The Impacts of Updated Standards on IFU Validations for Reusable Medical Device

As reusable medical devices continue to advance, the validations used to evaluate the reprocessing (cleaning, disinfection, and/or sterilization) procedures have had to advance as well. These advancements have resulted in numerous standards and guidance documents being either updated or created to ensure that reusable medical devices can be safely reprocessed. This presentation will discuss these changes as found in documents such as AAMI ST98, AAMI TIR12, ISO 17664, as well as others. Additionally, this presentation will discuss how these changes impact new and already completed reprocessing validations for reusable medical devices and what is next for these validations.