The following refers to: 3DPX-013883
The FDA has authorized production of protective face shields outside of the normal clearance pathway during the COVID-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff." This face shield has undergone review in a clinical setting and is recommended when fabricated as instructed.
This is an update of "DtM-v3.1 Face Shield PPE, 3D printable headband NO LOGO", item
3DPX-013359.
Updates made based on clinical feedback are:
- Reduced mass and print time
- Improvements to shield retention while reducing stress applied to the shield itself.
- Thinned forehead section to reduce pressure on the forehead
- Mount peg spacing changed for equivalency to "Swedish" headband
- Added brimless variant to further reduce print time and mass
- Added engineering definition for faceshield and headband
- Added cloth tie clips as an option
- Added option of foam headband
- Increased spacing to improve wearability with glasses and N95 mask underneath.
- Reduced weight solves for headaches from all-day wear of previous model
- Optimized build and assembly to standard materials that can be readily purchased (e.g., US letter-sized transparency)
For full and more detailed assembly instructions please go to our github:
https://github.com/mrjonny2/PNWS
Product Point of View
Due to a domestic supply chain gap for transparent face shields, this remixed 3D printed design immediately provides personal protective equipment (PPE) to healthcare workers responding to COVID-19, and incorporates clinical feedback and clinical reviews from other similar designs being used across hospitals across the nation. Face shield characteristics:
- limits aerosol and splatter exposure directly to the anterior head, specifically to the face and from above the head, while providing top ventilation to limit fogging and condensation
- reduces aerosol and splatter exposure on N95 and other face masks; this follows current recommendations to use full face shields to protect limited supply N95 masks
- re-usable for a single user (can survive multiple daily washes; transparent visor can be replaced from readily sourced materials when worn out)
- easy to fabricate within a few days of design approval (i.e., no complex supply chains or production bottlenecks)
- comfortable to wear and easy to don and doff (as it will be taken on and off dozens of times in a 12-24 hour shift)
- provides protection to broader area of face compared to standard safety goggles or glasses
Bill of Materials
Be sure to download the full fabrication package from this site or our Github https://github.com/mrjonny2/PNWS
For full Bill of Materials, please see BOM file in fabrication package
- Printed Frame
- Option Full Frame with Brim OR Short Variant (to be used with taller shields and caps)
- Face shield
- Option - Headband OR 2x Cloth ties and fabric strip
What to make?
PNWS Frame:
Print this: 1x FACESHIELD FRAME PNWS
Cut this design out of clear plastic: FACESHIELD PNWS
Cut this out of stretchy fabric: HEADBAND FACESHIELD
Optional Parts:
Foam strip to improve comfort: 1x 128836 FACESHIELD FOAM
Print Cloth Ties: 2x 128835-01 FACESHIELD CLOTH TIE A.1 Released.stl
Are any sliced files ready for my printer or ply cutter?
Yes! Please look at the Sliced Files folder. If you would like to contribute to these please reach out and we can get them added.
What are the Cloth Ties?
If you can't get stretchy fabrics or button hole elastic use two cloth ties and any fabric or elastic to make a headband.
How do I put it all together?
Please open: PNWS Assembly Instructions.pdf
Instructions for Use and Assembly
- Cut corners and Punch holes in standard US letter-sized transparency (8.5x11 in) with a standard US three-hole-punch. Recomended 10 mil (0.25mm) thick optically clear plastic.
- Attach transparency to headband on the 6 mounting pegs.
- Attach headband with cleats near temples, adjust to fit.
- To clean, follow CDC recommendations in Strategies for Optimizing the Supply of Eye Protection - Selected Options for Reprocessing Eye Protection. DO NOT submerge or soak 3D-printed headband in cleaning solution as the headband may absorb the solution and leak it out onto the wearer’s forehead over time.
- Discard and replace the transparent visor as appropriate, after excessive wear or fogging.
FDA Notice on Emergency Response
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/fda-efforts-connect-manufacturers-and-health-care-entities-fda-department-veterans-affairs-national
