Univ. Lille, CHU Lille, ULR 2694, METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, F-59000, Lille, France; Inserm, CIC-IT 1403, F-59000, Lille, France.
Univ. Lille, CHU Lille, ULR 2694, METRICS: Évaluation des Technologies de Santé et des Pratiques Médicales, F-59000, Lille, France; Inserm, CIC-IT 1403, F-59000, Lille, France.
Appl Ergon. 2024 Jul;118:104266. doi: 10.1016/j.apergo.2024.104266. Epub 2024 Mar 12.
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.
医疗器械总结性可用性评估法规强调，测试环境必须具有足够的生态有效性，以推广到实际使用中。在这里，我们研究了环境逼真度（生态有效性的一个组成部分）对医疗器械使用错误可检测性的影响。共有 140 名参与者在高逼真度条件或制造商可接受的条件（低逼真度条件）下参加了过敏性休克自动注射器设备的总结性可用性评估。通过应用描述性统计、逻辑和泊松多变量回归比较了每种条件下检测到的错误数量。我们发现，逼真度水平并不影响检测到的总错误数量，但会影响某些错误的检测。为了优化测试环境并增加使用错误的检测，首先应该检查测试任务中每个环境特征的作用。
