中国药物警戒 ›› 2013, Vol. 10 ›› Issue (5): 303-305.

• 药械安全性研究 • 上一篇    下一篇

高频电刀临床使用风险管理探讨

陈兴莉1,赵玉娟2*,赵燕3*   

  1. 1.青海省药品不良反应监测中心,青海西宁810000；
    2.山东省药品不良反应监测中心,山东济南250013；
    3.国家食品药品监督管理局药品评价中心,北京100045
  • 收稿日期:2013-04-19 修回日期:2016-03-09 出版日期:2013-05-08 发布日期:2016-03-09
  • 通讯作者: 赵玉娟,女,硕士,生物医学工程。 E-mail：zhaoyujuan@sdadr.gov.cn 赵燕,女,高级工程师,医疗器械不良事件监测。 E-mail：zhaoyan@cdr.gov.cn
  • 作者简介:陈兴莉,女,副主任药师,药械不良反应/事件监测。

Study on Clinical Use Risk Management of High-Frequency Electrical Knife

CHEN Xing-li1 ,ZHAO Yu-juan2*, ZHAO Yan3*   

  1. 1.Adverse Drug reaction Monitoring Center of Qinghai, Qinghai Xining 810000, China;
    2.Adverse Drug Reaction Monitoring Center of Shandong, Shandong Jinan 250013, China;
    3.Center for Drug Reevaluation, SFDA, Beijing 100045
  • Received:2013-04-19 Revised:2016-03-09 Online:2013-05-08 Published:2016-03-09

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摘要： 高频电刀是对安全性要求极高的医疗设备,本文通过介绍高频电刀的组成和工作原理,从器械故障和对人体伤害两大方面探讨高频电刀在临床使用中常见的不良事件及其产生原因,总结高频电刀在使用中的注意事项,提出了高频电刀临床安全使用的风险管理建议。为提高其风险管理水平,确保高频电刀安全有效的使用提供参考。

关键词: 高频电刀, 风险管理, 不良事件

Abstract: High-frequency electrical knife isa kind of medical equipment which has high safety requirements. This article introduces the composition and working principle of high -frequency electrical knife, discusses the common adverse events and their causes of high -frequency electrical knife from equipment failure and damage to human body, and summarizes precautions in its use. Some advices are given on risk management, so as to improve the level of risk management, and then to ensure safe and effective use of high-frequency electrical knife.

Key words: high-frequency electrical knife, risk management, adverse events

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