医疗器械不良事件监测主体责任落实现状及对策研究

      Research on the Efficacy of Fulfillment of Medical Device Adverse Event Monitoring Entities and Safeguard Mechanism

      • 摘要: 目的 针对医疗器械不良事件监测主体履职不到位的现状,提出若干改进对策,为完善上市后监管体系提供参考。方法 通过理论研究和实证研究探索提升医疗器械不良事件监测主体履职效果的对策。结果 监测主体报告数量少且质量低下,根本原因包括监测主体缺乏工作动力、制度不完善、监测能力不足等。结论 采用加强主体责任意识,建立评价制度和追责制度,构建社会共治网等方式促进监测主体履职到位。

         

        Abstract: Objective To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system. Method Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices. Results The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc. Conclusion The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.

         

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