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

Published Date: April 24, 2024

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.

This webinar covers 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 the questions.


  • To review the major updates for cleaning and disinfection validations for reusable medical devices.
  • To understand how different guidance documents linked to the reprocessing of reusable devices are aligned.
  • To review the gaps certain gray areas bring to reprocessing validations and the possible solutions.

Learn about the presenters below.

Griffin Cammack

Griffin Cammack

Reprocessing Expert

Griffin Cammack has worked at Nelson Labs for over 8 years, specializing in cleaning, disinfection, and sterilization validations of reusable medical devices. His current role as Expert Technical Consultant at Nelson Labs involves providing assessments and justifications for reusable medical device validations for manufacturers, such as master product (worst-case device) determinations, test method justifications, test...


Breanna Barber

Consulting Study Director

Breanna Barber has worked at Nelson Labs for over 5 years as a lab analyst, Study Director, and Regulatory Affairs Specialist. She is currently the Consulting Study Director for the Healthcare Reprocessing department, focusing on cleaning and disinfection validations of reusable medical devices. In this role, Breanna is the primary contact for sharing expertise related to testing requirements, ensuring medical device manufacturers are set up for success for their regulatory submissions. In addition, she helps resolve test failures and provides continued support to medical device manufacturers, even after the completion of their validations. Breanna graduated from Arizona State University with a Master’s in Regulatory Science in Spring 2023. Her time in school and at Nelson has made her passionate about regulations surrounding reusable medical devices.

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