No cancer-detection scans have been affected following a Winnipeg lab’s failure to pass another federal inspection.
The Winnipeg Cyclotron Facility failed a Health Canada inspection in April because officials determined there were delays in making changes after a previous failed inspection last fall. As a result, the facility has been listed as “non-compliant” by Health Canada. Spokespeople for both Health Canada and Shared Health said they are working together on compliance.
The cyclotron facility, part of the Health Sciences Centre campus on William Avenue, produces medical isotopes that are used in diagnostic imaging scans of the heart, brain, liver, muscles and tumours. The facility’s work makes possible positron emission tomography scans, also known as PET scans, which can be used to detect cancer and other conditions.
No PET scans have been cancelled, no test results implicated, and there is no immediate risk to the public, Shared Health and Health Canada said.
In April and October 2023, inspectors found the lab lacking in quality control procedures, sterilization, handling and documenting of test results, and staff training, among other issues, according to an inspection report, which was recently posted online.
“The Winnipeg Cyclotron Facility continues to operate and there is no evidence that deficiencies noted by Health Canada have impacted the results of any PET scans. No PET scans have been cancelled due to the inspection team’s findings (the cyclotron had unplanned shutdowns for four days in the past month for unrelated matters, including a minor mechanical issue and the availability of trained operators),” a Shared Health spokesperson said.
Since last fall’s inspection, a lead radiochemist was hired, the reporting process was changed, new in-house sterility testing methods were introduced and quality control unit improvements were added as part of the facility’s efforts to address the inspectors’ concerns, the Shared Health spokesperson said, adding the most critical findings from last fall’s inspection “were either eliminated or downgraded.”
“For the spring inspection, four of Health Canada’s five observations were repeated from the fall, which reflects that not all of the complex remediation work has been completed yet due to the relatively short time frame between inspections. Supply chain challenges were also a factor,” Shared Health said.
“Since the April inspection, we have completed work to address Health Canada’s recent observations relating to product sterility while making progress on findings tied to enhanced personnel training – particularly in areas of clean room practices and the validation of aseptic processing. Other work remains ongoing and is expected to be complete by year’s end.”
Health Canada is reviewing the cyclotron facility’s plan in response to the most recent non-compliant findings, and if the plan is accepted, another re-inspection could be scheduled in the coming months, a federal spokesperson said.
The facility has been in operation since 2010. In the years before that, medical isotopes had to be flown in from out of province.
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