Cord blood stored in Edmonton repository 'may pose serious health risks': Health Canada
The Canadian Cord Blood bioRepository in Edmonton. (Dave Mitchell/CTV News Edmonton)
A safety alert has been issued in connection with cord blood stored at the Canadian Cord Blood bioRepository (CCBR) in Edmonton.
The alert impacts any cord blood that was collected, processed, tested, and stored anytime between March 1, 2014, and present.
A visit by Health Canada found multiple issues at the facility, including processing, testing, and storing of cord blood in an environment that was unclean or cleaned with expired disinfectants, had inadequate measures in place to monitor temperature and humidity, and contamination in areas where cord blood is tested, processed, and stored.
Health Canada also found a lack of qualified personnel, the use of uncalibrated equipment, employees not following established processes, and a lack of proper record keeping.
The cord blood "may pose serious health risks," Health Canada said.
Health Canada also says CCBR was advertising online suggesting the cord blood could be used by people other than the person the blood came from, but CCBR is only permitted to store cord blood for use by the donor.
CCBR has been ordered to notify customers currently storing cord blood at the facility of the safety concerns.
They must also stop collecting, processing, testing, and storing new cord blood under unsanitary conditions, and provide a corrective action plan detailing how the sanitary, quality control, operations, and advertising concerns will be addressed.
Anyone who wishes to use cord blood that was stored at the facility should have it tested by a qualified third party.
Canadian Blood Services, which is not affiliated with CCBR, issued the following written statement:
"Canadian Blood Services operates a no-cost public Cord Blood Bank which is recognized by Health Canada, the Society of Obstetricians and Gynaecologists of Canada, and the Canadian Pediatric Society for the collection of high-quality cord blood which is available to any patient in need of a stem cell transplant."
"The Canadian Blood Services' Cord Blood Bank operates to the highest standards of safety. It is licensed by Health Canada and accredited by NetCord-Foundation for Accreditation of Cellular Therapy (FACT), the Association for the Advancement of Blood & Biotherapies (AABB), and the World Marrow Donor Association (WMDA)."
CTV News Edmonton has reached out to Health Canada and CCBR.
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