Hemotherm 3T devices, Although the bacteria did not directly enter the patient’s blood, it was aerosolized and could potentially be transmitted through the air during surgery. The risk was primarily associated with immunocompromised patients, as the bacteria could cause a severe infection known as non-tuberculous mycobacterium (NTM) infection.
In response to the FDA warning and to ensure patient safety, LivaNova, the manufacturer of the device, initiated a voluntary recall of the affected units. Additionally, they implemented enhanced cleaning and disinfection protocols for the devices to minimize the risk of bacterial transmission. It is crucial for healthcare facilities to adhere to these cleaning protocols and monitor the water quality in the device to mitigate the potential for contamination.
It’s important to note that when the Heater-Cooler System Hemotherm 3T device is used correctly, following the updated cleaning procedures and guidelines, it can still provide valuable temperature control during cardiac surgeries while maintaining patient safety. Healthcare providers are advised to stay informed about any updates or recommendations from regulatory authorities and the device manufacturer to ensure the safe and effective use of the device.
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