Flexibility, strength and adaptability are bringing textiles to the forefront of patient care, and concerns about safety are inspiring use beyond the hospital
By Holly O’Dell
Medical textiles present a wide variety of opportunities for manufacturers and applications for end users. As its name suggests, a medical textile—often used interchangeably with “healthcare textile”—is any textile that provides a medical benefit. These textiles run the gamut: surgical gowns, divider curtains in hospital rooms, antimicrobial upholstery fabrics, adult briefs, gauze, implantable structures, face masks and arm and knee braces. “Any place you want something that’s flexible and strong, a textile is a potential choice,” says Dr. Stephen Michielsen, an associate professor at the College of Textiles at North Carolina State University (NCSU) in Raleigh.
Because the demand for cutting-edge products is skyrocketing in the medical field, textile manufacturers continually find ways to improve upon the safety profile of existing products and introduce new medical textiles to the market. Here we’ll review some of the innovative products and uses for medical textiles, their necessary properties, the fabrics needed to create well-designed medical textiles, compliance issues and growth opportunities within the industry.
Researchers work to improve and create medical textiles
Creating a new medical textile or improving upon existing technology often involves integrating the right mix of research, marketability and innovation. Entegrion, a life sciences product development company in Research Triangle Park, N.C., is focused on the science of hemostasis (i.e., stopping bleeding), and has built such a team for its new product called Stasilon™ FR. Dr. Tom Fischer, an experimental hematologist in the department of pathology and laboratory medicine at the University of North Carolina at Chapel Hill and Entegrion’s chief science officer, developed Stasilon “to give the healthcare provider something that was simple to use like gauze, or the common products for bandage materials that people have been using for over 25 centuries—but one that actually promotes clotting in a quicker manner,” he says.
Stasilon was born from military use. “The motivation for developing the product was our studies of extremity wounds coming back from Iraq and Afghanistan about four years ago,” Fischer explains. “In the meantime, we found that it had broad-based applicability, such as in emergency medicine and surgical suites.”
Stasilon, which is available for over-the-counter and clinical settings, comprises a specific weave of type E continuous filament medical-grade glass woven with specialty rayon bamboo. “It has been known for several decades that glass very strongly activates hemostatic systems, so that was a logical component to try,” Fischer says. With input and support from the textile industry in North Carolina, Fischer tested 60 different fibers to determine which one, when mixed with the glass filament, would most rapidly clot the blood. Bamboo came in number two to glass. “It was something that would give the product fluid transport properties and more absorbency,” Fischer adds.
The textile was initially developed to stop bleeding with significantly less blood being shed, and has received Food and Drug Administration (FDA) clearance to make this claim. But in the process of continuing analysis, Fischer and the Entegrion team found another critical benefit in Stasilon: “In addition to stopping bleeding quicker, it does not stick to wound sites the same way gauze or other bandages do,” he says. “You don’t tear the tissue or clot off the wound and cause a re-bleed. This is turning out to be a highly desirable attribute of this product that clinicians and care providers are finding very desirable.” Stasilon is in the process of wrapping up two medical trials, after which the company will submit the non-adherence claim to the FDA.
The product offers two other significant factors to the medical textile market, according to Stan Eskridge Jr., CEO, president and co-founder of Entegrion. “This product is more expensive than gauze but it does stop the bleeding, and it is less expensive than some of the other very exotic products that have been designed to be hemostatic,” he says. “Because it’s the same form factor as gauze, meaning that it also is a textile, it’s something that nurses and clinicians are used to. There’s no extensive training required or difference in the way they do their procedures.”
Light-activated coating kills viruses and bacertia
In another example of research yielding a revolutionary medical product, NCSU’s Michielsen has invented a light-activated coating that, when applied to a textile surface, kills viruses and most bacteria. “We chemically bond to the surface a material that creates the antiviral,” Michielsen explains. “There are several fibers we can treat. Our preferred is nylon, but we can also treat polyester, cotton or cellulosics. We turn the fiber surface into a chemical factory. The particular approach we use does not allow anything to leach off. Our philosophy is that anything that leaches off ends up in the environment, which is undesirable.”
The antiviral material that Michielsen created has been licensed to LaamScience Inc. of Raleigh, N.C., which will bring the technology to the market. Potential uses for the technology may include hospital surgical masks, day care centers, in-home caretakers and air filters on airplanes.
Michielsen’s current research interests in textiles revolve around surface modification. “Most of these applications would fall under the realm of fiber or fabric finishing,” he explains. “One of those applications is in antiviral coating. Another is something that is superhydrophobic so water or waterlike materials roll right off the surface so that they don’t contaminate it. We’re working on other things that may in the distant future prevent contamination by blood or oily substances.”
