Up to 70% of KN95 masks tested by patient-safety organization ECRI do not meet U.S. standards for effectiveness, the group announced today.

The findings indicate increased risks of contracting COVID-19 for care providers and patients at hospitals and other healthcare organizations that imported the masks from China, according to the Plymouth, Pa.-based, not-for-profit group.

ECRI said that its researchers tested nearly 200 masks reflecting 15 different manufacturer models purchased by some of the largest health systems. They found that 60% to 70% of imported KN95 masks do not filter 95% of aerosol particulates, contrary to what their name suggests. The group has issued a high-priority hazard alert.

“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 ECRI president & CEO Dr. Marcus Schabacker, in a news release. “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 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.”

Despite a recent increase in government-supported PPE production in the United States, including the manufacturing of N95 masks, hospitals and health systems continue to report widespread shortages on quantities that can be purchased, causing providers to continue keep purchasing imported KN95 masks that do not meet U.S. regulatory standards, ECRI reported.

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, the organization said. The nationwide shortage of N95 respirators needed by healthcare workers and others during the coronavirus pandemic shows no indications of letting up, according to an article in yesterday’s Washington Post.

Although the majority of imported KN95 masks do not meet the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 standard for protecting wearers from 95% of airborne particles, 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. 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.

Early in the pandemic, the FDA barred import of KN95s from China, but it reversed itself in April 2020 in light of mask shortages.

“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, VP 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% 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.

More information about ECRI’s testing of KN95 masks and other personal protective equipment (PPE) is available here.