Blood services depend upon healthy blood donors to provide a safe and adequate supply of blood products. With a shrinking donor base, many blood collection agencies are challenging blood donor eligibility regulations that lack scientific basis. Several studies, in and outside of the United States (US), document the relatively poor correlation of donor vital signs outside of normal range and subsequent adverse donor reactions to collection. This session will explore and compare the requirements for vital signs to determine donor eligibility in the US, and the experience of other countries on donor safety after changing vital signs requirements for determination of donor eligibility. In this session, the Donor Health and Safety Committee and the Donor Hemovigilance Working Group will present the following: 1) an overview of donor vital signs regulations in the Code of Federal Regulations that govern donor eligibility in the US and the evidence supporting consideration of change; 2) a summary of the changes made by Canadian Blood Services/ Hema-Quebec related to blood donor vital signs requirements and their experience following implementation; 3) an overview of changes related to requirement of pre-donation vital signs in the Australia and the impact on donor safety; and 4) the position of the Food and Drug Administration on blood pressure and pulse as blood donor eligibility criteria.
Discuss evidence supporting and refuting the utility of assessing vital signs for safety of blood collection.
Compare the current regulations and recommendations regarding donor eligibility requirements in the United States, Canada, Australia and other countries.
Summarize the evidence related to the impact of blood pressure and pulse on syncopal reactions and cardiac events.
Medical Director, Donor & Clinical Services,
Canadian Blood Services
Medical Director and Vice President, Quality and Regulatory Affairs, Co-Director, Transfusion Medicine, Associate Clinical Professor, Laboratory Medicine and Pediatrics,
Innovative Blood Resources