GREENVILLE, S.C., March 25, 2020 /PRNewswire/ -- Prisma Health announced today that it has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for VESper™, 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. Produced using 3D printing technology, the device is developed with material already in use for medical devices and produced at minimal cost.
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.
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.
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"When we see rapid increases in patients who require machine-assisted breathing, an acute shortage of necessary equipment can happen overnight," said Peter Tilkemeier, M.D., chair of the Department of Medicine at Prisma Health-Upstate. "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."
A Prisma Health emergency medicine physician realized the opportunity of using a single machine to breathe for multiple patients. Working collaboratively with her husband, a software engineer and with a Prisma Health pulmonary critical care physician, this team began developing specifications for a "Y" splitter tubing that would meet international quality standards (ISO), be easily produced, allow for appropriate filtering of bacteria and viruses in the ventilator tubing, be strong and impact resistant, and would not impact the care of other patients connected to the same machine.
"Immediately, we realized we had an opportunity to impact patient outcomes all over the country, and potentially beyond the U.S.," said Marjorie Jenkins, M.D., chief academic officer for Prisma Health–Upstate and dean of the University of South Carolina School of Medicine Greenville. "What we needed was a collaborative team to put the plan in motion and close the loop between design, production, FDA approval and distribution to hospitals with critical need."