Duodenoscope Contamination – Surveillance Studies

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An article (April 2019) from the FDA about endoscopes used in Endoscopic Retrograde Cholangiopancreatography procedures (ERCP) provides some useful supplemental measures to enhance duodenoscope reprocessing.

A number of measures emerged from an agency-led expert panel that met in early 2019 that should be taken in addition to manufacturer. The additional steps are aimed at further reducing the risk of infection from these medical devices.

Areas of concern addressed following the studies were:

Being complex instruments, Duodenoscopes contain many small working parts which may have microscopic, hard-to-reach crevices. Without adequate cleaning and disinfecting, tissue,  fluid or residual bacteria from a patient may remain, exposing future patients to risk of infection.

Strict adherence to manufacturer’s reprocessing instructions can be labour intensive and is also prone to human error.

Even when manufacturer’s reprocessing instructions are meticulously followed, the FDA has been aware of instances of persistent bacterial contamination.

The FDA suggests the following supplemental measures for facilities/staff that reprocess duodenoscopes to consider:

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

The following article provides the article in full and this includes further information about the above supplemental measures:


This article is of particular interest to gastroenterologists, surgeons, endoscopy nurses, staff working in endoscopy reprocessing units and infection control practitioners.

Please contact us to find out more about endoscope decontamination.

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