基于风险管理的医疗器械不良事件分级监测模式研究  

Research on Classification Monitoring Model of Medical Device Adverse Events Based on Risk Management

作　　者：任文霞[1] 朱清[1] 丁静[1] 周双林[1] 茅鸯对[1] 王雯 REN Wenxia;ZHU Qing;DING Jing;ZHOU Shuanglin;MAO Yangdui;WANG Wen(Zhejiang Pharmaceutical College, Ningbo, 3151002;Zhejiang Medical Devices Evaluation Center, Hangzhou, 31110)

机构地区：[1]浙江医药高等专科学校,宁波市315100 [2]浙江省医疗器械审评中心,杭州市311100

出　　处：《中国医疗器械杂志》2018年第3期215-218,共4页Chinese Journal of Medical Instrumentation

基　　金：国家食品药品监督管理总局药品评价中心项目(诊断类医疗器械不良事件监测模式研究);浙江省食品药品监管系统科技计划项目(YQ201601)

摘　　要：目的提高医疗器械不良事件上报数量和质量,及时处理已发生不良事件,预防不良事件的发生,保障器械使用安全。方法基于风险管理方法,通过全面分析不良事件风险,科学评价风险程度,完成不良事件分级。行政监管部门根据分级结果采取相应监管措施。结果建立了基于风险管理的医疗器械不良事件分级监测模式。结论不良事件分级监管将有助于行政监管部门突出工作重点,降低工作量,提高监管效率。Objective To increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use. Methods Based on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results. Result Building a classification monitoring model of medical device adverse events based on risk management. Conclusion The classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.

关 键 词：医疗器械 不良事件分级监测 风险管理 

分 类 号：F203[经济管理—国民经济]