Physicians and regulators face a tough dilemma in the wake of the recent disclosure that dozens of patients at Virginia Mason Medical Center in Seattle were infected with a deadly bacteria spread by a type of endoscope essential for treating certain conditions but difficult to disinfect because of its design.
Experts say the device can't be taken off the market because it reduces the need for riskier open procedures, but also say it needs to be redesigned.
Thirty-two patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) from November 2012 to January 2014 at Virginia Mason were sickened by Carbapenem-resistant enterobacteriaceae (CRE), a drug-resistant superbug spread from patient to patient by duodenoscopes used in the procedures. Eleven of those patients died, but it's unclear whether the infections caused their deaths because they all had been diagnosed with other conditions.
In recent years, there have been three similar though less severe bacterial outbreaks associated with CRE-contaminated duodenoscopes reported at hospitals in Chicago and Pittsburgh. Experts say disinfection protocols were followed in all three cases, so it's likely that the duodenoscope's design makes it difficult to remove all traces of bacteria.
Experts say this is a national problem, particularly because the CRE bug is difficult to treat. “Clinicians don't have many tools to treat patients with CRE,” said Chris Lavanchy, engineering director for the ECRI Institute, a not-for-profit organization that studies medical products and services.
The infections raise broader questions about who is responsible for preventing and correcting duodenoscope infection problems. Officials at Virginia Mason say the design of the device and less-than-rigorous disinfection standards promulgated by the Food and Drug Administration and the device's manufacturers are at fault. Others say some hospitals are not following the basic cleaning guidelines.