FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic
The FDA’s updated policies are striving to make sure PPE is both available and regulated for safe use.
The medical landscape is constantly changing, particularly during the COVID-19 pandemic. With so much happening, there is a lot of confusion, particularly surrounding shortages of Personal Protective Equipment (PPE) and Face Masks. There have been many reports in the media about low-quality face masks and respirators flooding the market in recent months. Many of these products are made in China and do not meet the stringent quality requirements needed to ensure the safety of healthcare workers and their patients.
The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. In this article, we will cover Face Shields and Respirators.
Defining Face Masks, Face Shields and Respirators
So, what is the difference between Face Masks, Face Shields and Respirators?
These devices can be used to help prevent the spread of COVID-19 and to provide varying levels of protection to the wearer. It is important to clearly understand the terminology and the intended use of these devices to ensure they are marketed appropriately.
The FDA defines a Face Mask as a mask, with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier of filtration efficiency levels. Face masks are for use by the general public and Health Care Professionals (HCP) only as source control in accordance with CDC recommendations. When a face mask is designed to provide a barrier against blood, or other bodily fluids, it is considered a surgical mask and regulated as a medical device.
A Face Shield, on the other hand, is a device used to protect the user’s eyes and face from bodily fluids, liquid splashes or potentially infectious materials. You can think of a face shield as a splash guard.
A Respirator (technically, a Filtering Facepiece Respirator, or an FFR) is a device that is disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. You may have also heard the term N95 mask, which is a type of an FFR with 95% filtration efficiency as measured by a standard test from the National Institute for Occupational Safety and Health (NIOSH).
So, there are two parts to the definition of these devices – what they are and how they are used. A clear description of both these parts is required to understand the applicable regulatory requirements outlined by the FDA.
FDA’s Updated Requirements for Respirators
FDA has recently updated its Enforcement Policy for Face Masks and Respirators (link below in References) as more information has become available. The severe shortage of PPE in the United States created a surge in the market of sub-standard products that did not meet FDA’s requirements. In a recent test, FDA found out that 50% of respirators made in China that were initially authorized during the early phase of the COVID-19 pandemic failed the standard filtration efficiency test! As a result, FDA has now established additional requirements for authorization of Respirators made in China. Products made in other countries that may not have been tested or approved by the NIOSH also have different requirements. They also removed the failing respirators from the list.
The bottom line is that FDA is now more careful about what kind of products they will authorize for use during the current COVID-19 pandemic. Emergency Use Authorizations (EUA) are not without risk because FDA has relaxed many of the regulatory requirements otherwise applicable to medical devices during normal times. As a result, the revised EUAs for Face Masks, Face Shields and Respirators now have additional requirements based on where they are manufactured and if they are approved by NIOSH.
The video below explains the requirements for Face Shields and Respirators in greater detail, as well as considering the different EUAs that have been established and how they will affect the respirator market. For more information on Face Masks and Surgical Masks, be sure to watch our other video.
If you have any questions or comments, don’t hesitate to get in touch. Plus, subscribe here to start receiving our exclusive, in-depth analysis of new developments in the medical device industry.