Last year the FDA reported a total of 142 patients infected with the antibiotic-resistant infection linked to procedures using duodenoscopes. A study just released by the US Senate found reports of at least 250 infected patients in the United States and Europe.
The study was commissioned by Senator Patty Murray, ranking member of the Senate Committee on Health, Education, Labor, who called for the report after an outbreak in 2015 led to the death of 11 patients at Virginia Mason Medical Center in Seattle. Sen. Murray went onto say that “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.”
The Duodenoscope is a flexible, lighted tube that is inserted through the throat and stomach, into the top of the small intestines. “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.”
The scopes are used in roughly 700,000 procedures a year, providing a safer alternative to invasive surgery for conditions of the pancreas and bile duct. The instrument is designed in a way that makes it very difficult to clean. That’s the simple answer as to why these infections occur. The fix appears to be far more complicated.
The Senate study found at least 16 hospitals in the U.S. had linked the infections back to the devices yet did not raise any red flags about the infections to federal regulators. It was also noted that Olympus, which manufacturers 85% of the scopes used in the U.S., knew as early as 2013 about the dangerous bacteria but did not inform U.S. hospitals until early 2015. The Senate report lays the blame on all involved:
- Device manufacturers failed to test ability of complex devices to be properly cleaned in real world applications. Additionally, upon finding problems, the manufacturers failed to report to regulators in a timely fashion.
- Hospitals didn’t act promptly in reporting infections to the manufacturers and federal agencies.
- FDA failed to spot the deadly infections quickly enough and alert the public.
“The report recommends a number of legislative and regulatory changes. It urges Congress to require that unique device identifiers be included in insurance claims, electronic health records and device registries. It says the FDA should evaluate whether design modifications are needed and if so, require manufacturers to implement repairs through a phased recall.” (www.WashingtonPost.com, 01-13-16)
Ultimately this problem has to be addressed through a combined effort of the FDA, hospitals, doctors, nurses, and medical equipment manufacturers. The FDA stated that it is working to correct many of the issues cited in the Senate report—but we’ve heard that many times before. While the apparent number of folks impacted by this infection problem appears to be relatively small, tell that to the people and families of those affected. Regardless, this is a problem that they all should be able to fix.
For more background on the duodenoscope and the drug-resistant infection, click here.
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