FDA Reissues Certain EUAs Over Changes to Mask Decontamination Guidance

The FDA is reissuing certain emergency use authorizations (EUAs) to specify which personal protection respirators are appropriate for decontamination due to public health and safety concerns about certain masks. The agency has announced that certain respirators should not be decontaminated for reuse by health care personnel, a decision made by the FDA based on increased understanding of the performance and design of these respirators.^1,2

The EUAs are in place for the duration of the coronavirus disease 2019 (COVID-19) pandemic.

In 1 case, the FDA learned from the CDC’s National Institute for Occupational Safety and Health (NIOSH) testing that authorized respirators manufactured in China may vary in their design and performance. As such, the FDA determined that the available information does not support the decontamination of these respirators and the agency has accordingly revised the relevant EUAs.¹

In addition, the FDA is revising relevant EUAs to no longer authorize decontamination or reuse of respirators that have exhalation valves.¹

The FDA’s reissued EUAs include:¹

• Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the scope of authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.
• Multiple decontamination systems so that they are no longer authorized to decontaminate respirators manufactured in China, where applicable, and only authorize decontamination of non-cellulose respirators that do not have an exhalation valve that are either authorized in the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA or that are authorized and identified in exhibit 1 of the EUA for imported, non-NIOSH-approved disposable filtering facepiece respirators to be decontaminated.

According to the CDC’s recommendations, decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators are not available. The decontamination systems are only authorized to decontaminate non-cellulose compatible N95 respirators. Health care personnel should not reuse a respirator that is incompatible with an authorized decontamination system but has nonetheless been decontaminated.^1,2

Users of any respirator (whether or not decontaminated) should always assess for proper fit after placement. Respirators with poor fit, visible soiling, or damage should not be used.^1,2

For the 2 EUAs covering imported respirators, the FDA also is tightening criteria to not only include new language related to decontamination, but also to revise the Scope of Authorization with respect to which jurisdictions are included in the criteria for eligibility in both EUAs, among other revisions.¹

The FDA’s reversal on decontamination guidance for certain masks used for personal protection was cited as an example of the importance of input from front-line health care professionals by the Massachusetts Nurses Association (MNA). The MNA had called for the halt of decontamination of masks in April 2020 due to a lack of safety and efficacy evidence, according to the organization.²

MNA President Donna Kelly-Williams, RN, said mask decontamination processes have put front-line health care professionals at risk.²

“Nurses and health care professionals caring for patients during this pandemic knew all along that these processes lacked rigorous evidence, could damage N95 masks and may create lasting health problems,” Kelly-Williams said in a prepared statement.²

Anand Shah, MD, FDA Deputy Commissioner for Medical and Scientific Affairs, said the agency is continuing to adapt to the evolving needs of Americans, based on science and data, during the pandemic.¹

“We are committed to carefully evaluating available information and will continue to take action when there is a need to do so to protect the public health,” Shah said in a prepared statement. “While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected.”

In a public statement, the MNA encouraged health care organizations to immediately act in procuring an adequate supply of new personal protection equipment that meet pre-pandemic standards. It also urged the federal government to fully activate the Defense Production Act to mobilize immediate production of safe and appropriate N95 masks. Additional masks would allow for the safe reopening of health care services and help prepare the country for a potential second wave of COVID-19 exposure in the fall, according to the organization.²

“If proactive steps are not taken to secure these products now, the risks to public health and worker safety may be irreparable,” the MNA concluded.²

REFERENCES

• Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse [news release]. Silver Spring, MD; June 7, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reissues-emergency-use-authorizations-revising-which-types Accessed June 8, 2020.
• FDA Reversal on COVID-19 Mask Decontamination Follows MNA Opposition, Demonstrates Urgent Need for Implementation of Frontline Nurse and Healthcare Professional Guidance [news release]. Canton, MA; June 8, 2020: Massachusetts Nurses Association. [email]. Accessed June 8, 2020.