WASHINGTON – The number of patients harmed by contaminated medical scopes in recent years far exceeds previous estimates from federal regulators, according to findings in a Senate health committee report published Wednesday.
During a three-year stretch from 2012 to 2015, specialized devices known as duodenoscopes were linked to more than two dozen outbreaks of antibiotic-resistant infections that sickened at least 250 patients in the United States and Europe, the inquiry found. It also details a woefully inadequate warning system, in which manufacturers failed to inform health officials to potential problems linked to their devices, hospitals failed to alert federal regulators about outbreaks and the Food and Drug Administration was slow to identify the problem and alert the public.
“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.
Since 2012, other outbreaks have occurred at Advocate Lutheran General Hospital near Chicago, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill and 11 died.