May 2015

Endoscope Reprocessing Standard Makes Its Debut

In recognition of the need for additional guidance on the reprocessing of flexible and semi-rigid endoscopes, AAMI has unveiled a document that compiles information from  various sources into a single resource.

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.

ST91“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 AAMI Endoscope Reprocessing Working Group, which worked on the document. 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.

“ST91 compiles all the information practitioners need for processing flexible and semi-rigid endoscopes,” Chobin said.

This standard gives guidance on precleaning, leak-testing, cleaning, packaging, storage, high-level disinfecting, and sterilizing of flexible endoscopes used in a range of procedures.

“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.

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

FDA Action

The standard’s release comes at a time of growing regulatory and media interest in matters of medical equipment sterility. For example, in March, the U.S. Food and Drug Administration (FDA) finalized guidance that includes recommendations for writing clear reprocessing instructions for reusable medical devices, including endoscopes.

“The document provides the basis for the development and validation of instructions for reprocessing of medical devices in healthcare settings, in many ways harmonizing with existing standards and recommendations—such as AAMI/ANSI ST81 and ISO 17664, which is also undergoing a significant revision,” said Gerry McDonnell, vice president of STERIS Corporation.

Cynthia Spry, an independent consultant, said she thought the document will improve patient safety. “I believe this document, when used as a guide by device manufacturers for validation and labeling, will be greatly appreciated by personnel who have long struggled with inadequate processing instructions,” she said.