Sterilization Professionals Address Field’s Top Challenges during Standards Week


Posted October 18, 2017


Hear directly from Sterilization Standards Week attendees.

Efforts are underway to tackle patient safety issues related to endoscope reprocessing, the cleaning of reusable medical devices, and much more during AAMI Sterilization Standards Week in Baltimore, MD. This four-day standards meeting, which is taking place Oct. 16–19, is a heads-down, detail-oriented affair that has brought together 15 far-flung working groups whose more than 300 members are stationed all over the world.

“Some of the groups are working only on American national standards and AAMI technical information reports. Others function as US mirror groups to provide input to the development of international standards and guidance documents pertaining to sterilization.” said Amanda Benedict, director of standards at AAMI.

ST/WG84, for example, is hard at work on a revision of ANSI/AAMI ST91, Flexible and semi-rigid endoscope processing in health care facilities, with a new draft anticipated by March 2018. Another working group, ST/WG 15, is reviewing comments on the fourth draft of a revision of ANSI/AAMI ST67, Sterilization of health care products―Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ‘sterile’. Other groups, such as ST/WG 11 and ST/WG 16, are working on new projects that are underway at an international level and will be providing US input for the development of those standards.

Getting all these groups together in person is a big task, but it’s worth the effort, according to participants. The in-person meeting encourages diversity of opinion in ways that are difficult to replicate in an online setting, said Donna Swenson, president of Sterile Processing Quality Services, Inc. in Stickley, IL. That’s because when these groups meet in person it’s easier to see when members have something on their minds that they want to talk about.

“Standards week is where we can get people from multiple disciplines, companies, healthcare facilities, and organizations together at the same time, which really gives us the opportunity to collaboratively look at what the standards for medical devices and sterilization should be,” said Swenson, who serves on several AAMI sterilization standards committees. “When you get everyone together, you come up with better and stronger standards that are more realistic, so we can expect that they’ll be adhered to. We get everyone’s viewpoints.”

In addition to the work on current standards, those in attendance are also looking at future trends and sterility issues, as well as new regulations and how stakeholders are complying with them.

“It’s a busy week! We’re looking at revisions to existing documents, the formation of new groups to address the sterilizers themselves, as well as a new standard for vaporized hydrogen peroxide sterilization,” said Gerry O’Dell, a sterilization and microbiology consultant from Wesley Chapel, FL. “My hope for this week is to participate, make sure that the comments I submit are addressed, and hopefully by the end of the week everything is clear and we have a direction moving forward both for international standards and for what we’re developing here in the United States.”

For more information about AAMI’s sterilization standards committees or to learn how to participate in standards development, please visit www.aami.org/standards.