Testing surgical gowns for the "anticipated level of exposure"

Although the use of the surgeon's gown dates back to the turn of the century, the need for it to be made of a liquid-repellent material was disclosed only in 1952. Because of the relatively poor performance of the products that were introduced early on, the entire textile industry--makers of nonwoven disposable and woven reusable materials alike--was challenged to develop a test method to demonstrate a fabric's capability "under usual conditions of use." A cooperative attempt to do that was abandoned in 1983. With the emergence of HIV, the need to protect the wearer became the gown's priority. However, because there was no standard test method, the manufacturers used any of an array of tests to promote a product's suitability for use under what the Occupational Safety and Health Administration describes as the "level of exposure anticipated." Now, a standard test method has been adopted that describes the results on a pass/fail basis. However, the literature indicates that gowns made of materials that have passed this test have failed "under usual conditions of use." Nevertheless, the Food and Drug Administration is permitting manufacturers to mislead the surgical community by describing products as being "impervious" or "liquid proof."