Risk of Infection from Heater-Cooler Devices Prompts FDA Safety Communication

Washington, DC: The Food and Drug Administration (FDA) has issued a warning for all heater-cooler devices providing heated and/or cooled water to: oxygenator heat exchangers, cardioplegia (paralysis of the heart) heat exchangers, and/orwarming/cooling blankets.

Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems.

Between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015. Some reports describe NTM infections related to cardiothoracic surgeries, but other reports do not specify the procedure the patient was undergoing. Eight reports were related to 3 events describing patient infections occurring in U.S. health care facilities. The remaining 24 reports involved health care facilities outside the United States, most of these in Western Europe. In some cases, patients presented with infections several months to years after their surgical procedures. It is important to note that half of the 32 reports submitted to the FDA describe bacterial contamination of the heater-cooler device without known patient involvement or infection. The FDA is not aware of NTM infections acquired by hospital staff.

Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits 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 (aerosolize) through the device' exhaust vent into the environment and to the patient.

It is possible that some cases have not been reported to the FDA. It is challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections, particularly NTM infections, may be associated with the use of or exposure to a particular medical device. The FDA continues to evaluate reports through follow up with health care facilities and manufacturers to determine which factors may have contributed to the reported events.


 

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Published on Oct-16-15