In early June, a panel of expert advisors of the U.S. Food and Drug Administration will meet to evaluate the risks of potentially deadly bacterial infections acquired from heating and cooling devices used in heart surgeries, and to recommend regulations to protect consumers.
The announcement of the meeting comes six months after the FDA issued a safety warning about the risks of infection from such heater-cooler devices used to control the temperature of people undergoing open heart surgery.
Last year, officials announced that at least five people died after acquiring Nontuberculous Mycobacteria, or NTM, during surgeries at WellSpan York Hospital. Weeks later, officials at Penn State Milton S. Hershey Medical Center announced they had identified three heart surgery patients who acquired NMT. Two of the patients died.
The FDA’s Circulatory System Devices advisory panel will meet June 2 and 3 to examine, among other things, new rules governing the cleaning and disinfection of the devices.
Ross Feller Casey is actively investigating potential lawsuits involving NTM infection. If you or a loved one acquired the infection as a result of heart surgery, please contact one of our experienced hospital infection lawyers now for a free case evaluation.
For more information, go to Hospital Infection Lawsuits.