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FDA Warns that Use of Heater-Cooler Devices are Associated with Nontuberculous Mycobacteria Infections

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to improve health outcomes. Some heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets. Even though the water does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air through the device’s exhaust vent.

A similar device, the Bair Hugger Forced Hot Air Warming Blanket, was recently shown to be associated with deep joint infections. The Bair Hugger blows hot air in order to keep the patient warm, but the air filter is not efficient as was claimed by the manufacturer, 3M. This allows bacteria to migrate toward the surgical cite and cause infections. We are currently investigating claims of infection from surgical heating devices. If you were injured from a surgical heating device contact us today online or at 800-349-0004.

The FDA recently determined that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections. The infections occur mainly in patients undergoing cardiothoracic surgical procedures. NTM organisms are common in nature and can be found in soil and water. They are normally not harmful, but may cause infections in very ill patients and/or in individuals with compromised immune systems.

The FDA recommends that facilities and staff using heater-cooler devices consider implementing additional measures to reduce risk to patients:

  • Strictly adhere to the cleaning and disinfection instructions of the most current version of the manufacturer’s device labeling.
  • Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns to rinse, fill, refill or top-off water tanks.
  • When making ice needed for patient cooling during surgical procedures use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns.
  • Direct the heater-cooler’s vent exhaust away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient.
  • Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits, which may indicate bacterial growth. Consult your hospital infection control officials to perform the appropriate follow up measures and report events of device contamination to the manufacturer.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

The full FDA safety communication can be found here.

At Rheingold Giuffra Ruffo Plotkin & Hellman LLP, we have been helping people from New York and across the nation with their most critical legal problems for over 30 years. We are able to handle a wide range of medical device liability claims. If you were injured from a surgical heating device contact us today online or at 800-349-0004.

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