ISO 9000质量管理体系在医疗设备管理中的应用及其可靠性探讨  

Application and Reliability of ISO 9000 Quality Management System in Medical Equipment Management

作　　者：林洋[1] 李天庆 高敏[1] 高海鹏[2] LIN Yang;LI Tianqing;GAO Min;GAO Haipeng(Department of Medical Agency,China-Japan Friendship Hospital,Beijing 100029,China;Department of Service,China-Japan Friendship Hospital,Beijing 100029,China;Fuwai Hospital of Chinese Academy of Medical Sciences,National Center for Cardiovascular Diseases,Beijing 100037,China)

机构地区：[1]中日友好医院医学工程处,北京100029 [2]中日友好医院院办,北京100029 [3]国家心血管病中心中国医学科学院阜外医院,北京100037

出　　处：《中国医疗设备》2020年第4期106-108,134,共4页China Medical Devices

摘　　要：目的探讨ISO 9000质量体系在医疗设备管理中的作用及可靠性。方法选取2018年1月至2019年2月在我院接受治疗的患者及医生共106例,观察比较ISO 9000质量管理体系应用前后的设备故障率及正常使用率、患者满意度及医生满意度、账目与实物相符率。结果ISO 9000质量管理体系应用后的设备正常使用率为98.1%,显著高于ISO 9000质量管理体系应用前的设备正常使用率86.8%(P<0.05);ISO 9000质量管理体系应用后的医生及患者的满意度显著高于ISO 9000质量管理体系应用前的满意度(P<0.05);ISO 9000质量管理体系应用后医院设备账目与实物的相符率(98.2%),显著高于ISO 9000质量管理体系应用前的医院设备账目与实物相符率(91.7%,χ^2=5.621,P<0.05)。结论在医院设备管理过程中采用ISO 9000质量管理体系可有效降低设备的故障率,提高患者及医生满意度及账目与实物的相符率。Objective To explore the role and reliability of ISO 9000 quality system in medical equipment management.Methods A total of 106 patients and doctors who received treatment in our hospital from January 2018 to February 2019 were selected to observe and compare the equipment failure rate and normal utilization rate,patient satisfaction and doctor satisfaction,reconciliation rate before and after the application of ISO 9000 quality management system.Results The normal utilization rate of equipment after the application of ISO 9000 quality management system was 98.1%,which was significantly higher than that before the application of ISO 9000 quality management system(86.8%)(P<0.05).The satisfaction of doctors and patients after the application of ISO 9000 quality management system was significantly higher than before the application of ISO 9000 quality management system(P<0.05).The compliance rate(98.2%)of hospital equipment accounts after the adoption of ISO 9000 quality management system was significantly higher than that before the application of ISO 9000 quality management system(91.7%,χ^2=5.621,P<0.05).Conclusion In the process of hospital equipment management,adopting ISO 9000 quality management system can effectively reduce the failure rate of equipment,improve the satisfaction of patients and doctors and the rate of reconciliation between accounts and objects.

关 键 词：医疗设备管理 ISO 9000质量管理体系 设备故障 

分 类 号：R197.39[医药卫生—卫生事业管理]