Medical textiles produced for optimum performance
Regardless of their end use, medical textiles need to incorporate a multitude of characteristics to help them perform. “First and foremost, we must ensure that the products we manufacture are safe and effective for their intended use,” says Brad Bushman, vice president of technical affairs for Standard Textile Co. Inc, a Cincinnati, Ohio, company that has developed various surgical product lines including surgical gowns, draping systems, surgical wraps and operating room towels. “This includes extensive testing for biocompatibility, performance and durability.”
Cleanliness of facilities and materials is another important factor in producing quality medical textiles. “We take great cautions on cleanliness,” says Bruce Foote, corporate business account manager for Secant Medical, a Perkasie, Penn., company that designs, develops and custom manufacturers woven, nonwoven, knitted and braided implantable fabric structures for medical device designers and manufacturers. “Some of our materials are made in clean rooms, and almost all are in a controlled environment. Our water systems are validated, as we have to have pure water when we wash the products.” In addition, Secant uses approved, controlled raw materials and suppliers to ensure quality assurance for its customers.
Furthermore, many medical device manufacturers are racing to incorporate antimicrobial properties into their products. An antimicrobial is any substance that inhibits the growth of microorganisms such as bacteria, viruses and fungi—a primary goal in any clinical setting. “People want to get more protection with their medical textile products, and antimicrobial products have multiple functions,” says Dr. Min Yao, new product development manager for Medline Industries, a medical product manufacturer in Mundelein, Ill. “For example, antimicrobials can improve the protection of surgical gowns used during surgery, since these clothes are exposed to all different kinds of contaminants, including bacteria, fungi and virus. In some cases, such as a diaper or an incontinence pad, antimicrobial treatment is used to control the odor.
“Antimicrobials can also reduce infection,” Yao adds. “If you have an antimicrobial on a gauze product, you will reduce the possibility of infection and make the recovery process faster. Another consideration is cross contamination. If one patient is infected with certain pathogenic microbes, such as MRSA [staph] or other superbugs, some of these bad bugs may be carried with the nurse’s or doctor’s apparel. Then, when they visit the next room, it is possible that this kind of cross contamination can happen. By creating antimicrobial textiles, we’re making the textile less likely to harbor this bad fungi or bacteria and bring it to a new place to spread the problem.”
Like many textiles across a variety of industries, manufacturers are incorporating green properties into their medical textiles. “Standard Textile’s efforts are focused on reducing the environmental impact of all our products,” Bushman says. “During manufacturing, this includes reducing the CO2 emissions and energy consumed during the manufacturing and distribution process. On the use side, this includes working with customers to extend a product’s use life and identifying options for product recycling.”
The root of a medical textile’s performance, of course, is often found in the fibers used to create the product. Secant, for one, uses a variety of textiles, including polyesters and polypropylene, in addition to making fabrics out of absorbable polymers. In tandem with understanding the fibers themselves, a manufacturer also needs to understand their full potential. “Our textile processing capabilities run the whole gamut,” notes Keith Smith, director of corporate marketing and sales for Secant. “If a customer needs tubular fabric, many different processes can be used to make that tubular fabric, depending on the end use. Does it need to be stiff or flexible? Does it need to elongate? Does it need to have hoop strength? It’s important to listen to the requirements of the customer so we can give them the best design.”
Medical textile industry grows
The medical textiles industry presents greatly expanding opportunities for exploration and development. The use of environmentally friendly manufacturing processes and materials will continue to be a priority for many textile and medical device manufacturers. “Besides the need for environmentally friendly reusable products, the need for protective garments in healthcare has dramatically increased,” Bushman adds. “The same technology being used in surgery is now being applied to precaution and isolation gowns used throughout healthcare institutions. Anyone who handles blood, from the nurse on the floor to the lab testing these products, requires protection today.”
For manufacturers considering entering the medical textile market, putting together a diverse, experienced team of researchers and sales staff is paramount—not to mention the importance of having the appropriate facilities and equipment in place. In fact, manufacturers may not need to significantly overhaul their facilities. “Often existing equipment can be used, but manufacturers need to make sure they’re compliant with regulatory environmental requirements, and that they use current good manufacturing processes,” Michielsen advises. “A lot of people think they need all-new equipment, but that’s not always true. Much of the equipment is exactly the same, but make sure you’re operating under conditions that allow it to be approved by appropriate agencies, and that you don’t cause health problems because you didn’t clean your machine. You have to be careful to document everything, and run the facility under clean conditions.”
Developing a medical textile business requires substantial expertise and partnering with customers who are open to an engineer-to-engineer approach, as Secant has found. “We have customers who come to us thinking that they may be able to use a textile material but aren’t really certain,” says Karen West, Secant’s general manager. “We educate them about the possibilities. We help them capture the imagination of what textiles can do.”