The Association for the Advancement of Medical Instrumentation (AAMI) recently released the first cleaning validation standard for medical device manufactures, ANSI/AAMI ST98:2022 Cleaning validation of healthcare products—Requirements for development and validation of a cleaning process for medical devices.
This new standard that replaces AAMI TIR30 provides guidance and recommendations for manufacturers on how to design a validation plan to address their processing instructions, which must be specified in their instructions for use (IFU). If a medical device manufacturer is developing and validating a cleaning process for medical devices, then ST98 is required.
Although the standard provides a lot of details regarding validation strategies, there are some things that have been left to interpretation. If these things are not carefully considered, they can impact the outcome of the validation. Some of the significant changes in ST98 are discussed in the article.