Manitoba’s only producer of medical isotopes for cancer tests descended into a “sorry state” due to persistent bureaucratic delays by Shared Health, a physician told the Free Press Wednesday.
Dr. Sandor Demeter, a nuclear medicine physician, is hopeful deficiencies that led to two consecutive failed regulatory inspections of the Winnipeg Cyclotron Facility will be resolved, following the recent hiring of the site’s first non-acting director in about five years.
“From what I see, and from a memo that came out, I think Shared Health is making significant best efforts to try to deal with the remaining issues,” said Demeter, who interprets positron emission tomography, or PET scans, which are used to detect or assess conditions such as cancer and heart disease. “I’m optimistic they’ll meet Health Canada standards.”
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Dr. Sandor Demeter, a nuclear medicine physician, is hopeful deficiencies that led to two consecutive failed regulatory inspections of the Winnipeg Cyclotron Facility will soon be resolved.
The facility at Health Sciences Centre failed a Health Canada inspection in April, after officials determined there were delays implementing changes following a previous failed inspection in November.
The cyclotron facility continues to operate, while it is listed as non-compliant by the federal regulator.
A Shared Health spokesperson said none of the deficiencies has affected the results of any PET scans.
A report card from the April inspection cited five deficiencies — down from nine in November — related to quality-control procedures, product sterilization and staff training or duties.
Until the facility passes an inspection and becomes compliant again, Demeter disagrees with a Shared Health assertion there is no risk to patients.
He said Health Canada — “the best barometer for acceptable risk” — expressed a lack of confidence in the cyclotron program at Health Sciences Centre and does not feel the probability of product contamination is low enough.
That said, he doesn’t think the risk is significant. He would still get a PET scan at HSC if he had cancer.
“We haven’t had an adverse reaction from the product, that we know about,” he said.
A cyclotron creates radioactive material that is mixed with sugar and injected into patients. The “tracer” is meant to reveal any abnormalities in a PET scan.
The cyclotron facility has failed five of nine inspections since the first was recorded in 2013, three years after the facility opened.
“Shared Health leaders should not be surprised by this sad state of affairs… They delayed adequately resourcing and hiring key personnel for five years and have jeopardized the medical cyclotron program, their reputation and, most importantly, patient access to PET scans.”–Dr. Sandor Demeter
Demeter said the cyclotron facility failed three of five inspections after losing its dedicated PET radiochemist, who was in charge of quality assurance and good manufacturing practice protocols, in 2019.
External consultants were hired to review the program, delaying the hiring of a replacement, he said.
Demeter, an associate professor in the University of Manitoba’s community health sciences department, said the former Tory government had a policy of “erosion management,” in which it would not spend significant money until a crisis or “big crack” appeared.
Without a director, issues that arose were not adequately addressed, said Demeter, who outlined his concerns about the provincially funded program in an opinion column in Wednesday’s Free Press.
“Shared Health leaders should not be surprised by this sad state of affairs,” he wrote. “They delayed adequately resourcing and hiring key personnel for five years and have jeopardized the medical cyclotron program, their reputation and, most importantly, patient access to PET scans.”
Diagnostic tests were delayed for 35 cancer patients, after November’s failed inspection.
Four days of unplanned shutdowns occurred in May and early June due to a minor mechanical issue and, at a different point, the availability of trained operators, the Shared Health spokesperson said.
The health authority recently sent a memo to staff explaining the work that is being done to correct the remaining issues.
The spokesperson said Shared Health has taken steps to address Health Canada’s concerns, including significant changes to production lab practices prior to the April inspection, full requalification of two production operators and an increase in technologist staffing from 3.6 to 4.0 full-time equivalent positions.
The new radiochemist started in April.
Other ongoing work, including an improved training program and updated product quality-control testing, is expected to be completed by the end of 2024.
Health Canada is reviewing the corrective and preventative actions plan Shared Health created in response to April’s non-compliant rating.
“If deemed acceptable by Health Canada, another re-inspection will be scheduled in the coming months,” Health Canada spokeswoman Tammy Jarbeau wrote in an email.
She said Health Canada and the cyclotron facility are working together to achieve compliance.
“Should the facility continue to be deemed non-compliant, further enforcement actions will be considered,” Jarbeau wrote. “At this time, there is no immediate risk to the people of Canada.”
A failed inspection in 2017 led to a warning the facility’s licence could be suspended.
Health Canada didn’t suspend the facility’s licence after April’s failure. Demeter took it as a sign the regulator was confident the issues were manageable and Shared Health would resolve them.
In his column, Demeter suggested the facility could tap into a Saskatoon facility’s supply as a short-term option until the problems at HSC are fixed, even though it would reduce the number of scans.
Demeter said facilities such as the one in Winnipeg are treated as drug manufacturers under federal regulations. Some hospitals that produce medical isotopes struggle with a “one-size-fits-all approach” that also applies to large pharmaceutical companies, he noted.
Since being elected in October, the NDP government has pledged to address concerns related to the facility.
At an unrelated event Wednesday morning, Health Minister Uzoma Asagwara declined to comment on the problems at the cyclotron facility and asked the Free Press to contact their press secretary to arrange a conversation later in the day.
The minister said they had not yet read Demeter’s column.
At an unrelated afternoon news conference, the Free Press asked Asagwara if they had confidence in the program.
“As a government, we expect standards to be upheld, and we want to make sure that the services and the technologies that exist for Manitobans are working the way that they should,” the minister said.
chris.kitching@freepress.mb.ca
Chris Kitching
Reporter
Chris Kitching is a general assignment reporter at the Free Press. He began his newspaper career in 2001, with stops in Winnipeg, Toronto and London, England, along the way. After returning to Winnipeg, he joined the Free Press in 2021, and now covers a little bit of everything for the newspaper. Read more about Chris.
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