FDA Calls For Transition Away From Decontaminated Disposable Respirators As Supply Rebounds

Federal health regulators say it is now safe for hospitals and other health care facilities to transition away from decontaminating and reusing disposable face masks and similar respirators, which was necessary over the last year as the nation’s healthcare system struggled to handle the flood of COVID-19 cases.

In a letter to health care personnel and facilities sent on April 9, the FDA indicates that is time to stop using decontaminated disposable respirators; a practice which became widespread due to a respirator shortage caused by the coronavirus outbreak.

At the height of the pandemic last year, many hospitals and other health care facilities began reusing face masks which were designed to be disposable. This required the respirators be decontaminated, or undergo bioburden reduction, before being reused. Otherwise, they could have spread COVID-19 and other infections from one patient to the next.

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According to the FDA’s announcement, the National Institute for Occupational Safety and Health (NIOSH), a division of the U.S. Centers for Disease Control and Prevention (CDC), recently approved a new domestic supply of respirators, which has significantly bolstered the supply of respirators, such as the N95 mask and other filtering facepiece respirators (FFRs), which has alleviated the need for reusing disposable ones.

According to the letter, NIOSH has approved more than 875 respirator models or configurations from January 2020 through April 2021. However, the FDA is not yet revoking the emergency use authorizations (EUAs), which allowed hospitals to reuse the disposable respirators. Instead, the agency is calling for a transition away from reusing the devices.

“The FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. However, the FDA is not revoking the EUAs for decontamination and bioburden reduction systems at this time,” the letter states. “If there are insufficient supplies of FFRs resulting from the COVID-19 pandemic, health care personnel may continue to use currently-authorized decontamination and bioburden reduction systems, though such reuse of respirators should be limited to when no other respirators are available, including reusable respirators such as elastomeric respirators or PAPRs (powered air-purifying respirators).”

The FDA recommends health care personnel and facilities work to limit decontamination of disposable respirators, transition away from the crisis capacity strategy for respirators, and increase their available inventories of NIOSH-approved respirators.


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