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9
Jun

How Well is the FDA Doing Addressing the Issue of Stockert Heater-Cooler Infections?

The infection that results by use of the Stockert 3T Heater-Cooler device, caused by a bacterium known as m. chimaera, can be dormant for years following exposure. Apparently, it can take almost as long for the Food and Drug Administration to issue a public warning.

The infection risk was first reported in August of 2014 when tests conducted at the Sorin factory in Germany found the bacterial contamination – both on the production line and the factory water supply. Mycobacterium chimaera is an extremely hardy species, able to survive in conditions of extreme heat, freezing, aridity and wetness that would kill other types of bacteria. Even sulfuric acid has no effect on it.

For most healthy humans, m. chimaera is not a health threat. However, for surgical patients and those with compromised immune systems, m. chimaera can cause serious, even fatal pneumonia. M. chimaera infested Stockert 3T units were shipped to countries all over the world.

Federal regulators at the FDA were also aware of the contamination and health risk in the late summer of 2014. The revelation came when a Pennsylvania patient who had undergone open heart surgery suddenly developed symptoms several months later. As a result, the patient (who died last month) suffered partial loss of hearing and vision.

Yet, for some reason, the public was not given any warning by the FDA until well over a year later.

It gets worse. In a presentation in March of 2002 at the 40th International Conference of the American Society of Extra-Corporeal Technology in New Orleans, researchers reported that Stockert 3T units were contaminated with “germs and particles,” and keeping them sterile and bacteria-free was a difficult task at best. They also pointed out that the manufacturers of such equipment usually fail to take action or have technology in place to reduce the risks of bacterial contamination. Their findings were published later that year in the Journal of Extra-Corporeal Technology.

The risk of m. chimaera contamination is not unique to the Stockert 3T. Approximately three-fifths of the heater-cooler units employed in U.S. hospitals are manufactured by LivaNova (formerly Sorin Group GmbH); however, similar devices are also likely to have this problem. In February 2017, the FDA finally issued a patient advisory, stating that heater-cooler devices relying on water to maintain patient body temperature during surgery had the “potential for Nontuberculous Mycobacteria (NTM) to be present,” but added that “the benefits of temperature control during surgery outweigh the small risk of infection associated with these devices.”

However, there is no specific mention of the Stockert 3T. There is also no explanation as to why, if these dangers were known fifteen years ago, there has been no warnings or advisories until recently.

Meanwhile, over half a million patients have undergone open-heart procedures that employed the Stockert 3T. Since m. chimaera infections can have a dormancy period of years, these patients are walking around with what amounts to a ticking time bomb in their bodies.