On a day when COVID-19 cases soared, healthcare supplies were scarce and an anguished doctor warned about being sent to war without bullets, a cargo plane landed at Los Angeles International Airport, supposedly loaded with the ammo doctors and nurses were begging for: some of the first N95 medical masks to reach the US in almost six weeks.
Already, healthcare workers who lacked the crucial protection had gotten infected with COVID-19 after treating patients with the highly contagious new virus. One emergency room doctor, who had voiced concerns about feeling unsafe without protective supplies such as N95 masks, had died of the infection. According to the American College of Emergency Physicians, it was the first such death reported in the US.
The shipment arriving that night in March would turn out to not contribute to solving the problem. The masks were counterfeits, just as there are millions of forged medical masks, gloves and gowns, as well as other supplies being used in hospitals across the US.
Illustration: Kevin Sheu
Before the pandemic, federal trade law enforcement agencies were focused on counterfeit consumer goods such as luxury products and computer software, mostly imported from China.
As the US fell sick, the mission shifted to medical supplies. Since the beginning of the pandemic, US Immigration and Customs Enforcement has seized 519 shipments. Yet, according to the agency, counterfeit goods continue to pour in, not just masks, but also mislabeled medicines, and forged and ineffective COVID-19 tests and cures.
“It’s just unprecedented,” said Steve Francis, the agency’s assistant director for global trade investigations. “These are really bad times for people who are out there trying to do the right thing and be helpful, and they end up being exploited.”
The story of counterfeit medical supplies under the label of Shanghai Dasheng (上海大勝) illustrates how the lack of coordination amid massive shortages has plunged the US medical system into chaos. At usual times, Shanghai Dasheng is one of the world’s largest manufacturers of authentic N95 masks and one of only a handful of Chinese brands certified by US authorities.
The shipment of N95 masks seized at the airport bore the name of the Chinese factory, but differed significantly from their standard model. The seized masks, though stamped as if approved by US authorities, had ear loops, while authentic ones have bands that stretch across the back of the head, making for a tighter fit.
The day before the shipment, the US Centers for Disease Control and Prevention (CDC) had issued a specific warning about all Shanghai Dasheng N95 masks with ear loops being counterfeits.
Such masks are less expensive to manufacture as the straps are glued to the face covering, while headbands on genuine N95 masks are stitched, stapled or soldered to establish a tighter seal over the nose and mouth. Genuine N95 masks filter out 95 percent of all airborne particles, including the ones too tiny to be blocked by looser-fitting surgical masks. Masks with ear loops, even if genuine fabric is used, are not as effective, as tiny airborne droplets can get enter the mask from the sides.
“Fluid follows the path of least resistance. If someone is breathing and the respirator doesn’t have a good fit, it will just go around,” said infectious disease expert Shawn Gibbs, dean of Texas A&M University’s School of Public Health.
While the CDC has been in talks with Shanghai Dasheng about authenticity issues, the company did not respond to queries about its masks to the public. According to the US agency it is either possible that a third party is using Shanghai Dasheng’s certification numbers “without their permission,” or that the Chinese company produces the substandard gear themselves.
“Recently, [we have] received reports stating there is product being obtained directly from the Shanghai Dasheng factory, labeled as approved, with ear loops,” agency spokeswoman Katie Shahan said in an e-mail.
Shanghai Dasheng’s N95 masks with ear loops are counterfeit, Shahan said.
On its Web site, Shanghai Dasheng warns: “We don’t have any distributors, dealers or branch factories. Beware of counterfeit.”
The Chinese Ministry of Foreign Affairs on Tuesday said in a statement that the country has provided a robust and high-quality supply of medical items for global pandemic prevention and control.
“So far, only a few of the exported products have encountered quality or standard problems,” the ministry said.
Earlier this year, hawkers outside the guarded gates of the Shanghai Dasheng factory were offering to take orders for US-approved medical-grade N95 masks. It was not clear whether the sellers were getting their products from inside.
A security guard told a reporter that he believed the sellers were peddling counterfeits, but police at a nearby station were not able to confirm that.
The security guard ordered the journalists to leave.
