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Expert guidance on the optimal sterilisation process

IHEEM-registered AE (D), Dr Brian Kirk, explains the importance of using validated sterilisation processes to produce sterile single or multi-use medical devices such as re-usable metal surgical instruments, and the internationally agreed standards covering the sterilisation process and steriliser equipment. He considers both high and low temperature processes, and the key considerations when investing in sterilisation technology, and when faced with the challenge of a new medical device which requires sterilisation.

Sterile medical devices must be sterilised in a validated sterilisation process. The objective of any such process is to produce a product free of viable microorganisms. There are a variety of such sterilisation processes available, some of which are shown in Figure 1. Figure 1 shows sterilisation processes which achieve microbial inactivation by a physical process, and those that do so via the action of a microbicidal chemical agent. Physical processes can be sub-divided into those which take place at a high temperature (e.g. 121-138 °C) and those at a low temperature (room temperature to 80 °C). Processes achieving microbial inactivation using a microbicidal chemical usually employ oxidising agents such as hydrogen peroxide or alkylating agents such as EO (ethylene oxide). These processes almost invariably take place at lower temperatures (room temperature to 80 °C), and are often described as low temperature sterilisation (LTS). 

High temperature processes

In a healthcare setting, the majority (ca 90%) of reusable sterile medical devices will be sterilised at high temperatures and pressures in moist heat sterilisation processes employing saturated steam. The majority (ca 90%) of singleuse medical devices produced by the medical device industry will be sterilised in a low temperature sterilisation process, commonly using irradiation with ionising radiation (e.g. gamma), or using ethylene oxide gas sterilisation (EO). However, the industry is actively investigating alternative low temperature processes such as those employing vaporised hydrogen peroxide (VH2O2) as an alternative to EO. 

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Upcoming Events

The Fire Safety Event 2024

National Exhibition Centre (NEC), Birmingham
30th April - 2 May 2024

Wales regional conference, exhibition and awards dinner 2024

International Conference Centre (ICC) Newport
28th - 29th May 2024

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Crowne Plaza Newcastle Upon Tyne
3rd - 5th June 2024

Design in Mental Health 2024

Manchester Central
4th - 5th June 2024

InstallerSHOW 2024

National Exhibition Centre (NEC), Birmingham
25th - 27th June

Healthcare Estates 2024

Manchester Central
8th-9th October 2024

Access the latest issue of Health Estate Journal on your mobile device together with an archive of back issues.

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