At least eight people who received treatment at a hospital in York, Pennsylvania, developed an infection from a medical device used during open-heart surgery, according to hospital and health officials. Of the people infected, four died, though according to officials it was not clear whether the infection was the primary cause.
WellSpan York Hospital yesterday said it was notifying about 1,300 current and former patients of possible exposure to potentially harmful bacteria during open-heart surgeries performed over nearly four years, from 1 October 2011 to 24 July 2015.
According to the hospital, the infection had been identified in less than 1 per cent of patients who underwent open-heart surgery during the period.
According to the Food and Drug Administration, it had received 32 reports of infected patients or bacterial contaminations associated with the devices, which were used to heat and cool a patient's blood during heart surgery.
Of those, 25 were reported this year. Eight of the reported infections happened in the US and the rest were contracted in Europe. It was not clear if those US cases were at York Hospital.
The bacteria, known as non-tuberculous mycobacteria, or NTM, found in soil and water, are not usually harmful, but in rare cases, patients who were seriously ill or who had compromised immune systems could be infected, causing fever, weight loss, joint pain, loss of energy and even death.
The FDA provided a list of recommendations for the use of heater-cooler devices, including positioning the exhaust from the device so it does not vent on or near the patient.
It had been believed that some of the NTM infections that had been discovered were contracted by patient exposure to the exhaust. The device exhausts hot air and water vapour.
Non-tuberculous mycobacteria infections affect two of every 100,000 persons in the US yearly, according to National Jewish Health.
The various bacteria involved are related to the mycobacteria that cause tuberculosis (TB) and that cause leprosy (Hansen's Disease). NTM infections are non-contagious.