FDA: Duodenoscope design may impede effective cleaning

Duodenoscopes, used during ERCP, have been associated with a number of infections, most recently an outbreak of carbapenem-resistant Enterobacteriaceae at UCLA Ronald Regan Medical Center. The FDA has now released a safety communication focused on duodenoscopes.

The FDA warns that the intricate design of duodenoscopes may impede effective cleaning and sterilization. The communication is aimed towards gastroenterologists, GI surgeons, endoscopy nurses, endoscopy unit reprocessing staff, infection control practitioners and patients.

From January 2013 to 2014, the FDA received 75 medical device reports linking 135 patients to potential microbial transmission from reprocessed duodenoscopes. The FDA is in the process of:

•    Collaborating with the CDC and Environmental protection agency to better understand antibiotic-resistant organisms and their susceptibility to high-level disinfectants
•    Working with the CDC to minimize the risk of such infections
•    Communicating with international public health agencies to determine possible solutions
•    Reviewing reprocessing validation data from major duodenscope manufacturers FUJIFILM, Olympus and Pentax

In the meantime, the FDA recommends healthcare providers:

•    Inform patients of all benefits and risks associated with undergoing ERCP
•    Discuss with patients any symptoms following ERCP that merit prompt follow-up with a physician
•    Remove any duodenoscopes with a suspected link to a multidrug-resistant organism from active use
•    Submit a report to the FDA and scope manufacturer if any duodenscope has led to patient infections

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