A safety alert has been issued regarding umbilical cord blood stored at the Canadian Cord Blood bioRepository (CCBR) in Edmonton.
The alert applies to any umbilical cord blood collected, processed, tested and stored between March 1, 2014 and today.
A Health Canada visit found several problems at the facility, including the processing, testing and storage of cord blood in an environment that was unclean or cleaned with expired disinfectants, inadequate temperature and humidity monitoring measures, and contamination in areas, in which this was the case umbilical cord blood is tested, processed and stored.
Health Canada also found a lack of qualified staff, the use of uncalibrated equipment, employees not adhering to established processes and a lack of proper record-keeping.
The umbilical cord blood “may pose a serious health risk,” Health Canada said.
Health Canada also states that CCBR has advertised online suggesting that the umbilical cord blood could be used by people other than the person from whom it came. However, CCBR may store cord blood only for donor use.
CCBR has been directed 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 in unsanitary conditions and submit a corrective action plan detailing how hygiene, quality control, operational, and promotional concerns will be addressed.
Anyone wishing to use cord blood stored at the facility should have it tested by a qualified third party.
CTV News Edmonton has contacted Health Canada and CCBR.