A government report has found that the maker of most of the country’s medical scopes — the devices snaked down the throat to explore the stomach and intestines — knew they were prone to get dirty with harmful bacteria, but did nothing to warn hospitals for three years.
As a result, 250 patients were infected with a “superbug.” No matter how much they were scrubbed, they could never actually be cleaned thoroughly, The Associated Press reported.
It wasn’t specified if the tools were difficult to clean due to their design, but one of the recommendations that resulted from the investigation is a request for the Federal Drug Administration (FDA) to determine if design changes are needed.
According to The Seattle Times, tests found that the closed channel at the end of the tool is a tenacious holder of bacteria, even despite a meticulous scrubbing. As a result, whenever the dirty scopes were used to examine the gut for illnesses such as cancer or pancreatic duct blockages, they infected people with germs.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” said Sen. Patty Murray, D-Wash., who launched the investigation. “Unfortunately, this investigation makes clear that current policies for monitoring … safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented.”
The problem began in 2012, when at Seattle’s Virginia Mason hospital, people became infected with a multidrug-resistant bacteria. Over two years, at least 39 people got sick and 18 died, and the hospital suspected the tools. Like most hospitals, Virginia Mason didn’t notify the authorities fast enough, the probe found. By 2013, they knew the dirty scopes infected their patients, but didn’t tell their manufacturer until five months later.
It’s not clear if these people died as a direct result of the superbug they contracted.
In a Pasenda, California, hospital, some of its patients contracted a superbug after procedures and notified public health officials in August that the Olympus devices were to blame.
Over three years in multiple states, 250 patients were infected life-threatening superbugs, now linked to the duodenoscopes made by Olympus Corp. (which makes 85 percent of them in the country) and two other manufacturers. Last year, research into these infections by the FDA uncovered only 142 cases. At least 16 hospitals connected the dirty scopes to the outbreaks, but didn’t tell federal regulators about the cases.
Sen. Murray launched the probe in January 2015, after the outbreak in Virginia Mason. In June, the investigation demanded three makers — Olympus, Pentax Medical and Fujifilm Medical Systems — relinquish internal documents about the infections.
In the end, the report discovered that Olympus — which makes most of the scopes used in the U.S. — knew in 2012 that they couldn’t be cleaned of dangerous bacteria. Yet, the company never warned hospitals, not for three years as patients got sick left and right.
About 700,000 procedures are conducted every year using these scopes, frequently as an alternative to invasive surgery.
Going forward, the report has required several measures to make sure dirty scopes never infect unassuming patients again: identifiers to track performance through insurance claims; an evaluation system to monitor their safety; an analysis of scope design and a recall to fix the duodenoscopes; quicker notification when patient safety is at stake; and a policy to force facilities to report such problems much more quickly.
Outbreaks occurred in Washington, California, Connecticut, Florida, Illinois, Massachusetts, New York, North Carolina, Pennsylvania, and Wisconsin.
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