FDA: Time to Move Away From Using Decontaminated Respirators

Marcia Frellick

April 09, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The US Food and Drug Administration (FDA) today recommended that healthcare facilities cut back on the use of strategies for conserving capacity that have been in effect during the COVID-19 crisis, such as decontaminating disposable respirators for reuse.

The National Institute for Occupational Safety and Health (NIOSH) has increased the national supply of new respirators, and as a result, the FDA and the Centers for Disease Control and Prevention (CDC) believe it is now safe to stop using decontamination and bioburden reduction systems for respirators, including N95s and other filtering facepiece respirators (FFRs).

Among the FDA's recommendations for healthcare providers:

  • Use decontaminated respirators and respirators that have undergone bioburden reduction only when unable to obtain any new respirators.

  • Increase inventory of NIOSH-approved respirators. These include "N95s and other FFRs, elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room, and powered air-purifying respirators (PAPRs)."

"Even if you are unable to obtain the respirator model that you would prefer, the FDA recommends that you obtain and use a new respirator before decontaminating or bioburden reducing a preferred disposable respirator," the agency advises healthcare facilities.

However, the FDA is not revoking the emergency use authorizations (EUAs) for decontamination and bioburden reduction systems. If shortages of FFRs occur as a result of the pandemic, healthcare personnel may continue to use currently authorized decontamination and bioburden reduction systems, the FDA says.

The FDA says that between January 2020 and April 2021, NIOSH approved more than 875 respirator models.

"In addition, as of today, there are over 6,400 total respirator models or configurations on the NIOSH certified equipment list which met the NIOSH-Approved EUA criteria and thus had been FDA-authorized," according to the FDA.

CDC/NIOSH has also updated its Strategies for Optimizing the Supply of N95 Respirators to clarify the application of surge capacity strategies.

The agency will continue to monitor supply and demand to assess respirator availability during the transition from extreme conservation to contingency and eventually conventional use. Many respirators will remain on the FDA's device shortage list.

The FDA's announcement today represents a change from a directive it issued in November in which the agency said it would not object to hospitals or other healthcare sites using unapproved dry heat systems to "reduce the bioburden" on N95 respirators intended for reuse by one person.

As Medscape Medical News reported at the time, "In releasing its new guidance, the agency explicitly acknowledged the desperate measures being taken to conserve personal protective equipment during the surging COVID-19 pandemic."

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.


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