Title :

Detectability of use errors in summative usability tests of medical devices: Impact of the test environment.

Author(s) :

Marcilly, Romaric [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Schiro, Jessica [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Genin, Michaël [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Somers, Stéphanie [Auteur]
Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 [CIC Lille]
Migaud, Marie-Claire [Auteur]
Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 [CIC Lille]
Mabile, Frédéric [Auteur]
Crossject
Pelayo, Sylvia [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Del Zotto, Marzia [Auteur]
Hôpitaux universitaires de Genève = University Hospitals of Geneva [HUG]
Rochat, Jessica [Auteur]
Hôpitaux universitaires de Genève = University Hospitals of Geneva [HUG]

Journal title :

Applied Ergonomics

Abbreviated title :

Appl Ergon

Volume number :

118

Pages :

104266

Publisher :

Elsevier

Publication date :

2024-03-21

ISSN :

1872-9126

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

The regulations on summative usability evaluations of medical devices (MDs) emphasize that the test environment must have sufficient ecological validity for generalization to real-life use. Here, we examined the influence ...
Show more >The regulations on summative usability evaluations of medical devices (MDs) emphasize that the test environment must have sufficient ecological validity for generalization to real-life use. Here, we examined the influence of environmental fidelity (a component of ecological validity) on the detectability of MD use errors. A total of 140 participants participated in a summative usability evaluation of an anaphylactic shock auto-injector device under either a high-fidelity condition or a condition acceptable from the manufacturer's perspective, lower-fidelity condition. The numbers of errors detected in each condition were compared by applying descriptive statistics and logistic and Poisson multivariate regressions. We found that the level of fidelity did not influence the overall number of use errors detected but did influence the detection of certain use errors. To optimize the test environment and increase the detection of use errors, each environmental feature's role in the test task should first be examined.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2024-03-22T22:04:32Z
2024-05-22T06:36:37Z