Thousands of counterfeit 3M respirators have gone unnoticed by US researchers in recent months, reaching the cheeks and jaws of health professionals and perplexing experts who say they are not much inferior to real ones.
N95 masks are valued for their ability to filter 95% of the tiny particles that can carry the coronavirus. Even so, the counterfeits that are arriving in the country have deceived health leaders from coast to coast. About 1.9 million counterfeit 3M masks reached about 40 hospitals in Washington state, according to the state hospital association, encouraging authorities to alert employees and remove the masks from the shelf. The Cleveland Clinic elite recently recognized that, since November, it had inadvertently distributed 3M fakes to hospital staff. A Minnesota hospital made a similar admission.
Nurses at the Jersey Shore University Medical Center in Neptune, New Jersey, have long suspected since November that the deformed and weird-smelling “3M” masks they received are imitations, and their concerns have increased because the lot numbers of the masks match those the company listed online as possible counterfeits.
Complete coverage of the coronavirus outbreak
“People have been terrified for the past two and a half months,” said Daniel Hayes, a nurse and union vice president at the hospital. “They felt they were putting their lives in their hands and they had nothing else to wear.”
According to 3M, the largest American producer of N95s, more than 10 million counterfeits have been seized since the pandemic began, and the company responded to 10,500 inquiries about the authenticity of the N95s. The company said in a January 20 letter that its work in recent months has led to the seizure of fake 3M masks “sold or offered to government agencies” in at least six states. After Kaiser Health News sent photos of the masks that New Jersey nurses questioned, a 3M spokesman referred to them as “the fakes you identified”.
Testing counterfeits
At the request of KHN, ECRI, a nonprofit organization that helps healthcare professionals assess the quality of medical technology, agreed to test the masks that aroused the concern of nurses in New Jersey. Tests with a dozen masks showed that they filtered 95% or more of the 0.3 micron particles that they were supposed to capture.
ECRI engineering director Chris Lavanchy said several health organizations in the United States recently made similar requests for tests of seemingly fake 3M masks that the company warned of.
Lavanchy said the results showed similarly high levels of filtration, but also greater resistance to breathing than expected. He said that such resistance could tire the person wearing the mask or cause the mask to come off the face, allowing unfiltered air to enter.
“We are kind of scratching our heads trying to understand this situation, because it is not as black and white as I expected,” said Lavanchy. “I looked at other masks that we knew were fake and they usually perform terribly.”
3M spokeswoman Jennifer Ehrlich said that a critical feature of N95 masks, in addition to filtering, is their fit.
“Without a proper seal and fit, respirators do not filter [properly] – loopholes can allow air to enter, “said Ehrlich by email.
The materials management team at Hackensack Meridian Health, which owns the Jersey Shore hospital, is “working with an independent laboratory to validate the quality and compliance of specific batch numbers of 3M N95 respirators that the company has identified as potentially problematic,” according to with a company statement.
When the Washington State Hospital Association bought 300,000 N95s in December, it sent samples to hospital leaders, who said they looked legitimate.
“It’s not like we just ordered them not to be seen,” said Beth Zborowski, a spokeswoman for the association. “We had two major medical centers in Seattle … look at the quality, the straps, cut them out and decide ‘it looks like it’s real’ before you buy them.”
It is definitely cat and mouse.
She said the state’s main hospital systems bought more on their own, totaling 1.9 million.
During the pandemic, workers also received Chinese-made KN95 masks – approved by US regulators on an emergency basis – which proved to be much less effective than those charged.
In April, the Food and Drug Administration, responding to the dire shortage of high-quality masks for healthcare professionals, opened the door for KN95s, which reportedly offer the same level of protection as N95s.
However, over the months, researchers at the Centers for Disease Control and Prevention, Harvard University, MIT and ECRI found that KN95s did not meet the high standard: 40 to 70% of KN95s failed their tests, and some were filtered only 30 percent of the tiny particles.
More than 3,400 frontline health workers died during the pandemic, KHN and The Guardian found out in the ongoing Lost on the Frontline project, and many families raised concerns about inadequate protective equipment. However, the actual damage that any substandard or imitation device presents remains difficult to assess.
The researchers say it is unethical to conduct a study that involves giving healthcare professionals a product they know is less protective than another when lives are at risk. And in addition to carrying out an in-depth sequencing of the genome in the viral strain of each worker, it is difficult to know exactly how a person fell ill.
At the border with the United States, protecting the supply of medical equipment is a high priority, said Michael Rose, head of the US Immigration and Customs Enforcement Global Trade Section.
His job last year was to investigate a wide variety of scams related to Covid-19. Of all these cases, said Rose, the flood of fake 3M masks from China was the most consistent.
“It’s definitely cat and mouse,” said Rose. “Where can we improve” in the interception of counterfeits, “they can send it elsewhere, change the name of the company and continue”.
Many investigations have resulted in seizures at the country’s huge ports of entry, where huge cargo ships and airplanes transport gigantic containers of goods. There, agents can detect a dead offer like a box exiting a ship from Shenzhen, China, marked “3M” and “Made in the USA”.
“I would like to say that it makes everything easier, and it does, but the sheer volume of them coming in – it’s like a needle in a pile of needles,” he said.
Demand for high-protection masks increased twelvefold during the pandemic, said Chaun Powell, vice president for disaster response at Premier, a major hospital supply company. National medical use of N95s used to be about 25 million a year, but it rose to 300 million last year, he said.
This meant that hospitals and other health care providers could not rely on their usual sources of products to meet the needs for personal protective equipment.
Health care providers “had to find alternatives,” said Powell, “and this created opportunities for fraudulent manufacturers to be opportunistic and sneak in.”
Many of Rose’s investigations stem from customer complaints about apparent forgery to 3M, which forwards the reports to her team. Others come from hospitals, healthcare systems or first responders who send an email to [email protected].
Border patrol agents, working with Rose’s team and anticipating shipments from known counterfeiters, have seized thousands of fake N95s in recent weeks, including 100,080 at a port of entry near El Paso, Texas, in December and 144,000 flown from Hong Kong to New York. Altogether, federal officials say, they seized more than 14.5 million masks, many of them fake 3Ms, along with other fake cloths or surgical masks.
Download the NBC News app for complete coverage of the coronavirus outbreak
In New Jersey, team members began complaining in November about their masks for union leaders at the University of Jersey Shore Medical Center, said Kendra McCann, president of the hospital’s local union of Health Professionals and Allied Employees.
The masks, which looked fragile and burned the faces of some workers, were appearing in all units of the hospital. After a union member discovered a letter on the 3M website pointing out the batches of masks as potentially fake, managers started removing the masks, but the fakes continued to appear, McCann said.
Hackensack Meridian Health said that a daily call to hospital leaders includes “reminders to report any suspected PPE so that it can be removed immediately and evaluated”.
The episode increased stress for caregivers who are afraid of being infected and taking the virus to their homes.
“Nurses are scared to death,” McCann said in mid-January, while the masks continued to appear, “because they are not getting the proper PPE.”