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 recent Senate health committee report.
During a three-year stretch from 2012 to 2015, specialized devices known as duodenocopes 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,
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.
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 the recent 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 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 recommendation's from the report, and that mitigating the risk of deadly infections associated with duodenoscopes is a "top priority" for the agency.