SURGICAL GOWN AND DRAPE STERILITY ASSURANCE LEVEL REDUCED BY FDA
This article was originally published in The Gray Sheet
Executive Summary
SURGICAL GOWN AND DRAPE STERILITY ASSURANCE LEVEL REDUCED BY FDA until further scientific assessment of the issue can be made, according to agency staffers. The SAL (the probability of having one nonsterile unit after a sterilization process) is being cut from 10 to 10. FDA set the initial level in an August 1993 guidance document on submission of 510(k)s for surgical gowns and drapes.