FDA Updates Approved Respirators

It’s time to resume immediately disposing of one-time-use respirators, according to a revocation of Emergency Use Authorization by the U.S. Food and Drug Administration (FDA).

Over the past year, the FDA enacted the Emergency Use Authorization of non-NIOSH-approved disposable respirators in response to the shortage of proper personal protective equipment (PPE) during the COVID-19 response. Effective July 6, 2021, all non-NIOSH-approved disposable respirators or decontaminated disposable respirators will no longer be authorized.

The FDA bases this decision on the increased domestic supply of approved respirators by the Centers for Disease Control (CDC) and National Institute for Occupational Safety and Health (NIOSH) in combination with the Occupational Safety and Health Administration (OHSA).

The FDA has the following recommendations:

• Use only approved respirators. (List available on the website.)
• Dispose of all one-time-use respirators after use.
• Do not recondition disposable respirators. (Respirators that were previously allowed to be reconditioned are no longer allowed to be used after their first use as intended by the manufacturer.)
• Continue to increase supply reserves of approved respirators.
• Reallocate non-approved items to non-healthcare settings and/or other countries as allowed by the FDA.

For more information on the historical use and approval of these devices, visit the CDC page on the Emergency Use Authorization.

During survey, Acute Care Hospitals will be surveyed under standard 07.02.04 Personal Protective Equipment (PPE). This standard ensures the appropriate usage of PPE in accordance with nationally recognized standards of practice (OSHA, CDC, FDA, APIC). Staff must be trained during orientation and periodically thereafter on the use of PPE. The survey will focus on observation of appropriate donning and removal of approved PPE, evidence of staff training, and compliance with policies and procedures being based on national guidelines.

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The latest episode of ACHC’s Beyond the Standard podcast discusses the emotional effects of COVID-19 on healthcare workers at two HFAP-accredited hospitals and shares the perspective of a licensed clinical social worker specializing in anxiety and depression. Listen to Episode 3: The Age of Anxiety