关键词: 医疗器械, 不良事件, 报告, 质量分析

Abstract: 321 cases of suspicious medical device adverse event reports which were received by Beijing center of Adverse Drug Reaction Monitoring in 2009 were analyzed by existing quality evaluation method. The Results indicated that the traceability of products was poor from the quality assessment report. And some measures were proposed like strengthen publicity, improving the awareness of medical device adverse event monitoring; strengthen the management of high-risk medical devices traceability, conducting the research of key species report, the subject of evaluation norms.

Key words: medical device, adverse event, report, quality analysis