The Future of Duodenoscopes—FDA Pushes for Disposable Components

Several years ago, a large outbreak of carbapenem-resistant Enterobacteriaceae (CRE) occurred that opened our eyes to the dangers and risks associated with use of duodenoscopes. In this outbreak, several cases were identified as related to the use of duodenoscopes for endoscopic retrograde cholangiopancreatography (ERCP). While this was not the first outbreak associated with duodenoscopes, health officials ultimately found that there are inherent challenges in reprocessing these scopes and that even when used properly, the design of the scopes leaves room for transmission of microorganisms.

Over the years, these scopes have shown a propensity for making the transmission of multidrug-resistant organisms easier than we anticipated. There continues to be a strong infection control and regulatory focus on reprocessing to ensure patient safety. The flexible medical devices are used to help visualize and assess not only the small intestine, but also the pancreas and bile ducts. Since they products are reusable, the complex, error-prone process of reprocessing becomes critical to avoid disease transmission between patients.

Unsurprisingly, there has been increased pressure to move to avenues that reduce the risk for patient exposure and promote safety during these procedures. On August 29, 2019, the US Food and Drug Administration (FDA) put forth a recommendation that both duodenoscope manufacturers and health care facilities alike, should move towards those scopes with disposable components, specifically the endcaps.

“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in the statement.

The FDA press release references several human factors studies involving duodenoscopes, like including 1 involving Pentax Medical and a second involving Olympus Medical Systems. A third study also assessed the human factors involved in the reprocessing of Fujifilm duodenoscopes. The purpose of the study was “to determine if representative reprocessing personnel can understand and follow the recommended reprocessing instructions for ED-530XT duodenoscopes without causing reprocessing errors or failures”.

This single study found significant failures that led to the recommendation to switch to disposable parts. For example, they found that most participants in the study failed to successfully perform 2 of the 8 pre-cleaning tasks, 67% failed to properly clean the forceps elevator, and 41% failed to correctly provide air and then water through the air/water channel.

Of the 33 manual tasks involved in the critical cleaning of the duodenoscopes, only 2 were correctly performed by all participants in the study. The study also notes that “93% of participants failed to wipe and dry the scope and cleaning kit as instructed in the labeling and 67% of participants failed to purge the channels with compressed air for the required time.”

The study involving Olympus scopes found equally concerning failures across several models, like the TJF-160VF model, in which 17 of the 21 precleaning tasks were not successfully performed.

In human factor studies, we can clearly see that the reprocessing of duodenoscopes is extremely prone to human error and puts the patient at risk. The guidance from the FDA is long overdue and there should be more of a regulatory push to move to disposable components in these complex medical devices.