1295例静脉留置针不良事件分析及监管工作改进建议  

The Analysis of 1295 Adverse Events of Vein Detained Needles and Suggestions for Improvement in Regulatory Work

作　　者：李倩[1] 孟艳秋 郭洁[1] Li Qian;Meng Yanqiu;Guo Jie(Children's Hospital Affliated of Zhengzhou University,Henan Provincial Children's Hospital,Zhengzhou Children's Hospital,Zhengzhou Henan 450000,China;Center for Drug Reevaluation of Zhengzhou,Zhengzhou Henan 450000,China)

机构地区：[1]郑州大学附属儿童医院·河南省儿童医院·郑州儿童医院,河南郑州450000 [2]郑州市药物警戒中心,河南郑州450000

出　　处：《医疗装备》2024年第2期53-56,共4页Medical Equipment

基　　金：河南省儿童医院三英人才专项项目。

摘　　要：目的基于真实世界数据,探讨影响静脉留置针使用安全的相关因素,针对该产品不良事件监测工作提出改进建议。方法收集2020年4月至2021年3月河南省药品不良反应监测中心收到的河南省企业生产的静脉留置针不良事件报告,剔除错报、误报、重复上报及无效报告后共纳入1295例不良事件报告。对不良事件的上报情况、患者情况、类型、表现进行分析,并针对静脉留置针不良事件监测工作提出改进建议。结果1295例不良事件中,静脉留置针故障类不良事件919例,占70.97%,其中漏液、堵塞最常见,发生原因主要包括产品质量问题、操作技术及超范围使用等;患者伤害类不良事件548例,占42.32%,其中穿刺部位红肿最常见,发生原因主要包括软管有毛刺、操作不熟练、患者血管条件差等。结论建议通过以下方面改进静脉留置针不良事件监测工作:(1)建议医疗机构加强培训,培养主动监测及上报意识、持续提升不良事件报告质量;(2)建议产品生产、经营企业承担不良事件监测责任,加强分析评价并采取有效控制措施;(3)建议监管部门规范不良事件术语,积极开展重点监测,持续提升用械安全。Objective Based on real-world data,to explore the relevant factors that affect the safety of using vein detained needles,and propose improvement suggestions for adverse event monitoring of the product.Methods With the collection of adverse event reports of vein detained needles produced by enterprises in Henan Province received by the Henan Provincial Drug Adverse Reaction Monitoring Center from April 2020 to March 2021,deletion of false reports,duplicate reports,and invalid reports,a total of 1295 adverse event reports were included.With the analysis of adverse event reporting,patient condition,type and presentation,the suggestions for improvement were proposed for monitoring adverse events of vein detained needles.Results Among the 1295 cases of adverse events,there were 919 cases(70.97%)of vein detained needle failure,among which leakage and blockage were the most common,and the causes mainly included product quality problems,operation technology and out-of-range use;There were 548 patients with injury adverse events,accounting for 42.32%,among which redness and swelling at the puncture site were the most common,and the main causes included hose burrs,unskilled operation,poor vascular conditions of patients,etc.Conclusion Through the analysis of 1295 adverse events,it is recommended to improve the monitoring of adverse events related to vein detained needles through the following aspects:(1)It is recommended that medical institutions strengthen training and publicity,cultivate awareness of active monitoring and reporting,and continuously improve the quality of adverse event reporting;(2)It is recommended that product production/operation enterprises undertake the responsibility of monitoring adverse events,strengthen analysis and evaluation and take effective control measures;(3)It is recommended that the regulatory authorities standardize the terminology of adverse events,actively carry out key monitoring,and continue to improve equipment safety.

关 键 词：静脉留置针 真实世界数据 不良事件 用械安全 

分 类 号：R197.39[医药卫生—卫生事业管理]