AAMI Releases 'Must-Have' Guide for Endoscope Reprocessing


Posted April 29, 2015

A new standard that compiles information on the reprocessing of flexible and semi-rigid endoscopes from a number of sources into a single volume has made its debut.

The standard, titled ANSI/AAMI ST91:2015,Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities, comes at a time of heightened public concern about the cleanliness and decontamination of these devices. Infections caused by carbapenem-resistant Enterobacteriaceae (CRE) have been reported in North Carolina, Pittsburgh, Los Angeles, Chicago, and Seattle. These infections have been linked to a complex type of endoscope.

"The publication of this standard is timely, given the clinical focus on flexible endoscopes as a source of cross-contamination, infection outbreak, and other patient complications such as toxicity," said Gerry McDonnell, vice president of STERIS Corporation.  "It is a natural extension to the recently published standard AAMI/ANSI ST58: Chemical sterilization and high-level disinfection in health care facilities.  ST91 focuses on the same aspects as ST58, but with a particular focus on flexible endoscopes, which have some unique criteria." He added that ST91 builds on guidance from the U.S. Food and Drug Administration (FDA). 

The standard initially started out as a less formal document, known as a technical information report. However, the AAMI Endoscope Reprocessing Group saw there was a need for more formal guidance and determined a standard would be more appropriate.

"Healthcare personnel are constantly facing challenges with the new, sophisticated devices being developed for patient care," said Nancy Chobin, vice president for sterile processing services at Barnabas Health in West Orange, NJ, and co-chair of the working group. The processes of cleaning, sterilizing, and disinfecting flexible endoscopes are particularly challenging because of the numerous lumens and channels found in endoscopes, she added. There was no single document to turn to for guidance, and existing resources sometimes contradicted each other.

"I believe ST91 will be one of those 'must have' documents for hospitals," said Sue Klacik, the International Association of Healthcare Central Service Materiel Management representative on AAMI committees dealing with sterilization standards. She added that those who worked on the document represented a great cross-section of disciplines, including regulators, users, and manufacturers. "It provides a 360-degree view, providing information that readers might not have even thought about," she added.

For example, the standard advises that personal protective equipment (PPE) used during decontamination should not be worn when handling the scope or accessories that have gone through disinfection. "PPE should be removed and hands washed. Clean gloves not manufactured with natural rubber latex or dried natural rubber latex should then be worn when handling the scope and accessories," according to the document.

The release of the document comes ahead of a planned meeting of the FDA's Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. On May 14–15, the panel will hear expert testimony on the reprocessing of duodenoscopes and other endoscopes. It also plans to make recommendations on several topics, including the effectiveness of cleaning, high-level disinfection, and sterilization methods, as well as recommended approaches for ensuring patient safety.

ST91 is available at online for $195 list or $117 with an AAMI member discount. The product code is ST91.