Most KN95 masks fall short of U.S. standards for effectiveness, ECRI finds

ECRI, a patient safety organization, said it found 60% to 70% of imported KN95 masks do not filter 95% of aerosol particulates despite the standard the KN95 mask name suggests. (Getty/Chris Rogers)

Up to 70% of KN95 masks manufactured in China do not meet U.S. standards for effectiveness, an analysis by ECRI found. 

ECRI, a patient safety organization, said it found 60% to 70% of imported KN95 masks do not filter 95% of aerosol particulates despite the standard the KN95 mask name suggests. ECRI tested nearly 200 masks from 15 different manufacturer models purchased by some of the largest health systems in the U.S. 

The testing was conducted by ECRI's quality assurance researchers at the organization's independent medical device laboratory.

The finding raises concerns for the safety of both patients and providers in the midst of the COVID-19 pandemic. 

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"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, M.D., Ph.D., ECRI's president and CEO, in a statement.

There are still mixed reports of a lack of adequate personal protective equipment supplies at hospitals nationwide. Last week, Centers for Medicare & Medicaid Services Administrator Seema Verma told Fierce Healthcare that federal authorities assured the White House's coronavirus task force that hospitals had their necessary supplies. However, in some areas of the country, healthcare workers continue to protest a lack of adequate protection. 

In the early days of the pandemic, many providers even purchased their own PPE amid widespread shortages and reports hospitals were competing against the U.S. government for supplies.

ECRI recommends healthcare providers do more due diligence before purchasing masks that aren't made or certified in the U.S. It also recommends noncertified KN95 masks be reserved for use in healthcare settings in non-COVID-19 circumstances.