136例国际医疗器械严重不良事件的统计与分析

Statistics and Analysis of 136 Cases of Adverse Events of International Medical Devices

摘要: 为了探明医疗器械不良事件发生的规律及特点，为减少同类不良事件的再发生提供研究方法和思路，该研究收集了国际上具有代表性的5个国家的医疗器械安全信息，并对事件类别、管理类别和事件原因进行统计与分析。结果显示，136例严重不良事件中，召回原因占比位居前三位的分别是产品设计因素、软件因素和组件缺损。为降低医疗器械的应用风险，建议产品设计者、操作使用者和所在医疗机构正确实施医疗器械监测评价体系。

Abstract: 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.