Patients, including children, who underwent open-heart surgery at hospitals across North America — including six in Quebec — are being notified that they may be at risk of infection.
This is associated with devices, such as heater-cooler systems, that are used during cardiac surgeries under cardiopulmonary bypass.
“A machine we use in the operating room during open heart surgery – the machine is not connected to the patient, but it is in the room,” explained Dr. Louis P. Perrault, cardiac surgeon and head of the department of surgery at the Montreal Heart Institute (MHI).
“This machine can be contaminated with this micro-bacteria, that can become part of the air in the operating room and actually infect the patients.”
About 23,000 patients who have undergone surgeries since Nov. 1, 2011 are being contacted.
Affected hospitals in Quebec include:
- McGill University Health Centre (MUHC), including the Montreal Children’s Hospital and the Royal Victoria Hospital (over 1,300 letter sent)
- Centre hospitalier de l’Universite de Montréal superhospital (CHUM) (around 2,500 letter sent)
- Quebec Heart and Lung Institute (IUCPQ) (around 9,500 letter sent)
- Montreal Heart Institute (MHI) (over 8,400 letter sent)
- Centre hospitalier universitaire de Sainte-Justine (HSJ)
- Chicoutimi Hospital (over 1,000 letters sent)
Some hospitals, like the CHUM and the MHI, said they have stopped using the machines.
Others, like the MUHC and the IUCPQ, said they will continue.
“There are simply no other machines on the market,” said Gilda Salomone, a spokesperson with the MUHC.
“The risk is minimal, it’s 0.1 per cent to one per cent and it is a far lower risk than actually other risks associated with not having the surgery.”
Patients about to undergo open-heart surgeries are encouraged to speak to their doctors.
“It’s like if you were telling me we have an airplane and we don’t have any other motors, so we’re going to keep the motor because the risk to have a crash is so small – it’s a little worrisome,” said patients rights advocate Paul Brunet.
Montreal lawyer Jean-Pierre Ménard represents two patients who have been diagnosed with the bacterial infection after surgeries at the MHI.
“Because of this breach of safety, it could raise the issue of the manufacturer’s liability,” he told Globa News.
One of them is Marie-Claude Corbin, who had surgery in March 2015 and started to feel symptoms early this year.
“I lived without knowing what was wrong for so long,” she said, adding she is now on antibiotics.
“It was really hard to live like that.”
Risk of infection
Concerns over the machines come after two patients at the MHI were diagnosed with the infection.
All the devices, including audit and decontamination protocols used at the MHI, were replaced.
“Our main focus is to provide our patients with all the information, support and care they may need in order to cope with this situation,” said Dr. Denis Roy, chief executive officer at the MHI.
The heater-cooler systems are used in several North American and European hospitals.
They may have been contaminated by a Mycobacterium chimaera bacterium during their manufacturing in Germany
This type of bacterium is commonly found in nature and rarely causes adverse affects in people who contract it.
“This bacterium is not contagious, but could potentially lead to serious infection and should be diagnosed by laboratory testing (microbiology) when symptoms occur,” said Perrault.
According to the American Centers for Disease Control and Prevention (CDC), the potential for infection is low — 0.1 per cent to one per cent.
Patients exposed during heart surgery could develop symptoms months or years after surgery.