FDA panel to mull cardiac heater-coolers over infection risk

The FDA said today it will hold a public advisory committee meeting of its Circulatory System Devices Panel to discuss bacterial infections associated with the use of heater-cooler devices during cardiac surgical procedures.

The federal watchdog said it will seek expert scientific and clinical opinions on the contamination of heater-coolers, as well as patient infections and mitigation strategies to prevent future infections.

The agency said it will provide recommendations on cleaning and disinfection methods for such devices, the amount of premarket data needed to validate cleaning and disinfection and devices and appropriate risk mitigations to prevent infections.

Guidelines and criteria based on risk stratifications schemas will also be discussed, specifically for notifying patients who may have already been exposed to nontuberculous myobacteria infections prior to cardiac surgeries.

Background material will be made available 2 days before the meeting, the FDA said. The meeting is slated to be held June 2 and 3 in D.C.

Last October, the FDA issued a warning over issues with infections associated with heater-cooler devices during cardiothoracic and other surgical procedures.

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.

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