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 of reusable medical devices, such as 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 have the proper reprocessing validation. In addition, there are still gaps in guidance that have led to “gray areas” of reprocessing. These gray areas include reprocessing validations for single-use devices 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 we can rely on published documents to provide guidance in these gray areas, there are questions that need addressing to ensure the safety of the devices associated with these situations.
This presentation will cover the major changes stemming from AAMI ST98:2022 and AAMI TIR12:2020 for cleaning and disinfection validations. It will also discuss these “gray areas” of reprocessing validations, what questions you should be asking, and possible solutions for these questions.
Key Learning Points:
- Review the major updates for cleaning and disinfection validations for reusable medical devices.
- Understand how different guidance documents linked to the reprocessing of reusable devices are aligned.
- Review the gaps these “gray areas” bring to reprocessing validations and possible solutions.