Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued an alert that the complex design of ERCP endoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. This alert affects ERCP endoscopes supplied by all manufacturers.

Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed endoscopes even when manufacturer reprocessing instructions are followed correctly. From January 2013 through December 2014, the FDA received 75 medical device reports encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed endoscopes. Meticulously cleaning endoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.

The FDA is advising health care professionals to

• Inform patients of the benefits and risks associated with ERCP procedures
• Discuss with patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up
• Consider taking a endoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP and a link between the endoscope and the infection is suspected
• Submit a report to the manufacturer if problems with reprocessing a endoscope is suspected to have led to patient infections

Posted on 23 February 2015