Ellen Wuagneux, Associate Editor08.13.08
Considering the high-tech nature of nonwovens, it’s ironic that advanced medical technology has not necessarily been a boon for producers of disposable nonwovens in North America. The trend toward fewer invasive surgeries has translated into a lack of growth for disposable medical applications such as masks, drapes, gowns and sterile surgical instrument covers.
For example, many cardiovascular and orthopedic procedures are now done in a clinic or doctor’s office, bypassing the need for a full operation. “There is also an increasing reliance on diagnostic procedures, such as MRI, CAT scans and radiology testing, to determine the cause of pain, rather than exploratory procedures with full anesthesia,” commented Ian Butler, director of market research and statistics at INDA, Association of the Nonwoven Fabrics Industry.
Balancing this effect is an aging worldwide population—with increased incidences of acute diseases—fueling demand for disposable medical nonwovens. As the elderly population continues to grow throughout the world, surgical procedures using nonwoven disposables are also expected to multiply.
Another factor continuing to drive growth is ongoing awareness of and concern over hospital-acquired infections (HAI) such as hepatitis and AIDS. According to the CDC and other healthcare officials, 1.7 million infections impact hospital patients each year, costing hospitals an estimated $4.5 billion in additional medical costs.
As Joanne Bauer, president of Kimberly-Clark Health Care, pointed out, hospitals agree that HAIs are a serious patient safety concern and know the stakes are high. “Not only do hospitals make it their mission to deliver the best patient care possible because it’s the right thing to do, but the occurrence of infections can also have a major impact on a hospital’s financial health.”
HAIs are an unfortunate complication in virtually every hospital and can result in longer stays, more procedures and added healthcare costs. In its simplest definition, an HAI is an infection acquired by a patient while receiving medical care or treatment while in a hospital or healthcare facility. As an example, the CDC reports that surgical site infection, one form of an HAI, affects more than 370,000 patients in the U.S. each year.
With the increased range of infectious diseases and regulations put into effect in healthcare and hospital facilities, nonwovens continue to represent a solid, if not booming, business for roll goods manufacturers as nonwoven disposables make more inroads into the medical sector. Nonwovens producers are banking on the fact that preventing infection is critical for reducing patient suffering and morbidity, protecting medical staff in the operating theater and minimizing post-operative costs caused by infections, such as HAIs and Methicillin Resistant Staphylococcus Aureus (MRSA). Stringent standards being imposed by various regulatory agencies globally are also positively impacting the use of nonwovens.
According to INDA, nonwovens sales to end users in the medical market were in the $1.3 billion range for North America (the U.S. and Canada combined) in 2005. Surgical gowns and drapes were the largest portion of this total and were estimated at $850-$900 million.
Meanwhile, research firm Global Industry Analysts, Inc. estimated that approximately 3.3 billion square yards of nonwoven materials are used in medical and surgical applications each year in North America alone. Its findings report that, among product segments, surgical nonwovens is the largest and the fastest growing segment and is projected to exceed $5 billion by the year 2010, at a CAGR of about 5%.
The company predicts that sales in the U.S.—the largest medical nonwovens market in the world—will exceed $3.4 billion by the year 2010. With high-tech surgical intervention volumes growing rapidly, Europe is projected to experience high growth in the medical nonwovens sector in coming years. Alternatively, the Asia-Pacific region offers massive potential in the long run, driven by some of the fastest growing global economies, including China and India.
“Asia-Pacific is the fastest growing medical nonwovens market and is projected to register a CAGR of more than 5% during the 2000-2010 period,” according to Global Industry Analysts. “A large consumer base in these countries coupled with improving healthcare systems and safety awareness bodes well for the medical nonwovens disposables market.”
Key Players Hold Steady
While it may not be setting records, the level of growth in the medical market is enough to keep quite a few of the top roll goods players interested. One company offering a wide technology portfolio for medical fabrics is Ahlstrom, which uses spunbond, SMS, wetlaid, spunlace, needlepunch, film laminates, thermal bond and other processes to target medical applications. Although most of its medical manufacturing sites are located in the U.S., Ahlstrom does operate sites in Europe and is scheduled to start up a plant in India in 2009.
Commenting on future investment plans, Valeria Erdos, market development manager, medical fabrics, said Ahlstrom is always looking into ways to expand into new markets or add new technologies. “We are about to start a spunmelt line in Scotland that will have capabilities to manufacture products with recyclable and biodegradable raw materials, and next year we will have a start-up in India with a state-of-the-art SMS line mainly focused on the medical fabrics market.” She pointed to a range of mature applications using environmentally friendly nonwovens and said Ahlstrom considers itself to be in a good position to introduce new technologies.
