Researchers warn that contaminated 3T Heater-Cooler systems may be responsible for nearly 300 invasive infections every year, which may not surface until long after the devices are used during heart surgery or other procedures, suggesting that mandatory reporting policies be implemented for nontuberculous mycobacterial (NTM) infections.
In the March edition of Emerging Infectious Diseases, a journal published by the U.S. Centers for Disease Control and Prevention (CDC), Swiss researchers investigated how frequently patients undergoing surgery involving a 3T Heater Cooler devices (HCDs) were actually infected due to contaminated devices distributed worldwide in recent years.
The report warns that contaminated surgical heater-cooler systems have led to a “worldwide epidemic” of invasive Mycobacterium chimaera infections, which may remain dormant for months or even years after exposure, before resulting in life-threatening health complications.
Surgical heater-cooler systems are used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain Sorin 3T Heater-Cooler systems found in operating rooms nationwide were contaminated with bacteria, which may then be released in a mist into the operating room, where it may enter the sterile surgical site.
In this new report, researchers note that while Swiss officials were the first to identify the problem in 2014, it is unknown how widespread the surgical heater-cooler infections are on a global scale. To address that, researchers obtained data from a wide variety of sources, including the Swiss National Registry for Cardiac Surgery and the Swiss Federal Office of Statistics.
According to their findings, they estimate that there are 156 to 282 cases per year of new M. chimaera infections caused by contaminated 3T Heater Cooler systems in the 10 major cardiac valve replacement market countries.
“In summary, our data provide an estimate of the global burden of M. chimaera associated with open heart surgery, enabling policy makers to guide actions and to decrease the risk for transmission from HCDs. Our data suggest implementation of systematic lookback approaches in each country where LivaNova 3T HCDs have been used to optimize case finding,” the researchers concluded. “In addition, countries may consider mandatory reporting of invasive nontuberculous mycobacterial infections.”
As a result of the surgical heater-cooler infection risks, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated systems, recommending continued medical monitoring.
3T Heater Cooler Infection Lawsuits
Dozens of product liability lawsuits have been filed against the manufacturer of the device, on behalf of individuals diagnosed with NTM infections following heart surgery where a contaminated heater-cooler may have been used.
Given similar questions of fact and law raised in complaints pending in federal courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation recently established consolidated pretrial proceedings for the cases, centralizing the claims before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts.
In a safety communication issued last year, FDA officials highlighted concerns about the risk. At that time, the CDC also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
Over the coming months and years, as additional heart surgery infections may be diagnosed and injury lawyers investigate additional claims, the size and scope of the litigation is expected to increase substantially.