Sterilization and decontamination of medical devices

This page provides basic guidance on the decontamination of medical devices, however specific guidance should be provided by the manufacturer of the device.

Definitions

  • Decontamination - A combination of processes which removes or destroys contamination so that infectious agents or other contaminants cannot reach a susceptible site in sufficient quantities to initiate infection or other harmful response
  • Cleaning - Physical removal of organic matter and infectious agents
  • Disinfection - Reduction in viable infectious agents
  • Sterilization - Render an object free from all viable infectious agents

Note:
Transmissible spongiform encephalopathy agents (TSE’s) are particularly resistant to standard physical and chemical methods of inactivation and decontamination therefore effective cleaning is the most efficient method of eliminating these agents. *

General Guidance

  • Before purchasing a reusable medical device check that the manufacturer’s recommended reprocessing instructions are compatible with the local decontamination processes and products. If not, do not purchase.
  • Always follow the manufacturer’s Instructions for Use (IFU) where appropriate and acceptable. If not, do not use.
  • Only reprocess medical devices which the manufacturer states as being reusable and do not reprocess those designated for single use only.
  • Reusable medical devices should be decontaminated using validated processes and equipment designated for the specific purpose.
  • Use of automated decontamination processes are preferable to manual processes in that they have the ability to control and monitor their own parameters within strictly controlled tolerances.
  • Medical devices should be decontaminated away from treatment/clinical areas and preferably within a dedicated area/room. Ideally this would be within a dedicated Sterile Services Department (SSD).
  • Used devices should be segregated from those that have been processed and stored separately.

General advice on best practice for decontaminating medical devices is available in “Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Advisory Committee to the Department of Health, MHRA”.

* The Advisory Committee on Dangerous Pathogens (ACDP) (external link) - TSE agents safe working and the prevention of infection.


Page last modified: 07 February 2008