Post Tribune (Sunday)

FAKES A REAL DANGER

Counterfei­t face masks with inadequate protection distribute­d to frontline workers

- By Juliet Linderman and Martha Mendoza Associated Press

WASHINGTON — On a day when COVID-19 cases soared, health care supplies were scarce and an anguished doctor warned he was 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 U.S. in almost six weeks.

Already health care workers who lacked the crucial protection had caught COVID-19 after treating patients infected with the highly contagious new coronaviru­s. That day an emergency room doctor who earlier texted a friend that he felt unsafe without protective supplies or an N95 mask, died of the infection. It was the first such death reported in the U.S., according to the American College of Emergency Physicians.

But the shipment arriving that night in late March wasn’t going to solve the problem. An Associated Press investigat­ion found those masks were counterfei­ts — as are millions of medical masks, gloves, gowns and other supplies being used in hospitals across the country, putting lives at risk.

Before the pandemic, federal trade law enforcemen­t agencies were focused on busting knockoffs such as luxury goods and computer software, mostly from China. As America fell sick, the mission shifted to medical supplies.

Operation Stolen Promise, spearheade­d by Immigratio­n and Customs Enforcemen­t’s Homeland Security Investigat­ions, has netted roughly a dozen arrests and 520 seizures. And yet counterfei­t goods continue to pour in — not just masks, but also mislabeled medicines, and fake COVID-19 tests and cures, according to the agency.

“It’s just unpreceden­ted,” said Steve Francis, HSI’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 how one brand of counterfei­ts infiltrate­d America’s supply chains illustrate­s how the lack of coordinati­on amid massive shortages plunged the country’s medical system into chaos.

AP identified the counterfei­t masks when reviewing film of the Los Angeles shipment. The telltale sign: these masks had ear loops, while authentic ones have bands that stretch across the back of the head, making for a tighter fit.

The boxes being unloaded in a Southern California warehouse bore the name of the Chinese factory Shanghai Dasheng. The masks inside were stamped as if approved by the U.S. National Institute for Occupation­al Safety and Health — signifying they had been certified by the U.S. government as safe for workers in health care settings. N95 masks filter out 95% of all airborne particles, including ones too tiny to be blocked by looser fitting surgical masks.

But the day before they arrived, the U.S. Centers for Disease Control and Prevention issued a specific warning: all Shanghai Dasheng N95 masks with ear loops were counterfei­t.

Ear loop masks are less expensive to manufactur­e because the straps are attached with glue to the face covering, while headbands on genuine N95s, also called respirator­s, must be stitched, stapled or soldered to establish a tighter seal over the nose and mouth.

And even if the electrocha­rged fibers in the fabric are the same, masks with ear loops are not as effective because tiny airborne droplets carrying the virus can get sucked through the cracks.

“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, the dean of Texas A&M University’s school of public health.

AP tracked other shipments of Shanghai Dasheng ear loop N95 masks as they entered the vast U.S. medical system. Shipping labels and invoices, certified letters and interviews with more than a dozen buyers, distributo­rs or middlemen pointed to the corporate headquarte­rs and busy factory of Shanghai Dasheng Health Products Manufactur­e Company.

The company did not respond to AP’s queries about its masks. And AP could not independen­tly verify if they are making their own counterfei­ts, or, as the CDC said in a published warning, someone is using Shanghai Dasheng’s certificat­ion numbers “without their permission.“

The CDC separately told AP it has been in talks with Shanghai Dasheng about authentici­ty issues.

“Recently, NIOSH has received reports stating there is product being obtained directly from the Shanghai Dasheng factory, labeled as NIOSH-approved, with ear loops,” said agency spokeswoma­n Katie Shahan in an email to the AP. Shahan said Shanghai Dasheng’s N95s with ear loops are counterfei­t.

On their website, Shanghai Dasheng warns: “WE DON’T HAVE ANY DISTRIBUTO­RS, DEALERS OR BRANCH FACTORIES. BEWARE OF COUNTERFEI­T!”

The Chinese Ministry of Foreign Affairs said in a statement that the country has provided a robust and high quality supply of medical items for global pandemic prevention and control.

Florida-based importer Mark Kwoka said he believes the Shanghai Dasheng masks with ear loops that he obtained came from their factory, based on informatio­n he received from his partners in China.

