Originally published on WallStreetJournal.com
Faulty N95 Masks Hamper Hospitals on Coronavirus Front Line
Desperate to protect staff from infection, hospitals and health officials are buying goods that often fail quality tests—and keeping them
Employees from Magid Glove and Safety Corp. in Romeoville, Ill., conduct fit tests on face masks. The company hasn’t been able to buy N95 masks from its usual suppliers.
By Austen Hufford
Updated April 9, 2020 7:05 pm ET
Some hospitals say they are buying faulty imitations of the high-quality N95 masks workers need to treat patients with Covid-19, a new hazard for officials scouring the globe for scarce protective gear.
Hospital executives and local officials said they are trying to procure whatever masks they can from private stockpiles and lesser-known manufacturers around the world. Some have bought N95 masks—which block 95% of very small airborne particles—that are failing basic quality tests, indicating they might not guard against the new coronavirus.
CoxHealth, a hospital system based in Springfield, Mo., recently bought 100,000 N95 masks from a reseller outside its normal supply chain. After one of those masks failed what’s called a “fit test” to assure it is operating effectively, the reseller offered to buy them all back—and sell them to another hospital, said CoxHealth’s president, Steve Edwards. He decided to keep them.
“These aren’t perfect but they have some protection,” Mr. Edwards said. “Everything about it looks legit. But the product itself is clearly not.”
Mr. Edwards said CoxHealth paid around $4 each for the faulty masks, at the low end of a range up to almost $7 a mask that contracting-data provider GovSpend said it has found for N95 masks. That compares with about $1 each for N95 masks before the pandemic, GovSpend said.
Only 11 of the 39 samples Magid recently tested from a Chinese manufacturer met the minimum standard for ‘fit factor.’
Officials and manufacturers have asked the Trump administration for guidance on obtaining and distributing medical goods, including masks. The White House referred questions to F EM A, which said on March 31 that the agency is working to issue guidance to companies. President Trump this week said the government would work with 3M Co. to bring in nearly 167 million masks from China over the next three months, substantially boosting the amount of masks bought by the federal government.
Normally, manufacturers including 3M sell N95 masks that are certified by the U.S. government for use by medical workers through about a half-dozen big distributors. But as coronavirus cases approach what officials say could be a peak in some domestic hot spots, the demand for masks has far exceeded supply in those channels. The Trump administration said Wednesday that it would restrict the export of certain masks and gloves for four months, joining many other countries that have restricted exports to keep medical products at home.
Making Sense of the N95 Mask Shortage
With medical workers facing shortages and the CDC recommending the voluntary use of face coverings, many are wondering when they can get access to N95 masks. WSJ’s Gerald F. Seib explains. Photo: Sara Eshleman/Getty Images
Some hospitals in the U.S. are turning to a cast of smaller producers and shadowy middlemen. “We are getting a lot of ‘guy who knows a guy’ stories,” Mr. Edwards said. “We go down every rabbit hole.”
Dan Harris, a lawyer in Seattle who is helping hospitals verify mask sellers in China, said he has reviewed the same “proof of verification” certificate more than a dozen times, indicating it is fake or copied.
“They are either hucksters or con artists,” Mr. Harris said. “Normal safeguards are being ignored right now.”
Some deep-pocketed individuals and corporations with supply-chain expertise have helped local officials navigate this murky global marketplace. The Kraft family, owners of the New England Patriots, sent the team’s plane to China to pick up more than one million N95 masks for hospitals in New York and Boston. McDonald’s Corp. said it would give one million N95 masks to health-care officials in Chicago and Illinois. The Chicago-based company said it got the masks from a supplier in China while looking for nonmedical grade masks to protect restaurant workers.
Absent such largess, many state and city officials say they are on their own. Greg Holcomb, director of public-safety support for Lake County, Fla., said only one of several types of masks county officials have purchased from Chinese manufacturers passed its quality tests. He said health workers would use the flawed masks should less-sophisticated surgical masks run low.
“The fit tests are failing,” Mr. Holcomb said.
N95 masks are usually certified by the National Institute for Occupational Safety and Health and the Food and Drug Administration. A Niosh spokeswoman said officials are working seven days a week to test new masks from producers. The agency approved 63 new masks and denied nine others in March, double the number it usually reviews each month. The FDA has also allowed the use of N95-style masks certified in Europe, Mexico and South Korea and some masks that meet China’s standard, known as KN95.
Those dispensations have contributed to the influx of suspect masks on the market, according to hospital buyers and established manufacturers. They said it is difficult to corroborate claims that masks have been tested and certified in other countries.
“I am very concerned about the quality of the products they are offering,” Rosie Poole, purchasing manager for Three Rivers Hospital in Brewster, Wash., said, referring to new resellers who have contacted the hospital. She said the hospital is relying on residents to make cloth masks for patients and trying to minimize use of medical-grade masks by nurses and doctors rather than buy from unknown suppliers.
The FDA said it was working to increase the availability of protective equipment but would take action to stop fraudulent or substandard products. U.S. Customs and Border Protection said it was working to move medical goods through customs as quickly as it can while verifying their authenticity. China’s Ministry of Commerce said last week that it was implementing new export rules for masks and other medical products to “crack down on counterfeit and shoddy products.” 3M, which has ramped up N95 production in the U.S. and globally, said it was working with police to go after sellers of counterfeit products.
Andrew Shulman, chief executive of Mobile Health Management Services Inc., which provides background checks and physicals of home health-care workers, said he regrets wading into the mask market recently. He organized an order of 130,000 surgical masks for himself and a few dozen of his clients from a reseller, which said it would buy the masks from a producer in Mexico.
A mask that Andrew Shulman, chief executive of Mobile Health Management Services Inc., ordered through a mask reseller.
The masks arrived Monday in bags emblazoned with names of people he didn’t recognize. They were smaller than expected and lacked a flexible nose piece to insure a better fit.
“They are terrible,” Mr. Schulman said. “Until you get your hands on it, you don’t really know what you are getting.”
His clients still took them, telling him that bad masks were better than none.
Mr. Shulman had ordered 60,000 N95 masks from the same supplier, which he declined to name. He worried they would also arrive in poor condition. The supplier called on Tuesday to say the manufacturer had canceled the order, citing government restrictions.
Magid Glove and Safety Corp., a maker of gloves and distributor of other medical products in Romeoville, Ill., hasn’t been able to buy N95 masks from its usual suppliers since the pandemic began. Last month the company requested a sample from a new supplier ahead of placing an order for 300,000 masks made in China.
A Magid employee attached a sensor to the mask to test whether it was working while he altered his breathing rate and shook his head. The test gave the mask a “fit factor” of 1, well below the minimum standard of 10. Only 11 of the 39 samples Magid has tested rated 10 or above, said Magid Chief Executive Greg Cohen.
“We are finding a crazy amount of bad masks in the market,” he said.
—Heather Haddon contributed to this article.