Over 600 FFR models (of which there are over 530 N95 FFR models)
Over 5,500 elastomeric respirator configurations, including new elastomeric respirators without an exhalation valve
Over 360 PAPR configurations
CDC/NIOSH has also updated its Strategies for Optimizing the Supply of N95 Respirators to clarify the application of surge capacity strategies.
FDA Actions
The FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. However, the FDA is not revoking the EUAs for decontamination and bioburden reduction systems at this time. If there are insufficient supplies of FFRs resulting from the COVID-19 pandemic, health care personnel may continue to use currently-authorized decontamination and bioburden reduction systems, though such reuse of respirators should be limited to when no other respirators are available, including reusable respirators such as elastomeric respirators or PAPRs.

Of note, while there is an increase in domestic supply of respirators for healthcare personnel, the FDA will continue to monitor supply and demand to assess respirator availability as facilities systematically transition away from the most extreme measures of respirator conservation (that is, crisis capacity strategies) to contingency and eventually conventional use. Therefore, respirators, specifically surgical respirators, presently remain on the FDA’s device shortage list. The shortage list reflects the categories of devices the FDA has determined to be in shortage at this time and will be maintained and updated as the COVID-19 public health emergency evolves. The presence of a device type on this list does not necessarily indicate that patient care has been affected.

The FDA will continue to keep health care personnel and the public informed if new or additional information becomes available.

Reporting Problems to the FDA
The FDA encourages health care personnel to report any adverse events or suspected adverse events experienced with any medical devices, including decontamination systems, bioburden reduction systems, or respirators.

Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Back to HCB News

U.S. Healthcare Homepage