Millions of fake N95 respirators are contaminating the nation’s supply of protective face masks just as new strains of COVID-19 heighten concerns about spreading the virus.
A Newsy investigation of counterfeit N95s found the realness of the imitation masks is one reason they have ended up on hospitals shelves.
"They have fooled everybody," said Cassie Sauer, president and CEO of the Washington State Hospital Association.
Thousands of fake N95s were included in a December shipment of 1.9 million masks sent to hospitals in Washington State.
They had the 3M brand label but were not manufactured by the company, a discovery made after the hospital association received an alert from the Department of Homeland Security and sent samples to 3M for testing.
"They look, they feel, they fit and they breathe like a 3M mask," Sauer said. "How protective are they? We don’t know the answer to that."
There was no evidence of an increase in infections linked to the bogus masks, which lack FDA backing and have untested effectiveness.
Another batch of counterfeit 3M N95s was discovered in a shipment of 10,000 masks sent to a Minnesota hospital after a nurse reported they did not have a proper fit.
Demand in health care remains sky high for the N95, able to screen out 95 percent of airborne particles, as front-line workers treat new mutations of coronavirus.
"You have all these health care institutions with this immense demand chasing this very limited supply," said Jim Churchman, vice president of procurement and supply chain for Duke University Health.
Fraudsters are all too willing to fill that gap, duping distributors into selling masks not made by 3M or any other reputable brand.
U.S. Customs and Border Protection seized more than 12.7 million counterfeit masks last year.
Most of them are coming from China, said Homeland Security Investigations special agent Brian Weinhaus.
"Individuals and organizations that were already involved in intellectual property crimes sort of changed what they were doing to fit this new need," he said.
Arrests are rare despite international cooperation to thwart PPE fraud.
Weinhaus said producers of fake masks know how to evade detection, "shipping it through other countries, or they're mislabeling the address that it's being shipped from."
"So it takes a lot of work to actually run down the individuals," he said.
While 3M has an online portal to allow purchasers to quickly authenticate masks using a code, it’s not available for all models.
3M spokeswoman Jennifer Ehrlich said buyers can reach out to the company for help validating the authenticity of masks.
Unlike in fashion or electronics, masks are a new entry into the counterfeit world, said Shahzil Amin, founder and CEO of WellBefore, a retailer of PPE and other medical supplies.
"If you’re going to go back and say, 'hey, we need to figure out how to make sure every single mask can be authenticated,' it’s hard to go back and put those processes in reactively," he said.
Ehrlich said 3M has quadrupled production of its N95s while working with Homeland Security officials to pull forgeries off the market.
The company has a website with resources dedicated to fighting respirator fraud and has filed dozens of lawsuits aimed at keeping fakes off the market.
Anyone buying respirators from the company should ensure they’re coming from an authorized 3M dealer, Ehrlich said.
All government-approved N95 models will display certain markings on the mask itself, including "NIOSH," the CDC’s stamp of endorsement.
The mask also should have an approval code beginning with the letters TC, as well as a filter class and efficiency level marking beginning with the letters N, P or R, like "N95."
Knockoffs may be missing any of those details, might misspell the NIOSH stamp, or have ear loops instead of headbands.
Asking questions of a supplier may be the best way to feel confident what you’re buying is real, Amin said.
"When you can’t speak to the end sellers, that’s when my red flag goes up," he said.
The CDC recommends N95 masks for health care personnel only.
Outside of medical settings, the CDC says masking up with face coverings that contain two or more layers of fabric provides adequate protection.