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Nov

Stockert 3T Heater-Cooler Puts 500,000 at Risk for Infections

While the actual number of reported cases have been relatively low, federal agencies report that as many as 500,000 patients who have undergone open heart surgery since 2006 are at risk of developing a potentially deadly illness due to the Stockert 3T Heater-Cooler device.  This piece of equipment uses water in order to maintain a patient’s body temperature at a certain level during surgery.  The Centers for Disease Control reports that the device has provided an ideal breeding environment for a particular species of bacterium.

The bacterium is known as mycobacterium chimaera, or “non-tuberbulous mycobacterium” (NTM). This particular bacterium is fairly common and under most circumstances, innocuous. However, for patients with compromised immune systems who have undergone invasive surgery, it can be life-threatening. This year, nearly thirty cases have been reported in the U.S., with several more coming from Europe. However, these may only be the tip of the iceberg. NTM infections can have an incubation period of several months, and may not be identified for years. The reason: symptoms, which include muscle pain, chronic fatigue and fever are common to many illnesses. As if this were not bad enough, NTM is particularly resistant to most standard antibiotics.

The infection is fatal in about half of all cases.

Heater-cooler units are commonly used in surgical procedures in order to maintain the patient’s body temperature. About a quarter-million heart surgeries performed in the U.S. annually employ this piece of equipment. Most of them (three out of five) are Stockert 3T units, of which 2,000 are used in U.S. hospitals.

The Stockert 3T is a product of LivaNova, a medical device manufacturer in Germany. Recent investigations now indicate that the units were contaminated at the factory. Those manufacturing facilities were inspected in 2015, and revealed numerous violations of standard safety protocols. This past summer, the FDA issued a statement, reporting that almost every Stockert 3T unit manufactured before September of 2014 could be contaminated with NTM bacteria. As a result, as many as half a million people who have undergone open heart surgery since the device was introduced to the U.S. in 2006 either suffer from, or are at risk for developing, an NTM infection. This is far larger than the number of patients who have been notified that they may have been exposed.

Currently, the Food and Drug Administration is issuing statements to health care facilities around the country, advising personnel to discontinue use of the Stockert model and use new accessories, such as tubing and connectors, in order to avoid recontamination of any replacement equipment. The FDA also strongly recommends that only water that has been carefully filtered be used for these devices.