Following Duodenoscope Debacle, FDA Releases Safety Communication

By MedTech Intelligence Staff
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After an FDA expert panel held earlier this year, the agency is offering supplemental reprocessing measures.

In response to the series of severe infections and deaths from antibiotic-resistant superbug tainted duodenoscopes, FDA has released a list of reprocessing procedures that should be followed by healthcare facilities. These “infection mitigation strategies” are available in an agency safety communication released today.

“Duodenoscopes are complex instruments that contain many small working parts. Proper cleaning and disinfection of the elevator mechanism is of particular concern. The moving parts of the elevator mechanism contain microscopic, hard-to-reach crevices,” according to the FDA notice.

“If not thoroughly cleaned and disinfected, tissue or fluid and residual bacteria from one patient may remain in device crevices of a duodenoscope, exposing subsequent patients to risk of infection.”

When reprocessing duodenoscopes, FDA suggests that facility staff take the following steps:

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

These measures are detailed in the safety communication notice and should be followed in conjunction with adhering the device manufacturer’s reprocessing instructions.

Related Articles

  • Dr. Christopher Joseph Devine, President, Devine Guidance International

    Trading the potential health risk to a few patients versus the collective good of all patients is never acceptable. Even the experts are voicing concerns over the effectiveness of duodenoscope reprocessing.

  • Bigler v. Olympus & Virginia Mason Medical Center

    Perhaps now is the time to truly weigh patient outcomes versus the risks associated with the reprocessing of duodenoscopes.

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