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Diagnostic and Clinical Performance of Single-Use Versus Reusable Gastrointestinal Endoscopes: A Systematic Review
Natalie Tyldesley-Marshall1, Yen-Fu Chen1,2, Jefferson Buendia3
1Centre for Evidence and Implementation Science, University of Birmingham, Birmingham, UK.
Background:
Endoscopic procedures are fundamental in the diagnosis and management of gastrointestinal disorders. However, concerns over pathogen transmission have driven the development of single-use and partially single-use endoscopes (reusable endoscopes with disposable components). A comprehensive synthesis of comparative evidence is essential to inform decisions regarding clinical adoption.
Methods:
We systematically searched MEDLINE, EMBASE, Web of Science, Cochrane Library, and trial registries for randomized controlled trials, non-randomized comparative studies, diagnostic accuracy studies, and case series. Outcomes assessed included technical performance, diagnostic accuracy, infection risk, and adverse events. We also included systematic reviews estimating infection risk associated with exogenous pathogens for reusable gastrointestinal endoscopes. Summary data were pooled using a random-effects model where appropriate, and other findings synthesized narratively. The protocol was registered prospectively on PROSPERO (CRD42024496913).
Results:
Of 6979 records screened, 50 studies (965 960 patients) were included. Our meta-analyses demonstrated that in endoscopic retrograde cholangiopancreatography (ERCP), crossover from single-use (EXALT Model D) to reusable duodenoscopes occurred in 7% of cases (95% CI 6-9). Across endoscope types, single-use and partially single-use devices demonstrated similar or slightly reduced technical performance and diagnostic accuracy compared with reusable counterparts. Estimated infection risks from contaminated reusable endoscopes ranged from 0.01% to 0.8%, although these figures are limited by high risk of detection and reporting bias.
Conclusions:
The current evidence does not support wholesale replacement of reusable gastrointestinal endoscopes with single-use or partially single-use models. More robust and standardized data are needed to quantify infection risks from reusable endoscopes and inform evidence-based policy and procurement decisions.
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