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Amid continuing concerns about the risk of serious M. chimaera infections from cardiac surgery heater-cooler devices, a new report suggests that contamination problems may be extremely widespread, impacting almost 9 out of every 10 devices found in operating rooms.
In a study published this week ahead of print in the March 2017 edition of the CDC journal Emerging Infectious Diseases, researchers from Denmark indicate that nearly all 3T Heater-Cooler patient warming systems examined in that country contained the bacteria M. chimaera, which has been linked to serious infections that may surface months or years following open heart surgery.
Researchers found that the M. chimaera contamination all appears to have the same origin, and that the problems may not be limited to 3T Heater-Cooler Systems, as other similar devices may also be impacted.
The 3T Heater-Cooler has been commonly found in most operating rooms in recent decades, but certain units have been linked to contamination problems over the past year, which may cause the spread of nontuberculous mycobacterium (NTM) during surgery. The infections pose a serious and potentially life-threatening health risk, and individuals who were exposed to the contaminated cardiac surgery heater-coolers may face a risk of future problems, as the onset of symptoms could surface up to four years after exposure.
Last year, federal health officials warned about the heart surgery infection risk from heater-cooler devices, indicating that a large number of adverse event reports had been received. Following an FDA panel meeting over the summer to evaluate the problem, safety communications were sent to medical problems about contamination problems with 3T Heater-Cooler systems manufactured prior to September 2014.
The systems are used to control patient blood temperature during heart bypass surgery, valve surgery and other cardiac procedures. Temperature controlled water that become contaminated may result in the release of bacteria into the air from the exhaust system, potentially entering the open chest cavity during heart surgery.
In this latest study, researchers looked at 21 heater-cooler units (HCUs) in all five thoracic surgery departments in Denmark. They found that 18, or 86%, were contaminated with M. chimaera. Of those, four sites used the Sorin 3T Heater-Cooler system, with 14 of those 16 units, or 88%, contaminated.
However, one site used Maquet HCUs, of which four out of five were contaminated with M. chimaera. Some units also were contaminated with another strain, M. gordonae. Researchers found that the strains of M. chimaera were the same as those found in infected patients in the U.S. and the U.K., suggesting a common origin.
“We found that M. chimaera was present in most HCUs in Denmark. Isolates from Sorin 3T brand HCUs were identical to the HCU isolates from the United States and the United Kingdom, and thus they appear to have the same origin,” the researchers determined. “Because all 5 of the thoracic surgery departments in Denmark had contaminated HCUs and because mycobacterial contamination has been reported in multiple published studies during 2015–2016, we find it likely that most Sorin 3T HCUs made in the past 8–10 years potentially are contaminated by the same M. chimaera strain.”
The researchers noted that after the findings, two of the surgical departments removed the heater-coolers to the outside of the operating room, which could prevent bacteria from being blown out of the vents and into patients’ surgical sites.
Another decided to encase its heater-cooler systems inside of housings that allowed for separate ventilation to protect the integrity of the operating room’s air supply. Two others kept the units in the operating room, but moved them further away from patients and decided to decontaminate them more frequently.
It is not clear yet whether these approaches will decrease the risk of patient infections from contaminated units.
3T Heater-Cooler Infection Lawsuits
The U.S. Centers for Disease Control and Prevention (CDC) has previously 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 use of affected 3T Heater-Cooler systems.
In recent months, cardiac surgery patients have received hospital letters warning that they may have been exposed to a risk of M. chimaera infections or other nontuberculous mycobacteria (NTM) infections. Since the symptoms of infection may not appear for months or years after heart surgery, individuals typically require medical monitoring and regular testing.
A growing number of cardiac surgery infection lawsuits have been filed in recent months against the maker of the 3T Heater-Cooler, and the litigation is expected to continue to increase as individuals learn that M. chimaera infections diagnosed in recent years may have been caused by cardiac surgery heater-cooler contaminations.
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.