ASGE Recognized Industry Associate (ARIA) Training Program for Medtronic | March 2025-Duodenoscopes from Risk to Innovation

Duodenoscopes from Risk to Innovation

Pdf Summary

The document discusses the challenges and innovations related to duodenoscopes, particularly in the context of ERCP (endoscopic retrograde cholangiopancreatography) procedures. It highlights the increasing number of ERCP procedures in the United States from 2010 to 2014 and the associated risks of infection, including "superbug outbreaks" linked to duodenoscope use.<br /><br />These outbreaks often involved drug-resistant pathogens, and it was identified that while manufacturer guidelines were followed, the design of duodenoscopes, such as their long, narrow lumens and pitted surfaces, contributed to disinfection failures. This led to the recognition that cleaning and reprocessing were crucial for preventing infections.<br /><br />The FDA, in response to outbreaks, recommended measures such as double reprocessing with high-level disinfection and exploring the use of disposable components. Despite these measures, challenges in sterilization remain due to cost and logistical constraints.<br /><br />In 2016, Olympus recalled its duodenoscopes to reduce infection risks, and innovations such as single-use duodenoscopes and modifications like removable caps were explored. These developments aim to prevent infections but come with their own set of advantages and disadvantages, including financial and procedural considerations.<br /><br />The document also includes a cost analysis of different strategies to prevent infection, finding that ERCP followed by FDA-recommended procedures was the most cost-effective for settings with low CRE prevalence. In highly prevalent areas, an "endoscope culture and hold" strategy becomes more viable.<br /><br />Overall, the document emphasizes the need for improved infection control practices, advancements in duodenoscope design, and careful consideration of the costs and logistics associated with these innovations, marking a period of rapid change and adaptation to enhance patient safety in endoscopic procedures.

Keywords

duodenoscopes

ERCP

infection risks

superbug outbreaks

disinfection failures

FDA recommendations

single-use duodenoscopes

cost analysis

infection control

endoscope design