martes, 25 de octubre de 2016

FDA Discusses Recommendations to Mitigate the Risks of Infections Associated with Heater-Cooler Devices - November 1, 2016 2:30 PM ET

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Information for patients about FDA cardiovascular-related product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances. Please do not reply to this message. 

The U.S. Food and Drug Administration (FDA) will host a conference call for health care providers at 2:30 PM ET on November 1, 2016 to discuss Mycobacterium chimaera (M. chimaera) infections associated with the use of the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in U.S. patients who have undergone cardiothoracic surgeries and to review the recommendations from the FDA’s October 13, 2016 Safety Communication to help health care providers reduce the spread of infection related to use of this device.
A heater-cooler device is commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes.  Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.  Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.
Please mark your calendars to join the FDA on Tuesday November 1, 2016 to discuss this public health concern. Representatives from the Centers for Disease Control and Prevention will assist with answering questions during the question and answer portion of the call.
We also encourage you to share this information with your members, fellow health professionals, and others who may find this announcement of interest.
Conference Call Information:Date: November 1, 2016
Time: 2:30 – 3:30 Eastern Time
Dial-In: 1-800-475-0478, passcode HCD
International Callers Dial: 1-517-308-9373
To ensure you are connected, please dial-in 10 minutes prior to the start of the conference call. 
A replay of the briefing will be available one hour after the call ends until December 1, 2016. To hear the replay callers in the United States and Canada can dial 1-800-677-9149.  International Callers can dial 1-203-369-3408.
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the FDA’s Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100, or by email at

Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network

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