What’s New with Reprocessing Validations for Reusable Medical Devices?

There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations for reusable medical devices. Examples are AAMI ST98:2022 and recent updates to established standards like AAMI TIR12:2020 and ISO 15883-5:2021. It can be difficult to navigate these updates and ensure that your reusable devices undergo the proper reprocessing validation. Furthermore, there are still gaps in guidance that have led to gray areas in reprocessing. These gray areas include reprocessing validations for single-use devices that are provided non-sterile, reprocessing validations for novel reusable devices being used for clinical trials, reprocessing instructions for at-home devices, and wearable non-critical devices. While published documents can be relied on to provide guidance for these gray areas, questions will remain that need to be addressed to ensure the safety of the devices associated with these gray-area situations.