The following refers to: 3DPX-013359

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-v3.0 Face Shield PPE, 3D printable headband", item 
3DPX-013238.  We have removed the logo from the STL and CAD file, in order to improve cleanability and infection control.

Product Point of View

Healthcare workers responding to COVID-19 who face PPE (personal protection equipment) supply gaps while waiting for domestic face shield production to catch up with demand NEED a transparent face shield that:

• limits aerosol and splatter exposure from in front and above, while providing top ventilation

• reduces aerosol and splatter exposure on N95 and other face masks

• is re-usable for a single user (can survive multiple daily washes; transparent visor can be replaced from readily sourced materials when worn out)

• is easy to fabricate within a few days of design approval (ie no complex supply chains or production bottlenecks)

• is comfortable to wear and easy to don and doff (as it will be taken on and off dozens of times in a twelve-hour shift)

• provides protection to broader area of face compared to standard safety goggles or glasses

Bill of Materials

• 3d-printed headband in PLA, roughly 50g/1.75oz per part. Outer envelope of 3d-printed headband is 191mm wide, 148.5mm long, and 52.5mm tall. Print time is roughly 3h15m per part on a Prusa i3 MK2S and a Lulzbot Taz 6 at 30% infill, no supports.

  • Acceptable alternate 3d printing materials include PETG, ABS, ASA, Nylon

• Elastic for the headband: could be 7”x1/8” rubber bands, 13” strip of 3/4" wide buttonhole elastic, coflex/coban tape

• A standard US letter-sized transparency or report-cover for the shield, 2-10mil (0.002-0.01”, 0.05-0.25mm) thickness

  • Acceptable alternative materials include clear PETG, PMMA or mylar in the same thicknesses cut to 8.5” x 11” (215.9mm x 279.4mm). Dimensions for a US-style three-hole-binder punch: three 6-8mm diameter holes with each center spaced 108mm apart. Do NOT laser-cut PVC

• Options:

  • Clinicians and caregivers who have worn the device on service recommend the following additions to the headband to improve comfort: add a wrap of foam tape or "chest tube foam tape", tape layers of gauze or a folded paper towel on the headband; dispose as necessary

  • Before hole-punching, add tape (duct tape, medical cloth tape, etc) to reinforce the holes at top of the transparency sheet during repeat use and washings. Remove and replace tape between patients as necessary.

Instructions for Use and Assembly

1. Punch holes in standard US letter-sized transparency (8.5x11 in) with a standard US three-hole-punch.

2. Attach transparency to headband on the three mounting pegs.

3. Attach elastic to headband with cleats near temples, adjust to fit.  Some users may find 7” rubber band too tight, consider chaining elastic bands as necessary.

4. 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.

5. Discard and replace the transparent visor as appropriate, after excessive wear or fogging.  

This design is a remix from the Prusa Protective Face Shield - RC2. We are grateful to the team at Prusa for their design skills, their commitment to open hardware, and their leadership in a crisis.

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

For Fusion CAD files, see the PrusaPrints archive here:

https://www.prusaprinters.org/prints/27748-dtm-v30-face-shield-ppe-for-covid-19-remix-of-prus/files