Duodenoscope Superbug Outbreak: What You Need to Know

By ThinkReliability Staff

The bacteria involved in the outbreak are deadly: The recent outbreak in California involves Carbapenem-resistant Enterobacteriaceae (CRE). According to Centers for Disease Control and Prevention (CDC) Director Tom Frieden, “CRE are nightmare bacteria. Our strongest antibiotics don’t work and patients are left with potentially untreatable infections.” About 50% of patients with a CRE bloodstream infection will die. At least 7 people were infected at the UCLA Medical Center from October 2014 to January 2015, two of whom died.

Duodenoscopes are frequently used: Duodenoscopes are thin flexible scopes with a light and miniature camera attached, used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat liver, pancreas and bile-duct problems. The FDA hasn’t recalled the scopes because, according to US Food and Drug Administration (FDA) spokeswoman Leslie Wooldridge, “The FDA feels that the lifesaving nature of ERCP, performed on more than 500,000 patients annually in the U.S., makes it important for these devices to remain available.”

Duodenoscopes have been causing problems with infection for a long time: The President of the American Gastroenterological Association, John Allen, M.D. says that duodenoscopes have been causing superbug infections since 1987. He says, “It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long.” 16 patients developed serious infections after the use of a duodenoscope in France in 2008-2009, as reported in the journal Endoscopy. A 2013 outbreak infected 39 patients in Chicago (after which a duodenscope was destroyed because decontamination efforts were unsuccessful). The FDA received 75 reports involving 135 patients related to duodenoscope contamination from 2013 to 2014. 18 patients in North Carolina have been infected by CRE from duodenoscopes so far this year (2 of those patients have died).

Cleaning duodenoscopes is really difficult: The two duodenoscopes found to have been infected in the California outbreak were “sterilized according to the manufacturer’s specifications”, says the medical center. The FDA issued a warning February 19, 2015, noting that “Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” Effectively, even following the instructions may not fully sterilize the duodenoscope.

The FDA is working on label changes for duodenoscopes: According to Dr. William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, “We are working to expedite modifications to the label. We are also talking about updating the risk information.” The FDA recommends that hospitals “consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.” The FDA has also asked duodenoscope manufacturers to prove that their recommended methods provide adequate disinfection.

Some worry that may not be enough: Says Mary Logan, chief executive of the Association for the Advancement of Medical Instrumentation, “the devices need to be designed better, the instructions need to be more clear, the hospitals need better training, and adequate time needs to be given in hospitals to ensure sterility is top notch.” The CDC is working with duodenoscope manufacturers on a reprocessing (cleaning and sterilizing for reuse) protocol for the instruments. In the meantime, the UCLA Medical Center has turned to gas sterilization and has reported no new infections since the switch. However, the procedure is highly toxic and poses a risk to staff and patients. The FDA says it is “not something that we routinely recommend”.   Hospitals in North Carolina are screening patients for CRE and isolating infected patients, as well as decontaminating their rooms after they’re released. They’ve also enhanced the cleaning and sterilization processes for duodenoscopes.   At least one hospital is quarantining each device for 48 hours to verify by culture that it’s free of CRE and other infections.

It’s all part of a much bigger problem: Some worry that the time and money being spent dealing with the real, though comparatively small, risk of infection from contaminated duodenoscopes takes away from the broader effort of preventing all hospital infections, especially those that are resistant to antibiotics. The CDC has determined that about 1 in 25 patients acquire a hospital-acquired infection during a hospital stay (see our previous blog on this issue). Says David Ropeik, a consultant in risk perception and communication, the concern over this issue is “going to flare up and then it’s going to go away” but “the world will still be at serious peril from a risk we don’t take seriously, which is antibiotic resistance. Germs are figuring out how to resist our antibiotics faster than we can make new ones.”

If you would like to learn more, attend our FREE webinar “Healthcare Case Study – Hospital-Acquired Infections” on Thursday, March 5, 2015 at 11 am EST.  Register here.