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Patient Notices

Information for patients about nontuberculous mycobacterium (NTM) infections

Saskatoon Health Region is notifying adult patients who have had open-heart surgery (valve surgery, coronary artery bypass graft or CABG, heart or lung transplant and placement of ventricular assist device) between 2011 and 2016, about a potential infection related to a heating-cooling devices used during the surgery. While the possibility of infection is very low, we are working with patients and healthcare providers to ensure those who might be affected know what signs and symptoms to look for and what to do if they experience them.

The infection cannot be spread person-to-person. Patients who received a pacemaker, defibrillator, cardiac catheterization, angioplasty, stent or ablation are not at risk.

Since many hospitals across the country, the United States, and Europe use these heating-cooling devices, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and Health Canada are investigating reports that these devices, which are used to heat and cool the blood during surgery, have been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). National investigations to date show the devices were likely contaminated during the manufacturing process. For patients who have had surgery using these devices, the chance of getting this infection is less than 1 per cent. For most patients, the benefit of undergoing the procedure far outweighs any remote risk of infection.

More than 2,173 patients have undergone open-heart surgery in the last five years in Saskatoon, and to date, none have been diagnosed with this infection.

This infection develops slowly and it is possible to develop symptoms months or even years after surgery, so it is important to know the symptoms to look for. Symptoms of an NTM infection, which can be confused with influenza, may include unexplained fever and at least two of the following:

  • night sweats
  • muscle ache
  • weight loss
  • fatigue

We are following the safety recommendations issued by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and Health Canada regarding the devices to ensure we can provide patients who need this device in the future, with safe, high-quality care.

If you have experienced symptoms for more than one week contact your primary care doctor.

If you have additional questions or concerns about this information please contact Saskatoon Health Region Client Representative Services at 306-655-0250, 1-866-655-5066 or client.rep@saskatoonhealthregion.ca

Video

Dr. Greg Dalshaug Saskatoon Health Region's Division Head of Cardiac Surgery explains a potential infection risk to some open heart surgery patients connected to a heater-cooler device used during their surgery.

 

Questions and answers about nontuberculous mycobacterium (NTM) infections

What is the risk of infection?
The chances of getting this infection are very low (less than 1 per cent); for most patients, the benefits of undergoing the procedure far outweigh any remote risk of infection. Many hospitals across the country, the United States, and Europe use this equipment during open heart surgeries. We are not aware of any patients who have developed this infection following open heart surgery in Saskatoon and we are following the safety recommendations issued by Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and Health Canada regarding the devices to ensure we can provide patients who need this device in the future, with safe, high-quality care.

What are the symptoms of infection?
Symptoms of a non-tuberculosis mycobacteria (NTM) infection, which can be confused with influenza, may include unexplained fever and at least two of the following:

  • night sweats
  • muscle ache
  • weight loss
  • fatigue

Is the infection serious or life threatening?
Non-tuberculosis mycobacteria (NTM) is commonly found throughout nature in water and soil and in tap water. It is not known to cause human disease, except in rare cases with individuals with a weak immune system.

What should I do if I have had open-heart surgery since 2011 and now have symptoms?
If you have had symptoms for more than a week, please contact your family physician as soon as possible. If you are having severe symptoms please seek emergency medical attention.

Are patients who had non-invasive heart procedures, such as stents, pacemakers, defibrillators, cardiac catheterizations, angioplasites or ablations, also at risk?
No. Patients who had a non-invasive heart procedure are not considered at risk for this infection as the heating-cooling device is not used during the procedure.

Can I be screened for this infection?
There is no screening test to see if you have been exposed to non-tuberculosis mycobacteria (NTM) during open heart surgery. The infection is not detectable without symptoms. If you do not have any signs or symptoms, testing is not needed.

How is the infection treated?
If you have an non-tuberculosis mycobacteria (NTM) infection, treatment may vary, and will be determined by your doctor. Your doctor has been notified of the issue with the device and will order specific tests for you in case Mycobacterial infection is suspected. NTM infections can become chronic and require ongoing treatment, such as antibiotics for one to two years. Some patients, however, do not require treatment for their less severe infections.

Can a person who develops one of these non-tuberculosis mycobacteria (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, including tap water and is not known to cause human disease, except in rare cases with individuals with a weak immune system.

How did the devices get contaminated?
A device used to heat and cool blood during open heart surgery has been linked to a rare infection caused by Mycobacterium chimaera, a type of bacteria known as non-tuberculosis mycobacteria (NTM). These devices were likely contaminated during manufacturing as NTM is common in water and soil. Environmental testing at the manufacturing site identified contamination of water tanks and the pump assembly area of the facility.

How has Saskatoon Health Region responded to this risk?
Saskatoon Health Region is strictly following the safety recommendations of the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and Health Canada to ensure we can provide patients who need this essential device in the future, with safe, high-quality care. These safety recommendations include:

  • regular testing of the devices
  • replacement of all components of tubing of the machine
  • adherence to the strict protocols for cleaning as recommended by Health Canada
  • using filtered water (though a 0.2 micron filter) with the addition of hydrogen peroxide
Last Modified: Wednesday, December 14, 2016 |
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