人为因素测试对医疗设备设计的影响：自动连续血糖监测传感器涂抹器的验证
Impact of Human Factors Testing on Medical Device Design: Validation of an Automated CGM Sensor Applicator.
作者信息
North Robert, Pospisil Christine, Clukey Ryan J, Parkin Christopher G
机构信息
1 Human Centered Strategies, Colorado Springs, CO, USA.
2 Professional Education, Dexcom, Inc, San Diego, CA, USA.
出版信息
J Diabetes Sci Technol. 2019 Sep;13(5):949-953. doi: 10.1177/1932296819831071. Epub 2019 Feb 14.
Abstract
Improving user engagement with continuous glucose monitoring (CGM) is considered a major requirement for achieving optimal treatment efficacy. Human factors testing is needed to ensure that CGM product designs and requisite training simplify the user experience and enhance usability and patient safety. Dexcom, Inc, recently introduced a novel, "one-button" automatic sensor applicator (ASA) for use with the Dexcom G6 (rtCGM) system. The device was developed utilizing all phases of the human factors testing process. We recruited eight certified diabetes educators from independent health care institutions to conduct a comparative ease-of-use analysis to confirm the usability of the ASA. Participants judged the instructions and device to be easier to use than the previous sensor applicator.
摘要
提高用户对持续葡萄糖监测（CGM）的参与度被认为是实现最佳治疗效果的一项主要要求。需要进行人为因素测试，以确保CGM产品设计和必要培训能够简化用户体验，提高可用性并保障患者安全。德康公司（Dexcom, Inc）最近推出了一款新颖的“一键式”自动传感器涂抹器（ASA），用于德康G6实时连续葡萄糖监测（rtCGM）系统。该设备是利用人为因素测试过程的各个阶段开发的。我们从独立的医疗机构招募了八位认证糖尿病教育工作者，进行比较易用性分析，以确认ASA的可用性。参与者认为该说明和设备比以前的传感器涂抹器更易于使用。
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