JCI体系中医疗设备风险管理的实践和探讨.pdfVIP

科学管理 SCIENTIFIC MANAGEMENT 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 郑骏，陈斯尧，楼理纲，冯靖祎 [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 浙江大学医学院附属第一医院 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 医学工程科 ，浙江 杭州 310006 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 。 [关键词] 风险管理 ；风险等级 ；医疗设备 ；JCI体系 Abstract: 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 ZHENG Jun, CHEN Si-yao, equipment. LOU Li-gang, FENG Jing-yi Key words: risk management; risk level; medical equipment; JCI system Department of Medical Engineering, The First Affiliated Hospital of Medical [中图分类号] R197.3 [文献标志码] C School, Zhejiang University, Hangzhou doi ：10.396