Shin Jeehoon, Lee Hyuk
College of Informatics, Korea University, Seoul 02841, Republic of Korea.
Department of Computer Engineering, Changwon National University, Changwon 51140, Republic of Korea.
Healthcare (Basel). 2023 Jan 18;11(3):296. doi: 10.3390/healthcare11030296.
Medical device usability testing offers many benefits, including finding medical device usage errors and providing safety to users. As usability testing becomes mandatory for medical devices, manufacturers are increasing the cost burden. In order to perform a high-quality usability test, it is important to implement a usability test procedure, but guidelines for this are lacking. In this paper, we propose a method to systematically design and implement a usability test procedure. We propose methods to reduce test time-costs and apply them to implement the final procedure. Next, by applying the proposed method to sinus surgical navigation system, it is shown that the total time was reduced by 21% compared to the usability summative test procedure previously used in the same system.
医疗设备可用性测试有诸多益处，包括发现医疗设备使用错误并为用户提供安全保障。随着可用性测试成为医疗设备的强制要求，制造商的成本负担日益加重。为了进行高质量的可用性测试，实施可用性测试程序很重要，但目前缺乏相关指导方针。在本文中，我们提出一种系统设计和实施可用性测试程序的方法。我们提出了减少测试时间成本的方法，并将其应用于实施最终程序。接下来，通过将所提出的方法应用于鼻窦手术导航系统，结果表明与该系统先前使用的可用性总结性测试程序相比，总时间减少了21%。
