The Grapevine

Antibiotic Resistant Superbugs Are Tainting Medical Scopes And Making Hundreds Sick, According To U.S. Senate Probe

Doctor's office
Patients should be able to trust that the equipment at a doctor's office is safe, says Sen. Murray. Pixabay Public Domain

Patients generally visit their doctors in order to receive preventive care, or to be treated for an illness, but no one expects to catch something new, and particularly nasty, from the physician's office.  According to a new Senate committee report, that’s exactly what happened to at least 250 patients in the United States and Europe from 2012 to 2015.

The patients were sickened with a life-threatening antibiotic resistant infection that was directly linked to contaminated medical scopes. The number far exceeds previous estimates by the Food and Drug Administration, which reported that the contaminated medical devices were linked to 142 patient infections, according to the Associated Press,

The senate health committee’s report also detailed an inadequate warning system in which medical device manufacturers failed to inform health officials about potential problems linked to their devices, and hospitals which didn’t alert federal regulators about outbreaks. According to the report, even the Food and Drug Administration was slow to identify the issue and share a warning with the public.

The report was commissioned by Sen. Patty Murray, D-Washington, after an outbreak of antibiotic-resistant infections that was tied to medical devices in Seattle last January.

“Patients should be able to trust that the devices they need for treatment are safe and effective,” Murray said in a statement. “Unfortunately, this investigation makes it 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 devices in question, called duodenoscopes, are used in hundreds of thousands of procedures each year in the U.S. to drain fluids in various situations, most commonly from ducts blocked by cancerous tumors or gallstones.

The report detailed several regulatory and legislative changes recommended to tackle the problem. It urges Congress to require that unique device identifiers be included in electronic health records, insurance claims, and device registries. It also says the FDA should assess whether certain design modifications are needed, and if so, necessitate companies to implement the changes through a phased recall.

The FDA has been made aware of the report, and responded to its findings.

“We appreciate the report from Sen. Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address,” FDA spokeswoman Deborah Kotz wrote in an email to the AP.

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