In the early stage of the coronavirus pandemic, Washington state was desperate for protective gear for front-line workers. Government employees scoured the world for masks capable of filtering tiny airborne particles.
Unable to find a reliable stockpile of U.S. government-approved N95 respirator masks, state officials settled on an alternative, ordering about 13.5 million Chinese-made KN95 models for more than $37 million.
As it turned out, the alternative left much to be desired.
By early May, state officials had canceled more than half of the KN95s it ordered after they failed to pass quality checks. Weeks later, the state canceled another order after persistent delays by manufacturer BYD Co.
Many hospitals and first responders now don’t want KN95 masks, largely because they don’t consistently fit well enough to seal around their faces.
Washington has since stopped placing new orders for the masks. With previously ordered KN95s still arriving, state officials say they might give the masks to workers with less critical needs.
Despite disappointing results, Washington is still committed to spending $13.8 million on KN95s, which cost about five times as much as surgical masks.
The canceled orders and lack of demand are the latest troubles for Washington’s effort to procure protective equipment. As the state’s supplies lagged, medical workers turned to homemade masks and reused N95s, hoping the stopgaps would protect them from COVID-19.
State officials stressed that the masks won’t be wasted. The Department of Enterprise Services (DES), the state’s buying arm, says the KN95s are still in demand from some health care facilities with confirmed COVID-19 cases as well as others lower down its priority list for protective gear, such as jails and homeless shelters.
Linda Kent, a DES spokeswoman, said that when other types of masks aren’t available, the KN95s could be used as “general face coverings.” Cloth masks, which don’t filter as well as KN95s, can be had for far less.
Washington state, like others during the pandemic, has struggled to compete in a topsy-turvy international medical supply marketplace. Normal supply chains ran bare, especially for the N95 respirator, and the state’s expectation that the Strategic National Stockpile would fill the gaps has proven to be misplaced.
This led the state government to suspend procurement rules and sign no-bid contracts for more than $400 million of personal protective equipment (PPE). Now, three months into the pandemic, the supplies are still trickling in.
“Something is better than nothing”
BYD, an automotive conglomerate that now bills one of its factories in Shenzhen, China, as the world’s largest plant for face masks, has contracted to provide virtually all of the KN95s Washington state has purchased. The state has also received donations of 1.2 million KN95s from groups such as the nonprofit Americares and Eddie Bauer, the clothing manufacturer.
In Washington, BYD’s deliveries have been consistently late, part of the wider delays that have plagued the state’s ability to secure equipment. The company accounts for more than half the value of all the state’s orders for COVID-19 supplies.
As of June 2, Washington had received 3.2 million KN95s it had purchased from BYD, plus the 1.2 million donated masks. To date, the state has distributed 2.6 million KN95s, with the remainder either in a warehouse or being processed for distribution. BYD has yet to deliver an additional million of these masks.
Manufacturers who produce N95 masks, the preferred respirator for hospitals and first responders, have to meet U.S. regulatory standards and undergo federal testing. The KN95, approved by Chinese regulators, are designed and tested to similar specifications, yet one key difference has emerged.
The N95s typically are secured with elastic bands that go over the head; the KN95s often have bands that go around the ears, which may not provide as tight a seal, according to the U.S. Centers for Disease Control and Prevention (CDC).
BYD lists two KN95 models on its website: One has elastic bands that go over the head and neck, advertised as having a “very close facial fit“; the other has ear loops. Photos from a state warehouse show boxes of BYD masks with ear loops.
At around $3 apiece, the state was able to acquire the masks for less than the N95, but more than surgical masks, which cost around 60 cents each.
As DES was searching for masks in March, a spokeswoman said, the CDC had listed foreign standards comparable to N95s, so the agency placed the orders.
Then in early April the U.S. Food and Drug Administration authorized a list of foreign manufacturers, including BYD, to distribute KN95s in the U.S.
When the first order of BYD’s masks arrived in early April, the state tested them and they fit “about half the people we tried,” wrote one DES safety expert in an internal email obtained by The Seattle Times through a public disclosure request. She said it was “likely an indication of differences in individual face shape.” Another brand of KN95s fit just one of six people.
The BYD masks were deemed “acceptable to distribute and to continue to purchase, if we do not have better alternatives.”
A BYD spokesman didn’t respond to a request for comment.
KN95s typically came folded in half when packaged. Most of the failures among state testers were due to the seam in the middle of the chin, which created a gap for unfiltered air, according to the emails.
“The quality of the KN95 is just pretty dismal,” the safety expert noted in mid-April, speaking generally, after testing samples from various brands.
“Something is better than nothing,” a DES purchasing employee wrote in the email exchange.
By the time these fit issues surfaced internally, the state had already ordered more than 13 million KN95 masks. DES and the state Emergency Operations Center, after placing the orders, “put measures in place to perform initial quality checks,” a spokeswoman wrote in a statement. By May 1 they had canceled orders for more than 7 million masks that didn’t pass the tests.
Tara Lee, a spokeswoman for Gov. Jay Inslee, said the state ordered KN95s as the only federally authorized equivalent to N95s available “in an expedited fashion rather than delay shipments by weeks to engage in traditional, deliberative product assessment.”
Even with complaints about the fit, she said, the KN95s will still be useful in nonhospital settings “as well as to go into the state stockpile for potential future usages” in case of future outbreaks.
KN95 demand drops across the U.S.
State leaders hoped the KN95s could satisfy health care workers’ desperate need for protection against the coronavirus. But hospitals found that KN95 masks didn’t fit well, said Cassie Sauer, president of the Washington Sate Hospital Association.
“They have tended to be too large for hospital staff,” Sauer said. “They don’t fit many women.”
Similar stories have emerged from around the country. KN95s were among the masks delivered by the New England Patriots, in a splashy event in April, but some Boston hospitals have declined to use the masks, according to The Boston Globe.
In early May, the FDA revoked approval for some Chinese manufacturers of KN95s after testing found that certain models didn’t consistently meet the minimum filtration standards, and DES canceled a small order of KN95s that fell into that group.
The policy change contributed to a national drop in demand, said Jaime Getto, a spokesman for Project N95, a national nonprofit group helping organizations secure PPE.
“We know of importers in the LA area with warehouses of KN95 masks,” Getto said in an email.
After BYD signed mask deals with multiple states, it has run into some high-profile troubles, including with its own line of N95s that still must win U.S. regulatory approval.
In May, the company refunded California nearly $250 million after missing deadlines to obtain federal approval. Later that month, the National Institute for Occupational Safety and Health (NIOSH) denied approval for the company’s N95 masks, declining to specify the rationale but noting that “design, manufacturing and quality inspection of the device was concerning.”
BYD has said the masks passed NIOSH’s physical tests and that the denial was due to paperwork issues. The company has resubmitted its application, and Kent, the DES spokeswoman, said the agency could hear a decision as soon as Monday. Meanwhile, Washington has 5 million N95 masks from BYD waiting in a warehouse for regulatory approval.