South Carolina-based Prisma Health has secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its VESper ventilator expansion device, which will help increase ventilator capacity for COVID-19 patients.
VESper is an advanced ventilator expansion device that enables a single ventilator to treat up to four patients during times of acute equipment shortages such as the current COVID-19 pandemic.
The ventilator expansion device has been manufactured using 3D printing technology
The ventilator device, which is manufactured using 3D printing technology, has been developed with material already in use for medical devices.
Prisma Health said that its experts are coordinating with national COVID-19 teams who have no more ventilator capacity and who can begin emergency use of the prototype.
Prisma Health-Upstate department of medicine chair Dr Peter Tilkemeier said: “The VESper device can be lifesaving when the number of critically ill patients requiring breathing support is greater than the number of available ventilators. A number of U.S. hospitals are likely to begin experiencing this with COVID-19.”
Prisma Health’s Healthcare Simulation Centre has been used by the physicians to commence the testing of VESper device with medical manikins, helping to simulate multiple clinical scenarios.
The ventilator expansion device has the capacity to deliver the relevant breathing parameters without complication, helping to quickly apply the device directly into clinical use.
Prisma Health is also partnering with other companies such as HP and its Digital Manufacturing Network to quickly enhance the 3D production of validated parts for supplying in the areas of urgent need and areas with the potential to cross their ventilator capacity in the near future, such as COVID-19 “hot spots” as designated by the Federal Emergency Management Agency (FEMA).
Prisma Health president and CEO Mark O’Halla said: “I am so proud of the creativity and perseverance of our clinical team who came together to develop a potentially life-saving solution at a critical time for our country, our communities and our patients. We are anxiously awaiting the results of the prototype field tests.”
Recently, Quidel secured FDA emergency use authorisation (EUA) for its molecular COVID-19 diagnostic assay.