Reprocessing Instructions Validation

Andersen Caledonia has developed significant expertise in validating reprocessing instructions for reusable medical devices. Our support includes providing advice on the instructions and validating instructions through testing. We have access to a range of automated and manual cleaning equipment and a range of sterilizers commonly found in hospitals. We manufacture our own test soils to ensure a fresh and quality product.

Testing protocols can be developed for a wide range of devices that are to be used sterile or disinfected. Instructions are tested through coating device with a spiked soil as detailed in AAMI standards. The device is then processed using the manufacturers cleaning/sterilisation instruction. After processing the device is tested using a validated recovery method to obtain a log reduction of the organism used to spike the product. The log reduction is obtained by comparing positive controls to devices processed using the manufacturer’s instructions.

Core reference standards

ISO 17664:2004 
Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices