Originally Published MPMN May 2002

EDITOR'S PAGE

Dirty Laundry in the OR

I was in Geneva last month to attend Index '02, which claims to be the world's largest nonwovens exhibition and conference. Held every three years, the event attracted almost 500 exhibitors, several of whom provide materials, equipment, and services to the medical device sector. I will report on noteworthy product introductions, in particular a new nonwoven medical tape from 3M Medical Specialties, in the June issue of MPMN. For the time being, though, I wanted to pass along some disquieting information I learned regarding the reuse of surgical drapes and gowns in European hospitals.

The European Disposables and Nonwovens Association (EDANA), which sponsored Index '02, issued a press release at the show referencing a study conducted in 2000 on the quality of surgical drapes and gowns in England, Wales, and France. Researchers randomly collected reusable and single-use surgical sets containing drapes and gowns that were deemed ready for use in the OR. The sets were sent to an independent German testing house, which subjected the products to a series of infection control and impermeability tests based on European Committee for Standardization procedures.

A simple visual inspection of the processed reusable drapes and gowns revealed numerous defects. Specifically, holes and significant adhesive residue were observed near the wound isolation area, and more than a dozen products had traces of hair, presumably human in origin. When subjected to wet bacterial penetration tests, only 20 of the 98 reusable surgical drapes from England and Wales and 16 of the 59 from France were shown to be impermeable to bacteria.

Overall, 49% of the surgical drapes and 71% of the operating gowns from England and Wales had defects that either impaired functionality (called a Level I fault) or that could lead to functional impairment (a Level II fault). For France, the respective figures were a staggering 90% of surgical drapes and 57% of operating gowns.

By contrast, single-use surgical drapes showed no "conspicuous faults" in the Level I category. Some did, however, present Level II defects, primarily a "wrinkling" of the material underneath the adhesive tapes.

Against a backdrop of ongoing discussions at the European level on the prevention of nosocomial infections, the report stressed that only disposable products are able to provide an adequate degree of protection in the operating theater. Medical personnel have joined the crusade, citing the unreliability of traditional sterilization techniques to protect them from exposure to Creutzfeldt-Jakob disease and HIV. Healthcare workers have formed committees in France and other European countries with the aim of identifying and eliminating these and other sources of infection.

While the North American market for disposable surgical gowns and drapes is mature, Europe's medical sector is still beginning to gain awareness of the advantages of nonwoven materials for these types of applications, according to EDANA. The association forecasts continued growth in Europe's medical nonwovens market.

That will be good news to medical device OEMs that manufacture disposable gowns and drapes. It should also cheer patients and healthcare personnel, who have enough on their minds without having to worry about wayward hairs.

Norbert Sparrow

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