中心静脉导管类医疗器械不良事件风险研究  

Study on Adverse Event Risk of Medical Devices with Central Venous Catheters

作　　者：徐慧薇 尹建兵 吴海雯 李卫红 周杰 XU Huiwei;YIN Jianbing;WU Haiwen;LI Weihong;ZHOU Jie(Ningbo Center for ADR Monitoring,Ningbo Zhejiang 315042,China;Center for Medical Device Adverse Events Monitoring of Zhejiang,Hangzhou Zhejiang 310009,China;Taizhou Institute for Food and Drug Control,Taizhou Zhejiang 318000,China;Pufeisheng Medical Technology(Nanjing)Co.,Ltd.,Nanjing Jiangsu 210000,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]浙江省医疗器械不良事件监测中心,浙江杭州310009 [3]台州市食品药品检验研究院,浙江台州318000 [4]普非圣医药科技(南京)有限公司,江苏南京210000

出　　处：《中国医疗设备》2024年第10期126-131,共6页China Medical Devices

基　　金：浙江省药品监管系统科技计划项目(2022028)。

摘　　要：目的探究中心静脉导管类医疗器械不良事件风险种类、发生原因及应对措施。方法通过检索美国食品药品监督管理局官网、知网、国家药品监督管理局官网和浙江省药品监督管理局官网的中心静脉导管类产品不良事件信息源,收集整理并研究其风险种类,分析风险发生因素并提出应对措施。结果中心静脉导管类产品不良事件主要涉及产品自身设计风险、注册人产品生产质量控制风险、临床操作使用风险和患者风险4个方面。发生风险的原因主要包括注册人产品材质选择和结构设计、生产质量控制程度、临床实际操作方法、患者个体差异、患者及家属配合程度等。应对措施包括注册人改进产品、加强质量管理体系建设、规范临床操作、严格把握适用范围、充分沟通与宣教。结论中心静脉导管类产品存在可能导致人体伤害的已知和非预期风险,应在该类产品生产、使用和监管环节加强风险监测和风险管理,防止同类不良事件的发生率。Objective To study the risk types,occurrence causes and countermeasures of adverse events of central venous catheterbased medical devices.Methods By searching on the official website of the US Food and Drug Administration,CNKI,the official websites of the National Medical Products Administration and the Zhejiang Medical Products Administration,the types of risks was investigated,the risk factors was analysed and the countermeasures for the adverse events of central venous catheter products was put forward.Results Adverse events of central venous catheter products mainly involved four aspects:product design risk,registrant product quality control risk,clinical operation and use risk and patient risk.The reasons for the occurrence of risks mainly included the choice of material and structural design of the registrant’s products,the degree of production quality control,the actual clinical operation methods,individual differences in patients,and the degree of co-operation of patients and their families.Countermeasures included product improvement by the registrant,strengthening of quality management system construction,standardisation of clinical operations,strict control of the scope of application,and adequate communication and education.Conclusion Central venous catheter products have known and unintended risks that may lead to human injuries,and risk monitoring and risk management should be strengthened in the production,use and regulation of such products to prevent the recurrence of similar adverse events.

关 键 词：中心静脉导管 医疗器械不良事件 风险研究 风险应对措施 产品注册人 严重伤害 

分 类 号：R197.32[医药卫生—卫生事业管理]