FDA Updates Infection-Control Measures for LivaNova Heater-Cooler System

Disclosures

February 26, 2020

The US Food and Drug Administration (FDA) has issued another update to its October 2015 safety communication describing a potential risk of infection associated with the Stöckert 3T Heater-Cooler System from LivaNova and a new hardware upgrade with revised instructions that address the problem.

The 3T Heater-Cooler System provides temperature-controlled water through a closed circuit to heat-exchanger units and warming or cooling blankets during cardiac surgery. Its water has the potential for bacterial contamination, which could spread within the devices, aerosolize, and then be emitted into the operating room environment, possibly infecting the patient, the FDA notes.

LivaNova released a design upgrade in October 2018 consisting of a vacuum canister and internal sealant intended to reduce the risk of bacterial emissions, and updated instructions for cleaning and disinfection as well as enhanced monitoring of hydrogen peroxide concentrations in its circulated water.

The latest announcement reminds centers with the 3T Heater-Cooler System to follow the new instructions, which accompany a February 24 Device Correction Letter; to be aware of the vacuum canister and sealant upgrade; and recommend that it be added to any 3T Heater-Cooler System already in service.

Alternatively, the alert says, hospitals can replace their devices nearing the end of their projected service life with newly approved 3T Heater-Cooler Systems already equipped with the vacuum canister and sealant components.

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