FDA Grants Health Care Personnel Access to Industrial Respirators: Public Not To Use Them

March 3, 2020 Updated: March 3, 2020

The U.S. Food and Drug Administration (FDA) on March 2 granted a request by the Centers for Disease Control and Prevention (CDC) to allow health care personnel to use certain industrial respirators during the COVID-19 outbreak in health care settings.

In a news release, the agency said the action would allow certain National Institute for Occupational Safety and Health (NIOSH) approved respirators, which are not currently regulated by the FDA, to be used in a health care setting by health care personnel, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.

The FDA concluded that respirators approved by NIOSH, but which don’t currently meet the FDA’s requirements, “may be effective in preventing health care personnel from airborne exposure, including COVID-19.”

They include certain N95s, a mask which is used widely in the construction industry, and which the CDC says is the most effective when it comes to protecting health care professionals against the disease.

“At the FDA, we’ve been working diligently to mitigate any potential shortages in the supply chain, including addressing increased demand and supply challenges associated with personal protective equipment,” FDA Commissioner Stephen M. Hahn, M.D., said in the news release.

“It is imperative that we assure health care personnel on the front lines of this outbreak have sufficient supplies of respiratory protective devices.”

The action comes amid reports that an increasing number of Americans are buying masks while U.S. health care institutions are running short of the personal protective equipment. On Feb. 29, the U.S Surgeon General warned the general public against buying masks as it is putting a strain on supplies for healthcare providers.

“Seriously people—STOP BUYING MASKS! They are NOT effective in preventing general public from catching Coronavirus, but if healthcare providers can’t get them to care for sick patients, it puts them and our communities at risk!” he wrote on Twitter. 

“The best way to protect yourself and your community is with everyday preventive actions, like staying home when you are sick and washing hands with soap and water, to help slow the spread of respiratory illness. Get your Flu Shot—fewer flu patients equals more resources for COVID19,” he added. 

In it’s news release on Monday, the FDA and CDC said that as the COVID-19 outbreak continues to spread across the globe, growing demands for masks will continue to stress supply chains, and nationwide shortages are anticipated.

However, by expanding the use of respirators that are NIOSH approved, but do not currently meet FDA regulatory requirements, the agency’s hope to help optimize the availability and use of respirators for health care personnel.

The agency’s added that the general public should not wear these certain NIOSH-approved respirators to protect against the virus and that there is no health benefit in doing so. It also advised that the immediate health risk from COVID-19 is considered low. There are now 71 confirmed and presumptive positive cases of coronavirus in the United States.