The Montreal Heart Institute (MHI) informs all patients who underwent an open heart surgery at the Institute of a low infection risk associated with certain devices (heater-cooler systems) used during cardiac surgeries under cardiopulmonary bypass. Patients operated since 2012 at the MHI are being advised of this risk by phone and/or mail.
“Although the potential for infection is low (0.1% to 1% according to the American Centers for Disease Control and Prevention (CDC)), our main priority is the well-being and safety of our patients. Therefore, as a pre-emptive measure, we wish to get in touch with our patients in order to monitor their medical condition as adequately as possible,” said Dr. Denis Roy, Chief Executive Officer at the MHI. All patients operated since 2012 will be notified. An operation to get in touch with the concerned patients is currently underway.
The Centre d’expertise en retraitement des dispositifs médicaux (CERDM – the Centre of Expertise for Medical Devices Reprocessing) of the Institut national de santé publique (the National Institute of Public Health) and the ministère de la Santé et des Services sociaux (Ministry of Health) have been notified of the issue.
The heater-cooler systems in question are used in several North American and European hospitals and may have been contaminated by the Mycobacterium chimaera bacterium during their manufacturing in Germany. This type of bacterium is commonly found in nature and is rarely the cause of adverse events in people who contract it. However, patients exposed during cardiac surgery may develop symptoms much later (i.e. months or years after surgery).
“This bacterium is not contagious but could potentially lead to serious infection and should be diagnosed by laboratory testing (microbiology) when symptoms occur,” according to Dr. Louis P. Perrault, cardiac surgeon and head of the Department of Surgery at the Montreal Heart Institute.
All the devices used at the MHI have been replaced and the audit and decontamination protocols are continuously optimized with the acquisition of new knowledge regarding this issue.
“We are aware that the announcement of this potential risk of infection, albeit a low one, can be a source of concern for patients involved and we sincerely regret any inconvenience this can cause,” declared Dr. Denis Roy. “Our main focus today is to provide our patients with all the information, support and care they may need in order to cope with this situation. To date, two patients of the Institute, out of the 8458 patients who have undergone surgery since 2012, have been diagnosed with such an infection. They are being taken care of and their treatment is underway.”
To contact the dedicated call centre at the MHI please dial: 514 593-2505 and 1 844 593-2505.
A MHI professional is available Monday to Friday from 9 AM to 5 PM.
(SOURCE: Montreal Heart Institute Foundation)