Validation of Extraction Methods One of the new requirements in AAMI ST98 is that cleaning extraction methods should be validated. AAMI TIR30:2011 presents different methods for performing an extraction; however, it does not mention that the methods need to be validated or how to perform the validation. Per the new standard, ST98, two possible approaches for validating an extraction method are spike recovery and exhaustive extraction. The use of spike recovery for validating an extraction method involves soiling a medical device with a known amount of soil. The soils used for spiking are the same soils that are tested in the endpoint testing. Using this method, the extraction efficiency is a comparison between the amounts of soil recovered to the amount of soil added. The use of exhaustive extraction for validating an extraction method involves performing extractions several times on the same soiled device. The amount of Preparation of medical devices for the automated washing process. (Credit: Eurofins) Winter 2021 Resource Guide www.medicaldesignbriefs.com Cov ToC 35http://www.medicaldesignbriefs.com