“Patients should be able to trust that the devices they need for treatment are safe and effective," Sen. Patty Murray (D-Wash.), whose staff began investigating the issue a year ago, said in a statement. "Unfortunately, this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented."
Duodenoscopes are used in hundreds of thousands of procedures each year in the United States to drain fluids from pancreatic and bile ducts blocked by cancer tumors, gallstones and other conditions. During a typical procedure, a flexible, lighted tube is threaded down the throat and stomach and into the top of the small intestine. Unlike other endoscopes, duodenoscopes have a movable “elevator” mechanism at one end that allows the instrument to maneuver into ducts and fix fluid-drainage problems. That intricate design can make the devices difficult to sterilize between uses.
Doctors consider duodenoscopes an important tool in detecting and treating medical problems early and in a minimally invasive way. But in recent years, the devices also have been linked to the spread of a growing number of antibiotic-resistant "superbug" infections.
An outbreak involving contaminated scopes last year at Ronald Reagan UCLA Medical Center in Los Angeles left at least two people dead, and officials said scores of other patients potentially were exposed to the dangerous bacteria. At Cedars-Sinai Medical Center, also in Los Angeles, four patients were infected by a superbug after undergoing a duodenoscope procedure. A Connecticut hospital said it had contacted nearly 300 patients who might have been exposed to a dangerous type of drug-resistant E. coli after undergoing duodenoscope procedures.
Such incidents prompted the FDA in February to alert doctors and hospitals that duodenoscopes can be difficult to sanitize between uses and “may facilitate the spread of deadly bacteria.” The agency also sent warning letters to the primary manufacturers of the devices -- Olympus, Pentax and Fujifilm -- saying the companies failed to adequately report problems with the devices and, in some instances, failed to ensure that they could be cleaned properly between uses.
But Wednesday's Senate report documents a deeper history of infections linked to tainted scopes than previously reported. Investigators detailed dozens of outbreaks at hospitals from New York to Florida to Wisconsin, as well as overseas as hospitals in Germany, France and the Netherlands. "These outbreaks infected at least 250 people with life-threatening illnesses, including carbapenem-resistant Enterobacteriaceae (CRE), a dangerous superbug that is resistant to our most potent antibiotics and that kills about half of those it infects," they wrote.
The report spreads blame among device manufacturers, hospitals and the FDA, as well as what investigators say is an insufficient, outdated system of oversight that prevents health officials from spotting potential problems with medical devices in general. Device manufacturers failed to adequately test whether their scopes could be properly cleaned in a real-world setting, and didn't meet requirements to self-report problems quickly to regulators. Many hospitals also were slow to report infections to manufacturers and federal agencies. And the FDA, in part hamstrung by an ineffective surveillance system, failed to spot the deadly infections linked to contaminated scopes quickly or to alert the public. The report calls for a series of legislative and regulatory changes aimed at helping officials more rapidly identify and combat problems with medical devices.
The FDA said in a statement it will “carefully consider” the recommendations from Wednesday’s report, and that mitigating the risk of deadly infections associated with duodenoscopes is a “top priority” for the agency.
“We agree with the senator that a broader approach to understanding how well duodenoscope devices work in real-time use is critical to public health,” the agency wrote. “The FDA has taken several actions to address the issue of duodeoscope-related infections and will continue to work to protect patients, while ensuring access to these important devices for those who may benefit from minimally invasive procedures.”
Mark Miller, a spokesman for Olympus Corp. of the Americas, said the company had cooperated with Senate investigators, providing documents and answering questions. "Although we do not agree with all of the report’s conclusions, we are closely reviewing the recommendations in the report as part of Olympus’ ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes.”
A spokeswoman for Pentax said the company is reviewing Wednesday's report and that it "will continue to work with Congress, FDA and the industry to reduce the risk of infection in flexible endoscopy." A spokeswoman for Fujifilm said patient safety remains the company's top priority, "and we are committed to working together with all stakeholders, including patients, hospitals, regulators and lawmakers, to ensure the long-term sustainable use of duodenoscopes."
This post has been updated.