医疗器械不良事件监测专家问卷调查结果分析  

Analysis on Medical Device Adverse Events(MDAE) Montoring

作　　者：曲婷婷[1] 陈爱民 盛洪涛 杨兆慧[4] 陈建峰 

机构地区：[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

出　　处：《中国医疗器械信息》2010年第2期46-48,74,共4页China Medical Device Information

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。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 device adverse events. Conclusion： Increase awareness training and universal understanding, promote the introduction of relevant laws and regulations, standardize, and develop technical guidelines for monitoring work is effective measures to carried out.

关 键 词：医疗器械不良事件监测 问卷调查 结果分析 

分 类 号：R197[医药卫生—卫生事业管理]