The US Food and Drug Administration (FDA) has cleared a new version of the LivaNova Heater-Cooler System 3T, which is used during cardiothoracic surgery to warm or cool a patient to improve medical care and patient outcomes. The changes—designed, says the FDA, to help reduce the risk of patient infections—include new labelling, with validated cleaning and disinfection instructions.
In a statement from the organisation, Bram Zuckerman, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, says: “We cleared a new version of the LivaNova Heater-Cooler System 3T, which incorporates all of the corrections made to the device since 2015, and adds new validated cleaning and disinfection instructions and updated labelling. Facilities using a Heater-Cooler System 3T that is not the newly cleared version should immediately start using the new labelling that details the validated disinfection and cleaning instructions. We are also reminding health care providers and staff to continue to follow recommendations in the previous LivaNova Medical Device Correction Letters from April 2018 and October 2018 regarding the deep cleaning service and design upgrade.”
Heater-cooler devices have 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 and aerosolise. This could send non-tuberculosis mycobacteria (NTM) through the air and through the device’s exhaust vent or other unsealed pathways, the environment, and to the patient.