The FDA knew all about the endoscope risk six years ago, but has ignored it. Action Alert!

Over the last few years, you may have seen one of the several tragic stories of antibiotic-resistant “superbug” outbreaks in major hospitals that have killed dozens of patients and sickened hundreds more.

Some of these outbreaks are linked to contaminated endoscopes—medical devices used to diagnose and treat diseases of the liver, bile ducts, pancreas, throat, stomach, and the intestines. Similar devices are used in colonoscopies, which means that the colonoscope risk is likely to be just as bad. The design of the endoscopes makes them difficult to clean. “Biological debris” can get stuck in microscopic crevices on the instruments and can remain there for the next patient—even after the instruments are cleaned and disinfected following the FDA-approved instructions from the manufacturer.

Especially worrisome is that the “superbug” we know to be spread by the contaminated scopes, Carbapenem-resistant Enterobacteriaceae (CRE), is often completely untreatable and has a mortality rate of 40% or more.

Since 2009, there have been four major CRE outbreaks in American hospitals.

• In February 2015, nine people were infected and two patients were killed by a CRE outbreak at the Ronald Reagan UCLA Medical Center. Cedars-Sinai Medical Center, also in Los Angeles, reported CRE infections in four patients who had procedures using endoscopes.
• In an outbreak that stretched from 2012 to 2014 at Seattle’s Virginia Mason Hospital, thirty-nine patients were infected with CRE resulting in eleven deaths.
• A 2013 outbreak at a Chicago-area hospital infected thirty-eight patients with the deadly bacteria.
• Fifteen patients were killed and dozens were infected at a Florida hospital in 2009.

You may recall our 2012 report of an investigation revealing that between 2004 and 2009, over 11,000 colonoscopies were performed at three different Veterans Administration hospitals using inadequately cleaned equipment—and as a result of these colonoscopies, thirteen veterans tested positive for hepatitis B, thirty-four for hepatitis C, and six for HIV.

Almost from the start, the FDA has chosen simply to look the other way.

Recent investigations show that during the 2009 outbreak in Florida, health experts from the CDC together with other epidemiologists warned the FDA that the problem was likely not limited to Florida, and that action should be taken to warn hospitals of the danger. Only months later did the FDA issue any warning whatsoever—a measly two sentences buried in the fifty-seventh paragraph in a general advisory on the proper cleaning of medical scopes!

Not until February of this year—six years after they themselves were warned, and after at least twenty-eight people had died and dozens more had been made sick—did the FDA finally issue a proper warning that the endoscopes that are linked to superbug outbreaks may still transmit infections even when cleaned as directed by the manufacturers.

This March the FDA completed a guidance with additional measures to improve the safety of endoscopes and other hard-to-clean devices. But—and this is a big but—while the guidance may make the equipment safer, it still won’t make them sterile.

The FDA’s inaction is even more inexcusable considering health experts’ warnings that many of the infections from endoscopes go unnoticed, according to Jeffrey Duchin, a public health official who directed the investigation of the Seattle outbreak. Because CRE is so dangerous, it gets “red-flagged” by hospital staff and investigated. Patients who are made sick from more run-of-the-mill bacteria are simply treated with routine antibiotics, and that’s that. Who knows how many infections have been spread as a result of these scopes?

Duchin summed it up neatly: “There’s a likelihood that we’re just seeing a very small subset of the universe of infections from these types of scopes.”

Why is the FDA so reticent on this subject? Could it be because endoscopy and colonoscopy are such enormous businesses, producing billions of dollars of revenue per year? Powerful special interests do not want to see any changes in this area of medicine.

Action Alert! Write to the FDA and ask them to do more to protect the public from non-sterile endoscopes and prevent more deadly outbreaks. Please send your message immediately.