N-95s Moving Back to Single Use, Phase out Mask Reprocessing

April 23rd, 2021

By Gary Evans, Medical Writer

Hospitals should begin phasing out reprocessing systems for single-use N95 respirators, as national supplies have been replenished and it is time to end the temporary crisis response to the pandemic, the Food and Drug Administration (FDA) stated in a letter to the healthcare industry.

“We have stated all along that this is an extreme measure to be utilized when there are simply not adequate respirators available,” says Suzanne Schwartz, MD, MBA, director of the FDA office of strategic partnerships and technology innovation. “We authorized these under an appropriate benefit-risk calculus, with an understanding and communication to stakeholders that the intent of this wasn’t to become mainstay by any means. These [N95] respirators are designed, and have been studied as single-use devices, and eventually we have to get back there.”

The FDA has the power to revoke the emergency use authorizations (EUAs) granted for stop-gap measures enacted during the pandemic, but wanted to give the healthcare system some time to make the changes.

“This is not a flip of the switch,” she says. “It is not like one day you are decontaminating, and the next you are giving out new ones for every single interaction. This has to be done thoughtfully, systematically in a phased manner. That is why we communicated in a letter format to put healthcare organizations essentially on notice: the revoking of these EUAs is forthcoming.”

The FDA letter said the action was based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH). In the letter, the FDA recommends that healthcare personnel and facilities:

• Limit decontamination of disposable respirators. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new face-fitting respirators (FFRs) or if you are unable to obtain any new respirators.
• Transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other FFRs.
• Increase inventory of available NIOSH-approved respirators, including 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.

To be clear, the long-standing recommendation by the CDC is to don a single-use N95 respirator to care for a patient with a novel respiratory virus like COVID-19. This CDC recommendation was downgraded to a less protective, basic surgical mask rather quickly, as it became apparent in the early days of the pandemic last year that there were insufficient stocks of N95s on a broad scale. As the virus spread and the supply shortages became dire, the CDC at one point issued the widely criticized recommendation for healthcare workers to use bandanas and scarves as a last-ditch measure. Meanwhile hospitals began trying to reuse N95s for a limited number of days by having staff wear a single-use surgical mask over the respirator. Under these systems, the masks were discarded between patients.

The FDA gave emergency approval to N95 respirator reprocessing using such bioburden reduction approaches as vaporized hydrogen peroxide, ethylene oxide, ultraviolent germicidal irradiation, and moist heat treatments. There was some controversy to these approaches, and some studies showed respirators should be reprocessed only a limited number of times or lose protective integrity. There were also questions about whether reuse compromised the need for a tight fit with N95s and whether the chemicals used in reprocessing could cause any long-term health effects.

“Because [this reprocessing] was very narrow, very specific to crisis capacity, we don’t consider the exposures that have occurred to be the equivalent of chronic or long-term exposures,” Schwartz says. “That is not to say that we have all the answers now in terms of real-world data. The benefit of having respiratory protection for healthcare workers as opposed to their exposure to COVID-19 [was the deciding factor]. Knowing that this is not a long-term solution, the FDA determination was that the benefit exceeds the risk.”

For more on this story see the next issue of Hospital Employee Health.