FDANews
FDAnews Device Daily Bulletin

One in Three Heart Surgery Temperature Control Devices May Be Contaminated

June 20, 2017

More than one-third of the devices used to control blood and organ temperatures during open heart surgery may be contaminated, according to research presented at a recent conference.

Over an 18-month period, 37 percent of heater-cooler units at 23 hospitals tested positive for M. chimaera and/or legionella, according to research presented at the 44th Annual Conference of the Association for Professionals in Infection Control and Epidemiology. The water used in the device tanks does not come in direct contact with patients but can aerosolize and transmit bacteria to patients, according to the researchers.

LiveNova, which manufactures one of the most commonly used heater-cooler units, responded to the research by developing a three-part plan to resolve the issue. It will modify the device design to include internal sealing and a vacuum system, implement a no-charge deep infection service and loan users a new device at no charge. — Zack Budryk

View today's stories