Monday, May 23, will be a red letter day for most of us who work in blood centers. After years of effort, revisions to federal regulations for the collection of blood will become effective. The work involved with determining and implementing these changes has been massive, even without the distraction of Zika. A proposed rule was published on November 8, 2007, and the Food and Drug Administration (FDA) just published the final rule on May 22, 2015. The rules modernize the approach to regulation of infectious disease testing and make new provisions for donor selection.
The section on infectious diseases generalizes the approach to donor testing, defining “relevant transfusion-transmitted infection” (RTTI) and providing a framework to add and remove tests via guidance more nimbly as circumstances require. Current testing will remain in place, and a new requirement for control of bacterial contamination of platelets is added. Requirements are further spelled out in a guidance that has been issued on these topics. Platelet contamination was not previously addressed, and this approach, including the use of pathogen reduction, is welcome.
Most of the significant changes come under the selection and care of donors. The donor eligibility must be determined on the day of donation, allowing 24 hours after to clarify donor’s history if needed. Most medical history is unchanged, regarding risks of RTTI and risks to the donor. A separate guidance on deferral of MSM for one year past last episode will be implemented by many centers at this time, though it is not part of the CFR changes.
The most significant changes for donor assessment are gender-specific acceptable hemoglobin levels. Males must have a hemoglobin of 13.0 g/dL (or the equivalent 39 percent hematocrit). This raises the current standard of 12.5/38 for both sexes, reflecting a more normal level for males. Female thresholds are unchanged, with an option to go down to 12.0/36 with FDA approved measures to mitigate iron depletion. What are approvable is not yet clear, but will require methods to ensure donor iron stores remain sufficient.
Finally, the new requirements include a “donor acknowledgement.” In this section, the FDA wants to make sure the donor acknowledges salient risks of donation from our educational materials and those of RTTI’s. The agency has a touching faith that providing educational materials assures their reading and comprehension. The difficulty of providing such materials, especially to a new donor who is already nervous about phlebotomy, is substantial. Critically, donors, despite what we tell them, make their own judgments about the safety of their blood and relevance of their own history. It is not wrong to suggest otherwise, but it may be futile.
Thank you to all in our centers who have done the hard work of putting compliant processes in place. It has been a long and painful process, and is not done: the taskforce on the donor history questionnaire’s standard materials have not yet been accepted by the FDA, leaving centers in an unclear regulatory position. Things could have moved more quickly on all sides, but when we are done, we will have better blood products for our recipients and a safer process for our donors.
Susan Rossmann, MD, PhD; Board President; email@example.com