Potential infection risk in major heart and lung surgeries

Important Information

In 2015, we sent a letter to patients who had major heart, lung or liver surgery notifying them about a possible exposure to Nontuberculous Mycobacteria (NTM) during their surgery. Because this is a slow growing bacterium and can take up to five years to develop, we are reminding patients impacted by this news, to be alert for the symptoms. If you have unexplained fever, night sweats, weight loss or loss of energy lasting more than a month; please call our Patient Access Center at 1-800-654-5672, so we can help you follow up with a doctor.

At University of Iowa Hospitals & Clinics, our top priority is safe, high quality care for our patients. We are committed to making sure we have the most up to date and important information available. This web page is intended to provide patients, the public, and medical professionals with additional information regarding this issue.

Questions and Answers

What happened?

The U.S. Centers for Disease Control and Prevention (CDC) notified all hospitals of a potential bacterium exposure to patients that was been linked to heater-cooler devices on heart/lung bypass machines previously used during procedures.

What specific type of bacterium is involved?

The bacterium is nontuberculous mycobacterium (NTM). This bacterium is common in the environment and typically is not harmful. In rare cases, NTM can cause infections in patients who have had certain major heart, lung, or liver surgeries.

How were the heater-cooler devices believed to be associated with NTM exposure during surgery?

The heater-cooler devices were used to warm or cool a patient during surgeries requiring a heart/lung bypass machine. NTM can grow in the water in the heater-cooler devices. One European study showed that NTM was detected in the air of an operating room while a contaminated heater-cooler device was running.

What types of surgeries placed patients at risk for this infection?

Only surgeries using a heart/lung bypass machine carry this very low risk. Specifically, this only includes major heart surgeries. Patients who had other surgeries are not at risk because they did not require the use of a heater-cooler device in combination with a heart/lung bypass machine.

Was this a problem at other hospitals?

Yes. There were multiple cases documented in the United States and Europe. In the United States, federal health authorities issued health advisories to hospitals to help them prevent and detect these infections.

Has UI Hospitals & Clinics had any patients with this infection?

Yes. We are aware of one patient who has developed an NTM infection.

How has UI Hospitals & Clinics responded to this issue?

We have consistently exceeded manufacturer guidelines for disinfecting and maintaining the machines, as well as immediately implemented and even exceeded recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) in October 2015. After we identified a patient with an NTM infection, we consulted with the CDC for subsequent recommendations, all of which have been implemented. We are confident that the risk of this bacterial exposure has been eliminated.

What are the symptoms of an NTM infection?

Symptoms of NTM infection may include a fever lasting more than one week; pain, redness, heat, or pus around a surgical incision; night sweats; joint pain; muscle pain; loss of energy; and failure to gain weight or grow (in infants).

Is this infection treatable?

Yes, there are treatments available for this infection.

What are the chances of getting an NTM infection if I had one of these surgeries?

The chances are very low—estimated to be less than 1 percent by the U.S. Centers for Disease Control and Prevention. And, since implementing all of the CDC recommendations, we are confident that the risk has been eliminated.

If I have been exposed or develop an NTM infection, is my family at risk of getting the infection?

No. This bacterium cannot be spread by contact with those who have been exposed or have this infection.

Can I find out whether I'm infected?

If you do not have symptoms, you do not require testing. Because the bacterium grows slowly, it can take several months or years for symptoms of infection to develop. If you have or develop symptoms, it is important for your physician to know in order to arrange testing.

Additional information for medical professionals

At University of Iowa Hospitals & Clinics, our top priority is safe, high quality care. We value you as our partner and thank you for trusting us with the care of your patients. We are writing today to let you know of actions we have taken to address an issue that is affecting hospitals across the country and in Europe.

As you may be aware, in October of 2015 the CDC and FDA issued an advisory to hospitals regarding a bacterial contaminant that has been identified in the water reservoir of the heater-cooler devices used during cardiopulmonary bypass. Surgical site contamination results from the bacteria becoming aerosolized while the heater-cooler devices are in use, which may lead to infection.

The specific bacterium has been identified by the CDC as Mycobacterium chimaera, a nontuberculous mycobacterium (NTM), part of the Mycobacterium Avium Complex. It is commonly found in soil and water. Although NTM generally does not cause infection in immunocompetent patients, it has been identified in cases where these patients have undergone surgeries requiring cardiopulmonary bypass with heater-cooler devices. The CDC estimates the risk of infection to be less than one percent.

The most common symptoms of NTM are those associated with an unexplained infection: fever of undetermined origin, night sweats, joint pain, weight loss, myalgia, and malaise. Laboratory findings may include cytopenias, elevated transaminases, and elevated inflammatory markers. Diagnosis may be made up to four years after the surgery because symptoms of infection may take months, even years, to appear. In addition, the diagnosis requires special cultures.

As part of our commitment to high quality care and patient safety at UI Hospitals & Clinics, we were already exceeding manufacturer guidelines for disinfecting and maintaining the heater-cooler devices. At the time of the advisory released by the CDC in October 2015, we immediately implemented their new recommendations for disinfection.

We are confident that the risk of this bacterial exposure was eliminated when we established effective mitigation procedures.