ISEA has joined together with the American Mask Manufacturers Association (AMMA) to request the FDA revoke emergency use authorizations (EAUs) for disposable respirator decontamination and reuse and for use of imported non-NIOSH-approved respirators.
In a June 14 joint letter to Interim FDA Commissioner Dr. Janet Woodcock, ISEA and AMMA note, “FDA’s recent announcements, on April 9 and May 28, recommending that health care personnel and facilities transition away from crisis capacity conservation strategies such as ‘decontaminating or bioburden reducing disposable respirators for reuse‘ and ‘using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s‘” are appreciated.
However, the associations are urging FDA to immediately take the next steps and revoke the Emergency Use Authorizations (EUAs) for:
- respirator reuse,
- allowing the use of imported non-NIOSH-approved respirators, and
- allowing non-NIOSH-approved respirators imported from China (KN95s).
Recent actions and Executive Orders from President Biden have identified US respiratory protection manufacturers as national security assets. However, the combined effect of Non-NIOSH-approved respirators from China (KN95s) being allowed to be used in healthcare workplaces, plus the decontamination and reuse of disposable respirators, are diminishing the strength of this critical asset.
In short, domestic respiratory protective device manufacturers are at a critical juncture, and these EAUs are putting some companies at risk. But the publication of the OSHA ETS for protection from COVID-19 exposures, and FDA keeping in place the EUA allowing for NIOSH-certified respirators to be used in healthcare workplaces, would help to shore up this industry.
For more information, please contact Dan Glucksman at 703.525.1695 x119 or [email protected].