While the healthcare industry struggles to stay ahead of critically ill patients in need of ventilators, medical device makers are racing at a breakneck pace to scale up manufacturing for these desperately needed machines. Prisma Health is taking a different approach to the problem with the VESper Ventilator Expansion Splitter.
The hardware is designed to allow one ventilator to support up to four patients in the event of an emergency, and it can serve as a stopgap until other equipment becomes available. The VESper was developed in partnership with J&J subsidiary Ethicon and recently received an Emergency Use Authorization from the Food and Drug Administration (FDA).
The connector was created for use with ISO standard ventilator hardware and tubing and provides for filtering equipment that will block transmission of viruses and bacteria. The VESper splitter operates in device pairs with one attached to the intake of a ventilator while the other is connected to the return. The device can also be stacked in such a way that it allows up to four patients – if they are all receiving the same clinical treatment – to receive ventilator support at the same time.
It was an emergency room doctor, Dr. Sarah Farris, who came up with the idea for a ventilator splitter. She shared it with her software engineer husband, Ryan Farris, who developed the prototype design specification for 3D printing. Prisma and Ethicon have since taken up the cause and are making the hardware available upon request. The FDA is restricting the use of these devices to last-resort measures after all other options are exhausted.
As with many other coronavirus-related therapies and technologies recently developed in the United States, the ventilator splitter will initially only be available for distribution within the country. Ethicon will leverage its in-house 3D printing manufacturing to replicate this hardware and disseminate it at no cost to healthcare providers. The firm is currently negotiating the new regulatory waters in place to bring the Splitter to the global market.
“Our goal is to provide healthcare providers with an emergency use device for critical patients in rapid time at no cost,” said Mark O’Halla, Prisma Health president and chief executive officer. "We are pleased to announce this collaboration with Ethicon, which brings nationwide scale and expertise for the manufacturing and distribution of VESper by a top-tier medical device company.”
To properly prioritize orders, Prisma is consulting with national COVID-19 teams and other healthcare stakeholders to identify those providers most in need of this equipment. The firm will be collaborating with these agencies on an ongoing basis and evaluating clinical outcomes associated with these ventilator expansion splitters. The three-way connector is also freely available through its source code and 3D printing for hospitals.