ABSTRACT

Objective

The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment.

Research design and methods

Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session.

Results

Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective.

Conclusions

The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.

中文翻译：

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用于注射重组人生长激素的笔设备：欧洲可用性工程研究。

摘要

目的

对Aluetta™可重复使用笔设备和生长激素（r-hGH；Saizen®，Merck KGaA，德国达姆施塔特，德国）给药的使用说明书进行了人为因素可用性测试，以确保可以安全有效地使用它。预期使用环境中的预期用户。

研究设计与方法

在三组参与者的模拟条件下进行了可用性测试：患生长激素缺乏症（GHD）的儿科或成年患者，没有GHD的参与者和医疗保健专业人员（HCP）。测试包括45分钟的培训课程，2小时的测试课程和参与者反馈课程。

结果

26名参与者完成了培训课程，并在三种情况下执行了与笔使用有关的所有关键任务。最困难的任务与设备的准备，检查和维护有关。在注射过程相关的任务中，只有8％的使用错误发生。85％的人认为无需进一步修改即可安全，有效地使用笔，并且培训是清晰有效的。

结论

在整个开发过程中，笔设备和相关材料都受益于人为因素工程学。这些评估表明，患者和HCP可以安全有效地使用笔设备，并且IFU和培训清晰有效。