Update on plasma donation safety

Canadian Blood Services is aware that Health Canada has completed its assessment of the reports of deaths of two Grifols plasma donors within 72 hours of plasma donation. Health Canada has determined that no linkage has been established between the plasma donation process and the deaths of the donors in question.  

All donor centres in Canada are licensed by Health Canada and must undergo regular inspections, like we do, to ensure compliance with federal legislation. It is our expectation that Grifols is in good standing with its regulatory requirements. Any review undertaken by Health Canada is independent and grounded in evidence, and we trust in the guidelines and strict governance Health Canada brings. 

Canadian Blood Services is aware of the conditions that Health Canada has put in place for Grifols following inspection of their sites. We fully support Health Canada’s regulatory oversight to ensure safe procedures for blood and plasma operations in Canada. We have been reassured by Health Canada that their observations of Grifols have not been classified as critical, and that none of the sites have been ordered to pause operations or close. 

We have been in touch with Grifols, and our expectation is the implementation of a comprehensive plan to address the corrective action required by Health Canada, without delay. While regulatory oversight of quality and safety are the domain of Health Canada, Canadian Blood Services expects Grifols, and all other suppliers, partners, and providers, to be compliant with regulations and quality standards.  

Canadian Blood Services is working to collect more plasma than ever before to address the rising demand for immunoglobulins – a lifesaving medication that is made from plasma. In 2022 we entered into an agreement with Grifols because they are recognized as a global leader in plasma collection and manufacturing. Our agreement with Grifols remains an important part of increasing plasma sufficiency for immunoglobulins in Canada, a medication that thousands of Canadians rely on.