272例FDA医疗器械产品一级召回事件分析和探讨

目的通过对272例FDA医疗器械产品一级召回事件进行分类统计分析，探讨严重医疗器械风险事件的发生规律，为上市后医疗器械风险管理工作提供参考。方法检索2001—2012年FDA官网发布的最严重的医疗器械产品一级召回事件，对其中不涉及假劣、伪造等非法原因的272个事件案例进行分类统计和分析。结果构成比排前10位的产品种类占到90％的事件数量；能量型危害是主要危害形式，占79．4％；产品组件失效是最主要的直接原因，占76．1％。结论从产品的角度，严重医疗器械风险事件的产生主要与应用部分、组件可靠性及其功能、能量控制、可用性等主要因素有关。

Analysis and Discussion of 272 Cases of Class I Medical Device Recalls by FDA

Objective To investigate the occurrence of serious medical device risks and provide reference for the post-marketing medical device risk management through statistical analysis on 272 cases of FDA class I medical device recalls. Methods Statistical analysis is applied to the retrieval of 2001-2012 the most serious class I medical device recalls from FDA website which does not involve the cases caused by illegal factors. Results The constituent ratio of the top 10 categories of products accounts for 90% of the number of cases. Energy hazard is the main form, accounting for 79.4%. The product component failure is the main direct reason, accounting for 76.1%. Conclusion Serious medical device risks are mainly related to applied part, component reliability and function, energy control, usability, etc.