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医疗设备风险评估与安全管理
引用本文:郭恩宇,高鹏,刘秋莲.医疗设备风险评估与安全管理[J].中国医学装备,2012(4):36-38.
作者姓名:郭恩宇  高鹏  刘秋莲
作者单位:[1]郑州人民医院设备科,河南郑州450003 [2]不详,河南郑州450003
摘    要:目的:改变对医疗器械传统的"资产和物质管理"理念,对医疗器械实施"技术和风险管理"。方法:建立起涵盖医疗器械采购、验收、评价、检测、考核、维护等使用全过程的一系列管理制度,推行美国的国际联合委员会(JCI)管理标准的实施,建立设备风险评估体系,实现对医疗器械使用风险的全程控制,确保采购的医疗器械符合临床需求等。结果:最大限度降低风险发生率,避免设备安全问题的发生。结论:通过JCI标准中的风险评估模式使得医疗设备安全使用有了进一步的保障,减少了医疗机构的风险,提升了病患的医疗安全,减少了临床的医疗风险。

关 键 词:风险评估  高危险性设备  安全培训  失败模式分析

Risk assessment and safety control for medical equipment
GUO En-yu,GAO Peng,LIU Qiu-lian.Risk assessment and safety control for medical equipment[J].China Medical Equipment,2012(4):36-38.
Authors:GUO En-yu  GAO Peng  LIU Qiu-lian
Institution:( Department of Equipment Management,Zhengzhou People's Hospital,Zhengzhou 450003,China. )
Abstract:Objective:To establish the medical equipment safety management system for medical institutions.Methods:Our hospital is implementing American JCI management standard now,and has designed an equipment risk assessment system,The system was effective for equipment management.Results:The occurring rate of the risks was reduced as far as possible to avoid problems of safety.Conclusion:Through the risk assessment model of JCI certification,the safe use of medical equipment has a further safeguard.It reduces the risk of medical institutions,enhances the patients' medical safety and reduces the clinical risk.
Keywords:Risk assessment  High-risk device  Safety training  Failure mode analysis
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