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.

中文翻译：

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医疗器械总结性可用性测试中使用错误的可检测性：测试环境的影响

医疗器械总结性可用性评估的规定强调，测试环境必须具有足够的生态有效性，才能推广到现实生活中。在这里，我们研究了环境保真度（生态有效性的一个组成部分）对 MD 使用错误的可检测性的影响。共有 140 名参与者参与了过敏性休克自动注射器装置在高保真度条件或从制造商角度可接受的条件（低保真度条件）下的总结性可用性评估。通过应用描述性统计以及逻辑和泊松多元回归来比较每种条件下检测到的错误数量。我们发现保真度水平不会影响检测到的使用错误的总数，但会影响某些使用错误的检测。为了优化测试环境并增加对使用错误的检测，首先应检查每个环境特征在测试任务中的作用。