FDA In Brief: FDA Provides Update on Actions Taken to Help Reduce the Risk of Patient Infections During Cardiac Surgery

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-provides-update-actions-taken-help-reduce-risk-patient-infections-during-cardiac?utm_campaign=022520_FIB_FDA%20Update%20on%20Actions%20Taken%20to%20Reduce%20Infection%20During%20Cardiac%20Surgery&utm_medium=email&utm_source=Eloqua

FDA In Brief: FDA Provides Update on Actions Taken to Help Reduce the Risk of Patient Infections During Cardiac Surgery

The following quote is attributed to Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health:

“Heater-cooler devices are commonly used to warm or cool a patient to improve medical care and patient outcomes during cardiac surgery. They remain critical to patient care. The FDA takes seriously our responsibility to monitor device safety and performance and, after previously identifying the potential for contaminated water to aerosolize creating a risk of infection to patients, we’ve been working intensively with the device industry and medical community to understand this problem and reduce the risk of infection to patients. One specific model – the LivaNova Heater-Cooler System 3T – has been the focus of several FDA activities in recent years. The corrections made to this heater-cooler device since 2015, publicly available in the ... Read More