Material Factors to consider in Decontamination and Sterilisation Processes

Home 5 News 5 Material Factors to consider in Decontamination and Sterilisation Processes

The process of decontamination and sterilisation 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 sterilised, 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 categorised 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:

  • Design
  • Material
  • Weight
  • Sterile barrier
  • Packaging system

Why is design understanding important?

The purpose of this categorisation 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 sterilisation 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 categorisation 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 sterilisation 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.

Some challenges

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 >

Find out more about our Medical Device Decontamination Services >

Find out more about our Medical Device Decontamination Training Courses >

For more information on AVM Services’ range of consultancy, training and decontamination services contact us on 01223 254499 or

Material Factors - Decontamination and Sterilisation

Recent Articles

AP(D) Authorised Person Course – Glasgow

We are pleased to announce that our Authorised Person (Decontamination) Training Course (APD01) will be available between  14 to 17 May 2024 at NHS Greater Glasgow & Clyde.

This is a 4-day course to teach staff the skills and expertise needed to perform day-to-day tasks and duties to effectively manage aspects of decontamination.

read more

Quality Management Systems Course Showcased at IDSc

Cambridge University Hospitals-AVM attended the 17th Annual Institute of Decontamination Sciences (IDSc) conference on 28 and 29 November 2023 to showcase our newly-released online training course, Quality Management Systems 1 (QMS1). 

To ensure ease of use and broad-based accessibility, the course is video-based with interactive elements and is designed to be highly informative and beneficial to staff involved in the decontamination of reusable medical instruments such as surgical instruments or endoscopes.

read more

AVM Services – Decontamination Specialists

Professional training, consultancy and specialist services for decontamination testing and validation