中国药物警戒 ›› 2010, Vol. 7 ›› Issue (9): 542-546.

• 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完整性分析

努尔江·沙布开1,余永强1,蒋冬贵2,朱舒兵3,郭雪4   

  1. 1.新疆维吾尔自治区药品不良反应监测中心,新疆乌鲁木齐 830002；
    2.湖南省药品审评认证与不良反应监测中心,湖南长沙 410013；
    3.重庆市药品不良反应监测中心,重庆 400014； 4国家药品不良反应监测中心,北京 100045
  • 收稿日期:2009-09-03 修回日期:2016-03-09 出版日期:2010-09-08 发布日期:2016-03-09
  • 通讯作者: 郭雪,女,主管药师,医疗器械不良事件监测。E-mail： guoxue@cdr.gov.cn
  • 作者简介:努尔江.沙布开,女,副主任医师,药品不良反应监测及医疗器械监测。

The Integrity Analysis of Suspicious Medical Device Adverse Event Reporting Form

NUERJIANG·shabukai1 ,YU Yong-qiang1 ,JIANG Dong -gui2, ZHU Shu -bing3 ,GUO Xue4   

  1. 1.Adverse Drug Reaction Monitoring Center of Xinjiang Uygur Autonomous Region, Xinjiang Urumchi 830002, China;
    2.Hunan Center for Drug Reevaluation and ADR Monitoring,Hunan Changsha 410013, China;
    3.Chongqing Center for Adverse Drug Reaction Monitoring, Chongqing 400014,China;
    4.National Center for Adverse Drug Reaction Monitoring, Beijing 100045, China
  • Received:2009-09-03 Revised:2016-03-09 Online:2010-09-08 Published:2016-03-09

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摘要： 目的通过对上报的可疑医疗器械不良事件报告表内容进行统计、分析和评价,为进一步完善可疑医疗器械报告表质量提供方法和建议。方法对国家药品不良反应监测中心数据库自2002 年12 月1 日至2008 年12 月31 日收集的报告表,采取随机抽样的方法,抽取2 166 份报告表进行规整后通过Excel 表格及SPSS统计软件进行填报缺失率的分析,并与目前国际通行的报告内容进行比较。结果与结论本次研究采取5%抽样率进行随机抽样,所得样本的代表性较好,抽样方法灵敏度较高,得出的结论比较可靠。发现有统计学意义的缺陷项共39 项,占总项目数的88.6%；研究发现单位名称、报告人职业及使用场所分布中使用单位、医院及医护人员的报告缺失率占首位,其次是经营企业和生产企业。目前我国的医疗器械报告质量存在较多的问题,报告质量有待进一步提高。

关键词: 可疑医疗器械不良事件, 报告表, 填报项目, 缺失率

Abstract: Objective To bring Methods and make suggestions for the quality of suspicious Medical Device Adverse Event(MDAE )reports, we statisticed, analysised and evaluated all suspicious MDAE reports from 2002,Jan.1st to 2008, Dec.31th. Methods 2 166 reports were randomly sampled from the database of National Center for ADR Monitoring, Excel and SPSS statistical software package were used to analysis the loss rates after adopting these reports. The contents of 2 166 reports were compared with the current international reports. Results &Conclusion This study adopted randomly sample, and sample rate was 5%, so the representative of samples was better, and the method was sensitive, and the Conclusion was credible. The statistically significant deficiencies in total 39 accounts for 88.6% of the total number of items. This study indicated that the firstly loss rate was coming from using department, mainly including study de-partment's name and reporter's occupation. The secondly loss rate was coming from management corparation or manufacture corparation. At present, there were many deficiencies of Chinese MDAE reports, the reports' quality should be further enhanced.

Key words: Suspected Medical Device Adverse Event, report, item, loss rate

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