12:14 GMT +316 October 2019
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    BioHazard Material UCLA Medical School

    FDA Knew Deadly “Superbug” Could Spread but Issued No Warnings

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    Nearly two hundred people at a California hospital were recently exposed to a deadly bacteria, seven got real sick and two died, and it looks like federal regulators have known for several years that the medical devices used on these patients may have spread the lethal bug, but did nothing.

    The device is the reusable instrument called duodenoscope, and apparently it’s not the first time. Two years ago, the US Food and Drug Administration (FDA) received reports of infections from similar devices, and while several hospitals implemented more stringent sterilization procedures, the FDA made no such recommendation.

    In this new case, UCLA reported that 179 patients at the Ronald Reagan UCLA Medical Center were exposed to the deadly “superbug” through contaminated medical instruments which infected seven of those patients. The university says two deaths may be linked to the bacteria, which is resistant to most known antibiotics.

    Ronald Reagan UCLA Medical Center
    Ronald Reagan UCLA Medical Center

    UCLA officials say the infections may have been transmitted through specialized endoscopes, which are medical devices used to diagnose and treat of pancreatic and bile-duct problems. The instruments are inserted into the mouth, and the bacteria can cause infections of the bladder or lungs.

    The medical devices may have still had the bacteria even though they were sterilized according to instructions, but since the “superbug” outbreak the devices have been removed and the decontamination process upgraded, according to hospital officials.

    The FDA this week sent a warning about the instrument, saying that even when a manufacturer’s cleaning instructions are followed, infectious bacteria can “embed” and stay on the device because there are tiny parts that make disinfection very difficult. The federal agency has not issued any recommendation for stricter sterilization and disinfection procedures, but a spokesman said they are currently evaluating the situation.

    The manufacturer of the device, Olympus Corporation of the Americas, issued a statement on Thursday, saying “meticulous manual sterilization” is important, and the company says it is working with the FDA on the “superbug” issue. Earlier this month, the company disclosed it was being investigated by the U.S. Justice Department over allegations of kickbacks and improper payments to doctors and other customers.  

     

     

     

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    FDA, UCLA, bacteria, superbug
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