An analysis by researchers at ECRI found that 60% to 70% of imported KN95 masks do not filter 95% of aerosol particulates, and do not meet US standards for effectiveness. According to ECRI, using these masks raises the risk of contracting COVID-19 for care providers and patients at hospitals and other healthcare organizations.
Early indication from ECRI’s testing of nearly 200 masks, reflecting 15 different manufacturer models purchased by some of the largest health systems, raised alarms for ECRI, which issued a high priority hazard alert. According to the organization, the testing was done according to rigorous product testing protocols, conducted by ECRI’s quality assurance researchers at its independent medical device laboratory.
“Because of the dire situation, US hospitals bought hundreds of thousands of masks produced in China over the past six months, and we’re finding that many aren’t safe and effective against the spread of COVID-19,” said Marcus Schabacker, MD, PhD, ECRI’s president and chief executive officer. “Using masks that don’t meet US standards puts patients and frontline healthcare workers at risk of infection. As ECRI research shows, we strongly recommend that healthcare providers going forward do more due diligence before purchasing masks that aren’t made or certified in America, and we’re here to help them.”
Although the majority of imported KN95 masks do not meet the US National Institute for Occupational Safety and Health (NIOSH) N95 standard, ECRI researchers say the KN95s can be used in lieu of surgical or procedure masks for activities that involve limited contact with bodily fluids (because KN95s are not intended for fluid repellency), and they may provide superior respiratory protection. ECRI warns US healthcare organizations, however, to use KN95s or other non-NIOSH-certified masks only as a last resort when treating known or suspected COVID-19 patients.
“KN95 masks that don’t meet US regulatory standards still generally provide more respiratory protection than surgical or cloth masks and can be used in certain clinical settings,” said Michael Argentieri, vice president for technology and safety at ECRI. “Hospitals and staff who treat suspected COVID-19 patients should be aware that imported masks may not meet current US regulatory standards despite marketing that says otherwise.”