It’s 6 a.m. in the operating room of a large urban hospital. In walk two surgeons and two nurses dressed in blue gowns and green facemasks. Nearby, on a back table, wrapped sterilized surgical instruments are about to be opened. The patient, outfitted in a drape that has a cutout at the location of the surgical field waits to be operated on. Nothing appears out of the ordinary in this operating room, right?
Take a closer look. The gowns and masks worn by the medical staff and the drape covering the patient are not the reusable laundered garments made of cotton or linen that have long been a staple in most OR’s. They are one-time use, disposable garments made of nonwovens. And, the instruments on the tray have been sterilized in a wrap that is also made of a nonwoven.
This scene is being played out in an increasing number of hospitals worldwide. With the number of Hospital-Acquired Infections (HAIs) skyrocketing hospitals, doctor’s offices that perform surgery are increasingly seeking cost effective ways to protect their medical staff and patients. At the same time, they are seeking comfortable garments that offer a high level of barrier protection as well as little or no linting and anti-static properties. The outcome has been a boon to nonwovens producers who are using some gee whiz technologies to provide medical fabrics for gowns, drapes, masks and other medical products with all of these characteristics while keeping costs at bay.
According to a new report from the Centers for Disease Control (CDC), in American hospitals alone HAI’s account for an estimated 1.7 million infections and 99,000 associated deaths each year. Of these infections, 32% of all HAI’s are urinary tract infections; 22% are surgical site infections; 15% are pneumonia (lung infections); and 14% are bloodstream infections.
INDA, the Association of the Nonwovens Industry, reported that single-use nonwoven medical drapes and gowns are the first choice of healthcare professionals (over 85% of hospitals use single-use gowns and over 90% use medical single-use drapes).
Keeping Infections Out
No doubt about it. As awareness over infection control increases in the medical community, nonwovens manufacturers have been nipping at each others heels to introduce new products with improved barrier protection. At the same time, these companies have been challenged with offering comfortable products while keeping costs at bay.
One company focusing on infection protection is Ahlstrom, which provides an extensive portfolio of single-use medical fabrics using wetlaid, spunbond/SMS, spunlace/spunlace composites and film-based composites.
“Detecting and fighting viruses and bacteria such as HIV, Methicillin Resistant Staphylococcus Aureus (MRSA), hepatitis, SARS or more recently, H1N1, remains a permanent fight for healthcare workers. In hospitals, particularly in the operating room, there are many possible sources of infection—from a failure to wash hands properly to compromised sterile barrier systems to cleaning and disinfection procedures. Ahlstrom makes infection protection our first priority when designing single-use nonwoven fabrics. The requirements for medical fabrics are quite demanding. Fabrics must have sufficient strength to resist tearing and they must be repellent to body fluids including blood. They must be comfortable and breathable when worn for a long period of time,” said Ahlstrom spokeswoman Bethany Schivley.
Kimberly-Clark Health Care, which manufactures and converts medical nonwovens products is also on a tear in the medical sector with a focus on reducing HAI’s. K-C Health Care produces surgical drapes, gowns, surgical facemasks, headcovers, shoe covers and Kimberly-Clark One-Step Sterilization Wrap as well as a complete line of medical exam PPE from nonwoven fabrics and materials.
“We built our business around providing quality products for healthcare staff and patient protection. The cornerstone of that is HAI prevention. That’s a major focus for us. HAI is a very serious issue today. The CDC estimates that about 1.7 million HAI’s will occur in the U.S. this year. They also have data that show that HAI’s cause more than 90,000 deaths. That’s significant. K-C has and will continue to bring products that address those issues,” said Michael
Tuck, director of research and engineering for global K-C Healthcare.
Pointing out that K-C was the first to bring nonwovens into the OR setting with items such as surgical drapes, gowns and sterilization wrap, Mr. Tuck said, “Many of the instruments in a surgical setting are reusable, such as metal objects, retractors, extenders and scalpels. The sterilization wrap is an SMS nonwoven and it’s used to cover these instrument sets. It goes through a sterilization process, which is typically a steam sterilization process. If you do not have sterile instruments for your case, you may have issues right from the start of the procedure. The sterile wrap plays a very important role in setting you up for success in the case. The wrap stays on through the sterilization process, storage and transportation. As that instrument set is brought into the OR they remove the sterilization wrap and aseptically remove the instruments for preparation for surgery,” said Mr. Tuck.
