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. 2024 Jul:118:104266.
doi: 10.1016/j.apergo.2024.104266. Epub 2024 Mar 12.

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

Romaric Marcilly  1 , Jessica Schiro  2 , Michael Genin  3 , Stéphanie Somers  4 , Maria-Claire Migaud  4 , Frederic Mabile  5 , Sylvia Pelayo  2 , Marzia Del Zotto  6 , Jessica Rochat  6
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Free article

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

Romaric Marcilly et al. Appl Ergon. 2024 Jul.
Free article

Abstract

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.

Keywords: Ecological validity; Medical device; Usability test.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Frédéric Mabille is the head of the human factors unit of the manufacturer of the auto-injection device under evaluation. He participated in the design of the test situation to get the manufacturer's point of view. He did not participate in the data analysis. The other authors have no competing financial interests or personal relationships that could have appeared to influence the work reported.

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