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The action involves allowing specific National Institute for Occupational Safety and Health-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States.
On March 2, 2020 FDA and the Centers for Disease Control and Prevention (CDC) announced they are taking action to make more respirators available to healthcare personnel amid the outbreak of the novel coronavirus (COVID-19). The action involves allowing specific National Institute for Occupational Safety and Health (NIOSH)-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States, an FDA press release said.
“President Trump has made it clear that protecting the American people is his top priority, and that includes taking every necessary step to ensure America’s healthcare providers have the tools they need,” said Human Health and Services Secretary Alex Azar in the 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. We will continue pursuing every possible avenue to secure the protective gear needed for responding to the COVID-19 outbreak.”
According to the press release, the CDC’s request for emergency use authorization asked FDA to allow for the use of industrial respirators during the COVID-19 outbreak, including N95s, industrial face masks that can filter airborne particles more efficiently than traditional face masks used in healthcare settings.
“The action taken today by CDC and [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, in the press release. “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.”
While there is not currently a widespread shortage of respirators in the US, there has been an increase in the ordering of certain personal protective equipment, FDA said. FDA and the CDC decided to take this action to anticipate shortages of equipment as COVID-19 spreads globally.
“[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 the press release. “At [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 [FDA] can utilize during a public health emergency to respond to critical public health needs.”