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| 3 123例可疑医疗器械不良事件统计分析 | |
| 引用本文： | 曾令贵,龙丽萍,姚金成,周于禄,肖敏,臧萍.3 123例可疑医疗器械不良事件统计分析[J].药物流行病学杂志,2008,17(6). |
| 作者姓名： | 曾令贵 龙丽萍 姚金成 周于禄 肖敏 臧萍 |
| 作者单位： | 1. 湖南省药品审评认证与不良反应监测中心,长沙,410005 2. 湖南省药品审评认证与不良反应监测中心,长沙,410005;中国药科大学国家新药筛选中心 3. 中南大学湘雅三医院 |
| 摘 要： | 目的:对3 123例医疗器械不良事件报告进行分析,为加强医疗器械不良事件监测工作提供建议. 方法:采用回顾性研究方法,对湖南省2007年收集的医疗器械不良事件报告及其质量进行综合分析. 结果:我省医疗器械不良事件主要来源于医疗机构及其它使用单位,宫内节育器、外科缝线和金属接骨板等不良事件发生比例较高;医疗器械不良事件上报数量地区间存在不平衡. 结论:应进一步加强医疗器械不良事件监测工作的宣传培训,提高监测质量,为保障公众用械安全服务. |
| 关 键 词： | 医疗器械 不良事件 分析 |
Analysis of 3 123 Reports of Adverse Events Caused by Medical Devices |
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| Zeng Linggui,Long Liping,Yao Jincheng,Zhou Yulu,Xiao Min,Zang Ping .Hunan Center for Drug Reevaluation,ADR Monitoring,Changsh,Chin,.National Center of New Drug Screening,China Pharmaceutical University,.Third Xiangya Hospital,Central South University.Analysis of 3 123 Reports of Adverse Events Caused by Medical Devices[J].Chinese Journal of Pharmacoepidemiology,2008,17(6). | |
| Authors: | Zeng Linggui Long Liping Yao Jincheng Zhou Yulu Xiao Min Zang Ping Hunan Center for Drug Reevaluation ADR Monitoring Changsh Chin National Center of New Drug Screening China Pharmaceutical University Third Xiangya Hospital Central South University |
| Institution: | Zeng Linggui~1,Long Liping~1,Yao Jincheng~(1,2),Zhou Yulu~3,Xiao Min~3,Zang Ping~3 1.Hunan Center for Drug Reevaluation , ADR Monitoring,Changsha 410005,China,2.National Center of New Drug Screening,China Pharmaceutical University,3.Third Xiangya Hospital,Central South University |
| Abstract: | Objective:To analyze 3 123 cases of medical device adverse events(MDAE)and provide some suggestions for the MDAE monitoring.Method:By the retrospective case study,3 123 MDAE reports were analyzed in Hunan Province in 2007.Result:The reports mainly came from medical institutions and other drug-use units.Intrauterine devices (IUD),medical suture thread and orthopedic implants caused a higher proportion of adverse events.The quantities of MDAE reports were imbalanced in different regions.Conclusion:The MDAE mo... |
| Keywords: | Medical Device Adverse events Analysis |
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