For several years, healthcare facilities around the world which used certain heater/cooler units during open heart (open-chest) surgery, began notifying prior surgery patients that they may have been exposed to nontuberculous mycobacteria during their surgical procedure due to device contamination.
Specifically, some heater/cooler units were subsequently found to be contaminated with Mycobacterium chimera during the manufacturing process. The contamination occurring within the operating room during surgery resulted from water within the unit becoming aerosolized within the room. The water from the unit’s circuits does not come into direct contact with the patient.
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year, and approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infections. While M. chimera rarely makes people sick and the rate of infection so far appears to be low, the nature of the infection can be severe, and sometimes fatal. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.
The sooner a surgical patient is diagnosed with and given proper treatment for an NTM infection, the more likely they are to have a positive outcome of treatment. If there has been any implant, such as an aortic valve or other device, the implanted device MUST BE REMOVED. It is not possible to decontaminate the device with antimicrobial therapy, because a contaminated biofilm remains on the device.
The contaminated heater/cooler units must be moved out of the surgical area. They cannot be decontaminated, and simply culturing from the units is not an effective predictor of whether it will cause infection in patients.
Both the United States Centers for Disease Control (CDC) and the U.S. Food & Drug Administration (FDA) have been continuously monitoring this situation, and have put out information and guidance documents for both patients and healthcare providers.
If you are a patient and you believe you are experiencing symptoms related to NTM exposure from surgery, you should contact your healthcare providers right away. This includes the facility where you had your surgery, and your primary care provider. From there, those physicians should be able to guide you to an infectious disease specialist who can help diagnose, manage and treat any infection you may have.
The FDA has compiled an information page for patients on heater-cooler unit device infections. Click here to visit that page. They have also provided a sample letter you can print out, customize with your name and information, and take with you to your healthcare provider. Click here to view and download that letter.
The CDC has also issued several alerts and press releases, and their site contains useful information including a Notification Toolkit with sample letters for providers, facilities, and patients.
Australia has also published updates and alerts for Australian providers and patients who may have been exposed during surgery. Click here if you have had surgery involving a heater-cooler unit in an Australian facility.