Thrive Networks has announced that a new neonatal breathing device for use in low-income countries has received the CE mark, an important step in preparing the device for use in hospitals in low-resource settings around the world.
The device, a neonatal bubble CPAP – or Continuous Positive Airway Pressure – machine, is designed to help premature and sick newborns who cannot breathe well on their own. Thrive Networks worked with its partner, Vietnam-based social enterprise MTTS, to develop and prepare the device for CE-mark approval with funding from the Wellcome Trust.
The new device, called the Dolphin CPAP, was developed specifically for low-resource hospitals. These facilities often have limited funding, unstable electricity supplies and difficult conditions. The Dolphin CPAP has several advantages over devices currently being used in these settings. It is more durable and easier to operate, and suitable for facilities that may not have compressed air or oxygen-monitoring equipment available. It also is compatible with battery and solar energy, making it less dependent on a constant power supply. In addition, the device uses tubing that is sterilized for each patient, thus reducing the need for consumable products and lowering the lifetime operating costs while reducing the risk of infection caused by re-using tubes meant to be disposable.
The CE mark, which is mandatory for certain products sold within the European Economic Area, indicates that a product meets certain safety, health and environmental protection requirements set by the European Commission’s managing agency. The Dolphin CPAP will be piloted by MTTS in India and ready for distribution in 2017.
Thrive Networks helped to develop this new device under its Newborn Health Program, which began in 2004 and has operated in nine low-resource countries. Thrive has reached more than 500,000 newborns in need through this program, providing medical devices, materials, clinical training and research to address respiratory distress, jaundice, infection prevention and other critical issues affecting babies born in limited-resource settings.