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Medical fabrics for operating rooms: a challenge for nonwovens.

Rising concerns over AIDS, hepatitis and resurging tuberculosis are expected to manifest a concomitant rise in nonwoven medical fabric usage. Preventing opportunities for transmittance of these diseases to healthcare workers is expected to lead to increased requirements for protection--both in terms of the level of protection provided by the garment or device and the number of procedures and patient contact situations that will require gowns, masks et al. Some have even suggested that protective apparel for visitors and patients themselves will be introduced.

In the European arena, the medical market is estimated to be about 17,000 tons in the ten main European countries (1991 figures), with a projected growth rate for the medical nonwovens market estimated at 6% per year. This growth will be due mainly to the increasing penetration of disposables versus linens; current hospital consumption is shown in Figure 1.

Significant opportunities for surgical drapes and gowns exist for nonwovens producers in Europe. The nonwoven penetration rate for drapes and gowns in Europe--40% for drapes, 30% for gowns--is very low when compared to the 90% penetration in the U.S.

Medical Nonwovens: The European Market

Dry laid material is the main converted nonwoven, representing 32% of the European medical market. This includes underpads and hydrophilic drapes combined with films and face masks. Wet laid technology also has a significant position in the medical market and is mainly used for drapes, surgical pack parts and CSR wraps. In order of importance, spunlaced materials follow wet laids and because of their strong barrier properties, high burst strength and good drape, are used mainly for hydrophobic drapes and gowns (Figure 2).

Today, spunbonds still have a low position in the European market but their use is increasing rapidly at the expense of dry laid and wet laid technologies. Part of this increase is due to improvements in the spunbonded fabric itself, such as improved filament distribution. The spunbonding technology is currently used for commodities (iso gowns, shoe covers, face masks, etc.), but is becoming more integrated in drapes and surgical gowns. The use of spunbonds in composite constructions provides fabrics with designed high performance in multiple areas, such as barrier, strength and abrasion resistance.

Thanks to the new spunbonded generation and improvements in terms of distribution and barrier properties, the technology's share will continue to grow. New spunbonded fabrics will also soon compete with spunlaced materials. The higher strength and abrasion resistance of spunbonds, especially in wet conditions, allow for reduction of basis weight and consequently waste reduction and lower price.

Three key end product manufacturers, Molnlycke, Baxter and Johnson & Johnson, dominate manufacturing in the European medical markets. In addition, there are three other companies with strong positions in their domestic markets--Hartmann in Germany, Smith and Nephew in the U.K. and Bollore in France.

In Europe, there are two concepts for drapes--breathability and imperviousness. Breathable fabrics were the first generation of products. The drapes were constructed as one layer of either spunlaced or spunbonded nonwovens (i.e. "Sontara"). For impervious drapes, the main function is to totally protect the patient and the operating room staff from blood-transmitted virus contamination.

The barrier effect is achieved by using film. Currently, two types of impervious drapes are available. Two layer fabrics, made with a film and absorbent or repellent nonwoven (dry laid, spunlaced or spunbonded material), are available, as are three layer fabrics of a nonwoven (dry laid or spunbonded fabrics), film and tissue..

Currently, the principal requirements for gowns are barrier properties and breathability. This combination can be difficult to deliver and many gown constructions utilize a film or other auxiliary barrier fabric as a reinforcement in certain high penetration zones, like the center front and sleeves from wrist to elbow.

It can be expected that composite fabrics will also figure prominently in gown constructions in the years to come for the same reasons as the reinforcements are used now-higher barrier performance. Comfort is also a major issue with the users and this includes softness as well as breathability. This one concept--breathability--can be provided by either spunlaced or spunbonded fabrics.

Medical Nonwovens: The U.S. Market

The U.S. market for medical nonwovens includes surgical packs and parts, sterilization wrap, iso gowns, shoe covers, head covers and underpads. Of these, surgical packs and parts, sterilization wrap and gowns represent almost 80% of the market for hospital applications--more than one billion sq. yards.

In the U.S., the national annual expenditure for healthcare is $800 billion, 13.4% of the gross national product. Sales of nonwovens to the manufacturers/distributors of medical products were approximately $841 million in 1991. The annual growth rate of these sales, in U.S. dollars, has been 2.3% since 1990. However, during that same time frame, the consumption of nonwoven yardage in these segments declined an average of 1.6% per year, indicating a price increase at the hospital level.

The penetration rate of disposable nonwovens in the major medical market segments in the U.S. is about 90% overall. Therefore, other factors control the rate of growth and decline in the market. Factors that have decreased nonwoven usage include declines in the number of procedures performed during the study period and a thrust by durable linen suppliers to regain market share--based on improved fabric designs and a marketing plan that focuses on total life cycle costs. AIDS and hepatitis are creating increased attention on prevention of transmission of the viruses by use of barriers and by handling of contaminated devices afterward. These can be expected to have a strong positive impact on nonwoven usage in the future.

