广东省二、三类医疗器械生产企业不良事件监测工作调查和分析  

Investigating and Analyzing the Second and Third Type Medical Device Manufacturers to Carry Out Adverse Events Monitoring in Guangdong Province

作　　者：王宏[1] 杨丽君[1] 邓剑雄[1] 邢欣[1] 卢淑棠[1] 

机构地区：[1]广东省药品不良反应监测中心,广东广州510080

出　　处：《中国药物警戒》2011年第9期543-546,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的调查二、三类医疗器械生产企业开展不良事件监测工作情况和存在的问题。方法收集我省二、三类医疗器械生产企业开展不良事件监测工作的信息,录入Epidata 3.02软件,用Excel对信息进行统计分析。结果在本次调查中,59.1%的企业设有专职人员从事不良事件监测工作,但从业人员学历偏低和从业时间较短。75.7%的企业建立了不良事件监测小组,小组主要由企业负责人、质量控制部门、行政部门和生产部门的工作人员组成,但企业内部开展医疗器械不良事件监测培训工作力度不够。企业主要通过产品使用情况跟踪(91.9%)和投诉(66.8%)的方式收集其产品的安全性信息,而对不良事件监测认识了解不够(83.2%)是影响企业开展不良事件监测工作的最大因素。结论二、三类医疗器械生产企业在不良事件监测工作中存在认识不清、监测制度不完善、监测水平低等问题,需要加强宣传培训和监管。Objective To conduct investigation on how the second-and-third-class medical device manufacturers in Guangdong Province monitor adverse events and what problems exist in their work. Methods To collect information on how the second-and-third-class medical device manufacturers in Guangdong Province monitor adverse events, enter the information into EpiData 3.02 software and conduct statistical analysis in Excel software. Results The investigation reveals that 59.1% of enterprises have full-time professional personnel to monitor adverse events. However, personnel are generally not sufficiently well-educated and lacking in work experience. 75.7% of enterprises have set up the working group, which consists of business executives and personnel from quality control department, administrative department and production department, to monitor adverse events. However, training on monitoring ：adverse events is not sufficient in these enterprises. Safety information on products is mainly collected through products tracking（91.9%） and consumer complaints（66.8%）. Insufficient knowledge on adverse events（83.2%） is the major factor that hinders the monitoring work. Conclusion Problems such as insufficient knowledge, inadequate monitoring system and low-quality monitoring in adverse events monitoring exist in the second-and-third-class medical device manufacturers. Training and supervision should be strengthened to tackle these problems.

关 键 词：医疗器械不良事件 监测 医疗器械安全性 生产企业 

分 类 号：R955[医药卫生—药学]