Development of a novel neonatal resuscitation monitor to ensure safe and effective provision of breathing support to newborn infants

英国医疗器械SME，Europlaz是ISO13485，拥有由Frede Jensen(新生儿医疗器械专家)，Ian Gooduck(工程经理)，Katharine O‘Keeffe(商业赞助商和项目经理)组成的核心项目团队。10%的新生儿需要产房复苏。新生儿的复苏压力很大，但临床医生没有设备来准确评估婴儿的心肺系统并采取相应的行动。四分之三的新生儿复苏被认为不安全或低于可接受的标准(Vaidya，2021)。产妇保健索赔的总成本为42亿GB，其中分娩期间的脑损伤占39%，即16亿GB。缺乏可靠、客观的数据阻碍了对错误的评估，并限制了学习/改进的机会。Europlaz的解决方案是一种直观的多参数呼吸监护仪，即使是最小的患者也可以显示潮气量、二氧化碳消除、Sp02、双(R/L)氧合和面罩渗漏。该设备增强了NICU的能力，并将技能转移到服务不足、技术含量低的产房。实时数据以直观的条形图显示，导出能够记录复苏事件，以供问责和学习/改进。Europlaz正在将ICU技术(潮气量/二氧化碳)引入产科病房。Europlaz设备将提高复苏效率，防止容量引起的肺和二氧化碳引起的脑损伤。它将减少2.2%的婴儿升级为高重症监护，并可以为NHS节省1500万GB的新生儿重症监护。这项创新弥补了人员短缺和技能缺陷。该项目将使研发活动增加50%，并将为英国一家生产救生产品的医疗器械制造公司创造20多个就业机会。

UK medical device SME, Europlaz is ISO13485 and has a core project team of Frede Jensen (Neonatal Medical Device Specialist), Ian Goodacre (Engineering Manager), Katharine O'Keeffe (Business Sponsor and Project Manager).Delivery room resuscitation is needed for 10% of newborns. Resuscitation of neonates is stressful and highly pressured, but clinicians do not have the equipment to enable them to accurately evaluate the baby's cardio-respiratory system and act accordingly. Three-quarters of newborn resuscitations are considered unsafe or below the accepted standard (Vaidya,2021 ). Total cost of maternity care claims are £4.2bn and brain damage during birth accounts for 39%, or £1.6bn. The lack of reliable, objective data hinders the evaluation of errors and limits opportunities for learning/improvement.Europlaz's solution is an intuitive, multiple-parameter, respiratory monitor to display tidal volume, C02 elimination, Sp02, dual (R/L) oxygenation and mask leak for even the smallest patients. The device enhances NICU capability and transfers skills to the under-served, low-tech delivery room.Real-time data is displayed as a straightforward bar graph, and export enables recording the resuscitation event for accountability and learning/improvement. Europlaz is bringing ICU technology (tidal volume/CO2) into the maternity ward.The Europlaz device will improve resuscitation efficiency and prevent volume induced lung and CO2 induced brain injuries. It will reduce the escalations of 2.2% of babies into high-intensive care and could save the NHS £15M in neonatal intensive care. The innovation compensates for staffing shortages and skills deficits.The project will increase R&D activity by 50% and will create 20+ jobs for a medical device manufacturing company producing life saving products here in the UK.