体外诊断医疗器械不良事件全程化云监测模式研究  

Research on the Whole-process Cloud Monitoring Mode of in Vitro Diagnostic Medical Devices Adverse Events

作　　者：茅鸯对[1] 丁静[1] 任文霞[1] 朱清[1] 张永秉 谢敏 MAO Yangdui;DING Jing;REN Wenxia;ZHU Qing;ZHANG Yongbing;XIE Min(Zhejiang Pharmaceutical College,Ningbo,315100)

机构地区：[1]浙江医药高等专科学校

出　　处：《中国医疗器械杂志》2019年第3期205-208,219,共5页Chinese Journal of Medical Instrumentation

基　　金：国家药品监督管理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);浙江省食品药品监督管理与产业发展研究会项目(ZYH2018002)

摘　　要：目的完善体外诊断医疗器械不良事件监测模式,制定科学有效的技术程序。方法通过探讨体外诊断医疗器械不良事件的特征、表现及成因等客观规律,明确监测工作的关键节点。结果构建基于风险管理的体外诊断医疗器械不良事件全程化云监测模式,制定收集与上报、调查、分析与评价、控制四大核心环节的工作程序。结论全程化云监测模式有助于提高我国体外诊断医疗器械不良事件监测水平与监测效率,从而加强风险控制能力,保障大众用械安全。Objective To improve the monitoring mode of in vitro diagnostic medical devices adverse events.Methods By discussing the objective laws of the characteristics,performances and causes of in vitro diagnostic medical devices adverse events,the key points of monitoring work were clarified.Results The whole-process cloud monitoring mode for adverse events of in vitro diagnostic medical devices was constructed based on risk management,and the working procedures for the four core links i.e.collection and report,investigation,analysis and evaluation,and controlling were formulated.Conclusion The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of in vitro diagnostic medical devices adverse events in China,so as to strengthen risk control capability and ensure the public can use medical devices safely.

关 键 词：体外诊断医疗器械不良事件 全程化云监测模式 监测工作程序 

分 类 号：F203[经济管理—国民经济] R197.39[医药卫生—卫生事业管理]