Saskatoon – Saskatoon Health Region is notifying adult patients who have had open-heart surgery between 2011 and 2016, about a potential infection related to a heating-cooling device used during their surgery. While the possibility of infection is very low, the Region is working with patients and healthcare providers to ensure those who might be affected know what to do.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) as well as Health Canada have recently been investigating reports that a device used to heat and cool the blood during surgery has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). NTM is commonly found throughout nature in water and soil and is not known to cause human disease, except in individuals with a weak immune system. The heating-cooling devices, which are essential to performing open heart surgeries, are routinely used in hospitals throughout Canada, the United States and Europe. Investigations to date show the devices were likely unknowingly contaminated with the bacteria during the manufacturing process. Environmental testing at the manufacturing site identified contamination of water tanks and the pump assembly area of the facility.

For patients who have had open-heart surgery, the chance of getting the infection is less than one per cent. Over 2,173 patients have undergone open-heart surgery over the last five years in Saskatoon, and to date, none have been diagnosed with this infection. There are no known infections in Saskatchewan.

"For most patients, the benefits of undergoing heart surgery far outweigh any remote risk of infection," said Dr. Greg Dalshaug, Saskatoon Health Region's division head of Cardiac Surgery. "As a precautionary measure, and because safety is our highest priority, we are notifying patients and healthcare providers of this potential risk." 

All patients who received open-heart surgery since 2011 are being contacted by letter to explain the potential risk and associated symptoms of infection. Physicians throughout the province are also being notified.

"Saskatoon Health Region is also strictly following the safety recommendations issued by the Centers for Disease Control and Prevention, the Food and Drug Administration and Health Canada regarding the devices to ensure patients who need this essential device in the future are provided with safe, high-quality care," said Dalshaug. "These national safety recommendations include device testing, replacing all components of tubing of the machine, adhering to strict protocols for cleaning and using filtered water.

The infection is not contagious and cannot be spread person to person. Patients who received a pacemaker or defibrillator, cardiac catheterizations, or angioplasties are not at risk.

There is no screening test to determine if a patient has been exposed to the NTM bacteria. The rare NTM infection develops slowly and it is possible to develop symptoms months or even years after surgery. Symptoms of the NTM infection, which can be confused with influenza, may include unexplained fever and at least two of the following: night sweats, muscle aches, weight loss or fatigue. Patients who experience the combination of symptoms for more than one week should contact their primary care physician.

Patients with questions or concerns may contact Saskatoon Health Region Client Representative Services at 306-655-0250, 1-866-655-5066, client.rep@saskatoonhealthregion.ca or visit www.saskatoonhealthregion.ca/PatientNotices.

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