Issue: March 2015
February 20, 2015
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UCLA reports CRE exposure related to endoscopic procedure

Issue: March 2015
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The University of California, Los Angeles Health System has reported that some patients may have been exposed to carbapenem-resistant Enterobacteriaceae during a procedure last fall.

On Feb. 18, the UCLA Health System notified 179 patients that they were potentially exposed to CRE during endoscopic procedures at the Ronald Reagan UCLA Medical Center from Oct. 3, 2014, to Jan. 28, 2015. Seven patients have confirmed infections. The infections contributed to the deaths of two patients, according to a UCLA statement.

The health system reported following national guidelines and sterilization standards stipulated by Olympus Medical Systems Group, the manufacturer of the instruments. An internal investigation in late January found that CRE may have been transmitted by two of the seven Olympus scopes used during the 4-month period. The hospital has notified all the patients who were examined with one of the seven scopes during the time frame.

The infected scopes were removed and returned to Olympus. There have been other CRE exposures related to the same type of scope at other U.S. hospitals. The hospital notified the Los Angeles County Department of Health and the California Department of Public Health when the outbreak was detected.

The UCLA infection prevention staff identified the small group of infections that appeared to happen after endoscopic retrograde cholangiopancreatography. In conjunction with the Los Angeles County Department of Health, the staff determined that routine cleaning of the scopes, recommended by the manufacturer, does not completely eradicate CRE as it does other pathogens. The scopes will require additional cleaning techniques or a significant redesign. UCLA has begun outsourcing gas sterilization of the scopes after use, and cultures will be performed on the scopes.

In response to the outbreak, Rep. Ted W. Lieu, D-Calif., requested a Congressional hearing and investigation. In his letter, Lieu said the FDA was aware that the current guidelines for scope cleaning were inadequate, as reported by the Los Angeles Times.

“According to the Times investigation, the FDA knew about the design and sterilization problems of duodenoscopes for over 2 years,” Lieu said. “Manufacturers of the device apparently knew about the design challenges as well.”

Lieu also noted a 2013 CDC report, titled “Antibiotic resistant threats in the United States,” which identified CRE as an “urgent threat.” Between 2013 and 2014, the FDA received reports of contaminated scopes that affected 135 patients, he said. The congressman said that duodenoscope-related outbreaks have affected other states as well, including Pennsylvania, Illinois and Washington.

In a joint statement, the Association for Professionals in Infection Control and Epidemiology and the Society for Healthcare Epidemiology of America expressed concern over the recent reports of CRE infections at UCLA, and detailed the process for cleaning duodenoscopes, which are more complex than other endoscopic instruments. “Infection preventionists and health care epidemiologists are experts in tracking down the sources of infection and limiting their spread in health care facilities and can play a significant role in the endoscopy department’s quality improvement program as it relates to scope processing,” the statement said. “After observing the cleaning and disinfecting processes and asking questions so that each step of the process is understood, the [infection preventionist] or [health care epidemiologist] may visit the department regularly to observe scope cleaning practices and reinforce the importance of the work being done.”

APIC and SHEA also said these personnel will confirm that proper lighting and magnification are provided in cleaning areas and that staff are not distracted with interruptions or demands for rapid turnaround of scopes.