Events such as H1N1 are also driving increasing demand in the market for K-C’s facemasks. “The demand increases significantly in times of pandemic. We are also seeing an increase in compliance in facilities in terms of wearing and changing the personal protective equipment which is leading to an increase in demand as well. The number is around 8% year-on-year growth for the markets we are involved in. The (medical) markets in which we compete today, which include our medical device business are around $8 billion and they are growing at low to middle single digit rates,” said Mr. Tuck.
Cardinal Health, which manufactures surgical gowns, surgical drapes, facial protection, head and shoe covers, is also responding to the healthcare industry’s call for infection protection while meeting demands for comfortable garments.
Cardinal’s SmartGown offers full protection with advanced wicking technology to keep clinicians cool and comfortable. SmartGown’s Responsivemembrane wicks excess moisture from the surface of the skin, transporting it to the surface of the fabric, where it evaporates quickly. This
technology allows the body to cool naturally while maintaining complete protection.
“For procedures requiring Association for the Advancement of Medical Instrumentation (AAMI) Level 4 protection, the SmartGown is essential because of its proven protection and breathability,” said Caroline Gullion, product manager, surgical apparel at Cardinal Health. “SmartGown offers a fully impervious barrier to guard against the risk of liquid and viral penetration, and its Active Moisture Management keeps clinicians cool and comfortable through the most challenging procedures.”
While the trend from laundered items to disposable nonwovens in the 1980s to 1990s was fueled by demands for better barrier protection, the current trend is for hospitals to continue to demand high barrier and high quality products at a reasonable cost.
Previously, K-C witnessed a lot of facilities exit from multiple use products made from linens and cotton in favor of nonwoven articles because they provided barrier protection that wasn’t available in woven fabrics, according to Mr. Tuck.
“Our customers are faced with increasing cost pressures so they are looking for innovative products that bring high quality at a respectable price. That’s a major trend in the market today. There is diversity of products out there and some differentiation. However, cost is a key factor for many of the products that nonwovens are going to represent in medical and acute care settings. The level of barrier protection initially was the main driver for that. We are seeing more and more cost competitive examples of reusables. The technology is getting better. From a healthcare perspective, there are many choices they can use today. Due to the single-use aspect, nonwoven products typically offer a higher level of quality and consistency versus a reusable product. When you look at the evolution and understanding of the technology from a nonwovens perspective, the more experience the folks have in making the products and the technology advancements we’ve seen from 1980 to today continue to enable higher barrier fabrics at lower weights. That’s a key benefit. You are seeing softer, lighter weight materials in the market that are definitely viewed as more comfortable than the initial products you were seeing in the market in the late 1980s to early 1990s,” said Mr. Tuck.
Ahlstrom is also helping the healthcare industry keep costs at bay with its single-use medical fabrics, which are designed for facemasks, surgical drapes and gowns, sterilization wraps and other infection control products. “Choosing a single-use fabric rather than a reusable is an environmentally responsible choice, as the lifecycle assessments prove that single-use medical fabrics have a lower environmental burden index (EBI) compared to reusable linens and eliminate water and energy costs associated with laundering,” said Ms. Schivley.
Cardinal Health’s vice president of marketing and product management Carl Hall agreed that the demand for cost efficiencies is driving a shift from laundered products to nonwovens. “To some extent, it’s more cost effective, because a shift to alternative sources may mean a switch away from commodity markets. It’s growing, because it’s a more cost-effective solution. Nonwovens are easier to produce and dispose, and there is not as much supply chain involvement with disposable products as there is with reusables. Essentially, the reuse process involves much more energy and water consumption as well as staff time during processing and quality inspection,” said Mr. Hall.
Suppliers’ commitments to medical nonwovens are particularly evident through their recent investment plans.
