Zhang Yi, Masci Paolo, Jones Paul, Thimbleby Harold
Biomed Instrum Technol. 2019 May/Jun;53(3):182-194. doi: 10.2345/0899-8205-53.3.182.
The current work assessed U.S. medical device recalls during 2012-15, with the goal of under-standing the impact and nature of user interface (UI) software errors in medical devices. Based on information from the Food and Drug Administration's public and internal recall databases, 423 (~140/year) medical device recalls were identified as resulting from UI software errors, which accounted for nearly one-half of recalls caused by software errors during the same period. A total of 499 UI software errors were identified as the root causes of medical device recalls, and a detailed classification of those errors (into 20 categories) was established. This error classification can be used by device manufacturers, end users (e.g., healthcare providers), and regulatory authorities to raise awareness of the type and impact of UI software errors. The classification also provides stakeholders with an evidence-based challenge to assess and improve the quality of UI software in medical devices.
当前的研究评估了2012年至2015年期间美国医疗器械召回情况，目的是了解医疗器械中用户界面（UI）软件错误的影响和性质。根据美国食品药品监督管理局公开和内部召回数据库中的信息，确定有423起（约每年140起）医疗器械召回是由UI软件错误导致的，这几乎占同期软件错误导致召回事件的一半。共识别出499个UI软件错误是医疗器械召回的根本原因，并对这些错误进行了详细分类（分为20类）。设备制造商、终端用户（如医疗保健提供者）和监管机构可利用此错误分类来提高对UI软件错误类型和影响的认识。该分类还为利益相关者提供了基于证据的挑战，以评估和提高医疗器械中UI软件的质量。
