Guidance on the use of full face snorkel masks as PPE
With personal protective equipment in short supply the FDA has issued guidelines regarding the use of face masks.
Wildhorn worked with Stanford University, the University of Utah and others to design and test an adaptive solution that allows the Seaview full face snorkel mask line to be converted into PPE.
The solution is an adapter that fits in place of the snorkel tube. This adapter can be 3D printed and can then receive a filter. 3D print files are available for free. You must go through the form process above. Users are responsible for their own filters.
Please note FDA guidance on face masks at this time from Stanford's website:
The FDA has issued Emergency Use Authorization (EUA) for PPE, including NIOSH approved respirators, which has significantly altered the clearance process for solutions such as ours. We are actively seeking guidance from the FDA for our approach in order to provide regulatory clarity to our partners and clinical sites to expedite implementation. It is our understanding that this approach will allow for NIOSH approved filtration and meet or exceed fit specifications for N95 and elastomeric respirators currently authorized by the EUA.
Upon further discussions with the FDA, we have received the following communication regarding use solutions such as the Full-Face Snorkel Mask PPE:
FDA recognizes the urgent need for face masks in the setting of the COVID-19 pandemic due to increased use and shortages in their availability.
FDA does not object to the marketing and distribution of face masks in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:
- It states it may be used when FDA cleared masks are unavailable;
- It recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;
- It makes no claims of antimicrobial or antiviral protection;
- It makes no claims of infection prevention or reduction;
- It makes no claims regarding flammability
- The labeling contains a list of the body contacting materials.
- The mask is not labeled as a “surgical mask”; rather it may be labeled as a “face mask”
In addition, FDA does not intend to object to marketing of masks that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.
As an update, on 3/25/2020, the US FDA issued updated guidance titled “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency”(FDA-2020-D-1138). In summary, this guidance now covers solutions such as the Reusable Full-Face Snorkel Mask PPE project with the following (pg3):
FDA recognizes that, when alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.
The CDC has published guidelines on Crisis/Alternate Strategies for PPE decisions in the setting of N95 respirator shortages. At this time, our solution can be considered a case of “HCP use of non-NIOSH approved masks or homemade masks” which is permissible in a setting where N95 respirators are so limited that routine use of them is no longer possible and surgical masks are not available. While we believe and have documented that our solution can provide higher levels of protection than homemade or simple cloth masks, we cannot make legal claims at this time until further guidance is received from regulatory authorities.