Ensuring medical devices are free of microbiological contamination requires microscopic attention to detect any sources of contamination, including those from the environment and health care personnel themselves.
The factors and requirements are many, depending on where the medical devices are used and how they are cleaned prior to sterilization. A new technical specification from the International Organization for Standardization (ISO) provides the first set of internationally agreed requirements for sterilizers.
ISO/TS 22421, Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities, provides high-level, overarching requirements and respective test methods, and sets the scene for further, more detailed standards to be developed.
It considers many of the factors that contribute to the safe and effective performance of medical equipment, such as its design and construction, the provision of indicating, monitoring, controlling, and recording devices, emissions from the equipment and information to be provided by the manufacturer.
ISO/TS 22421 was developed by technical committee ISO/TC 198, Sterilization of health care products, whose secretariat is held by ANSI, ISO’s member for the USA. It can be purchased from your national ISO member or the ISO Store.