FDA Recommends Caution When Using Heater-Cooler Devices in Cardiothoracic Surgery

The US Food and Drug Administration (FDA) has updated a previous safety communication regarding the risk of mycobacteria infections from heater-cooler devices used to regulate body temperature during cardiothoracic surgery. The update provides recommendations for institutions, staff, and patients coming into contact with the devices. 

The subject of the safety communication is the Stӧckert 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH). The FDA has previously reported that the manufacturer found M. chimaera contamination on the production line and water supply at its facility and subsequently added cleaning and disinfection procedures effective September 2014.

Although the FDA says it is not aware of any patients infected with M. chimaera from 3T devices manufactured after September 2014, the agency is advising patients to be aware of the risk and signs and symptoms of the infection as well as urging healthcare professionals to prevent airborne transmissions by being cautious when using these devices.

The FDA says healthcare workers using 3T devices should immediately remove from service any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been associated with known patient infections. They also should use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device, and direct and channel the heater-cooler exhaust away from the patient during surgery. It is also important, the agency notes, to be aware that device contamination can occur from other sources, such as environmental contamination or device contact with contaminated accessories.

For institutions that are using 3T devices manufactured prior to 2014, the FDA strongly recommends transitioning away from using them in open-chest cardiac surgery “until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.” Furthermore, the agency suggests limiting use of these devices “to emergent and/or life-threatening situations if no other heater-cooler devices are available.”