A “superbug” contracted from use of a flawed medical device is being blamed for the deaths of 2 patients at the Ronald Reagan UCLA Medical Center in Los Angeles. The device, a type of scope used in approximately 500,000 medical procedures annually, is allegedly so hard to clean properly that federal officials believe its use is responsible for the deadly bacteria outbreak. In addition to the 2 deaths, 5 other patients have tested positive for the drug-resistant bacteria, and 179 additional individuals may have been exposed.
The Device, the Procedure, and Who Is at Risk
The medical device at the center of this outbreak is called a duodenoscope and it is an endoscopic device used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. Duodenoscopes are flexible tubes with lights and cameras that can go through the mouth, throat, stomach, and into the top of the small intestine, allowing medical professionals to obtain tissue samples or treat certain abnormalities.
According to the U.S. Food and Drug Administration (FDA), the ERCP procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, and other conditions. This technique also aids in early detection of certain illnesses.
What Is the Superbug and How Did This Happen?
The “superbug” is scientifically known as a carbapenem-resistant Enterobacteriaceae (CRE). The Centers for Disease Control and Prevention (CDC) defines CRE as “a family of germs that are difficult to treat because they have high levels of resistance to antibiotics.” When patients are exposed to bacteria that have become resistant to even the most potent antibiotics, the results can be deadly. The CDC says 1 report cites that CRE can contribute to death in up to 50% of patients who become infected.
The spread of the bacteria at UCLA is being blamed on the design of the duodenoscopes, which are reusable and made by manufacturers like Olympus Corp, Pentax Medical, and Fujifilm Holdings Corp. The scopes are so complex that it is difficult for medical professionals to disinfect them properly, even when they follow the exact instructions provided by the manufacturers.
The FDA’s Response: Too Little, Too Late?
The FDA is being scrutinized because they have been aware of the potential design flaws for years and have not made it a priority to issue definitive cleaning guidelines. An FDA spokeswoman explained that they felt the devices’ benefits outweighed the risks.
Unfortunately, similar outbreaks have occurred across the country. A larger epidemic happened at Virginia Mason Hospital in Seattle in 2012 that infected 32 patients and claimed the lives of 7 people within 30 days.
Now that the outbreak at UCLA is making national headlines, the FDA is being forced to make decisions to try and prevent this from happening again.
Concerned? Call Us Today
If you believe that you or a loved one were exposed to CRE after having an endoscopic procedure, you may be entitled to compensation. Call Sokolove Law now for a free legal consultation.
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