Disposable Duodenoscope Elevator Caps Appear Effective in Preventing Infections, Study Finds

Following a number of deadly hospital infection outbreaks in recent years, where “superbug” infections were spread among patients undergoing procedures involving the same duodenoscope devices, the finding of a new study suggests that a switch to using endoscopes with disposable elevator caps has greatly reduced the risks.

Duodenoscopes are a type of endoscope used during endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, difficulties cleaning device manufactured by several different companies have resulted in a number of problems in recent years, typically involving aggressive infections that are resistant to available antibiotics, and often result in life-threatening injuries.

Concerns about the risk of duodenoscope infections emerged about seven years ago, following infection outbreaks at a number of different hospitals. Investigations by health officials identified problems with the cleaning procedures provided by Olympus and other manufacturers, which may allow the devices to transfer tissue or bacteria between patients.

In response to a continuing risk of problems, the FDA issued a safety communication in April 2022, urging hospitals nationwide to change over to using disposable duodenoscopes and disposable duodenoscope parts.

In a study published this month in the medical journal JAMA Internal Medicine, Canadian researchers indicate that the use of duodenoscopes with disposable elevator caps results in a two-thirds reduction in detectable microbial contamination.

Researchers conducted a randomized clinical trial that involved 518 patients undergoing ERCP between December 2019 and February 2022. Half underwent the procedure with traditional duodenoscopes, while duodenoscopes using disposable elevator caps were used on the other half of the patients.

According to the findings, persistent microbial contamination was detected in 11.2% of the standard duodenoscopes, but that contamination was only found on 3.8% of duodenoscopes with disposable elevator caps. Contamination appeared to be reduced by two-thirds when duodeonscopes with disposable elevator caps were used, the researchers determined.

“In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited lower rates of persistent microbial contamination after high-level disinfection compared with standard duodenoscopes while maintaining noninferior rates of technical performance for ERCP,” the researchers concluded. “There were no differences between study groups for adverse events, ease of duodenoscope use, or patient tolerability. These results were consistent across all clinically relevant subgroups.”

FDA Promotes Use of Disposable Endoscope Components Due to Infection Risks

Questions about the safety of the devices first emerged after a duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections, which resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined at that time that the instructions sent out at the time were inadequate, and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

In response to the problem, the FDA approved the first design with a disposable elevator tip, the most problematic and hard to clean part of the duodenoscope, in November 2019. Now, the agency says there are enough various disposable parts and entirely disposable duodenoscopes on the market that hospitals in the United States can, and should, transition to these devices and end use of reusable duodenoscopes with fixed endcaps.