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FDA to Investigate Heater-Cooler Infections

The FDA is working with specialists to improve strategies for reducing incidences of bacterial infections associated with heater-cooler systems used to regulate a patient’s temperature during surgery.

The U.S. Food & Drug Administration (FDA) is working with specialists to prevent non-tuberculous mycobacteria (NTM) infections associated with heater-cooler devices.

Free Confidential Lawsuit Evaluation: If you had an infection after surgery with a heater-cooler machine, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

What’s the Problem?

June 6, 2017 – FDA recently issued an update into its ongoing investigation into heater-cooler infections, saying that it was collaborating with “professional societies, public health partners, heater-cooler manufacturers, and experts to evaluate additional strategies for mitigating infections associated with heater-cooler devices.”

In related information for healthcare providers, the agency urges hospitals and medical centers to be careful when cleaning and disinfecting heater-cooler units, and to make sure they are using the latest versions of manufacturers’ recommendations for doing so.

In October 2016, the Centers for Disease Control and Prevention (CDC) issued an advisory regarding Stockert 3T heater-cooler units manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH). The agency warned that some of the machines “were likely contaminated with rare bacteria Mycobacterium chimaera during manufacturing.”

A year earlier, investigators in Switzerland reported on an outbreak of a rare strain of NTM called M. chimaera in six heart surgery patients at the same hospital. A hospital in Pennsylvania also reported an M Chimera outbreak that summer.

FDA is continuing to investigate the problem and is coordinating with healthcare facilities to find ways to reduce potential health risks associated with heater-coolers. The agency is also working with infectious disease specialists to find ways to minimize patient exposure to NTM bacteria.

Do I Have a Heater-Cooler Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in heater-cooler lawsuits. We are handling individual litigation nationwide and currently accepting new infection cases in all 50 states.

Free Case Evaluation: Again, if you had a heater-cooler infection, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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