Scientific article
OA Policy
English

Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors

Published inStudies in Health Technology and Informatics, vol. 234, p. 298-302
Publication date2017
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.

Keywords
  • Human engineering
  • Usability
  • CE marking
  • Use-errors
  • Validation
Funding
  • Swiss National Science Foundation - 164279
Citation (ISO format)
SCHIRO, Jessica et al. Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors. In: Studies in Health Technology and Informatics, 2017, vol. 234, p. 298–302.
Main files (1)
Article (Published version)
Identifiers
Journal ISSN0926-9630
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610downloads

Technical informations

Creation29/11/2017 15:11:00
First validation29/11/2017 15:11:00
Update15/03/2023 02:31:05
Status update15/03/2023 02:31:04
Last indexation31/10/2024 08:54:01
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