Ventilator Shortage: Prisma Health just created an FDA-authorized 3D-printed ventilator expansion device that lets one ventilator support four patients
With coronavirus claiming thousands of lives worldwide, doctors and hospitals around the country are urging the federal government to provide ventilators to coronavirus patients in hospitals across the country. A ventilator is a machine designed to provide mechanical ventilation by moving breathable air into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe, or breathing insufficiently.
The demands for ventilators, ventilator accessories, and other respiratory devices far outpace the supply available to health care facilities during the Coronavirus Disease 2019 (COVID-19) outbreak. Ventilator shortage is more acute in Washington, California and New York. To Address this shortage, Prisma Health, the largest not-for-profit health organization in South Carolina, announced today it has developed an expansion device called VESper that lets one ventilator to support up to four patients under emergency use authorization by the FDA.
Produced using 3D printing technology, the device is developed with material already in use for medical devices and produced at minimal cost. VESper is a unique ventilator expansion device that allows a single ventilator to support up to four patients during times of acute equipment shortages such as the current COVID-19 pandemic.
Prisma Health said two VESper devices are needed for each ventilator, one on the intake and one on the return. VESper™ splits the airflow to the ventilator, acting as a Y connector. “Multiple combinations of the VESper device can be configured to allow a single machine to be used for up to four patients. It is important to match the clinical characteristics of the patients connected to a single machine as the machine will deliver the same settings such as oxygen concentration, amount of air in each breath and the pressure of the air delivered,” the organization said.
Prisma Health also confirmed that it has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for VESper. Emergency use authorization can offer critical care patients access to a medical device that has not gone through normal FDA approval; this is used when no comparable or satisfactory alternative options are available.
Prisma Health experts are working with national COVID-19 teams who have no more ventilator capacity and who can initiate emergency use of the prototype. We will be working closely with these teams during their field testing to monitor clinical outcomes. Those field tests will determine whether the device performs as designed, per FDA guidelines.
Hospitals can apply to receive the free source code and printing specifications for the device.