Thousands of open-heart surgery patients may be at risk for a dangerous infection linked to a medical device used at hospitals across the country, including many in the Chicago area.
Letters are being sent to patients warning them of the infection risk tied to a device that is commonly used during surgery. Experts found the device may have been contaminated and could transmit bacteria.
The device is a heater-cooler unit. Surgeons depend on it to keep patients stable during open-heart surgery. But the Centers for Disease Control and Prevention is warning that the FDA-approved device, which has been used in surgeries since 2012, may have been contaminated when manufactured.
“These invasive infections can be life-threatening,” said Dr. Suzanne Schwartz with the Food and Drug Administration.
Researchers say the chances are very low, but the infection could result in severe injury or even death.
Sixty percent of heart bypass procedures performed in the US used the devices in question.
No infections linked to the heater-cooler unit have been reported in Illinois, but experts caution the infection is slow-growing and hard to diagnose.
“It can take several months to several years for an NTM infection to develop in a patient and for symptoms to appear,” Schwartz said.
A number of hospitals in Illinois have been alerting patients to the infection risk.
“AMITA Health has notified patients who have undergone open-heart surgery about a potential infection risk related to a device used during heart surgery to heat and cool the blood. Notification letters were sent to 1000 patients because the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration are investigating reports that during certain open-heart surgeries using the Sorin Stöckert 3T Heater-Cooler Unit Device has been linked to a rare infection," a letter from Amita Health reads. "The CDC estimates the risk of getting the slow-growing infection is less than 1 percent. AMITA Health has not identified any cases in which the infection has occurred, but out of an abundance of caution has stopped using the Sorin device and it has been replaced."
The company said it has established a hotline at (847) 252-5360 for patients and families with questions about the issue. It also has sent notification letters to primary-care physicians, cardiologists and surgeons "so they can monitor patients for any symptoms of the infection."
A letter from the University of Chicago warned 1,800 patients about the device it says was used worldwide.
“Immediately after the CDC alert, we notified about 1,800 of our patients who had open-heart surgeries involving this device, and we set up a system to evaluate any patient who was worried or had any symptoms of concern. No 3T-related infections have been identified in our patients,” the hospital said in a statement. “UChicago Medicine proactively transitioned to an alternative system that heats and cools blood during open-heart surgeries approximately in August (two months prior to the CDC alert) when further published research suggested a continued link to M. chimaera infection and the 3T device. In addition, UChicago Medicine uses state-of-the-art laminar flow ventilation in operating rooms, which dramatically reduces the risk of infection even further.”
Advocate Health Care also said it was notifying patients about the issue.
"Given our unwavering commitment to safety, we proactively notified impacted patients and established a dedicated call line staffed by clinicians to answer all questions," the healthcare company said in a statement. "Most importantly, we haven’t identified any patients who have experienced an infection related to the device, which is used at hundreds of hospitals nationwide. In alignment with the CDC, we continue to follow our comprehensive quality control program to ensure the continued safety of our patients."
Some symptoms of the infection include night sweats, muscle aches, weight loss and fatigue. Anyone who has had open heart surgery in recent years and experiences such symptoms is being told to contact their doctor.