By Ozair Shariff

Nearly one year into the pandemic, healthcare providers and anxious Americans have another threat with which to contend: counterfeit personal protective equipment (PPE). CNN recently reported U.S. Customs and Border Protection seized over 14 million counterfeit face masks entering the U.S. from the time the pandemic began through the end of 2020.

In early February of 2021, New York City authorities raided a Long Island City warehouse containing more than 1.7 million counterfeit N95 masks. Healthcare providers and their supply chain managers, fighting daily to provide for the health and safety of their front-line workers, must remain vigilant to ensure the efficacy of the PPE provided to employees and visitors at their facilities.

Demand Increases

At the onset of the pandemic, demand for PPE increased to levels never seen in the domestic healthcare market. Demand for N95 masks increased to 1,700 percent over base levels. U.S. health systems’ purchases of N95 respirators grew from approximately 25 million in 2019 to an unexpected 300 million in 2020, with supply unlikely to catch up until later this year.

For example, IU Health, Indiana’s largest healthcare system with 17 hospitals, reported use of 200-300 masks per day prior to COVID-19, while it now uses 1,000 to 1,300 per day (and 3,000 per day in November of 2020).

And while demand continued to spike during this time, production slowed because of manufacturer shutdowns throughout China, where most surgical masks are made. An unintended, but not entirely unexpected, consequence has been the entry of counterfeit masks that allegedly hold approvals from either the Food and Drug Administration (FDA) or the National Institute for Occupational Safety and Health (NIOSH) to be worn safely by healthcare workers.

EUAs

To help address concerns about availability during the pandemic, the FDA exercised its authority to issue Emergency Use Authorizations (EUAs) for certain PPE products. Specifically, on August 5, 2020, the FDA issued an umbrella EUA for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by healthcare personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent healthcare personnel exposure to respiratory droplets and large particles during surgical mask shortages resulting from the pandemic.

Authorized Surgical Masks

Given the influx of counterfeit products currently flooding the domestic healthcare market, those purchasing surgical masks or respirators that have been confirmed by the FDA to meet the criteria under the EUA should always consult the searchable “Appendix A: Authorized Surgical Masks” database maintained on the FDA’s website.

Separately, NIOSH requires manufacturers to submit detailed test data with applications for approval for any N95 respirator, which is only one of seven classes of available filters for NIOSH approval. While most consumers and healthcare professionals are familiar with the N95 sold by 3M, the largest manufacturer of NIOSH-approved N95 respirators (producing two billion globally in 2020), there are several other NIOSH-approved products alphabetically listed by brand on the CDC’s website.

In addition, there are certain products that are approved by NIOSH as an N95 respirator and separately cleared by the FDA as a surgical mask (i.e., Surgical N95 respirators) to be used specifically in the healthcare setting. The suppliers and manufactures of which should similarly be verified by consulting the CDC’s online database.

Whether you are purchasing on behalf of a healthcare facility or an employer in need of face masks and respirators for use on your assembly line, there are certain things you can do to verify the accuracy, and thus the efficacy of your N95 respirators. For instance, all individual filtering facepiece respirators that are NIOSH-approved are required to bare specific markings that consumers should be on the lookout for, including the following:

• The name of the approved holder/manufacturer business name, a registered trademark, or an easily understood abbreviation of the applicant/approval holder’s business name as recognized by NIOSH.
• NIOSH in block letters or the NIOSH logo.
• NIOSH testing and certification approval number (e.g., TC-84A-XXXX).
• NIOSH filter series and filter efficiency level (e.g., N95, N99, N100, R95, P95, P99, P100).
• Model number or part number, which includes the approval holder’s respirator model number or part number represented by a series of numbers or alphanumeric markings (e.g., 8577 or 8577A).

If you are unable to purchase through a distributor with which you have an existing relationship and are buying directly through a web site or other third-party marketplace, be on the lookout for the following potential red flags:

• Typographical or grammatical errors on the product, packaging or website.
• Products that overuse words such as “genuine” or “real”.
• Heavily discounted pricing (i.e., too good to be true pricing).

The Biden administration’s recent announcements regarding increased access to vaccine supplies in the coming months has provided many people with much needed hope. However, health experts have cautioned against the premature notion that masks will soon become a thing of the past.

As such, healthcare providers and employers alike will continue to need safe and effective masks. While it may be impossible to fully guarantee a mask’s authenticity and efficacy without comprehensive testing, consumers should remain vigilant against the drastic influx of counterfeit products that continues to plague our nation.

– Ozair Shariff is a member of the Healthcare Services Group in the Louisville office of Stites & Harbison.