Guidelines ineffective for reprocessing of endoscopes, researchers say




Reprocessing guidelines currently in place for clinical gastrointestinal endoscopes need to be reevaluated and updated as soon as possible, according to a new study published in the American Journal of Infection Control (doi: 10.1016/j.ajic.2015.03.003).

Procedures that follow current guidelines do not include fully decontaminating the colonoscopes and gastroscopes after they’re used for procedures, leaving behind microbe levels that are well above the accepted benchmark standards.

“Previous studies show that cleaning endoscope channels is laborious and time consuming, and technicians often skip steps,” wrote the study’s authors – led by Cori L. Ofstead, MSPH, of Ofstead & Associates, St. Paul, Minn. “This is concerning, given that the procedure-related risk of endoscopy may be higher than previously thought [and] without objective verification, clinicians can unknowingly use contaminated endoscopes for procedures.”

The study, conducted at the Mayo Clinic in Rochester, Minn., examined the use of 15 endoscopes involved in 60 separate procedures over the period of Nov. 4-8, 2013, to determine how each endoscope was treated after an operation and whether these cleaning procedures followed guidelines and effectively decontaminated the devices.

“Endoscope testing was performed in a dedicated room adjacent to the procedure room, which allowed for rapid sampling and testing [and] barrier separation [minimized] potential for environmental cross-contamination.” the authors explained.

They maintained aseptic environmental conditions while gathering data, using disinfectant wipes on surfaces, using disposable absorbent pads, and restricting room access. The researchers wore gloves, impervious gowns, face masks with splash protection, hair nets, and shoe covers; the gloves were changed between each sample collection, and gowns were changed between endoscope collections.

Microbial cultures and rapid indicator tests were conducted for ATP, protein, hemoglobin, and carbohydrate residue. Viable microbe samples were collected from 92% of bedside-cleaned endoscopes, 46% of manually cleaned endoscopes, 64% of “high-level disinfected” endoscopes, and 9% of stored endoscopes. Results from rapid indicator tests showed that some form of contamination was present on 100% of bedside-cleaned endoscopes, 92% of manually cleaned endoscopes, 73% of high-level disinfected endoscopes, and 82% of stored endoscopes which had viable microbes.

“Current guidelines rely on visual inspection to verify cleaning [but] visible contamination was never present, potentially because blood and feces may be difficult to discern from endoscopes’ black exteriors, and microscopic organisms cannot be seen by the naked eye,” the researchers wrote.

Consequently, Ms. Ofstead and colleagues called for a reexamination of current guidelines to move away from the eyeball test, saying that the results found here should pave the way for future studies to devise methods of more effectively cleaning and disinfecting endoscopes in a shorter amount of time.

“In the meantime, methods to ensure effectiveness of reprocessing practices are needed, including the potential use of routine monitoring with rapid indicators and microbiologic cultures,” they suggested.

Ms. Ofstead is president and CEO of Ofstead & Associates, which has received research funding and speaking honoraria related to endoscopic procedures from 3M, Advanced Sterilization Products, Medivators, Invendo Medical, Boston Scientific, and Steris. Three coauthors are employed by Ofstead & Associates, but have no other disclosures to report. The remaining coauthors had no disclosures to report. Funding was provided by 3M, Mayo Clinic, and Ofstead & Associates.

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