One such upgrade is Ahlstrom’s bicomponent technology for radiation-stable fabrics, which has evolved and continues to improve to target a large segment of the market with superior products. Ahlstrom also sells high-tech composites developed for specific customers as well as bi-laminates for the general market, especially in Europe. “Our barrier and breathable fabric, BVB, still enjoys great success in the marketplace due to the recognized advantages of its monolithic film for the protection of users.” She added that 36% of Ahlstrom’s revenues come from new developments.
Also strengthening Ahlstrom’s position in the medical arena is its strategic alliance with Saudi Arabia-based Advanced Fabrics (SAAF) for the sale of SAAF’s Medalon range of spunbond/meltblown medical drape and gown fabrics. This cooperation allows both companies to benefit from SAAF’s manufacturing expertise and innovative product range and Ahlstrom’s global presence, strong relationships and vast product offering.
SAAF’s specific know-how has allowed Ahlstrom to offer a multitude of technologies to its customer base, providing the complete range to meet guidelines for liquid barrier performance and classification of apparel and drapes in healthcare facilities. Ahlstrom and SAAF also co-operate to supply spunmelt fabrics (Plasma Wrap) into the European market for sterile barrier system applications.
“Our alliance with Ahlstrom continues to develop,” reported Ian Disley, general manager, international sales and marketing at SAAF, “and we believe the announcement of Ahlstrom’s investment in India will strengthen the alliance further.”
For its part, SAAF is a spunmelt specialist operating two Reicofil lines located in Saudi Arabia. The first is a 3.2-meter SSMMS Reicofil 3 system and the second is a 4.2-meter SMMMS Reicofil 4 line. These lines service both SAAF’s medical and hygiene customers with business evenly split in each sector.
The company’s second line, an SS system, was originally installed in 2006-7; since then, three meltblown beams were added with a planned start up of August 2008. “This supports our medical business by both freeing up more capacity on line one for medical use and enabling us to develop medical fabrics off line two,” explained Mr. Disley. “The 4.2-meter width is ideal for drape products and the state-of-the-art 3x M beam configuration opens up the potential for new barrier products.”
With SAAF’s extra capacity and the capability of its new SMMMS configuration, the company plans to further develop its Medalon+ range (a higher hydrohead version of Medalon) and revisit the Medalon A (inherently antimicrobial) range. “The Medalon A range was developed and patented a couple of years ago, but was shelved due to the fact that our capacity was being taken up by standard products,” said Mr. Disley.
Spanning The Globe
Armed with a broad range of technologies and a global scope, Polymer Group Inc. (PGI) is another player at the forefront of the medical market. The company offers spunmelt, spunlace, EFP and adhesive bond technologies and has assets located in North America, Europe, Asia and Latin America. In addition to the medical market, PGI also serves the protective apparel market with coated and laminated fabrics featuring high-barrier properties that provide enhanced safety and greater comfort for workers.
On the Chinese front, the company is underway with a multi-million dollar investment in a state-of-the-art spunmelt line and a world-class finishing line in Suzhou, China. “With this significant investment, PGI became China’s largest producer of spunmelt fabrics and the only vertically integrated producer of medical fabrics in Asia,” commented Fernando Marin, PGI’s senior director, global medical business. “This strategic location, with close proximity to Asia’s major medical garment manufacturers, has enabled us to reduce turnaround times and deliver greater value solutions for our global customers.”
In terms of future investment plans, PGI plans to invest in resources and capabilities to serve the needs of the market and grow its position. “We plan to invest in this segment globally across our various asset platforms,” Mr. Marin said.
By way of new products, PGI offers its premium MediSoft Ultra, which provides a high level of barrier protection without sacrificing comfort and softness. “We have made proprietary advances in our spunmelt manufacturing process to achieve the barrier protection, comfort and softness that the market is seeking.”
Mr. Marin added that PGI is addressing opportunities to extend its new Spinlace platform into the medical segment. By incorporating continuous filament with hydroentanglement and eliminating the carding step, the Spinlace process enables PGI to achieve a variety of product attributes, such as enhanced softness and greater strength, which are desirable in the medical market.
One company with a technological focus outside of the spunmelt circle is DuPont, a specialist in composite medical fabrics. The company offers a portfolio of products combining multiple technologies to perform a number of functions. For instance, DuPont’s Suprel combines polypropylene and polyester to offer two functions in one material—strength and protection.
