Montreal Heart Institute issues recall for thousands of surgical patients
The Montreal Heart Institute is contacting thousands of open-heart surgery patients since 2012 because they might be at risk of developing a bacterial infection after exposure to a piece of tainted medical equipment, the MHI’s executive director announced Monday.
The equipment in question — a heater-cooler machine that is used to regulate a patient’s body temperature during certain operations — was found to have been contaminated by a potentially fatal bug, Mycobacterium chimaera.
The MHI has so far discovered that two patients out of 8,458 operated on since 2012 developed infections. The patients are now undergoing treatment.
“Although the possibility of infection is low — 0.1 per cent to one per cent, according to the U.S. Centres for Disease Control and Prevention — our priority is the well-being and safety of our patients,” Denis Roy, head of the MHI, said in a statement.
“Therefore, as a prevention measure, we wish to get in contact with our patients in order to monitor their medical condition as adequately as possible.”
The MHI issued the alert 11 days after Consumer Reports in the U.S. published an article about the medical device being linked to heart and lung infections.
From Jan. 1, 2010, to Feb. 29, 2016, the U.S. Food and Drug Administration received 180 incident reports related to heater-cooler devices around the world, Consumer Reports noted. Among the incidents were at least 45 American patients who later became infected and at least nine who died.
Those infected developed non-tuberculosis mycobacteria (NTM), which is usually harmless, but if it makes its way into the chest cavity or onto a prosthetic heart valve of a surgical patient, it can turn fatal.
“This bacteria is not contagious, but it can be responsible for a serious infection and has to be diagnosed following a microbiological laboratory analysis during the appearance of symptoms,” said Dr. Louis P. Perrault, chief of surgery at the MHI.
The institute added in its statement that patients exposed to the bacterium during surgery could develop symptoms months and even years after their operations.
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