Today, in a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.
“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 HHS Secretary Alex Azar. “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.”
Respiratory protective devices are designed to achieve a very 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. The FDA regulates respirators intended for use in a health care setting, however, most respirators are used in ...
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