On March 23, Cornell University published a novel design for a mechanical ventilator that claims to allow for easier mass production than current designs. At this time, the design is not Food and Drug Administration-approved, though researchers are attempting to expedite this process in publishing the design and soliciting feedback.
In the battle against COVID-19, there is already a significant shortage of mechanical ventilators, which help patients to breath mechanically and deliver above-normal quantities of oxygen. State governors in New York and Louisiana have requested thousands of such devices from federal stockpiles, which are already stretched thin.
Cornell’s design, tested on March 20 with a silicone bag test lung, claims that using electrically driven pneumatic valves instead of mechanical switches will make mass-producing the ventilators easier.
“The parts required for the construction of the MVM [Mechanical Ventilator Milano] have been selected by investigating current inventories available worldwide at major resellers of hardware suppliers,” the design states. “The parts selected are also characterized by their ease of mass-scale manufacturing.”
Kevin Sunday, director of government affairs for the Pennsylvania Chamber of Business and Industry, said the current preference for hospitals and the health care supply chain is to work with FDA-approved manufacturers.
“At the end of the day you’re probably talking about a patient in a medically induced coma if they’re on a ventilator,” he said. “While everyone’s working as fast as they can, there’s still a question of liability.”
Mr. Sunday added that the state’s priority is to squeeze as much out of existing supply chains as possible.
William Federspiel, a professor in the University of Pittsburgh’s bioengineering department, said in an email exchange, “I think the only impact that will mitigate the ventilator shortage would be companies that have approved ventilators ...”
He added that he is not an expert in ventilators, though he does have secondary appointments in chemical engineering and critical care medicine at Pitt.
“This at best seems like some help to some garage enthusiast or survivalist to construct something for his or her own use in a very apocalyptic scenario,” he said. “This is just not going to go anywhere in my opinion.”
Nevertheless, around the world, researchers and universities are exploring a variety of designs to mass-produce ventilators. The Massachusetts Institute of Technology has submitted an emergency-use-only ventilator design to the FDA for authorization. The University of Minnesota has also created a makeshift ventilator, which the Star Tribune in Minneapolis reported kept a pig breathing for an hour.
The small satellite company Virgin Orbit has also created a new ventilator design that is not fit for an ICU but that instead acts as a “bridge ventilator” for partially recovered patients. The company is waiting for FDA approval to begin production on a larger scale.
A New York Hospital system has even designed a way to split and share a single ventilator between two patients.
Manufacturers of standard ventilators are ramping up production, with Ford Motor Co. and General Motors pledging thousands in the coming weeks, but this will take time to materialize. In Murrysville, Philips Respironics is increasing its production of ventilators as well. As of Tuesday evening, the company had not responded to a request for comment on whether it could produce the Cornell-designed ventilator.
To date, the FDA has not approved any new ventilator designs.
In Spain, medical professionals have approved an emergency 3D-printed respirator for short-term use only. Production is ramping up to create hundreds of units per day.
Mr. Sunday said that even if a design were approved, it could still take weeks for a manufacturing company to switch its supply to begin building the new design.
“The FDA is trying to be as quick as it can to get designs through their admittedly clunky process,” he said. “Even looking at a company like GM working with the federal government — that’s a highly sophisticated operation, but even they’re taking five or six weeks to get it up and going.”
Jeremy Reynolds: email@example.com or 412-263-1634; twitter: @Reynolds_PG. Mr. Reynolds' work at the Post-Gazette is supported by a grant from the San Francisco Conservatory of Music, Getty Foundation and Rubin Institute.