Efficacy of duodenoscope with disposable distal cap in reducing microbial contamination: A systematic review and meta-analysis.

BACKGROUND

Persistent microbial contamination of duodenoscopes remains a critical vector for healthcare-associated infections involving multidrug-resistant organisms. Despite adherence to standard high-level disinfection (HLD) protocols, contamination rates remain alarming. To mitigate this risk, the United States Food and Drug Administration has recommended transitioning to duodenoscopes with disposable components.

AIM: To investigate the efficacy of disposable distal cap compared to standard duodenoscope reprocessing with HLD in reducing microbial contamination.

METHODS

Following Preferred Reporting Items for Systematic Reviews and Meta-analysis and Cochrane guidelines, we conducted a systematic search of MEDLINE, EMBASE, Google Scholar, and grey literature for randomized controlled trials comparing disposable distal cap vs standard duodenoscopes. The primary outcome was the rate of microbial contamination, defined as an adenosine triphosphate level > 40 relative light unit. Risk ratio was pooled using a random-effects model, and the quality of evidence was assessed using the Grading Recommendations Assessment, Development, and Evaluation methodology.

RESULTS

Four randomized controlled trials met the inclusion criteria, encompassing 1092 duodenoscopes (543 disposable distal cap, 549 standard). The use of disposable cap demonstrated a significant and substantial reduction in post-HLD contamination rates. The pooled analysis showed a risk ratio of 0.32 (95% confidence interval: 0.16-0.67; P = 0.003), representing a 68% reduction in contamination risk. No statistical heterogeneity was detected (I 2 = 0%). The overall quality of evidence for this outcome was rated as high.

CONCLUSION

Disposable distal cap significantly decreases microbial contamination rates compared to standard duodenoscope reprocessing protocols. This technology represents a robust and effective strategy to enhance the safety of duodenoscope reprocessing.