• S R Patel, D Urech, and H P Werner.
• Br J Theatre Nurs. 1998 Nov 1; 8 (8): 27, 30-2, 34-7.

AbstractAccording to the MDD (Medical Devices Directive) 93/42/EEC of 13 June 1993, medical products including gowns and drapes must provide a high level of protection for patients, users and others. The European Commission CEN/TC 205/WG 14, under the leadership of its convenor, Professor Werner, is developing a mandatory European standard on the basic requirements and test methods for disposable and reusable materials for protection of patients, surgical personnel, and operating room facilities i.e. gowns and drapes. This European standard is intended to clarify the situation with respect to products and their properties, defining basic requirements, for users and manufacturers of medical products. Future use of standard cotton textiles and conventional cotton-polyester mixed textiles is uncertain as they may not meet the requirements of the new standard, i.e. resistance to penetration by microbiological microorganisms, liquids and particle release. However, there are innovative reusable barrier surgical drapes and gowns which meet the basic requirements of the standard made from liquid repellent micro-filament materials, material laminates and perhaps some specific cotton polyester materials which have been chemically modified. In the new standard based on CEN/TC 205/WG 14, quality assurance for reprocessing of surgical gowns and drapes is critical. The manufacturer/distributor must use validated processes to prove that the requirements of this European Standard are met. Quality Assurance Systems will be required to give proof of decontamination, disinfection and sterilisation. Specified processes are to be used to maintain the properties of the materials throughout reprocessing. It is the responsibility of the hospital to assure optimal protection of patients and users. In case of a lawsuit, this could lead to the burden of proof being shifted to the hospital, with related risk of liability because it is always assumed that the work is being done according to the 'state of the art'. Difficult situations arise when it must be proved that one has acted equivalent to or better than the standard procedures and that no mistakes are made. Because of this risk of liability alone, the question of what surgical materials are used in the future should be considered very carefully.

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