ABSTRACT
Technical breakthroughs, advanced concepts and state-of-the-art product designs are not new to the medical device industry. The popularity of ethylene oxide commercial use began in the 1960s when the use of disposable medical devices gained in acceptability. Bulk density is generally calculated by the contract sterilizer in order to categorize a product in a low, medium, heavy or extra-heavy density group; each sterilizer categorizes density groupings differently. Some medical device manufacturers may be willing to share personal success or failure stories with other device manufacturers. Establishing the criteria to render a product sterile is the responsibility of the device manufacturer; once the contract sterilizer establishes that it can meet those criteria, it is then the responsibility of the contract sterilizer to deliver those requirements consistently. The safety and efficacy of a medical device is ultimately the responsibility of the medical device manufacturer.
