Stockert 3T Heater-Cooler medical devices, used in several types of thoracic procedures, have been linked to serious infection after heart surgery.

According to an article in ScienceDaily, 37% of 89 devices tested between July 2015 and December 2016 were found to have a bacteria known as Mycobacterium chimaera present within them. This bacteria is definitively associated with infection after heart surgery that can sometimes be fatal.

A warning from the FDA says that former heart bypass patients may harbor the bacteria for several months or even years after the initial operating room exposure, making diagnosis difficult. The infection after heart surgery that comes after this slow-growing bacteria has incubated for some time may not be diagnosed until months or years after surgery.

What is a Heater-Cooler Device?

A heater-cooler device is used in open thoracic (chest) surgeries to stabilize a patient’s temperature by either heating or cooling them. It uses water within a closed tank to exchange heat with other surgical devices that control blood temperature.

The water does not actually ever touch the patient, but by controlling its temperature and feeding it to warming and/or cooling blankets through closed circuitry, it is able to keep the patient stable. The water can also come in contact with external heat exchangers.

Many have questioned how bacteria existing in a closed water tank that doesn’t come in contact with a patient directly can cause infection after heart surgery or other open thoracic procedure.

According to the FDA, it is believed to enter other parts of the machine itself and aerosolize or mist bacteria into the very air of the operating room via the heater-cooler’s exhaust vent. In such an otherwise sterile environment, such an action is quite disturbing.

According to the Texas Heart Institute, more than 200,000 heart bypass surgeries are performed in the United States alone each year. A full 60% of these procedures have involved usage of a Stockert 3T heater-cooler device.

A few years ago, inspectors found evidence of Mycobactierum chimaera in the manufacturing facility where these cardiac heater-coolers are made. Updated testing found the plant to be free of bacterium.

Recent research that was made available at the 44^th Annual Conference of the Association for Professionals in Infection Control and Epidemiology seemed to indicate that the problem is much wider than originally thought.

In addition to the 33 Stockert 3T heater-cooler units (37%) that tested positive for Mycobacterium chimaera, four other units tested positive for other contaminants.

Critical Agency Communication Hopes to Make Fatal Infection After Heart Surgery A Thing Of The Past

The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to update heater-cooler device communications dedicated to medical professional audiences.

The communications warn hospitals, surgeons, nurses, and operating room personnel about how to maintain units to ensure the safety of patients for the long-haul, and avoid infection after heart surgery.

These urgent messages also encourage medical personnel to talk to their patients. The two agencies hope that communication about symptoms of infections will help ensure that proper medical treatment is sought early and lethal infection after heart surgery becomes a thing of the past.