Diagnostic and Clinical Performance of Single-Use Versus Reusable Gastrointestinal Endoscopes: A Systematic Review...

Area of Science:

• Gastroenterology
• Medical Device Technology
• Infectious Disease Control

Background:

• Endoscopic procedures are vital for diagnosing and managing gastrointestinal disorders.
• Concerns about pathogen transmission have led to the development of single-use and partially single-use endoscopes.
• Evidence synthesis is crucial for guiding the adoption of new endoscope technologies.

Purpose of the Study:

• To systematically review and synthesize comparative evidence on single-use and partially single-use endoscopes versus traditional reusable endoscopes.
• To assess technical performance, diagnostic accuracy, and infection risks associated with different endoscope types.
• To inform clinical adoption and procurement decisions for gastrointestinal endoscopes.

Main Methods:

• Systematic literature search across multiple databases (MEDLINE, EMBASE, Web of Science, Cochrane Library) and trial registries.
• Inclusion of randomized controlled trials, non-randomized comparative studies, diagnostic accuracy studies, and case series.
• Meta-analysis for pooled data and narrative synthesis for other findings, focusing on technical performance, diagnostic accuracy, and infection risk.

Main Results:

• 50 studies involving 965,960 patients were included.
• In endoscopic retrograde cholangiopancreatography (ERCP), crossover from single-use to reusable duodenoscopes occurred in 7% of cases.
• Single-use and partially single-use endoscopes demonstrated similar or slightly reduced technical performance and diagnostic accuracy compared to reusable models, with estimated infection risks from reusable endoscopes ranging from 0.01% to 0.8%.

Conclusions:

• Current evidence does not support the wholesale replacement of reusable gastrointestinal endoscopes with single-use or partially single-use alternatives.
• Further high-quality, standardized data are required to accurately quantify infection risks associated with reusable endoscopes.
• Evidence-based policy and procurement decisions necessitate more robust data on endoscope safety and efficacy.