The process of decontamination and sterilization is a complex one, requiring a highly detailed protocol for establishing and carrying out the processes, and a rigorous and periodic testing programme to ensure the maintenance of standards.
Added to this, a comprehensive training programme should be implemented, with regular follow-ups to ensure any new knowledge is transferred, staff can maintain standards and an external consultant is able to assess all aspects of the overall operation.
One of the key aspects to consider in all the above is what products will be decontaminated and sterilized, and more specifically how these devices have been engineered.
Part of the assessment of a device to determine the most effective decontamination process is to know how the device has been categorized according to the ANSI/AAMI/ISO TIR 17655-3 Sterilisation of Health Care Products, Moist Heat: Part 3 Guidance on the designation of a medical device to a product family and processing category.
There are 28 device families categorized in the document which gives detail including:
- Sterile barrier
- Packaging system
Why is design understanding important?
The purpose of this categorization is to understand the nature of the design and process used in the construction of a medical device so that a decontamination operative can apply the most appropriate procedure for sterilization and testing of these devices.
Factors to consider include how the packaging or sterile barrier systems, or indeed the combination of various devices in a procedure might affect a device. For example, how might these factors impact on conductivity, air removal, moisture build-up or removal, and heat penetration?
Using the categorization chart as a starting point already helps operatives identify areas of concern, as well as establishing any pre-treatments such as washing, cleaning and disinfection to reduce biological matter prior to full decontamination.
The information on which moist heat sterilization processes should be applied is based not only on engineering and operational factors, but also on experimental data, ensuring that operatives are able to use a complete data set as a foundation for their process choices.
The categorization document should not be viewed as static – from time to time new devices are introduced which may not fit into any existing categories, in which case new product families are introduced, based on the product’s attributes as well as performance testing.
Find out more about the impact of material, weight, sterile barrier systems and packaging systems on the categorization of medical devices and decontamination process selection in our next article.