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FDA Warning: Duodenoscope Design May Impede Effective Cleaning

Agency issues guidelines for health care providers

The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes –– also called duodenoscopes –– may impede effective reprocessing.

Reprocessing is a multistep process to clean and disinfect or sterilize reusable devices. According to the FDA, recent medical publications and adverse-event reports have associated multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturers’ reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes before high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it, the FDA says.

The agency is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by carbapenem-resistant Enterobacteriaceae (CRE), such as Klebsiella species and Escherichia coli. From January 2013 through December 2014, the FDA received 75 medical-device reports related to possible microbial transmission from reprocessed duodenoscopes. It is possible that not all cases have been reported to the agency.

Recently, the University of California, Los Angeles reported that more than 100 patients may have been exposed to CRE from contaminated duodenoscopes at its Ronald Reagan Medical Center after similar outbreaks at other hospitals across the country.

According to the Los Angeles Times, these outbreaks are raising questions about whether hospitals, medical-device companies, and regulators are doing enough to protect patient safety. Some consumer advocates are also calling for greater disclosure to patients of the increased risks for infection before undergoing these procedures.

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach, and into the top of the duodenum. They contain a hollow channel that allows the injection of contrast dye or the insertion of other instruments to obtain tissue samples for biopsy or to treat certain abnormalities.

The FDA’s recommendations for health care providers include the following:

  • Inform patients of the benefits and risks associated with ERCP procedures.
  • Discuss with patients what they should expect after 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 duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism after ERCP, and suspect that there may be a link between the duodenoscope and the infection.
  • Submit a report to the manufacturer and the FDA if it is suspected that problems with reprocessing a duodenoscope have led to infections.

Sources: FDA; February 19, 2015; and Los Angeles Times; February 19, 2015.


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