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'Meaningless' FDA Certificates Are Used To Tout Dubious Face Masks
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When the order of 100,000 masks arrived at an unnamed factory for use in protecting workers against COVID-19, they were covered in dirt, dust and mysterious stains. In short, they were "not fit to be used," according to a complaint filed with the Food and Drug Administration in late March.
The masks came from Shenzhen Newstar Optical Electronic Technology, a company in Shenzhen, China, that appears primarily to make LED displays. Because the report was filed in the FDA database for medical device problems, the complainant's name and other facts have been redacted.
"When i started to question them, they provided me with a fda certificate (dated april 7th 2020) in an attempt to silent [sic] me," the complainant wrote. The certificate had a date in the future on it. It was still March at the time.
When the COVID-19 pandemic left facilities scrambling for surgical masks, new manufacturers stepped up to meet demand and turn a profit. But the mix of first-time manufacturers and first-time buyers has led to confusion and concerns about quality.
Many sellers are touting FDA certificates of registration as evidence their masks can be trusted, said people who work in the health care supply chain. They usually include an FDA logo and, often, a cartoon eagle. The certificates are particularly popular with companies in China.
But the certificates are meaningless.
While the FDA requires makers of medical products to register their facilities with the agency so it can keep track of them, it doesn't issue such certificates. Even when the registrations themselves are legitimate, they don't mean a product or a facility has met any kind of regulatory standard.
Shenzhen Newstar Optical Electronic Technology did not respond to requests for comment. FDA records indicate that it is a registered facility with the agency, but it has never been inspected and doesn't hold any medical device clearances from the FDA.
"There are a lot of manufacturers now in the industry because they were making, you know, hats, socks last week — teddy bears — and now they're making masks," said Benjamin England, a consultant and attorney based in Maryland, who has several dozen clients who import products to the United States.
Nearly 80% of imported surgical mask shipments from March until July 2 came from China or South Korea, according to an NPR analysis of bills of lading from ImportGenius.com. Most mask shipments were co-signed by separate logistics companies, making it impossible to tell from which manufacturers the masks came.
Although FDA registration is mandatory for companies seeking to sell medical products in the U.S., the listing is more like getting in a phone book than anything else. Information provided to officials isn't verified for accuracy.
But in China, manufacturers expect a regulatory certificate, said England, explaining that it is just part of the culture. As a result, the consultants who help Chinese manufacturers get registered in the U.S. simply design one and print it out.
"You come in and you see other certificates in the lobby, at the office or the waiting area," he said of manufacturing facilities in the country. "And they are completely commercially meaningless, of absolutely no value whatsoever."
Most of the time, the certificates include fine print that says the FDA doesn't create or honor such certificates. For its part, the agency said in an FAQ: "The FDA does not issue any kind of certification to demonstrate a manufacturer is in compliance with the FDA's requirements."
A glance at a recent page of surgical masks offered for sale on the online commerce site Alibaba.com shows how common the certifications are. NPR examined the top surgical mask wholesale listings on July 6. All 21 of them were posted by manufacturers based in China, and about half of them included an image of a certificate of registration with the FDA. NPR found valid registrations for all of these facilities, but none had ever been inspected by the agency, and none had received FDA premarket clearance for selling surgical masks, according to FDA records.
Surgical masks typically need to go through FDA premarket clearance, which involves making sure they meet certain standards. However, the FDA is waiving this requirement for surgical mask manufacturers amid the current pandemic.
But with so many newcomers buying and selling surgical masks, what a certificate means — and what it doesn't — often gets lost in the shuffle.
"They use it to imply that the product is approved by FDA or the facility is somehow approved and inspected or compliant" with quality standards, England said. "And when FDA discovers that, they consider that to be misbranding, clearly misbranding and fraudulent. So many people are doing it now. The FDA is just busy. They're not really focusing on it."
Alibaba Group, the company that owns Alibaba.com, looked into the certificates on surgical mask listings after NPR inquired about them.
"Merchants on Alibaba.com are required to meet the regulatory requirements for the markets in which their goods are sold," the company said in a written statement. "While these sellers are expected to act in good faith, a review of certain listings revealed some information that could be misconstrued. We have removed such listings and are actively requiring sellers to delete any information that could create confusion before relisting on our marketplace."
But Alibaba.com isn't the only place where sellers and buyers can connect, and there are more certificates out there. Health care facilities, factories and even private citizens have encountered them searching high and low for personal protective equipment in recent months. Some may not even point to a real FDA registration.
"It is easy to believe the certificates are authentic because they appear to have the FDA logo, and they list company registration numbers, devices and certificate numbers," said Pamela Anderson, who directs quality assurance and regulatory affairs for Vizient Inc., a company that helps hospitals negotiate contracts for supplies.
