Device Turns 1 Ventilator Into 4 - Prisma Health introduces VESper™
Courtesy of Prisma Health
VESper™ is a new device that allows one ventilator to support up to four patients under emergency use authorization by the FDA.
Hospitals can apply to receive the free source code and printing specifications for the device.
What is VESper™?
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.
Produced using 3D printing technology, the device is developed with material already in use for medical devices and produced at minimal cost.
The device:
designed to work with ISO standard respiratory connections;
can be easily produced;
allows for appropriate filtering of bacteria and viruses in the ventilator tubing;
is strong and impact resistant; and
does not impact the care of other patients connected to the same machine.
How VESper™ works
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.
Is it FDA approved?
Prisma Health 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.
How was it developed?
A Prisma Health Emergency Medicine physician realized the opportunity of using a single machine to breathe for multiple patients. She worked collaboratively with her husband, a software engineer, and with a Prisma Health pulmonary critical care physician to develop specifications for the device.
Physicians used Prisma Health’s 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, creating an opportunity to pursue an application for emergency use authorization with the FDA in order to rapidly bring this life-saving device directly into clinical use.
Learn more about the Prisma Health representatives who are introducing VESper™.
Our partners
Drawing on the strength of Prisma Health’s existing academic partnerships, we have worked with engineers at University of South Carolina for 3D materials testing and printing of prototypes. Prisma Health is collaborating with other major companies such as Hewlett-Packard to multiply production of the device for distribution in areas of greatest need and areas with the potential to exceed their ventilator capacity in the near future, such as COVID-19 “hot spots” as designated by the Federal Emergency Management Agency (FEMA).
Thank you
We are grateful for the Sargent Foundation of Greenville, SC, and their generous gift that will help make the VESPer possible.
“We are proud to support such an innovative and timely endeavor that will benefit our community and nation in this time of crisis.” – Sargent Foundation
Source: https://www.prismahealth.org/vesper/
