对2005-2006年美国FDA召回的医疗器械产品分析

摘要

Objectives To analyze medical device recall information of FDA U.S.and to address the safety issue of medical device.Method: For each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.Results 3093 reports were identified; the recalling reasons of the three classes were significantly different.It is found that the main recall reason for medical material is package problems(39％) and design defectiveness(19％),for medical tools are design defectiveness(27％) and package problems(26％), and for medical equipments are design defectiveness(45％) and system failures(39％).The number of software recalled is 109.The main recall reason for high risk equipment is design defectiveness, and the Ⅰ class level of high risk equipment recalled was decline in 2006 compared to that in 2005.Conclusion: Monitoring and application of medical device recall information should be strengthened, and the objective law of medical device safety issue should be summed up, in order to provide reference for supervision of medical device.%目的分析美国FDA医疗器械召回信息的特点,探讨医疗器械安全性问题.方法对每份报告记录了召回级别、产品名称、产品类别和召回原因,并进行了归类分析.结果分析了3093份召回报告,I、Ⅱ、Ⅲ级召回原因类别具有显著差异;材料类召回原因主要是包装问题(39%)、设计缺陷(19%);器械类主要是设计缺陷(27%)、包装问题(26%);设备类主要是设计缺陷(45%)和系统故障(39%);软件召回109例.高风险医疗器械召回主要原因是设计缺陷,其1级召回比例2006年比2005年有所下降.结论应加强对医疗器械召回信息的监测和利用,总结医疗器械安全性问题的客观规律,为更好地开展我国医疗器械监测提供参考.