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FDA Aware that Duodenoscopes Can Spread Fatal 'Superbug' But Did Not Enforce Fix

Feb 24, 2015

The U.S. Food and Drug Administration (FDA) has been aware that duodenoscopes can spread life-threatening infections since at least 2009 but did not implement any new safety requirements, Reuters reports. Duodenoscopes are devices that are inserted down the throat to diagnose or treat gastrointestinal tract disorders. In the United States alone, they are used in roughly 500,000 procedures each year. Duodenoscopes are at the center of a "superbug" outbreak at UCLA.

UCLA's Ronald Reagan Medical Center in Los Angeles said that 179 patients may have been exposed to an antibiotic-resistant bacteria called CRE; the infection may have contributed to two deaths. Reuters reports that there are three main manufacturers of duodenoscopes, Olympus Corp, Pentax and Fujifilm Holdings Corp. These companies are all medical units of Japanese companies. The Olympus model was used at UCLA.

Prior to the UCLA outbreak, duodenoscopes had been linked to the transmission of lethal infections. The FDA issued its first notice about pathogens spread by duodenoscopes in 2009, after 16 patients in France were infected. In 2013, physicians led by Dr. John Greene, an infectious disease specialist at Moffitt Cancer Center in Tampa said that patients in two Tampa hospitals were infected by an antibiotic-resistant pathogen. Another outbreak occurred that year in Chicago, where 44 patients at Advocate Lutheran General Hospital were infected with CRE. Duodenoscopes were also linked to infections at the University of Pittsburgh Medical Center in 2012. Virginia Mason Medical Center in Seattle said in January that duodenoscopes infected 32 people over the course of two years; 11 of these patients died.

According to Reuters, hospitals that implemented a more rigorous cleaning process did not have any more cases of scope-related infections. Considering this, Dr. Greene said "I would be in favor of the FDA putting out more stringent rules,"

The FDA has issued a "safety communication" on the issue but did not implement new rules. The notification said that the design of the devices can inhibit effective sterilization. The agency said for the first time that multidrug-resistant bacterial infections can be spread even when manufacturers' instructions were followed as directed. The agency said that it received a total of 75 reports involving 135 patients in 2013 and 2014. However, the agency said that this number is likely an underestimation because healthcare providers do not always submit reports for these events.

Reuters reports that according to experts in academia and government, there are three options to prevent duodenoscope-linked infections. One option is for manufacturers to redesign the scopes. Experts agree that the movable "elevator" mechanism at the tip of the device would be the biggest obstacle to overcome. The other two options are to sterilize with ethylene oxide gas after each use or swab the scopes after each procedure and quarantine them until they are sterile.

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