Almost KN95 masks imported from China don't meet standards of the US

New report says, over 70% of imported KN95 masks, mostly from China, fail U.S. filtration standards.
September 25, 2020 | 14:04
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A shortage of N95 masks forced hospitals in the U.S to find alternatives to protect health care workers tending COVID-19 patients. And KN95 mask from China is one among some other suppliers, reported USA Today.

As its name advertises, the KN95 mask is meant to filter out 95% of aerosol particles. However, ECRI, an NGO in the U.S issued a high-priority hazard alert against these masks after an analysis found that up to 70% of KN95 masks imported from China did not meet these filtration standards.

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Up to 70% of KN95 masks imported from China don't meet filtration standards, study says. Photo: Chris Rogers/Getty Images/iStockphoto

U.S. hospitals purchased hundreds of thousands of KN95 masks produced in China over the past six months.

“We’re finding that many aren’t safe and effective against the spread of COVID-19,” said Dr. Marcus Schabacker, ECRI’s president and chief executive office. “Using masks that don’t meet U.S. standards puts patients and front-line health care workers at risk of infections.”

ECRI tested nearly 200 masks from 15 different manufacturer models purchased by some of the largest health systems in the country. Schabacker said there was not only variability among the different brands but also inconsistencies among masks made by the same manufacturer.

“We are concerned about the safety of health care workers and patients when using KN95s in high-risk procedures, and that’s why we sent out the hazard alert,” he said. “We don’t use this lightly; we reserve that for immediate risk.”

In April, the FDA issued an umbrella emergency use authorization for masks that are manufactured in China and not approved by the National Institutes of Occupational Safety and Health (NIOSH). The agency reissued the order in June.

Besides the filtration concerns, public health experts criticized KN95 masks for their inability to create a tight seal on someone’s face. N95 masks have head and neck straps; KN95s have ear loops.

“What’s important to realize is that it’s the tight-fitting seal on your face that gives the N95 superior protection, other than the actual high-quality filtering properties of the mask itself,” said Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City.

Schabacker said the ECRI analysis controlled for the KN95's inferior ear loops by taking them off and creating a seal when testing the models. This means that even if the KN95 mask had head and neck straps, it still wouldn’t protect health care workers to the degree that an N95 mask would.

He clarified that this applies only to KN95 masks manufactured in China. Some KN95s are imported from South Korea.

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U.S. hospitals purchased hundreds of thousands of KN95 masks produced in China over the past six months. Photo: Matthew Horwood/Getty Images

Schabacker said health care providers should consider testing KN95 masks before using them. He suggested extending the use of N95 masks.

Schabacker and Glatter said quick fixes won’t resolve the overall shortage of personal protective equipment in the USA, and they advocate for a more centralized approach to production and distribution so hospitals have the equipment they need.

“Nearly nine months into the pandemic, we need a national plan to ensure the safety and health of all first responders and health care workers,” Glatter said. “We need to create a trusted and continuous supply of PPE ... so we don’t have to rely on other countries.”

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