| 山东省医疗器械不良事件监测工作调查分析 |
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| 引用本文： | 公培献,任绍彦,孔庆衍,周勇,田月洁,谢彦军. 山东省医疗器械不良事件监测工作调查分析[J]. 中国药物警戒, 2008, 5(6): 354-359 |
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| 作者姓名： | 公培献 任绍彦 孔庆衍 周勇 田月洁 谢彦军 |
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| 作者单位： | 1. 山东省食品药品监督管理局,山东,济南,250013
2. 山东省药品不良反应监测中心,山东,济南,250013 |
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| 摘 要： | 医疗器械不良事件监测是医疗器械上市后风险管理的重要手段之一。通过对山东省医疗器械不良事件监测工作现状的调查，分析了现阶段山东省医疗器械不良事件监测工作中存在的问题和困难，提出了加强医疗器械不良事件监测的新思路。
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| 关 键 词： | 医疗器械不良事件 监测 调查 |
Investigation of Medical Device Adverse Events Monitoring in Shandong Province |
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| GONG Pei-xian,REN Shao-yan,KONG Qing-yan,ZHOU Yong,TIAN Yue-jie,XIE Yan-jun. Investigation of Medical Device Adverse Events Monitoring in Shandong Province[J]. Chinese JOurnal of Pharmacovigilance, 2008, 5(6): 354-359 |
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| Authors: | GONG Pei-xian REN Shao-yan KONG Qing-yan ZHOU Yong TIAN Yue-jie XIE Yan-jun |
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| Affiliation: | GONG Pei-xian , REN Shao-yan , KONG Qing-yan , ZHOU Yong , TIAN Yue-jie , XlE Yan-jun( 1Shandong Food and Drug Addverse (Shandong Jinan 250013, China) 2Shandong Center for ADR monitoring (Shandong Jinan 250013, China) |
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| Abstract: | Medical Device Administration Events (MDAE) monitoring is one of the important methods for risk management of the post-market medical devices. By analyzing the current situation and problems of MDAE monitoring in Shandong province, to provide new references to strengthen the MDAE monitoring. |
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| Keywords: | Medical Device Adverse Events(MDAE) monitoring investigation |
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