Product News and Recalls

FDA Panel Investigates Heater-Cooler Role in Infections

fda investigating heater-cooler blanketsThe FDA’s Circulatory System Devices Panel met earlier this year to hear from scientists and clinicians over concerns that heater-coolers used in cardiac surgeries may be contributing to an increased risk of patient infection. If a definitive link is found, it could bring significant changes in the way the devices are used in these procedures.

Cardiac surgery is serious. Opening a patient’s chest and operating on their heart is a task reserved for those that are among the best at what they do. The patient’s life is, quite literally, in the surgeon’s hands and recovery can be just as threatening as the operation itself. Infection is a grave concern at this stage as the patient’s body works overtime to recover from the trauma of the procedure it just endured.

The heater-cooler is essentially a blanket with a network of tubes running through it. These tubes circulate warm or cold water, depending on the needs of the surgeon, and can be used to keep the patient’s core temperature within a range that is optimal for cardiac surgery. While no water from the device ever makes contact with the patient assuming the device is working as intended, the design of the device has been found to lend itself to bacterial growth in other internal components. Operation of the machine can then send this bacteria into the air of the surgical suite, eventually finding its way into the patient.

The specific infection is known as an M. Chimaera, or NTM infection, and it can be serious and even life threatening. Worse, the infection can take months or years to manifest.

The goal of the panel’s meeting is to determine whether additional guidelines regarding the cleaning and disinfection of heater-coolers are needed as well as determining what action, if any, is necessary for those patients that already had cardiac surgery where a heater-cooler was used.

32 reports of heater-cooler associated infection have been reported to the FDA. 25 of those were received last year alone. Patients who had cardiac surgery and show symptoms of M. Chimaera or NTM infection are urged to contact their doctor or surgeon immediately, regardless of how long ago the procedure may have been completed.