FDA Pulls EUAs For Non-NIOSH Masks And Decontamination Systems

Source : Medtech Insight

The US Food and Drug Administration has revoked emergency use authorization (EUA) for certain imported respirators for health care workers, and decontamination systems that were allowed due to a shortage of domestic N95 masks. However, the agency says domestic manufacturers are able to produce enough high-grade masks and recommends the lower-grade masks may be exported to countries that are still lacking in personal protective equipment.

In the early days of the coronavirus pandemic, the FDA was forced to authorize EUAs for certain respirators not approved by the National Institute for Occupational Safety and Health (NIOSH) and decontamination systems for use by health care workers due to a lack of availability of N95 masks. ("COVID19 Leads FDA To Relax Rules On Surgical Masks Offer EUAs For Reprocessing Some Respirators" "Medtech Insight" )

Over the past six months, however, the FDA has started reversing those policies as N95 masks have become more available. The agency decided on 30 June to go even further by pulling EUAs for non-NIOSH-approved respirators and decontamination systems.

“Early in the public health emergency, there was a need to issue emergency use authorizations for non-NIOSH-approved respirators, as well as decontamination and bioburden reduction systems to disinfect disposable respirators. Today, those conditions no longer exist,” said Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation within the agency’s device center.

“As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic,” she added.

The FDA notes that between January 2020 and May 2021, NIOSH approved more than 875 respirator models or configurations, and many of those are being produced domestically by approximately 20 new companies. There are currently at least 6,400 total respirator models or configurations on the NIOSH-certified equipment list that meet EUA criteria, the agency says.

While decontamination systems are no longer authorized as of 30 June, non-NIOSH disposable respirators can stay on the market until 6 July when the EUA for that product expires.

The decision comes after the FDA announced on 27 May that frontline health care workers should be weaned off non-NIOSH masks and kept from reusing decontaminated disposable respirators.

The FDA makes a number of recommendations for what to do with an excess of non-NIOSH respirators, including using them in non-health care settings for non-medical use, such as construction, and sharing them with other countries that may still be suffering from a lack of masks for health care workers. The agency also advises health care institutions to keep increasing their inventory of NIOSH-approved respirators such as N95 masks, elastomeric respirators and powered air-purifying respirators.

The latest announcement follows the FDA’s decision in March to stop updating its list of imported disposable filtering facepiece respirators, signaling the agency was more confident that domestic manufacturers would be able to fill any supply gaps. ("FDA No Longer Accepting Certain Face Mask EUAs Signaling A More Manageable Pandemic" "Medtech Insight" )

The FDA on 30 April went even further and revoked an EUA for the Battelle CCDS Critical Care Decontamination System at the company’s behest. The system was the first such decontamination system given an EUA but the company decided to cease its service as the demand for its device dwindled due to the availability of N95 masks. ("Battelle Closes Sites Asks FDA To Pull Mask Decontamination EUA" "Medtech Insight" )

The FDA has scheduled a webinar on 13 July to discuss its decision to pull EUAs for non-NIOSH-approved respirators and decontamination systems. Stakeholders interested in hearing from the agency about the decision can learn more about the webinar here.

By Ferdous Al-Faruque