医院医疗器械不良事件监测现状与改进措施研究  

Research on the Current Situation and Improvement Measures of Adverse Events Monitoring of Medical Devices in Hospitals

作　　者：何建忠 HE Jianzhong(Outpatient and Emergency Department of Hengyang Hospital of Traditional Chinese Medicine,Hengyang,Hunan Province,421001 China)

机构地区：[1]衡阳市中医医院门急诊,湖南衡阳421001

出　　处：《中国卫生产业》2021年第30期9-12,共4页China Health Industry

摘　　要：目的分析该院医疗器械不良事件监测现状,及改善现状制定的改进措施。方法按照《医疗器械分类目录》,对2016年1月—2018年12月衡阳市中医医院上报的21类65种医疗器械不良事件管理类别、各大类医疗器械分布、发生率较高前3位分析,同时分析医疗器械不良事件的发生的原因。结果衡阳市中医医院发生的167件医疗器械不良事件中,第一类医疗器械、第二类医疗器械、第三类医疗器械分别为24件(14.37%)、74件(44.31%)、69件(41.32%)。6815注射穿刺器械类与6866医用高分子材料及制品类不良事件发生率最高。167件医疗器械不良事件中,以一次性无菌注射器、一次性输液器、一次性导尿包发生率最高。造成该院医疗器械不良有事件主要包括产品质量、产品设计,两者分别占比86.83%、5.39%。结论医院医疗器械不良事件监测是保证临床医疗器械安全使用、减少医患纠纷的重要环节。医院医疗器械不良事件监测应从医疗器械的采购计划开始贯穿至医疗器械报废每个环节,医护人员应做好主体责任,设备科技术人员更新观念,通过不断学习与培训,提高风险识别,通过不断监测、评价、持续改进来减少医疗器械不良事件的漏报、误报,提升医疗器械不良事件的管理水平。Objective To analyze the current status of adverse event monitoring of medical devices in the hospital,and to formulate improvement measures to improve the status.Methods According to the"Catalog of Medical Devices Classification",the 21 types of 65 medical device adverse event management categories reported by Hengyang Traditional Chinese Medicine Hospital from January 2016 to December 2018,the distribution of major types of medical devices,and the top 3 with higher incidence rates analyze.At the same time,analyzed the causes of adverse events of medical devices.Results Among the 167 medical device adverse events that occurred in Hengyang Hospital of Traditional Chinese Medicine,the first category medical devices,the second category medical devices,and the third category medical devices.They were 24(14.37%),74(44.31%),and 69(41.32%).6815 injection puncture devices and 6866 medical polymer materials and products have the highest incidence of adverse events.Among the 167 medical device adverse events,disposable sterile syringes,disposable infusion sets,and disposable catheterization kits have the highest incidence.The adverse events of the hospital mainly include product quality and product design,which account for 86.83%and 5.39%,respectively.Conclusion Monitoring of adverse events of hospital medical devices is an important link to ensure the safe use of clinical medical devices and reduce medical disputes.The monitoring of adverse events of medical devices in hospitals should start from the procurement plan of medical devices and run through every link of medical device scrapping.Medical staff should be responsible for the main body,and equipment technicians should update their concepts.Through continuous learning and training,improve risk identification,through continuous monitoring,evaluation,and continuous improvement to reduce underreporting and misreporting of medical device adverse events,and improve the management level of medical device adverse events.

关 键 词：医院 医疗器械 不良事件 监测 持续改进 风险 

分 类 号：R19[医药卫生—卫生事业管理]