REGULATORY UPDATE: FDA Issues New Guidance on Donor Blood Pressure and Pulse Requirements

The Food and Drug Administration released a final guidance today, “Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy,” which allows for greater flexibility in the responsible physician’s medical oversight of these donor eligibility determinations.

The new compliance policy follows FDA’s consideration of feedback from blood collection facilities concerning existing donor eligibility requirements for blood pressure and pulse in 21 CFR 630.10 and the corresponding requirements for medical supervision in 21 CFR 630.5.

The guidance outlines the circumstances in which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain regulations for determining the eligibility of blood donors with blood pressure or pulse measurements outside of specified limits. FDA intends to apply this compliance policy as follows:

Blood Pressure:

• Donors with blood pressure measurements outside of the specified limits (90-180 mm Hg systolic or 50-100 mm Hg diastolic) may donate when the responsible physician conducts a telephonic or other off-site consultation and determines and documents that the donor's health would not be adversely affected by donating.
• The responsible physician must not delegate this responsibility.

Pulse:

• Healthy athletes: Donors with a pulse measurement below 50 bpm who self-report being a healthy athlete can donate without consultation with the responsible physician. Blood establishments must maintain and follow standard operating procedures that are approved by the responsible physician and allow for donation by a donor with a pulse measurement below 50 bpm who self-reports at each donation being a healthy athlete. 
• Irregular pulse: Certain donors with an irregular pulse may be permitted to donate without consultation with the responsible physician, provided the establishment maintains and follows standard operating procedures, approved by the responsible medical director, which define the medical criteria for donation by a donor with an irregular pulse. For example, the medical criteria should define what is considered an irregular pulse, donor health conditions or other circumstances that would allow for donation.

Blood centers that intend to implement these changes must report the changes to their SOPs made to reflect the compliance policy as changes being effected (CBE) supplements under 21 CFR 601.12(c)(5). AABB is preparing a toolkit outlining these new considerations for donor blood pressure and pulse. Members with questions may contact regulatory@aabb.org.

In 2022 comments in response to FDA’s draft guidance, AABB requested flexibility to the current donor eligibility regulations for blood pressure and pulse. AABB appreciates FDA’s agreement that an on-site examination by a responsible physician for donors with blood pressure measurements outside the specified limits is unnecessary to protect donor health and can be conducted remotely. Additionally, AABB supports FDA’s recognition that consultation with the responsible physician is not always needed to ensure the health of athletic donors with a pulse below 50 bpm or certain donors with an irregular pulse.