USFDA Guidance: Updates on Blood Donor Eligibility, Donation Suitability, and Blood Pressure and Pulse Requirements
The US Food and Drug Administration (FDA) has issued two compliance policy guidances addressing requirements for blood establishments that collect blood and blood components, including Source Plasma. The guidance on Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements and the guidance on Blood Pressure and Pulse Donor Eligibility Requirements describe circumstances where FDA does not intend to take regulatory action for certain failures to meet specified requirements.
Together, the guidance provides compliance flexibility while continuing to focus on donor health and the safety and availability of blood and blood components.
The first guidance addresses certain requirements concerning donor eligibility and donation suitability, including blood pressure, pulse, weight, donation frequency, pregnancy and red blood cell loss for plasma collected by plasmapheresis. FDA does not intend to take regulatory action in specified circumstances when a donation is otherwise suitable but a post-donation review identifies an inadvertent failure involving certain donor health requirements. Blood establishments must continue to determine donor eligibility before collection and must not knowingly collect blood from a donor who has been determined to be ineligible. The policy does not apply to all reasons for an unsuitable donation and excludes certain screening test results, transfusion-transmitted infection risk factors and specified requirements involving hemoglobin, hematocrit, total protein and other testing requirements.
The guidance also provides flexibility when donor information is incomplete or requires clarification. FDA does not intend to take regulatory action when an establishment clarifies a donor's response or obtains omitted information within 72 hours of collection, provided the applicable requirements are met. Blood establishments using the policy must investigate relevant errors, maintain required records and provide applicable information to FDA through annual reporting, including information on donations released under the policy and corrective actions taken to prevent recurrence. The guidance also addresses Source Plasma collected from paid donors for further manufacturing into injectable products. While the applicable regulation specifies a minimum 60-calendar-day quarantine hold, the compliance policy provides that FDA does not intend to take regulatory action when Source Plasma is released after a 45-calendar-day hold, provided the conditions described in the guidance are satisfied.
The second guidance specifically addresses blood pressure and pulse requirements for donor eligibility. Blood pressure is assessed on the day of donation and before collection, with the specified limits of 90 to 180 mm Hg for systolic blood pressure and 50 to 100 mm Hg for diastolic blood pressure. When a donor's blood pressure is outside these limits, the applicable requirements provide for evaluation by the responsible physician to determine whether donation would adversely affect the donor's health.
The compliance policy provides flexibility for this medical evaluation to be performed through telephonic or other offsite consultation, including under the applicable conditions described in the policy. For pulse, the applicable requirements specify that a donor's pulse should be regular and between 50 and 100 beats per minute on the day of donation and before collection. The policy provides specific flexibility for certain donors with a pulse below 50 beats per minute who self-report that they are healthy athletes. Under appropriate written standard operating procedures approved by the responsible physician, these donors may be permitted to donate without consultation with the responsible physician when the applicable conditions are met. The policy also provides flexibility for certain donors with an irregular pulse when approved procedures define the circumstances under which donation may be permitted. The guidance therefore provides targeted flexibility for blood establishments while maintaining appropriate medical oversight, standard operating procedures and donor eligibility controls.
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