Health Canada said Wednesday that cord blood banked at a repository in Edmonton could pose “serious health risks.”
The notice pertains to cord blood that was collected, processed, tested, and/or stored at the Canadian Cord Blood bioRepository (CCBR) between March 1, 2014 and the present.
The agency said in a statement that a site visit identified “significant issues” with the facility that could lead to contamination or the transmission of infectious diseases. In a statement to Global News, Health Canada did not specify the health impacts and diseases when asked, but said CCBR has to meet the requirements under the Food and Drugs Act.
“Health Canada has the authority to take action under the FDA if it becomes aware of non-compliance or potential safety concerns,” the agency said.
The inspection found that the centre was unclean or cleaned with expired disinfectants, and had “inadequate” measures to monitor temperature, humidity and contamination where the cord blood is processed, tested and stored.
“Health Canada also found issues related to a lack of qualified personnel; the use of uncalibrated equipment; not following established processes; and a lack of proper record-keeping,” the agency said.
In addition, Health Canada said it found online advertising suggesting cord blood could be used by people other than whom it came from, which CCBR was not permitted to allow with its stored cord blood.
Cord blood is the blood left in the umbilical cord and placenta after a baby is born and is rich in lifesaving stem cells that can help treat over 80 diseases and disorders, according to Canadian Blood Services.
Health Canada has ordered the centre to notify its customers of the safety concerns, to stop collecting, processing, testing, and storing new cord blood under unsanitary conditions, and to come up with a corrective action plan.
Health Canada says any cord blood stored at the centre should be tested first by a qualified third party for infectious disease agents and cell viability.