Sept. 24, 2020 -- Up to 70% of N95 masks certified in China do not meet U.S. standards for effectiveness, the nonprofit patient safety organization ECRI warned this week.
"Because of the dire situation, U.S. hospitals bought hundreds of thousands of masks produced in China over the past 6 months, and we're finding that many aren't safe and effective against the spread of COVID-19," Marcus Schabacker, MD, ECRI president and CEO, said in a statement.
ECRI quality assurance researchers tested nearly 200 N95-style masks, reflecting 15 different manufacturer models purchased by some of the largest health systems in the United States.
They found that 60% to 70% of the imported masks – known as KN95 masks -- that had not been certified by the National Institute for Occupational Safety and Health (NIOSH), do not as effectively filter particles from the air. They are "significantly inferior" to NIOSH-certified N95s, the report says. These masks did not filter 95% of aerosol particulates, despite what their name suggests.
"Using masks that don't meet U.S. standards puts patients and frontline healthcare workers at risk of infection. As ECRI research shows, we strongly recommend that health care providers going forward do more due diligence before purchasing masks that aren't made or certified in America," Schabacker said.
According to ECRI, U.S. domestic production capacity for N95s has increased significantly, but there remain widespread limits on how many can be purchased.
The organization says non-NIOSH-certified masks should only be used as a "last resort" when treating COVID-19 patients and only when NIOSH-certified N95s or other respirators offering comparable or better protection are not available.
"KN95 masks that don't meet U.S. regulatory standards still generally provide more respiratory protection than surgical or cloth masks and can be used in certain clinical settings," Michael Argentieri, ECRI vice president for technology and safety, said in the statement.