• Skip to main content
  • Skip to primary sidebar
Transfusion News
  • About Us
  • Topics
    • Adverse Events (non-infectious)
    • Blood Donation
    • Cell Therapy
    • Coagulation & Plasma Transfusion
    • Platelet Transfusion
    • Policy and Guidelines
    • Quality Control and Regulatory
    • RBC Transfusion
    • Serology/Genotyping
    • Special Transfusion Situations
    • Transfusion Transmitted Infections
  • Continuing Education
  • Archives
  • Podcasts
  • Question of the Day
  • Search
  • Subscribe to Email Alerts
  • Follow us on
  • Search
  • Subscribe to Email Alerts

Updated FDA Guidance for Blood Donor Eligibility for Blood Pressure and Pulse

July 30, 2024

The U.S. Food and Drug Administration (FDA) has previously provided guidance for the eligibility of blood donors with blood pressure or pulse outside of the normal range. Guidance for potential blood donors with either blood pressure or pulse outside of specified parameters have only permitted blood donations when “the responsible physician determines that their health would not be adversely affected by donation” on-site the day of donation. Based on feedback and comments, the FDA now allows for a greater amount of flexibility. For donors with blood pressure that is above or below the normal range (90-180 mm Hg systolic and 50-100 mm Hg diastolic), the FDA will now permit telephonic or other off-site consultation with the responsible physician to ensure that blood donation will not affect the health of the donor. Furthermore, self-reporting healthy athletes with a pulse below 50 bpm are now considered eligible to donate if the blood establishment maintains standard operating procedures for this subcategory of donors that are approved by the responsible physician. Similarly, donors with irregular pulses are eligible to donate if their pulse and other health circumstances are defined and approved by the responsible physician as part of standard operating procedures. Licensed blood establishments must report changes in their standard operating procedures if they wish to implement changes based on this new FDA guidance.

Reference:

U.S. Food and Dru Administration Guidance for Industry.  Blood pressure and pulse donor eligibility requirements—compliance policy.  July 2024.  

Filed Under

  • Blood Donation
  • News

Recommended

  • High Titer Convalescent Plasma Does Not Improve Survival of Hospitalized Patients with COVID-19

  • Costs are High for Administrating Blood Transfusions

  • Donor-specific HLA antibodies can be reduced in kidney transplant patients with multiple plasmapheresis procedures

Show Comments

Comments on this article are closed.

Get the latest news. Subscribe to our mailing list. Sign Up

Primary Sidebar

Latest News

  • Directed Blood Donations Should be Limited

  • Babesia Infection Reduces Red Cell Deformability

  • New Erythropoietin Gene Variants Linked to Hereditary Erythrocytosis

  • Multifaceted Threats to the Blood Supply from Climate Change

    Question of the Day

    Copyright © 2025 John Wiley & Sons, Inc. All Rights Reserved.
    Privacy Policy

    Association for the Advancement of Blood and Biotherapies Wiley