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

Background and study aims Expired medical devices represent an environmental and economic concern, yet their magnitude and true shelf life remain poorly defined. We aimed to quantify the volume and cost of expired endoscopic devices and evaluate their sterility and functionality beyond the labelled expiry date. Methods We conducted an investigator-initiated, prospective study (December 2023-May 2025) across 25 endoscopy units from Europe, Canada, and the USA. Expired devices were inventoried during one-week audits. An institutional questionnaire assessed storage practices. Microbiological sterility and ex vivo functionality were assessed in randomly selected samples. Physicomechanical testing included matched case–control comparison with non-expired counterparts. Results We identified 1,448 expired devices (median per centre, 42; range 3-262), with an estimated cost of €192,141.67. Of these, 273 underwent microbiological testing, 210 ex vivo functional assessment, and 57 physicomechanical evaluation. No microorganism growth was detected in any evaluated device (100%, 95% CI 98.6-100). All but one overtube retained functionality (99.5%; 95% CI 97.4-99.9). Physicomechanical testing showed no clinically relevant differences compared with non-expired devices. Only six centres (24%) reported written protocols to minimise accumulation of expired accessories, and three (12%) had electronic tracking systems. Conclusions Expired endoscopic consumables are frequent and costly, with suboptimal inventory management within endoscopy units. In this multicentre bench and ex vivo study, analysed devices preserved sterility and functional performance beyond their labelled expiry dates. These findings challenge current shelf-life assumptions and support further regulatory evaluation, but should not be interpreted as evidence supporting routine clinical use of expired devices.

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Journal
Endoscopy
Published
2026-10-09
DOI
https://doi.org/10.1055/a-2977-6099
Primary Topic
Medical Device Sterilization and Disinfection
Type
article
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article

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

Mathieu Pioche, Christoph Römmele, Francesc Bas‐Cutrina, Κonstantinos Τriantafyllou et al.
Endoscopy
Medical Device Sterilization and Disinfection
article

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

Mathieu Pioche, Christoph Römmele, Francesc Bas‐Cutrina, Κonstantinos Τriantafyllou, Guillermo Vilariño‐Feltrer, Glòria Fernández‐Esparrach, Mário Jorge Dinis-Ribeiro, Federico Soria, Luca Elli, Mikel Fiallegas Cano, Javier Tejedor‐Tejada, Matilde Topa, Kareem Khalaf, Arnaud Lemmers, Isabel Tort-Ausina, Miguel Pantaleón Sánchez, Andrei Mihai Voiosu, Ana García García de Paredes, Vicente Lorenzo‐Zúñiga, Vicente Pons, Enrique Vázquez-Sequeiros, João A. Cunha Neves, Alberto J. Campillo-Fernández, Patricia Pedregal, Eduardo Valdivielso Cortázar, Dorothea Henniger, Marina García-Castellanos, Enrique Rodríguez de Santiago, Fausto Riu Pons, Neil Robert O’Morain, Pedro José Rosón, Anastasia Tsalouka, Sílvia Ferraz, Alexander Meining, D Villaescusa Arenas, Rosa Sáiz-Chumillas, Heiko Pohl, Marianna Arvanitakis, Douglas Graham Penman, Elia Gómez G de la Pedrosa, Oliva Ros-Fargas
article en

Abstract

Background and study aims Expired medical devices represent an environmental and economic concern, yet their magnitude and true shelf life remain poorly defined. We aimed to quantify the volume and cost of expired endoscopic devices and evaluate their sterility and functionality beyond the labelled expiry date. Methods We conducted an investigator-initiated, prospective study (December 2023-May 2025) across 25 endoscopy units from Europe, Canada, and the USA. Expired devices were inventoried during one-week audits. An institutional questionnaire assessed storage practices. Microbiological sterility and ex vivo functionality were assessed in randomly selected samples. Physicomechanical testing included matched case–control comparison with non-expired counterparts. Results We identified 1,448 expired devices (median per centre, 42; range 3-262), with an estimated cost of €192,141.67. Of these, 273 underwent microbiological testing, 210 ex vivo functional assessment, and 57 physicomechanical evaluation. No microorganism growth was detected in any evaluated device (100%, 95% CI 98.6-100). All but one overtube retained functionality (99.5%; 95% CI 97.4-99.9). Physicomechanical testing showed no clinically relevant differences compared with non-expired devices. Only six centres (24%) reported written protocols to minimise accumulation of expired accessories, and three (12%) had electronic tracking systems. Conclusions Expired endoscopic consumables are frequent and costly, with suboptimal inventory management within endoscopy units. In this multicentre bench and ex vivo study, analysed devices preserved sterility and functional performance beyond their labelled expiry dates. These findings challenge current shelf-life assumptions and support further regulatory evaluation, but should not be interpreted as evidence supporting routine clinical use of expired devices.

Endoscopy
Dartmouth–Hitchcock Medical Center (US), St. Michael's Hospital (CA), Université Libre de Bruxelles (BE), Carol Davila University of Medicine and Pharmacy (RO), University of Milan (IT), Universidad de Alcalá (ES), Instituto de Salud Carlos III (ES), Hospital de Sant Pau (ES), University Hospital Augsburg (DE), Erasmus Hospital (BE), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Valencia Catholic University Saint Vincent Martyr (ES), Hospital Universitari i Politècnic La Fe (ES), Universitat Internacional de Catalunya (ES), Hospital Regional Universitario de Málaga (ES), Administração Regional de Saúde de Lisboa e Vale do Tejo (PT), Hospital General de Granollers (ES), Hospital General de Almansa (ES), St. Vincent's University Hospital (IE), Hospital de Galdakao (ES), Algarve Biomedical Center (PT), Hôpital Edouard Herriot (FR), Universitätsklinikum Würzburg (DE), Instituto Ramón y Cajal de Investigación Sanitaria (ES), Hospital Del Mar (ES), Comunidad de Madrid (ES), University General Hospital Attikon (GR), Complexo Hospitalario Universitario A Coruña (ES), Hospital Universitario De Cabueñes (ES), Hospital Ruber Internacional (ES), Spitalul Clinic Colentina (RO), Hospital del Mar Research Institute (ES), Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES), Hospital Universitario Ramón y Cajal (ES), Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (ES), Liverpool University Hospitals NHS Foundation Trust (GB), Universitat Politècnica de València (ES), Universitat de Barcelona (ES)
Openalex Percentile: Top 15%
Medical Device Sterilization and Disinfection
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