A site visit by Health Canada to the Canadian Cord Blood bioRepository (CCBR), located in Edmonton, Alberta, has identified significant issues that may pose serious health risks. The issues identified at the site could lead to the possibility of contamination and/or the transmission of infectious diseases and could negatively impact the cord blood stored. These concerns include processing, testing, and storing cord blood in an environment that was unclean or cleaned with expired disinfectants and having inadequate measures in place to monitor temperature, humidity, and contamination in areas where 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. Health Canada also identified online advertising suggesting that cord blood can be used by people other than the person the blood came from. CCBR is only permitted to store cord blood for autologous use (the donor and recipient are the same individual). The Department informed CCBR of the concerns identified during the site visit, and that it is prohibited by law to collect, process, test, or store cord blood under unsanitary conditions. Health Canada has requested CCBR to: notify customers currently storing cord blood at CCBR of the safety concerns, so they can make informed choices about using the cord blood banked there; stop collecting, processing, testing, and storing new autologous cord blood under unsanitary conditions; and provide a corrective action plan detailing the measures it will put in place to address the sanitary, quality control, operational, and advertising concerns. Health Canada continues to communicate with CCBR to make sure that the compliance and safety concerns are appropriately addressed.
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