Sterilization is defined as a validated process used to render products free from viable microorganisms (ISO/TS 11139, 2006). Sterilization should be considered at the earliest stages of the design of any new medical device intended for use in contact with sterile tissues, mucous, or breached skin, to ensure that the final product can be sterilized effectively and safely.
Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. However, since 1950, there has been an increase in medical devices and instruments made of materials (e.g., plastics) that require low-temperature sterilization. Ethylene oxide gas has been used since the 1950s for heat- and moisture-sensitive medical devices. Within the past 15 years, a number of new, low-temperature sterilization systems (e.g., hydrogen peroxide gas plasma, peracetic acid immersion, ozone) have been developed and are being used to sterilize medical devices. This section reviews sterilization technologies used in healthcare and makes recommendations for their optimum performance in the processing of medical devices.
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