscopists using disposable duodenoscopes.
• Disposable duodenoscopes offer comparable safety and efficacy to reusable models.
• Findings support the clinical adoption of single-use duodenoscopes to mitigate infection risks.