我国医疗器械不良事件监测现状分析

Situation analysis on the adverse events monitoring of medical device in China

目的分析我国医疗器械不良事件监测数据,为医疗器械不良事件的监测与防范提供参考。方法全面梳理2013—2018年间共计6份《医疗器械不良事件监测年度报告》,运用复合年均增长率和增幅对变化趋势进行描述性分析。结果2003—2017年全国医疗器械不良事件报告数持续增长,复合年均增长率达62.09%。医疗器械不良事件的报告来源中,使用单位占近90%。医疗机构为不良事件主要涉及的实际使用场所,Ⅱ类医疗器械和Ⅲ类医疗器械是引发不良事件的主要医疗器械管理类别。结论全国医疗器械不良事件整体趋势平稳,建议重点培养和提升相关单位的监测能力,加强不良事件预警和上报的公众宣传。基于全生命周期管理,鼓励生产、经营企业参与到不良事件监测和上报环节中。

Objective To analyze monitoring of the national data of the medical device adverse event to provide reference for the monitoring and prevention of the occurrence of medical device adverse events. Methods Compound annual growth rate was calculated to provide a descriptive analysis for the trend of the occurrence of medical device adverse events in the Annual Report on Medical Device Adverse Event Monitoring from 2013 to 2018. Results The number of medical device adverse events of the country in total continued to grow from 2003 to 2017,with the compound annual growth rate of 62.09%. Among the reported cases of medical device adverse events,the utility institutions accounted for nearly 90%. Medical institutions were the places where the majority of adverse events occurred,and Class Ⅱ medical devices and ClassⅢ medical devices were the main categories of medical device that caused adverse events. Conclusion The overall occurrence trends of medical device adverse events across the country was stable. It is recommended to focus on building up and improving the monitoring capabilities of relevant units,and strengthening the transparency of early warning and reporting of adverse events. It is also recommended to encourage production and operation enterprises to participate in the monitoring and reporting of adverse events based on the whole life cycles management.