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Upcoming Changes to Cleaning Validations for Reusable Medical Devices

Published Date: December 1, 2021

AAMI TIR30 has been one of the primary documents used to provide guidance on the recommendations for the cleaning validations of reusable medical devices for the last ten years. During this time, the industry has changed due to the advancement of reusable medical devices and the test methods used to evaluate the effectiveness of the cleaning procedures. To ensure that the recommendations for cleaning validations are current with the industry changes, AAMI TIR30 is being revised to become a standard, AAMI ST98. Additionally, this standard will to provide clear guidance on how to perform cleaning validations as such a standard does not currently exist. This presentation will cover the upcoming changes to the requirements for the cleaning validations of reusable medical devices that will be found in AAMI ST98. The following will also be covered:

  • Review current guidance for cleaning validations of reusable medical devices.
  • Review the upcoming changes to cleaning validations of reusable medical devices as found in AAMI ST98
  • Discuss the impact of these changes will have on the medical device industry.

Griffin Cammack

Expert Technical Consultant

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 failure risk assessments, reprocessing validation report summaries, and gap assessments. He presents at Nelson Labs seminars across the U.S. Griffin graduated from Brigham Young University (BYU) – Idaho with a bachelor’s degree in biology and started at Nelson Labs in 2014. By actively participating in the development of guidance documents and standards as a member of the American Association of Medical Instrumentation (AAMI) and the American Standard Test Methods (ASTM), he has remained up to date with the current industry recommendations.

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