The FDA is temporarily waiving its enforcement and inspection requirements to allow companies outside the healthcare industry—such as automakers and other manufacturers—to begin fabricating much-needed parts for ventilators and other respiratory hardware.
Across the country, cities and hospitals have reported quickly diminishing supplies of ventilators and open intensive care beds for people who need assistance breathing, even as the number of confirmed COVID-19 cases continues to rise. U.S. totals have more than doubled in the past five days to over 35,000 as of early March 23.
The new FDA policy will make it easier for manufacturers to repurpose their production lines, according to Department of Health and Human Services Secretary Alex Azar. It also allows hospitals to repurpose the hardware they may already have to serve as makeshift ventilators—such as continuous positive airway pressure devices, or CPAP machines, used to treat sleep apnea.
Additionally, “medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages,” Azar said in an agency statement.
FDA Commissioner Stephen Hahn described the moves as offering “maximum regulatory flexibility” while still providing agency oversight.
The agency’s new guidance describes how hospitals can repurpose ambulance transport ventilators for long-term hospital care, among other alternatives. It also allows healthcare facilities to use ventilators beyond their indicated shelf life.
“We will continue to engage with both traditional medical device manufacturers and other manufacturers about ways we can facilitate a ramping up of production of these life-saving medical devices,” Hahn said.
The FDA is also working with manufacturers of protective equipment such as gowns, gloves and masks. Previously, the agency authorized industrial respirators and filters for use in the healthcare setting.
Ford, General Motors and Tesla are being given the go ahead to make ventilators and other metal products, FAST! @fema Go for it auto execs, lets see how good you are? @RepMarkMeadows @GOPLeader @senatemajldr— Donald J. Trump (@realDonaldTrump) March 22, 2020
But it could still take weeks or more for manufacturers to stand up their capacity.
General Motors said that it would work in collaboration with ventilator maker Ventec Life Systems to increase its production. However, the Detroit automaker is also in the midst of suspending operations at all its North American plants, due in part to market conditions and to give facilities a chance to deep clean machinery and personnel spaces against the coronavirus.
The structured, plant-by-plant suspension will last until at least March 30, GM said, with subsequent production to be reevaluated on a weekly basis. Ford and Fiat Chrysler are taking similar measures at their factories in the U.S. and worldwide.
Meanwhile, Tesla CEO Elon Musk and Medtronic both tweeted over the weekend that they have had engineering discussions regarding ventilator production and the possibility of working across industries.