Eight patients and possibly more who underwent open-heart surgery at a hospital in Pennsylvania developed an infection from a device used during the surgery. Four of them have died, but it is not clear if the infection was the chief cause of their deaths.
The surgeries took place at WellSpan York Hospital in York, PA. The hospital said that it is notifying approximately 1,300 current and former patients that they were possibly exposed to potentially harmful bacteria during open-heart surgeries that were performed October 2011 to July 2015. The hospital has stated the infection had been identified in less than 1% of patients who had open-heart surgery there during that time.
The device is called a heater-cooler and it is used during heart surgery to regulate the temperature of a patient's blood. It uses water to regulate temperature through a closed circuit of warming and cooling blankets. Although the water does not come into contact with the patient, "there is the potential for contaminated water to enter other parts of the device" and be transmitted through the air to the patient through the device's exhaust vent, the U.S. Food and Drug Administration said in a statement.
The bacterial infection that occurred is caused by nontuberculous mycobacteria (NTM), an organism that can be found in soil and water. In rare cases, NTM can infect patients who are seriously ill or who have compromised immune systems. When it does infect a person, the symptoms include fever, weight loss, joint pain, loss of energy, and, in extreme cases, death. However, because the bacterium grows slowly, it may take months for symptoms to appear, which also makes the infection hard to track back to a particular surgical procedure.
NTM had caused infections during treatment for decades but had never been known to infect patients through heater-cooler devices until this summer, when European researchers published reports cases that occurred there.
The FDA said it has received 32 reports of infected patients or bacterial contaminations associated with the devices. Of those cases, 25 occurred this year. Eight of the reported infections happened in the United States; the rest occurred in Europe. It is not clear if those American cases were at the Pennsylvania hospital.