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March 11, 2022
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GI societies reject 2021 revisions to endoscope processing

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Gastrointestinal societies voted not to support the Association for the Advancement of Medical Instrumentation’s 2021 revisions to the standards of endoscope processing in health care facilities, according to a published joint statement.

The revisions to ST91 made by the AAMI and the American National Standards Institute include updated guidelines for cleaning, packaging, storing, disinfecting and sterilizing flexible and semi-rigid GI endoscopes.

“Our societies appreciated the opportunity to provide our perspectives as clinicians and end-users to the revision of ST91,” ASGE President-Elect Bret T. Petersen, MD, MASGE, of the Mayo Clinic, told Healio. “The GI community, including both clinical teams and industry, has made significant strides in addressing concerns about the risk of acquiring infections from endoscopic procedures.

“To ensure uninterrupted patient access to high-quality, affordable, life-saving GI endoscopic care, we must maintain focus on training, oversight and enhancement of cleaning practices and technologies while pursuing alternative endoscopes and novel reprocessing technologies. Reliable uniform cleaning of instruments is our top priority, as insufficient cleaning prevents disinfection or sterilization.”

According to the joint statement, the AASLD, ACG, AGA, ASGE, American Society of Colon and Rectal Surgeons, Society of American Gastrointestinal and Endoscopic Surgeons and Society of Gastroenterology Nurses and Associates had endorsed evidence-based guidelines for reprocessing of flexible GI endoscopes. However, the process of revising ST91 varied significantly from standard guidelines and did not meet the expectations of the GI societies.

The societies expressed concern about the inability of health care teams to implement the ST91 standard at practice level because of the length, construction, internal redundancies, disparate definitions and conflicting recommendations.

The GI societies detailed the following issues with revisions to ST91:

The opening editorial contains statements that lack data to support often inflammatory claims.

There was lack of transparency in the development process.

The guidelines are inappropriate and impractical.

There are statements in the revisions that are not supported by evidence.

There are notable disparities in the standard’s normative and formative sections.