Cancer patients’ tests delayed after Health Canada inspection

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This article was published 16/02/2024 (606 days ago), so information in it may no longer be current.

Diagnostic tests were delayed for 35 Manitoba cancer patients after Health Canada found deficiencies at the facility that makes radioactive isotopes needed to use a scanner.

Positron Emission Tomography (PET) scans had to be rescheduled after a routine inspection found 10 deficiencies in the Winnipeg Cyclotron Facility at the Health Sciences Centre in November 2023.

Inspectors determined there were problems with sterility testing of the isotopes, training was inadequate and there was a lack of quality oversight.

The federal agency has issued non-compliance orders to the cyclotron facility three times in the last 11 years.

The cyclotron produces the radioactive material, which is then mixed with a sugar, and then injected into patients so the scanner can find where cancer is located in the body.

Shared Health said a scheduled maintenance shutdown of the cyclotron was extended to more than two weeks to help address deficiencies listed in the federal agency’s non-compliance rating.

While that was being conducted, radioactive isotopes were trucked in daily from a facility that produces them in Saskatoon.

“It is important to note that the deficiencies noted by Health Canada do not impact the results of any PET scans,” a Shared Health spokesman said in a statement on Friday.

The spokesman said the cyclotron has produced isotopes for 12 years and there have been “no documented adverse reactions in the approximately 25,000 scans completed.”

Dr. Daniel Levin, a nuclear medicine physician at HSC who interprets PET scan tests for doctors and specialists, said while there have been no adverse reactions in patients, they are still adversely affected by the non-compliance ruling and temporary shutdown of the cyclotron.

“The only other place where they make enough (of the radioactive isotopes) is Saskatoon and when we don’t operate (the cyclotron) here, we have it brought here on trucks,” Levin said.

“By the time it gets here, it is only a 16th of the original material. So, you can’t do as many patients as you would like to do.”

Normally, Levin said, the facility’s two PET machines can scan 20 patients a day. If isotopes must be trucked in from Saskatoon, that number drops to seven per day.

“It means, in some cases, people needing urgent scans didn’t get them done,” he said.

“If you know you have cancer, it is a horrible feeling and every day makes a difference in your head… People want to know and every delay is hard psychologically and emotionally.”

Tammy Jarbeau, a Health Canada spokeswoman, said Friday the agency inspects facilities where drug products are produced every two to three years. The agency considers the radioactive mixture made from the isotopes, which is injected into patients for the scan, a manufactured drug product.

She said the Winnipeg Regional Health Authority’s plan to address the deficiencies has been “deemed acceptable by Health Canada and the site will be reinspected sometime in the coming months.”

Jarbeau said if the deficiencies have been addressed, “a compliant rating will be assigned.”

The Shared Health spokesman said to address some of the Health Canada concerns “the cyclotron and quality program now has an optimal staffing complement of 10.6 full-time equivalent positions.

“We have offered the lead radio-chemist position to a successful candidate who has accepted and will be starting in the role in the spring.”

Health Minister Uzoma Asagwara said the government takes patients’ health and safety seriously.

“The Health Canada inspections are welcomed as they provide independent oversight to determine if there are any deficiencies that need to be addressed,” Asagwara said in a statement.

“I will address any concerns brought to my attention regarding staffing or resources.”

kevin.rollason@freepress.mb.ca