a Medical Devices and Services , Merck Serono S.A ., Coinisins , Switzerland (An affiliate of Merck KGaA, Darmstadt, Germany).
b Human Factors Engineering , Merck Serono S.A ., Coinisins , Switzerland (An affiliate of Merck KGaA, Darmstadt, Germany).
Expert Opin Drug Deliv. 2016 Sep;13(9):1221-9. doi: 10.1080/17425247.2016.1203899. Epub 2016 Jun 24.
The prefilled, multidose, GONAL-f (®) (follitropin alfa) pen injector was redesigned to improve ease of use and pen functionality. This usability engineering evaluation aimed to demonstrate that the redesigned pen injector could be used by the intended users to safely and effectively deliver follitropin alfa.
Formative and summative usability engineering evaluations of the pen injector, training and instructions for use (IFU) were conducted. This included an expert review, and formative and summative evaluations involving patients with infertility and fertility nurses. For the summative evaluation, participants received training and subsequently performed tasks based on three selected hazard-related use scenarios to evaluate real-world use, including simulated injections.
The formative evaluations confirmed that the pen injector was ready for summative evaluation. Task performance was high in the summative evaluation for both patients and nurses; the tasks that were observed to be most difficult to complete were priming the pen, completing an incomplete injection and completing the treatment diary. Participants rated the device as having above average usability. Most patients ranked the overall system (pen injector, device training and IFU) and its individual components to be either 'extremely easy' or 'somewhat easy' to use.
These usability engineering evaluations demonstrated that patients and nurses could safely and effectively use the redesigned GONAL-f pen injector, and that they also found the IFU and device training to be easy to use.
预充式、多剂量 GONAL-f（®）（卵泡刺激素阿尔法）笔式注射器进行了重新设计，以提高易用性和笔的功能。这项可用性工程评估旨在证明，经过重新设计的笔式注射器可被预期使用者安全有效地使用，以输送卵泡刺激素阿尔法。
对笔式注射器、培训和使用说明（IFU）进行了形成性和总结性的可用性工程评估。这包括专家审查，以及涉及不孕不育患者和生育护士的形成性和总结性评估。在总结性评估中，参与者接受了培训，随后根据三个选定的与危害相关的使用场景进行了任务操作，以评估实际使用情况，包括模拟注射。
形成性评估证实笔式注射器已准备好进行总结性评估。患者和护士在总结性评估中的任务执行率都很高；观察到最难完成的任务是给笔预充、完成未完成的注射和填写治疗日记。参与者认为该设备具有高于平均水平的可用性。大多数患者将整个系统（笔式注射器、设备培训和 IFU）及其各个组件评为“非常容易”或“有些容易”使用。
这些可用性工程评估表明，患者和护士可以安全有效地使用重新设计的 GONAL-f 笔式注射器，并且他们还发现 IFU 和设备培训易于使用。
