On April 12, FDA issued a safety communication releasing new information on the duodenoscope contamination rate from postmarket surveillance studies and medical device reports. 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.
AGA encourages all members to stay vigilant when it comes to duodenoscope reprocessing and strictly adhere to the manufacturer’s reprocessing and maintenance instructions.
In the safety communication, FDA reports:
• In the past 6 months, three people died and 45 people developed infections from contaminated endoscopes.
• Results from sampling studies show up to 5.4% of all properly collected samples tested positive for “high concern” organisms. “High concern” bacteria are more often associated with disease, such as E. coli or Staphylococcus aureus.
• Additionally, up to 3.6% of properly collected samples tested positive for low to moderate concern organisms; while these organisms don’t usually lead to dangerous infections, they are indicative of a reprocessing failure.
Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, also issued a communication on continued efforts to assess duodenoscope contamination risk. Dr. Shuren puts this new data into perspective:
“While the current contamination rates we’re seeing in the postmarket studies show the need for improvement, I want to emphasize that an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use.”
The AGA Center for GI Innovation and Technology (CGIT) continuously monitors this issue and engages with industry and FDA on efforts that will help us reach our goal of zero device-transmitted infections to our patients.
“We continually meet with industry partners, just as recently as last week at the AGA Tech Summit, to understand how they are innovating to reduce the risk of potential infection. We are also in close communication with FDA and other key stakeholders. We all have a role in preventing device-transmitted infections, and we don’t take our role lightly,” added V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair of the AGA CGIT.