中国药物警戒 ›› 2014, Vol. 11 ›› Issue (4): 235-240.

• 药械安全性研究 • 上一篇    下一篇

272例FDA医疗器械产品一级召回事件分析和探讨

文强1, 夏世韬1, 钟玲1, 钟代笛2, 苗宇2   

  1. 1重庆市药品不良反应监测中心,重庆400014;
    2重庆大学生物工程学院,重庆400044
  • 收稿日期:2013-12-06 修回日期:2016-02-03 出版日期:2014-04-08 发布日期:2016-02-03
  • 作者简介:文强,男,硕士,医疗器械不良事件监测和评价。

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

WEN Qiang1, XIA Shi-tao1, ZHONG Ling1, ZHONG Dai-di2, MIAO Yu2   

  1. 1Center for ADR Monitoring of Chongqing, Chongqing 400014, China;
    2Bioengineering College of Chongqing University, Chongqing 400044, China
  • Received:2013-12-06 Revised:2016-02-03 Online:2014-04-08 Published:2016-02-03

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摘要： 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。

关键词: 医疗器械, 召回, 风险管理

Abstract: ObjectiveTo 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. MethodsStatistical 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. ResultsThe 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%. ConclusionSerious medical device risks are mainly related to applied part, component reliability and function, energy control,

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