Duodenoscopes and Superbug Infections Scrutinized by FDA
Patients who have acquired a superbug CRE infection after undergoing an ERCP endoscopy can call 1-888-341-1405 for a no-obligation evaluation of your legal rights, or tell us your story using our online contact form.
Antibiotic-resistant superbug infections caused by duodenoscopes have become more and more common. In an effort to prevent future infections, the FDA has ordered the three manufacturers of duodenoscopes to perform postmarket surveillance on how the devices are being cleaned and sterilized (reprocessed) in clinical settings.
Duodenoscopes are a specialized endoscope used for one medical procedure: the ERCP, which stands for endoscopic retrograde cholangiopancreatography. The ERCP is the least invasive way to examine and treat pancreas and bile ducts blocked by cancerous tumors, gallstones, or other conditions. Like all endoscopes, the duodenoscope consists of a tube fitted at the end with a tiny camera and a light that allows the gastroenterologist to see the area being treated. They also contain a tiny moving part known as an elevator which allows a tube or a stent to be inserted into the ducts. The devices are reusable and the elevator part is extremely difficult to clean properly between uses.
The FDA has ordered the three manufacturers of duodenoscopes — Olympus America, Fujifilm Medical Systems, USA, and Hoya Corp. (Pentax Life Care Division) — to submit plans for the surveillance studies within 30 days. The manufacturers must study how the devices are actually being used and whether hospital personnel are following the manufacturer’s recommendations for reprocessing.
The order follows several deadly outbreaks of CRE — carbapenem-resistant Enterobacteriaceae — in hospitals across the country, and the world, over the past two years. In February the FDA noted 135 possible infections from duodenoscopes had been reported from January of 2013 to December of 2014. The most recent reported outbreaks were at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center in Los Angeles.
For now, the FDA has decided to allow the devices to stay on the market, finding that the benefits of diagnosis and treatment via ERCP outweigh the risk of infection. Patients are advised to discuss risks and benefits of the procedure with their doctors, and after undergoing ERCP be aware of these potentially dangerous complications:
Call your doctor if, following your procedure, you have a fever or chills, or other symptoms that may be a sign of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools)
If you or someone you love has been injured by a superbug infection after an endoscopy procedure, call the duodenoscope lawyers at Thornton Law Firm at 1-888-341-1405 for a free, no-obligation consultation, or tell us your story here. Like all legal claims, superbug infection claims have short, strictly enforced time limits, so seek legal advice at your earliest opportunity.