August 4, 2015 — Following several outbreaks of antibiotic-resistant infections, the FDA has recommended enhanced cleaning of duodenoscopes to reduce the risk of disease transmission between patients.

Duodenoscopes are snaked down a patient’s esophagus to treat conditions involving the liver, bile ducts, and pancreas. Earlier this year, the FDA warned that complex mechanisms in the tip of the scope could be extremely hard to sterilize between uses, even after following the manufacturer’s cleaning instructions.

The agency’s supplemental reprocessing measures included:

  • Microbiological culturing to check if cleaning worked
  • Ethylene oxide (EtO) gas sterilization after manual cleaning
  • Another liquid sterilizing treatment after EtO sterilization
  • Repeat “high level disinfection” (such as manually applied liquid disinfectants)

The recommendations appear to follow steps taken at Virginia Mason Medical Center in Seattle, where at least 39 infections and 18 deaths from drug-resistant E. coli occurred between 2012 and 2014.

Gas sterilization was implemented at UCLA’s Ronald Reagan Medical Center after dirty duodenoscopes exposed 179 patients and infected seven with carbapenem-resistant Enterobacteriaceae (CRE).

Many hospitals started testing the scopes for microbial contamination before re-using them on new patients. However, the FDA has given mixed recommendations about the use of EtO gas.

At Virginia Mason, staff said EtO sterilization had fallen out of favor because it is a carcinogen that poses a danger to the staff. Dr. William Maisel, deputy director and chief scientist at the FDA, also told the LA Times that gas sterilization can be harmful to patients or damage the scopes themselves.


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