Over a period of three years from 2012 to 2015, the use of contaminated medical scopes, known as duodenoscopes, have been linked with over two dozen antibiotic-resistant infections, a number that exceeds what was previously thought, according to an article on nationalpost.com.
A Senate health committee report details an inadequate warning system in which manufacturers of the devices failed to inform health officials about problems with the devices, issues where hospitals did not alert federal regulators to the infectious outbreaks, and found the US Food and Drug Administration (FDA) was slow to recognize the problem and alert the public.
In a statement, Senator Patty Murphy, D-Wash., 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.”
During a procedure, duodenoscopes, used in hundreds of thousands of procedures each year, are threaded down the throat, through the stomach and into the top of the small intestine. The devices have a movable “elevator” system on the end that increases the maneuverability of the probe, and enables it to repair fluid-drainage problems. Unfortunately, that same feature prevents the devices from being completely sterilized after use.
In the past few years, the devices have been linked to antibiotic-resistant “superbug” infections, but doctors still consider them to be an important tool for detecting and repairing medical problems.
The FDA released a statement saying it will “carefully consider” the recommendations from the report, adding, “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 continued, “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.”
An outbreak at Ronald Reagan UCLA Medical Center in Los Angeles last year led to a large number of patients potentially being exposed to dangerous bacteria, and at least two people lost their lives.