近日，国家药品监督管理局经审查，批准了东莞科威医疗器械有限公司生产的创新产品“集成膜式氧合器”注册。

　　集成膜式氧合器由氧合器组件(集成气体交换器和热交换器)和静脉贮血器系统组成，可组合使用，氧合器组件集成动脉微栓过滤功能(可选)。该产品适用于体重>10kg的患者。氧合器适用于体外循环手术(时间不超过6小时)中血液的氧合和二氧化碳的排除，并调节血液温度。静脉贮血器系统用于收集、存储和过滤血液。

　　该产品采用了螺旋导流集成化结构，在血液入口处通过螺旋导流结构引导血液快速分散流动，在进入变温室进行气体交换时，通过由内到外的多孔状导流结构，实现血液的二次分流，使血液在整个氧合器腔体内均匀的分布，缩短血流路径，提升氧合器的气体交换能力同时降低压力损失。在临床应用中集成的结构设计具有可减少整体预充量，减少血液稀释的临床意义。

　　药品监督管理部门将加强该产品上市后监管，保护患者用械安全。

　　Integrated membrane oxygenator approved for marketing

　　Recently, the innovative product integrated membrane oxygenator of Dongguan Kewei Medical Device Inc. is approved for marketing by China NMPA.

　　The integrated membrane oxygenator is composed of oxygenator components (integrated gas exchanger and heat exchanger) and a venous blood reservoir system, which can be used in combination. The oxygenator components integrate the arterial micro thrombus filtering function (optional). This product is suitable for patients weighing more than 10kg. The oxygenator is applicable to oxygenation of blood, elimination of carbon dioxide and regulation of blood temperature during cardiopulmonary bypass surgery (up to 6 hours). The venous blood reservoir system is used to collect, store and filter blood.

　　The product adopts a spiral flow guide integrated structure, which guides the rapid dispersion of blood flow at the blood inlet. When entering the tempering chamber for gas exchange, the secondary diversion of blood is realized through the porous flow guide structure from inside to outside, so that the blood is evenly distributed in the whole oxygenator chamber, shortening the blood flow path, improving the gas exchange capacity of the oxygenator and reducing the pressure loss. The integrated structure design in clinical application has the clinical significance of reducing the overall pre-charging volume and hemodilution.

　　The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.