(November 1, 2016)

Important information for patients who have undergone open-chest cardiac surgery

UCHealth is notifying patients and their health care providers of recent findings from the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) regarding patients who have undergone open-chest cardiac surgery.

Across the nation, heater-cooler devices used during certain major surgeries that require the use of a heart/lung bypass machine have recently been linked to a rare bacterial infection caused by Mycobacterium chimaera, a slow-growing species of nontuberculous mycobacteria (NTM). Investigations into several clusters of infections have determined that these devices were likely contaminated with M. chimaera during manufacturing. It is possible that not all of the devices were contaminated during manufacturing.

The devices are used at hundreds of hospitals across the nation including three UCHealth hospitals: Medical Center of the Rockies, University of Colorado Hospital and Memorial Hospital Central.

All our hospitals will continue to closely follow CDC and manufacturer guidelines for disinfection, screening and maintenance practices.

CDC is recommending that clinicians, including cardiologists and primary care providers who care for patients who undergo or have undergone cardiac surgery, be aware of the risk and consider NTM as a potential cause of unexplained chronic illness. Infections can take months to years after surgery to develop, and symptoms are often general and nonspecific. There is no test to determine whether a person has been exposed to the bacteria. A test can identify infection once symptoms begin, but results can take about two months.

What are possible symptoms of an NTM infection?

Symptoms of an NTM infection may include:

  • night sweats
  • muscle aches
  • weight loss
  • fatigue
  • unexplained fever

If a patient experiences these symptoms after an open heart surgery, he or she should contact their doctor and share their history of surgery and potential exposure to a heater-cooler device.

UCHealth will continue to work with the CDPHE, CDC and FDA to ensure we are following all safety recommendations. We believe that with our current practices we can continue to provide patients who need this device with safe, high-quality care.

Questions and answers

Do UCHealth hospitals use these devices?
Yes, hundreds of hospitals across the nation use these devices including Memorial Hospital Central, University of Colorado Hospital and Medical Center of the Rockies.
What are UCHealth, Memorial, UCH and MCR doing to protect patients?
All our locations will continue to closely follow CDC and manufacturer guidelines for disinfection, screening and maintenance practices.
What is the risk 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 to these infections to show up? What's the shortest amount of time it's taken for an infection to occur following exposure to a contaminated heater-cooler device during bypass surgery? The longest?
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 a family member?
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, standard antibiotics given for surgery are not effective at preventing 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. 

Can patients be tested to know if they might have been exposed to the bacteria?
There is no test to determine whether a person has been exposed to the bacteria.

A test can identify infection once symptoms begin, but results can take about two months. 


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 does the CDC 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. A national recall could result in patients not getting life-saving surgeries that are needed now.