A team of five Northwestern University engineering students and Rosalind Franklin University medical students formed Fabric Medical a week ago to get thousands of KN95 certified respirators from a factory in China to counter a nationwide shortage of N95 masks in the U.S. during the COVID-19 pandemic.
One of the engineering students, Vishall Mali, 22, of Evanston, said they are awaiting results from a testing facility in Ohio that can certify that these respirators are equal to the quality of the N95 masks.
“The motivation on our end is that people are flooding the market with millions of dollars of fake masks and getting them into hospitals,” Mali said. “We want to get the testing done. … I’d rather not have a mask than have a fake one, where you think you’re safe, when you’re really not. We’re trying to do this the right way.”
Mali said once their masks are certified, the group would submit the report to the Centers for Disease Control. They also are pursuing certification from the National Institute for Occupational Safety and Health or NIOSH, which is part of the CDC.
Once the private lab certifies the masks as reliable to filter out 95% of particulates, hospitals that accept that report would be comfortable to receive them for use, he said.
“Then we can truly ramp up production and provide reliable masks to hospitals,” Mali said.
Some hospitals have already put in pre-orders while awaiting test results, he said.
To explain how an N95 respirator mask works, Mali said there are five layers of non-woven fabric inside. But it is the third layer known as the melt blown fabric that is what gives respirators the ability not to allow 95% of the particulates do not pass through, Mali said.
Because of the pandemic, the cost of this third layer of fabric has gone up anywhere from 10 to 100 times its normal price, Mali said.
Masks that would normally cost 20 cents to produce are now costing $2 to make and are selling from $6 to $12.
His group is looking to sell the masks for $4 to $5 a mask, with all profits going back into buying more to aid health workers during the pandemic, Mali said.
“We’re trying to keep the price as close to cost as possible,” Mali said.
One of the hurdles to overcome are different countries’ standards for these masks, Mali said.
“Everyone has their own standard, but all the testing is the same,” Mali said. “They take around 20 masks and put it in a machine that pumps sodium chloride particles through the mask. That is how they see if 95% of the sodium chloride is not being passed through.”
Other tests involve inhalation and exhalation, as to how easy it is to breathe in and out while wearing the mask, he said.
“What differs from country to country is minimal. Every country is accepting other countries’ respirators except for the U.S.,” Mali said. “That is why there is not a shortage of respirators in Italy. China is sending 10 million there. The U.S. will not accept the KN95 standard that other countries are accepting."
One example is that the KN95 respirator from China was left off the CDC’s list of acceptable respirators because of the trade war, Mali said.
But the CDC lists the KN95 as acceptable, if N95 supplies are not available.
CDC media sent an automatic response via email that did not answer questions about KN95, but referred a reporter to back to its website. Voicemail for various CDC media spokespeople was full and no further messages could be left.
“No other country can produce the volume of masks that China can,” Mali said. “The U.S. has not been good at manufacturing for the last 40 to 50 years. Even for China to convert a factory and ramp up production with the right equipment and labor force – it would take the U.S. six to eight months of lead time to do it.”
The China company that is making the masks for Medical Fabric has an FDA stamp to allow them to be imported, Mali said.
“We are working with a third party inspection factory in China where they go through and do quality control and inspection,” Mali said.
Once the masks’ quality is certified, Fabric Medical will be expecting its first shipment, Mali said.
They plan to do a second round of quality control, he said.
“As engineers, we wanted to take a first principles approach: We asked is there a way to correctly certify respirators while manufacturing them in China? And leverage certification and testing to coincide with that so we can be assured of that quality?” Mali said. "We hope we can find the answer to that question once the masks are certified and we can move forward to provide them to health care workers."