FDA Revokes Authorizations for Certain Respirators, Decontamination Systems

The Food and Drug Administration (FDA) has revoked its emergency use authorization for disposable respirators that haven’t been approved by the National Institute for Occupational Safety and Health (NIOSH). Emergency use authorizations for decontamination and bioburden reduction systems were also revoked as of June 30.

The actions were taken to align with updated recommendations from the CDC and the Occupational Safety and Health Administration (OSHA) that reflect an increased domestic supply of approved respirators. This means facilities no longer need to rely on crisis strategies to cope with supply shortages, such as the reuse of disposable respirators.

The FDA ruling, which took effect July 6, allows for a transition period. The agency suggests that health care facilities consider redistributing unapproved respirators to countries in need as well as to nonmedical industries, such as construction.

Every employer must have plan to protect workers.

Also in June, OSHA issued an Emergency Temporary Standard to protect health care workers from exposure to COVID-19. The standard requires that every employer have a plan in place that identifies COVID-19 hazards in the workplace and lists additional requirements for reducing transmission of COVID-19, including the use of respirators and PPE. OSHA will continue to monitor and assess the need for changes to the standards.

ANA: Permanent standard still needed.

According to the American Nurses Association (ANA), an important provision of the OSHA standard is the requirement that employers engage employees in developing the plan. Although the ANA advocated for the emergency standards, ANA president Ernest Grant cautioned in a statement that “it is not a replacement for a permanent standard with strong respiratory protections.”

—Gail M. Pfeifer, MA, RN

You can find a version of this and other news stories in our October issue, including “Widely Raised Sepsis Warning System Missed Two-Thirds of Cases” and an update on cancer diagnoses and death rates in the United States. All are currently free to read.