New chemical-sterilization standard from AAMI

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With an eye on ensuring the safety of medical devices that are too delicate for sterilization by steaming, the Association for the Advancement of Medical Instrumentation (AAMI) has introduced an updated international standard for chemical sterilization.

The standard is primarily intended to help manufacturers of such devices as heart valves containing animal tissue make sure their sterilized products are indeed free of pathogenic microorganisms.

The standard contains a new feature to help manufacturers identify hard-to-kill microorganisms, according to Charles Roberts, the organizer of the AAMI working group that produced the update.

“Manufacturers have to figure out a way to sterilize devices so that no viable microorganisms survive,” said Roberts, director of research and development for Advanced Sterilization Products, a subsidiary of Johnson & Johnson, in prepared remarks.

AAMI said the standard, ANSI/AAMI/ISO 14160:2011, includes a new list of rare and obscure microorganisms. It’s available for purchase on the organization’s website.