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作 者:许耘 任英 杨宇希 刘威 程茂波 XU Yun;REN Ying;YANG Yuxi;LIU Wei;CHENG Maobo(Center for Medical Device Evaluation,NMPA,Beijing 100076,China)
机构地区:[1]国家药品监督管理局医疗器械技术审评中心,北京100076
出 处:《中国医药导刊》2024年第12期1179-1183,共5页Chinese Journal of Medicinal Guide
摘 要:随着血管介入技术的发展,对配合使用血管内导管的需求日益增加,单腔的外周和中心血管内导管已不能完全满足临床的需要。多腔设计使原本需要多次穿刺的血管通路只需一次穿刺即可实现多种临床操作需求,因此多腔血管内导管在临床心血管介入领域得到广泛应用,并逐渐成为进行血流动力学监测,安全输液及静脉营养支持的主要途径。然而随之产生的多腔血管内导管相关并发症,包括导管扭结、塌陷等机械损伤,感染、血栓形成等问题也日益突出,延长了患者住院时间并且加重了医疗负担。目前相关研究多聚焦于此类产品的临床应用及感染相关问题。本研究基于多腔血管内导管不同于单腔导管的设计参数和性能指标,探讨了多腔血管内导管产品的关键评价点,从器械描述、性能验证、检测注意事项、生物学评价、灭菌和有效期验证、临床评价、说明书及标签等方面进行梳理,明确了多腔血管内导管产品需要额外关注的技术问题和需要进行验证的内容,以期提高此类产品的安全性和有效性,并为其注册和申报提供相关技术指导。With the development of vascular intervention technology,the demand for the use of intravascular catheters is increasing,and single-lumen peripheral and intravascular catheters can not fully meet the clinical needs.The multi-lumen design enables the vascular access that requires multiple puncture to achieve a single puncture.Therefore,the multi-lumen endovascular catheter has been widely used in the field of clinical cardiovascular intervention and has gradually become the main way for hemodynamic monitoring,safe infusion and intravenous nutrition support.However,the resulting multi-lumen endovascular catheter-related complications,including mechanical injuries such as catheter kink and collapse,infection,thrombosis and other problems,are also becoming increasingly prominent,which have prolonged hospital stay and increased medical burden.Relevant researches mainly focus on the clinical application and infection-related problems of such products.This study focused on the design parameters and performance indicators of the multi-lumen endovascular catheter that are different from the single-lumen catheter,explored the key evaluation points of the multi-lumen endovascular catheter in aspects of the device description,performance verification,test precautions,biological evaluation,sterilization and shelf life verification,clinical evaluation and specification requirements,so as to improve the safety and effectiveness of such products,and provide relevant technical guidance for their registration and declaration.
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