County health officials in Los Angeles have confirmed three cases of bacterial infections in patients who underwent open heart surgery, and are investigating the possibility of a fourth case. The infection has been linked to a specific heater-cooler device that is used during the procedure and which may have been contaminated during the manufacturing process.
The infection stems from a bacteria called Mycobacterium chimaera, which is slow growing and therefore difficult to catch and diagnose. It is so slow growing, in fact, that the associated infections can occur “months or years following a surgery.”
The acting director of LA county's acute communicable disease control program, Benjamin Schwartz, told reporters that all four patients had survived their infections. The risk of infection is “very low” according to officials, about 1 in 1000 chance; however, more than 70 cases have been reported worldwide since October 2016.
The bacteria most likely came from the LivaNova 3T heater-cooler device which is used in about 60% of heart bypass surgeries. The device is designed to regulate a patient's temperature while they are under the anesthetic. The particular heater-cooler linked to the infections has been in use since 2012.
After performing an investigation, the Food and Drug Administration explains that this particular heater-cooler has a water tank apparatus containing water which is not designed to come in contact with the patient. If the water is contaminated with the bacteria during the manufacturing process, however, the bacteria can become airborne and end up inside a patient's open chest in the middle of surgery. Mycobacteria are actually found naturally in the air and soil, according to the Center for Disease Control, but their ability to make people sick is heightened when they are introduced directly into a surgical incision site.
Deanna Wilke, a spokesperson for the manufacturer, LivaNova, told reporters last month, “We are working with regulators, clinicians and all relevant parties to resolve this important industry-wide issue.” While some hospitals are choosing to switch their heater-coolers to ones manufactured by different companies, other have chosen to continue using the LivaNova 3T. Officials are telling hospitals that they should warn their patients about the risk before they elect to go into open heart surgery that will utilize this particular model of heater-cooler.
In fact, hospitals both in the US and in Canada are warning previous open heart surgery patients to be on the lookout for possible signs of infection. A hospital in Ontario said that patients should be on the lookout for the following signs:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained fever and redness, heat, or pus around the sternal surgical incision
Infections of this kind are generally more likely to affect those with compromised immune systems, chronic diseases, and/or underlying health conditions.
Attorneys Charles Gilman and Briggs Bedigian have a proven track record litigating medical malpractice cases. They will work to hold doctors, hospitals, and medical manufacturers responsible for their errors and get you the compensation you deserve for your injuries. Call them today at 800-529-6162 or contact them online. The firm handles cases in Maryland, Pennsylvania, and Washington, D.C.