In April Ahlstrom, whose medical manufacturing sites are located in the U.S and in Europe started up a new plant in Mundra, in the western Indian state of Gujarat to deliver a wide range of nonwovens for application in single-use protective products used inside and outside of the operating room.
The plant uses state-of-the art technology to produce a wide range of SMS protective fabrics for the medical market. Employing approximately 70 people, the plant is conveniently positioned close to the Mundra port, which ensures easy logistics for both incoming raw materials and the shipment of products.
“The investment in Mundra supports Ahlstrom’s strategy to strengthen its leading global position in roll goods nonwovens for the medical industry, while increasing its presence in Asia. Service to customers in the region is guaranteed by a network of 13 sales offices throughout Asia-Pacific,” said Ms. Schivley.
Longstanding player PGI has also invested signficantly in Asia during the past decade, banking on medical converting growth in the region. The company offers the medical market a broad technology base which includes spunbond, meltblown, SMS, adhesive bond and spunlacing/hydroentangling, plus a wide range of in-house finishing and treating technologies, particularly at its Suzhou, China location. Applications using PGI materials include surgical gowns, surgical drapes, patient gowns, isolation gowns, lab coats, warm-up jackets, headwear, footwear, scrub suits, face masks, CSR wrap, transfer wrap, patient screens, back table covers, mayo stand covers, wound care substrates, patient wipes, baby blankets, pillow cases/linens, ice packs and blood pressure cuffs.
PGI, which has facilities in the U.S., Latin America, Europe and Asia recently announced a Center of Excellence in Suzhou, China to develop state-of-the-art materials that combine barrier, comfort and breathability.
“This center will employ our existing portfolio of technology in concert with new technologies being developed internally and externally through joint developments, licensing, acquisition and pure product development,” said Tore Wistedt, PGI’s global marketing director for healthcare.
PGI is in the process of expanding its spunmelt ouput in Suzhou, China and Waynesboro, VA with new lines that will produce commercial material in 2011 and recently completed capability upgrades in San Luis Potisi, Mexico and Benson, NC.
“The Center of Excellence is actively involved in aligning with partners where there is mutual benefit in improving market positions. PGI is forming alliances with research companies, universities, technology think-tanks, raw material suppliers and customers.
PGI will continue to invest in our nonwoven franchise in terms of people and technology as required to address current and emerging opportunities and maintain our market leading position,” said Mr. Wistedt.
Expansion is also on the drawing board for Saudi Arabia-based rolls good supplier Advanced Fabrics (SAAF), a spunmelt specialist operating two Reifenhauser lines. The first is a 3.2 meter SSMMS Reicofil 3 machine and the second is a 4.2 meter SMMMS Reicofil 4. SAAF upgraded a treatment line in 2009 and plans to soon finalized plans for a third line although the location has not yet been determined.
“We’ve been in the medical market since 2002. In 2003, we knew the medical market was a market we wanted to grow in. We got there in 2004 with a 50/50 balance in hygiene/medical market. Our capacity for treating fabric has increased by 50%. The Reicofil 4 was intended to do mainly hygiene, but to be able to do some things for medical that we couldn’t do on line one. It gives SAAF a wide range of options in terms of the technology and the two different widths. Occasionally in drapes, people want 2.1 meters wide and obviously we couldn’t do it on the 3.2-meter line effectively. With the 4.2 you can very easily. The newer technology has certain advantages. It has three meltblown beams which gives us all the options,” said Ian Disley SAAF’s general manager international sales and marketing.
Noting that SAAF was a pioneer in putting a treatment line in-house for alcohol repellency and antistatic properties, Mr. Disley said, “With most of the barrier fabrics in medical when you get into the surgical gown area AAMI level 3 standards requires the fabric to be treated for alcohol repellency.”
In response, SAAF offers Medalon, which was designed as a high barrier for surgical gowns and drapes.
