A team of doctors at Prisma Health has developed a device that allows a single ventilator to be used on up to four patients, potentially saving thousands of lives in the midst of the current COVID-19 pandemic.
On Wednesday, March 25, Prisma Health officials announced that the device, dubbed the VESper, or ventilation expansion splitter, had received emergency use authorization from the U.S. Food and Drug Administration.
“We believe the device can be lifesaving,” said Peter Tilkemeier, chair of the Department of Medicine at Prisma Health-Upstate.
Produced using 3D printing technology, the device is developed with material already used in existing medical devices and produced at minimal cost.
Upstate Business Journal: Greenville-based laboratory named first SC commercial laboratory validated for COVID-19 testing
Prisma Health experts are now working with national COVID-19 teams that have no more ventilator capacity and can initiate emergency use of the prototype.
Emergency use authorization can offer critical care patients access to a medical device that hasn’t gone through normal FDA approval, Tilkemeier said at a news conference late Wednesday. It’s only used when no comparable or satisfactory alternative options are available.
Hospitals around the country are already facing a critical shortage of ventilators, which help patients breathe and can mean the difference between life or death for those suffering from the most severe respiratory effects of the novel coronavirus.
Nationally, more than 65,285 cases of the virus have been reported, and at least 926 people have died, according to a John Hopkins University database tracking the spread of the outbreak.
It was a Prisma Health emergency room physician who first came up with the idea of using a single machine on multiple people, according to Marjorie Jenkins, chief academic officer for Prisma Health-Upstate and dean of the University of South Carolina School of Medicine Greenville.
Working collaboratively with her husband, a software engineer, and a Prisma Health pulmonologist, the trio began developing specifications for a “Y” splitter tubing that could be easily produced on a 3-D printer.
“Immediately, we realized we had an opportunity to impact patient outcomes all over the country, and potentially beyond the U.S.,” Jenkins said.
Physicians used Prisma Health’s Healthcare Simulation Center to begin testing the VESper device with medical manikins, allowing for the simulation of multiple clinical scenarios. The device was able to deliver the appropriate breathing parameters without difficulty, officials said.
With Jenkins’ help, the team was able to secure FDA approval within a matter of days.
“It truly has taken a village to develop this device,” Jenkins said.
Anyone can download the source code and printing specifications for the device. Hospitals can apply by registering on Prisma Health’s website. The health system is also collaborating with other companies such as HP Inc. and its Digital Manufacturing Network to quickly scale 3D production and distribution to COVID-19 “hot spots” designated by the Federal Emergency Management Agency.
Specifications for the device can even be shared globally, Tilkemeier said.