U.S. N95 Respirator Supply Finally Deemed Adequate
By Jonathan Springston, Editor, Relias Media
The FDA has removed N95 respirators from the agency’s medical device shortage list, signaling supply has finally caught up with healthcare demand and seemingly ending a saga that has been going on for more than two years ago.
When the COVID-19 pandemic started in March 2020, there were not enough N95 respirators in the supply chain to meet surging demand. This left healthcare providers to improvise solutions, including reusing and reprocessing devices meant only for one use, which raised safety concerns.
Federal agencies and private sector manufacturers kept chipping away at the problem. Slowly, regulators backed away from N95 reprocessing in favor of approving disposable N95s and devices that could be reused safely.
“We have worked very closely with our partners at [the National Institute for Occupational Safety and Health], the Occupational Safety and Health Administration, and with U.S. manufacturers to stabilize, rebuild, and secure healthcare access to high-quality, single-use respirators, including those that are American-made. Today, our national capacity for production of these devices is stronger and our supply chain is more resilient because of these collective efforts on behalf of the dedicated people working to save lives,” said Suzanne Schwartz, MD, MBA, director of the FDA’s Center for Devices and Radiological Health’s Office of Strategic Partnerships and Technology Innovation.