Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors
| Autor: | Jessica, Schiro, Sylvia, Pelayo, Thomas, Weinhold, Marzia, Del Zotto, Romaric, Marcilly |
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| Přispěvatelé: | Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Lille |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: | |
| Zdroj: | Studies in Health Technology and Informatics, Vol. 234 (2017) pp. 298-302 Studies in Health Technology and Informatics Studies in Health Technology and Informatics, 2017, ⟨10.3233/978-1-61499-742-9-298⟩ |
| ISSN: | 0926-9630 1879-8365 |
| DOI: | 10.3233/978-1-61499-742-9-298⟩ |
| Popis: | International audience; In order to prevent use errors with their medical devices, manufacturers have to integrate a safety-oriented usability engineering process in their product development lifecycle. A critical step of this process is the identification of potential use-errors. Standards and guidelines recommend to triangulate several sources of information e.g. scientific literature, incident reports, manufacturer's files and user's feedbacks. This paper presents lessons learned from applying these recommendations during an international project. We identify issues with (i) searching literature and databases, and (ii) interpreting collected data. Nevertheless triangulation of information sources allows to identify different types of use errors therefore providing valuable lists of potential use errors. Issuing recommendations aim at making easier this critical task. |
| Databáze: | OpenAIRE |
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