How to evaluate a flexible ureterorenoscope? Systematic mapping of existing evaluation methods

Area of Science:

• Urology
• Medical Device Engineering
• Quality Assessment

Background:

• Flexible ureterorenoscopes are crucial in urological procedures.
• Evaluating their quality is essential for optimal patient outcomes and device selection.
• Existing quality assessment methods lack standardization.

Purpose of the Study:

• To identify and map parameters used for evaluating flexible ureterorenoscope quality.
• To review scope-related and user-related parameters.
• To identify key assessment items and variability in grading systems.

Main Methods:

• Systematic scoping review adhering to PRISMA guidelines.
• Literature search across four major databases (MEDLINE, EMBASE, Web of Science, Google Scholar, Cochrane Library).
• Screening of 2386 articles, with 48 included in the final review.

Main Results:

• Five key quality parameters identified: Manoeuvrability (87.5%), Optics (64.6%), Irrigation (56.3%), Handling (39.6%), and Durability (35.4%).
• Each key parameter can be further divided into specific subcategories.
• Significant variation observed in the denomination, measurement methods, circumstances, tools, number of measurements, observers, and outcome units.

Conclusions:

• The field of ureterorenoscope quality assessment is heterogeneous.
• A standardized, uniform grading tool is necessary for consistent and comparable quality assessment of flexible ureterorenoscopes.
• This will facilitate better device selection and improve clinical practice.