Federal officials have traced a series of severe bacterial infections to heater-cooler units, devices that regulate the body temperature of open-heart surgery patients.
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In a series of unusual outbreaks, dozens of surgical patients have developed rare and life-threatening infections after undergoing cardiopulmonary bypass procedures. Government authorities, including researchers at the FDA and Centers for Disease Control, believe that infectious pathogens are being spread by heater-cooler devices, machines commonly used during open-heart surgery.
Lawsuits are now being filed on behalf of injured patients, who accuse healthcare facilities and medical device manufacturers of failing to protect public safety.
Outbreaks of Non-Tuberculous Mycobacterium (NTM), a class of potentially-fatal bacteria, have been reported around the world:
In every case, researchers have linked these severe infections to contaminated heater-cooler units, machines used to regulate the body temperature of open-heart surgery patients. Over the last three years, regulators at the Food & Drug Administration have repeatedly warned health care facilities about the dangers posed by contaminated heater-coolers. These warnings apply to all heater-cooler devices, but one model in particular, the Stöckert 3T, has come under increased scrutiny.
The Stöckert 3T (or Sorin 3T) heater-cooler, manufactured by English medical device company LivaNova, is used in around 60% of the heart bypass surgeries conducted in the United States. Extensive testing has now confirmed that these machines are the likely source of most NTM infections in surgery patients. In fact, the vast majority of confirmed infection cases involve a single species of NTM, Mycobacterium chimera (M. chimaera), which appears to have been introduced to many Stöckert 3T units during the manufacturing process.
The FDA has instructed hospitals and surgical centers throughout the nation to “strongly consider transitioning away from the use of [Stöckert 3T heater-cooler units] until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.”
While bacteria can begin to grow inside a unit’s water tank, CDC researchers believe that many Stöckert 3T heater-coolers were contaminated during the manufacturing process.
In a series of 2014 tests conducted by the machine’s manufacturer, M. chimaera contamination was found on both the production line and in the water supply for the company’s manufacturing facility. LivaNova soon implemented a stronger disinfection program at the plant, but subsequent FDA investigations found the company’s response “inadequate.”
In 2015, authorities from the FDA conducted a series of inspections at LinaNova manufacturing facilities in Colorado and Munich. The investigators discovered evidence of numerous deficiencies, including multiple violations of US federal regulations. The company’s new safety instructions were “incomplete,” FDA researchers found. In fact, the FDA could find no evidence that LinaNova had ever even tested its new cleaning protocol for the heater-coolers. Testing carried out by a third-party laboratory was deemed “inadequate.” LinaNova’s system for accepting reports of adverse events also failed to meet FDA regulations. The agency quickly moved to sanction LinaNova, blocking all imports of Stöckert 3T heater-cooler units until the company corrected its violations.
Despite these strong enforcement efforts, LinaNova’s problems have only continued. FDA investigators have discovered newly-manufactured Stöckert 3T units that test positive for M. chimaera. It remains unknown whether or not these newer devices were contaminated at LivaNova’s manufacturing facility or after their purchase by a hospital.
Genetic tests, on the other hand, indicate that many of the infections reported in America have a common source. After outbreaks of M. chimaera were reported by hospitals in Pennsylvania and Iowa, the FDA quickly stepped in. Researchers analyzed the genetic makeup of bacterial samples, taken both from infected patients and the Stocker 3T heater-cooler machines that had been used during their surgeries. The samples from Pennsylvania and Iowa were remarkably similar – so similar that the investigators soon concluded that all of the 3T machines had been contaminated from the same source.
Similar results were found in a recent study out of Denmark. Analyzing samples of M. chimaera bacteria isolated in the United States, United Kingdom and Denmark, the researchers discovered that each bacterial sample was “nearly identical” from a genetic standpoint. In conclusion, the Danish team wrote:
“We find it likely that most [Stöckert] 3T [heater-cooler units] made in the past 8 – 10 years potentially are contaminated by the same M. chimaera strain. In addition, because 80% of the Maquet [heater-cooler units] also contained M. chimaera, although phylogenetically different from the [Stöckert] 3T strains, we suggest mycobacterial contamination might be a general problem for [heater-cooler units].”
As we’ve seen, epidemiological research clearly demonstrates that most, if not all, Stöckert 3T heater-cooler machines were contaminated before ever being sold. Unsurprisingly, practicing surgeons have begun to assume that every heater-cooler made by LivaNova is contaminated with M. chimaera. The dangers, however, may go far beyond a single device.
