title: Perceived usefulness of a usability issues reporting form to help understand "usability-induced use-errors": a preliminary study.
abstract: The Medical Device regulation requires manufacturers to anticipate and prevent risks of use errors of their medical device. However, manufacturers experience difficulties to understand the concept of "usability-induced use-errors". Based on a "usability framework" aiming at describing the relationship between usability design principles, usability flaws, usage problems, and outcomes, a usability evaluation reporting form had been designed to support understanding the use-error concept. This paper reports the preliminary evaluation of the perceived usefulness of this form. Results show that manufacturers found helpful the presentation of the results of a usability evaluation through this form for it supports the understanding of the usability origins and the consequences of use-errors. Even if the use of this reporting form should be made easier as usability experts experience difficulties to fill it, it seems a promising way to clearly present "usability-induced use-errors" to manufacturers.
authors.affiliation: INSERM CIC-IT, Lille ; Univ Lille Nord de France ; CHU Lille ; UDSL EA 2694 ; F-59000 Lille, France.
authors.forename: Romaric
authors.initials: R
authors.lastname: Marcilly
authors.affiliation: INSERM CIC-IT, Lille ; Univ Lille Nord de France ; CHU Lille ; UDSL EA 2694 ; F-59000 Lille, France.
authors.forename: Cesar
authors.initials: C
authors.lastname: Boog
authors.affiliation: INSERM CIC-IT, Lille ; Univ Lille Nord de France ; CHU Lille ; UDSL EA 2694 ; F-59000 Lille, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Leroy
authors.affiliation: INSERM CIC-IT, Lille ; Univ Lille Nord de France ; CHU Lille ; UDSL EA 2694 ; F-59000 Lille, France.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Pelayo
mesh_terms: D004562:Electrocardiography / Q000295:instrumentation*; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods*; D004869:Equipment Safety / Q000379:methods*; D006804:Ergonomics / Q000379:methods; D008328:Man-Machine Systems; D062527:Meaningful Use; D019300:Medical Errors / Q000517:prevention & control*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D013673:Technology Assessment, Biomedical / Q000379:methods*