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FDA Warned About Endoscope Infection Risk in 2009


February 20, 2015 — The FDA has known since at least 2009 that contaminated endoscopes can transmit “superbug” infections, but they have not issued any new safety requirements — such as ethylene-oxide sterilization or banning designs that are impossible to clean.

Recent outbreaks of CRE infections have been linked to duodenoscopes with complex mechanisms and intricate features that are nearly impossible to sterilize using traditional methods.

At least 179 people were exposed to CRE, including 7 who were infected and two who died at UCLA after undergoing duodenoscope procedures.

The scopes are used in about 500,000 procedures every year in the United States. Some hospitals have implemented more rigorous sterilization using ethylene-oxide gas, but not all.

Recent disease outbreaks linked to endoscopes, according to Reuters:

  • January 2013-2015 — In the last two years, an estimated 32 people were infected and 11 died from infections caused by contaminated medical scopes at Virginia Mason Medical Center in Seattle, WA.
  • March-July 2013 — At least 44 patients developed CRE infections at Advocate Lutheran General Hospital in Chicago, IL, including 38 who had endoscopic procedures.
  • 2012 — Four patients died from an outbreak of antibiotic-resistant infection after undergoing duodenoscope procedures in Tampa Bay, Florida.
  • 2012 — An outbreak of infection was linked to duodenoscopes at the University of Pittsburgh Medical Center. Investigators “determined that the normal process [of disinfecting] failed to eliminate all bacteria.”
  • 2008-2009 — The FDA issues its first Safety Communication about disease-transmission on endoscopes after 16 people are infected in an outbreak in France. Half of the victims developed bloodstream infections.


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