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Deadly Infections from Surgical Device Linked to Factory

Scientists are saying heater-coolers used during heart procedures were contaminated at the factory where they were produced.

Open-heart surgery is an extremely serious procedure, and yet death rates for those who undergo it are actually quite low.

So when a recent global outbreak of serious โ€“ and sometimes deadly โ€“ infection began impacting patients who had undergone heart procedures, a team of scientists began examining variables to try to pinpoint the cause.

The analysis included samples from crucial procedural devices, called heater-coolers, that circulate water to warm or cool patientsโ€™ blood during bypass operations. German brands LivaNova and Maquet were investigated, along with hospital water sources and environmental sources. The results of the study identified heater-cooler devices made at the LivaNova PLC plant in Munich, with scientists saying they were contaminated during production.

But even though theyโ€™ve pinpointed it, hereโ€™s the scariest part: Experts say that at least five other manufacturers also sell heater-coolers in the U.S. โ€” โ€œand they all share a design that could pose a risk for infectionsโ€ โ€“ meaning many brands of heater-cooler could cause bacteria to form in a hospital setting which could result in patient infections.

Perhaps this is why LivaNova hasnโ€™t been quick to accept responsibility. Kaiser Health News says that a spokesperson for the company told them they are concerned that a recent journal article published on the study โ€œexpresses a level of certainty about a point source tie to the manufacturing process that is not warranted by the data.โ€

Other experts cautioned hospitals to not become lax on the issue based on the results of the study. While there doesnโ€™t currently seem to be a way fully decontaminate these machines, there are steps that can be taken onsite to reduce patient risk. One hospital found a way to separate the air coming out of the heater-cooler from the rest of the air in the hospital room, which doesnโ€™t allow bacteria to settle on surgical sites or cardiac implants before they are inserted. They have experienced zero cases of infection since.

Iโ€™m Anna Wells and this is IEN Now.

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