A commonly used medical scope has been linked to a deadly carbapenem-resistant Enterobacteriaceae (CRE) superbug outbreak at UCLA's Ronald Reagan Medical Center in Los Angeles. The scope has not been recalled but the FDA was aware of the design flaw, and says it's outlining new sterilization practices for the device. The agency finally took action after two patients died and five have tested positive for the bacteria. To date, 179 people at the hospital may have been exposed to the CRE infection and are now being monitored, according to the Los Angeles Times.
"FDA didn't do its job," said Diana Zuckerman, president of the nonprofit National Center for Health Research.
The hospital says that it cleaned the medical devices according to proper protocol but it says that even high levels of disinfection may not entirely get rid of the CRE infection. There have been six separate outbreaks this year at other hospitals.
"If we pulled the devices from the market, we would prevent hundreds of thousands of patients from accessing a beneficial and life-saving procedure," an FDA spokeswoman, who, like other agency officials, spoke on condition she not be named, said to the Los Angeles Times. "So at this time, the continued availability of these devices is in the best interest of the public health."
CRE is a family of germs that are known for high levels of resistance to antibiotics and therefore, they’re difficult to treat. If the infection enters your bloodstream, patients have a 50 percent chance of survival. Healthy people don’t normally get CRE infections because they’re acquired in healthcare settings like hospitals and nursing homes, especially when patients need ventilators, catheters, or take long courses of antibiotics.
The medical scope that seems to be to blame for this outbreak is problematic because some parts of the scope are difficult to reach and therefore, difficult to clean. As a result, unless healthcare officials receive better guidance for how to clean the scopes or they’re redesigned, problems will continue to persist.
"The FDA's move is a step in the right direction, but it doesn't have a lot of guidance about how to reduce the risk beyond what was already known," said Dr. Jeffrey Duchin, an epidemiologist who oversaw the Seattle-King County investigation of the recently disclosed bacteria outbreak at Virginia Mason Medical Center in Seattle.
Superbugs are an ever growing risk as a result of the overuse of antibiotics. According to the CDC, 2 million people become infected each year and 23,000 people die as a result of antibiotic resistant superbugs. Many more die as a result of complications that were made worse by superbugs. The two main culprits are the use of antibiotics in livestock, which contributes to 80 percent of all antibiotic use. Additionally, doctors tend to overprescribe antibiotics for viral rather than bacterial infections (for which they are ineffective).
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