Duodenoscopes Linked to More Superbug Infections, FDA Updates Safety CommunicationMar 6, 2015
Duodenoscopes have been linked to more cases of drug-resistant bacterial infections. The New York Times reports that four patients at Cedars-Sinai Medical Center in Los Angeles have been infected with carbapenem-resistant Enterobacteriaceae (CRE) through the hard-to-clean devices. The hospital said the patients were infected after undergoing procedures between August and January. NYT reports that one of the patients later died, but due to an unrelated illness. Letters were mailed to dozens of other patients who had procedures with duodenoscopes "out of an abundance of caution." hospital officials said.
Duodenoscopes are long flexible tubes inserted down the throat to view the digestive tract. These devices were recently implicated in an outbreak of CRE infections at Ronald Reagan UCLA Medical Center. There, seven patients were infected and two died.
The U.S. Food and Drug Administration (FDA) initially issued a Safety Communication on February 19 warning that the complex design of duodenoscopes are difficult to clean. The FDA acknowledged that meticulous cleaning could reduce the risk of infection, but may not eliminate it altogether. On March 4, the agency issued updated information for healthcare providers using duodenoscopes. The notification addressed the fact that some healthcare providers were questioning procedures with the device considering the newly discovered fact that it has not been approved by the FDA. The agency stated that a 510(k) application is pending for the device. In the meantime, the scopes remains on the market.
Duodenoscope-linked infections have occurred with all three manufacturers, the FDA said. The notice reads "FDA is not taking action against Olympus regarding its device during our review of the application, because, based on the information currently available to the Agency, we believe that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year".
The FDA issued several recommendations for healthcare providers, including to thoroughly clean and disinfect the scope according to manufacturers' instructions and having a comprehensive program in place for the scopes to be reprocessed, or sterilized. Any device suspected to be linked to an infection should be removed, cleaned and disinfected vigorously until it is free of pathogens. Healthcare professionals should also inform patients about what to expect after the procedure and tell them to be aware of certain symptoms, such as fever, chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting or black and tarry stools.