我国药品不良反应监测工作对开展医疗器械不良事件监测的启示

Enlightenment of the Adverse Drug Reaction Monitoring Experiences to Medical Devices Adverse Event Monitoring in Our Country

为探讨我国医疗器械不良事件监测工作开展模式,分析比较影响药品不良反应监测与医疗器械不良事件监测工作发展的关键因素。根据医疗器械不良事件监测工作的特点,从相关法律法规制订、组织机构与人员配备、技术体系建设等方面提出了医疗器械不良事件监测的工作思路。

Objective In order to explore the way of establishing the medical devices adverse event （MDAE） monitoring in our country. Analyzed and compared the key factors of the development process of the two. According to the development of MDAE monitoring system of the construction of the laws and regulations system, building the establishments is the main idea, which include the mon- itoring organization equip with professional person, mature technology system, and so on.