非均衡性测量法在一次性使用静脉采血针不良事件报告风险信号挖掘与分析中的应用  

Application of Non-Equilibrium Measurement Method in Mining Risk Signals and Analysis of Adverse Events Report of Disposable Venous Blood Collection Needle

作　　者：肖育华[1] 蔡权周 傅渊锋 王宏[1] XIAO Yuhua;CAI Quanzhou;FU Yuanfeng;WANG Hong(Center for ADR Monitoring of Guangdong,Guangzhou Guangdong 510080,China;Foshan Center for Food and Drug Control,Foshan Guangdong 528000,China)

机构地区：[1]广东省药品不良反应监测中心,广东广州510080 [2]佛山市食品药品检验检测中心,广东佛山528000

出　　处：《中国医疗设备》2024年第11期93-97,119,共6页China Medical Devices

基　　金：广东省药品监督管理局科技创新团队项目(2021TDB26)。

摘　　要：目的及时识别一次性使用静脉采血针风险,发挥医疗器械不良事件监测体系的实时监测效能。方法采用非均衡性测量法中的报告比值比(Reporting Odds Ratio,ROR)法和比例报告比(Proportional Reporting Ratio,PRR)法对广东省医疗机构上报的234例一次性使用静脉采血针不良事件的真实世界报告进行风险信号挖掘,调查、分析事件发生原因。结果监测发现,不同持有人的一次性使用静脉采血针有关连接组件松脱不良事件报告数量与占比存在失衡,符合风险信号判定标准。经分析研究,该风险信号得到确认,发生原因主要为产品原因,含说明书不完善、生产工艺问题、设计缺陷。结论非均衡性测量法中的ROR法和PRR法可有效挖掘和识别不同持有人的一次性使用静脉采血针不良事件风险,在有源、无源和体外诊断试剂类医疗器械不良事件风险信号的挖掘、识别、分析应用方面具有一定参考和推广价值。Objective To promptly identify the risks associated with disposable venous blood collection needles and leverage the real-time monitoring effectiveness of the medical device adverse event monitoring system.Methods Using the reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method in the non-equilibrium measurement approach,a real-world report of 234 cases of adverse events related to disposable venous blood collection needles reported by medical institutions in Guangdong Province was analyzed to explore risk signals,investigate,and analyze the reasons for the occurrence of events.Results Monitoring revealed an imbalance in the number and proportion of adverse event reports related to the connecting component loosening of disposable venous blood collection needles among different holders,meeting the risk signal determination criteria.Through analysis and research,the risk signal was confirmed,with the main cause being attributed to product-related issues,including incomplete instructions,production process problems,and design defects.Conclusion The ROR and PRR methods in the non-equilibrium measurement approach effectively explore and identify the risk of adverse events related to disposable venous blood collection needles among different holders.They have a certain reference and promotional value in the mining,identification,and analysis of risk signals for adverse events in active,passive,and in vitro diagnostic reagent medical devices.

关 键 词：非均衡性测量法 报告比值比 比例报告比 静脉采血针 连接组件 针座 不良事件 

分 类 号：R197.39[医药卫生—卫生事业管理]