A provincially run Manitoba facility that creates crucial materials used to detect cancer got a passing grade on its latest Health Canada inspection after failing its two most recent reviews by the regulator over concerns that included mishandling test results, not following proper sterility practices and inadequately training workers.
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 two routine inspections.
The most recent of those failures earlier this year marked the fifth time over roughly the last decade the facility was found non-compliant during an inspection.
The site’s latest inspection from late last month resulted in its first passing grade since 2022, according to Health Canada’s website.
The isotopes the facility produces are used to create the radioactive material — often called a tracer — that is injected into patients during a positron emission tomography (PET) scan.
The most common tracer uses a form of radioactive sugar that accumulates in abnormal spots to highlight possible tumours in a scan. That can help a doctor decide where the cancer is, how far it has spread, whether it has responded to therapy or whether a cancer has come back.
Concerns licence might be pulled
Experts who previously spoke with CBC News about the facility’s repeated non-compliance findings by Health Canada raised concerns that the regulator could pull the site’s drug establishment licence — the federally issued licence that allows the facility to make and distribute isotopes.
That’s what almost happened to the Winnipeg facility in 2018.
WATCH | A February report on the facility’s 4th Health Canada failure:
The Winnipeg Cyclotron Facility makes medical isotopes, which are critical in detecting certain cancers. It has failed its most recent Health Canada inspection and is at risk of being temporarily closed, which would delay cancer screening for some patients.
The facility failed its 2017 inspection, and the regulator threatened to suspend its licence after it felt the facility hadn’t done enough to address the findings, according to Health Canada’s drug and health product inspection database.
In the end, a spokesperson for the provincial health agency Shared Health said the Winnipeg Cyclotron Facility was able to demonstrate “sufficient progress on the outstanding corrective actions” to maintain its licence.
The routine inspections are done every few years to ensure the facility meets the regulator’s standards.
If the facility were to lose its licence to produce isotopes, that could lead to a drop in the number of scans able to be done in Manitoba, the experts who previously spoke to CBC News said.
That’s because the materials have a short lifespan, and the longer it takes to transport them from a facility to being injected into a patient, the less usable tracer there will be.
Following the most recent inspection results, a spokesperson for Shared Health said staff at the facility have been working for more than a year to make the site compliant with Health Canada’s standards, including:
- Restructuring its quality unit.
- Significantly revising its aseptic processes.
- Appointing a project manager to support a corrective action plan.
The facility has also hired a lead radiochemist who now directs the cyclotron program to ensure production processes meet expectations.
The spokesperson said the radiochemist also reviews all documents “prior to the release of radiopharmaceuticals for clinical use to ensure it is complete, accurate and compliant,” which they described as “over and above the standard quality review process.”
While Health Canada found the site was compliant in its most recent inspection, it also made a number of observations that the Shared Health spokesperson said the facility’s staff will continue working to address in the year ahead.
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.
