医疗器械不良事件监测上报情况分析与思考  

Analysis and Reflection on the Monitoring and Reporting of Medical Device Adverse Events

作　　者：雷硕[1] 林锦穗 LEI Shuo;LIN Jin-sui(Medical Materials and Equipment Service Center,the First Affiliated Hospital of Fujian Medical University,Fujian Fuzhou 350005;Operating Room of the First Affiliated Hospital of Fujian Medical University,Fujian Fuzhou 350005)

机构地区：[1]福建医科大学附属第一医院医用材料与设备服务中心,福建福州350005 [2]福建医科大学附属第一医院手术室,福建福州350005

出　　处：《中国医疗器械信息》2020年第9期8-10,共3页China Medical Device Information

摘　　要：目的:提高医院医疗器械不良事件上报质量,提升临床医护人员发现医疗器械不良事件的能力。方法:结合福建省与本院2017年和2018年医疗器械不良事件统计数据分析对比,做出针对性的改进方案。结果:本院来源于医务人员的医疗器械不良事件上报数量已经超过了临床工程师所上报的数量,医务人员对医疗器械不良事件监测工作的了解更加透彻。结论:医院作为医疗器械不良事件监测的重要环节,需要重视医疗器械不良事件监测上报政策的贯彻落实。Objective:To improve the quality of reporting adverse events of medical devices in hospitals and the ability of clinical medical staff to discover adverse events of medical devices.Methods:Based on the analysis and comparison of medical device adverse event statistics of Fujian Province and our hospital in 2017 and 2018,a targeted improvement plan was made.Results:The number of medical device adverse events reported by medical staff in our hospital has exceeded the number reported by clinical engineers,and medical staff has a better understanding of the monitoring of medical device adverse events.Conclusion:As an important part of medical device adverse event monitoring,hospitals need to pay attention to the implementation of the policy of monitoring and reporting of medical device adverse events.

关 键 词：医疗器械 不良事件 分类分析 临床工程师 培训 

分 类 号：R197.39[医药卫生—卫生事业管理]