The Food and Drug Administration is alerting health care professionals and the public about the association with duodenoscopes and the transmission of multidrug-resistant bacterial infections in patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP), despite proper cleaning and disinfection of the devices.
Between January 2013 and December 2014, the agency received 75 medical device adverse event reports for about 135 patients in the United States “relating to possible microbial transmission from reprocessed duodenoscopes,” according to a safety communication issued by the FDA on Feb. 19.
These reports and cases described in the medical literature have occurred even when manufacturer instructions for cleaning and sterilization are followed, which appears to be related to the design of the duodenoscope.
“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to the statement, which points out that it can be difficult to access some parts of the duodenoscopes when they are cleaned. Problems include the “elevator” mechanism at the tip of the duodenoscope, which should be manually brushed, but a brush may not be able to reach microscopic crevices in this mechanism and “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” possibly exposing patients to serious infections if the fluids are contaminated with microbes.
The infections reported include carbapenem-resistant Enterobacteriaceae (CRE), according to the FDA statement, which does not mention whether any of the reports were fatal.
But on Feb. 18, UCLA Health System announced that CRE may have been transmitted to seven patients during ERCP procedures, and may have contributed to the death of two of the patients. The two devices implicated in these cases are no longer used and the medical center has started to use a decontamination process “that goes above and beyond manufacturer and national standards” for the devices, the statement said. More than 100 patients who had an ERCP between October 2014 and January 2015 at UCLA have been notified they may have been infected with CRE.
The FDA statement includes recommendations for facilities and staff that reprocess duodenoscopes, patients, and health care professionals. One recommendation is to take a duodenoscope out of service if there is any suspicion it may be linked to a multidrug-resistant infection in a patient who has undergone ERCP.
The FDA is asking health care professionals to report any infections possibly related to ERCP duodenoscopes to the manufacturers and the FDA’s MedWatch program.