The U.S. Food and Drug Administration (FDA) recently provided an update regarding the agency’s ongoing investigation into the link between Stockert 3T heater-cooler units and serious non-tuberculous mycobacteria (NTM) infections. People diagnosed with this infection after having open-chest surgery are filing 3T heater-cooler lawsuits to recover damages for their related infections.
The FDA is collaborating with “professional societies, public health partners, heater-cooler manufacturers, and infectious disease specialists to evaluate additional strategies for mitigating infections associated with heater-cooler devices.” The agency is urging hospitals and medical clinics to use extreme caution when cleaning and disinfecting heater-cooler units, and also to ensure that they are using the most up-to-date version of the manufacturer’s instructions when doing so.
What Are Heater-Cooler Units Used For?
The Stӧckert 3T heater-cooler unit is used during major open heart and lung transplant surgeries to help sustain the patient’s body temperature. The system circulates water through tubes into a heat exchanger to keep the patient warm, but tainted water from inside the unit can be circulated into operating room air, where it can contaminate the exposed surgical site of the patient.
According to the Centers for Disease Control and Prevention (CDC), there is a one percent risk that patients who have undergone cardioplegic surgery involving a Stӧckert 3T will contract M. chimaera.
3T Heater-Cooler Lawsuits
Of the 16 heater-cooler lawsuits that have been filed in six different districts, 10 of the cases are being informally coordinated in South Carolina federal court, and six actions are pending outside of South Carolina.
The heater-cooler lawsuits make common allegations that the plaintiffs were exposed to M. chimaera or M. abscessus, types of non-tuberculous mycobacteria (NTM) after undergoing surgery utilizing the 3T Heater-Cooler system. While some patients do not become ill from NTM exposure, those with a weak immune system may contract a slowly progressive and destructive disease that may become chronic and require ongoing medical treatment.
If you or anyone you know has experienced an infection post open-chest surgery, you may be able to file a claim. Please share this 3t heater-cooler lawsuits blog to those who may benefit.