FDA Issues Warning on Heater-Cooler Device

The U.S. Food and Drug Administration (FDA) recently issued a warning that heater-cooler devices used during invasive procedures such as open-heart surgery could spread potentially deadly bacteria. The agency is investigating the possibility that nontuberculous mycobacteria (NTM) can form in the water tanks of the devices, be spread throughout an operating room and cause severe complications when they enter a patient’s open chest cavity.

How the Bacteria Spreads

Heater-cooler devices, which are somewhat similar in appearance to a portable air conditioner, are used to keep a patient’s body at a safe temperature during surgery. The devices have tanks that are used to store water. While the water does not directly contact the patient, heater-cooler devices are not airtight. As a result, water can spray through the device’s exhaust vent and move throughout an operating room.

The water in these tanks can sometimes harbor NTM, which can enter the body and cause severe infections. NTM are commonly found in the water and soil but is typically harmless. However, NTM are extremely dangerous for someone with a compromised immune system.

Hospitals in several states have reported NTM infections, most of which have been traced to a specific model of heater-cooler device, LivaNova’s Stockert 3T. According to a recent article in Consumer Reports, NTM infections have been found in 16 U.S. hospitals and at least nine patients have died.

FDA Recommendations

The FDA issued a list of recommendations for healthcare providers in order to help reduce the risk of infections.

• Providers should strictly adhere to manufacturer cleaning and disinfection instructions and establish regular cleaning, maintenance and disinfection schedules.
• Tap water should never be used to fill, rinse or top off heater-cooler device water tanks, because the water may contain NTM.
• The device’s exhaust vent should be directed away from the patient in order to reduce potential exposure.