Health Sciences North: Heater-Cooler Unit Advisory issued by Health Canada

Information for adult open heart surgery patients:

In response to an advisory issued by Health Canada, Health Sciences North (HSN) is notifying approximately 2,300 former open heart surgery patients of the extremely low risk of infection related to potential exposure to bacteria during their procedure. Letters have been mailed to patients advising them of the situation, and letting them know who to contact should they have any questions or concerns.

Heater-cooler units (HCUs) are used to heat and cool blood during open heart surgery. Some of these units have been linked to a Mycobacterium chimaera infection according to safety alerts issued to hospitals across North America by Health Canada and Public Health Ontario and the Federal Drug Administration (FDA) and Centers for Disease Control (CDC) in the United States.

The risk of infection is extremely low, less than 1% internationally. At this time, there are no known cases of this infection at HSN or in Ontario.

Individuals who have had open heart surgery at HSN should monitor for the following symptoms:

• Unexplained fever that lasts for weeks or months, or that comes and goes over many months
• Night sweats
• Fatigue
• Weight loss and
• Muscle aches.

Patients with any of the symptoms or who have been diagnosed with sarcoidosis since their heart surgery are advised to contact their primary care provider and share the HSN notification letter with them.  Patients with questions or concerns can also contact Patient Relations at HSN by email at patientrelations@hsnsudbury.ca or by calling (705) 523-7100, extension 3737.

HSN is monitoring the situation very closely and will continue to follow Health Canada’s guidance and direction related to the use of heater-cooler units.

Frequently Asked Questions:

What is the heater cooler unit used for?
HCU are commonly used during cardiac surgeries to warm or cool a patient in order to optimize medical care and improve patient outcomes.

Which heater cooler unit is used at HSN?
HSN currently uses the Sorin 3T heater cooler.

How does the HCU cause infection?
This unit requires water to operate. Although the water in the circuits does not come into direct contact with the patient, there is the very low potential for contaminated water to transmit bacteria through the air and into the environment around the patient in the operating room.

What is the infection & where did it come from?

Mycobacterium chimaera is a type of bacteria known as nontuberculous mycobacteria (NTM). NTM is commonly found in the environment from sources such as soil and water, including tap water. Transmission is thought to occur via aerosolization of contaminated water from this heater-cooler unit.

Some confirmed cases in Europe and North America have been traced to a specific unit – the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T heater-cooler system – which was likely contaminated with M. chimaera during manufacturing.

What is the infection & where did it come from?

Mycobacterium chimaera is a type of bacteria known as nontuberculous mycobacteria (NTM). NTM is commonly found in the environment from sources such as soil and water, including tap water. Transmission is thought to occur via aerosolization of contaminated water from this heater-cooler unit.

Some confirmed cases in Europe and North America have been traced to a specific unit – the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T heater-cooler system – which was likely contaminated with M. chimaera during manufacturing.

What is the infection & where did it come from?

Mycobacterium chimaera is a type of bacteria known as nontuberculous mycobacteria (NTM). NTM is commonly found in the environment from sources such as soil and water, including tap water. Transmission is thought to occur via aerosolization of contaminated water from this heater-cooler unit.

Some confirmed cases in Europe and North America have been traced to a specific unit – the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T heater-cooler system – which was likely contaminated with M. chimaera during manufacturing.

What is Mycobacterium chimaera?
Mycobacterium chimaera (M. chimaera) is one of a group of bacteria called nontuberculous mycobacterium (NTM), which is commonly found in the environment, including soil and water. NTM typically is not harmful; however it can in very rare cases cause infections in post-operative surgical patients, especially in people with weakened immune systems.

Some confirmed cases in Europe and North America have been traced to a specific unit – the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T heater-cooler system – which was likely contaminated with M. chimaera during manufacturing.

What is the risk of infection?
At this time, there are no known cases of this infection at HSN or in Ontario.  There have only been two confirmed cases in Canada, both in Quebec. The rate of infection is less than 1% internationally.At this time, there have only been two confirmed cases in Canada, both in Quebec.

What are the symptoms and how can we detect this infection?
The symptoms associated with this infection are non-specific but last for a prolonged period of at least two weeks, possibly months, and include:

• Fever, night sweats
• Unexplained weight loss
• Muscle and joint pain and fatigue
• Enlarged lymph nodes
• Persistently draining surgical wound.

What should I do if I have symptoms?
If you have these symptoms for more than two weeks, we recommend that you contact your primary care provider for a clinical assessment.

If you have had these symptoms as a result of another illness or infection that was treated and improved – you do not need to do anything.

Patients with questions or concerns can also contact Patient Relations at HSN at (705) 523-7100, extension 3737, or contact us by email at patientrelations@hsnsudbury.ca.

How long does it usually take for symptoms to develop?

Because these NTM are very slow growing, initial signs and symptoms may be nonspecific. The incubation period for identified M. chimaera cases ranges from three months to five years, with a median of 18 months after the index surgery.

If I have been exposed to M. chimaera, is there a risk to others?
No, M. chimaera is not contagious and cannot be spread from person to person.

How is this infection treated?
If the medical assessment and analysis confirm a diagnosis of M.chimaera, an antibiotic treatment is available and would be prescribed.

Who is HSN contacting?
HSN is sending notification letters to all patients who had open heart cardiac surgery that involved the use of this particular medical unit since November 2011.

Are you still using HCUs in surgery?

Yes. HSN has 3 heater-cooler units (HCUs) currently in use.  HSN has followed the manufacturer’s recommended protocol for cleaning and disinfection as well as Health Canada’s recommendations to minimize the risk of infection.  Since the Fall, HSN has exceeded the recommendations and is sending each heater-cooler unit to the manufacturer for deep disinfection and baseline testing.

Should I postpone my surgical procedure?

Patients with concerns about infection risks should consult their doctor. However, life-saving surgical procedures should not be delayed. Patients should ask their doctor what to expect following their procedure and when to seek medical attention.

Contact:

Patients exhibiting the symptoms listed above or have been diagnosed with sarcoidosis since heart surgery, please contact your physician and share this letter with them.  If you have not experienced any of these symptoms – or had these symptoms as a result of another illness or infection that was treated and got better – you do not need to do anything.

If you have any further questions or concerns, please contact HSN Patient Relations at (705) 523-7100, extension 3737 or by email at patientrelations@hsnsudbury.ca.

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