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

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.

Endoscopes and Colonoscopes Killing People - Difficult to Clean - Spread Disease

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.

Read more:

Risk of colon perforation during colonoscopy at Baylor University

The risk of perforation at BUMC was 0.57 per 1000 procedures or 1 in 1750 colonoscopies. Continued efforts to make colonoscopy safer are needed.


Major complications of coloscopy: bleeding and perforation

1 patient died of an unrecognized perforation of the sigmoid colon, resulting in a 0.09% mortality rate. Of 14 complications reported in this series, 12 occurred during the early experience (less that 40 procedures) of the coloscopist. Training programs in coloscopy need to be established in order to reduce the morbidity and mortality associated with a physician’s early coloscopic experience.

Gastrointestinal perforation: MedlinePlus Medical Encyclopedia

Treatment most often involves emergency surgery to repair the hole. Sometimes, a small part of the intestine must be removed. One end of the intestine may be brought out through an opening (stoma) made in the abdominal wall. This is called acolostomy or ileostomy.