摘要
目的探讨医用注射泵的主要故障表现、故障原因和处理措施,为临床正确使用和维护提供参考。方法收集2020年1月至2022年12月国家医疗器械不良事件监测信息系统中临沂市的290例医用注射泵不良事件报告数据,并对医用注射泵不良事件报告的上报情况、所涉产品情况、器械故障表现、伤害表现、故障原因及上市许可持有人的调查处置情况进行统计分析。结果医用注射泵不良事件报告来源主要是二级及以上医疗机构,多为国产医用注射泵,故障主要为注射速度不准,可能原因为老化磨损、长时间未维护校准等。结论医用注射泵设计、生产和使用单位应高度重视不良事件报告,加强监测数据的分析与利用,强化医用注射泵的使用培训和维护保养。
Objective The main symptoms,causes,and treatment measures for malfunction of medical injection pumps were explored,to provide reference for correct clinical use and maintenance.Methods With collection of data on 290 adverse event reports of medical injection pumps in Linyi City from January 2020 to December 2022 in the National Medical Device Adverse Event Monitoring Information System,the reporting status of adverse event reports for medical injection pumps,the situation of the products involved,the performance of device malfunctions,injury symptoms,the causes of malfunctions,and the investigation and disposal of marketing license holders were statistically analyzed.Results The main sources of adverse event reports for medical injection pumps were secondary and above medical institutions,among which most are domestic medical injection pumps.The main fault was the inaccurate injection speed,which may be due to aging and wear,as well as long-term failure to maintain and calibrate.Conclusion The design,production,and use institutions of medical injection pumps should attach great importance to adverse event reporting,strengthen the analysis and utilization of monitoring data,and strengthen the training and maintenance of medical injection pumps.
作者
史玉清
Shi Yuqing(Linyi Pharmacovigilance Center,Linyi Shandong 276000,China)
出处
《医疗装备》
2023年第18期34-36,共3页
Medical Equipment
关键词
医用注射泵
医疗器械不良事件
分析
Medical injection pump
Medical devices adverse events
Analysis
