STORY FROM: Drugs & Medical Devices

3T Heater-Cooler Manufacturer Issues Updated Infection Prevention Info

WASHINGTON, D.C. — The maker of the 3T Heater-Cooler System, LivaNova, has issued a letter informing health care providers of ways to reduce potential cardiac surgery infection associated with the device, according to an alert from the Food and Drug Administration.

In the letter, LivaNova (formerly Sorin Group Deutschland GmbH), has “provided updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that sufficient concentration of hydrogen peroxide is present to limit microbial growth, and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm,” the FDA explained in an Oct. 22 ...

Associated Documents
Letter



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