中国药物警戒 ›› 2010, Vol. 7 ›› Issue (11): 676-680.

• 管理及工作研究 • 上一篇    下一篇

可疑医疗器械不良事件报告表质量分析方法研究

苗会青1,黄盛铨2,马宁3, 郭雪4*, 张素琼4, 曹波4   

  1. 1.海南省药品不良反应监测中心,海口570216；
    2.福建省建瓯市食品药品监督管理局,建瓯353100；
    3.北京市药品不良反应监测中心,北京10024；
    4.国家食品药品监督管理局药品评价中心,北京100045
  • 收稿日期:2010-07-12 修回日期:2016-03-09 出版日期:2010-11-08 发布日期:2016-03-09
  • 作者简介:郭雪,女,主管药师,医疗器械不良事件监测与再评价。据的分析、利用提供有效的经验。

Study on Quality Analysis of Adverse Events of Medical Device Reports

MIAO Hui-qing1, HUANG Sheng-quan2 ,MA Ning3, GUO Xue4* ,ZHANG Su-qiong4, CAO Bo4   

  1. 1.Certer for Adverse Drug Reactions Monitoring of Hainan Province, Hainan Haikou 570216, China;
    2.Jianou Food and Drug Administrator, Fujian Jianou 353100, China;
    3.Beijing Center for ADR Monitoring, Beijing 100024, China;
    4.Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2010-07-12 Revised:2016-03-09 Online:2010-11-08 Published:2016-03-09

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摘要： 目的 根据可疑医疗器械不良事件报告表的特点,结合药品不良反应报告表质量评估标准,探讨可疑医疗器械不良事件报告表质量评估方法。方法 采用文献研究、调查问卷、小组讨论方法,根据报告表各项在分析评价中的权重,制定报告表质量评分表,对报告表进行质量分析,综合评价。在此基础上,从国家药品不良反应监测中心医疗器械不良事件数据库2010 年1～4 月份的报告表中随机抽取5%,对报告表进行质量评分,验证此方法的可行性及优点。结果 建立了可疑医疗器械不良事件报告表质量评分法。结论 通过验证,可疑医疗器械不良事件报告表质量分析方法科学、有效、易于操作,结果符合实际,有利于不断提高报告表质量,有利于为监管部门采取风险管理措施提供可靠的信息来源。

关键词: 可疑医疗器械不良事件报告表, 质量评分表

Abstract: Objective To explore quality analysis of adverse events of medical device(MDAEs) Reports with characteristic of MDAEs Reports and quality standard of adverse drug reactions Reports. Methods Quality scoring table is prepared with the Weighted Coefficient of each item in Reports by using literature research, questionnaire and small group discussion. MDAEs Reports of a random 5% of MDAEs Reports database from Jan. to Apr. 2010 in center for drug deevaluation of SFDA were analysed with the scoring table, that is to validate feasibility and merit of Quality scoring table. Results Quality scoring method of MDAEs Reports is established. Conclusion The quality scoring method is scientific, effective and easy to be operated. The Results are accurate. It is propitious to improve quality of MDAEs Reports and to furnish true information for risk management of supervisory board.

Key words: adverse events of medical device reports, quality scoring table

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