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徐汇区医疗机构植入/介入性医疗器械使用情况的调研
引用本文:王芳,陈尧水,高吾名,顾伟. 徐汇区医疗机构植入/介入性医疗器械使用情况的调研[J]. 中国医疗设备, 2014, 0(6): 74-77
作者姓名:王芳  陈尧水  高吾名  顾伟
作者单位:[1]上海市食品药品监督管理局徐汇分局,上海200030 [2]上海交通大学附属胸科医院门诊办公室,上海200030
摘    要:本文以上海市徐汇区11家二、三级医疗机构为样本,通过问卷调查、现场核查、专家研讨座谈会等形式,对植入/介入性医疗器械的管理现状、使用情况进行了调研。并针对区域内医疗机构目前存在的医疗器械证照管理、医疗器械不良事件监测、医疗器械废弃物管理和骨科“非消毒包装植入性医疗器械”管理的现状与不足,进行分析和研究,提出了植入/介入性医疗器械的管理新思路、新构想。

关 键 词:植入  介入性医疗器械  医疗设备管理  质量控制

Research on the Usage of Implantable/Interventional Medical Devices in Medical Institutions of Xuhui District
WANG Fang,CHEN Yao-shui,GAO Wu-ming,GU Wei. Research on the Usage of Implantable/Interventional Medical Devices in Medical Institutions of Xuhui District[J]. Chinese medical equipment, 2014, 0(6): 74-77
Authors:WANG Fang  CHEN Yao-shui  GAO Wu-ming  GU Wei
Affiliation:1 .Branch of Xuhui, Shanghai Food and Drug Administration, Shanghai 200030, China; 2.Office of Outpatient Service, Chest Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200030, China)
Abstract:The current management situation and usage of implantable/interventional medical devices were investigated in 11 medical institutions in ShanghaiXuhui district by questionnaire survey, field veriifcation, expert discussion forums and so on. Status and inadequate of the management of medical device license, medical device adverse event monitoring, management of waste medical devices and orthopedics "non-sterile packaging of implantable medical devices" were analyzed and researched. The new ideas of the implantable/interventional medical devices were put forward in this paper.
Keywords:implantable/interventional medical devices  medical equipment management  quality control
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