The Principles of Medical Device Decontamination

for all device decontamination irrespective of the ‘Provider’, and this includes any externally contracted services. This liability cannot be transferred; the CEO is vicariously responsible for his/her organisational activities.

The life cycle model above highlights each stage of the decontamination process through which surgical instruments, endoscopes and other medical devices pass before every use. Effective decontamination requires the attainment of acceptable standards at all stages. Failure to address issues in any of these stages may result in inadequate decontamination and the device not being fit for purpose. At all stages of reprocessing, the following issues need to be taken into account:

• The location and activities where the decontamination takes place • Facilities and equipment at each location

• Ensuring that any equipment used is validated, routinely monitored, maintained and tested in accordance with the manufacturer’s guidelines, legislation and standards • The existence of effective management arrangements • The existence of written policies and procedures detailing all aspects of decontamination work • Appropriate training and education of the operators carrying out the decontamination It is not the intention of this document to duplicate information that is readily available. ‘A guide to the decontamination of reusable surgical instruments’ report was written by NHS Estates in 2003 (now superceded by the HTM 01-01) which is still relevant today. This document was developed in support of the National Decontamination Programme and an update report titled, ‘The decontamination of surgical instruments in the NHS England Update report’ 2 is available on the UK Parliament website to view.

Manual versus Automated Processing

Within the healthcare environment there are many examples of decontamination of medical devices. Central processing in a certified Sterile Services Unit, employing a formal quality management system i.e. ISO 13485 Quality Management System for Medical Device Manufacturing, is the preferred option.

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