Zhang Qiang, Liu Shenglin, Yan Yi, Fang Pengqian
School of Medicine and Health Management, Tongji Medical College of HUST, Wuhan, 430030, China.
Zhongguo Yi Liao Qi Xie Za Zhi. 2011 Jul;35(4):280-3.
To analyze medical device recall information of FDA U.S. and to address the safety issue of medical device.
For each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.
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 equipment 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.
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.
分析美国食品药品监督管理局（FDA）的医疗器械召回信息，探讨医疗器械安全问题。
记录每份报告的召回类别、产品名称、产品类别及召回原因，并进行分类分析。
共识别出3093份报告；三类产品的召回原因存在显著差异。发现医用材料的主要召回原因是包装问题（39%）和设计缺陷（19%），医用工具是设计缺陷（27%）和包装问题（26%），医疗设备是设计缺陷（45%）和系统故障（39%）。召回的软件数量为109件。高风险设备的主要召回原因是设计缺陷，2006年召回的高风险设备I级水平与2005年相比有所下降。
应加强医疗器械召回信息的监测与应用，总结医疗器械安全问题的客观规律，为医疗器械监管提供参考。
