A recent study has concluded that more than one-third of all surgical heater-cooler devices may be contaminated heater-cooler units due to mycobacteria that can potentially be deadly.

The study found that out of 89 heater-cooler units in 23 hospitals in the United States and Canada, 33 of those units, or 37%, were contaminated heater-cooler units that tested positive for Mycobacterium chimera.

In the fall of 2016, the CDC and Health Canada issued warnings to hospitals, physicians and patients concerning the potential for mycobacteria infection that was associated with open-heart surgeries where the contaminated heater-cooler units may have been used since 2012. The FDA and Public Health Ontario have issued warnings similar to those of the CDC and Health Canada.

The study has raised new concerns about the widespread nature of the problem. “The extent of contamination from such a rare organism in multiple units from all over the country was surprising,” the study author stated, according to a press release that followed the presentation of the research at an annual conference held by the Association for Professionals in Infection Control and Epidemiology.

Across Canada and the United States, thousands of patients have received warning letters from hospitals informing them that they may potentially have been exposed to the mycobacteria and may develop an infection as a result.  Patients were urged to seek urgent medical care if they experienced certain symptoms suggesting a mycobacteria infection.

What are Heater-Cooler Units?

Heater-cooler units are medical devices used during open-heart surgery. They are designed to stabilize the patient’s blood temperature while undergoing surgery. The devices themselves use water tanks, but water never actually comes into contact with the patient. However, as the machine runs, water is aerosolized from the machine and can spread any potential bacteria into the air where it may deposit into the patient.

Approximately 60% of surgeries for heart bypass in the U.S. use the particular brand of heater-cooler unit that has been found to have a high percentage of contaminated heater-cooler units. Researchers traced the contamination to similar bacteria found at the facility where these devices were manufactured.

The bacteria that is present in the water that becomes aerosolized is known as Mycobacterium chimera. This is a rare non-tuberculosis mycobacteria that is typically not even considered as a diagnosis by physicians unless they specifically know to look for of this type of infection. Patients who become infected may not show symptoms until years later, and the symptoms are quite nonspecific.

Symptoms associated with the mycobacteria infection include night sweats that are unexplained and persistent in nature, weight loss that is not intended, fever, fatigue, muscle aches and perhaps redness or the presence of pus appearing at the site of the heart surgery incision. Because of the delay in symptom onset, many patients may not connect their symptoms their previous heart surgery.

If treated early, the infection may be able to be completely controlled with the use of long-term antibiotics. However, antibiotics taken long-term have problems of their own, such as permanently altering the composition of the gut microbiome which is essential for immune health. If not treated properly, the mycobacteria infection can be fatal.

Filing a Lawsuit over Contaminated Heater-Cooler Units

If you developed a mycobacteria infection after contaminated heater-cooler units were used during your heart surgery, you may be eligible to seek legal compensation. An attorney familiar with issues surrounding contaminated heater-cooler units can review your case for free and can advise you on how to take the next steps to pursue legal action.