Respirator masks made in China and purchased by U.S.-based healthcare systems often don't meet federal filtration standards, according to a new analysis by the not-for-profit patient safety organization ECRI.
N95 respirator masks are used by healthcare personnel when interacting with suspected or confirmed COVID-19 patients. Shortages of these masks in the U.S. has forced some providers desperate for them during the COVID-19 pandemic to buy from suppliers that haven't received certification from the U.S. government, many of which are based in China. These masks tend to be called KN95. In an analysis of nearly 200 masks from 15 mask models manufactured in China, ECRI found 60% to 70% of the masks didn't filter 95% of aerosolized particles as their name suggests and is standard for N95 respirator masks in the U.S.
ECRI received the masks from its health system members that purchased them.
ECRI is now advising its provider members not to use KN95 respirator masks from China when treating suspected or confirmed COVID-19 patients.
"We are, quite frankly, taken aback by this finding. We didn't expect this," said Dr. Marcus Schabacker, CEO of ECRI. "We can't recommend at this point for high-risk procedures KN95s from China."
Schabacker added he assumes some of ECRI's members had personnel use these masks during the pandemic if they were short U.S.-certified N95 respirators. Shortages of U.S.-made N95 respirators have also caused systems to reuse them more than once, which isn't recommended by ECRI.
The shortages have also caused stakeholders and policymakers to call for changes in America's dependency on foreign products.
Even before the pandemic, the Peterson Institute for International Economics estimated that China already exported more respirators, surgical masks, medical goggles and protective gear than the rest of the world combined.
"Not only did our reliance on China fail us during this pandemic, it has broader implications for our safety and economic success," wrote Sen. Rick Scott (R-Fla.) in an op-ed for Modern Healthcare recently.
ECRI's results are in line with those from the National Institute for Occupational Safety and Health, which certifies N95 respirators and conducted similar assessments of masks from China.
ECRI followed similar testing techniques the National Institute for Occupational Safety and Health uses to certify N95 respirators, including using the same equipment and protocols. The certification by the National Institute for Occupational Safety and Health is typically displayed on masks.
Standards for KN95 masks in China are similar to the U.S., Schabacker said, but many of the masks made in China likely still don't meet filtration standards because the enforcement of standards isn't as rigorous as in the U.S., which ensures a manufacturer can consistently maintain the quality before it's certified. Schabacker said ECRI found many masks from the same manufacturer had differing levels of filtration, demonstrating holes in quality control.
ECRI plans to conduct a similar analysis on respirator masks manufactured in Korea.
Correction: The article previously misstated how many mask models ECRI tested.