FDA Issues New Standardized Duodenoscope Protocols Following Infection Outbreaks, Recalls

In the wake of a number of hospital infection outbreaks, lawsuits and eventual redesigns for duodenoscopes used in certain endoscopic procedures, federal regulators have released new, voluntary, standard protocols for hospitals to use to ensure that the devices are properly cleaned and sanitized between patients. 

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning device manufactured by several different companies have resulted in a number of serious hospital infection outbreaks in recent years, typically involving aggressive, antibiotic-resistant “superbugs”, which have caused a number of severe injuries and deaths.

On March 22, the FDA announced that it had issued a set of new standardized protocols for duodenoscope surveillance sampling and culturing (PDF). The agency also announced it will hold a web-based seminar, or webinar, on March 22 to go over the protocols and answer questions.

Sampling and culturing helps to detect whether bacterial contamination may be present on a medical device after it has been cleaned, or reprocessed, according to instructions. The new protocols are based on recommendations by the U.S. Centers for Disease Control and Prevention, which first put out a preliminary version of the protocols in 2015.

“The protocols are intended to minimize the workload for staff in healthcare facilities that choose to implement duodenoscope surveillance sampling and culturing while maximizing the potential for detecting viable microbes,” the protocols state. “The sampling fluid, sampling locations, and culture conditions and media were selected with those goals in mind. The primary focus of this protocol is for the detection of organisms of concern, some of which have been associated with infectious outbreaks.”

The protocols warn that they are not intended for use during a suspected outbreak, and that they cannot be used to certify than an endoscope is sterile.

The safety of the devices came into question after a  duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that 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 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 August 2015, the FDA posted a warning letter to Olympus, Pentax and FujiFilm, indicating that the companies had failed to report links between their devices and serious patient infections, injuries and deaths.

The letters suggested that duodenoscope makers knew for years that their devices were linked to infection outbreaks, but failed to warn the FDA or address the problem. The companies are also currently under investigation by the Department of Justice..

Several duodenoscope infection lawsuits have already been filed against Olympus over the infections linked to the UCLA outbreak, and it is possible that Pentax and FujiFilm will face similar cases. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.

The FDA says it will continue to closely monitor links between duodenoscopes and infections. For more details on how to view the March 22 webinar, see the FDA announcement for details.