Winnipeg facility that produces essential cancer-screening material fails 4th Health Canada inspection

A provincially run Manitoba facility that creates crucial materials used to detect cancer failed its latest Health Canada inspection after the regulator found the facility mishandled test results, didn't follow proper sterility practices and inadequately trained workers.

This is the fourth time the Winnipeg Cyclotron Facility — the sole producer of medical isotopes in Manitoba — was found non-compliant by Health Canada in the past 10 years. 

These isotopes 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 decide where the cancer is, how far it has spread, whether it has responded to therapy or if a cancer has come back.

One doctor says the facility needs more staff and resources to meet the high bar set by Health Canada. 

The regulator is "very particular," said Dr. Daniel Levin, a nuclear medicine physician at Winnipeg's Health Sciences Centre, which is also where the Winnipeg Cyclotron Facility is located.

The facility, he said, "has very good staff that are there, but it doesn't have enough staff to meet all the requirements.… It hasn't had the support, perhaps, that it should have."

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. 

Levin said the materials created there are safe, but the real threat is that Health Canada could pull its drug establishment licence — the federally issued licence that allows the facility to make and distribute isotopes. 

John Root agrees. He's the executive director of the Sylvia Fedoruk Canadian Centre for Nuclear Innovation, a non-profit corporation located at the University of Saskatchewan that's responsible for producing the medical isotopes for that province.

His facility has never had a non-compliant rating from Health Canada. 

But if a facility's licence is revoked, "you're not allowed to make [isotopes] any more. So being non-compliant could be bad."

That's what almost happened to the Winnipeg facility in 2018.

The facility failed its 2017 inspection, and the regulator threatened to suspend its licence after it felt the facility didn't do enough to address the findings, according to Health Canada's drug and health product inspection database.