中国药物警戒 ›› 2011, Vol. 8 ›› Issue (11): 651-654.

• 管理及工作研究 • 上一篇    下一篇

医疗器械不良事件报告质量控制的实践与探讨

田月洁, 李泮海, 谢彦军, 黄琳   

  1. 山东省药品不良反应监测中心,山东 济南 250013
  • 收稿日期:2010-09-01 出版日期:2011-11-10 发布日期:2015-07-30
  • 作者简介:田月洁,男,副主任药师,药品不良反应监测,医疗器械不良事件监测。

The Discussion and Practice of Quality Control for Medical Device Adverse Event Reports

TIAN Yue-jie, LI Pan-hai, XIE Yan-jun, HUANG Lin   

  1. Shandong Center for ADR Monitoring, Shandong Jinan 250013, China
  • Received:2010-09-01 Online:2011-11-10 Published:2015-07-30

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摘要： 上市后医疗器械的安全性评价基于高质量的医疗器械不良事件报告,建立科学规范的控制机制是报告质量的有力保证。本文通过在宏观管理和微观控制两个层面的实践,探讨了监测机构控制医疗器械不良事件报告质量的模式,为我国医疗器械不良事件报告质量的提高提供参考。

关键词: 医疗器械不良事件, 质量, 评价, 控制

Abstract: The safety evaluation of post-marketing medical devices based on high-quality medical device adverse event(MDAE) reports. Establishment of scientific and standardized control mechanism is an effective guarantee for the quality of reports. Through the practices at the level of macro-management and micro-control, we discussed the mode of MDAE reports quality control to provide references for the improvement of MDAE reports quality.

Key words: medical device adverse event, quality, evaluation, control

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