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An analysis by the nation’s largest patient safety organization shows that up to 70 percent of KN95 masks tested do not meet U.S. standards for effectiveness, raising the risk of contracting COVID-19 for care providers and patients at hospitals and other health care organizations that imported masks from China.

Researchers at ECRI, a not-for-profit organization that for decades has advised hospitals, government organizations and other health care stakeholders on product safety, found that 60 to 70 percent of imported KN95 masks do not filter 95 percent of aerosol particulates, contrary to what their name suggests.

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. The testing was done according to rigorous product testing protocols, conducted by ECRI’s quality assurance researchers at the organization’s independent medical device laboratory.

“Because of the dire situation, U.S. 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 U.S. standards puts patients and frontline health care 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, and we’re here to help them.”

As U.S. healthcare providers felt forced to fend for themselves in the early days of the pandemic amidst a massive shortage of personal protective equipment (PPE) for their workers, they turned to thousands of companies newly registered in China to manufacture KN95 masks. Despite a recent increase in government-supported PPE production in the United States, including manufacturing N95 masks, hospitals and health systems continue to report widespread shortages on quantities that can be purchased, causing providers to keep purchasing imported KN95 masks that do not meet U.S. regulatory standards. Hospitals report significant challenges ordering American-made masks, with some believing they are competing with the U.S. government as it seeks to replenish its PPE stockpile.

Although the majority of imported KN95 masks do not meet the U.S. 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 U.S. health care 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 U.S. 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 U.S. regulatory standards despite marketing that says otherwise.”

While not providing 95 percent protection, ECRI researchers say many non-certified masks that have head and neck straps, as opposed to masks with ear loops, better conform to and seal against the wearer’s face, ensuring that air being breathed is filtered.

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