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Gastroenterology · 3 h ago

Expired endoscopic devices retained sterility and function in multicentre laboratory study

A prospective study across 25 endoscopy units identified 1,448 expired devices costing an estimated €192,142. Selected devices largely retained sterility and laboratory functionality, but the findings do not support routine clinical use beyond labelled expiry dates.

An investigator-initiated prospective study published in Endoscopy assessed expired endoscopic consumables across 25 units in Europe, Canada, and the USA between December 2023 and May 2025. Investigators inventoried expired devices during one-week audits and surveyed storage practices. Randomly selected samples underwent microbiological and ex vivo functional testing, with matched comparisons against non-expired devices for physicomechanical evaluation.

Audits identified 1,448 expired devices, with a median of 42 per centre and an estimated total cost of €192,141.67. No microbial growth was detected among 273 devices tested for sterility (100%; 95% CI 98.6–100). Of 210 devices assessed for functionality, all but one overtube remained functional (99.5%; 95% CI 97.4–99.9). Physicomechanical testing of 57 devices found no clinically relevant differences from non-expired counterparts.

Only six centres (24%) reported written protocols to minimise expired accessory accumulation, and three (12%) used electronic tracking systems. The findings identify opportunities for inventory improvement and support further regulatory evaluation of shelf-life criteria. However, this was a bench and ex vivo study, not an assessment of patient safety or clinical outcomes. The authors explicitly caution against interpreting the results as support for routine use of expired devices. Details here are limited to the available abstract.

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Source

Endoscopy: Expired endoscopic devices remain sterile and functional: an international multicentre study challenging current shelf-life criteria ↗

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