Up to 70 percent of KN95 masks imported from China don’t meet U.S. health standards and could endanger health care workers and patients, an independent medical product evaluation found.
As the name suggests, KN95 masks should be capable of filtering out 95 percent of hazardous particles in the air. The masks, which aren’t officially certified by U.S. authorities, are the Chinese version of the N95 model.
But recent testing determined that among almost 200 KN95 masks imported from China, 60 to 70 percent of them are “significantly inferior” and don’t live up to the packaging claims.
The analysis sampled 15 Chinese manufacturers that supply major U.S. hospitals and health systems, according to Pennsylvania-based ECRI, a patient safety advocacy group that released the findings on Sept. 22. The lapse in quality prompted the ECRI to issue a hazard alert (.pdf).
Such alerts are usually reserved for situations when “health care professionals need to be informed immediately,” ECRI President and CEO Marcus Schabacker told The Epoch Times in an interview.
ECRI began testing the masks in April at the request of hospitals that have started sourcing from these Chinese suppliers, Schabacker said.
Thousands of manufacturing startups have sprung up in China to serve as conduits for medical supplies—which were in dire shortage in the wake of the pandemic. Chinese KN95 masks have been among the most prevalent goods imported to the United States, the institute said.
There are currently around 35,000 mask suppliers in China, according to Schabacker’s estimates.
“We’re finding that many aren’t safe and effective against the spread of COVID-19,” said Schabacker in a statement. He added that health care providers need to “do more due diligence before purchasing masks that aren’t made or certified in America.”
As a second defect, the Chinese masks ECRI tested all have ear loop straps rather than the head or neck band design that could seal the mask more tightly against the face—as required by the National Institute for Occupational Safety and Health (NIOSH), the U.S. federal agency overseeing workplace safety.
The institute suggested that healthcare workers use NIOSH-certified respirators, and only use KN95s or other alternatives as a “last resort.” These masks can still offer a higher level of protection than surgical or cloth masks, and might be suitable for medical staff not involved with “high-risk procedures”—such as intubation, suction of airways, or swabbing of patients, Schabacker said.
While Chinese quality standards for such masks are essentially the same as those in the United States, “there is no guarantee that what you buy will meet KN95 filtration requirements,” the alert says.
It cautioned that one “cannot judge the authenticity of a respirator by its appearance, labeling, or packaging.” Some imported respirators, despite being labeled with the same model names, have a slightly different look and “perform significantly differently in filtration testing,” it said.
To ensure the quality of mask purchases, ECRI recommended that buyers request a test report about the mask performance for review, request samples for testing to verify its filtration efficiency, and check the strap area and conduct tests to ensure a proper fit.
U.S. federal authorities have previously cracked down on faulty Chinese medical gear.
Most recently, custom officers in Chicago in September seized a half-million counterfeit N95 masks shipped from China’s Shenzhen city. The officers had sent 30 masks from the shipment for testing, and 10 percent turned out to be substandard.
In June, prosecutors charged a Chinese mask producer for exporting more than 140,000 defective models advertised as KN95. The masks only filtered 22 percent of small particles, according to the Department of Justice.
In the same month, another Chinese manufacturer was charged with selling 495,200 low-quality masks to the United States, which acting FBI-Newark Special Agent in Charge Douglas Korneski said shows “a blatant disregard for the safety of American citizens.”
In May, the Food and Drug Administration banned 65 Chinese mask-makers from exporting to the United States because their products didn’t meet filtration standards, cutting the number of U.S.-authorized Chinese manufacturers to 14.
To ensure “critical supplies are readily available at home,” Schabacker said, the United States needs to produce more or secure goods from trustworthy manufacturers around the world.