The device – Sorin’s 3T Heater-Cooler system – is widely used during cardiovascular surgery to warm and cool patients. It is seen as an essential part of the operating rooms that utilize it.
In reports dating back to January 2010, the FDA was aware of adverse events related to use of the device. Though the first lawsuits were not filed until July of this year.
Now, additional actions against LivaNova, the London-based medical device manufacturer that was created after the merger of Sorin and Cybertronics, Inc., are beginning to mount.
The device has been linked to the occurrence of slow-growing infections of cardiac tissue by Mycobacterium; a commonly occurring genus of bacteria traditionally found in soil and water. The infections can take months to manifest, are difficult to treat, and have proved fatal in a number of cases.
The source of the bacteria from the devices is believed to be aerosolized droplets of water from the machines heating and cooling loops. The water inside these loops does not come into direct contact with the patient. Therefore it had not been thought of as a potential vector for infection. This resulted in clearing directions from the manufacturer to disinfect the heat exchange loops once every two weeks.
However, dangerous levels of bacteria were found to have grown within a day and a half; and the supposedly contained water was being released into the air by the device’s exhaust fan. Once in the air, the bacteria can settle into the patient’s open chest or infect other equipment and devices used during surgery.
In October of last year, the FDA officially acknowledged the issue in a safety alert posted on the agency’s website. In the alert, the agency claims to have received 32 reports of patient infections linked to heating and cooling devices between 2010 and 2015.
The FDA also acknowledged that many instances of infection likely go unreported. Since it can be difficult for healthcare providers to recognize that infections are associated with the use of a certain device.
In addition, the slow-growing nature of the infections can make them difficult to track; with many patients not developing symptoms for months or even years following initial exposure. This also means that new infections related to the device may be yet to emerge. Despite the fact that safety guidelines released by the FDA last year may have been put into effect.
According to a letter from LivaNova released on December 2nd, hospitals now have the option of acquiring “loaner” devices while the company works to resolve the infection issue.
With more than 250,000 bypass procedures performed using heater-cooler devices in the U.S. every year, the number of cases associated with infections could prove substantial.