对医疗器械不良事件监测机构建设的思考

A Study On The Construction of Technical Organization for Medical Device Postmarket Monitoring in China

目的:探讨在原有药品不良反应监测系统的基础上建立医疗器械不良事件监测系统的模式方法,并提供建议;方法:采用定性与定量研究相结合的方法,提出医疗器械不良事件监测机构建设的基本概念、框架;结果:医疗器械不良事件监测机构建设的远景目标是建立一个具备检测新出现问题能力、测量危险因素变化和趋势能力、干预能力、评价干预措施和政策效果能力的医疗器械不良事件监测系统;监测机构内部设置应包括政策研究部、综合干预部、规范实施部、监测评价部、宣传培训部等部门来共同协调工作;需要合理的人力资源和必要的经费支持;机构建设在硬件设施配置的基础上,更需要相应规章制度的软件建设;结论:目前需要在框架建设阶段充分论证监测模式,制定客观科学的监测机构建设策略,统一思想、统一认识,在监测机构建设早期树立科学的监测理念,制定有效的、可行的具体措施。

Objective: To investigate the construction model for medical device postmarket monitoring in china;Method: The combination of qualitative and quantitative analysis were conducted in this study; Results: The long term development objective of the monitoring system of medical instrument and devices adverse effects: establish a monitoring system of medical instrument and devices adverse effects that have the abilities to examine the new problems, measure the change trend of dangerous elements, intervene and evaluate intervention treasures and policy effects according to the working function of the supervision; the internal establishments of the monitoring organization should include policy study department, comprehensive intervention department, regulation implementation department, monitoring evaluation department, propagandizing and training department to cooperate in the work together; Conclusion: At the early stage of the construction of the monitoring organization we set up scientific monitoring concept, draw up effective and feasible specific measures.