Patient Information:  Important Information regarding Open-Heart Surgery Infections

While there have been no reported cases of Nontuberculous Mycobacterium (NTM) infections at Hackensack University Medical Center and the possibility of infection is low, our top priority is always the health and safety of our patients. We take reports of potential bacteria exposure during open-heart surgery very seriously and are proactively reaching out to patients who have been impacted. If you received open-heart surgery at Hackensack University Medical Center between October 2012 and October 2015 and have questions about whether or not you were exposed to a potentially contaminated heater-cooler device during surgery, please review the information provided below or contact us immediately. We want to provide you with as much information as possible.

Patients or families with any questions or concerns should contact Hackensack University Medical Center at (551) 996-2131.

If you recently received a letter from Hackensack Meridian Health regarding your open-heart surgery and potentially have been exposed to this bacteria, then you are among those patients who may have been exposed to NTM during your procedure at Hackensack University Medical Center.

We have dedicated health care team members who can help you

  • We have an outstanding team of physicians, nurses and health care professionals who are available to answer any questions you may have about this issue. Please contact Hackensack University Medical Center at (551) 996-2131.
  • This service is provided at no cost to you or your family

Your physicians are here to help you

  • We have alerted our physicians and health care team members about this issue and we are ready to help you
  • If you have received a letter from us regarding this issue, we recommend you make an appointment with your primary care physician or cardiologist to discuss and monitor any potential symptoms of infection

Patients who are experiencing symptoms such as night sweats, muscle aches, weight loss, fatigue or unexplained fever should contact Hackensack University Medical Center at (551) 996-2131 immediately to discuss testing for any potential infection.

Frequently Asked Questions

What is Nontuberculous Mycobacterium and what is the incubation period?

  • Nontuberculous Mycobacterium (NTM) is a slow growing organism. Symptoms are usually delayed and are flu-like in nature.
  • The incubation period, or time to diagnosis, is variable and likely depends on several factors, including the extent of the bacteria, site of the infection and the level of suspicion by the physician.
  • Patients presented symptoms anywhere between five months to 40 months post-surgery.

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.

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.

What does testing of the bacteria entail?

  • Testing for NTM is done by submitting blood cultures and/or tissue-biopsy specimens to be sent for culture. Growth of the bacteria can take up to 7 weeks.

What does treating the bacteria entail?

  • Recommended treatment includes a minimum of four antibiotics for an extended period of time, with or without cardio-surgical intervention.

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

Additional Resources

State and Federal Resources Regarding NTM and Heater-Cooler Units:

best-hospitals-cardiology    high-performing-indicator-heartfailure    high-performing-indicator-heartbypass     HG_Americas_50_Best_Award_Image_2014      HG_Americas_100_Best_Stroke_Care_Award_Image_2014        HG_Americas_100_Best_Pulmonary_Care_Award_Image_2014     red-bulllgbt      tkc_homepagelogo-2

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