The National Institute for Occupational Safety and Health (NIOSH) has revoked the public health emergency approval of an N95 respirator manufacturer after sample products failed filtering tests, according to a recent agency announcement.

“As of April 8, 2021, Plastikon Industries, Inc. respirator model PLASMA N95-01 N95 filtering facepiece respirator is no longer NIOSH-approved,” NIOSH stated.1 “Revocation also means that respirators bearing NIOSH approval numbers TC-84A-PH19 may no longer be manufactured, assembled, sold, or distributed.”

NIOSH conducted a product audit of Plastikon’s PLASMA N95-01 N95 respirator and found the mask failed to meet filter efficiency standards. “The Institute reserves the right to revoke, for cause, any certificate of approval issued pursuant to the provisions of this part,” NIOSH stated. “Such causes include, but are not limited to, misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the quality control requirements of the certificate of approval.”

Based in Hayward, CA, Plastikon Inc. had not replied to a request for comment as this story was filed.

In related regulatory action, hospitals should begin phasing out reprocessing systems for single-use N95 respirators, since 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) NIOSH.

In the letter, the FDA recommends that healthcare personnel and facilities do the following:

  • 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.2

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 last year that there were insufficient stocks of N95s on a broad scale. Some hospitals began reusing 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, ultraviolet 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.3

There also were 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.

“That guidance was based on over 10 years worth of research that NIOSH had conducted on decontamination of filter facepiece respirators,” says Maryann D’Alessandro, PhD, director of the NIOSH national personal protective technology laboratory.

This was done because NIOSH determined that in an influenza pandemic, N95 supplies could run short and decontamination could be a temporary solution, she explains.

“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 the products’ composition,” D’Alessandro says. “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 that 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 determination was that the benefit exceeds the risk.”

Respirator Revisions

The CDC and NIOSH moved to be in sync with the transition on April 9, 2021, 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 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.”4

For conventional capacity strategies, which are essentially pre-pandemic 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 that N95 respirators be prioritized for those wearing them as 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 revisions include the following:

  • removed the strategy of using non-NIOSH-approved respirators developed by manufacturers who are not NIOSH-approval holders;

  • highlighted that the number of reuses should be limited to no more than five uses (five donnings) per device by the same healthcare worker to ensure an adequate respirator performance;

  • removed decontamination of respirators as a strategy with limited re-use;

  • emphasized that facemasks for caring for a patient with suspected or confirmed SARS-CoV-2 infection should only be used for certain scenarios as a last resort if respirators are severely limited.

REFERENCES

  1. National Institute for Occupational Safety and Health. NIOSH Respiratory Protective Device Information NIOSH CA 2021-1035. Revocation of Public Health Emergency Approval TC-84A-PH19. May 2021. https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/respprotect/pdfs/CA-2021-1035-P.pdf
  2. Food and Drug Administration. FDA recommends transition from use of decontaminated disposable respirators – Letter to health care personnel and facilities. April 9, 2021. https://www.fda.gov/medical-devices/letters-health-care-providers/fda-recommends-transition-use-decontaminated-disposable-respirators-letter-health-care-personnel-and
  3. 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.
  4. Centers for Disease Control and Prevention. Strategies for optimizing the supply of N95 respirators. Updated April 9, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html