WHY SHOULD SOMEONE WEAR A FACE SHIELD?
- According to the CDC, COVID-19 spreads mainly from person to person through respiratory droplets and COVID-19 can be spread by people who do not have symptoms and do not know that they are infected so they are “asymptomatic”. Merely isolating people who show symptoms is insufficient in containing the spread in businesses.
WHAT LEVEL OF PROTECTION DOES THIS FACE SHIELD PROVIDE?
Fluid Resistance: This face shield has been tested to protect the wearer's eyes and face against exposure to bodily fluids, liquid splashes, or potentially infectious material. This is in line with the FDA requirements regarding materials used in Occupational And Educational Personal Eye And Face Protection Devices (ANSI/ISEA Z87.1-2020 (USA))
WHAT CAN THIS FACE SHIELD BE USED FOR?
- The Catalyst® Face Shield is to be worn to protect the user’s eyes and face from exposure to bodily fluids, liquid splashes, or potentially infectious material.
- This Face Shield falls under the CDC Strategies for Optimizing the Supply of Eye Protection as a “Contingent Capacity Strategy” in the CDC prioritization table for use "Implement extended use of eye protection" and should ideally be used in combination with a respirator or face mask with the face shield covering the entire front (that extends to the chin or below) and sides of the face and can be considered to provide protection equivalent to a Level 1 protection standard ANSI/AAM IPB70.
- The Face Shield is not a substitute for a face mask or face covering. If due to a lack of alternatives, a face shield is used without a mask, it should wrap around the sides of the wearer’s face and extend to below the chin. Source: CDC
Pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, it is reasonable to believe that face shields may be effective at preventing HCP exposure to certain particulates during face shield shortages by providing minimal or low barrier HCP protection to the wearer during COVID-19, when used consistently with the Scope of the Emergency Use Authorization, pursuant to Section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available to FDA, and concludes that face shields for use by HCP as PPE (as described in the EUA), meet the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness. Face shields can be intended for medical or nonmedical (e.g., industrial) purposes. Face shields intended for a medical purpose are regulated by FDA under 21 CFR 878.4040 – Surgical apparel. These devices are classified as class I (general controls) and are exempt from the premarket notification requirements in 21 CFR Part 807 (“510(k) clearance”).
WHAT IS THE EMERGENCY USE AUTHORIZATION?
- According to the FDA, there are not sufficient quantities of face shields to meet the needs of the U.S. healthcare system. These articles of PPE are an integral part of patient care during the COVID-19 pandemic, particularly during Aerosol Generating Procedures, such as intubation of patients prior to administration of mechanical ventilation. Providing authorization for the introduction into interstate commerce of face shields by manufacturers that do not customarily engage in the manufacture of medical devices helps meet the needs of the healthcare system. Providing Healthcare Providers who are on the forefront of the COVID-19 response with sufficient PPE is necessary in order to reduce the risk of illness in HCP and increase their availability to provide care to affected patients or those suspected of having COVID-19.
- The FDA has issued an EUA for this product to increase the availability of face shields for medical purposes during the COVID-19 pandemic because there are insufficient quantities of face shields to meet the needs of the U.S. healthcare system.
IS THIS FACE SHIELD REUSABLE?
The face shield has been created to be disposable. However, in accordance with the FDA and CDC's guidance, in the absence of other alternatives, this Face Shield may be cleaned and reused following the CDC's recommendations for "Selected Options for Reprocessing Eye Protection" and the User Instructions for this product*. For multiple uses by the same user, reuse following cleaning instructions. The Centers for Disease Control (CDC) does not recommend this strategy as it is not standard practice.
- A face shield should be used by one person.
- They should be immediately cleaned when they are visibly soiled, whenever they are removed, and at least daily, prior to putting them back on.
- After cleaning, the face shield should be stored in a transparent plastic container and labeled to prevent accidental sharing between users.
Note: The number of times a disposable face shield could potentially be cleaned is unknown; therefore, face shields should be closely examined prior to each reuse to ensure the integrity of the foam headband, elastic strap, and clarity of the shield. *
*For more information, Please visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/emergency-considerations-ppe.html