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Thousands of counterfeit 3M respirators have passed US investigators in the past few months and made it to the cheeks and chin of health workers and confusing experts who say their quality is not far inferior to reality.
N95 masks are valued for their ability to filter out 95% of the tiny particles that cause Covid-19. But the fakes that are pouring into the country have fooled those in charge of health care from coast to coast. Up to 1.9 million counterfeit 3M masks found their way into about 40 hospitals in Washington state, according to the state hospital association, prompting officials to alert staff and drag them off the shelf. The Cleveland elite clinic recently admitted that it had accidentally distributed 3 million fakes to hospital workers since November. A hospital in Minnesota took a similar picture.
Jersey Shore University Medical Center nurses have been very suspicious since November that the misshapen and strange-smelling "3M" masks they received were counterfeit. Their concerns are fueled by mask lot numbers that match those the company has listed online as possible fakes.
"People have been scared for the past two and a half months," said Daniel Hayes, a nurse and union vice president at the New Jersey hospital. "They felt like they were in control of their lives and they have nothing else to wear."
According to 3M, the leading US manufacturer of N95, more than 10 million counterfeits have been seized since the pandemic began, and the company has made 10,500 inquiries about the authenticity of N95. In a January 20 letter, the company said that its work in at least six states in the past few months has resulted in the seizure of counterfeit 3M masks that have been "sold or offered" to government agencies. After KHN sent photos of the masks interviewed by the New Jersey nurses, a 3M spokesperson described them as "the fakes you identified."
At the request of KHN, ECRI agreed to test the masks that caused concern among nurses in New Jersey. Tests on a dozen masks showed that they filtered out 95% or more of the 0.3 micron particles they are expected to catch. (ECRI is a non-profit organization that helps healthcare providers assess the quality of medical technology.)
Chris Lavanchy, ECRI's technical director, said several US health organizations had recently made similar requests for testing of what appear to be counterfeit 3M masks that the company warned about.
Lavanchy said the results showed similarly high levels of filtration, but also greater breathing resistance than expected. He said such resistance could tire the person wearing the mask or cause them to lift off their face and let in unfiltered air.
"We scratch our heads trying to understand this situation because it is not as black and white as I would have expected," said Lavanchy. "I've looked at other masks that we knew were fake and that usually perform terribly."
3M spokeswoman Jennifer Ehrlich said an important characteristic of N95 masks, besides filtration, is how well they fit.
"Without a proper seal and fit, the respirators won't filter (properly) – gaps could let air in," Ehrlich said via email.
Hackensack Meridian Health's materials management team, which owns Jersey Shore Hospital, “is working with an independent laboratory to validate the quality and compliance of certain lot numbers of 3M N95 respirators that the company identifies as potentially problematic, according to a company statement Has" .
When the Washington State Hospital Association bought 300,000 N95s in December, it sent samples to hospital directors who said they were legitimate.
"It's not as if we just ordered them to see unseen," said Beth Zborowski, spokeswoman for the club. "We had two big medical centers in Seattle … look at the quality and the straps, cut them open and decide," It looks like the real deal "before they bought them.
She said large hospital systems in the state bought more of themselves, adding up to 1.9 million.
During the pandemic, workers were also provided with Chinese-made KN95 masks, which were approved by U.S. regulators in an emergency and were found to be far less effective than invoiced.
In April, in response to the severe shortage of quality masks for healthcare workers, the Food and Drug Administration opened the door to KN95, which is said to provide the same level of protection as N95.
Over the months, researchers from the Centers for Disease Control and Prevention, Harvard, MIT, and ECRI found that KN95s failed to meet high standards: 40% to 70% of KN95s failed their tests, and some only filtered 30% out tiny particles.
More than 3,400 frontline health workers have died during the pandemic, KHN and The Guardian noted on the ongoing project Lost on the Frontline, and many families have raised concerns about inadequate protective equipment. However, it is still difficult to assess the actual damage caused by an inferior or counterfeit device.
Researchers say it is unethical to conduct a study where health workers are given a product they know is less protective than another when it comes to life. And without thorough genome sequencing of each worker's virus strain, it's difficult to know exactly how a person got sick.
Securing medical equipment supplies is a high priority at the U.S. border, said Michael Rose, division manager in the global trade division of U.S. immigration and customs.
His job last year was to investigate a wide variety of Covids-related scams. Of all these cases, Rose said, the flood of counterfeit 3M masks from China was the most persistent.
"It's definitely cat and mouse," said Rose. "Where we could do better (at catching counterfeits) they can send elsewhere, change the company name, and move on."
Many investigations lead to seizures in the country's massive ports of entry, where huge cargo ships and planes carry huge containers of goods. There agents could discover a dead giveaway like a box right next to a ship from Shenzhen, China, labeled “3M” and “Made in the USA”.
"I want to say it makes it easier, and it does, but the sheer amount of them come in …" he said. "It's like a needle in a pile of needles."
The demand for protective masks has increased twelve-fold during the pandemic, said Chaun Powell, vice president of disaster relief at Premier, a major hospital utility company. National medical uses of N95 used to be around 25 million per year but rose to 300 million last year, he said.
This meant that hospitals and other health care providers could not rely on their usual product sources to meet their personal protective equipment needs.
Healthcare providers "had to find alternatives," Powell said, "and this opened up the opportunity for fraudulent manufacturers to be opportunistic and sneak in."
Much of Rose's investigations stem from customer complaints made to 3M about apparent counterfeits, which are forwarding reports to its team. Others come from hospitals, health systems, or eagle-eyed first responders who email Covid19fraud@dhs.gov.
Border guards working with Rose's team awaiting deliveries from known counterfeiters have confiscated thousands of counterfeit N95s in the past few weeks, including 100,080 at a port of entry near El Paso, Texas in December and 144,000 that flown from Hong Kong to New York were. According to their own statements, federal officials have confiscated more than 14.5 million masks, many of them counterfeit 3M, but also other counterfeit fabrics or surgical masks.
In New Jersey, workers began complaining about their masks to union leaders at Jersey Shore University Medical Center in November, said Kendra McCann, president of the hospital's local Health Professionals and Allied Employees union.
The masks, which looked threadbare and made the faces of some workers burn, appeared in every unit of the hospital. After a union member discovered a letter on the 3M website declaring the masked lots to be potentially fake, managers began removing the masks, but suspected fakes continued to emerge, McCann said.
Hackensack Meridian said a daily call to hospital administrators included "reminders to report suspicious PPE so that it can be removed and evaluated immediately".
The episode added stress to caregivers who are afraid of contracting the virus and bringing the virus into their own four walls.
"Nurses are scared to death," McCann said in mid-January when the masks continued to emerge, "because they are not provided with the correct PPE."
Eli Cahan contributed to this report.
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.