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A number of hospitals nationwide have sent letters to former patients in recent months, warning that they may have been exposed to a potentially life-threatening nontuberculous mycobacteria (NTM) during open heart surgery where a 3T Heater-Cooler System was used.
Boston Children’s Hospital, the Mayo Clinic, WellSpan York Hospital and many other prominent hospitals have sent out thousands of letters to heart surgery and valve replacement patients following an FDA warning earlier this year, which warned that certain 3T Heater-Cooler systems found in operating rooms nationwide may have been contaminated, releasing bacteria into the air of the operating room.
At least 16 hospitals in 10 states have confirmed NTM infections among patients exposed to the heart surgery device, including cases of M. Chimaera and M. Abscessus infections.
The Sorin 3T Heater-Cooler, which is now distributed by Livanova PLC, is used to control blood temperature during open heart surgery. The system involves the use of tanks with temperature-controlled water that is circulated through tubes into a heat exchanger. Certain devices manufactured before September 2014 have been found to release contaminated vapor into the air through an exhaust fan.
While the bacteria does not typically pose a serious risk, during open heart surgery organs and the chest cavity may be directly exposed to this NTM contaminated vapor, causing severe and potentially fatal infections.
To complicate matter, nontuberculous mycobacteria (NTM) infections from the heater-coolers may not surface for months, or even years after exposure. Therefore, heart surgery patients may face a risk of problems long after their procedure.
Last month, Consumer Reports announced that it had learned from a patient that the Mayo Clinic sent warning letters to 17,000 heart surgery patients about the potential risk of 3T Heater-Cooler System NTM infections. According to Consumer Reports, at least one Mayo Clinic patient has been confirmed as suffering from the infection, and it has found a number of 3T systems in its inventory to be contaminated.
“There is currently no risk of bacterial exposure at WellSpan York Hospital,” the site notes. “In an effort to ensure the safety of patients, the hospital has notified approximately 1,300 open-heart surgery patients of possible exposure to this bacteria during open-heart surgery procedures performed between Oct. 1, 2011 and July 24, 2015.”
The web page has links to information for both patients and medical professionals.
Facebook users who have been patients at other hospitals have also indicated receiving the letters in recent months, including one from Boston Children’s Hospital, which indicates it knows of no cases of infection linked to its facility.
The FDA first warned about the surgery infection risk from surgical heater-coolers in October 2015, reporting that a large number of adverse event reports had been received in connection with the devices.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
In October, federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, noting that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve the use of affected 3T Heater-Cooler systems.
The FDA is now advising facilities using 3T devices to remove the devices and any accessories from service if they have tested positive for the bacteria, or have been linked to patients who later were identified as infected. The agency also recommends using new accessories, tubing and connectors if using a new heater-cooler device, channeling exhaust from the devices away from patients and into an operating room exhaust vent, and to review the recommendations in the CDC’s health advisory.
Symptoms of an NTM infection following heart surgery may include fatigue, fever, pain, redness, heat or puss at the surgical site, nausea, vomiting and other complications.
A number of patients exposed to the 3T Heater-Cooler devices are now pursuing NTM infection lawsuits or class actionclaims for medical monitoring in the future.