Robert Glatter, MD. (2020). ‘Almost 70% Of Chinese KN95 Masks Don’t Meet Minimum Safety Standards’, Forbes, 25 Sep.
Nearly 70% of Chinese KN95 masks recently tested by ECRI, the nation’s largest nonprofit patient safety organization, did not meet U.S. standards for filtration efficiency. In simple terms, this translates to increased risk of contracting Covid-19 for healthcare workers and patients at hospitals as well as other healthcare organizations that use such imported masks from China.
In their review, researchers at ECRI found that 60 to 70 percent of imported KN95 masks did not filter 95% of aerosol particulates, the basis for the very name of the product. They tested close to 200 such masks, representing 15 different manufacturer models purchased by some of the largest health systems in the US. The masks were evaluated based on rigorous testing protocols according to ECRI.
“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 CEO. “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.”
Due to a massive shortage of PPE during the first several months of the pandemic, hospital administrators and health care providers contracted with thousands of Chinese companies that were able to quickly manufacture KN95 masks. The promise of large quantities of masks delivered in a short time frame led many organizations to ink such deals.
In April, the FDA issued an umbrella emergency use authorization for masks that are manufactured in China and not approved by the National Institutes of Occupational Safety and Health (NIOSH). The FDA then reissued the same order in June.
Even though there has been a recent increase in government-supported PPE production in the US—including manufacturing N95 masks—hospitals and health systems continue to report large scale shortages on quantities that can be purchased, causing providers to keep purchasing imported KN95 masks from China that do not meet U.S. regulatory standards.
In fact, hospitals continue to report significant challenges ordering N95 masks made in the U.S., with some believing they are in direct competition with the federal government as they aim to replenish their PPE stockpiles. As a result, many U.S. hospitals continue to order PPE made in China as a result of ongoing shortages of masks manufactured in the U.S.
While the majority of imported KN95 masks do not meet the U.S. NIOSH N95 standard, ECRI researchers explain that the masks can still be used for procedures or activities that don’t involve contact with bodily fluids. However, ECRI warns hospitals and healthcare providers to only use KN95s or other non-NIOSH-certified masks 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 know that imported masks may not meet current U.S. regulatory standards despite marketing that says otherwise.”
KN95 masks are manufactured with ear loops, which do not provide an adequate seal on a person’s face compared with head and neck straps that are present on a standard N95 mask. The head and neck straps present on an N95 mask create a tighter and more effective seal against the wearer’s face, ensuring that air being breathed is properly filtered.
In addition, the foldable nature of KN95s may prohibit the creation of a tight seal that is vital to ensure a high level of protection. Ear loop retention straps are also not considered acceptable by NIOSH for sealing the mask against a person’s face. Its important to emphasize that head and neck straps are standard for U.S. NIOSH-certified N95s.
To control for the issue associated with ear loops and a poor seal, ECRI removed the ear loops when testing the KN95 models. Even after fitting the KN95 masks with head and neck straps, they did not provide the level of protection compared to the filtration efficiency of an N95 mask. It’s important to note that this only applied only to KN95 masks manufactured in China as KN95s are also imported from South Korea.
An N95 mask provides 95% filtration efficiency against droplets and airborne particles less than 0.3 microns. They provide significantly more respiratory protection compared to a standard surgical or procedure mask, which can only serve as a barrier against saliva, splashes and large droplets.
In light of the review by ECRI, it’s important that healthcare workers and hospital leadership recognize the superior filtering efficiency of certified N95 masks, as opposed to KN95s. That said, even KN95s that do not meet U.S. standards for filtering efficiency might still provide better protection against Covid-19 than a surgical or cloth mask. It’s vital when purchasing masks and PPE to inquire where the mask is manufactured, and if possible, to get feedback from other hospitals and providers regarding mask quality before making any purchase.
The ongoing shortage of PPE in US hospitals continues to create conditions that leave healthcare workers at risk for contracting Covid-19. We need to create a trusted and continuous supply of PPE for all healthcare workers in the US, so we don’t have to rely on other countries such as China. GetUsPPE, a novel physician-led organization that helps get donated PPE for those in need (hospitals, nursing homes, school nurses, home healthcare workers ) has also made significant strides in helping to fill the void of PPE in many underserved and under resourced communities across the U.S. They also advocate to shorten the duration of time to manufacture PPE.
“We still lack adequate supplies of properly manufactured N95 masks across the country, which is why these substandard KN95s are being purchased,” said Megan Ranney, MD, MPH, FACEP, Associate Professor of Emergency Medicine at Brown University School of Medicine, and Co-founder, GetUsPPE. “We at GetUsPPE are working tirelessly to get donated PPE to those who need it most, but it isn’t enough.”
“It is time for our federal government to step up and support increased domestic manufacturing of PPE. This crisis is not going away, and this report reminds us that we cannot depend on imported PPE to keep our frontline workers safe,” added Ranney.
Nearly 9 months into the pandemic, we need a national strategy to ensure the safety and health of all first responders and healthcare workers. This means trusted masks, gowns and gloves manufactured in the U.S. under strict NIOSH requirements. This also means tapping the full resources of the Defense Production Act, which has yet to be fully harnessed.