中国药物警戒 ›› 2014, Vol. 11 ›› Issue (1): 31-34.

• 药械安全性研究 • 上一篇    下一篇

FDA医疗器械设备问题术语集的应用研究

钟玲1,王刚2,文强1,李穗3,董放2*,*   

  1. 1重庆市药品不良反应监测中心,重庆 400014;
    2国家食品药品监督管理局药品评价中心,北京 100045;
    3江西省药品不良反应监测中心,江西 南昌 330046
  • 收稿日期:2016-02-03 修回日期:2016-02-03 出版日期:2014-01-08 发布日期:2016-02-03
  • 通讯作者: 董放,男,高级工程师,医疗器械不良事件监测与评价。
  • 作者简介:钟玲,女,硕士,医疗器械不良事件监测与评价。

Application Research of FDA Event Problem Codes about Medical Devices

ZHONG Ling1, WANG Gang2, WEN Qiang1, LI Sui3, DONG Fang2, *   

  1. 1Center for ADR Monitoring of Chongqing, Chongqing 400014, China;
    2Center for Drug Reevaluation, SFDA, Beijing 100045, China;
    3Center for ADR Monitoring of Jiangxi, Jiangxi Nanchang 330046, China
  • Received:2016-02-03 Revised:2016-02-03 Online:2014-01-08 Published:2016-02-03

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摘要： 美国食品药品监督管理局（FDA）于2009年7月开始实施新的设备问题术语集。通过阐述FDA设备问题术语集的实施概况及其术语集结构,基于美国MAUDE数据库论证了该设备问题术语集对医疗器械风险评价的实际意义,分析了FDA设备问题术语集对于我国监测实情的应用难度,并结合监测现状提出了借鉴FDA设备问题术语集的实施建议,以期对我国设备故障术语集的建立提供有益思路。

关键词: FDA, 设备问题术语集, 医疗器械故障, 术语集, 风险评价

Abstract: The U.S. Food and Drug Administration(FDA) implemented a new device problem codes in July 2009. In this paper, we presented an overview of the device problem codes and their structure, demonstrated device problem codes' practical significance to medical device risk assessment using the Manufacturer and User Facility Device Experience(MAUDE) database, discussed the difficulties in applying the device problem codes to China considering the current conditions of medical device adverse events monitoring, and made suggestions for implementation using the device problem codes for reference. The objective of this paper was to provide some helpful information for establishment of the medical device failure terminology in China.

Key words: FDA, device problem codes, medical device failure, terminology, risk assessment

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