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Surgical Textiles: Battle Lines Being Drawn

The battle of the reusables vs. disposables is entering a new phase. New products and claims are being prepared on each side as the reusable industry eyes the marketplace for surgical products from a new perspective. This perspective is being driven in both the US and Europe by the new performance standards for protective apparel, gowns and drapes, which are entering final development stages. The U.S. standard is expected to be published in 2004. The European standard has already adopted part one of a three-part document.

Up to now, most of the political posturing has been conducted outside of the public view. Expect this to change as the new rules alter expectations of those charged with making purchasing decisions. “Perceived” product quality and performance expectations are now being replaced with quantitative measures that provide the reusables industry an opportunity to compete on a level playing field and dispel many of the myths promulgated by the disposables industry.

First, on the issue of product quality, the tables can be turned in our favor as studies are showing that disposables are not as good as manufacturers would have you believe. A recent European study focusing on the barrier performance of disposable materials showed a relatively high variation in barrier performance, even within the same sample. This variability is due to the manufacturing processes used for nonwovens. In contrast, reusable materials are much more homogeneous.

With the publication of this European report, one of the first stones in the battle is being tossed. We should fully expect the disposables industry to respond by continuing hits historical assault on the quality of reusables and the safety of laundering processes. But the U.S. reusables industry has a tremendous tool that ARTA helped forge – the Association for the Advancement of Medical Instrumentation (AAMI) document ST65:2000, Processing of Reusable Surgical Textiles for Use in Health Care Facilities. AAMI's document outlines quality expectations and provides credibility to the laundering process. It should not be overlooked that this document is not a self-serving publication but one that comes from an association that that publishes most of the sterilization and sterility assurance standards used by surgical professionals.

Second, on the issue of product performance, both U.S. and European performance standards will rely on quantitative test methods that should allow end users to make better decisions because they will be better able to compare products. This is unlike the current situation in which every conceivable type of test method or dog-and-pony show is being used to sell products. It is very difficult for an end user today to filter through this information to compare apples with apples and make the best, most informed decision possible.

One of the most revealing issues that will become apparent is that traditional spun-laced disposable products, which have enjoyed large market share primarily because they are made of wood pulp are very cheep to produce, will be positioned at best, at the very bottom of the performance scale – Level 1 in the U.S. If it were not for the 11 th -hour efforts of the disposables industry, these products might not of even made the cut when the U.S. standard had only three levels. A fourth level with very low expectations was added to appease the producers of spun-laced products.

Manufacturers of spun-laced products will no longer be able to support their broad claims that this Level 1 fabric is as good as or better than a two-ply or even a one-ply reusable gown made from filament polyester. Spun lace clearly does not perform as well. To put this in perspective, most manufacturers of reusable gowns will place their one-ply products in Level 2, their two-ply in Level 3, and coated or laminated fabrics in Level 4. Our industry should be able to capitalize on this distinction and grow our market share at the expense of low-end spun-laced disposable products.

The U.S. has one important additional requirement – the performance of sleeve seams. Seams in critical areas must perform at the level being clamed for the entire product. Additional costs will be incurred for both reusables and disposables to upgrade seams for higher level products.

Whether you are a manufacturer of reusable surgical products or a processor servicing the surgical marketplace, you need to ask yourself the question – Do I live in a glass house? The stones are starting to be tossed and we need to be prepared to take the offensive and protect our positions as necessary. We need to:

  • Be knowledgeable about processing standards and performance requirements for surgical textiles.
  • Develop a marketing plan based on the four performance levels end users will be faced with.
  • Be able to support product claims by using specified test methods with quantitative data about fabric and seam performance.
  • Know and capitalize on the shortcomings of the disposables competitors.
  • Make the commitment necessary to ensure consistent product quality, especially on the processing side.

Make no mistake about it, a battle is brewing and will be here sooner than later. The ammunition now at our disposal includes product quality, product performance, cost per use and environmental stewardship. All these advantages have not historically been ours to promote but with these changes, we need to be prepared to capitalize on our strengths and the weaknesses of our disposable counterparts. The plan is to meet this challenge head on and create opportunities in the light of change.

Quick Rinse - News From Around The World

LAUNDRY FIRE – Guests Evacuated

CHEEKTOWAGA, NY — A fire in a Days Inn laundry room forced guests to evacuate the building during the evening hours. The fire which began in a dryer was contained to the laundry room and there were no injuries.