Current research suggests that nearly every heater-cooler device is contaminated with at least one strain of Non-Tuberculous Mycobacterium. Researchers in Denmark have found that nearly 90% of heater-cooler devices may already be contaminated with M. chimaera.
Published online by the journal Emerging Infectious Diseases in January 2017, the Danish study shows that 86% of the heater-cooler units tested in five thoracic surgery departments were positive for M. chimaera, with a second strain of mycobacteria, M. gordonae, identified in close to 24% of the machines. Four out of the five surgical departments were using the Stöckert 3T heater-cooler; nearly 88% of these machines were contaminated. A second type of heater-cooler, manufactured by German company Maquet, was found to be contaminated in a majority of cases.
Every year, over 250,000 cardiopulmonary bypass procedures involve a heater-cooler, the Centers for Disease Control & Prevention reports. Used in hospitals around the world, heater-cooler devices are designed to regulate a patient’s body temperature during surgical procedures.
Most common during cardiothoracic surgeries, heater-cooler machines provide a carefully-regulated supply of warm or cold water to cardiopulmonary bypass machines and oxygenators, along with heating and cooling blankets – devices that maintain a patient’s body temperature at appropriate levels during open-heart surgery. The heater-cooler relies on a closed water circuit. In theory, no liquid from the machine itself touches the patient during use.
In practice, however, there is strong evidence to suggest that these machines can allow dangerous bacteria to enter a patient’s body. According to the US Food & Drug Administration, NTM bacteria can grow inside the water tank contained in heater-cooler units. While this water never comes into direct contact with a patient, the heater-cooler is not entirely self-contained. Water inside the machine can easily evaporate, bringing both moisture and bacteria into the operating room.
Once “aerosolized,” dangerous bacteria can quickly reach a surgery patient’s open chest cavity, leading to an infection. The bacteria can also land on sterile surgical equipment, including implants intended to be placed around the patient’s heart.
Many bacteria can become “airborne,” spreading throughout the environment along with currents of air. In a surgical setting, controlling airflow through precisely-designed ventilation is extremely important, one of our best safety measures to prevent patients from being infected by virulent pathogens. Experts now believe that heater-cooler units, most which feature at least one exhaust fan, may disrupt the carefully-calibrated airflow within an operating room, allowing airborne forms of Non-Tuberculous Mycobacterium into the supposedly-sterile surgical field.
The term “mycobacteria” refers to a large family of bacterial species that share certain characteristics. Most notably, all mycobacteria have thick cell walls, at least thicker than the walls observed in other species of bacteria. Several serious pathogens belong to the mycobacteria family, including species that cause tuberculosis and leprosy. The subgroup of bacterial species referred to as Non-Tuberculous Mycobacteria are defined in contrast to mycobacteria that can cause tuberculosis or leprosy. In short, any mycobacterium that does not cause tuberculosis or leprosy is considered a Non-Tuberculous Mycobacterium.
NTM can be found throughout the environment, especially in marshes, wet soil and rivers. While these bacterial species do not cause tuberculosis or leprosy, the pathogens can lead to severe infections in humans, although disease cases are relatively rare. This appears to be true even for the specific bacterium, M. chimaera, that is being spread by heater-cooler units. While millions of open-heart surgery patients have likely been exposed to the bacterium during procedures, only a handful of infection cases – around – have been reported so far.
NTM is particularly dangerous in patients who have undergone invasive procedures, along with people with weakened immune systems.
The medical community’s reporting on M. chimaera infections is undoubtedly incomplete. M. chimaera is a “slow-growing” bacteria and the symptoms of an infection may not develop until months – or years – after a surgical patient is actually infected:
These symptoms are not specific to an infection caused by Non-Tuberculous Bacterium and can be caused by numerous other medical conditions. Even so, patients who have undergone open-heart surgery – even years ago – should remain vigilant.
Treating a mycobacterial infection can be difficult. A multi-drug regimen of anbiotics will be prescribed in most cases, but these bacteria are fairly resistant to traditional antibiotics. Some patients will require exceptionally long courses, up to 12 months.
For patients who have undergone a heart surgery, especially those who received implants, additional procedures may become necessary. There is a possibility that the bacteria are growing on the implant itself, which may indicate the implant’s removal.
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