Unlike the European market, where dry laid fabrics are the main nonwoven used, spunbonded and SMS (spunbond/melt blown/spunbond) fabrics have the largest share in the U.S. at 36% of the 1.3 billion square yard market volume.

Spunbonds have been utilized mainly in head and shoe covers and iso gowns, where abrasion resistance is critical but barrier performance is not. Spunbonds are also being incorporated into face mask constructions. Spunlaced material occupies a significant position in the U.S. medical market at 28%, where its barrier properties, high burst strength and good drape have established it principally as a gown and drape fabric. Wet laid products, also 28% of the market, are used for drapes, pack parts and sterilization wrap.

The U.S. end product supplier market is dominated by Baxter (31%) which uses wet laid, spunlaced and laminated structures. Baxter offers a full line of medical nonwoven products, including gamma sterilized gowns, drapes and surgical packs. Kimberly-Clark and Johnson & Johnson are nearly equal at 21% and 20% respectively (Figure 3). Kimberly-Clark markets internally sourced spunbonded and SMS fabrics, utilizing ethylene oxide sterilization for its pre-sterilized products. Johnson & Johnson supplies mostly spunlaced products, also gamma sterilized.

Sterilization wraps, which are used for wrapping instrument trays and large instruments, require high barrier performance, strength and puncture resistance. Sterilization is performed in the hospital using either steam autoclaves or the ethylene oxide procedure. Performance for these wraps used to be defined by 140 count muslin, but the introduction of composite nonwoven structures significantly changed the criteria for successful competition in this market. The laminated constructions offer unmatched barrier and breathability in this product. As the functional attributes have been secured by fabric engineering, the marketplace has begun to demand other performance features that benefit the supply room worker. Key among these are softness and ease of use; stiff, bulky fabrics are difficult to manage while wrapping trays and instruments.

The use of the term "sterile" indicates that the sterile gowns and surgical packs are destined for the operating room and are provided to hospitals in pre-sterilized packages. Barrier is a key requirement for the drapes included in the surgical pack. When total barrier is required, film reinforcements are used. The combination of barrier and drapability of nonwoven composite constructions make them ideal fabrics for this use. U.S. surgeons have a significant impact on the selection of gown and pack materials utilized in their operating rooms, making comfort for the user a most critical criterion to consider in the design of fabrics for this end use.

The U.S. market is dominated by nonwovens principally. Paper products, prevalent in Europe, essentially have no place, due to their lack of ability to deliver on requirements. Performance in the field is rather clearly defined by the existing competitors, with the laminate structures showing distinct advantages in the area of combined breathability and barrier.

European Vs. U.S. Markets

In Europe there is no specific regulation governing medical fabrics although different regulations have to be considered. These include the European Pharmacopeia, National Pharmacopeia, national norms and national certification and homologations. It is up to the producer to make reference or not to the Pharmacopeia; however, if it does, the regulation has to be applied. All packaging for sterile fabrics is also subject to regulations. To be registered as a "pharmaceutical laboratory" is the best guarantee, as this ensures that Good Manufacturing Practices (GMP's) are being used.

In the U.S., fabric-based products used by medical personnel involved in patient care are considered to be medical devices. As such, their manufacture and sale come under regulation by the Federal Drug Administration (FDA) and are required to be produced in accordance with GMP guidelines. These requirements are applied to end product manufacturers, such as Baxter and Johnson & Johnson. Suppliers of roll good fabrics are considered "second removed suppliers" and are not directly liable to the FDA or required to conform to GMP.

Before marketing a new medical product or product line extension, the selling company is required to obtain a 510(k) from the FDA, which essentially provides sufficient laboratory data to substantiate a claim that the proposed product will perform at least as well as existing products accepted in the field. Once granted, any changes in the composition of the product or its performance against the original claims must be documented in a letter to the 5 10(k) file. Licensing and registration is also required when manufacturing medical devices.

In cases of deficient performance in the field, product recall, etc., the holder of the 510(k) is liable to the FDA. If a roll goods supplier becomes involved in converting all or part of the end product, it also becomes accountable to the FDA at a level that is defined by how extensively it had become involved in converting.

GMP guidelines differ from ISO 9000 standards in that they extend into control of the manufacturing and quality assurance processes as well as the document control emphasized by ISO. Written and approved procedures for every step of the manufacturing process, from acceptance of raw materials through control of the warehouse, are part of full GMP compliance.
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Title Annotation:excerpt from paper presented at INDEX '93
Author:Lickfield, Deborah
Publication:Nonwovens Industry
Date:Sep 1, 1993
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