A REVIEW: Taking the sterile out of sterility

Users of in-dwelling medical devices, prostheses and surgical dressings rel y implicitly on their sterility. Rarely do consumers give any thought to wh at sterility really means. The general assumption is that manufacturers hav e adopted the most efficient and cost-effective methods of achieving steril ity. Currently, terminal sterilization processes appropriate for the manufa cture of medical devices are those that are deemed to give less than one ch ance in a million of a single, finished product item containing a viable or ganism. Such a definition of sterility is embodied in the European standard EN556 as a Sterility Assurance Level of 10(-6), based on the properties of heat-resistant endospores. However, is this level of sterility assurance a ppropriate for all categories of medical device; Moreover, do all medical d evices which are labelled as sterile require the same level of treatment; T his paper will demonstrate that in some instances, the high standards set f or sterilization processing are unreasonable, not cost-effective and exclud e new sterilization technologies from being accepted by the regulatory auth orities.