FDA Removes N95 Respirators From the Medical Device Shortage List

On August 26, the United States Food and Drug Administration (FDA) announced the removal of N95 Respirators from the Medical Device Shortage List. Offering the best protection against COVID-19, N95s supplies became scarce at the start of the pandemic as demand for them skyrocketed past the available supply.

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Why were there shortages of N95s?

Compared to other types of masks, N95s offer the best protection. Simple medical masks are too loose fitting and only filter droplets or large particles. KN95 masks filter large and small particles, offering more protection than medical masks. However, both are made of a thin material that isn’t as effective as N95’s protection.

Medical experts do not recommend the reuse of N95 masks. However, the onset of the pandemic quickly saw their shortage. Despite the masks not being intended for reuse, many medical professionals resorted to doing so. As soon as April 2020, a paper published in the Cambridge University Press proposed sterilizing used N95s with ultraviolet germicidal irradiation. Later, the Center for Disease Control (CDC) released guidelines on the limits of N95 reuse. 

Despite these measures, N95 supplies remained low. However, the US government ramped up domestic production of N95s, increasing to 1 billion a year in 2021. 

Combined Efforts Remove N95s from the Shortage List

Due to the combined efforts of reuse and manufacturing, the FDA removed N95 respirators from the Medical Device Shortage List. This decision came after the FDA assessed that the demand for the masks no longer exceeds the supply. 

On the removal, Suzanne Schwartz, MD, MBA, director of the FDA’s Center for Devices and Radiological Health’s Office of Strategic Partnerships and Technology Innovation, said, “We have worked very closely with our partners at NIOSH, the Occupational Safety and Health Administration and with US manufacturers to stabilize, rebuild and secure health care access to high-quality, single-use respirators, including those that are American-made. Today, our national capacity for production of these devices is stronger and our supply chain is more resilient because of these collective efforts on behalf of the dedicated people working to save lives.”

This news comes after the CDC loosened many of its guidelines surrounding COVID-19 protection, including required mask usage, earlier this month. 

Although the removal comes at a time when the pandemic seems to be winding down, experts still recommend masking as the most effective prevention of COVID-19, especially as new strains develop.

Author

Max Heirich