The FDA‘s Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices

In October 2015, the FDA issued a Safety Communication to share recommendations with health care providers to help mitigate potential device contamination and subsequent patient infection associated with heater-cooler devices. Over the past few months, FDA has continued to evaluate contamination and infection-related issues associated with these devices and today, FDA launched a web page specific to heater-cooler devices.

See this link to the web page for further information: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/default.htm

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health