Winnipeg facility that produces vital cancer-screening material fails Health Canada inspection for 5th time
Winnipeg Cyclotron facility failed reinspection for issues including product sterilization, lack of training
A provincially run Manitoba facility that creates crucial materials used to detect cancer has once again failed its Health Canada inspection, for many of the same reasons it failed a late 2023 inspection.
Earlier this year, CBC News reported the Winnipeg Cyclotron Facility — the sole producer of medical isotopes in Manitoba — was found non-compliant by Health Canada during its last routine inspection, in late October.
A new report released last week shows it failed its reinspection in April after the regulator found five deficiencies, including problems with the sterilization of products, investigations into defective products and a lack of training.
"It raises suspicion if there are deficiencies that continue to not be completely addressed," said Dr. Daniel Levin, a nuclear medicine physician at Winnipeg's Health Sciences Centre, which is also where the Winnipeg Cyclotron Facility is located.
This is the fifth time the facility has failed its inspection in the last decade.
The isotopes produced in Winnipeg are used to create the radioactive material — often called a tracer — that is injected into patients during a positron emission tomography, or PET, scan.
The most common tracer uses a form of radioactive sugar and accumulates in abnormal spots to highlight possible tumours in a scan. That can help a doctor diagnose whether someone has cancer, how far it has spread, whether it has responded to therapy or if a cancer has come back.
No PET scans affected: Shared Health
No PET scans have been affected by the most recent failure and there is no risk to Manitobans, said a Shared Health spokesperson. The facility was shut down for four days this week for "annual preventative maintenance," the provincial health agency spokesperson said.
A Health Canada spokesperson said the facility had delays in addressing the problems found in the facility in the fall.
Further enforcement options are on the table, said the spokesperson, which could include temporarily pulling the facility's licence.
That's what almost happened to the Winnipeg facility after it failed a 2017 inspection. At that point, however, the facility was able to demonstrate "sufficient progress on the outstanding corrective actions" to maintain its licence, Shared Health previously said.
WATCH | A February report on the facility's 4th Health Canada failure:
Experts have been saying for months the closure of the crucial facility is a real risk.
If the facility loses its licence, isotopes would have to be shipped from Saskatchewan. They have a short shelf life and the extra time getting them into Manitoba would mean fewer PET scans, Levin previously told CBC.
That could mean doing only 10 scans a day instead of 20, he said earlier this year.
The facility, which opened in 2010, also failed its 2020 inspection and its first recorded inspection in 2013, which found 21 deficiencies, including issues with disinfection, poor documentation and testing procedures.
New radiochemist hired
Since the facility failed the late 2023 inspection, it has hired a new radiochemist, made changes to its organizational structure and implemented sterility tests, Shared Health told CBC.
The facility is working with Health Canada to address the deficiencies and bring it into compliance, the spokesperson said.
Of the five deficiencies found in the latest inspection, four were also noted in 2023, "which reflects that not all of the complex remediation work has been completed yet," wrote the spokesperson.
Levin doesn't work in the facility, but as a nuclear medicine physician is responsible for reporting on PET scans and works with the facility.
He says the constant failures suggest the real issue is with the leadership of the facility.
"It's a difficult thing to run, and you need specific people for it. And I think that the leadership hasn't been collaborative enough," he said.
Health Canada is reviewing the facility's action plan for addressing the noted problems. Another inspection is expected in the coming months.
WATCH | Winnipeg facility fails Health Canada inspection for 5th time:
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