ABSTRACT
T HE medical device industry is using contract sterilization at an increasing rate. A contractual relationship must exist between the manufacturer and the sterilization contractor in order to guarantee a well-controlled sterilization process capable of producing a sterile, safe, and effective product. A direct impact ofthis trend is a downsizing of the sterilization support and technical knowledge within the medical device manufacturer's staff. Proper communication and understanding of the sterilizer's activities is essential. The responsibility for sterility is therefore shared, and the division of responsibilities must be clearly defined and understood by both parties. A partial list of contract sterilization facilities is included in Appendix 1.
