CRE outbreak at Cedars-Sinai linked to duodenoscopes

Cedars-Sinai Medical Center reported that four patients were infected with carbapenem-resistant Enterobacteriaceae, and 71 patients may have been exposed to the bacteria from duodenoscopes that were used during endoscopic procedures, according to a hospital press release.

Officials linked the same duodenoscope to all four patients who were infected after they underwent endoscopic retrograde cholangiopancreatography (ERCP) between August 2014 and January. One of the patients died due to an unrelated disease, according to the release.

Cedars-Sinai said the infection occurred despite following the recommended cleaning protocols provided by the manufacturer (Olympus Corporation) and the FDA. The medical center will send letters to all 71 patients who had an ERCP between August 2014 and February and offer them a free home-testing kit for CRE. Results would be sent to Cedars-Sinai for examination.

According to the release, there currently is no evidence that any other patients were infected.

Since initial reports of CRE exposure associated with duodenoscopes were publicized on Feb. 19, Cedars-Sinai used additional techniques to prevent an outbreak by conducting microscopic laboratory analyses, including cultures, of the scopes before and after they were used. These techniques were used in addition to following the manufacturer’s cleaning recommendations.

Infection-control specialists continue to monitor patients and the medical center recently resumed performing nonemergency duodenoscope procedures. The specialists are exploring other methods to ensure patient protection and also have been in contact with local, state and federal agencies, including the California Department of Public Health and the CDC.

In response to the CRE outbreak at the University of California, Los Angeles Health System where seven patients were infected after endoscopic procedures, including two patients who died, the FDA told Infectious Disease News that Olympus, the scopes’ manufacture, modified the FDA-approved scopes but did not pursue 510(k) clearance for the modifications.

“In March 2014, the FDA informed Olympus that a 510(k) must be submitted, which the company did in October,” the FDA said. “That submission is pending because the FDA requested more data from the company.”

The FDA also said it is important to know that it received reports of infections linked with scopes that were manufactured by two other companies. There are no alternative devices that can be used for ERCP.

“While we are working to determine what more can be done to reduce the incidence even further, the risk of transmission of multidrug-resistant bacteria must be weighed against the consequences of not seeking necessary treatment,” the agency said. “The FDA believes at this time that the continued availability of these devices is in the best interest of the public health.”

For more information:

The FDA updated a safety communication for health care professionals explaining the difficulties with cleaning duodenoscopes on March 4: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm.