FDA Approves New Heater-Cooler System Designed to Prevent Bacterial Contamination That Has Plagued Competitors

Federal health regulators have approved the use of a new surgical heater-cooler system, which is intended to prevent nontuberculous mycobacterial (NTM) infections and patient deaths that have been linked to earlier devices sold in prior years.

On May 6, the U.S. Food and Drug Administration announced the approval of the Spectrum Medical Quantum Heater-Cooler and Qura Quantum PureFlow Heat Exchangers, for the warming and cooling of a patient’s blood during cardiopulmonary bypass procedures. According to the agency, the devices forgo using water, as other heater-cooler systems do, and instead use a glycol-based heat transfer fluid (HTF), which suppresses the growth of NTM and other bacteria.

Concerns over the safety of heater-cooler systems began to emerge in late 2015,  when the FDA warned about reports of heart surgery infections linked to heater-coolers, indicating that a large number of adverse event reports had been received by the agency.

In 2018, federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

Since then, problems with heater-cooler devices have continued, with the FDA warning the medical industry of ongoing NTM heater-cooler infections, and announcing recalls for four different heater-cooler systems, as recently as last October.

The problems have been linked to contamination of tanks and water in the systems, which then spread to patients, often leading to heart infections that take months of treatment to resolve and which have been linked to reports of “vegetation” growing on patient hearts.

These new devices use the HTF as a replacement for water, and the FDA says the fluid is designed to have antibacterial effects which make it a hostile medium for bacteria.

As early as 2016, the U.S. Centers for Disease Control and Prevention (CDC) issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

These concerns were centered around the Sorin 3T Heater-Cooler manufactured by Livanova, which faced about 100 product liability lawsuits brought by individuals who indicated that they contracted NTM infections following surgery, which were difficult to get rid of and led to numerous adverse health effects, including some deaths.

Livanova settled the majority of the cases for $225 million in April 2019.

Until these new devices are in broader circulation, the FDA is urging healthcare professionals not to use tap water to rinse, fill, refill or top-off heater-cooler tanks, since that could introduce NTM organisms to the devices; to always direct or channel the exhaust vents away from surgical or sterile fields and toward an operating room exhaust vent; to create regular cleaning and disinfection schedules for the devices, and immediately remove any heater-cooler from service if it shows discoloration or cloudiness in the fluid lines or circuits.

The agency also recommends an environmental, air, and water sampling and monitoring in the event contamination is suspected. Patients suspected of having developed an infection after the use of a heater-cooler device during surgery should be notified and evaluated, and any issues linked to the devices, including infections and contamination, should be reported via the FDA MedWatch Adverse Event Reporting Program.