浅析美国FDA对医疗器械上市后监测的信息化手段及其启示

研究美国食品与药品管理局（FDA）对医疗器械上市后监测所采用的信息系统以及其为公众提供的信息服务手段,探讨美国医疗器械不良反应监测的基础数据库——厂商和用户使用设备体验数据库（MAUDE）的数据来源及各种应用特点。根据研究结果并结合国内实际情况,对国家建设符合规范的自发报告系统及综合数据库提出内容和结构上的建议。

Informational Methods Used for Medical Devices Post-marketing Surveillance by FDA and Its Inspiration

The information system used for the medical devices post-marketing surveillance and the information service provided to the public performed by the U.S.A.Food and Drug Administration（FDA） are studied.The data source and application characteristics of Manufacturer and User Facility Device Experience（MAUDE） are also investigated.Combining the research results and the current condition in China,suggestion about the system structure is presented about establishing the voluntary reporting system and the comprehensive database for the adverse events with uniform standards in China.