ERCP Duodenoscopes Unsafe, FDA Advisory Committee Says

A panel of independent experts have advised federal regulators that a type of endoscope linked to a number of recent infection outbreaks are not safe, nor have they proven to be effective. 

The FDA’s Gastroenterology and Urology Devices advisory committee met on May 14 and 15 to discuss the safety of duodenoscopes, a type of endoscope used during endoscopic retrograde cholangiopancreatography (ERCP) procedures.

According to the FDA’s summary of the meeting (PDF), the panel concluded that the devices “do not provide a reasonable assurance of safety and effectiveness.”

The decision comes after the devices after a number of duodenoscope hospital infection outbreaks, including an outbreak of carbapenem-resistant enterobacteriaceae (CRE) that was revealed in February at UCLA’s Ronald Reagan Medical Center. The outbreak caused at least seven infections, two deaths, and raised concerns that nearly 200 other patients had been placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections have been linked to problems with the “reprocessing” instructions used to clean the devices for use by another patient. FDA reviewers told the panel before the meeting 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.

After reviewing the evidence, the panel said that manual cleaning is still important and needs to continue, but the panel also recommended that the FDA reclassify duodenoscopes from semi-critical medical devices to critical medical devices and said reprocessing needs to be taken from “high level disinfection” processes to full sterilization.

Despite the concerns, the panel also determined that the benefits provided by ERCP procedures still outweigh the risks associated with the use of duodenoscopes. They called on the FDA to develop a guide of best practices to make sure that manufacturer instructions are followed, in addition to the need for better instructions overall.

The advisory panel’s recommendations are not binding, however the FDA usually factors those recommendations heavily in determining final rules and guidance.

Ineffective Protocols And Design Flaws

The most recent outbreak of antibiotic-resistant bacteria surfaced last month at the UCLA Ronald Reagan Medical Center in California, after the facility confirmed that nearly 200 patients who underwent an ERCP between October 2014 and January 2015 needed to be tested for the deadly superbug CRE due to contaminated scopes.

The confirmed infections occurred despite the medical scopes being sterilized according to manufacturers specifications, leading the FDA to issue a warning to about duodenoscope cleaning problems last month.

During the ERCP procedure, the scope is sent through the mouth, down the throat to the stomach and small intestine to drain fluid from pancreatic and biliary ducts. These scopes have been linked to other infections for years.

A similar CRE superbug outbreak from infected duodenoscopes occurred in Chicago in 2014. The FDA called on manufacturers to submit test results for review, discovering in some cases the tests were poorly carried out.

In other instances, the cleaning and disinfecting protocol simply failed or was improperly conducted.

Under the 1996 FDA guidance, manufacturers were not required to submit data proving the cleaning protocols were effective and were allowed to set their own standards for effectiveness. The FDA is attempting to focus on this gap in oversight of regulation of medical scope cleaning protocols and potential design flaws.

Specific requirements were imposed by the FDA following the Chicago outbreak, calling for the elimination of 99.999% of microbes at several ovations on the scope.

The outbreaks call into question the safety and reliability of the current cleaning procedures. Following the UCLA outbreak, the duodenoscopes were pulled and a heightened protocol was implemented, one going above and beyond that recommended by the manufacturers.

Several ERCP infection lawsuits have already been filed  against Olympus over the duodenoscopes linked to the UCLA outbreak. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.

Exposure to the CRE superbug following an ERCP poses a serious risk of illness, as the bacteria kills 40% to 50% of patients after spreading to the bloodstream.

The company has since released new cleaning instructions for its duodenoscopes, which the FDA approved.