Respirator Availability Improving in the USA

The U.S. Food and Drug Administration (FDA) announced action to make more respirators, including certain N95s, available to healthcare personnel in the USA.

Currently, the majority of respirators on the market are indicated for use in industrial settings. 

Respiratory protective devices are designed to achieve a close facial fit and very efficient filtration of airborne particles. 

When properly fitted, respirators, such as N95s, can filter more airborne particles than face masks, which is important during an outbreak of a respiratory disease like COVID-19, says the FDA.

Additionally, while this EUA can help increase the availability of certain NIOSH-approved respirators to healthcare personnel, this EUA does not apply to the public, who should not wear these respirators to protect against COVID-19.

There is a little health benefit to the general American public to wear a respiratory protective device, such as an N95 respirator.

In a previous clinical trial involving 2,862 health care personnel, there was no significant difference found in the incidence of laboratory-confirmed influenza among healthcare personnel with the use of N95 respirators (8.2%) vs medical masks (7.2%).

The action announced on March 2, 2020, enables certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in healthcare settings by healthcare personnel during the coronavirus disease (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.

Of note, the agencies are not currently aware of specific widespread shortages of personal protective equipment, but there are reports of the increased ordering of these products and shortages have been observed in some U.S. health care institutions.

HHS Secretary Alex Azar said in a press release, “The FDA and CDC’s action to allow a wider range of respirators to be used in healthcare settings will help those on the front lines of this outbreak and their patients, which will keep all Americans safe.”

Given the increased demand and supply challenges on the availability of respirators, today’s EUA helps to provide alternatives that can enable more healthcare personnel to have access to this potentially life-saving personal protective equipment. 

This action is the result of the close collaboration between the FDA and the CDC to prioritize access to needed medical products during this outbreak to support health care personnel.

FDA Commissioner Stephen M. Hahn, M.D., added, “At the FDA, we’ve been working diligently to mitigate any potential shortages in the supply chain. It is imperative that we assure health care personnel on the front lines of this outbreak have sufficient supplies of respiratory protective devices.”

Currently, the CDC says ‘the immediate health risk from COVID-19 is considered low. The CDC recommends everyday preventive actions, such as hand washing, to help prevent the spread of respiratory diseases.’

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Coronavirus FDA and CDC news published by Precision Vaccinations.