Description

The following refers to: 3DPX-013830 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. This is an update of "DtM-v3.1 Face Shield PPE, 3D printable headband", item 3DPX-013359, designed specifically for production at scale via injection molding. We have also made the following safety improvements (see photos for details): We increased the height of the front face holding the mounting pegs to eliminate the risk of the transparency forming a splatter-gutter at the base of the visor. We closed the sides of the visor to create improved protection against aerosol and splatter from above. We increased the spacing of the gap between the inner and outer headband segments to make it easier to wipe the entire surface clean between patients Other design modifications are intended to adapt the design to production at scale via injection molding: adding gate recesses, and increasing draft angles and adding ejector pin bosses for ejecting the part out of the mold. These features have no effect on the function of the 3d-printed part. This design has been testing in clinical settings and reviewed by infection control experts, who have rated the design as functionally equivalent to the DtM-v3.0 and DtM-v3.1 (no logo) designs. For access the full, open source, turnkey face shield design package from Design that Matters and Spark Health Design including updated, open source, editable instructions for use, and advice on labeling, packaging, regulatory, and quality systems to enable new manufacturers to quickly scale face shield production, see the DtM-v4 Turnkey Package for High Volume Manufacture (Google Archive). (https://drive.google.com/drive/folders/16oo67PoyABMb8sTtRxkbJtxMu05FUsBK) 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 infectious aerosol and liquid splatter from in front and above, while still providing top ventilation to limit fogging, and enabling the HEADBAND FRAME to flex slightly to the head. Reduces infectious aerosol and liquid splatter on N95 and other face masks. Can be used for multiple uses by a single user (easy to clean, can survive multiple daily wipe-downs; transparent visor can be easily replaced when worn out). Can be rapidly assembled to limit time healthcare practitioners spend in preparing and cleaning face shields. Is comfortable to wear (inner band accommodates microfoam surgical tape) Is easy to don and doff (as it will be taken on and off dozens of times in a 12-hour shift). Provides protection to a broader area of face compared to safety goggles or glasses. Has no moving parts: in designing medical devices for low-resource settings, DtM learned that moving parts are the first to break. Bill of Materials This face shield consists of three (3) components: the HEADBAND FRAME, the TRANSPARENT SHIELD, and the HEADBAND STRAP. HEADBAND FRAME: The Headband Frame could be made of a variety of injection molded or cast materials that provide some flexibility to conform to the head, are resistant to typical hospital cleaners, and are durable during drops. Polypropylene (PP) and high-density polyethylene (HDPE) are two possibilities. TRANSPARENT SHIELD: This face shield is designed to be compatible with an extra-large TRANSPARENT SHIELD as well as a standard US Letter-sized report cover (or similar transparent sheet) that can be attached and secured by using the geometry found in a standard 3-hole punch. Options include polyethylene terephthalate (PET) and polypropylene. The Transparent Shield could be made with a variety of clear materials. If using off-the-shelf US-Letter clear report covers, the following options are recommended: GBC ClearView Presentation Covers (polypropylene) (P/n: GBC 2000041) Avery (P/n: 16741) Office Depot Binding Covers (polypropylene) (P/n 459-207) HEADBAND STRAP: Recommend an elastomer that is Shore A 40-60 material, and also resistant to typical hospital cleaners. Options include latex-free silicone rubber and Teknor Apex resins TDS Monoprene PR-23040 and Monoprene CP-28350. Instructions for Use and Assembly From the EPA guidelines in List N: Disinfectants for Use Against SARS-CoV-2 (https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2), it is recommended to use the following four solutions when following the Recommended Cleaning procedures of the face shield. Th