Since the beginning of the pandemic, Shanghai Dasheng has held itself up as a vital part of the COVID-19 response. Just days into a week-long Lunar New Year holiday in January, company chairman Wu Shengrong (吳勝榮) called back employees and ordered cleaners, cooks and a skeleton crew of workers to work long shifts on assembly lines.
Eleven days later, Wu invited a group of journalists and said his company had increased its daily mask production from 40,000 to 70,000, and aimed for 200,000 once back at full strength. “I am not a learned man, but as a [Chinese] Communist Party member and army veteran, I am a patriot and Dasheng is just a drop of water in China’s ocean of private enterprises,” the chairman said.
One recipient of the Shanghai Dasheng ear loop masks in the US was Direct Relief, an international humanitarian aid organization. Like other buyers, Direct Relief at first thought the factory inadvertently sent the wrong mask model and set aside the entire shipment. However, after reading the CDC’s warnings, Direct Relief CEO Thomas Tighe said they had come to believe the masks were counterfeit and reported them to the federal government.
“It’s a little scary that it had gone through what we understood was an aggressive customs investigation for export, and an aggressive customs import by the US and still got through,” Tighe said. “It’s been a real lesson.”
Direct Relief has since caught more poorly constructed masks donated to their warehouse. Even for those looking out for fakes, it has been difficult to keep up with changing federal guidelines for medical-grade masks.
Citing an acute shortage of N95 masks, US government officials relaxed standards in March. The US Food and Drug Administration announced that other, unapproved masks with ear loops were appropriate for COVID-19 care.
Eventually government testing of newly arrived models found most were inadequate, and on Thursday last week, the agency banned mask imports from 65 Chinese factories. Shanghai Dasheng is among 14 others that remain on the list of approved factories. Still, millions of masks now considered inadequate for medical protection are in use.
State and local governments, hospitals and private care companies have spent hundreds of millions of US dollars on the flawed masks. Before the pandemic, N95 masks sold for about US$0.60 per piece. Today their price is as high as US$6.
“It’s terrible, just terrible,” Massachusetts Nursing Association spokesman David Schildmeier said.
A hospital, which had solicited mask donations online, handed out Shanghai Dasheng-labeled masks with ear loops to as many as 40 nurses in a COVID-19 unit before noticing.
In West Virginia, Shanghai Dasheng-labeled masks have been passed to thousands of paramedics and firefighters, prison guards and hospital workers.
State officials knew of the CDC warnings, but dismissed concerns, saying that, with a proper fit, they would be safe.
In a letter to first responders, West Virginia Secretary for Military Affairs and Public Safety Jeff Sandy said he had reviewed the masks, checked with the vendor, the importer, the Chinese exporter and with Shanghai Dasheng itself. According to him, the 50,000 N95 masks with ear loops that the state provided are “genuine products” that provide adequate protection.
Some first responders in his own state disagree.
“While trusting the equipment to protect them, our members may have unknowingly placed themselves in situations that put them at further risk,” West Virginia State Firemen’s Association President Jerry Loudin said.
Some of the masks were purchased by charities or well-intentioned community members who held online fundraisers. Wendy Chou Le, a marketing consultant based in Southern California, frustrated with reports about frontline medical workers not having N95 masks, launched a fundraiser, and ordered N95 masks through a client. Within weeks, Shanghai Dasheng delivered a shipment of ear loop masks to her, which she passed on to caregivers.
Lee said the nurses she gave them to near Los Angeles have been grateful and did not raise concerns. Tyler Alvare, a pediatric physician’s assistant in Alexandria, Virginia, had run his own fit tests on the masks when they arrived. But after reviewing the federal warnings, he said he had notified everyone he gave them to.
The government should have taken responsibility for providing enough protective equipment as soon as the shortage of masks became apparent instead of having every medical provider figure it out themselves, he said.
“It’s really outside of our area of expertise,” he said.
However, even experts were caught off guard.
Franco Sagliocca, Mount Sinai hospital’s procurement director in New York City, was working 18-hour days, seven days a week, to keep enough safety supplies in the hospital’s emergency unit as COVID-19 overwhelmed New York. He was searching, ordering and hustling for N95 masks, and was planning to buy from Shanghai Dasheng.
“Our sourcing lead said, ‘Wait a minute guys, this is something we don’t want,’” Sagliocca said.
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