FDA Update on Heater-Cooler Device Infections

FDA has provided an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using the devices.

Two heater-cooler manufacturers (CardioQuip and Gentherm Medical) announced voluntary recalls to provide updated labeling with interim mitigation strategies to help reduce the risk of NTM infections, while they complete further testing for cleaning and disinfection validation, and aerosolization. And, two manufacturers (Terumo and Maquet) announced voluntary recalls to tell facilities to discontinue using their devices because they will not be pursuing a cleaning and disinfection protocol that addresses the risks of NTM infection.

Additionally, FDA previously announced in 2/2020 that the LivaNova Heater-Cooler System 3T was cleared with changes to help reduce the risk of patient infections, with validated cleaning and disinfection instructions and the 3T Aerosol Collection Set to reduce (but not eliminate) the risk of potential emission of aerosols.