JCI体系中医疗设备风险管理的实践和探讨  

Practice and Discussion on Risk Management of Medical Equipment in JCI System

作　　者：郑骏[1] 陈斯尧[1] 楼理纲 冯靖祎[1] 

机构地区：[1]浙江大学医学院附属第一医院医学工程科,浙江杭州310006

出　　处：《中国医疗设备》2014年第6期78-80,共3页China Medical Devices

基　　金：浙江省医药卫生一般研究计划(2012KYA086)

摘　　要：本文介绍了JCI体系下医疗设备风险管理的过程,首先采用特定风险分析工具完成医疗器械的风险等级划分及风险等级分析。然后,根据风险分析结果进行风险管理计划的制定并进行实施。由医疗器械管理部门采集数据、实施监控,必要时实施医疗器械报废甚至召回。以实施的结果和经验来进一步完善该管理计划,促使风险管理计划的持续改进,逐步实现医疗器械"安全、有效"的管理目标。The process of risk management of medical equipment in JCI system is introduced in this paper. Firstly, the risk level of medical equipment was classified and analyzed by risk analysis tool. Secondly, the plan of risk management was formulated and implemented according to the results of risk analysis. Data was collected and monitoring was implemented by medical equipment management department. When necessary, medical equipment could be scrapped or recalled. This management plans should be further improved based on the results and experience of implement, which can promote continuous improvement of risk management plan and realize safe and effective management of medical equipment.

关 键 词：风险管理 风险等级 医疗设备 JCI体系 

分 类 号：R197.3[医药卫生—卫生事业管理]