Description
Re-Use of the Face Shield
Feedback from physicians and infection control groups suggests that the Face Shield product is suitable for reuse with appropriate cleaning in between patients (see “Cleaning the Face Shield”). Each hospital should determine appropriate use / reuse protocols based on a review of the product by the hospital’s Infection Control group.
Cleaning the Face Shield
Face shields delivered to facilities should be considered non-sterile. Consult the CDC for the latest guidance on disinfectants known to be effective against COVID-19. The following cleaning materials may be appropriate:
- Soap-water
- Isopropanol (70%) wipe
The following are not to be used to clean face shields:
- Hydrogen peroxide vapor sterilization
- Autoclave
- Soak in isopropanol or other organic solvents
Regulatory Status
In the U.S., Face Shields are considered Class I 510(k) exempt products by the Federal Drug Administration. Based on current FDA Guidance, these Face Shields do not require FDA clearance.
Per the FDA Guidance:
These products are not “surgical masks” or “full face respirators”.
The products are not recommended for use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high (without the use of a primary barrier such as a N95 or surgical mask); and use in the presence of a high intensity heat source or flammable gas.
The product does not make any claims of particulate filtration or possession of antibacterial or anti-viral properties.
