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

英国医疗器械中小企业Europlaz通过ISO13485认证，核心项目团队由Frede Jensen（新生儿医疗器械专家）、Ian Goodacre（工程经理）、Katharine O’keeffe（业务赞助商和项目经理）组成。10%的新生儿需要产房复苏。新生儿的复苏压力很大，而且压力很大，但临床医生没有设备使他们能够准确地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是不安全的或低于可接受的标准（Vaidya,2021）。产妇护理索赔的总费用为42亿英镑，分娩期间的脑损伤占39%，即16亿英镑。缺乏可靠、客观的数据阻碍了对错误的评价，限制了学习/改进的机会。europlaza的解决方案是一种直观的多参数呼吸监测仪，即使是最小的患者也可以显示潮汐量，二氧化碳消除，Sp02，双（R/L）氧合和面罩泄漏。该设备增强了新生儿重症监护室的能力，并将技能转移到服务不足、技术含量低的产房。实时数据显示为一个简单的条形图，导出可以记录复苏事件，以便进行问责和学习/改进。europlaza正在将ICU技术（潮汐容积/二氧化碳）引入产科病房。europlaza装置将提高复苏效率，防止体积性肺损伤和二氧化碳性脑损伤。它将减少2.2%的婴儿进入高重症监护，并可以为NHS在新生儿重症监护方面节省1500万英镑。这一创新弥补了人员短缺和技能不足。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设备制造公司创造20多个就业岗位。

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.