From the May 2022 issue of HealthCare Business News magazine
By Mary Ann Drosnock
On March 3, 2022, the new ANSI/AAMI Standard, ST91, was published. Although it was released in 2022, the official date is 2021, since that is when it was approved by the working group and the sterilization standards board. ST91 (2021) is officially entitled “Flexible and semi-rigid endoscope processing in health care facilities”, and is applicable to the processing of all types of flexible endoscopes in all healthcare settings. ST91 (2021) is a replacement for the original from 2015, not an amendment, as we saw with the updating of ST79 for steam sterilization practices. So, it will be necessary to order the new document.
As an overview, the improved guidance document ST91 addresses both concerns about the risk of infection and patient safety, as well as new technologies. The new ST91 focuses on instituting additional quality measures to improve patient safety related to endoscope processing. There are an innumerable number of changes in both recommendations and requirements found within the document. Many topics that were recommendations in the previous version have moved to requirements of the standards, and many new recommendations are made.
Within ST91 there are many critical areas of focus, including an emphasis on training, competency, and certification, as well as considerations for the design of the processing area, environmental, HVAC, and water quality monitoring that have been updated. Critically evaluate these new recommendations and identify areas of noncompliance in your facility. To create your cross-functional team, involve leadership, facilities, environmental cleaning, infection prevention, biomedical engineering, and other departments in your evaluation.
Additional important updates include the renaming of precleaning to Point of Use Treatment. This is now standardized to the terminology found in ST79. There is also now a recommendation to note the time when the point of use treatment is performed and convey that information to the processing staff so that they know whether or not to follow the delayed reprocessing procedure. We call this step “hand-off communication”. Follow the delayed reprocessing procedure if more than 60 minutes have elapsed before manual cleaning is initiated.
The process for Leak testing has been changed to 60 seconds of observation instead of 30 seconds to allow for a thorough evaluation of the endoscope for leaks. Also, there is now a recommendation to test the leak test units for pressure output every day the unit is used. Another important update is the new designation of “high-risk” endoscopes. The standard contains different guidance for processing high-risk versus non-high-risk endoscopes. Examples of high-risk endoscopes are duodenoscopes, bronchoscopes, ultrasound endoscopes, and ureteroscopes among others.
