In March, the Association for the Advancement of Medical Instrumentation (AAMI) updated ANSI/AAMI ST91:2021, its standard for the cleaning and storing of flexible endoscopes. The new guidance document — which addresses new technologies used for the care of endoscopes, concerns about the cleanliness of the instruments and how proper care impacts patient safety — is based on insights and consensus of industry leaders, clinicians, sterilization professionals and FDA representatives. The authors of the document, which expands upon new recommendations for endoscope reprocessing released by the FDA in April based on concerns over the proper reprocessing of urologic endoscopes, wanted to make sure everyone’s voice was heard and that all comments were discussed and resolved. Ultimately, the guidance is about improving patient safety with data-driven initiatives.
Garland-Rhea Grisby, CFER, CSPDT, an endoscope service manager at Kaiser Permanente in Northern California and co-chair of AAMI’s Endoscope Reprocessing Working Group, which revised the guidance document, says the updated standards, requirements and recommendations are based on peer-reviewed research and account for scientific discovery, patient safety data and manufacturers’ instructions for use.