FDA Sends Recommendations to Hospitals Stop Superbug Infections

Posted on September 04, 2015 by Shapiro Law Group

The U.S. Food and Drug Administration (FDA) has sent recommendations to hospitals on how to clean duodenoscopes. Superbug infections involving the devices have been linked to 13 deaths and hundreds of infections.

Duodenoscopes are used in 660,000 medical procedures every year, putting countless people at risk for infections from CRE, an antibiotic resistant superbug.

Swab tests are sometimes used by hospitals to detect harmful bacteria on duodenoscopes. However, bacteria can hide in the small internal parts of the devices, evading the detection of tests. The internal parts also make cleaning the devices very difficult. At a University of California Los Angeles hospital, staff discovered two of their duodenoscopes were harboring CRE, despite following manufacturer instructions on cleaning.

Can New FDA Recommendations Stop CRE And Other Superbug Infections?

Instead of pulling the devices from the market, the FDA has responded by sending recommendations to hospitals on how to clean duodenoscopes. The FDA was reluctant to pull the devices from the market, claiming the benefits of duodenoscopes outweigh the risks. Under the recommendations, hospitals might use ethylene oxide sterilization or a multi-step disinfection process. Ethylene oxide gas could potentially reach into the small crevices of duodenoscopes where liquid disinfectants cannot.

The FDA has also sent warning letters to the manufacturers of duodenoscopes. FDA letters accuse the manufacturers of failing to report safety issues with the devices.

Allegations against the manufacturers may have merit. Since 2013, there have been eight outbreaks involving duodenoscopes. If FDA recommendations do not work, patients and hospitals will continue to be at risk from superbug outbreaks.

Shapiro Law GroupTampa Bay Medical Malpractice Attorneys

Tags: FDA


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