Mayo Clinic Alerts 17,000 Patients about Infections caused by LivaNova Heater-Cooler Device

Mayo Clinic Alerts 17,000 Patients about Infections caused by LivaNova Heater-Cooler Device

After identifying a rare infection in a patient following a heart surgery at one of its hospitals, the Mayo Clinic is notifying 17,000 patients across the country who might also be at risk. The infection, like others around the world, is linked to the faulty heater-cooler devices (HCDs) made by LivaNova PLC. According to the Food and Drug Administration (FDA), 16 hospitals in 10 states have reported similar HCD incidents.

An HCD helps patients to regulate their body temperature during open-chest operations, but because of a design oversight, the LivaNova device may instead be infecting patients with deadly bacteria.

LivaNova’s Dangerous Device

According to a statement from LivaNova, the design of their device may allow for contaminated water to be dispersed into the air of the operating room. This “creates the potential for the aerosolized bacteria to ultimately come into direct contact with the patient through the open chest during the surgical procedure.” But where does this bacteria come from?

While it is possible that the contamination could happen in a hospital, it appears to be more likely that the contamination of the devices occurred at the site of manufacture. A European study discovered contamination at the device production site and in new HCDs in three countries. What this means is that these devices were shipped out the door with deadly bacteria waiting inside.

The action by the Mayo Clinic represents part of a broader effort to understand and address the international outbreak. According to the Center for Disease Control (CDC), LivaNova produces 60 percent of all HCDs used in the United States, and is used in more than 250,000 procedures every year. Somehow, a defective machine has become the industry standard.

Hard to Detect, Harder to Treat

These type of infections are difficult to detect. Mycobacterium chimaera is a slow-growing, nontuberculous mycobacterium (NTM), and it can take months or years for symptoms to develop. What’s worse is that, once detected, treatment for NTM is not an option for some patients. In 2014, a South Carolina man died 3 weeks after NTM detection because he was too sick to withstand the powerful drugs needed to treat the infection.

The risks are real, even if infection is rare. Mayo’s chief of anesthesiology, Brad Narr, outlined the rationale behind the large scale notification, “We just felt strongly that every patient that had had cardiac surgery that could have been exposed to this bacteria should know about it.” In the letter, the Mayo Clinic advises patients who have undergone an operation using an HCD to contact their primary doctor if they experience any of the following symptoms:

  • Night sweats
  • Substantial weight loss over several months
  • Persistent, unexplained fever.

Patients should be aware that these symptoms may take months or years to develop. According to an alert issued by the FDA, “there may be an increased risk of infection if you received a heart valve, graft, left ventricular assist device (LVAD), or any other prosthetic product/material or had a heart transplant.”

Dangerous Ignorance of the Outbreak

A new study published by the Society for Healthcare Epidemiology of America (SHEA) builds on the work done by the FDA and CDC. What the researchers found is that, “many healthcare providers are unaware of the entity ‘invasive M. chimaera infection,’ which may result in misdiagnosis or delayed diagnosis.” This lack of awareness is only going to make the problem worse.

The study’s lead author, Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland, said:

“It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world . . . Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”

Despite the growing awareness of this problem, the study concluded that most hospitals “did not (or still do not) provide strict separation between [operating room] air and HCD exhaust air, many more patients were (and will continue to be) at risk.”

As of October, the study puts the worldwide case count at 70, but, “Given the difficulty of surrounding this diagnosis with a latency of up to 5 years and the absence of a standardized case identification strategy, it is likely that there are additional cases.”

Each “additional case” represents a real person who does not know the serious risk they are in. This is not right. Given the prevalence of LivaNova HCD’s, more hospitals should be following the Mayo Clinic’s example and taking immediate measures to alert at-risk patients.

Anyone who has had an open-chest operation can find helpful information in this notification from the CDC.

Sokolove Law Team

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Last modified: September 28, 2020