The Principles of Medical Device Decontamination

The Facilities - are they dedicated for the purpose? e.g. a sterile services department or endoscopy decontamination unit? (See Health Building Note 13) 1 or is decontamination undertaken in a treatment area or ward and department? Is there a clear segregation of clean and dirty areas to minimise recontamination of clean devices? Equipment - what is recommended by manufacturers to decontaminate the devices? What do their instructions for use (IFU) state? Who is responsible for testing and maintenance of any equipment used? e.g. washer disinfectors; sterilisers etc. What standards apply to the equipment?

Management - who is responsible for ensuring decontamination is being undertaken to the appropriate guidance and standards? Are there clear governance arrangements in place? Is there an assurance framework?

Policies and Procedures - are there local polices and procedures describing the way that devices are to be processed? Do these describe how decontamination should be undertaken and what is the chosen method? Is there a formal quality management system (QMS) in place? Traditionally, decontamination of devices has been the responsibility of the departmental heads of specialist units, for example sterile services, endoscopy units, theatre suites etc. but with the increased use of probes and endoscopes used for diagnosis e.g. ultrasound probes, transvaginal and transrectal probes, nasendoscopes etc., decontamination is often undertaken at the point of use. Centralised automated processing should always be the preferred option however, it is acknowledged that this cannot always be applied due to local circumstances. Irrespective of the location of decontamination of medical devices, there must always be a nominated lead responsible for all activities including staff training and competency.

Whilst individual functions may have a nominated lead and be undertaking decontamination according to extant guidance, the organisations’ executive team (ultimately the Chief Executive Officer [CEO]) remain fully responsible and accountable

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