Interventional gastroenterology

Contamination warning for duodenoscopes


Higher than expected rates of duodenoscope contamination have prompted the US Food and Drug Administration (FDA) to issue a safety alert urging gastroenterologists to closely follow reprocessing instructions.

On April 12, the FDA issued a safety communication stating that preliminary results obtained from three manufacturers of duodenoscopes showed that contamination rates exceeded the expected rate of 0.4%.

In post-marketing surveillance studies, which manufacturers Fujifilm, Olympus and Pentax were forced to conduct by the FDA, up to 5.4% of samples tested positive for “high concern” organisms such as E. coli, Staph aureus and Pseudomonas aeruginosa, an increase from the 3% contamination rate previously reported.

Additionally, up to 3.6 % tested positive for low-to-moderate concern organisms, indicative of a reprocessing failure.

The FDA said rates of duodenoscope contamination had fallen following the initially safety alerts issued in 2015 but cases continued to be reported. Its safety advisory noted there had been three deaths in the past six months and 45 people had developed infections from contaminated endoscopes.

“These reports indicate that although the number of reports has declined, there continues to be a need for improvement of the safety of reprocessed duodenoscopes,” it said

The FDA issued a 4-point reminder for all gastroenterology facilities using duodenoscopes, emphasising the need for:

  • Cleaning by hand of the elevator mechanism.
  • Comprehensive quality control programs for reprocessing duodenoscopes.
  • Adhering to manufacturer recommendations for inspection, leak testing and maintenance.
  • Supplemental reprocessing measures such as microbiological culturing, sterilisation, use of a liquid chemical sterilant processing system and repeat high-level disinfection.

In a statement the American Gastroenterology Association said it was encouraging members to stay vigilant on duodenoscope reprocessing and to strictly adhere to the manufacturer’s reprocessing and maintenance instructions.

“While the outlook has improved significantly since this issue first arose in 2015, we are not yet at our goal of zero device-associated infections,” it said.

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