中心静脉导管用于胸、腹腔积液引流的使用风险  

Risk Analysis on the Application of Central Venous Catheter to Thoracic and Ascites Drainage

作　　者：卞蓉蓉[1] 李尧[1] 赵燕 赵敏[1] 马丹华[1] 宋杏芳 BIAN Rongrong;LI Yao;ZHAO Yan;ZHAO Min;MA Danhua;SONG Xingfang(Center for ADR Monitoring of Jiangsu,Nanjing Jiangsu 210002,China;Center for Drug Reevaluation,NMPA,Beijing 100022,China)

机构地区：[1]江苏省药品不良反应监测中心,江苏南京210002 [2]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国医疗设备》2020年第5期141-143,148,共4页China Medical Devices

摘　　要：目的对中心静脉导管用于胸、腹腔积液引流的不良事件进行研究,通过监测数据和文献调研挖掘使用风险点,为降低该类不良事件的发生率提出控制措施和建议。方法对近三年江苏省收集到的58例中心静脉导管用于胸、腹腔积液引流的不良事件进行统计,对1999-2018年中国知网数据库中相关文献进行可视化分析,与辖区内生产企业进行风险会商。结果国内和进口的中心静脉导管均在临床上被用于胸、腹腔积液引流,预期用途有胸腔、腹腔和心包积液引流;主要产品故障表现为堵塞、折叠、压扁不能回弹等;文献研究得知,中心静脉导管广泛用于积液引流;从中心静脉导管的功能、使用部位、适用人群、结构设计等方面探讨,均不能确保安全有效。结论中心静脉导管用于积液引流,属于超适应症范围使用。相关生产企业应尽可能告知产品超范围使用的风险,使用单位应在产品注册范围内规范用械。Objective To identify the risk of central venous catheter for thoracic and ascites drainage,and to propose control measures and recommendations to reduce the rate of such adverse events.Methods A total of 403 cases of the adverse events of central venous catheter for thoracic and ascites drainage collected in Jiangsu Province in the past three years were used for the statistical analysis;The relevant literatures in the China Knowledge Network database from 1999 to 2018 were visually analyzed.Risk meeting of the relevant manufacturers was performed and considered.Results Both domestic and imported central venous catheters were clinically used for drainage of thoracic and peritoneal effusions.The main product failures are catheter blocked,folded,?attened and unable to rebound.According to literature research,the central venous catheters were widely used for effusion drainage.Considering the discuss of central venous catheters function,use site,applicable population,and structural design,it was not safe and effective for drainage of thoracic and peritoneal effusions.Conclusion It is off-lable use of the central venous catheter for drainage of thoracic and peritoneal effusions.Relevant manufacturers should warn the product risk of over-range use,and the users should standardize the use within the scope indicated in product lea?et.

关 键 词：中心静脉导管 引流 医疗器械不良事件监测 使用风险 超适应症用械 

分 类 号：R561.3[医药卫生—呼吸系统]