Winnipeg facility that produces essential cancer-screening material fails 4th Health Canada inspection
Non-compliant rating puts facility at risk of getting shut down by health regulator, experts say
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."
Failed 3 previous tests
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.
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 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.
WATCH | Here's what the Winnipeg Cyclotron Facility does — and why it matters:
The routine inspections are done every few years to ensure the facility meets the regulator's standards.
The latest, which found the facility non-compliant, was launched in late October and flagged nine deficiencies with the facility under Canada's Food and Drug regulations.
Four involved quality control regulations, three involved sterility regulations and the others concerned personnel and record keeping.
The non-compliant rating forced the facility to close for two and a half weeks to address the issues, which delayed 35 PET scans, said a spokesperson for Shared Health.
Both Levin and Root said it is important to be able to make the tracer in Manitoba. The materials have a short lifespan, and the longer it takes to transport from a facility to being injected into a patient, the less usable tracer there will be.
That could mean doing only 10 scans a day instead of 20, said Levin.
"If we can't produce it here, we'd be doing half as many patients," said Levin.
'No quality management program in place'
The latest inspection failure comes at a time when more PET scans are being ordered by doctors.
Data provided by Shared Health shows about 175 scans were done in February 2020. Now, more than 300 are completed each month.
The median wait for a scan is about two weeks, according to Shared Health.
A 2020 external review of the Winnipeg Cyclotron Facility obtained by CBC — intended to create a long-term plan to ensure the cyclotron program remained successful, up-to-date and clinically relevant — addressed its past failed inspections. It found the facility was consistently failing in the same areas — quality assurance and quality control.
There was "no quality management program in place that could prove things were actually under control," the review found.
It recommended creating new staff positions, such as a radiochemist who could provide leadership at the facility and ensure it meets quality control requirements.
When asked about its response to the 2020 review, a Shared Health spokesperson said more resources were dedicated to a quality assurance program and four new full-time equivalent positions were added.
Shared Health is also in the process of hiring a lead radiochemist, who will begin in spring, the spokesperson said. Because it is a new position, it took longer than usual to develop and fill following the review, the spokesperson said.
In response to the most recent failure, a Shared Health spokesperson said the facility has made changes to its organizational structure, and implemented sterility tests, among other measures.
So far, Shared Health says the deficiencies found by Health Canada did not impact the results of any PET scans, the spokesperson said.
The spokesperson said there have been no documented adverse reactions from the roughly 25,000 PET scans completed at the facility in the last 12 years.
"Patient safety is our top priority, and in the event that an investigation indicates that there may be an impact to a patient, a product recall is considered," the spokesperson wrote in a prepared statement.
Shared Health has submitted a plan that is under review by Health Canada, the regulator said in a statement.
The facility will soon undergo another inspection, where Health Canada will decide if it has done enough to be given a compliant inspection rating.
In a prepared statement, Manitoba Health Minister Uzoma Asagwara said they welcome these inspections and will address "any concerns brought to my attention regarding staffing or resources."
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