Taken from Kaiser Health News
February 11, 2021
Thousands of counterfeit 3M respirators have slipped past U.S. investigators in recent months, making it to the cheeks and chins of health care workers and perplexing experts who say their quality is not vastly inferior to the real thing.
N95 masks are prized for their ability to filter out 95% of the minuscule particles that cause covid-19. Yet the fakes pouring into the country have fooled health care leaders from coast to coast. As many as 1.9 million counterfeit 3M masks made their way to about 40 hospitals in Washington state, according to the state hospital association, spurring officials to alert staff members and pull them off the shelf. The elite Cleveland Clinic recently conceded that, since November, it had inadvertently distributed 3M counterfeits to hospital staffers. A Minnesota hospital made a similar admission.
Nurses at Jersey Shore University Medical Center have been highly suspicious since November that the misshapen and odd-smelling “3M” masks they were given are knockoffs, their concerns fueled by mask lot numbers matching those the company listed online as possible fakes.
“People have been terrified for the last 2½ months,” said Daniel Hayes, a nurse and union vice president at the New Jersey hospital. “They felt like they were taking their lives in their hands, and they don’t have anything else to wear.”
According to 3M, the leading U.S. producer of N95s, more than 10 million counterfeits have been seized since the pandemic began and the company has fielded 10,500 queries about the authenticity of N95s. The company said in a Jan. 20 letter that its work in recent months led to the seizure of fake 3M masks “sold or offered to government agencies” in at least six states. After KHN sent photos of the masks the New Jersey nurses questioned, a 3M spokesperson referred to them as “the counterfeits you identified.”
At KHN’s request, ECRI agreed to test the masks that sparked the New Jersey nurses’ concern. Tests of a dozen masks showed they filtered out 95% or more of the 0.3-micron particles they’re expected to catch. (ECRI is a nonprofit that helps health providers assess the quality of medical technology.)
ECRI engineering director Chris Lavanchy said several health organizations across the U.S. have recently made similar requests for tests of apparently fake 3M masks that the company warned about.
Lavanchy said the results have shown similarly high filtration levels, but also higher breathing resistance than expected. He said such resistance can fatigue the person wearing the mask or cause it to lift off the face, letting in unfiltered air.
“We’re kind of scratching our heads trying to understand this situation, because it’s not as black-and-white as I would have expected,” Lavanchy said. “I’ve looked at other masks we knew were counterfeit and they usually perform terribly.”
3M spokesperson Jennifer Ehrlich said a critical feature of N95 masks, aside from filtration, is how well they fit.
“Without a proper seal and fit, respirators are not filtering [properly] — gaps could allow air to enter,” Ehrlich said via email.
The materials management team for Hackensack Meridian Health, which owns the Jersey Shore hospital, is “working with an independent lab on validating the quality and compliance of specific lot numbers of 3M N95 respirators the company identified as potentially problematic,” according to a company statement.