Respirators typically reserved for industrial settings are becoming available to healthcare workers in the wake of the coronavirus (COVID-19) outbreak, according to an emergency use authorization (EUA) issued by the Food and Drug Administration (FDA) earlier this week.
The FDA said that certain respirators, including N95s, which are regulated by the National Institute for Occupational Safety and Health (NIOSH), not the FDA, will be available to healthcare workers after the CDC requested the EUA from the FDA.
“The FDA, alongside the CDC and other federal, state and local partners, have been aggressively addressing the COVID-19 outbreak,” said FDA Commissioner Stephen M. Hahn, MD, in a statement.
“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. It is imperative that we assure health care personnel on the front lines of this outbreak have sufficient supplies of respiratory protective devices. Actions like today’s emergency use authorization are one of many tools the FDA can utilize during a public health emergency to respond to critical public health needs.”
Respirators like the N95 can filter more airborne particles than facemasks when fitted properly, and the FDA said that this can limit healthcare personnel’s exposure to highly contagious diseases.
“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. We will continue pursuing every possible avenue to secure the protective gear needed for responding to the COVID-19 outbreak,” HHS Secretary Alex Azar said.
While no shortages of these devices have been reported yet, it is a possibility – and one the FDA is anticipating – as more institutions seek additional personal protective equipment for their employees.
“The action taken today by CDC and the FDA will increase the availability of N95 respirators to healthcare professionals across the country and we will continue to work together with our agency partners to protect the health and safety of all Americans,” said CDC Director Robert R. Redfield, MD.
“It is important to remember the best way to prevent the spread of respiratory disease is by using everyday preventative actions. These include hand washing, using tissues to cover a cough, disinfecting frequently-touched surfaces and keeping distance from people who are coughing and sneezing. CDC does not recommend the use of masks by the general public.”