内蒙古自治区医疗器械不良事件监测培训需求的调查研究

Investigation of Training Demand on Medical Device Adverse Event Surveillance in Inner Mongolian Municipality

目的 探索适用于当前医疗器械相关工作者的培训模式。方法 对内蒙古自治区的医疗器械生产企业、经营企业、监管企业和医疗机构的 10 7名工作人员进行横断面调查。结果 内蒙古自治区 6 9 2 %的医疗器械相关工作人员对医疗器械不良事件监测仍然不太了解 ,但是对培养需求程度较高 ,需求率 98 1% ;需求的前三位培训内容分别是产品安全信息、基本概念和报告范围。结论 内蒙古自治区的医疗器械不良事件监测培训应该尽量在当地进行短期、中小规模的集中式讲座培训 ,培训内容应该以产品安全信息。

Objective The aim of this study was to establish a set of training model for workers presently concerning about medical device in Inner Mongolian Municipality.Methods The training model was established by cross sectional investigation of 107 workers from medical device manufacture enterprise, medical device sale enterprise, medical device management enterprise and medical organization in Inner Mongolian Municipality.Results 69.16% of workers concerning about medical device couldn't clearly make knowledge of medical device adverse event surveillance, while 98.13% of them highly wanted to master it.Conclusion The training about medical device adverse event surveillance in Inner Mongolian Municipality should be lectured in medium to small scale during short time concentratively in their own area. The training content should be emphasized on the knowledge about product safety, the basic concept and the reporting scope.