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医疗器械不良事件监测专家问卷调查结果分析
引用本文:曲婷婷,陈爱民,盛洪涛,杨兆慧,陈建峰.医疗器械不良事件监测专家问卷调查结果分析[J].中国医疗器械信息,2010,16(2):46-48,74.
作者姓名:曲婷婷  陈爱民  盛洪涛  杨兆慧  陈建峰
作者单位:1. 大连市药品不良反应监测中心,大连,116021
2. 新疆建设兵团药品不良反应监测中心,乌鲁木齐,830002
3. 山东省淄博市药品检验所,淄博,255086
4. 北京市药品不良反应监测中心,北京,100024
5. 福建莆田市食品药品监督管理,莆田,351100
摘    要:目的:研究我国医疗器械不良事件监测工作开展的现状。方法:用Excel对83份调查问卷进行统计分析。结果:接近半数的临床医务人员对医疗器械监督管理的法律、法规、规章制度不太了解;超过40%的临床医务工作者不太了解医疗器械上报的流程;77.11%的临床医务人员没有接受过医疗器械不良事件监测的培训。结论:加大宣传培训力度,普及认识;促进相关法规的出台,制定规范及技术指南是促进监测工作开展的有效措施。

关 键 词:医疗器械不良事件监测  问卷调查  结果分析

Analysis on Medical Device Adverse Events(MDAE) Montoring
QU Ting-ting,CHEN Ai-min,SHENG Hong-tao,YANG Zhao-hui,CHEN Jian-fen.Analysis on Medical Device Adverse Events(MDAE) Montoring[J].China Medical Devices Information,2010,16(2):46-48,74.
Authors:QU Ting-ting  CHEN Ai-min  SHENG Hong-tao  YANG Zhao-hui  CHEN Jian-fen
Institution:QU Ting-ting1 CHEN Ai-min2 SHENG Hong-tao3 YANG Zhao-hui4 CHEN Jian-feng5 1 Dalian Center for ADR Monitoring(Dalian 116021) 2 Xinjiang produce construction large unit Center ADR Monitoring(Urumchi 8300002) 3 Zibo Institute for Drug Control(Zibo 255086) 4 Beijing Center for ADR Monitoring(Beijing 100024) 5 Putian SFDA(Putian 351100)
Abstract:Objective:Study on the current situation of medical device adverse events monitoring.Method:Using Excel on 83 surveys conducted statistical analysis.Results:Nearly half of the clinical medical staff on the medical device administration and management of the laws,regulations,rules and regulations do not quite understand;More than 40% of clinical medical staff know little about the process of medical device adverse events reported;77.11% of the clinical medical staff have not received the training of medical ...
Keywords:medical device adverse events(MDAE) montoring  questionnaire  analysis  
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