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INSTRUCTIONS FOR USE | DtM FACE SHIELD
Indications for Use
The DtM Face Shield is intended for multiple uses by the same user in medical use applications. Face shields may be effective at preventing healthcare practitioner (HCP) exposure to certain particulates during face shield shortages by providing minimal or low barrier HCP protection to the wearer during COVID-19.
Limitations / Appropriate Use Criteria
The use of this DtM face shield should always come secondary to existing PPE equipment, standards, and protocol options if available. The decision to implement this device should be made with consultation of the corresponding institution’s occupational health and infection control departments and in line with CDC Strategies for Optimizing the Supply of Eye Protection (https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/eye-protection.html)
FDA Emergency Use Authorization (EUA)
This device is being offered for the duration of the FDA Emergency Use Authorization for Face Shields (9 April, 2020). This product is only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. It is not an FDA-registered or approved product, nor is it manufactured under a quality systems manufacturing process compliant with 21 CFR Part 820. See FDA EUA: (https://www.fda.gov/media/136842/download)
Recommended by the U.S. National Institutes of Health
The DtM-v3 has gone through a verification process expedited strictly for the response to the COVID-19 pandemic leading to its recommendation by the U.S. National Institutes of Health. Learn more about this effort by viewing the 31 March 2020 release: FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 response Public-Private Partnership. (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) See the DtM-v3 design with additional information about the verification process in the comments: https://3dprint.nih.gov/discover/3dpx-013359
HEADBAND FRAME
TRANSPARENT SHIELD
HEADBAND STRAP
Figure 1
transparent shield mounting pegs
headband strap hook
Components to be disinfected and reused for multiple uses by the same user as long as proper disinfectant protocol is followed and there is no visible damage to parts (See Appendix A for disinfecting solutions recommended for this device). If any cloth materials are used, for example buttonhole elastic for the HEADBAND STRAP, those components should be disposed of daily and/or when exposed to bloodborne pathogens (whichever comes first).
Device Overview
This face shield consists of three (3) components: the HEADBAND FRAME, the TRANSPARENT SHIELD, and the HEADBAND STRAP as seen in Figure 1.
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.
UW DFab
Address
City/State/Zip, United States
https://dfab.uw.edu/
If the face shield is not properly cleaned before first use and before reuse, there is a risk of infectious material deposited on the shield during manufacturing or during use to infect the wearer or other people that come in contact with the face shield.
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**Do not use in the presence of high intensity heat source or flammable gas
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Appendix A: Recommended Disinfectants
From FDA guidelines on Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency released March 2020, it is recommended that “this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act)”.
The policy recommends to use an approved disinfection agent as it should “minimize the viability of SARS-CoV-2” on the surface of the components of the face shield. 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)
and American Chemistry list of Novel Coronavirus (COVID-19)—Fighting Products (https://www.americanchemistry.com/Novel-Coronavirus-Fighting-Products-List.pdf).
Based on the testing done on TRANSPARENT SHIELD made of polypropylene, a HEADBAND FRAME made of PLA, and HEADBAND STRAP made of silicone rubber, it is recommended to use the following disinfection or cleaning agents for the Recommended Cleaning procedures of the face shield, listed in preferential order. Other disinfectants may work as well but have not been evaluated.
1. Super Sani-Cloth
2. 10% chlorine bleach solution (*May fog TRANSPARENT SHIELD over time)
3. CaviWipes
4. Soap and water
In addition, parts that are not 3D-printed (not porous) can be exposed to disinfectants for a longer period of time in keeping with recommended exposure times in EPA-List N for full disinfection against COVID-19.
(https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2)
INSTRUCTIONS FOR USE | DtM FACE SHIELD
Need Help?
For questions or to report any issue, please contact __________________ at ________________________. Hours of operation are __________________
*This material is latex free.
Appendix B: Device Materials
Materials for face shield components are listed below.
HEADBAND FRAME
Note, this material will be in direct contact with skin.
TRANSPARENT SHIELD
In addition, the following clear report covers obtainable through office supply stores could be used as a replacement for the manufacturer-provided TRANSPARENT SHIELD, listed in preferential order:
HEADBAND STRAP
Note, this material will be in direct contact with skin.