CardioQuip Modular Cooler-Heaters Increase Risk Of Infections During Heart Surgery, FDA Warns

Federal regulators warn that certain CardioQuip cooler-heater devices used to regulate patient temperatures during surgery could pose a risk of serious and life-threatening infections.

In a Letter to Healthcare Providers sent on September 30, the FDA indicates it was aware of, and continues to monitor, Nontuberculous mycobacteria (NTM) infections among patients who underwent cardiothoracic surgical procedures involving heater-cooler devices.

According to the letter, it has linked infections among three such patients to the use of the CardioQuip Modular Cooler-Heater (MCH), but similar problems also impact other surgical heater-cooler systems on the market.

The medical devices are designed to help regulate blood temperature during surgery. However, concerns over the safety of the devices emerged in late 2015, when the FDA warned about reports of heart surgery infections linked to other heater-coolers designs, indicating that a large number of adverse event reports had been received by the agency.

In June 2016, a panel of experts were convened to evaluated the problems, identifying at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems that were received between January 2010 and August 2015.

The FDA has continued to monitor the issue and now has determined the problem affects all heater-cooler systems, industry-wide.

“Previously, the FDA had not received reports of NTM patient infection or NTM device contamination with use of the CardioQuip MCH device. At this time, the root cause of NTM patient infection and device contamination with use of this device is not known,” the agency warned in the letter. “NTM patient infections, NTM device contamination, and in some cases both issues, have now been reported for all manufacturers of heater-cooler devices in the United States.”

The letter gives doctors several recommendations, indicating it still believes the use of such systems outweigh the potential infection risks. In addition, the FDA called on doctors to strictly adhere to cleaning and disinfection instructions for the devices, and to never use tap water to rinse, fill, refill or top off heater-cooler water tanks.

The FDA also urges healthcare professionals to establish regular cleaning and maintenance schedules for the devices, to always direct the devices’ exhaust vents away from sterile surgical fields and toward an operating room exhaust vent, and to immediately remove any heater-cooler from service if it shows signs of discoloration or cloudiness, and to consider environmental sampling if contamination is suspected.

The agency urges doctors to notify and evaluate any patients they believe could be infected due to the use of a heater-cooler system, and calls for health care facilities to report any suspect heater-cooler devices, which may have contributed to a patient infection, to its FDA Medical Product Safety Network (MedSun), and not its MedWatch Adverse Event Reporting System.