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FDA Safety Alert for Cardiovascular Heater-Cooler Devices

November 4, 2015

Doylestown Hospital complies fully with safety precautions

The FDA issued a “Safety Communication” recently about a possible association with heater-cooler devices and Non-tuberculosis Mycobacterium (NTM) infections. The devices are used to heat or cool a patient’s blood during cardiac surgery and have been in use for many years. DH reviewed five years of records and found no evidence of any infections related to use of the heater-cooler devices. Maintenance records also reveal that DH met or exceeded the manufacturer’s recommendations.

Please remember that the FDA Alert is related to a possible connection between NTM infections and the heater-cooler devices. Very few cases have been identified in very few hospitals – and absolutely zero cases have been found at Doylestown Hospital in a five-year review of our use of the devices.