中国药物警戒 ›› 2013, Vol. 10 ›› Issue (4): 232-234.

• 药械安全性研究 • 上一篇    下一篇

1059例可疑医疗器械不良事件报告分析

孔祥红,张维华,严婷婷   

  1. 沂水县食品药品监督管理局,山东沂水 276400
  • 收稿日期:2012-10-16 修回日期:2016-03-09 出版日期:2013-04-08 发布日期:2016-03-09
  • 作者简介:孔祥红,女,药士,药械安全性监测和药品快检。

Analysis of 1059 Suspected Medical Device Adverse Event Reports

KONG Xiang -hong ,ZHANG Wei –hua, YAN Ting –ting   

  1. Yishui Food and Drug Administration,Shandong Yishui 276400,China
  • Received:2012-10-16 Revised:2016-03-09 Online:2013-04-08 Published:2016-03-09

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摘要： 目的 调查研究我县医疗器械不良事件（Medical Device Adverse Events,MDAEs）发生概况,探讨器械不良事件发生规律,为临床安全用械提供警示。方法 采用回顾性分析的方法,利用Microsoft Excel 对收集数据进行汇总、筛选,就产品类别及主要不良事件表现等方面进行统计、评估和分析。结果 MDAEs 与性别、年龄无显著相关性；三类医疗器械中,Ⅱ类、Ⅲ类为监测主体；医用高分子材料及制品的报告数量最多,植入材料和人工器官的有伤害报告数最多；从具体品种分析,宫内节育器引起不良事件数量居第1位,主要不良事件表现多与器械质量、患者过敏体质等因素有关；MDAEs 报告人主要为医师。结论 加强对MDAEs 风险的认识,加大对重点品种的监测力度,不断提高对医疗器械的控制及管理水平。

关键词: 医疗器械, 不良事件, 分析, 重点监测, 安全用械

Abstract: Objective To investigate the general situation of MDAEs in our county, find out the regularity, and provide warning for clinical safe use of medical devices. Methods With the retrospective analysis, use Microsoft Excel to summarize and screen the collected data, make statistics, evaluation and analysis in terms of product category and main manifestations of adverse events. Results The MDAEs have no significant correlation with gender and age. Among the three types of medical devices, typeⅡand typeⅢare the monitoring subjects. Medical polymer materials and products have the largest number of reports. Implant materials and artificial organs have the maximum number of reports on injury.As for analysis of the specific variety, the number of intrauterine device adverse events is the first, the main adverse event manifestations are related to device quality and patients'allergic constitution, etc. These cases were reported mainly by doctors. Conclusion To strengthen the understanding of MDAEs risk, intensify the monitoring on key varieties, and continuously improve the medical device control and management level.

Key words: medical devices, adverse events, analysis, intensive monitoring, safe use of medical devices

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