The FDA says cloth face masks are helpful against spreading COVID-19 via face and mouth moisture, but are not a viable substitute for N95 respirators or surgical face masks.
“After receiving questions and concerns about the Emergency Use Authorization (EUA) for face masks posted on April 18, 2020, the FDA updated and re-issued the EUA. In doing so, the FDA clarified that face masks, including cloth face coverings, that are authorized by the EUA are only authorized for use by the general public and health care personnel as source control. These face masks are not authorized to be personal protective equipment, meaning they are not a substitute for filtering face piece respirators or surgical face masks.” (FDA.gov)
The U.S. Food and Drug Administration (FDA) clarified its rules around personal protective equipment (PPE) and its Emergency Use Authorizations (EUAs) regarding COVID-19. In an FAQ posted to their site, the FDA offered more detail around best practices when wearing and decontaminating PPE.
Noting that changes were made due to feedback received in late April, the FDA explained, “the FDA updated and re-issued the EUA to clarify that face masks, including cloth face coverings, that are authorized by the EUA are only authorized for use by the general public and health care personnel as source control.
Further explaining that cloth face masks are for “use by the general public and health care personnel as source control,” the FDA shared that cloth face masks are helpful against spreading the virus via face and mouth moisture, but are not a viable substitute for N95 respirators or surgical face masks. A full guide to cloth face masks may be found here.
One important point the FDA noted was that, “(Cloth) face masks are not personal protective equipment. Health care facilities should not purchase or offer these masks as substitutes for surgical masks or filtering facepiece respirators.” Many hospitals and clinics have been struggling to purchase PPE and have turned to cloth masks with filters to try and offer an alternative for health care professionals.
The FDA further explained that approved PPE (such as surgical masks and N95 respirators) are, “critical supplies that must continue to be reserved for health care personnel and other medical first responders, as recommended in the CDC’s Strategies for Optimizing the Supply of Facemasks.”
With many healthcare facilities struggling to keep up with the demand both by employees and the FDA for PPE, limitations in the supply chain could further slow elective care and surgeries. With new companies manufacturing masks, face shields and other protective coverings, unlikely candidates like home 3D printers, Nike, and package manufacturers are stepping forward to offer front-line workers safety and relief.