While much of Suprel’s exposure has come through DuPont’s agreement with gown maker Medline, the company offers several medical grade fabrics containing Suprel. For instance, Isolation Wear medical fabrics are designed for use during procedures with high-risk exposures such as dialysis, outpatient surgery and blood draw. Orthomax drapes offered by DuPont are significantly wider than standard drapes for optimal coverage in orthopedic procedures.
These materials complement other DuPont Nonwovens offerings to the medical market including its original Softesse (formerly Sontara) spunlace material and its Acturel film material, which provide varying degrees of protection and comfort to the medical market.
REACH Regulations & More
Following the implementation in the U.S. of the Association for the Advancement of Medical Instrumentation (AAMI) institute medical garment standards, Europe has established its own set of standards and is making aggressive changes in the form of EN13795 part 2 compliance and introducing a set of REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) guidelines.
Being phased in since its inception in June 2007, REACH is a comprehensive European system that affects all manufacturers who import chemicals into the European Union or produce chemicals in Europe. Basically, it establishes safety and environmental guidelines for chemicals produced in Europe or exported to Europe from anywhere in the world while changing the responsibility from government to industry to prove that a chemical is safe for use.
The pre-registration process for REACH began in June and continues through November. Failure to pre-register may require removal of a product from the European market after January 2009.
Meanwhile, in the U.S., the AAMI guidelines are designed to provide an objective measure and classification system of liquid barrier performance of protective apparel. Developed by a committee of healthcare professionals and based on industry-accepted test methods, the standards are broken into four levels and many nonwovens producers are aiming to provide products that fit all levels.
By specifying a consistent basis for testing and labeling protective apparel and drapes and providing a common understanding of barrier properties, the classification system, known as AAMI PB70: 2003, can assist healthcare personnel in making informed decisions when selecting the appropriate product for the anticipated task.
What does all of this mean for nonwovens? According to Ahlstrom’s Ms. Erdos, recent regulatory changes favor higher performance nonwovens and present an opportunity to accelerate single-use penetration. “Today’s regulations require that fabrics for medical use have high levels of quality and homogeneity so that use and applications can be widespread. While many products offered today have similar technical structures, special features are obtained through focus and experience in the field.”
Mr. Marin of PGI agreed and pointed to greater homogeneity of regulations around the globe. “Other countries are adopting some U.S. and European standards for various medical products,” he said. “This homogenization is enabling the use of existing test methods and certification procedures and should allow for greater and faster penetration of single-use products.”
He also pointed to increasing awareness about disposability of single-use medical products at different levels—from hospitals to government and regulatory bodies. “The industry is becoming more conscious of the need to better handle the waste stream and is seeking solutions as well as exploring the use of different resins that degrade better in the environment.”
Mr. Marin added that PGI is watching these developments closely to see how it can best help its customers in this area. “We expect that in the next five years disposability will attract more attention by regulatory agencies. The question is whether customers will be willing to pay more for some of these solutions.”
Not At The Sake Of Comfort
Wrapping up, suppliers pinpointed an important goal for the future: achieving a balance between barrier protection, comfort and overall value. Better barrier protection continues to be an important goal but comfort remains a vital consideration as well. “While the market needs greater protection to prevent the spread of infection, comfort is also very important,” said Mr. Marin. “Surgeons, hospital personnel and patients are not willing to fully compromise on comfort in wearing disposable garments to achieve barrier protection.”
Ahlstrom’s Ms. Erdos pointed to the growth of barrier protection throughout the western world and Japan. She suggested that barrier and protection are valued even higher where users are educated in the value of improved protection, through regulations and/or marketer/association education programs. “However, beyond the need to improve barrier properties in base fabrics, the industry still requires benefits in terms of users’ comfort (breathability, softness, lightweight) and ‘smart’ features that can reduce labor, energy or cost.”
Although one might guess that nonwovens would be generally accepted in the medical field by now, they are, surprisingly, still finding new uses as replacements for reusable fabrics—and this is good news for the future. “We are seeing hospitals realizing the value of using disposable materials in areas like hospital linens and other non-patient applications,” observed Mr. Marin.
SAAF’s Mr. Disley cited a similar trend. “We are seeing continued replacement of laundered gowns with disposables in those areas where laundered is still common. In Europe, we see growth of SMS at the expense of other technologies such as spunlace.”