Amid the pandemic, new suppliers have contacted hospitals offering to meet the increased demand for personal protective equipment and other things. Some have touted FDA certificates.
Vizient has been helping hospitals review mask offers, including those for N95 respirators, which offer a higher level of protection than surgical masks and are more strictly regulated.
Of the nearly 1,700 offers the company had reviewed by the end of May, more than two-thirds were not even "potentially appropriate for use in a health care setting," said Cathy Denning, a senior vice president involved in supply sourcing for Vizient. Sixty-five of those offers were specifically for surgical masks, but only 39 offers included potentially acceptable products.
Fishy companies often sent the certificates and photos of the products but no samples. Yet the suppliers required large down payments, Denning wrote in an email to NPR.
"We had one hospital tell us that they bought the products and when they got to their dock, the quality was so poor they put them aside until the FDA issued a guidance that they could be used as a ASTM level 1 mask," she wrote, referring to the lowest level of protection a mask can offer. This was for N95s.
Since March, the FDA has received at least 37 reports about malfunctions and injuries stemming from masks, according to an NPR analysis of data provided by Device Events, a website that tracks FDA's medical device adverse event data. The products include surgical masks as well as N95 respirators, KN95 respirators and face shields.
Reports cited masks that had holes, mold, disintegrating ear loops and were made of the wrong materials. Five include allegations that sellers falsely told them their products had the FDA's OK. The reports, filed to FDA's public database for medical device problems called MAUDE, are voluntary and therefore considered an underestimate.
"The FDA acknowledges that there is some confusion about device registration and listing and clearance or approval of medical devices during this pandemic," FDA spokesperson Brittney Manchester wrote in an email to NPR, pointing to a webpage set up to help with some of that confusion.
Health care workers aren't often looped into how their hospitals and facilities go about buying masks, but they've felt the effects.
In three decades as a nurse, Betsy Marville had never had any kind of reaction to a surgical mask. But the organizer for 1199SEIU United Healthcare Workers East in Florida said the union started to get complaints about what nurses called "hairy masks" that arrived during the pandemic.
"They've got some kind of fibers that are shedding off of them," she said. "They're irritating their nose and eyes and their respiratory tract."
Marville asked the nurses for photos of the boxes in which the masks arrived.
Normally, these boxes are marked with lot numbers and other manufacturing information. Not this time.
"It just says, 'blue face mask,' " Marville said, adding that the word blue is comically large. "And it says 'Made in China.' And there's no company. There's no lot number. Just 'blue face mask.' "
There were also yellow masks with a chemical smell that nurses said made them feel sick.
Westside Regional Medical Center in Plantation, Fla., was one of the hospitals that got the masks, Marville said. A hospital spokeswoman said it hadn't received any complaints about them.
"Early in the COVID-19 crisis, Westside Regional Medical Center implemented processes to review personal protective equipment ... to validate appropriate levels of coverage and check for defects before the masks go into the facilities for use," Westside Regional Medical Center spokeswoman Bruna Doering wrote in an email to NPR.
Across the country in California, another nurse described something similar: The surgical masks she had begun wearing during her shifts were shedding small fibers. By the weekend, she had "extremely chapped skin" on her face. The nurse declined to be named for this story, fearing doing so would get her in trouble at work.
"I've been in there for like 12, 13 years. I've never had that happen from wearing a mask before," the nurse said, adding that the strange masks arrived during the pandemic as masks became scarce and alternative suppliers entered the market.
The box again said the masks were made in China, and there was a company name: Sunrise Industries Inc., based in Albertville, Ala. The company did not respond to requests for comment.
An FDA spokesperson said the agency has no record of a premarket clearance for Sunrise's surgical mask. But it "does not intend to object" to the distribution of certain masks during the pandemic as long as the masks "do not create an undue risk."
In Auburn, Wash., Greg Byrge, executive director at Wesley Lea Hill, a retirement community with varying levels of care, said that when the pandemic began, it became harder to purchase surgical masks. His usual suppliers didn't have any, and the new suppliers sold products at higher prices and lower quality.
Some masks wouldn't even last a whole shift, he said. Others, like the ones with ear loops made out of the wrong material, broke before his employees could even get them on their faces. What's more, masks cost the facility 75 cents apiece before the pandemic. Now, they run up to $3 a mask.
In early June, the facility got a package of masks from the Federal Emergency Management Agency.
"We received cloth masks that were white and black," he said. "They had the consistency and the feel of underwear."
His staff opted not to use them. Residents in the assisted living, skilled nursing and independent living parts of the retirement community sewed better masks and gave them to the staff.
You can contact NPR pharmaceuticals correspondent Sydney Lupkin at slupkin@npr.org.
Copyright 2020 NPR. To see more, visit https://www.npr.org.
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