摘要
目的:对医院可疑医疗设备不良事件(MDR)报告进行数据挖掘,分析不良事件产生的原因,提出相应的解决对策,以确保医疗设备临床使用安全。方法:从国家药品不良反应监测中心数据库中筛选出经过省、市评价的可疑MDR报告300例,利用SPSS统计软件对不良事件所涉及的医疗设备类别数量、不良事件主要表现、风险类别以及产生的主要原因进行统计分析。结果:MDR产生的原因依次为产品质量相关问题、患者体质与医疗设备之间存在生物不相容性和操作或使用不当。结论:医疗设备生产企业应严格按照生产质量管理规范(GMP)生产,确保产品质量。医疗机构应严格执行标准操作规程(SOP),主动询问患者过敏史,完善监测上报工作。
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.
出处
《中国医学装备》
2016年第12期20-24,共5页
China Medical Equipment
关键词
医疗器械
不良事件
过敏
对策
监测上报
Medical device
Adverse events
Hypersensitivity
Countermeasures
Monitoring and reporting of adverse events
作者简介
蒋贻芳，女，（1995-），本科学历，药师。南京市高淳人民医院药剂科，从事临床药剂工作。
