ABSTRACT

Background

Use-related risks related to autoinjector devices have been previously identified. To minimize these problems, the identification of potential use errors is a critical task during device development.

Methods

This article presents iterative human factor studies, which aim to assess user interaction with the tested push-on-skin BD Intevia™ 1 mL Disposable Autoinjector, across a wide range of indications, and a broad user population.

Results

Through the different human factor studies, use errors were recorded when the participants completed the critical tasks, but their occurrence continuously decreased. First, the incidence of use errors was reduced when the participants read the IFU. In addition, the IFU updates and design change implemented contributed to improve the usability performance. During the validation study, some use errors were still observed, mainly during the first uses. Nevertheless, providing a training to the participants almost fully eliminated the remaining use errors.

Conclusion

Thus, these results demonstrated that this new autoinjector can be safely and efficiently used for its intended uses and under the expected use conditions by all tested user groups.

中文翻译：

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用于皮下注射慢性疾病治疗的新型一次性自动注射器的形成和验证人为因素研究

摘要

背景

与自动注射器设备相关的使用相关风险先前已被确定。为了尽量减少这些问题，识别潜在的使用错误是设备开发过程中的一项关键任务。

方法

本文介绍了迭代人为因素研究，旨在评估用户与经过测试的推入式皮肤 BD Intevia™ 1 mL 一次性自动注射器的交互作用，涵盖广泛的适应症和广泛的用户群体。

结果

通过不同的人为因素研究，在参与者完成关键任务时记录了使用错误，但其发生率不断下降。首先，当参与者阅读 IFU 时，使用错误的发生率降低了。此外，IFU 更新和实施的设计更改有助于提高可用性性能。在验证研究期间，仍然观察到一些使用错误，主要是在第一次使用期间。尽管如此，为参与者提供培训几乎完全消除了剩余的使用错误。

结论

因此，这些结果表明，所有测试用户组都可以安全有效地将这种新型自动注射器用于其预期用途和预期使用条件。