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FDA Recommends Duodenoscope Sterilization Methods


August 4, 2015 — The FDA has recommended additional steps to clean duodenoscopes to reduce the risk of infections.

The scopes are inserted down a patient’s throat to treat diseases of the liver, pancreas, and bile ducts. The tip of the scope has a complex “elevator” mechanism that is extremely difficult to clean between uses, even after following the manufacturer’s instructions.

In March, the FDA warned that high-level disinfection should reduce the risk of disease-transmission, but does not entirely eliminate the risk.

Enhanced cleaning procedures recommended by the FDA include:

  • Microbiological Culturing
  • Ethylene Oxide (EtO) Sterilization
  • Use of a Liquid Chemical Sterilant Processing System
  • Repeat High-Level Disinfection

Some of these steps were implemented at Virginia Mason Medical Center in Seattle, Washington, after 39 infections and 18 deaths were linked to the scopes between 2012 and 2014.

Gas sterilization was implemented at UCLA’s Ronald Reagan Medical Center after the scopes transmitted “superbug” to seven patients. No infections have been reported at either hospital since enhanced cleaning procedures were implemented.

However, FDA recommendations on EtO gas have been mixed. The gas is a highly-toxic carcinogen that poses a danger to staff and patients and can damage the scopes, FDA deputy director and scientist Dr. William Maisel told the LA Times.


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