The News Room

The Association for the Advancement of Medical Instrumentation (AAMI) is about to adopt and release a new technical information report (TIR) to help manufacturers and healthcare professionals comply with moist heat sterilization requirements.

ISO TR/17665-2:2009, Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ANSI/ AAMI/ISO 17665-1, offers examples and guidance for complying with ANSI/ AAMI/ISO 17665- 1:2006, Sterilization of health care products — Moist Heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.

The new guidance document offers examples and acceptable methods for complying with the standard; and is relevant to both healthcare workers and industrial manufacturers who use steam sterilization, says Donna Swenson, manager of central sterile processing at Resurrection West Suburban Medical Center in Oak Park, IL, and co-chair of the AAMI Industrial Moist Heat Sterilization Working Group, which developed the report.

Among other things, the new TIR focuses on the different requirements in Europe and the United States for certain facets of moist heat sterilization — such as containerized products and saturated steam that uses hot air to sterilize instruments.

“One of the critical issues with steam sterilization is air removal, and the United States and Europe uses different Bowie-Dick tests,” says Charles Hancock, a medical device sterilization consultant and member of the working group. A Bowie-Dick test is used to detect air leaks. “The European approach is a steam penetration test, while the American approach is an air removal test,” Hancock says.

“The TIR explains how the two different approaches can yield different performance cycles,” he adds. The TIR also has information on process variables, which are used to determine the exposure time and steam temperature for certain products, Swenson says. “The report provides helpful information on what type of tests you should be doing,” she says.