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4 Deaths Linked to Cardiac Device Infections

Eight people treated with a medical device used in open-heart surgery in York, PA ended up getting infections.

Qmed Staff

As many as 1300 patients at WellSpan York Hospital may have been potentially exposed to a bacterial strain known as nontuberculous mycobacterium during open-heart surgeries performed from October 1, 2011 to July 24, 2015. A medical device known as a heater-cooler system, which is used to heat or cool blood during heart surgery, was believed to have played a role in spreading infections to at least some of these patients.

According to the hospital, less than 1% of patients who underwent this procedure had been identified as being affected by the bacterium.

The hospital stated that the four patients deaths from 2010 to 2015 have been linked to the infection. The hospital pointed out, however, that all four patients had underlying health conditions that also could have played a role in their deaths. Patients treated using other invasive heart procedures are not at risk for the bacterial infection, according to the hospital.

The hospital is working collaboratively with the Pennsylvania Department of Health and the CDC to address questions from affected patients and healthcare professionals, and has set up a website dedicated to this means.

FDA also has released a safety communication related to the matter. "We are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedure," the report states. "NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems."

FDA has, to date, received 32 of patient infections or bacterial contaminations linked to the device.

European health professionals noticed a similar problem, and a report published in the July 2015 issue of Clinical Infectious Diseases helped bring attention to the problem in the United States.

A recall of a heater-cooler device was given Class II-status from FDA in July. The recall stated that the device could cause "[p]otential colonization of organisms, including Mycobacteria [...] if proper disinfection and maintenance is not performed per Instructions for Use."

The maker of the device, Sorin, released new instructions for use following the recall.

Hal Baker, MD, who head up infection control at York Hospital, acknowledged that the hospital hadn't been following the 2010 instructions for the device "to the letter," in an interview with The New York Times.

The problem was hard to track because the bacterial strain reproduces slowly and the onset of symptoms can take months to appear.

The device infection case is the second to receive widespread press attention this year--the first being the duodenoscope's association with superbug infections in a handful of hospitals across the United States.

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