Heater-cooler devices use water tanks to provide temperature-controlled water to keep patients warm or cool during surgical procedures.
While water in the devices does not contact patients, the federal watchdog warned that there is potential that contaminated water could enter other parts of the device, which could be aerosolized through its exhaust vent.
Exhausted contaminated water could transmit bacteria through the air to the environment and patient, the FDA warned.
The agency warned that the devices have been associated with nontuberculous mycobacteria infections, primarily in patients during cardiothoracic surgical procedures. The data came from analysis of adverse events, medical literature and other public health agencies.
The FDA said it has received 32 medical device reports of patients with infections associated with the devices, with 25 of the reports received during 2015.
The federal agency released a list of recommendations for operators using the device, suggesting strict adherence to cleaning and disinfecting instructions, not using tap water to rinse, fill, refill or top-off water tanks, directing exhaust vents away from the surgical field.
The FDA also suggested operators develop and follow quality control programs for maintaining, cleaning and disinfecting the device, and to immediately remove devices that are discolored or cloudy.