“This is kind of getting out of control,” said Kwoka, who made a career in bridal gown design and manufactur­ing in China but turned to masks earlier this year.

Earlier this spring, hawkers outside the guarded gates of the factory were offering to take orders for U.S.-approved, medicalgra­de N95s. It wasn’t clear whether the sellers were getting their products from inside. A security guard told a reporter he believed the sellers were peddling counterfei­ts, but police at a nearby station weren’t able to confirm that. The security guard ordered the journalist­s to leave.

One recipient of the Shanghai Dasheng ear loop masks was Direct Relief, an internatio­nal humanitari­an aid organizati­on in Southern California.

Like other buyers AP contacted, Direct Relief at first thought the factory inadverten­tly sent the wrong model and set aside the shipment. But after reading the CDC’s warnings, CEO Thomas Tighe said they had come to believe they 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 U.S. and still got through,” Tighe said.

Direct Relief has since caught even more poorly constructe­d masks donated to their warehouse.

Even for those looking for fakes, it has been difficult to keep up with changing federal guidelines for medical-grade masks.

Citing an acute shortage of N95 masks, government officials relaxed standards in March. The U.S. Food and Drug Administra­tion announced that other, unapproved medical masks with ear loops were appropriat­e for COVID-19 care.

But government testing of newly arrived models found most were substandar­d, and on May 7 the agency banned mask imports from 65 Chinese factories. Shanghai Dasheng is among 14 that remain on the approved list.

For more than four weeks, millions of masks now considered inadequate for medical protection entered the U.S. and are in use.

Meanwhile, state and local government­s, hospitals, private caregivers and well-wishers have spent hundreds of millions of dollars on the flawed masks. Before the pandemic, N95 masks sold for 60 cents each. Today they’re priced as high as $6 apiece.

“It’s ...just terrible,” said David Schildmeie­r, spokesman for the Massachuse­tts Nursing Associatio­n. He said Lawrence General Hospital, which had solicited mask donations online, handed out ear loop Shanghai Dashenglab­eled masks to as many as 40 nurses in a COVID-19 unit before someone noticed.

— Steve Francis, assistant director for global trade investigat­ions for Immigratio­n and Customs Enforcemen­t’s Homeland Security Investigat­ions

In West Virginia, the state passed the masks to thousands of paramedics and firefighte­rs, prison guards and hospital workers. State officials knew of the CDC warnings about Shanghai Dasheng’s ear loops, but dismissed concerns saying that, with a proper fit, they would be safe.

In a letter to first responders, Jeff Sandy, the state’s secretary for Military Affairs and Public Safety, said he reviewed the packaging and the masks, checked with the vendor, the importer, the Chinese exporter and — through a lawyer — Shanghai Dasheng.

He wrote he is certain the 50,000 N95 masks with ear loops that the state provided are “genuine products” that provide adequate protection.

Some first responders disagree. “While trusting the equipment to protect them, our members may have unknowingl­y placed themselves in situations that put them at further risk,” said West Virginia State Firemen’s Associatio­n President Jerry Loudin.

Some of the masks were purchased by charities or well-intentione­d community members who held online fundraiser­s.

One Southern California marketing consultant, frustrated with reports that front-line medical workers didn’t have N95 masks, had a client who makes custom, rekeyable locks in China. That client said he had sources who could get legitimate N95s, and so she launched a fundraiser, and within weeks delivered a shipment of the Shanghai Dasheng ear loop masks to caregivers.

The consultant, Wendy Chou Le, said the nurses she gave them to near Los Angeles have been grateful and didn’t raise concerns.

But even experts were caught off guard.

Franco Sagliocca, Mount Sinai procuremen­t director, was working 18-hour days, seven days a week, to keep enough safety supplies in the hospital system’s ERs and ICUS as COVID-19 overwhelme­d New York. He was searching, ordering and hustling for N95s, 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.

“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.”

 ?? JONATHAN INGALLS/FRONTLINE/PBS/GRC ?? Direct Relief, an internatio­nal humanitari­an aid organizati­on in California, received counterfei­t N95 masks.
JONATHAN INGALLS/FRONTLINE/PBS/GRC Direct Relief, an internatio­nal humanitari­an aid organizati­on in California, received counterfei­t N95 masks.

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