JMA (Syracuse, NY), among the U.S. leaders in 5G wireless technology and software-based communication systems, announced that it has formed PREVAIL NY, an LLC dedicated to the design and manufacture of an emergency mechanical ventilation system. The plans for the device are available as a free, open-source design for manufacturers globally.
“Two weeks ago we heard the plea around the world for more ventilators,” commented Dave Jackson, president of transmission line systems at JMA. “We sat down to determine what we could do to help with our engineering talent and manufacturing capabilities. In only a week and a half, the team developed a manufacturable design that we call ‘PREVAIL NY.’”
PREVAIL NY stands for Pandemic Response Emergency Ventilation Assembled In Liverpool, New York. The design has not yet been authorized for emergency use by the FDA or any other regulatory body. PREVAIL NY has submitted an initial application to the FDA for emergency use authorization (EUA) and will submit additional information and documentation in the coming days in the hopes of securing an EUA for the device.
“The team is ready to jump-start manufacturing here in New York state, and devices can also be built at our facility in Bologna, Italy, for their local needs,” said John Mezzalingua, CEO and founder of JMA, which formed PREVAIL NY LLC.
PREVAIL NY is designed to augment the existing ventilator supply in the short term when no other traditional U.S. Food and Drug Administration (FDA)-approved ventilation options are available, providing key basic ventilation functions to relieve doctors of the need to make life-and-death decisions due to ventilator shortages. The design supports rapid manufacturing by leveraging readily available parts such as motors, controllers and standard sheet metal capabilities meant for mass production. The approximate cost to produce is less than $500.
The design uses an FDA-approved manual resuscitator kit known as a bag valve mask or Ambu bag, which hospitals carry in quantity. The system supports the low tidal volume ventilation strategy for acute respiratory distress syndrome, as used in patients with COVID-19. This device provides control of three key ventilation functions: respiratory rate (breaths per minute), tidal volume (how much air is delivered) and inspiratory/expiratory (inhale to exhale) ratio. The device is compatible with components that retain humidification and offer HEPA filtration.
In developing the blueprint JMA led a joint effort that includes Dr. John Callahan, a physician of internal medicine, and Syracuse University. In preclinical testing, the system was able to provide and restore ventilation in acute respiratory distress syndrome-damaged lungs.
“This emergency ventilation system takes advantage of existing medical equipment and marries it to a unique mechanical apparatus,” said Dr. Callahan. “I am excited about its familiarity to physicians around the world and that it has many of the same technical components that are common to existing ventilators. I am amazed by its creation in only 10 days.”
In addition to developing the open-source design, PREVAIL NY LLC estimates its immediate manufacturing capacity at hundreds of systems per week. Other manufacturers can sign up to download the free design specifications and components list at www.jmawireless.com to quickly scale production.