Mr. Disley believes that the trend to replace spunlace with spunmelt is becoming dominant. “One of the reasons is that traditionally people like the spunlace is because it felt ‘textiley’ so they assumed it was. When people get uncomfortable, they don’t work well. One of the things that happens with spunmelt fabrics is because they have a higher barrier for the same weight you can use lighter fabrics. Most spunmelt in the market is 60 gsm or above. Traditionally the spunmelt was 50, 52 grams. Increasingly that’s going down. It’s around 45 grams. In Europe where the standards are different in some cases, it’s down to 35. I don’t think it will go much lower than that because you start to get to the point where the fabric feels very thin and people don’t believe it’s giving you the barrier properties even though you can prove that it is. The fabric also becomes increasingly transparent as you go thinner and thinner. It’s more comfortable, lighter and lets more air through but still meets all the standards in terms of the barrier properties,” said Mr. Disley, adding that spunmelt, which is also becoming more popular for central supply room wrap is less expensive than spunlace because the technology and the speed of production is incredibly high compared to conventional textile machinery.
Disposable Versus Laundered
While nonwovens have made inroads in hospitals worldwide, laundered articles are still being used with confidence. One advantage of laundered items is the positive sustainability message that they send but users and makers of nonwovens assert that disposables can be just as green. “There’s a similar message from a nonwovens perspective in terms of sustainability as we continue to use less and less energy and mass to produce those products and the confidence in barrier in the single use that you get is an advantage for the nonwovens products and customers,” said Mr. Tuck.
Cardinal’s Mr. Hall took Mr. Tuck’s thoughts one step further. “With surgical drapes and gowns, the advantage is in the consistency and reliability of the product. For example, there is consistent quality in protection from bloodborne pathogens with the use of nonwovens. A reusable product provides less consistency of protection because of its continued wash and reuse. Our customers are looking for consistent protection and quality of product. They’re also looking for a comfortable product — especially when they’re considering drapes and gowns. They want a product that isn’t irritating or distracting.”
Single-use disposable gowns have been the mainstay in the U.S., Europe and Japan, and their use is catching on in less developed countries. “People don’t want to launder items these days. One of the biggest costs to health service is people going in to hospitals and catching something. Disposables have a lot of advantages because they are taken off at the end of the operation, bundled up and taken away from the hospital and disposed of. In poorer countries they still use laundered. The problem with laundered is that every time it’s laundered you reduce its barrier properties somewhat, ” said Mr. Disley.
Valeria Erdos, product manager, gowns and apparel for Ahlstrom said, “Single-use cost benefits depend a lot on assumptions. If a product is reused less than 50 times, single-use is more cost effective. Fifty times is an accepted threshold for safety. However, if reusable gowns are used infinite times, they are more cost effective but at this point the barrier properties are compromised.”
“Reusable products can never get over their key disadvantage—high lint, which is a source contamination and can lead to HAIs,” said Mark Berman, Ahlstrom’s product manager, drapes, adding, “Hospitals must also take into account the environmental impact and costs associated with laundered gowns as they must be resterilized and packaged before entering the operating room again.”
Static-free and lint-free properties are also crucial properties for articles in the medical arena. “To have a spark during a procedure could lead to a fire in the operating room. Products that are in the OR need to be static free or static proof and have some treatment. One of the features we have on our product is anti-static. The issue when dealing with a surgical case is that any type of foreign object that can get into an open area or wound could be a chance for infection. Low to no lint is a key requirement,” said K-C’s Mr. Tuck.
The Picture of Health
So where is the medical nonwovens market headed in the future?
Ahlstrom’s Ms. Schivley believes the future of medical nonwovens lies in a continued focus on infection protection through the growing use of single-use medical fabrics, especially in emerging markets. “North America and Europe are mature markets with over 80% penetration of single-use nonwovens products into hospitals, whereas Asia and South America with 12.5% of penetration represent new opportunities for our company. The growing single-use penetration rate in emerging markets is reinforced by the introduction of regulations and medical standards that single-use medical nonwovens need to follow to protect from infection. In addition, the effect on demand of an aging population worldwide gives more opportunities for Ahlstrom and for the healthcare industry in general,”said Ms. Schivley.
