The last inspection of the facility by Health Canada took place in April 2024. The health authority declared the facility non-compliant and had five different deficiencies. The reasons explaining this non-compliance include inadequate validation of the aseptic process, inadequate aseptic practices by operators to maintain sterility, inadequate ongoing training of staff, or the fact that the Quality Control Department did not take all necessary measures.

In the eleven years of inspection, this is the fifth time that the plant has failed this inspection.

When asked about this issue, Soins Communs wants to reassure people and points out that “there is no indication that the deficiencies identified by Health Canada had an impact on the results of the PET scans,” explains a spokesperson for the organization.

Improvements are planned for the end of the year

Soins Communs also highlights the progress made since the October 2023 inspection, which this time found nine deficiencies. “Since then, a restructuring of the reporting process has taken place, a senior radiochemist has been hired, new internal sterility testing methods for the FDG product have been implemented and improvements have been made in the functioning and independence of the quality unit.” As a result, the most critical findings of the autumn inspection have either been deleted or downgraded. »

The Manitoba organization still believes that four of the five observations from April 2024 are the same as those from the 2023 inspection, “which shows that all complex remediation work has not yet been completed due to the relatively short time between inspections.” Supply chain difficulties also played a role,” the spokesperson explains.

The cyclotron facility in Winnipeg was opened in 2010. The cyclotron produces in particular an imaging technology called PET (Positron emission tomography (in English: positron emission tomography, in French) non-invasive, which allows the study of metabolic activity in the brain, heart, liver, tumors and muscle tissue.

And to detect the presence of cancer, the patient ingests a type of sugar called fluorodeoxyglucose (FDG). This sugar gives off a trace that can be identified by the scanner’s rays.

Soins Communs hopes for improvements in the coming months. “Further work is underway and is expected to be completed by the end of the year.”