September 24, 2020
Most KN95 masks manufactured in China do not meet minimum U.S. safety standards and should be reserved for use in non-COVID-19 circumstances, according to ECRI, a U.S. patient safety organization based in Plymouth Meeting.
Their analysis found that up to 70% of KN95 masks are problematic because they don't filter 95% of aerosol particles, as their name suggests. Using KN95 masks leaves health care providers – and the patients under their care – more prone to COVID-19 than N95 respirators, the preferred option.
N95 respirators have been an important line of defense against the spread of COVID-19 since the first coronavirus cases were identified in the U.S. They provide the wearer protection against aerosols – tiny respiratory droplets that can linger in the air. But hospitals have struggled to maintain adequate supplies.
Some health systems have turned to KN95 masks as a way to deal with shortages of American-made personal protective equipment.
In April, the U.S. Food and Drug Administration issued an emergency use authorization allowing health systems to order KN95 masks that haven't been approved by the National Institute of Occupation Safety and Health.
Since then, U.S. hospitals have purchased hundreds of thousands of KN95 masks manufactured in China, according to Marcus Schabacker, ECRI’s chief executive officer.
"Using masks that don’t meet U.S. standards puts patients and front-line health care workers at risk of infection," Schabacker said. "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."
Another concern is that many KN95 masks have ear loops instead of straps that go around the head and neck, which offer a better seal of protection around the face.
ECRI tested nearly 200 KN95 masks from 15 manufacturers and found that 60% to 70% of imported masks failed to meet the U.S. National Institute for Occupational Safety and Health's standards for N95 respirators.
To test the masks, quality assurance researchers attached each mask to a machine that blew particles at it. They then counted the number of particles found on the inside of the mask. Only KN95 masks from China were included in the study, though some KN95 masks are imported from South Korea.
Still, ECRI researchers emphasized that the KN95 masks aren't completely useless. They may still provide better respirator protection than surgical or cloth masks.
The patient safety organization recommends they only be used in hospital situations where there is limited contact with bodily fluids. They should only be used as a last resort when treating COVID-19 patients.
Despite the federal government's recent push to increase the manufacturing of personal protective equipment manufacturing in the U.S., health systems are still reporting difficulty ordering American-made N95 masks.
Pubic health experts have said a more centralized approach to the production and distribution of PPE is needed.
"Nearly nine months into the pandemic, we need a national plan to ensure the safety and health of all first responders and health care workers," Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City told USA Today. "We need to create a trusted and continuous supply of PPE ... so we don't have to rely on other countries."