LivNova PLC has announced a plan to remediate 3T Heater-Coolers. The devices, which are designed to warm and cool patients undergoing cardiac thoracic surgery, have been implicated in outbreaks of M. chimaera bacterial infections at several U.S. hospitals.
“The remediation plan developed by the Company consists primarily of a modification of the 3T Heater Cooler design to include internal sealing and the addition of a vacuum system to new and existing devices,” LivNova said in a statement issued on March 1st. “These changes are intended to address regulatory actions and further reduce the risk of possible dispersion of aerosols from the 3T Heater Cooler device in hospital operating rooms. The deployment of this solution for commercially distributed devices will commence upon final validation and verification of the design changes and approval or clearance by regulatory authorities worldwide.”
In addition, LivNova indicated that it will implement a no-charge deep disinfection service for 3T Heater-Cooler users who have reported confirmed M. chimaera contamination. The Company has also started a program to loan existing users new 3THeater-Cooler devices at no charge pending regulatory approval and implementation of the vacuum system addition and deep disinfection service.
The U.S. Food & Drug Administration (FDA) announced a Class II recall for the 3T Heater-Cooler System in June 2015, due to the “potential colonization of organisms, including Mycobacteria” in the devices. A second safety communication was issued a year later, after a study suggested a direct link between the devices and M. chimaera infections reported among open-heart patients in Europe. And last October, the U.S. Centers for Disease Control and Prevention (CDC) announced that its own testing had implicated 3T Heater-Coolers in infection outbreaks reported among cardiothoracic surgery patients in this country.
A number of Heater-Cooler lawsuits have been filed in U.S. courts on behalf of patients who allegedly developed life-threatening bacterial infections due to contamination of the 3T system. In January, a petition was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) that seeks to have all federally-filed claims of this nature centralized in the U.S. District Court, District of South Carolina, in order to undergo coordinated pretrial proceedings. However, a response filed with the JPML last month indicated that LivNova and other defendants oppose centralization, arguing that the cases do not have enough facts in common to warrant centralized proceedings
The JPML is scheduled to hear Oral Arguments on the matter during its March 30th Hearing Session.