October 19, 2018
“Heater-cooler devices provide important benefits to control a patient’s temperature during heart surgery, but these devices also have been associated with infections spread by bacteria that can be released into the air from water contained in the device components. Today, the FDA is highlighting important new actions that will reduce the risks associated with one such device,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “We believe the steps taken by the company to implement new labeling changes and a design change will help reduce the emission of aerosols that potentially contain harmful bacteria. Today’s action aligns with the agency’s ongoing commitment to reducing the risk of infections associated with heater-cooler devices.”
The U.S. Food and Drug Administration issued a safety communication today to alert health care providers about labeling changes and a design correction announced by device manufacturer LivaNova for its Stӧckert 3T Heater-Cooler System; this is a device used to control a patient’s temperature during open-heart surgery. LivaNova will also be executing a correction to the device to include a design upgrade consisting of a new vacuum canister and internal sealing that will reduce the emissions of aerosols from the device, potentially reducing the spread of bacteria. As part of the recall, the company announced updated labeling instructions advising users to monitor the concentration of hydrogen peroxide in the device’s water circuit and to adjust the concentration if it falls below 100 ppm. Hydrogen peroxide helps to reduce the growth of bacteria that may be present in the water.
Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. The FDA has been conducting an ongoing analysis of adverse event reports and has been collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts to evaluate strategies for mitigating infections associated with heater-cooler devices. These infections are caused by nontuberculous mycobacteria, which are widespread and typically found in soil and water, including tap water sources.
Over the past three years, the FDA has communicated numerous times on the issue of infections associated with heater-cooler devices to provide guidance to health care providers and patients. The agency issued several safety communications, held meetings with health care providers, hospital administrators and public health agencies, and held a public advisory committee meeting to gain input on this issue. The FDA website contains information and resources for patients and recommendations to health care providers and staff at health care facilities to help minimize patient risks of infections associated with all heater-cooler devices.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.