According to a recently published report from a Senate health committee, the number of patients harmed by contaminated medical scopes in recent years is much higher than previous estimates had shown. From 2012 to 2015, specialized devices called duodenoscopes have been linked to more than two dozen outbreaks of dangerous bacterial infections that sickened over 250 patients across the United States and Europe.
According to the probe, the manufactures of these devices largely failed to inform health officials about the potential dangers associated with their usage. Additionally, hospitals never alerted regulators about the outbreaks, while the Food and Drug Administration was slow to identify the problem and inform the public.
Senator Patty Murray of Washington said, “Patients should be able to trust that the devices they need for treatment are safe and effective. 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.”
In the United States, duodenoscopes are used in hundreds of thousands of procedures every year. The devices are typically used to drain blocked fluids from patients. They are inserted through the mouth and they travel down the throat and stomach to the top of the small intestine. The devices include a movable “elevator” mechanism that allows the medical instrument to maneuver into small ducts and fix fluid-drainage issues.
However, this intricate design makes the device difficult to sterilize between uses. While doctors consider them to be an important medical device, they have also been associated with the increase of antibiotic-resistant “superbug” bacteria that is extremely difficult to treat.
Last year, the FDA issued a warning to doctors and hospitals stating that duodenoscopes are difficult to sanitize and that they might encourage the spread of deadly bacteria. The agency also sent warnings to the primary manufacturers of the medical devices.
The Senate report has blamed the device manufacturers, hospitals and the FDA for being responsible for the widespread superbug bacterial infections. According to the report, the FDA should have issued its warnings more quickly. So far, no major actions have been taken to replace or improve the duodenoscopes that are currently used in most hospitals.
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