Usability validation of medical devices: ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
Usability validation of medical devices: issues in identifying potential use errors
Author(s) :
Schiro, Jessica [Auteur]
Pelayo, Sylvie [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Weinhold, Thomas [Auteur]
Del Zotto, Marzia [Auteur]
Marcilly, Romaric [Auteur]

Pelayo, Sylvie [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Weinhold, Thomas [Auteur]
Del Zotto, Marzia [Auteur]
Marcilly, Romaric [Auteur]

Journal title :
Studies in health technology and informatics
Abbreviated title :
Stud Health Technol Inform
Volume number :
234
Pages :
298-302
Publication date :
2017-01-01
ISSN :
0926-9630
English keyword(s) :
validation
use-errors
CE marking
usability
Human engineering
use-errors
CE marking
usability
Human engineering
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
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 ...
Show more >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.Show less >
Show more >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.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
Université de Lille
Université de Lille
Submission date :
2019-12-09T18:18:01Z