Article

Switching to Disposable Duodenoscopes: Risks and Rewards

In 2013, the CDC warned the FDA that patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) were being infected with multidrug-resistant bacteria, and that the bacteria were likely coming from the duodenoscopes.1 Subsequent changes to the instrument’s cleaning protocols did not significantly improve infection rates.2 Thus in 2019, the FDA urged endoscopists to abandon use of reusable, hard-to-clean duodenoscopes when performing ERCP.3 The FDA wanted surgeons to adopt either single-use models or reusable tools redesigned with disposable tips.

The FDA’s request has created a lively debate among endoscopists.4 While single-use instruments would, by definition, eliminate risk of infection and save time related to endoscope cleanings, the constant replacement costs and the environmental impact of their disposal have prompted much discussion.2,4 The estimated amount of greenhouse gas emissions, for example, from manufacturing the single-use instruments is remarkably higher than for other instruments.5

Alternatively, a “hybrid” duodenoscope, a reusable instrument equipped with a one-time-use tip, has been available for a few years; its use has been shown to significantly reduce bacterial contamination.6 However, that use has not entirely eliminated risk of microbial contamination despite adherence to high-level disinfection and reprocessing.7

Although the primary driver for disposable duodenoscopes has been reduction of infection risk from ERCP, other improvements are anticipated changes in ergonomic design for instrument operators with smaller hands, for example. A small case study has shown that expert endoscopists can finish ERCPs of different levels of complexity using disposable duodenoscopes.8

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  • There is a need for technique modifications and training to improve ergonomics and comfort in the endoscopic space. A survey of 107 gastroenterologists highlighted differences in techniques, primarily due to physical differences.

  • Data from the Nationwide Inpatient Sample showed a small increase in ERCP utilization (from 0.38% to 0.44%), along with an increase in related adverse events such as pancreatitis and perforation.10

  • Estimated costs of single-use duodenoscopes, based on hospitals performing high and low volumes of ERCP.


 

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