When it comes to processing multi-use medical devices, sterilization often gets the splashy headlines, but cleaning is just as—if not more—important, and with ANSI/AAMI ST98:2022, cleaning is the star. The new standard, which formalizes requirements for cleaning validation methods, not only advances understanding of and conformance with cleaning best practices but has the potential to have an impact on the design and development of medical devices for years to come.

Many of the core ideas behind ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices have been part of important discussions since 2014, when thought leaders were working to revise ISO 17664 and TIR12. These documents cover information to be provided by manufacturers for the processing of re-sterilizable medical devices and compliment the new cleaning standard.

Nupur Jain, director of sterility assurance and reprocessing at Intuitive Surgical and co-chair of the AAMI Cleaning of Reusable Medical Devices Working Group (AAMI ST-WG93) noted how the standard builds upon previous guidance from AAMI, FDA, and other organizations, as well as its close ties to a technical information report (TIR) used by manufacturers, AAMI TIR30. . .

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