两款输液泵的输血安全性评估  

Safety evaluation of blood transfusion using two infusion pumps

作　　者：孙晋红 杨金婉 贾凤仙 张威鹏 Sun Jinhong;Yang Jinwan;Jia Fengxian;Zhang Weipeng(Censorship Center,Market Supervision Administration of Shenzhen Municipality,Guangdong Province,Shenzhen 518000,China;Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.,Guangdong Province,Shenzhen 518000,China)

机构地区：[1]深圳市市场监督管理局许可审查中心,深圳518000 [2]深圳迈瑞生物医疗电子股份有限公司,深圳518000

出　　处：《现代仪器与医疗》2022年第2期13-16,共4页Modern Instruments & Medical Treatment

摘　　要：目的随着市场上新设备迅速出现,当前使用的新型输液泵缺乏强有力的数据支撑.亟须对市面上的新型输液泵的安全性进行评估.方法使用BeneFusion VP3与BeneFusion nVP输液泵体外模拟输血,与重力输注后的测量值相比较,进行相应的评价指标测试.测试中使用血液制品包括去白悬浮红细胞、单采血小板以及血浆.结果经输液泵输注后血液制品的各项指标与重力自由流输注相比差别不大,均满足国家标准.且输液泵输注相较于重力输注对流速控制更加精准.结论根据体外模拟输血测试结果与上市后临床跟踪结果综合评估,可证明文中两款输液泵输血应用的安全有效.Objective It has been proved that infusion pumps can be used for blood transfusion.However,robust data are lacking and literature on the newer infusion pumps in current use is sparse and inherently incomplete as newer devices rapidly appear on the market.It is necessary to evaluate the safety of new infusion pumps on the market.Methods By using BeneFusion VP3 and BeneFusion nVP infusion pumps,this paper measured the effect after simulated blood transfusion using infusion pumps and compared these results to transfusion simulated without use of an infusion pump.Blood products used in the test include red blood cells,platelet and plasma.Results None of the infusion pumps were inferior to the gravity flow method.Indexes after transfusion meet the national standards.In addition,compared with gravity infusion,pump infusion is more accurate in controlling the flow rate.Conclusion Based on the comprehensive evaluation of in vitro simulated blood transfusion test results and post-marketing clinical follow-up results,it is proved that BeneFusion VP3 and BeneFusion nVP infusion pumps perform to an acceptable level and appear safe to be used for blood transfusion.

关 键 词：输液泵 BeneFusion VP3 BeneFusion nVP 输血 

分 类 号：R197.32[医药卫生—卫生事业管理]