Medical scope risks extensive, report says
Written by: Brady Dennis
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 duodenocopes were linked to more than two dozen outbreaks of antibiotic-resistant infections that made at least 250 patients sick in the United States and Europe, the inquiry found.
It also details an 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,’’ said Senator Patty Murray, Democrat of Washington, whose staff began investigating the issue a year ago. ‘‘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 device 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.
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.
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.
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 FDAfailed 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 it will ‘‘carefully consider’’ the recommendations and make mitigating risks a priority.
Dennis, Brady; “Medical scope risks extensive, report says”; Washington Post; 14 Jan 2016
Boston Globe; 14 Jan 201