Ahlstrom is constantly innovating on new technologies and new applications outside of the operating room which include fabrics for temperature management or fabrics with sustainable raw materials. Ahlstrom has the ability to blend natural and renewable fibers into wetlaid, spunlaced, resin bonded and thermal bonded fabrics. Wood pulp is our key fiber competence and a renewable resource. Ahlstrom’s position in the medical market is continually confirmed by adding capacity and/or capability such as our new plant in India or by designing, producing and promoting single-use medical fabrics. The clean and safe fabrics reduce infection in the operating room or HAI (Hospital Acquired Infections), which are an ever growing concern for the hospitals. Ahlstrom is continually and actively engaged in new technology and market development. With an aging population, growing sophistication of healthcare services in emerging economies and evolving surgical procedures, we see considerable opportunities for new products and technology development,” said Ms. Schivley.
PGI’s Mr. Wistedt summed up the future of nonwovens with this sentiment: “With a 90%-plus penetration in the U.S. and 70%-plus penetration in Europe, disposables are clearly replacing laundered products. And with concern growing globally on infection control, pandemic preparedness, antibiotic resistance and hospital acquired infection reduction, plus world-wide shortages of fresh water, the performance advantages of nonwoven solutions over alternatives is likely to drive continued overall growth for the category and increases in penetration for the foreseeable future.”
John Gray, president Biomedical Structures envisions the trend to use nonwovens in surgical applications will become even more dominant in the future.
A provider of technical materials for biomedical applications, BMS specializes in the design and manufacturing of crafted and nonwoven specialty fabrics for orthopedic, cardiovascular and tissue engineering applications, including implantable devices such as tissue scaffolds and woven vascular grafts, components for surgical procedures and drug delivery tools.
“Nonwovens had been used as a base platform for tissue engineering. The trend is that these nonwovens are finding their way into surgical applications. They are being used for hemostatic structures, other supplemental materials on existing medical devices to build resorbable surface areas on them. It’s gone beyond en vivo tissue engineering and now they are being used internally. The polymers are completely biocompatible and the fact that they are metabolized and are bioresorbable is the benefit everyone is looking for. The healing process doesn’t take very long and if the material can be implanted in the body and be able to assist in the healing process, and once the healing process is complete if the material can then be metabolized and excreted by the body it’s the best of both worlds. It’s done its job and then it’s gone and the residual issues of a foreign material in a body is no longer applicable.”
Creating active antimicrobial fibers and having active pharmaceuticals either in or on the fibers may be the wave of the future. “Antimicrobials are the gateway to bringing other materials into fibers. Antimicrobials have been around for quite awhile but building structures—purposely building antimicrobials into the fibers is a trend rather than just overlaying the final structure with a coating. Once you start impregnating fibers with materials it leads to the next stage where you can then begin to say that we now have the method for impregnating antimicrobial materials into fibers, now let’s take it another step and start to infuse or impregnate fibers with active pharmaceuticals,” said Mr. Gray.
Mr. Hall said Cardinal Health sees a trend toward concern for sustainable/green materials. “There are a number of our customers expressing concern about their personal protective equipment being environmentally friendly, but they aren’t always able to identify why that is important to them or what their facility is trying to accomplish with the use of green materials. Is it about energy consumption? Or is it landfill waste? They haven’t developed an overarching goal or pinpointed concrete objectives,” he said.
Perhaps K-C’s Mr. Tuck summed up the future of medical nonwovens best. He believes that advancements in medical procedures and technology bode well for nonwovens in the medical sector. “As we talk about surgical drapes, obviously in surgery there are new procedures that come out, there are advancements in robotics and other procedural areas that are shortening the amount of time people are under anesthesia and are open and smaller incisions are reducing the amount of fluids encountered during procedures. With all of the transformations happening in surgery throughout the years, the products that you use to help deliver those procedures will change as well. The surgical drape is one area that has to be able to evolve with the procedures, the size and amount of fenestration, positioning of opening, place where you have tube holders, all of those things within the design of the drape are changing along with practice and procedure. As the practices and procedures evolve so will the products they use.”