UPDATE 1-Reprocessed endoscopes often contaminated

Reuters Health Information: UPDATE 1-Reprocessed endoscopes often contaminated

UPDATE 1-Reprocessed endoscopes often contaminated

Last Updated: 2018-04-18

(Updates with FDA warning on endoscope connectors)

By Lorraine L. Janeczko

NEW YORK (Reuters Health) - Many patients may be undergoing endoscopy with contaminated instruments, a pair of new studies suggest.

Current guidelines from the U.S. Centers for Disease Control and Prevention and others allow the reuse of flexible endoscopes after cleaning and high-level disinfection (HLD). But the instruments often remain contaminated and may infect the next patient, researchers say.

Cori L. Ofstead, who led one of the studies, said it "shows that current reprocessing methods weren't effective, and endoscopes retained fluid and harbored contamination, including pathogens."

"This study identified problems with reprocessing effectiveness for all types of flexible endoscope, not just the complex gastrointestinal endoscopes with elevators. We believe the risk for patients may be highest for bronchoscopes and urology scopes," said Ofstead, president and CEO of the independent research organization Ofstead & Associates in Saint Paul, Minnesota.

"We were surprised to find that two hospitals accredited by The Joint Commission were skipping so many steps or doing them poorly, but we were even more surprised to find that reprocessing failed about half the time, even in a hospital that had very good practices," she told Reuters Health by email.

As reported in the American Journal of Infection Control, online March 30, Ofstead and her colleagues evaluated the endoscope reprocessing, drying and storage practices of three multispecialty hospitals.

All sites used automated endoscope reprocessors (AERs) with peracetic acid HLD. At each hospital, the researchers sampled fully reprocessed endoscopes that had been stored for over 24 hours. The authors performed adenosine triphosphate (ATP) tests on effluent, biopsy ports, control handles and distal ends. They sampled ports and distal ends with sterile swabs moistened with sterile deionized water and placed the channel effluent and swabs in Dey-Engley neutralizing broth transport media.

The samples were sent for analysis at microbiology laboratories that were registered with the U.S. Food and Drug Administration and certified by the International Organization for Standardization.

The authors found high ATP levels in 22% of the endoscopes and microbial growth in 71% of the endoscopes. Organisms they detected included Stenotrophomonas maltophilia, Citrobacter freundii and Lecanicillium lecanii/Verticillium dahliae.

The research team also visually examined and photographed retained fluid and other irregularities with a camera and borescopes designed to examine channels and ports, and they used a sterile swab and chemical indicator to test for water.

They found fluid in 22 (49%) of 45 endoscopes they examined, and the prevalence of moisture varied significantly by site (from 5% to 85%). None of the drying methods eliminated all residual fluid or waterborne pathogens. Residual fluid was associated with significantly higher levels of ATP and microbial growth.

Reprocessing and drying practices conformed to guidelines at one site and were substandard at the other two; damaged endoscopes were in use at all sites.

The authors acknowledge the possibility of selection bias as well as the inability to quantify the amount of fluid and contamination levels.

Mariah Quick, an epidemiologist and research projects manager at Ofstead & Associates, told Reuters Health by email, "It's critically important to ensure that endoscopes are completely dry before storage. Our statistical analysis found very high concordance between a moisture indicator strip and visual inspections done by time-consuming 'scoping the scope.' This means that reprocessing centers can implement an inexpensive, practical protocol for testing reprocessed endoscopes to ensure that no residual fluid remains inside them."

As recommended by guidelines, "an expert should do periodic audits to confirm proper reprocessing practices. Clinicians should ask to see their reports so they can feel confident that any issues have been resolved," Ofstead urged. "To reduce risk, clinicians should also visually inspect every scope before use to confirm that it's free of damage and debris."

"Ultimately, to reduce patient risk, clinicians should move toward the use of sterilized endoscopes," the authors advise.

In the second study, online April 10 in Gut, Dr. Margaret C. Vos of Erasmus MC University Medical Center in Rotterdam, the Netherlands, and colleagues found at least one patient-ready duodenoscope contaminated with 20 or more CFUs of any organism in 39% of all Dutch centers that perform endoscopic retrograde cholangiopancreatography (ERCP).

Overall, 23 (15%) of the 150 duodenoscopes tested were positive for microorganisms with gastrointestinal or oral origin (MGO), indicating that inadequate disinfection left residual organic material on the scopes from previous patients.

"These results suggest that the present reprocessing and process control procedures are not adequate and safe," the researchers conclude.

On April 18, the FDA sent an alert to health care providers and facilities warning about the risk of cross-contamination with certain endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing.

To date, the FDA has not received acceptable testing to demonstrate the safe use of these so-called "24-hour multi-patient use endoscope connectors" and recommends against their use.

To mitigate the risk of cross-contamination and possible infection between patients, the FDA recommends the use of connectors with features that prevent patient fluids from flowing backwards into the endoscope (backflow prevention features). These connectors may be either single-use connectors that are discarded after each patient, or reusable connectors that are reprocessed according to their instructions for use prior to each patient.

In the advisory, the FDA notes that one manufacturer, Erbe USA Inc, currently markets a 24-hour multi-patient use endoscope connector, called the Erbeflow port connector, which does not include a backflow prevention feature.

SOURCES: https://bit.ly/2J5ASmi https://bit.ly/2J5ASmihttps://bit.ly/2qFUVRN and https://bit.ly/2qFUVRN

Am J Infect Control 2018.

Gut 2018.

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