The US Food and Drug Administration has issued another update to its ongoing evaluation of heater-cooler systems from different manufacturers, which are used to regulate the temperature of patients undergoing cardiothoracic surgery via sternotomy, and concerns over their associated risks of nontuberculous mycobacterial infections.
Two such companies, CardioQuip and Gentherm Medical LLC, have announced voluntary recalls for labeling updates that outline interim mitigation strategies for lowering the risk of such infections “while these manufacturers complete further testing for cleaning and disinfection validation, and aerosolization,” the agency said. CardioQuip initiated its recall of affected devices on July 30, Gentherm on June 7.
Two other companies, Maquet and Terumo, announced their recalls of affected devices on July 14 and April 30, respectively, and instructed centers “to discontinue use of their heater-cooler devices because these manufacturers will not be pursuing a cleaning and disinfection protocol that addresses the risks” of nontuberculous mycobacterial infections.
The FDA statement follows its February announcement that it had approved similar labeling changes for the LivaNova Heater-Cooler System 3T, which featured “validated cleaning and disinfection instructions” and an aerosol collection system “to reduce (but not eliminate) the risk of potential emission of aerosols.”
The FDA reassures that “in appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission.”
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