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.1

“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 stopgap 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,” Schwartz stresses. “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.”

In the letter, the FDA said the action was based on the increased domestic supply of new respirators approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH).

The FDA gave these recommendations:

  • only use decontaminated respirators when new face-fitting respirators (FFRs) are in short supply;
  • begin to transition away from a crisis capacity strategy for respirators;
  • increase inventory of available NIOSH-approved respirators, including N95s and other FFRs. If hospitals cannot obtain a preferred respirator, the FDA recommends obtaining and using a new respirator before decontaminating a disposable respirator.1

Changing Recommendations

To be clear, the longstanding 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 there were insufficient stocks of N95s on a broad scale.

As the virus spread and the supply shortages became dire, the CDC issued the widely criticized recommendation for healthcare workers to use bandanas and scarves as a last-ditch measure. Meanwhile, hospitals began reusing N95s for a limited number of days by requiring staff to 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 techniques, such as as vaporized hydrogen peroxide, ethylene oxide, ultraviolent germicidal irradiation, and moist heat treatments. These approaches are controversial, and studies showed respirators should be reprocessed only a limited number of times or risk losing protective integrity.2 Questions arose 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.

As states were left largely on their own in a politicized pandemic with an insufficient national stockpile, measures thought to be enacted on a limited basis extended through the pandemic to the present. One union nurse leader said these unconventional methods meant nurses were “expendable.” (For more information, see the August 2020 issue of Hospital Employee Health.)

“That guidance was based on over 10 years' worth of research that NIOSH had conducted on decontamination of filter face piece respirators,” says Maryann D’Alessandro, PhD, director of the NIOSH National Personal Protective Technology Laboratory. This research was conducted because NIOSH determined that in an influenza pandemic, N95 supplies could run short, and decontamination could be a temporary solution.

“If you use this as a crisis capacity strategy, it should be based on a unit-by-unit situation and a manufacturer-by-manufacturer situation based on the products’ composition,” D’Alessandro explains. “For crisis capacity, we believe these types of techniques would be appropriate. But this is not something you would continue as conventional operations. They are meant to be single-use products.”

Clarifying there were no incidents nor occupational infections that led to the FDA letter, Schwartz says the EUAs were granted on a temporary basis based on lack of supplies.

“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,” she 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 determinization was that the benefit exceeds the risk.”

CDC Respirator Revisions

The CDC and NIOSH moved to be in sync with the transition on April 9, the same date as the FDA letter.

“NIOSH is part of CDC, so our recommendations are the same,” D’Alessandro says. “We clarified that N95s should be discarded immediately after being removed — that is a contingency strategy.”

In updating the respirator recommendations, the CDC stated, “once PPE [personal protective equipment] supplies and availability return to normal, healthcare facilities should promptly resume conventional practices. The supply and availability of NIOSH-approved respirators have increased significantly over the last several months.”3

For conventional capacity strategies, which are essentially prepandemic practices, the CDC added a recommendation that respirators used by a symptomatic healthcare worker for source control can be reused under certain conditions.

“Extended use of N95 respirators can be considered for source control while healthcare personnel are in the healthcare facility to cover one’s mouth and nose to prevent spread of respiratory secretions when they are talking, sneezing, or coughing,” the CDC stated. “When used for this purpose, N95s may be used until they become soiled, damaged, or hard to breathe through. They should be immediately discarded after removal. Extended use of N95 respirators as PPE is a contingency capacity strategy.”

For these contingency capacity strategies during expected shortages, the CDC recommends prioritizing N95 respirators for PPE while caring for patients. Respirators should not be used by healthcare workers only as source control during the contingency stage.

For crisis capacity strategies during known shortages, the CDC:

  • removed the use of non-NIOSH-approved respirators developed by manufacturers that do not hold a NIOSH approval;
  • limited the number of reuses to no more than five per device by the same healthcare worker to ensure adequate performance;
  • removed the practice of decontaminating respirators;
  • noted face masks for caring for a patient with suspected or confirmed COVID-19 should be used only as a last resort in certain situations if respirator supply is severely limited.

Reusables Coming to the Market

The FDA and NIOSH see the long-range solution to the pandemic shortages in the emerging market of reusable respirators, including elastomeric and powered air purifying respirators (PAPRs). The FDA letter cited this option for those discontinuing reprocessing, stating if “a reusable respirator is needed, organizations should first try to acquire respirators like elastomeric respirators and PAPRs, which are designed to be reusable.”1

Many traditional elastomeric respirators include an exhalation valve, which raised some questions about their use during the pandemic and whether the wearer could expose others.

“Over the past year, we have been working with manufacturers of elastomeric devices to approve new options that would both protect the wearers and provide source control,” D’Alessandro says. “Since the fall, we have approved three different devices, including two that do not have exhalation valves.”

In addition, the Department of Health and Human Services is purchasing 750,000 elastomeric respirators for the national stockpile, some of which will be distributed to hospitals who have agreed to work with NIOSH to test their real-world utility. This will complement NIOSH’s ongoing work with the University of Maryland and the Allegheny Health System in Pennsylvania, which has shown the elastomeric respirators “could be rapidly fit-tested and used in the healthcare environment,” D’Alessandro says. “We will be conducting surveys and talking about the use of the products and the acceptance from the workers.”

The goal from this work is to issue a CDC/NIOSH best practices guideline on reusable respirators in healthcare.

“We have a lot of research underway that will contribute greatly to using these respirators as a supplement to the N95s, which is the standard that is used in healthcare,” D’Alessandro says.

The FDA will continue to monitor domestic supply of respirators for healthcare personnel as facilities transition away from reprocessing and other crisis measures, Schwartz says.

“Crisis capacity standards were absolutely necessary in order to make certain that our healthcare workers had access to respirators,” she says. “We recognize the importance now of drawing down or dialing back from these crisis capacity measures — these extreme measures of last resort — toward one that will eventually bring the nation back to conventional use of respirators.”

REFERENCES

  1. Food and Drug Administration. FDA recommends transition from use of decontaminated disposable respirators — letter to health care personnel and facilities. April 9, 2021.
  2. Peltier RE, Wang J, Hollenbeck BL, et al. Addressing decontaminated respirators: Some methods appear to damage mask integrity and protective function. Infect Control Hosp Epidemiol 2020;41:1446-1448.
  3. Centers for Disease Control and Prevention. Strategies for optimizing the supply of N95 respirators. Updated Apr. 9, 2021.