On July 17th, the U.S. Food and Drug Administration (FDA) published the guidance titled, “Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy.” According to the agency, “the [blood pressure and pulse] guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) for transfusion or for further manufacturing use, including Source Plasma.” FDA describes the circumstances in which, “[it] 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 the specified limits.”
Blood Pressure. The guidance states that, for a donor with blood pressure measurements outside of the specified limits (90-180 mm Hg systolic or 50-100 mm Hg diastolic), FDA does not intend to take regulatory action with respect to the requirement in 21 CFR 630.10(f)(2) that the donor may be permitted to donate only when the responsible physician examines the donor. FDA intends to apply this compliance policy when the responsible physician conducts a telephonic or other offsite consultation (e.g., telemedicine), and determines and documents that the health of the donor would not be adversely affected by donating.
Pulse. For a donor with a pulse measurement below 50 bpm who self-reports being a healthy athlete, FDA does not intend to take regulatory action with respect to the requirement in 21 CFR 630.10(f)(4) that the donor may be permitted to donate only when the responsible physician determines and documents that the health of the donor would not be adversely affected by donating, and the requirements in 21 CFR 630.5(b)(1)(i)(B) and 21 CFR 630.5(c)(1)(i)(A)(2) that the responsible physician must not delegate this determination of the donor’s health. FDA will apply this compliance policy, as long as the blood establishment maintains SOPs that:
- are approved by the responsible physician of the blood establishment; and
- allow for donation by a donor with a pulse measurement below 50 bpm who self-reports at each donation being a healthy athlete without consultation with the responsible physician.
For a donor with an irregular pulse, FDA does not intend to take regulatory action with respect to the requirement in 21 CFR 630.10(f)(4) that the donor may be permitted to donate only when the responsible physician determines and documents that the health of the donor would not be adversely affected by donating, and the requirements in 21 CFR 630.5(b)(1)(i)(B) and 21 CFR 630.5(c)(1)(i)(A)(2) that the responsible physician must not delegate this determination of the donor’s health, as long as the blood establishment maintains SOPs that:
- are approved by the responsible physician of the blood establishment; and
- define medical criteria for donation by a donor with an irregular pulse without consultation with the responsible physician.
Implementation. Blood establishments that intend to implement changes described in this guidance must report changes to their SOPs made to reflect the compliance policy in this guidance as Changes Being Effected (CBE) supplements under 21 CFR 601.12(c)(5) (see 21 CFR 601.12(a)(3).