Description

The following refers to: 3DPX-013406 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. According to the CDC, COVID-19 is believed to be spread mainly from person-to-person contact through respiratory droplets produced when the infected person coughs or sneezes [1]. Face shields provide a physical barrier for the user against airborne droplets. Several open source face shield designs are available that can be produced rapidly by using inexpensive and distributed Fused Deposition Modeling (FDM) plastic 3D printing for the visor together with polyethylene sheeting for the face protection. In addition to health care professionals (HCPs), others that can benefit from access to face shields as a first line of defense include first responders, security personnel, and those working in essential customer service (grocery stores, pharmacies, and delivery services). The availability of 3D printed face shield designs for the general public can also ease the demand on traditional supply chains used by HCPs. This is an open source design for a 3D-printed face shield visor that was iterated upon in order to improve producibility and speed to print. Features FDM 3D prints without supports Uses three-hole punch size and spacing for each of assembly and replacement of polyethylene sheet Includes a brow guard to provide continuous coverage over the user's forehead Two methods of attaching elastic or string: Hooking over tab Looping through hole Limitations A face shield does not substitute the use of an approved face mask. In cases where approved masks are not available and a non-approved mask is used as a last resort, CDC guidance recommends use of a face shield in conjunction with the non-approved mask [2]. [1] https://www.cdc.gov/coronavirus/2019-ncov/prepare/transmission.html (https://www.cdc.gov/coronavirus/2019-ncov/prepare/transmission.html) [2] https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html (https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html)