论文部分内容阅读
目的对1 028例医疗器械不良事件发生的特点及规律进行统计分析,为医疗器械不良事件监测工作提供建议。方法采用回顾性分析方法,对贵阳市2012年收集的1 028例医疗器械不良事件报告进行综合分析。结果宫内节育器引起的严重不良事件所占比例较高。基层用户上报意识有待提高。医疗器械不良事件报告质量有待提高。结论加强宫内节育器的监测。从开展有针对性的宣传培训、建立健全医疗器械不良事件监测网络两方面提高不良事件监测工作水平。
Objective To analyze the characteristics and laws of the occurrence of adverse events in 1 028 medical devices and provide suggestions for the monitoring of adverse events in medical devices. Methods A retrospective analysis method was used to analyze a total of 1 028 cases of medical device adverse events collected in Guiyang in 2012. Results IUDs caused a higher proportion of serious adverse events. Grassroots users need to raise awareness. Medical device adverse event report needs to be improved. Conclusion To strengthen the monitoring of IUD. From the implementation of targeted publicity and training, establish and improve a medical device adverse event monitoring network to improve the level of adverse event monitoring work.