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Infections and Deaths at Pennsylvania Hospital Linked to Heating-Cooling Device Used in Heart Surgery

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A heater-cooler system used to heat or cool blood during heart surgery is believed to have spread infections to patients at WellSpan York Hospital in York, Pennylvania. Four deaths have been linked to the device.

The hospital is contacting about 1300 patients who may have been exposed to nontuberculous mycobacterium during open-heart surgeries performed between October 1, 2011 and July 24, 2015, Qmed reports.

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, according to Qmed. To date, the Food and Drug Administration (FDA) has received 32 reports of patient infections or bacterial contamination linked to the device.

WellSpan Hospital said less than 1 percent of patients who underwent cardiac procedures using the device had been identified as being affected by the bacterium, but the hospital said that the four patient deaths from 2010 to 2015 have been linked to the infection. The four patients who died also had underlying health conditions that could have contributed to their deaths.

The heater-cooler device provides temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits to control patients’ blood temperature. The water does not come into direct contact with the patient, but contaminated water could enter other parts of the device or transmit bacteria through the device’s exhaust vent into the environment and to the patient, the FDA explains. The problem was hard to track because the bacterial strain reproduces slowly and symptoms can take months to appear.

The hospital said it is working collaboratively with the Pennsylvania Department of Health and the Centers for Disease Control and Prevention (CDC) to address questions from health care professionals and patients, and has set up a web site dedicated to this situation.

On October 15, the FDA released a safety announcement related to the heater-coolers. The FDA said it is “aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.” The FDA explains that NTM organisms can commonly be found in soil and water, including sources of tap water. They are “typically not harmful,” but in rare cases—such as those at WellSpan Hospital—they may cause infections in very ill patients and/or in individuals with compromised immune systems.

The FDA recommends that hosptials carefully follow the manufacturer’s cleaning and disinfection instructions for the heater-coolers. In addition, tap water should never be used to rinse, fill, refill or top-off water the device’s tank since this may introduce NTM organisms. Only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns should be used for heating or to make the ice needed for cooling. During a procedure, the exhaust vent should be directed away from the surgical field to lessen the risk of aerosolizing heater-cooler tank water into the sterile field and possibly exposing the patient to bacteria.

 

 

 

 

 

 

breakinglawsuitnews.com disclaimer: This article: Infections and Deaths at Pennsylvania Hospital Linked to Heating-Cooling Device Used in Heart Surgery was posted on Tuesday, November 3rd, 2015 at 6:09 am at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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