植入式心脏复律除颤器常见风险点浅析  

Common Risks from Implantable Cardioverter Defibrillators

作　　者：沈晓华 张龙瑛 丘婧婷 吴正善 赵燕 SHEN Xiaohua;ZHANG Longying;QIU Jingting;WU Zhengshan;ZHAO Yan(Fujian Center for Drug Evaluation and Monitoring,Fuzhou Fujian 350000,China;Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China)

机构地区：[1]福建省药品审评与监测评价中心,福建福州350000 [2]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076

出　　处：《中国药物警戒》2024年第11期1284-1287,共4页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2021YFC2701302);福建省药品监督管理局科技项目(2023012)。

摘　　要：目的分析植入式心脏复律除颤器(Implantable Cardioverter Defibrillator,ICD)常见风险发生特点,为临床安全用械提供参考。方法提取2015年1月1日至2024年3月15日期间,某省医疗器械不良事件监测数据库和美国食品药品监督管理局厂商和用户使用设备体验数据库中关于ICD的不良事件报告,结合国内召回信息,对其进行统计分析。结果ICD不良事件涉及的器械故障主要为误放电、电池提前耗竭、电极导线故障等;主要伤害为二次手术、感染、心律失常等。结论临床医务人员应充分认识该产品使用风险,权衡患者风险受益比,慎重适应证选择,规范临床使用;生产企业应加强该产品上市后风险管理,认真分析风险发生可能原因,将其作为上市前风险因素识别参考,改进产品设计,增强产品性能,降低产品固有风险。Objective To analyze the common risks posed by implantable cardioverter defibrillators(ICD)and provide references for clinical safety.Methods The reports about ICD-related adverse events were retrieved from the medical device adverse event monitoring system database of one province between Jan 1,2015 and Mar 15,2024 and from Manufacturer and User Facility Device Experience of the US Food and Drug Administration.Combined with the domestic information on recalls,these reports were statistically analyzed.Results The device failures included inadequate shock,premature discharge of batteries and depletelectrode failure.The dominating injuries involved were secondary surgeries,infections,and arrhythmia.Conclusion Clinical medical personnel should have an intimate knowledge of the impact of adverse events of the product on patients,weigh the risk-benefit ratio of patients,select indications with caution,and standardize clinical use.Manufacturers should strengthen the post-marketing risk management of the product,analyze the possible causes of risks and use them as the pre-market risk factors,improve product design,enhance product performance,and reduce the inherent risk of products.

关 键 词：植入式 除颤器 心脏 不良事件 风险 误放电 电池提前耗竭 电极导线故障 

分 类 号：R197.39[医药卫生—卫生事业管理] R994.11[医药卫生—公共卫生与预防医学]