AAMI

There is “tremendous enthusiasm” about disruptive innovation – as long as it is clinically validated. When it comes to AI in health care, transparency in how these tools are designed and validated will be essential to establishing that trust.

“AAMI is the de facto world leader driving the safe and effective use of healthcare technology via their standards and education,” said James Sharpe, cofounder of AmbiFi. “We can’t wait to see what they can do with the AmbiFi platform at their disposal, and we look forward to working together closely to support AAMI members and stakeholders.” 

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.

The U.S. FDA has recognized ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities as a guidance document “appropriate for meeting requirements for medical devices under the Federal Food, Drug, and Cosmetic Act.” Additionally, five other new or updated AAMI standards were added to the federal regulator’s list.

The 11th KILMER Conference, hosted by Johnson & Johnson in Athens, Greece, brought together more than 300 microbiological quality and sterility assurance professionals from industry, academia, government agencies, notified bodies and healthcare delivery organizations around the world.

This increased transport distance brings up new concerns and issues that are not already addressed in the transport section of ST79. The goal of this new TIR is to introduce best practice guidance for transporting clean, disinfected, sterilized, and soiled devices across longer distances, including addressing requirements for the transport vehicles used to transport the devices. For regular updates about this developing technical information report, check aami.org.