Frequently Asked Questions

Frequently Asked Questions about Heater-Cooler Infection 

Questions & Answers provided by the Centers for Disease Control and Prevention (CDC)

  • What is the rick of infection?
    • Overall, the risk is thought to be very low. In hospitals where at least one infection has been identified, the risk of infection was between about 1 in 100 and 1 in 1,000 patients. Initial information suggests that patients who had prosthetic implants are at higher risk. It is possible that not all of the devices introduced these bacteria into the operating room or exposed patients.
  • How long does it usually take for these infections to show up?
    • NTM are slow-growing bacteria and infections may take months to develop. Cases associated with this device have been diagnosed within months and up to several years after an open-heart surgery involving heater-cooler unit exposure.
  • Can a person who develops one of these NTM infections spread it to others, such as family members?
    • No, the bacteria cannot be spread to others from an infected patient. Also, it is important to keep in mind that NTM is common in soil and water but rarely makes healthy people sick.
  • Should everyone who was exposed to these devices during open-heart surgery receive antibiotics just in case?
    • The risk that patients will develop an infection following exposure to a contaminated heater-cooler unit is very low. There is also no evidence that giving antibiotics just prior or during surgery with a potentially contaminated heater-cooler device will prevent infection. Although antibiotics can be life-saving drugs, there is no antibiotic treatment available to ward off this specific infection and antibiotics are also not without risk themselves. Antibiotics put patients at risk for allergic reactions and a potentially deadly diarrheal infection caused by the bacteria Clostridium difficile. Antibiotic use is also a key driver of antibiotic resistance, which can put patients at risk for antibiotic-resistant infections later.
  • How long does it take to find out if an infection is being caused by NTM?
    • M. chimaera is a slow-growing species of NTM that can take eight weeks and sometimes longer to grow and allow final identification.
  • Why are these infections so deadly?
    • Symptoms of infection can take months to develop, and are often general and nonspecific. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. Clinicians may not immediately consider an NTM diagnosis. Delayed diagnosis can result in more widespread disease in a patient. This, combined with underlying health problems such as heart disease can make these infections difficult to treat.
  • How do you think the devices got contaminated?
    • NTM is common in water and soil. Recent CDC findings are consistent with previous reports suggesting that the heater-cooler units were contaminated during production. Testing conducted by the manufacturer in August of 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.
  • Have these devices ever been recalled? Why aren’t they being recalled now?
    • In 2015, the manufacturer recalled the instructions for use, but not the device itself. Information provided by the manufacturer reminded users that while water from the device itself is not intended to contact the patient directly, under certain circumstances, due to fluid leakage and/or aerosolization, NTM could reach a patient’s surgical site. Heater-cooler devices are critical for life-saving surgery. 

Questions and Answers 

Information for Patients Notified of the Risk of Infection Related to Heater-Cooler Devices Used in Their Open Heart Surgeries

  • Why did I receive the letter?
    • You received the letter because of a national alert from the Centers for Disease Control and Prevention (CDC). The CDC has notified all hospitals of risk of infection linked to heater- cooler devices used for open heart surgeries. The bacterium associated with this infection is called Mycobacterium chimaera, a Nontuberculous Mycobacteria (NTM). Although we have not yet identified any infections related to these devices at our hospital, out of an abundance of caution, we are reaching out to all the patients that may have been exposed to these devices to ensure they are aware and seek medical attention if they have any related symptoms. Your safety is a top priority for us.
  • Why am I receiving this letter now?
    • We have sent a letter to all patients who underwent their surgeries up to four years ago (July 2012). The reason for our decision was based on the CDC recommendations. These infections may present months to years after the surgery (up to 3.5 years). The chances are even lower after two years, but we wanted to ensure follow-up.
  • What is the risk of infection?
    • Overall, the risk of infection is thought to be very low. In hospitals where at least one infection has been identified, the risk of infection was between approximately 1 in 100 and 1 in 1,000 patients. Initial information suggests patients who had prosthetic implants are at higher risk (for example, the patient had a valve replacement or graft). So far, we have not had any of these infections associated with Sorin 3T HCU machines identified at our hospital. It is possible you may not have had this specific device used during your surgery.
  • What are the symptoms?
    • The symptoms are not specific to Mycobacterium chimaera infection, but if present, your physician will need to evaluate you further to make sure you do not have it. The infection is very uncommon (resulting in <1% of the surgeries that used these devices). It is important for a physician to evaluate you for more common reasons for your symptoms. The symptoms may include:
      • night sweats
      • muscle aches
      • weight loss
      • fatigue
      • unexplained fever
      • redness or drainage from sternal wound site

If you do not have symptoms, no further action is needed at this point. We encourage you to continue regular follow-up visits or communication with your physician and notify him/her of any changes in your condition. If you have one or more of these symptoms, further evaluation will be needed.