Is the FDA Doing Enough to Prevent Stockert 3T Heater-Cooling Device Infection?

Washington, DCThe FDA warns that M. chimaera infection may take months or even years to develop. Ironically, after sitting on reports of infection associated with the Stockert 3T heater-cooler system and similar systems during open chest surgeries, it takes the agency months or years to warn the public.

Working with the FDA, the Centers for Infectious Diseases (CDC) first warned of potential exposure to contaminated heater-cooler devices in 2015, which left hospitals scrambling to manage M. chimaera  infection risk in open chest surgeries, mainly because 60 percent of these necessary devices are Stockert 3T units, and there isn’t an abundance of water-cooler devices readily available. And they are expensive. But Nontuberculous Mycobacterial Infection has been associated with the heater-cooler devices for some time before the agency’s warning.

In August and September of 2014, M. chimaera contamination was found during tests at Sorin, the Stockert 3T manufacturing facility. So Sorin knew their products were contaminated for about two years before the American public was notified. According to Kaiser Health News, the FDA also knew back in the summer of 2014 about this potentially deadly infection tied to the 3T heater-cooler devices.

Going back even further, doctors at a German hospital in 2002 found that the units were polluted with “germs and particles” and the devices were difficult to keep sterile. A report was published and presented at a medical conference in New Orleans that said manufacturers of the devices often “do not provide any technology to reduce bacterial or other contamination,” with potentially serious consequences for patients.

The FDA knew about infections associated with the Stockert 3T device in 2014, when doctors at a York, PA hospital diagnosed an open-heart surgery patient with a serious mycobacterial infection acquired during his surgery. Vincent Karst suffered partial hearing and vision loss, according to his negligence lawsuit, reported by the York Dispatch (Jun 2016).

Why did the CDC and the FDA wait until 2015 to publish information and alerts about these potentially contaminated heater-cooler devices? And how many patients were at risk? Perhaps it will take investigating attorneys and more Stockert 3T lawsuits to answer such questions.