中国药物警戒 ›› 2012, Vol. 9 ›› Issue (11): 681-685.

• 药械安全性研究 • 上一篇    下一篇

医疗器械使用错误的风险评估方法研究

文强1, 钟玲1, 夏世韬1, 钟代笛2, 熊学财1, 王强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:2012-05-22 出版日期:2012-11-10 发布日期:2015-08-07
  • 作者简介:文强,男,硕士,医疗器械不良事件监测和评价。

Study on the Risk Assessment Approach for Use Error of Medical Device

WEN Qiang1, ZHONG Ling1, XIA Shi-tao1, ZHONG Dai-di2, XIONG Xue-cai1, WANG Qiang2   

  1. 1 Center for ADR Monitoring of Chongqing, Chongqing 400014, China;
    2 Bioengineering College of Chongqing University, Chongqing 400044, China
  • Received:2012-05-22 Online:2012-11-10 Published:2015-08-07

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摘要： 当前医疗器械不良事件监测已成为上市后医疗器械风险管理的重要研究方向。使用错误是与医疗器械使用相关的潜在风险,其研究具有重要意义。本文针对医疗器械使用错误及其风险评估方法进行了一些探讨和研究,以期对医疗器械不良事件监测与评价工作有所帮助。

关键词: 医疗器械, 不良事件, 使用错误, 风险评估, 危害, 伤害

Abstract: The research on medical device adverse events(MDAE) monitoring has become an important aspect of the post-marketing medical device risk management. Use error is a potential risk related to the use of medical devices, it is significant to study. The article analyzed the use error of medical devices and the approach for risk assessment, in order to be helpful to the medical device adverse event monitoring and evaluation.

Key words: medical device, adverse events, use error, risk assessment, hazard, injury