Medical Device Cleaning Validations

References: ABHI SI SIS 0034 Report on the Validation of a Reprocessing Instructions Template for Generic Class I Medical Devices

Re-useable medical devices are commonly reprocessed using a wash / disinfect process and sterilised with steam. In order to ensure that medical devices are being successfully decontaminated and sterilised, a reprocessing test protocol has been developed.

Devices are coated in test soil spiked with known quantities of commonly occurring microorganisms. Devices are put through a validated washer / disinfector cycle and tested for bioburden. The difference compared to a positive control is established and the log reduction in organisms is calculated.

Devices can then be put through a sterilised autoclave cycle and tested for sterility.

91-Morton (Microbiological Laboratory Services) Ltd can offer this service to customers based in the UK and around Europe.