The FDA is continuing to investigate the risks associated with heater-cooler devices used in major surgeries, particularly cardiothoracic procedures.
The heater-cooler devices have been associated with potentially fatal infections, such as Nontuberculous Mycobacterium (NTM), and the FDA issued a safety alert on these devices in June.
At issue is the failure by manufacturers to provide adequate cleaning instructions for their heater-cooler devices, and, until recently, to advise those operating the devices on safe placement during surgeries. The FDA is also examining the connection between the infections and the basic design of heater-cooler devices.
Anapol Weiss has played a crucial role in the successful resolution of thousands of cases where unsafe medical devices have caused injury and resulted in mounting medical expenses.
Anapol Weiss Shareholder Sol Weiss specializes in unsafe medical device cases and is a great resource if you have questions or concerns regarding an experience with heater-cooler devices or other poorly designed medical devices.