中国医学装备2016，Vol.13Issue(12)：20-24,5.DOI:10.3969/J.ISSN.1672-8270.2016.12.007
医院可疑医疗设备不良事件的分析与对策
Analysis and countermeasures of suspected medical devices adverse events of hospital
蒋贻芳 1高小坤2
作者信息
- 1. 南京市高淳人民医院药剂科 江苏 南京 211300
- 2. 苏北人民医院化学试剂耗材采购中心 江苏 扬州 225001
- 折叠
摘要
Abstract
Objective:To sort out cases of suspected medical device adverse events in Subei hospital, analysis for the reasons of adverse events, and propose measures to ensure the safe clinical use of medical devices.Methods: From the National Adverse Drug Reaction Monitoring Centre database, 300 cases of suspicious medical device adverse events were selected from cities and provinces. The number of categories of adverse events involving medical devices and the main reasons resulting adverse events were analyzed by SPSS.Results: The main reasons resulting the medical device adverse events were quality-related issues of the product, biological incompatibility existing between the patient and the physical device, and improper operation or use.Conclusion: The enterprises of medical devices should product on the basis of GMP strictly to ensure the quality of product. The medical institutions should ask hypersensitivity of patients actively and operate on the basis of SOP strictly to improve the work of monitoring and reporting.关键词
医疗器械/不良事件/过敏/对策/监测上报Key words
Medical device/Adverse events/Hypersensitivity/Countermeasures/Monitoring and reporting of adverse events分类
医药卫生引用本文复制引用
蒋贻芳,高小坤..医院可疑医疗设备不良事件的分析与对策[J].中国医学装备,2016,13(12):20-24,5.
