By Winston-Salem Journal
This article was originally published in the Winston-Salem Journal October 24, 2020. We are sharing because it discusses how textile innovation is being used to help protect against the pandemic.
Hanesbrands Inc. has taken the next step toward making personal protective equipment a manufacturing mainstay with the development of a more breathable, single-use surgical mask.
The Winston-Salem manufacturer is being assisted by two Triangle universities — the Nonwovens Institute at N.C. State University, a shared biomedical engineers program between N.C. State and UNC-Chapel Hill, and UNC Health infection prevention experts.
Hanesbrands is the lone publicly traded corporation with headquarters in Winston-Salem, as well as the city’s only Fortune 500 company. The manufacturer has about 2,500 employees in Forsyth County.
The two-ply surgical mask was added Oct. 5 to the Food and Drug Administration's Emergency Use Authorization supplier list after meeting requirements for fluid resistance, flammability performance, particulate filtration and breathability.
The emergency-use authorization was established by the FDA in response to concerns about insufficient supply and availability of disposable single-use surgical masks that provide a physical barrier to fluids and respiratory droplets.
The FDA authorization for the Hanes-branded surgical mask lasts for the duration of a declared pandemic.
The masks are being used at UNC Health and Duke Health.
However, the surgical masks have not been FDA cleared or approved. They are not available to consumers, Hanesbrands said.
"Until we go through the FDA approval process, which is long and arduous, we can't say that it can be used in a surgical setting," said Mike Abbott, Hanesbrands’ director of research and development.
Abbott said appropriate health care settings for the two-ply surgical masks include "extended care and areas where a standard surgical mask is not allowed."
"We're focusing right now on institutional orders, but they are available right now for other orders," Abbott said.
"Clinicians can use it when doing medical exams and extended-care professionals can use it in their work environment."
Hanesbrands spokeswoman Carole Crosslin said that "given the quality, comfort and price point, we believe there is a market for our surgical masks in health care systems across the country."
"The company applied-for-and-received FDA authorization as a first step in developing an on-going market."
"Ultimately, however, the size of the market for our surgical mask is yet to be determined," she said.
How it works
Nonwoven fabrics are defined as those made of fibers held together by interlocking or bonding, such as by chemical or thermal means, rather than being woven, knitted or felted.
The spun-bond fabric is composed of two different polymer materials to make a single fiber "that has significant strength and bulk that is as effective in filtration as current materials on the market," according to the institute.
The Hanes-branded 100% synthetic mask uses a duckbill shape for better breathability, a wire nosepiece and foam insert to enhance a contoured fit, and placement of stretchable straps for a secure fit.
By comparison, the three-ply cotton mask has loops around the ears and is considered as a "community mask that protects against aerosolized materials in the air."
The two-ply surgical masks "exceeded the standard for a surgical mask for breathability, which makes it more comfortable to wear for an extended time," Abbott said.
The filtration standard for a surgical mask is to capture 95% of bacteria and 95% of particles, with Abbott saying "we are well above 95%."
"It does not quite meet respirator levels right now, but we're very, very close to being there."
Filling a need
Hanesbrands' design work has been handled locally, while production is taking place within its global supply chain.
UNC Health has tested the masks to assure they meet FDA particulate filtration standards and OSHA respiratory protection program requirements.
“We provided the Hanes mask to clinical areas concerned with protection during specific clinical encounters where N95 respirators are not recommended, but the risk of COVID-19 exposure is perceived to be high,” said Dr. Emily Sickbert-Bennett, director of infection prevention at UNC Medical Center.
"The Hanes mask made these providers feel safe and well-protected. I expect we will broaden use of the Hanes mask given the degree of protection it provides.”
Abbott said he was told by institute officials that they could produce fabrics for additional surgical mask products and options.
"Anything that is new and different we're always interested in," Abbott said.
"So, they had the material, but didn't have anyone who could actually turn it into a mask. Then UNC Health expressed a need for the surgical masks, so it all came together from each group meeting and filling a need."
Dr. Behnam Pourdeyhimi, executive director of the Nonwovens Institute, said the collaboration helps "to ensure that high-quality and affordable protective gear remains available to frontline health care workers during the pandemic."
Abbott said that while there was some development overlap in April and May between the three-ply medical masks Hanesbrands made for the U.S. Department of Health and Human Services, work on the two-ply surgical mask began after the first initiative wrapped up.
Abbott said the desire to accelerate the development and sample processes since May "had people driving back and forth at night from here to the two universities."
Other health care products
The new surgical masks follow up on Hanesbrands' development during the early stages of the pandemic of medical face masks and reusable medical gowns.
Those products initially were for health care use, but have in recent months become available to consumers.
The surgical gowns were distributed by the U.S. Federal Emergency Management Agency to hospitals and temporary treatment facilities. The long-sleeve gowns are made from fabric designed to be splash resistant and can be washed.
The medical-gowns contract was considered as one of the largest in the federal PPE sourcing effort.
Hanesbrands served as one of the top 10 vendors of COVID-19 supplies to the federal government, according to a Government Accountability Office report released in late July.
Hanesbrands ranked seventh with six personal protective equipment contracts valued at $523.5 million. The breakdown was $348.5 million for medical face masks and $175 million for reusable medical gowns.
Hanesbrands produced the three-ply cotton surgical masks at some of its factories in Latin American as part of a federal contract to combat a national shortage of face masks. At peak production, its plants produce about 40 million a week.
A portion of the two-ply surgical masks is being made in facilities in North Carolina.
Hanesbrands said July 5 it had completed production and distribution of more than 450 million all-cotton cloth face coverings ordered by the U.S. government.
It also made more than 20 million medical gowns for the federal government.
Those federal government contracts played a major role in Hanesbrands reporting in July a 7.8% increase in second-quarter net income to $161.2 million.
During the second quarter, Hanesbrands began selling those same products to businesses and consumers. The products, sold under the Champion and Hanes brands. They are available online, in retail stores and in Hanesbrands outlet stores.
Altogether, face masks and medical gowns represented $752 million in sales, or 43% of its second-quarter revenue.
With the federal government contract completed for now, Hanesbrands projected more than $152 million in PPE sales to businesses and consumers in the second half of fiscal 2020.
Gerald Evans Jr., who recently stepped down as the company’s chief executive, told analysts in July that business and consumer PPE sales could reach $250 million to $300 million annually.
Although Abbott said Hanesbrands is limited for now on how it can market the two-ply surgical masks, he did believe it would be beneficial to long-term care facilities for both staff and residents.
One of the most somber parts of the pandemic in North Carolina has been the death toll on long-term care residents.
As of Thursday, there had been 2,041 COVID-19 related deaths in long-term care facilities, representing half of the 4,082 deaths statewide, while the 18,903 cases are just 7.4% of the 252,992 cases.
The commercial potential for the two-ply surgical masks may be limited, but with spillover potential with the commercially available three-ply medical masks.
"Because of the learnings that we've had just from our standard three-ply mask, and efforts to make that mask better for community use, we believe there is a commercial potential to use the technology to make those three-ply masks more comfortable and breathable with better filtration," Abbott said.
"For extended care facilities, it would be something advantageous for staff and less likely for residents to try to take it off because they can't catch their breath," Abbott said.