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Consumer Reports Warns of Deadly Infections From Surgical Heater-Cooler Devices

Consumer Reports Warns of Deadly Infections From Surgical Heater-Cooler Devices

Fifteen patients at Greenville Medical Center in South Carolina have been diagnosed with a rare infection known as non-tuberculosis mycobacteria (NTM), which has been linked to heater-cooler devices (HCDs) used in certain heart and lung operations. Four out of the fifteen patients have already died from the infections.

HCDs are an essential component of operations like heart bypasses, open-chest heart surgery, and valve replacements, because the devices help regulate patient body temperatures. However, waterborne bacteria like Legionella and Mycobacterium can potentially be transmitted to patients via contaminated medical devices.

According to Consumer Reports, “Similar incidents have been publicly reported at hospitals in other states, including Iowa and Pennsylvania. And some hospitals and federal agencies, as well as at least one manufacturer, have acknowledged that those devices can harbor and then spray deadly bacteria through their exhaust vents, across the operating room, and into patients’ open cavities.”

From January 1, 2010 to February 29, 2016, 180 incidents were reported to the U.S. Food and Drug Administration (FDA) regarding heater-cooler devices. Among the reports, 45 patients developed an infection and at least nine died, in 16 hospitals across 10 different states. Most of these cases were linked to a specific brand of HCD: the Sorin Stockert 3T Heating-Cooling System, manufactured by the European company LivaNova.

Director of Consumer Report’s Safe Patient Project, Lisa McGiffert, stated that hospitals need to take more responsibility on the spread and occurrence of infection within their healthcare facilities: “More should be done to protect patients and inform them of the risk of infection months and even years after exposure. Without that notice, patients don’t know what symptoms to watch out for and can’t be promptly treated with antibiotics, making recovery less likely. They have a right to know. We believe that every hospital using these devices should inform all patients who have surgery with these devices about this risk of infection.”

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The Institute of Medicine has estimated that 98,000 Americans die each year from preventable medical errors, most of which they note from infections. If you or a loved one has been injured as a result of a hospital infection, please contact an experienced personal injury attorney here or call us toll-free at 1 (800) 541-7358 for a free case review.