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
Center for Devices and Radiological Health
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