Zhao Fei, Gao Mingxian, Liu Pu, Wang Yang, Zhang Hangyao, Zhang Yuye, Zhan Qin, Wang Shouli
Pathology Laboratory, Institute of Health and Environmental Technology, Suzhou University, Suzhou, 215123.
Department of Cardiology, People's Hospital of Sihong County, Sihong, 223900.
Zhongguo Yi Liao Qi Xie Za Zhi. 2020 Feb 8;44(2):166-171. doi: 10.3969/j.issn.1671-7104.2020.02.015.
To explore the law and characteristics of adverse events of medical devices and to provide research methods and basis for reducing the recurrence of similar adverse events, we collect medical devices safety information from five representative countries in the world, and make statistics and analysis on the types of events, the types of management and the causes of events. The results show that among 136 serious adverse events, the top three causes of recall are product design factors, software factors, and component defects. In order to reduce the application risk of medical devices, it is suggested that product designers, operating users and medical institutions should correctly implement the monitoring and evaluation system of medical devices.
为探究医疗器械不良事件的规律和特点，为减少类似不良事件的再次发生提供研究方法和依据，我们收集了世界上五个有代表性国家的医疗器械安全信息，并对事件类型、管理类型及事件原因进行了统计分析。结果显示，在136起严重不良事件中，召回的三大主要原因是产品设计因素、软件因素和部件缺陷。为降低医疗器械的应用风险，建议产品设计者、操作使用者及医疗机构应正确落实医疗器械监测与评估体系。
