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Following reports of heart surgery infections linked to contaminated 3T Heater-Coolers in recent years, the manufacturers indicate the blood temperature regulating machines will be redesigned, and new cleaning instructions have been issued for hospitals that are designed to reduce the risk of infections.
Livanova issued a medical device correction letter (PDF) on October 18, providing customers with updated instructions on the monitoring and use of hydrogen peroxide in the 3T heater Coolers to help prevent microbial growth.
The company also announced that it is making changes to the devices’ vacuum canister and internal sealing to prevent the risk of water vapor being emitted as an aerosol into the operating room, which has been identified as a cause of severe and life-threatening infections that may surface months, or even years, after open heart surgeries where the heater-cooler systems were used.
The FDA also issued a safety communication late last week, passing on the Livanova information and indicating that the agency is staying actively involved with the manufacturer.
The U.S. Centers for Disease Control and Prevention (CDC) is also evaluating Livanova’s infection mitigation efforts and conducting its own scientific research, according to the FDA statement, which indicates that the CDC will issue further updates as appropriate.
Sorin 3T Heater-Coolers are commonly found in operating rooms to regulate blood temperature during heart bypass surgery, valve replacement surgery and other cardiac procedures. However, in recent years it has been discovered that certain devices manufactured prior to September 2014 may be contaminated with a slow growing bacteria, which may be enter the sterile operating room through vapors released by the devices.
For individuals with compromised immune systems and an open chest cavity during heart surgery, this has resulted in reports of Mycobacterium chimaera or Mycobacterium abscessus infections that surface long after the procedure.
The FDA first warned about the heart surgery infection risk from heater-cooler devices in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Later that year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air.
“Although the water in the 3T heater-cooler unit does not come into direct contact with the patient, users should be mindful that aerosols are emitted when the 3T is used, primarily during the patient warming phase and at the end of a procedure, when water is returned to the tanks,” Livanova states in the medical device correction letter. “Depending on the characteristics of the bacteria and the concentration of bacteria in the water in the tanks, these aerosols may carry bacteria into the operating room environment. Another risk of contamination for the patient is a direct contact transfer of water/solution droplets containing water-borne, pathogenic microorganisms into the surgical field.”
The letter indicates that users should monitor the hydrogen peroxide concentration in the water solution daily to ensure that there is enough present to fight microbial contamination. The concentration should always remain about 100 parts per million, the letter indicates. It also includes an attachment that has monitoring instructions.
The letter also notes that the company has developed a vacuum canister and internal sealing design change which cuts down on the risk of airborne transmission of NTM. However, it notes that the change would not eliminate the threat entirely.
Customers will be contacted by a company representative to plan the upgrade of affected products.
Livanova faces a growing number of open heart surgery infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.