基于医疗器械不良事件探讨我院的医疗器械使用质量控制  

Discussion on the Medical Device Quality Control in Use Based on Medical Device Adverse Events

作　　者：马娟[1] MA Juan(Department of Equipment, Nantong Third People’s Hospital, Nantong Jiangsu 226001, China)

机构地区：[1]南通市第三人民医院设备科,江苏南通226001

出　　处：《中国医疗设备》2017年第8期163-165,共3页China Medical Devices

摘　　要：医疗器械广泛应用于疾病的预防、诊断、治疗和康复的过程中,医疗器械使用质量越来越受到重视。本文汇总了我院医疗器械不良事件(Medical Device Adverse Events,MDAE)监测工作,分别从医用耗材和医疗设备两个方面介绍了医疗器械使用质量控制方法和管理方式,同时由MDAE监测工作这一个点推及到我院医疗器械使用质量控制这一条线,建立完整的医疗器械使用质量控制体系。Medical devices are widely used in the prevention,diagnosis,treatment and rehabilitation of the disease,thus the monitoring of medical device adverse events has attracted much attention.The paper summarized the monitoring of medical device adverse events(MDAE)in our hospital,and introduced medical equipment quality control and management in aspects of medical supplies and medical equipment respectively.Meanwhile,the paper spread the line of medical device quality control from the point of MDAE monitoring,and established a complete quality control system for medical devices.

关 键 词：医疗器械 不良事件监测 质量控制 输液器 

分 类 号：R197.32[医药卫生—卫生事业管理]