Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.
The Food and Drug Administration (“FDA”) has warned that using heater-cooler devices during surgery has been linked to non-tuberculous mycobacteria (“NTM”) infections. “NTM organism are widespread in nature and can be found in soil and water, including tap water sources,” the FDA explained. “They are typically not harmful, but in rare cases may cause infections in very ill patients and/or individuals with compromised immune systems.”
According to an October 15, 2015 FDA safety communication, “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’s exhaust vent into the environment and to the patient.”
The FDA stated, “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 hospitals staff.”
According to the FDA, Eight reports were related to three events describing patient infections occurring in U.S. health care facilities, and the remaining 24 reports involved health care facilities mostly in Western Europe. It is possible that some cases have not been reported to the FDA, the communication says, but the FDA says it is “continuing to evaluate reports through follow up with health care facilities and manufacturers to determine which factors may have contributed to the reported events.”
The Food & Drug Administration recommends facilities using these devices implement the following measures:
-
Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer’s device labeling. Ensure you have the most current version of the manufacturers’ instructions for use readily available to promote adherence.
-
Do not use tap water to rinse, fill, refill or top-off water tanks since this may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. 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. Deionized water and sterile water created through reverse osmosis is not recommended because it may promote corrosion of the metal components of the system.
-
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.
-
Establish regular cleaning, disinfection and maintenance schedules for heater-cooler devices according to the manufacturers’ instructions to minimize the risk of bacterial growth and subsequent patient infection.
-
Develop and follow a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. Your program may include written procedures for monitoring adherence to the program and documenting set up, cleaning, and disinfection processes before and after use.
-
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.
-
Consider performing environmental, air, and water sampling and monitoring if heater-cooler contamination is suspected. Environmental monitoring requires specialized expertise and equipment to collect and process samples, which may not be feasible in all facilities.
-
Health care facilities should follow their internal procedures for notifying and culturing patients if they suspect infection associated with heater-cooler devices.
-
Submit a report to the manufacturer and to the FDA via MedWatch, as described below, if you suspect heater-cooler devices have led to patient infections.
Doctors and patients should report adverse events or side effects related to the use of heating-cooling to the FDA.
