Last year, the FDA warned doctors and patients that open-chest surgery performed with a Stockert 3T heater-cooler devices could increase a patient’s risk of developing a dangerous NTM infection. The devices had been linked with Mycobacterium chimaera (M. chimaera) and Mycobacterium Abscessus (M. abscessus) infections, among others, which can cause non-healing wound infections and other serious injuries and can sometimes lead to death.
A number of subsequent studies linked the devices, manufactured by Sorin Group Inc. and LivaNova, to these dangerous infections. Many hospitals also reported heater-cooler related infections and sent warning letters to patients to alert them to the possible symptoms of an M. chimaera infection.
3T Heater Coolers Can Transmit Dangerous Bacteria into the Operating Room
The Stockert 3T heater-cooler device has three water tanks that temperature-controlled water travels through to reach external heat exchangers or warming/cooling blankets through closed circuits. Though the water inside the water tanks never comes into contact with the patients, as it travels through the tanks, contaminated water inside the device can aerosolize. The device’s exhaust fans can then push the aerosolized water into the operating room where it can transmit bacteria to the patient undergoing surgery.
Now, a new study suggests that the contamination of these devices may be more widespread than previously believed. The results of the research were presented at the 44th Annual Conference of the Association of Professionals in Infection Control and Epidemiology (APIC).
Over One-Third of Heater-Cooler Devices Contaminated
In the new study, researchers took water samples from 89 heater-cooler units that were in use in 23 hospitals in 14 states, the District of Columbia, and Canada, to find out if any of them were contaminated. They found that 33 of the units (37 percent) tested positive for M. chimaera, while four more units were contaminated with Legionella, another type of bacteria that can cause Legionnaires’ disease (a severe form of pneumonia). Other strains of mycobacteria were also detected in many of the units, and 97 of the 653 water samples were deemed “uninterpretable” because of high levels of bacterial and fungal contamination.
“The extent of contamination from such a rare organism in multiple units from all over the country was surprising,” said John Rihs, lead author of the study. Some of the devices tested positive for the bacteria “for months” indicating that the contamination persisted even after the devices were cleaned. “These results highlight the importance of monitoring the decontamination and maintenance schedules of these devices to minimize the risk of patient harm,” Rihs said.
Hospitals Alerted by CDC to Notify Open-Chest Surgery Patients
The Centers for Disease Control and Prevention (CDC) issued an alert to hospitals, advising them to notify patients who had undergone open-chest surgeries involving a Stockert 3T heater-cooler device that they may be at risk for a life-threatening infection. The alert also noted that the devices were “likely contaminated with the rare bacteria Mycobacterium chimaera during manufacturing.”
In 2016, the FDA held a meeting with medical experts, and health care providers to discuss the problem, and to review recommendations to help prevent the spread of infection. The FDA recommended that medical centers direct the heater-cooler exhaust away from the patient, and strongly consider transitioning away from the use of any 3T heater-cooler devices manufactured prior to September 2014.
Exclusively focused on representing plaintiffs—especially in mass tort litigation—Roopal Luhana prides herself on providing unsurpassed professional legal services in pursuit of the specific goals of her clients and their families. While she handles complex cases nationwide on behalf of consumers, Ms. Luhana resides with her family in Brooklyn, New York.