基于真实世界多源数据全景分析定位针类产品临床使用风险研究  

Research on Clinical Use Risk of Localization Needle Products Based on Panoramic Analysis of Multi-Source Data in the Real World

作　　者：徐慧薇 宋雅娜 尹建兵 晁园 张坤智 吴海雯 XU Huiwei;SONG Yana;YIN Jianbing;CHAO Yuan;ZHANG Kunzhi;WU Haiwen(Ningbo Center for ADR Monitoring,Ningbo Zhejiang 315042,China;Center for Drug Reevaluation,NMPA,Beijing 100022,China;Zhejiang Center for Medical Device Evaluation,Hangzhou Zhejiang 310009,China;Center for Medical Device Adverse Events Monitoring of Zhejiang,Hangzhou Zhejiang 310009,China)

机构地区：[1]宁波市药品不良反应监测中心,浙江宁波315042 [2]国家药品监督管理局药品评价中心,北京100022 [3]浙江省医疗器械审评中心,浙江杭州310009 [4]浙江省医疗器械不良事件监测中心,浙江杭州310009

出　　处：《中国医疗设备》2025年第2期75-81,88,共8页China Medical Devices

基　　金：国家药监局“十四五”医疗器械不良事件重点监测项目{药监综械管[2021]99号}。

摘　　要：目的探究定位针类医疗器械产品上市后临床使用风险监测真实世界种类、产生原因和控制措施。方法通过检索国家药品监督管理局官网、国家医疗器械不良事件监测信息系统、美国食品药品监督管理局官网MAUDE和Medical Device Recalls数据库、中国知网数据库获取定位针类产品安全性信息,规整和统计多源数据,研究定位针类产品风险种类,分析风险产生因素并提出风险防控措施。结果定位针类产品主要涉及2种故障类风险(无法激发与释放、脱落与移位)、3种伤害类风险(气胸与出血、遗落体内异物未取出、致敏)和3种其他类风险(超范围使用、被其他合并用械损伤、产生伪影)。风险产生主要原因包括产品研发设计、生产过程控制、临床适应证选择、合并器械使用、患者个体差异等。风险防控措施包括注册人优化产品、提升质量,临床使用单位准确把握适应证规范使用产品。结论定位针类产品上市后应用于临床真实世界,存在故障、伤害和其他可能导致患者伤害等各种风险,应加强该类产品生产、使用和监管环节的安全性监测和管理,以期减少风险、降低伤害。Objective To explore the real-world types,causes and control measures for post-market clinical use risk monitoring of localization needle-based medical device products.Methods By searching the official website of the National Medical Products Administration,the National Medical Device Adverse Event Monitoring Information System,the MAUDE and Medical Device Recalls databases of the US Food and Drug Administration,and the CNKI database,safety information of localization needle products was obtained.Multiple sources of data were organized and statistically analyzed to study the types of risks associated with localization needle products,analyze the factors that cause risks,and propose risk prevention and control measures.Results Localization needle products mainly involved two types of fault risks(inability to trigger and release,detachment and displacement),three types of injury risks(pneumothorax and bleeding,failure to remove foreign objects from the body,sensitization),and three other types of risks(excessive use,damage from other combined equipment,and artifact generation).The causes of risk included product development and design,production process control,clinical indication selection,combined device use,individual patient differences,etc.Risk prevention and control measures included the registrant optimizing the product to improve quality,and clinical use units accurately grasping the indications for standardized use of the product.Conclusion After the launch of localization needle products in the real world,there are various risks such as fault,injuries,and other potential harm to patients.Therefore,it is necessary to strengthen the safety monitoring and management of the production,use,and supervision of such products in order to reduce risks and injuries.

关 键 词：定位针 真实世界 临床使用 不良事件 风险研究 临床适应证选择 

分 类 号：R197.3[医药卫生—卫生事业管理]