The Principles of Medical Device Decontamination

Validation, testing and maintenance of probe decontamination systems is a critical factor in ensuring systems are safe, effective and fit for purpose. Device compatibility confirmed by the manufacturer is also a crucial factor for consideration.

Intra-operative probe decontamination

The development and use of intra-operative devices for imaging of internal areas of the body require the device to enter sterile body cavities. Under the Spaulding classification these devices are defined as critical items, having a high risk for infection if they are contaminated with any microorganism. Critical devices that enter sterile tissue or the vascular system must be sterile because any microbial contamination could transmit disease.

Due to their design, the materials used and complex electrical components these devices often are not compatible with high temperature process such as thermal disinfection and steam sterilization. Alternative decontamination methods are therefore required to ensure the device is safe for reuse between patients. These typically involve the following processes: • Low temperature cleaning and disinfection (i.e. Endoscope Washer-Disinfector or similar automated washer utilising chemical disinfection) followed by • Hydrogen Peroxide Sterilization where the sterilization chamber is evacuated and hydrogen peroxide solution is injected from a cassette and is vaporised in the sterilization chamber to a set concentration. The hydrogen peroxide vapour diffuses through the chamber, exposing all surfaces of the load to the sterilant, and initiates the inactivation of microorganisms. This vapour can penetrate compatible sterilization packaging (wrap material or pouches) to ensure

112

@ 2025 Central Sterilising Club. All rights reserved. Do Not duplicate