TOPLINE

Single-use and partially single-use gastrointestinal (GI) endoscopes offer a sterile alternative meant to reduce the risk of cross-contamination, but a new meta-analysis found they performed similarly to, or slightly worse than, reusable endoscopes across endoscope types in technical performance and diagnostic accuracy.

METHODOLOGY

• Endoscopic procedures are fundamental to the diagnosis and management of GI disorders, but concerns over transmission of pathogens owing to the use of contaminated reusable endoscopes have driven the development of single-use and partially single-use alternatives.
• Researchers conducted a systematic review and meta-analysis of English-language studies identified by searching multiple databases and trial registries through September 2024 to compare single-use and partially single-use GI endoscopes with reusable endoscopes and assess technical performance, diagnostic accuracy, infection risk, and adverse events (AEs).
• A total of 50 studies were included, comprising randomized controlled trials (RCTs), diagnostic test accuracy studies, nonrandomized comparative studies, and case series; 31 studies were published as full-text articles and 19 were available as conference abstracts.
• Eligible studies recruited either patients who underwent diagnostic or interventional procedures of the GI tract and their family or caregivers, or healthcare professionals involved in endoscope preparation, use, reprocessing, cleaning, and disposal.
• Studies were grouped by broad endoscope type, including duodenoscopes, other upper GI endoscopes, and lower GI endoscopes, and then by the specific device used.

TAKEAWAY

• A pooled analysis of eight studies found that crossover from the single-use EXALT Model D duodenoscope to a reusable duodenoscope was required in 7% of cases (95% CI, 6%-9%), and the pooled rate of successful endoscopic retrograde cholangiopancreatography (ERCP) following crossover was 69%. Overall, single-use duodenoscopes performed about as well as, or slightly worse than, reusable ones.
• Among 16 studies evaluating other upper GI endoscopes, successful intubation or procedure completion rates for single-use or sheathed multiuse endoscopes ranged from 85% to 100%, with image quality rated similar to or slightly below standard reusable scopes. Seven studies found that the sensitivity and specificity of single-use and sheathed multiuse endoscopes were similar to, or lower than, those of reusable endoscopes, and they may be suitable for esophageal screening or triage applications but less reliable for detecting other GI conditions.
• In 2 RCTs evaluating single-use endoscopes for the lower GI tract, procedure success rates, therapeutic outcomes, adenoma detection, and AEs were similar to those associated with reusable endoscopes; however, the image quality and detection of diminutive polyps were lower and endoscopic mucosal resection took significantly longer with single-use endoscopes (466 vs 206 seconds; P < .001).
• One nonrandomized comparative study reported lower odds of hospitalization for infection within 7 days of ERCP with single-use duodenoscopes than with reusable duodenoscopes (odds ratio, 0.32; 95% CI, 0.17-0.60), but a subsequent analysis by the same research group found no significant difference in post-ERCP infection between device types. Two systematic reviews estimated the risk for post-ERCP infections associated with contaminated reusable duodenoscopes at 0.01% and 0.8%, respectively, though these figures are limited by a high risk of detection and reporting bias.

IN PRACTICE

"Our findings suggest that SU [single-use] and partially SU GI endoscopes had similar or slightly worse technical performance and diagnostic accuracy compared with their MU [multiuse] counterparts. Blanket replacement of MU GI endoscopes by their SU or partially SU counterparts is therefore not recommended with the exception of duodenoscopes and in situations where patients are at high risk of acquiring or transmitting infection," the authors of the study wrote.

SOURCE

The study was led by Natalie Tyldesley-Marshall, University of Birmingham, Birmingham, England. It was published online in the Journal of Gastroenterology and Hepatology.

LIMITATIONS

The review included only English-language studies. Publication and reporting bias could not be assessed because too few studies were available, and some evidence was obtained from preliminary conference abstracts. The review did not include new technologies such as capsule endoscopes, which are also single-use devices.

DISCLOSURES

The study was supported by the National Institute for Health and Care Research and Social Care Delivery Research Programme, with payments made to the University Hospitals Coventry and Warwickshire, University of Warwick, and University of Birmingham. One of the authors was partly supported by a grant from the Health Research Board (Ireland) and the HSC Public Health Agency through Evidence Synthesis Ireland, and a related grant was paid to the University of Warwick to support that author's attachment to the project as an Evidence Synthesis Ireland Fellow. Several authors disclosed receiving payments or honoraria for lectures, presentations, speakers bureau, manuscript writing, or educational events; funding for PhD studentship; educational grants; consulting fees; holding grants; and financial support to attend conferences and meetings from multiple companies. One author disclosed receiving financial support through an advanced fellowship from the study funding source.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.