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.