Devices

FDA Updates Precautions on Heater-Cooler Devices

FDA has updated a June safety communication calling attention to infections associated with Stӧckert’s 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) and to add steps that healthcare providers and facilities can take to mitigate patient risk. Over the past few months, the agency says it has continued to evaluate contamination and infection-related issues associated with the device, which is used during cardiothoracic surgeries and other procedures to warm or cool a patient include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although there is no direct patient contact with the water, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air through the device’s exhaust vent, FDA’s revised notice says.

FDA is recommending the following for facilities using 3T devices:

Immediately remove from service any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been associated with known M. chimaera patient infections at your facility.
Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.
Direct and channel the heater-cooler exhaust away from the patient, e.g., to the operating room exhaust vent.
Be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.
Review the recommendations in CDC's Health Advisory.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome