ANSI/AAMI publishes long-waited ST91 updates

Editor's Note

After 7 years, ANSI/AAMI has updated its standard for cleaning and storing medical devices, such as flexible bronchoscopes and various endoscopes.

The updated standard, “ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities,” addresses new technologies and concerns about device cleanliness and patient safety.

“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.” 

The revised standard no longer recommends that staff disinfect endoscopes manually in any setting—hospital, outpatient, or physician office. It also reflects and expands on recommendations issued by the FDA this year to help prevent infections caused by or related to reprocessed urological endoscopes. (See OR Manager January 2021, and OR Manager March 2022.)