Health Canada says there are concerns surrounding umbilical cord blood stored at the Canadian Cord Blood bioRepository in Edmonton that “may pose serious health risks.”
The issues could lead to the possibility of contamination and transmission of infectious diseases and could harm the products, the regulator said on Tuesday.
“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.”
What’s more, Health Canada said online advertising suggests the cord blood can be used be people other than the person the blood came from. The facility in question is only permitted to store cord blood for use by the same individual.
Blood collected from a newborn’s placenta and umbilical cord is rich in certain stem cells that can be used to treat some health conditions, such as leukemia.
The inspection also identified issues including:
- A lack of qualified personnel.
- Use of uncalibrated equipment.
- Not following established processes.
- Lack of proper record-keeping.
The company has been asked to provide a corrective action plan and to notify customers about the safety concerns.
Health Canada advises anyone who wants to use their stored cord blood to have it tested by a qualified third party for infectious disease agents and cell viability at a minimum.
View original article here Source