Prospective evaluation of an assessment tool for technical performance of duodenoscopes

Abstract

Objective While single‐use and detachable‐tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. Methods An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6‐month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach’s coefficient alpha (α). The secondary outcome was validity of the assessment tool. Results The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach’s coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. Conclusions The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

Risk assessment of corona virus: Implementing hierarchy of hazard control in workplaces

“…Nanoparticle treated air fi lters can also reduce the airborne virus concentration [36]. Nevertheless, disinfection procedures of equipments in hospitals and wards must be provided in high attention against patients in isolation precautions because of higher bacterial loads and a potential higher CFU load [37,38]. Since behavior change is diffi cult and requires sustained motivation and support, nevertheless most efforts to change behaviours have had limited success [39], training is crucial for employees' support for of any safety plan.…”

Comprehensive evaluation of endoscope performance involves balanced assessment, accurate feedback, and suggested improvements by endoscopists

“…In this issue of Digestive Endoscopy , Bang et al 6 . proposed a tool for assessing the performance of duodenoscopes and prospectively validated its usefulness.…”

“…First, Bang et al 6 . only assessed the usefulness of their assessment tool for evaluating the performance of duodenoscopes TJF‐180 (Olympus Co., Tokyo, Japan).…”

“…Third, Bang et al .’s 6 study excluded cases of failed cannulation. They stated that the exclusion of such cases is valid to accurately evaluate all parameters.…”

“…In Bang et al .’s study, treatment of bile duct stones accounted for 33.6% cases; stent placement in the bile duct, 46.3%, other biliary interventions, 12.9%; and pancreatic interventions, 7.2%. The performance of duodenoscopes alone cannot adequately explain the success or failure of therapeutic procedures 6 . The performance of duodenoscopes as well as the selection and performance of other therapeutic devices can affect procedural outcomes.…”