The U.S. government has revoked its pandemic-era authorizations for all mask decontamination systems and certain respirators not approved by the National Institute for Occupational Safety and Health.
These devices no longer will be authorized for use by healthcare personnel in healthcare settings, the Food and Drug Administration announced Wednesday. The authorization for decontamination and bioburden reduction systems for conserving disposable masks was revoked as of June 30. Non-NIOSH-approved disposable respirators, including imported masks, will no longer be approved for use as of July 6.
The move comes as more NIOSH-approved N95s and other personal protective equipment enter the U.S. supply chain, the agency said.
“As access to domestic supply of disposable respirators continues to significantly improve, healthcare organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic,” the FDA said.
The emergency use authorizations originally were enacted in response to the COVID-19 public health emergency and a severe shortage of needed personal protective equipment. The shortages left thousands of U.S. nursing homes scrambling for protective gear and equipment to help decontaminate and reuse the limited masks available.
The FDA now recommends that healthcare workers:
- Use only FDA-cleared or NIOSH-approved respirators, including N95s and other respirators under the Emergency Use Authorization;
- Begin using conventional capacity strategies rather than wearing disposable respirators for respiratory protection for an extended time period. This includes wearing a disposable respirator for each patient contact, according to guidance from the Centers for Disease Control and Prevention;
- Consider redistributing current inventory of non-NIOSH-approved respirators; and
- Continue to increase inventory of available NIOSH-approved respirators.
The FDA’s actions follow its May 27 letter recommending that healthcare workers begin transitioning away from the use of this equipment.
More details can be found on the FDA’s website.