美国医疗器械不良事件报告数据库研究

Study on the MAUDE database

美国作为医疗器械不良事件监测工作起步较早的国家,监管体系较为成熟全面,其中的医疗器械不良事件报告数据库,是上市后监测的重要工具之一。本研究从涵盖内容、使用方法、注意事项、未来发展趋势等几方面详细介绍了美国医疗器械不良事件报告数据库,研究制造商和使用机构器械使用经历数据库(MAUDE)的设计思路、使用分析方法,为我国医疗器械上市后监测的信息化建设提供参考。

As a pioneer in medical device postmarket surveillance, U.S. has a comprehensive regulatory system. The medical device report （MDR） is one of the important tools used to monitor device performance, detect potential devicerelated safety issues, and contribute to benefit-risk assessments of these products. This paper gives an introduction to MAUDE database on its contents, usage, notes and prospection, studies the design solution and relative analytic method, aims on providing ideas for improving information system of medical device postmarket surveillance in China.