Published On: Wed, Oct 28th, 2015

4 Dead After Being Infected by a Device in Surgery at a Pennsylvania Hospital

BacteriaNew York Times — At least eight people who received treatment at a hospital in York, Pa., have developed an infection from a medical device used during open-heart surgery, hospital and health officials said. Four of those who were infected have died, though officials said it was not clear whether the infection was the primary cause.

WellSpan York Hospital said Monday 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 Oct. 1, 2011, to July 24, 2015. The hospital said the infection had been identified in less than 1 percent of patients who had open-heart surgery during the period.

The Food and Drug Administration said it had received 32 reports of infected patients or bacterial contaminations associated with the devices, which are 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 United States; the rest were contracted in Europe. It was not clear if those American cases were at York Hospital.

The bacteria, known as nontuberculous mycobacteria, or NTM, can be found in soil and water, and they are usually not harmful. In rare cases, they can infect patients who are seriously ill or who have compromised immune systems, causing fever, weight loss, joint pain, loss of energy and even death.

The machine, known as a heater-cooler device, uses water to regulate temperatures through a closed circuit of warming and cooling blankets. Though 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 F.D.A. said in a statement.

The announcement followed a disclosure this year that two patients had died and five others had fallen ill at a California hospital from a drug-resistant bacteria, most likely picked up from another type of medical device — a difficult-to-clean scope inserted down the throat. Called duodenoscopes, the devices were used to diagnose and treat diseases of the liver, bile ducts and pancreas.

Joseph Perz, an epidemiologist at the Centers for Disease Control and Prevention, which helped conduct an investigation at York Hospital, said 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 on the topic.

In June, the manufacturer, Sorin Group, issued a safety notice instructing hospitals and other health care facilities that own the machines to maintain them with a new set of guidelines.

Sabrina Tavernise

Sabrina Tavernise

Writer at New York Times
Sabrina Tavernise is an American journalist who writes for The New York Times. She previously reported for the Times from Iraq, Lebanon, and Russia. She received an honorable mention in the 2003 Kurt Schork awards for "her depth and human insight in covering Russia".
Sabrina Tavernise

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