Tuesday, October 06, 2020 by Zoey Sky
During the early days of the coronavirus (COVID-19) pandemic, organizations like the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) said face masks weren’t required. But as the pandemic showed no signs of slowing down, studies have found that wearing face masks was crucial to preventing infections.
But not all masks are effective and according to experts, at least 70 percent of KN95 masks imported from China don’t meet U.S. health standards. Independent medical product evaluation also revealed that these defective masks can even endanger health care workers and patients.
Both N95 and KN95 masks are designed to prevent 95 percent of hazardous particles in the air from passing through. For N95 masks, these must meet the standards of the U.S. National Institute for Occupational Safety and Health for air filtration. KN95 masks, on the other hand, must meet a similar standard in China.
At first glance, both types of masks seem similar, and they both filter out most small particles and are similarly breathable.
KN95 masks, however, often use loops around the ears, while N95 masks use elastic bands stretched around the head. The headbands on the latter provide a more secure fit, making a mask more effective at preventing the spread of the virus, explained public health officials.
Recent testing has found that out of 200 brands of KN95 masks imported from China, up to 70 percent are “significantly inferior” and don’t live up to packaging claims.
On Sept. 22, ECRI, a Pennsylvania-based patient safety advocacy group, released its findings on KN95 masks that it analyzed from 15 Chinese manufacturers. They found that the masks, which have been provided to major U.S. hopsitals and health systems, were of poor quality, prompting the group to issue a hazard alert.
Marcus Schabacker, president and CEO for ECRI, explained that these alerts are often reserved for situations when “health care professionals need to be informed immediately.” (Related: Chinese company charged with sending defective face masks to the US.)
Schabacker noted that ECRI first tested the masks in April at the request of hospitals that started sourcing them from Chinese manufacturers. Because of the increase in demand during the pandemic, thousands of manufacturing startups were established in China to provide various medical supplies to various countries across the globe.
According to ECRI, Chinese KN95 masks were some of the most in-demand products that have been imported to the United States. Schabacker suggests that there are at least 35,000 mask suppliers in China.
In a statement, Schabacker revealed that a lot of these products “aren’t safe and effective against the spread of COVID-19.” Schabacker added that health care providers need to “do more due diligence before purchasing masks that aren’t made or certified in America.”
NIOSH, the federal agency overseeing workplace safety in America, requires masks to have a head or neckband design that helps seal the mask more tightly against the face. The Chinese masks ECRI tested all have ear loop straps instead of the required head or neckband design.
ECRI advised that healthcare workers use NIOSH-certified respirators whenever possible, only using KN95s or other alternatives as a “last resort.” While KN95 masks can offer a higher level of protection than surgical or cloth masks, they are suitable for medical staff not involved with “high-risk procedures” like intubation, the suction of airways, or swabbing of patients, and only if they are from a trusted manufacturer.
ECRI said that Chinese quality standards for KN95 masks are similar to those in America, but there is no guarantee that what you buy will meet KN95 filtration requirements. The organization also warned that it can be difficult to determine the authenticity of a respirator simply by looking at its appearance, labeling or packaging.
Even imported respirators, which may have the same model names, may also have a slightly different look and perform significantly differently in filtration testing.
ECRI advised buyers to ask for a test report about the mask performance for review, along with samples for testing to verify its filtration efficiency. Buyers were also told to check the strap area and conduct tests to ensure a proper fit and to guranteed the quality of mask purchases.
Federal authorities have already sanctioned manufacturers for sending faulty Chinese medical gear.
Back in May, the Food and Drug Administration (FDA) banned 65 Chinese mask-makers from exporting to American since their products didn’t meet filtration standards. This decreased the number of U.S.-authorized Chinese manufacturers to 14.
In June, prosecutors charged a Chinese mask producer for exporting over 140,000 defective models advertised as KN95. The Department of Justice found that the masks only filtered 22 percent of small particles.
In September, custom officers in Chicago seized a half-million counterfeit N95 masks shipped from Shenzhen. After sending 30 masks from the shipment for testing, findings showed that 10 percent were substandard.
Aside from the U.S., defective Chinese medical gear has also drawn complaints from countries like Sweden. On Aug. 25, Sweden’s Public Health Agency announced that over 3,700 Swedes were mistakenly told they had coronavirus due to defects in testing kits made in China.
Schabacker concluded that to ensure “critical supplies are readily available at home,” America must focus on producing or acquiring quality supplies from reliable manufacturers around the world.
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