ABSTRACT
Until recently, the sterilization of reusable medical devices was seen as the major stage in making them safe for reuse. Cleaning and disinfection were merely prior stages to sterilization, the purpose of which was to destroy bacterial spores. The challenge of new contaminants and a better understanding of the complete decontamination process have led to the cleaning stages sharing the importance of sterilization. While the emphasis may have changed, the fundamentals of the sterilization process remain of prior importance. Development of new processes and sterilants has only added to the need to understand these basic principles fully, enabling users to confirm the sterilization process as effective. Further constraints within European and International Standards require better definitions of sterilants and sterilization processes, and quality systems require full and comprehensive validation, testing and maintenance of sterilizing equipment. Indeed, the Medical Devices Directive (European Union, 1995) requires the user to confirm that medical devices undergo processes that are fully validated and monitored so that they do no harm to the patient.
