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Infection outbreak blamed on surgical device

Heater-cooler devices that are used during many open-heart surgeries in Kentucky hospocould be the cause of serious infections, according to a study led by a Swiss doctor. The Centers for Disease Control and Prevention estimates that HCDs are used in about 250,000 surgeries each year in the United States. A global outbreak of Mycobacterium chimaera has been linked to water circuits in the devices.

The study, published in the peer-reviewed journal Infection Control and Hospital Epidemiology, contains evidence that HCDs are the source of M. chimaera infections. After a significant increase in the infections, investigators began looking at hospital water sources and found bacteria in the HCDs. The most common type of HCD that was linked to the infection is the LivaNova 3T. M. chimaera bacteria was also found in air samples that were taken during surgeries involving LivaNova HCDs.

Researchers included safety recommendations in their report in an effort to prevent more patients from coming down with M. chimaera infections during open-heart surgery. Hospitals were advised to keep contaminated HCDs separate from spaces where critical medical procedures are being performed. The researchers also recommended infection education for doctors and infection screening for patients that have recently had surgery.

Patients who have contracted an infection from a defective medical device during a surgical procedure may want to meet with an attorney in order to see how best to seek compensation for the losses that they have incurred, including the additional out-of-pocket medical expenses. Under the theory of product liability, all parties who participated in the chain of distribution of the device could be held financially responsible.


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