CHARLESTON, S.C. — Members of the governing board of the Medical University of South Carolina expressed concerns Thursday that hospital staff are still using equipment that may cause heart bypass patients to develop severe bacterial infections, according to the (Charleston) Post and Courier.
Last year, the Food and Drug Administration issued a warning about the Stӧckert 3T Heater-Cooler System, which is used to heat and cool blood outside the body during some adult and pediatric open-heart surgeries.
The device is used by approximately 60 percent of heart surgery centers in the United States. The MUSC Board of Trustees learned the hospital owns eight of the $50,000 machines.
In rare cases, patients exposed to the device during surgery have developed severe, hard-to-treat bacterial infections. The Greenville News reported last month that four patients who developed the infection in 2014 died from it.
Dr. Danielle Scheurer, medical director for health quality and safety at MUSC, said none of the hospital’s heart bypass patients have contracted the infection, but she told board members it may take years before patients present any symptoms.
In January, MUSC told patients who may have been exposed to the device during surgery that they should monitor potential symptoms, including night sweats, muscle aches, unexplained weight loss, fatigue and unexplained fever.
Some board members wanted to know why MUSC staff can’t test the machines for bacteria and why the hospital hasn’t stopped using them.
Scheurer explained the bacteria inside the machines is difficult to detect. Surgical staff at MUSC are now testing equipment made by another company, but she said the hospital has not decided to purchase new heater-coolers.
MUSC Board Chairman Donald Johnson, a spine surgeon, said the FDA warning raises a lot of “red flags” and the heater-cooler machines may expose the hospital to medical malpractice lawsuits. He said there are several devices used for spine surgery that his private practice abandoned because the FDA deemed them potentially unsafe. The devices worked well, he said, but they posed too great a risk.
“What a horrific problem if you get (an infection) yourself,” he said.
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