Most N95 Masks From China Do not Meet US Requirements


Sept. 24, 2020 — As much as 70% of N95 masks licensed in China don’t meet U.S. requirements for effectiveness, the nonprofit affected person security group ECRI warned this week.

“Due to the dire state of affairs, U.S. hospitals purchased a whole lot of hundreds of masks produced in China over the previous 6 months, and we’re discovering that many aren’t secure and efficient in opposition to the unfold of COVID-19,” Marcus Schabacker, MD, ECRI president and CEO, mentioned in an announcement.

ECRI high quality assurance researchers examined almost 200 N95-style masks, reflecting 15 totally different producer fashions bought by among the largest well being methods in the US.

They discovered that 60% to 70% of the imported masks – generally known as KN95 masks — that had not been licensed by the Nationwide Institute for Occupational Security and Well being (NIOSH), don’t as successfully filter particles from the air. They’re “considerably inferior” to NIOSH-certified N95s, the report says. These masks didn’t filter 95% of aerosol particulates, regardless of what their title suggests.

“Utilizing masks that do not meet U.S. requirements places sufferers and frontline healthcare employees vulnerable to an infection. As ECRI analysis exhibits, we strongly advocate that well being care suppliers going ahead do extra due diligence earlier than buying masks that are not made or licensed in America,” Schabacker mentioned.

In accordance with ECRI, U.S. home manufacturing capability for N95s has elevated considerably, however there stay widespread limits on what number of will be bought.

The group says non-NIOSH-certified masks ought to solely be used as a “final resort” when treating COVID-19 sufferers and solely when NIOSH-certified N95s or different respirators providing comparable or higher safety usually are not out there.

“KN95 masks that do not meet U.S. regulatory requirements nonetheless usually present extra respiratory safety than surgical or fabric masks and can be utilized in sure medical settings,” Michael Argentieri, ECRI vp for expertise and security, mentioned within the assertion.

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