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5 Takeaways From The FDA Emergency Use Authorization for Face Shields


 

Face shields provide excellent protection against blood and other biological fluids in the dental health care setting. Dentists have often kept a small supply of face shields for surgical procedures. A face shield combined with a level 3 surgical face mask, has provided ample protection to dentists world-wide.

Enter the COVID-19 pandemic and many things have rapidly changed, including the necessity of the face shield.

The FDA has issued strong statements for the criterion for the issuance of this EUA. This makes EUA both important and relevant to our dental offices as we develop new protocols and build our PPE armamentariums.

In this article I will review 5 key takeaways from the current FDA Emergency Use Authorization for face shields.

1 Authorized Face Shields Must Meet the Following Criteria

Face shields used by dentists as PPE are authorized for use under the updated EUA. They must be used in accordance with CDC recommendations to cover the front and sides of the face and provide barrier protection in a clinical setting.

All EUA approve face shields must also meet the following criteria:

        • The product must be labeled accurately to describe the product as a face shield for medical purposes.
        • The face shield must not be integrated with any other article of PPE such as a face mask. It must be used as a stand-alone face shield.

          mask with face shield attached

          *attached face mask. Not a standalone face shield

           

          face shield with glasses frame attached

          attached glasses frame- not a standalone face shield

           

        • The face shield must be designated as single or multiple use. Cleaning and disinfection instructions must be included, if applicable.
        • The face shield can not contain any material that will cause flammability.
        • The face shield is not intended or marketed to prevent infection as a solo PPE item

2 Face Shields are Effective at Protecting Health Care Providers

“based on the totality of scientific evidence available to FDA, that 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 combining other approved PPE, dentists and staff can feel protected against exposure to particulate matter during treatment.

It should be noted this does not mean full protection again aerosols generated in the dental setting.  A 2004 JADA literature review discusses known aerosols generated during dental treatment and is worth a read.

Buy Face Shields Here

3 Certain FDA Requirements for Manufacturing Face Shields Have Been Lifted

Denise M. Hinton, Chief Scientist for the FDA, has waived certain manufacturing requirements for face shields during the current EUA.

        • Good Manufacturing practice requirements which include quality systems requirements under 21 CFR Part 820. This means that there may be masks on the market that do not meet the normal quality standards but are authorized under the current EUA.
        • Normal labeling requirements that fall under FDA regulations. (see Subpart B of 21 CFR Part 801).

 

4 Protections Are Still In Place To Protect Consumers

Even with the lax regulations for face shield manufacturing, there are still protections in place to keep us safe as consumers.

Manufacturers must still label face shields appropriately and for medical use as well as if the protective face shield is meant for single or multiple uses. There should be adequate instruction to clean and disinfect face shields, especially if designated as re-usable.

In my opinion, the most important protection is that manufacturers must have a process to report adverse events to the FDA. This means that if a certain brand of face shield is underperforming the manufacturer may be removed or “blacklisted”. This provides policy and financial incentive for manufacturers to put their best foot forward.

 

 

Lastly, manufactures must maintain a thorough process of inventory control and maintain distribution records. This creates a paper trail in the unfortunate event that a negative event takes place in the field with a health care provider.

5 Predatory Advertising and Promotion & False Claims are Prohibited

The current EUA states that no advertising may suggest that face shields are safe or effective for the prevention of infection during the COVID-19 pandemic. While this may seem obvious, it is important that the FDA prevent less than honest manufactures from publishing false claims that may hurt HCP or patients.

Many of the new products on the market will only be approved as long as the current EUA is active. Daily changes in the pandemic situation may cause the FDA to terminate or revoke the Emergency Use Authorization at any time. These products are only authorized for the duration of the current EUA in its current form.

In summary, the use of a protective face shield will become the gold standard for infection control in the dental office. Particularly with researchers showing that dental providers and their teams are at risk of exposure to aerosols containing viruses and bacteria in the dental setting.

These are great takeaways from the current FDA EUA on face shields. However, it still paints an incomplete infection control picture for the dental practitioner. A face shield, by itself, can only provide so much protection for dentists and our staff.

As dental practitioners we must continue to monitor CDC, FDA, and OSHA guidelines and changes. It is necessary to stay at the forefront of ever-changing protocols and mandates as changes continue with the current COVID-19 pandemic.