Swiss Study Confirms Global Outbreak of M. Chimaera Linked to LivaNova Heater-Coolers. A new study published in Infection Control & Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America, has linked a global outbreak of bacterial infections to heater-cooler devices (HCD) manufactured by LivaNova (formerly known as Sorin Group). Swiss researchers found that contamination of the devices, which are stand-alone devices used for heat exchange in heart-lung machines, are associated with infections caused by Mycobacterium chimaera (M. Chimaera), a type of nontuberculous mycobacterium (NTM).
Personal injury attorneys at Parker Waichman LLP note that this study is the latest piece of evidence linking LivaNova heater-cooler devices to M. chimaera infections. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been issuing warnings as well.
The study was led by Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland. “It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” said Sommerstein. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”
M. chimaera is a slow-growing bacterium, and infections are difficult to diagnose. The researchers made several recommendations to prevent contaminations, which include removing contaminated heater-coolers from air near critical medical areas. The authors also advised education for clinicians so they know about the risks associated with M. chimaera. Additionally, researchers recommended screening for patients with unexplained fevers who had open heart surgery, heart transplantation or those who were exposed to ventricular assist devices.
“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,” Sommerstein said.
CDC, FDA Heater-Cooler Infection Warnings
Last month, genetic fingerprinting showed that M. chimaera infections stemmed from a single source where the Stöckert 3T Heater-Coolers were manufactured in Germany. The finding was a strong piece of evidence, and suggests that other heater-coolers may be contaminated. As a result, half a million surgery patients may have been exposed to the bacteria, Washington Post reported. Parker Waichman notes that regulators have been aware of the potential link for some time.
In an Oct. 2016 Safety Communication, the FDA said findings “strongly suggest the 3T heater-cooler units are the source of M. chimaera contamination”
The CDC also issued a warning, stating “Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger,”
M. chimaera, a type of NTM, can be difficult to detect because it grows slowly. Treatment requires surgery and prolonged periods of antibiotics. When symptoms do manifest, they can easily be misinterpreted for another medical condition. Some patients with infections were not diagnosed for four years.
Symptoms of NTM infection include:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained fever
In June 2016, the FDA updated the public on findings of a European study linking M. chimaera infections with 3T Heater-Coolers. “The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and one specific heater-cooler model – the 3T.” the agency said.
The FDA also issued a warning in October 2015, noting that contamination occurs through the air. “Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.” the agency said.
There were 32 reports of NTM infections linked to heater-cooler devices between January 2010 and August 2015, the FDA said; 25 reports were submitted in 2015 alone.
In 2014, the FDA said 3T heater-cooler manufacturers identified M. chimaera contamination on the production line and water supply at the manufacturing facility. These devices were distributed worldwide. “Although the manufacturer of 3T devices added cleaning and disinfection procedures to the production line in September 2014, the FDA is now aware of some 3T devices manufactured after September 2014 which have tested positive for M. chimaera.” the agency stated.
LivaNova 3T Heater-Cooler Infection Lawsuits
LivaNova is involved in litigation over its 3T heater-cooler devices, with plaintiffs alleging infections. A wrongful death lawsuit was recently filed on behalf of a woman whose husband died following a bypass procedure at a South Carolina hospital. During the operation, which occurred in March 2014, a heater-cooler was used to maintain the temperature of his blood. The lawsuit alleges that the device was contaminated, introducing NTM and subsequently causing a fatal infection. The plaintiff holds LivaNova accountable, alleging the company did not take the proper steps to protect patients or warn the medical community.
The plaintiff states that the hospital where her husband underwent surgery announced in June 2014 that 14 of its patients tested positive for mycobacterium abscessus, a type of infection. Three patients died. The infections mostly occurred in patients who had undergone open-heart surgery. The hospital issued another update the following month, confirming 15 infections and four deaths. In light of these findings, the hospital sent 180 letters to patients who may be affected as well. The plaintiff’s husband was one of the recipients.
In addition to the wrongful death suit, LivaNova is also facing a class action lawsuit over infections allegedly caused by the 3T heater-cooler. The first two plaintiffs in the class action underwent procedures using the HCDs in separate hospitals. They subsequently developed NTM infections, allegedly due to the LivaNova heater-cooler devices.