title: Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors.
abstract: 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.
authors.affiliation: EVALAB, Université Lille Nord de France; France.
authors.forename: Jessica
authors.initials: J
authors.lastname: Schiro
authors.affiliation: EVALAB, Université Lille Nord de France; France.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Pelayo
authors.affiliation: Hôpitaux Universitaires de Genève et Université de Genève, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Weinhold
authors.affiliation: Hôpitaux Universitaires de Genève et Université de Genève, Switzerland.
authors.forename: Marzia
authors.initials: M
authors.lastname: Del Zotto
authors.affiliation: EVALAB, Université Lille Nord de France; France.
authors.forename: Romaric
authors.initials: R
authors.lastname: Marcilly
mesh_terms: D016208:Databases, Factual; D004864:Equipment and Supplies / Q000009:adverse effects*; D019300:Medical Errors; D012308:Risk Management
keywords: CE marking; Human engineering; usability; use-errors; validation