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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、基本概念和报告范围为重点
Objective To explore training models applicable to current medical device related workers. Methods Cross-sectional surveys were conducted among 107 employees of medical device manufacturers, operating companies, regulatory companies, and medical institutions in the Inner Mongolia Autonomous Region. Results 699 2% of medical equipment related workers in Inner Mongolia Autonomous Region still do not understand the monitoring of medical device adverse events, but have a high degree of demand for training, the demand rate is 981%; the top three demands for training content are product safety information. , basic concepts and report scope. Conclusion The monitoring and training of medical device adverse events in the Inner Mongolia Autonomous Region should be conducted in local short-term, medium- and small-scale centralized lecture training. The training content should focus on product safety information, basic concepts and report scope.