北京生物医学工程

中国医疗器械不良事件报告现状

Status of medical device adverse event reporting in China

作者：郭柯磊欧阳昭连杜然然池慧

单位：中国医学科学院北京协和医学院医学信息研究所(北京100020)

关键词：医疗器械; 不良事件；监管；报告

分类号：

出版年·卷·期（页码）：2012·31·5（518-523）

摘要：

目的分析中国医疗器械不良事件报告的现状及存在问题，提出建议，为促进科学监管、保证用械安全提供参考。方法在万方、CNKI等数据库及FDA、SFDA等医疗器械监管机构网站搜集医疗器械不良事件监测方面的数据，在文献评阅的基础上，比较中、美医疗器械不良事件监管报告的现状及采取的措施。结果通过与美国比较，发现中国医疗器械不良事件报告存在报告数占发生数比例较低、生产企业报告数最少及相同问题重复上报等问题，影响产业创新。进一步分析认为，主要存在监管不力、各方认识不足、技术评价难度大及信息上报渠道不畅通等方面原因。结论建议逐步完善法规、扭转“重审批，轻监管”的倾向，不断提高监管方、制造方和使用方的认识，促进医、企共同评价，拓宽上报渠道并及时反馈，以改善中国医疗器械不良事件报告的状况。

Objective We analyzed the status and problems of medical device adverse event reporting in China and provided the recommendations in order to offer references for promoting scientific supervision and ensuring the safe use of medical devices. Methods We retrieved the information on medical device adverse event monitoring in the databases of Wanfang and CNKI and the webs of FDA and SFDA, compared the status and measurements of medical device adverse event reporting between China and America on the basis of literature review. Results The problems of medical device adverse event reporting, such as repeated reporting, the less reporting number than the real, the lest reporting number from manufactures, affected the innovation of medical device industry in China. The reasons were analyzed as lack of supervision, inadequate awareness of medical device adverse events, huge difficulties in the technical evaluation, imperfect channels to report the information. Conclusions We should gradually improve the laws, reverse the mode of “tight registration and loose regulation”, continuously enhance the awareness of the parties about medical device adverse events, evaluate the reports together, broaden the reporting channels and provide the feedbacks timely, in order to improve the status of medical device adverse event reporting in China.

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