Prisma Health has received Emergency Use Authorization (EUA) from the FDA for VESper, a ventilator expansion device that allows a single ventilator to support up to 4 patients .
Prisma Health has received Emergency Use Authorization (EUA) from the FDA for VESper, a ventilator expansion device that allows a single ventilator to support up to 4 patients during times of acute equipment shortages, according to the company.1
VESper uses 3D printing technology and is developed with material already in use for medical devices. The ventilator is designed to work with ISO standard respiratory connections, and allows for appropriate filtering of bacteria and viruses in the ventilator tubing.2
Each ventilator needs 2 VESper devices: 1 on the intake and 1 on the return; VESper then splits the airflow to the ventilator, acting as a Y connector.2
The device can be configured into multiple combinations to allow a single machine to be used for up to 4 patients. The clinical characteristics of the patients connected to a single machine is important to match, as the machine will deliver the same settings, such as oxygen concentration, amount of air in each breath, and the pressure of air delivered.2
Prisma Health is working with COVID-19 health care teams across the country that have no more ventilator capacity and can initiate emergency use of the prototype. Field testing will be conducted to monitor clinical outcomes to determine whether the device performs as designed.1
Physicians have begun to test the VESper device with medical manikins, allowing for the stimulation of multiple clinical scenarios. The device was able to deliver the appropriate breathing parameters without difficulty, creating an opportunity to pursue an application for EUA, according to the company.1
REFERENCES