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ST91 - Extensive updates for endoscope cleaning, patient safety - AAMI

Press releases may be edited for formatting or style | March 03, 2022 Endoscopy Risk Management
After seven years, the standard for cleaning and storing a long list of medical devices, such as flexible bronchoscopes and various endoscopes, has been updated to reflect the consensus of industry, clinicians, and sterilization professionals from around the world. The improved guidance document, ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities, addresses new technologies as well as concerns about medical device cleanliness and patient safety.

“We really beefed it up,” said Mary Ann Drosnock, director of Clinical Affairs at Healthmark Industries and a member of AAMI’s Endoscope Reprocessing Working Group (ST-WG 84) since its inception.

“We wanted to make sure that everybody's voices were heard and that all comments were discussed and resolved properly,” she added. “There was no question afterwards. This guidance is about patient safety and we have the data baked in to support it.”

Drosnock was joined by Garland-Rhea Grisby, an endoscope service manager for Kaiser Permanente in Northern California, in co-chairing ST-WG 84 and leading the ST91 revision effort. According to the co-chairs, this updated standard is the fruit of the combined work of medical device manufacturers, sterilization professionals, academics, physicians, nurses, hospital accreditation organizations, and the US FDA and other government agencies.

Grisby added that oftentimes, it is the sterilization professionals who are pushing for more stringent regulations and requirements in the interest of safety, even if it means more work within their department.

“When they want to introduce change in their facility that can improve safety, they might get pushback from leadership because there are few guidelines out there that say what they should do or how to do it,” he explained. “That’s why they need this document to back up and outline what needs to be done.”

ANSI/AAMI ST91:2021 includes:

Classification for high-risk scopes, such as bronchoscopes and ureteroscopes
Updated guidance for drying of scopes, as well as proper storage and handling
Recommendations against manual disinfection
Guidance for testing water in automated endoscope re-processors (AERs) to avoid the final-rinse water re-contaminating the scopes
Guidance for determining the length of storage, or “hang time,” that a scope can withstand before needing to be reprocessed
ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities

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