Last Thursday, the FDA issued a warning letter concerning the design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes.
What is an Endoscopic Retrograde Cholangiopancreatography Duodenoscopes
In plain English, these devices are used in very common procedures involving the gallbladder and pancreas. According to the FDA, there are 500,000 ERCP procedures performed with duodenoscopes in the United States annually. Duodenoscopies are designed to drain fluids from the pancreas and biliary ducts, among other things.
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The FDA Warning Letter
The FDA’s letter says that the way these scopes are designed can make it difficult for hospitals to clean them, even when following the manufacturer’s instructions. The devices are very complicated and contain a movable “elevator” mechanism at the tip. The complex design of the device improves its capabilities, but it also makes it extremely difficult to clean. Moving parts in the elevator mechanism contain microscopic crevices that cannot be reached with cleaning materials. These devices may be completely impervious to proper cleaning as they are currently designed. This results in an increased risk that the devices will carry infection.
Link to Drug-Resistant Bacteria
The FDA is currently investigating the link between reprocessed duodenoscopes and the transmission of serious infections, including those caused by a multidrug-resistant bacteria called Carbapenem-Resistant Enterobacteriaceae (CRE). From January 2013 to December 2014, the FDA received 75 reports relating to possible bacterial infection from the duodenoscopes. However, this does not mean that all such cases have been accounted for. Some people may have suffered a bacterial infection caused by the duodenoscope and not realized the cause.
The CRE infection is already suspected in the deaths of two people at the University of California Los Angeles Medical Center who underwent duodenoscopes. The hospital has also contacted 179 other patients who may have come into contact with the medical device. At UCLA, the hospital used an Olympus Corp. of Americas duodenoscope, but the Food and Drug Administration is also investigating devices made by Fujifilm USA and Pentax Medical.
In the most recent development, CNN reports that the manufacturer, Olympus, never received permission to sell the now controversial device. The device hit the market in 2010. However, the FDA did not notice until 2013 or early 2014 that Olympus never asked, let alone received permission to sell the device that is now linked to two “super-bug’ related deaths.
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We encourage you to do these three things if you are undergoing a duodenoscope procedure:
- Talk to your physician about the risks and benefits of the procedure: The FDA is advising doctors to inform patients of any risks involved in the use of the duodenoscope. All patients are entitled to make an informed decision about their own healthcare.
- Inform your doctor right away if you feel sick following the procedure: There may be some normal side-effects associated with the procedure, however, severe illness should is not one of them. Fevers or chills may indicate that you have an infection carried by the duodenoscope. If you are experience those symptoms, you should probably call your doctor right away.
- Show your doctor the FDA’s Letter: Although the issue has been all over the news the past couple of days, your physician may not be aware that the duodenoscopes are difficult to clean. Show your doctor the FDA’s letter so he or she is completely informed about the issue and can take any steps necessary to improve the outcome of your procedure.