AAMI Responds to GI Societies’ ST91 Rebuttal

Gastrointestinal Endoscopy Applications

AAMI Responds to GI Societies’ ST91 Rebuttal

“Many on the working group were dismayed that the GI Societies’ statement misrepresented the content of the standard itself numerous times and contained basic factual inaccuracies.”

The Association for the Advancement of Medical Instrumentation (AAMI) published a strongly-written response rebuking a joint statement issued by several GI societies opposing the organization’s updated guidelines for cleaning and disinfecting flexible and semi-rigid endoscopes.

AAMI published ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities in March. The following month, many GI societies released a joint statement saying changes to ST91 create obstacles to implementing standards and “offer impractical, inappropriate, or conflicting guidance.”

AAMI defended the “transparent, open, consensus-based process” used to develop ST91 and the emphasis on patient safety.

“Many on the working group were dismayed that the GI Societies’ statement misrepresented the content of the standard itself numerous times and contained basic factual inaccuracies,” the AAMI statement read. “Even more concerning was that the statement further criticized the overall development process.”

ST91 classifies flexible endoscopes — including duodenoscopes, bronchoscopes, ureteroscopes, cystoscopes, and others — as "high-risk," and recommends their sterilization rather than high-level disinfection to rid the scopes of contaminants that could harm patients.

The GI statement included the American Association for the Study of Liver Diseases (AASLD), American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American Society of Colon and Rectal Surgeons (ASCRS), American Society for Gastrointestinal Endoscopy (ASGE), Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and Society of Gastroenterology Nurses and Associates (SGNA).

The group’s fundamental concern: GI practices will not be able to implement ST91 because of its length, construction, redundancies, disparate definitions, and conflicting recommendations.

The biggest sticking point is the sterilization recommendation, which “could generate significant risk aversion among both practitioners and consumers, thereby reducing both availability and willingness to employ endoscopy for screening, surveillance, and therapy while increasing liability before widespread, cost-effective, alternative endoscopes and novel reprocessing technologies would be available.”

It is critical, the GI societies add, that the national dialogue focus on issues including training, oversight, and enhancement of cleaning practices and technologies.

As an accredited standards development organization, AAMI responded that it adheres to an approach geared to reaching consensus — not unanimity, necessarily, but more than a simple majority, with views and objections considered and efforts made to reach resolution.

“AAMI strongly affirms that ANSI/AAMI ST91:2021 prioritizes patient safety, accurately represents available data and research, and adhered entirely with AAMI’s rigorous, accredited, and consensus-based standards development process,” the response concludes.

Revisions to ST91 were initiated in 2017 and each society engaged in the process. Each society endorses “Multisociety guideline on reprocessing flexible GI endoscopes and accessories,” which was reviewed and approved by ASGE’s governing board in 2020.

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