摘要
《医疗器械使用质量监督管理办法》已经实施2年,本文将结合本院医疗设备验收经验,介绍如何根据18号令加强医疗器械使用质量监督管理,并保证医疗器械使用的安全性和有效性。医疗设备验收作为医院使用质量监督管理的第一步,而验收检测数据作为今后设备运行的基准参考,其质量的把控与管理的规范,将为全生命周期管理提供有效的保障。
The medical device use quality supervision and management measure has been implemented for 2 years.In this article,we combined the acceptance experience of medical equipment in our hospital to introduce how to strengthen the quality supervision and management of medical devices according to the management measure,and ensure the safety and effectiveness of medical devices.Medical equipment acceptance is the first step to use quality supervision,and its detection data can be used as the reference of the benchmark of the equipment operation.The quality control and management of the specification will provide effective guarantee for the whole life cycle management.
作者
赖金滔
杨绍洲
柳明
余展聪
徐宝燕
LAI Jintao;YANG Shaozhou;LIU Ming;YU Zhancong;XU Baoyan(Department of Equipment and Instrument,Integrated Hospital of Traditional Chinese Medicine,Southern Medical University,Guangzhou Guangdong 510315,China;Department of Equipment and Instrument,Nanfang Hospital Affiliated to Southern Medical University,Guangzhou Guangdong 510515,China)
出处
《中国医疗设备》
2019年第1期146-147,151,共3页
China Medical Devices
基金
广东省科学技术计划(2015A030401038)
关键词
医疗设备
验收
质量控制
设备管理
medical equipment
acceptance testing
quality control
equipment management
