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Shortage of key heart surgery equipment hangs over Alberta operating rooms

Open heart surgery is performed by surgeons. During these procedures the heart and lungs are bypassed using a cardiopulmonary bypass.  Oxygenators are a key component of the machines, putting oxygen back into the blood. (Shutterstock - image credit)
Open heart surgery is performed by surgeons. During these procedures the heart and lungs are bypassed using a cardiopulmonary bypass. Oxygenators are a key component of the machines, putting oxygen back into the blood. (Shutterstock - image credit)

A shortage of a key component of heart-lung machines sparking concern in Alberta is the latest supply problem plaguing cardiac operating rooms, health care workers say.

Oxygenators put oxygen back in the blood when the heart and lungs are bypassed during many cardiac surgeries, and can only be used once.

Terumo Cardiovascular, the company that produces the adult oxygenators normally used in Calgary and Edmonton, has been dealing with a shortage for nearly a year, according to Health Canada.

Alberta Health Services (AHS) confirmed three Calgary surgeries were delayed recently but said they were quickly rescheduled. The health authority has ordered different oxygenator models from other companies and it said surgery volumes have not been cut.

Calgary cardiac surgeon, Dr. Scott McClure, says a lot of work is being done behind the scenes to ensure there is enough supply of oxygenators for Calgary surgeries as the shortage continues. (Supplied by Scott McClure)

As the supply problems drag on, a lot of work is going on behind the scenes to ensure surgeries move forward, according to Calgary cardiac surgeon, Dr. Scott McClure.

"Although they're doing everything they can to mitigate it from being a problem there is the potential there for us to have a shortage that affects our ORs," said McClure, co-director of the Calgary Aortic Program.

"It hasn't happened. But it's a real concern."

According to McClure, a backup supply from another manufacturer is now being used.

"We are getting all of our cases done. But we are very aware of the supply issue and we have to monitor it very closely because there absolutely is a potential there for a problem," he said, adding he believes Calgary has enough stock for the next few months.

"If supply comes back it's not a problem. But if at some point there's such an issue with the supply chain and we don't know why, then it can affect care."

AHS orders alternatives

Alberta Health Services said it is working to ensure it has enough stock.

"We have been closely monitoring the global oxygenator supply issue to support the delivery of patient care and cardiac surgeries ... cardiac surgeries are continuing in Alberta," a spokesperson said in a statement.

"AHS is working with multiple vendors who provide oxygenators to ensure we have the resources available to support our cardiac operating rooms."

According to Health Canada, there has been a shortage of the Terumo device since Feb. 22, 2023, due to a manufacturing disruption.

Dr. Ansar Hassan, the president of the Canadian Society of Cardiac Surgeons, said he's hearing from colleagues in other parts of the country too.

"This particular oxygenator — this is the lion's share of the market," he said.

"The spinoff negative effect is if they're not able to supply the demand, then what happens is the other companies are approached," he said.

It is unclear to what extent other manufacturers can fill the void, according to Hassan.

"Every program is having to deal with this. Surgeons are having to deal with this [and] the hospitals. They have to make important decisions: How do we best utilize what we have? And how do we continue ... to make sure that we have an oxygenator supply that will allow us to keep doing the case volumes that we can?"

Naresh Tinani is president of the Canadian Society of Clinical Perfusion. He works as a perfusionist in Regina.
Naresh Tinani is president of the Canadian Society of Clinical Perfusion. He works as a perfusionist in Regina.

Naresh Tinani is president of the Canadian Society of Clinical Perfusion. He works as a perfusionist in Regina. (Supplied by Naresh Tinani)

According to Naresh Tinani, president of the Canadian Society of Clinical Perfusion,  there are about five oxygenator manufacturers supplying the Canadian market. Perfusionists operate the cardiopulmonary bypass machines during surgery.

"We are certainly aware that this is a real challenge for health care overall," he said, noting this is the latest shortage putting a strain on cardiac ORs.

For example, he said there have been ongoing supply problems with different types of tubing, including cannulas which are placed in a patient's major arteries and veins when the heart-lung machine is in use.

"We're hearing quite a bit across the country from a lot of cardiac centres simply around all of our supply chain management. A lot of it is becoming a bit tenuous. There are very few manufacturers in this space ... and all of these companies have had production issues over time," he said.

Health Canada response

Health Canada said it is working with provincial and territorial governments along with manufacturers and others to mitigate the problem.

"When shortages of medical devices arise, provincial and territorial governments, including health authorities, may take measures to conserve stock, identify and secure additional supplies or substitute medical devices," a spokesperson said in an email.

Health Canada has also authorized alternatives through its special access program and the exceptional importation and sale pathway.

According to its website, this can be done in a number of circumstances, including emergencies and when conventional therapies are not available.

Terumo Cardiovascular said in a statement that the problem has been caused by a "short-term production challenge" in its North American operations.

"Shipments are resuming, although global demand continues to outpace supply," a spokesperson said, adding it's unclear when the shortage will be resolved.