Updated Guideline on Reprocessing GI Endoscopes Issued

Megan Brooks

June 02, 2011

June 2, 2011 — An updated guideline on reprocessing flexible gastrointestinal (GI) endoscopes outlines the best current methods of disinfection and discusses new and evolving technology and disinfection systems. The document contains 39 bullet-point recommendations and summarizes outstanding issues and areas for further study.

The updated guideline was published online June 1 in GIE: Gastrointestinal Endoscopy.

"Despite the strong published data regarding the safety of endoscope reprocessing, concern over the potential for pathogen transmission during endoscopy has raised questions about the best methods for disinfection or sterilization of these devices between patient use," the guideline committee notes.

"Given the ongoing occurrence of endoscopy-associated infections attributed to lapses in infection prevention, an update of the multisociety guideline is warranted."

The 2011 guideline updates a 2003 draft guideline developed by the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Healthcare Epidemiology of America (SHEA) in collaboration with multiple physician and nursing organizations, infection prevention and control organizations, federal and state agencies, and industry leaders.

Reprocessing Principles "Remain Valid"

More than 20 million GI endoscopic procedures are performed each year in the United States. Reports of pathogen transmission remain rare and are tied to the failure to adhere to currently accepted cleaning and disinfection guidelines.

In a statement, Bret T. Petersen, MD, FASGE, chairman of the ASGE Quality Assurance in Endoscopy Committee, noted that endoscopy is a "safe and effective procedure. Despite the large number and variety of GI endoscopic procedures performed, documented instances of infectious complications remain rare, with an estimated frequency of 1 in 1.8 million procedures."

Since 2003, high-level disinfectants, automated reprocessing machines, endoscopes, and endoscopic accessories have all evolved, the guideline authors note. "However, the efficacy of decontamination and high-level disinfection is unchanged and the principles guiding both remain valid."

For instance, the 2011 guidelines state that flexible GI endoscopes should first be completely cleaned and then subjected to at least high-level disinfection, a standard already recommended by several organizations, including the US Food and Drug Administration, Centers for Disease Control and Prevention, ASGE, SHEA, and the American College of Gastroenterology.

Guidance documents that detail the sequence and specifics of each element of appropriate endoscope reprocessing have been developed by these organizations. Importantly, the guideline committee notes, there are no published studies of confirmed transmission of infection when these guidelines have been followed.

Maximal "Hang Time" One of Several Unresolved Issues

Several issues regarding flexible endoscope reprocessing remain unresolved, based on currently available data, and warrant further study to clarify optimal practices, the committee notes.

A key unresolved issue is "hang time or shelf life"; that is, how long a reprocessed endoscope can be stored before it needs reprocessing again before use. This issue has received only limited investigation. For now, reuse within 10 to 14 days appears safe, the guideline states, although there are not sufficient data at present to provide a maximal safe duration.

Until more data become available, the guideline suggests that reprocessing during this 10- to 14-day interval "may be advisable," particularly for instruments used infrequently because of low volumes or specialty applications, those used in patients at high-risk for infections, and those used in procedures with anticipated entry to otherwise sterile regions such as the biliary tree, pancreas, and peritoneal space.

The guideline also notes that in the interest of "utmost caution," the Association of Perioperative Registered Nurses and the Association for Professionals in Infection Control and Epidemiology recommend a maximal storage interval without reprocessing of 5 and 7 days, respectively.

Another unresolved issue is the optimal frequency of replacement of clean water bottles and tubing for insufflation of air and lens wash water, and the optimal frequency of replacement of waste vacuum canisters and suction tubing.

There are no data on the safety or potential risk of exchanging these attachments on a per procedure or per day basis, the guideline notes. The Association of Perioperative Registered Nurses currently supports changing the clean air/water bottle and tubing for each patients. "Both issues warrant study," the guideline committee concludes.

The role of microbiological surveillance testing of endoscopes after reprocessing also remains uncertain. The committee "encourages" further research on the methodology and utility of surveillance cultures or sampling. The durability and longevity of endoscopes is another area requiring further study.

New Technologies

The updated guideline makes note of 2 relatively new technologies now available for high-level disinfection. One is the EvoTech (Advanced Sterilization Products) automated washer and disinfector, which eliminates manual endoscope cleaning. The other is the OER-Pro (Olympus America) endoscope reprocessor.

"These technologies and those still to come warrant further well-designed, peer-reviewed studies by using commercially available machines in clinical settings," the guideline concludes.

The 2011 guideline has been endorsed by the American Society for Gastrointestinal Endoscopy, Society for Healthcare Epidemiology, American College of Gastroenterology, American Gastroenterological Association, American Society of Colon and Rectal Surgeons, Accreditation Association for Ambulatory Health Care, Association of Perioperative Registered Nurses, Association of Professionals in Infection Control and Epidemiology, Joint Commission, Society of American Gastrointestinal and Endoscopic Surgeons, and Society of Gastroenterology Nurses and Associates.

Dr. Petersen was a speaker for Boston Scientific until September 2009; Jonathan Cohen, MD, is a consultant to Boston Scientific and a stockholder in Beacon Endoscopic Inc; Thomas E. Kowalski, MD, is a consultant to Boston Scientific; Walter G. Park, MD, is a consultant to and receives honoraria from Advanced Sterilization Products; Irving M. Pike, MD, is a consultant to Olympus; Joseph Romagnuolo, MD, is a consultant to and speaker for Olympus and receives honoraria from Cook Endoscopy; and William A. Rutala, PhD, MPH, is a consultant to and receives honoraria from Clorox and from 3M.

Gastrointest Endosc. Published online June 1, 2011. Full text

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