By Leslie Small
The recent carbapenem-resistant Enterobacteriaceae (CRE) outbreak burst onto the scene when reports surfaced in February that it caused two patient deaths at UCLA's Ronald Reagan Medical Center. In addition to the California outbreak--which also sickened patients at Cedars-Sinai Medical Center in Los Angeles--cases of the superbug linked to duodenoscopes also cropped up at hospitals in North Carolina, Pittsburgh, Chicago and Seattle.
The Centers for Disease Control and Prevention (CDC) has cautioned hospitals that they must do more to mitigate the threat of CRE, which it dubbed "nightmare bacteria" due to their resistance to even last-resort antibiotics. When it reaches the bloodstream, CRE can kill up to half of all patients it infects.
The Food and Drug Administration (FDA) issued a warning in February that the complex design of duodenoscopes makes them difficult to sterilize even when hospitals follow the device manufacturers' instructions. However, the FDA has refused to take the devices off the market because they are used for the potentially life-saving procedure known as endoscopic retrograde cholangiopancreatography (ERCP), a technique that diagnoses and treats cancers and other digestive diseases. The agency estimates that 500,000 ERCPs are performed each year. A special advisory panel recently endorsed this decision, though it urged the FDA to better protect patients from the infection risk posed by duodenoscopes, FierceHealthcare has reported.
The panel was also critical of major duodenoscope manufacturer Olympus, which declined to participate in the advisory panel's forum but says it has supplied the FDA with data to prove that its updated cleaning instructions and new cleaning brush allow for safe reprocessing.
Indeed, news surfaced recently that the company was aware of the infection risk associated with the devices in 2013, which it communicated to European hospitals two years before the UCLA outbreak. The situation has led California lawmaker, Rep. Ted Lieu (D-Los Angeles) to call for congressional hearings into the matter. Meanwhile, Olympus faces two patient-driven lawsuits, and Virginia Mason Hospital in Seattle also has pursued legal action against the manufacturer.
The outbreaks have left many hospitals wondering what to do to make sure patients are safe and still have access to important medical devices. For its part, the FDA panel did not outright endorse any specific sterilization method.
Jackie Caynon, pictured right, a lawyer with more than 18 years of health law experience, and partner and co-chair of Mirick O'Connell's Health Law Group, told FierceHealthcare in an exclusive interview that the answer has to come from each hospital's unique risk management assessment.
"I've heard some hospitals say, you know these things are really life-saving, so if we get rid of the product we won't be able to, obviously, save lives," he said. But for others, he said, the risk may be too great.
"To me it just seems too risky to use it," Caynon said. "If you're going to do informed consent, I could see you saying to the patient 'oh you know, this could save your life, but we won't know until we actually go in there and look, but you run the risk of having a CRE infection because we cannot guarantee that we can properly clean this device.'"
And now that the infection risk surrounding the devices has been made public, "I think you're going to have a lot of patients that are going to say 'I don't want you to use that device, period,'" he said.
Regardless of what each individual facility decides to do about the scopes, it would be a mistake to hold hospitals responsible for manufacturers' mistakes or regulatory failures, according to Caynon.
"Holding hospitals and physicians liable here is kind of going after the wrong folks," he said, because "the hospital is just as much of a customer as patients (are)."