Four Dead After Being Infected by Medical Device Used During Open-Heart Surgery Surgery

At least eight people who were treated at a Pennsylvania hospital have developed an infection from a medical device used during open-heart surgery, hospital and health officials said.

Four of those who became infected have died, though officials say it was not clear whether the infection was the primary cause, the New York Times reports.

On Monday, WellSpan York Hospital said it was notifying about 1,300 current and former patients of their possible exposure to potentially harmful bacteria during open-heart surgeries performed 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 machine involved, a heater-cooler device, is used to regulate temperatures through heated or cooled water flowing through warming and cooling blankets, the Times explains. The water does not come into contact with the patient, but “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, according to the Food and Drug Administration (FDA).

The FDA received 32 reports of infected patients or bacterial contamination associated with the devices. Twenty-five of the reports came this year. Eight of the infections happened in the United States, the rest in Europe. It was not clear if all the American cases were at York Hospital, the Times reports.

The bacteria—nontuberculous mycobacteria (NTM)—can be found in soil and water, and usually are not harmful. But in rare cases, these bacteria can infect patients who are seriously ill or who have compromised immune systems. The infection can cause fever, joint pain, weight loss, loss of energy and even death. The bacteria grow very slowly, and symptoms can take months to appear, making it hard to tie the problem to a health care procedure, the Times explains.

Joseph Perz, an epidemiologist at the Centers for Disease Control and Prevention (CDC), which conducted an investigation at York Hospital, said NTM had never been known to infect patients through heater-cooler devices until this summer, when European researchers reported such infections. Dr. Perz said, “It’s simply unknown whether the deaths were caused by infection.” The hospital said in a statement that the bacterial infection was “likely a contributing factor” in the deaths.

In June, Sorin Group, the manufacturer of the heater-coolers, issued new guidelines to hospitals and other health care facilities for maintaining and cleaning the machines. Tap water should not be used to rinse, fill, refill or top off the heater-cooler water tanks because 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 in the heater-cooler’s tank or for making the ice needed for cooling procedures. In addition, the FDA advises, the machine’s exhaust vent should be directed away from the surgical field to reduce the risk of exposing the patient to aerosolized heater-cooler tank water.

from Parker Waichman http://www.yourlawyer.com/blog/four-dead-after-being-infected-by-medical-device-used-during-open-heart-surgery-surgery/