As my site name implies, and just in case you were wondering, I’m a guy (a dude, a male-type person, a gentleman-ish bloke, you get the picture). Perhaps because of my Y chromosome, there are some things that I seem to worry less about than does my beautiful bride (ALERT: Potentially sexist-sounding stuff coming, none of which I intend in a sexist way…NOW!). For example, I can walk past a sink that is half-full of dishes or return an empty jar of peanut butter into the corner of a semi-disorganized refrigerator and it doesn’t bother me in the least! Meanwhile, my wife grinds her teeth and wonders why I don’t see the obvious DISASTER in our home (OK, no e-mails, please, unless they are condolences for my wife: I acknowledge that this difference may not be gender-related at all! Perhaps I’m simply still stuck in my bachelor years?).
One of the lesser-known benefits of dude-hood is that there is one other thing I never worry about: Whether or not I will have an acceptable hemoglobin level when I go to donate blood! But, thanks to changes U.S. blood collectors are implementing in 2016, I may have to add a new worry to my list.
The “Final Rule” for blood donors
WAAAAY back in November 2007 (that’s not a typo!), The United States Food and Drug Administration (FDA) published a proposed rule entitled, “Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use” (you’ve gotta hand it to the FDA; they come up with truly snappy titles!). This document proposed numerous changes to the regulations for processes surrounding blood, including donor collection in ways that impact male donor eligibility. We’ll circle back to that in a moment. To finish the story, seven and a half years later (after many, many comments submitted by blood centers), in May 2015, FDA finally released the final version of this document (we will call it the “Final Rule”), with an effective date of May 23, 2016. Since FDA Final Rules are considered “law” in the United States, these changes are not optional.
What does the Final Rule say?
The Final Rule itself, in classic government fashion, is a 66-page, triple-column, single-spaced, horrible beast of a document. There are numerous required changes to current practices (way too many to outline here), and U.S. blood establishments are scrambling to update procedures to comply with the changes before May 2016.
Let’s focus specifically on the issue of male blood donors: All voluntary blood donors are tested before donation to ensure they have adequate hemoglobin levels to minimize their risk of harm from donating blood. As of today, the minimum hemoglobin level at which a potential U.S. donor qualifies to give blood is 12.5 mg/dL (or for facilities that measure hematocrit instead, the minimum hematocrit is 38%). This cutoff is the same for both males and females, and applies to every donor, regardless of age, if the donor is 17, 27, or 87. However, the Final Rule raises that threshold from 12.5 mg/dL (38%) to 13.0 g/dL (39%), but only for males.
What was wrong with the old way?
Using the same hemoglobin criteria for male and female donors has been a potential problem for some time now, for several reasons. First, a male with a hemoglobin level of 12.5 (who is perfectly qualified under today’s donor criteria), is (wait for it): ANEMIC! According to the World Health Organization (WHO), any male with a hemoglobin below 13.0 is anemic. So, for decades, we have allowed anemic males with hemoglobin levels between 12.5 and 13 to donate blood!
Second, the WHO anemia threshold for mild anemia in non-pregnant adult females is 12.0 g/dL, which is 0.5 mg/dL below the current donor cutoff! So, many NON-anemic women are excluded from blood donation! Potential female blood donors (especially those younger than 50) have long known maintaining a hemoglobin of 12.5 can be difficult. Reports by the American Red Cross (and supported by anecdotal evidence from every blood center you could ask) prove that female donors are deferred over TEN TIMES as often as males for “anemia!”
Third, and this is important, so pay attention: Checking hemoglobin level is NOT the same thing as assessing a donor’s iron stores! When someone becomes iron deficient, hemoglobin level (easily assessed in routine, pre-donation testing) falls considerably slower than ferritin level (or “stored iron,” which is not a routine test in blood donors). As a result, “normal” hemoglobin does not always mean that the donor has normal iron stores. That fact has been shown repeatedly in studies showing a significant proportion of both male and female blood donors who are qualified to donate by hemoglobin level actually have depleted iron stores (see the “RISE” study referenced below).
So, we have a problem with current criteria, and the problem isn’t new. Many possible solutions have been proposed, including lengthening the time between blood donations, monitoring repeat donors for laboratory evidence of iron deficiency, and supplying oral iron to repeat donors. Despite numerous recommendations (including AABB Association Bulletin 12-03, suggesting that blood collectors consider things like recommending or supplying donors with oral iron supplements, measuring ferritin levels, or making frequent donors wait longer to donate), the industry has not yet agreed on a uniform approach.
Does the Final Rule fix everything?
The portion of the Final Rule dealing with donor hemoglobin criteria represents FDA’s solution to the issue. The new minimum cutoff of 13.0 g/dL hemoglobin or 39% hematocrit for males (a 0.5 g/dL increase in hemoglobin and a 1% increase in hematocrit over the previous requirement) will certainly lead to a loss of previously qualified male donors (“Dude, I’m anemic??”). We don’t know with certainty just how many will be affected, but my personal belief from a quick look at data from a California blood center is that this will affect less than 2% of male donors. Such a decrease would have an impact on blood supply, but the effect would likely not be devastating.
Now, I know what you must be thinking: Clearly, since FDA followed the WHO definition and RAISED the male donor hemoglobin cutoff to 13.0, they must have gone ahead and DROPPED the female requirement to 12.0, right? It makes sense, but that is NOT what FDA chose to do. In the Final Rule, FDA states that they would maintain the “current requirements for hemoglobin and hematocrits for female donors [12.5 hemoglobin/38% hematocrit].” Confused? No rationale was offered, but my suspicion is that FDA chose not to change the level for females because females have a higher incidence of iron deficiency at hemoglobin 12.5 than males already, and they were concerned that decreasing the cutoff might worsen the situation.
Does the Final Rule offer any other options?
FDA did offer one little loophole in the Final Rule. Blood collection facilities are permitted to drop the female donor cutoff to 12.0 hemoglobin/36% hematocrit, “provided that the establishment has taken additional steps to assure that the alternative standard is adequate to assure donor safety, in accordance with a procedure that has been found acceptable for this purpose by FDA” (emphasis added). As of this writing, blood centers are still struggling to figure out just what kind of procedure WILL be found acceptable by the FDA (will it include providing iron supplements to female donors? Will centers have to check ferritin levels or lengthen deferral periods for females?). Whatever is ultimately approved, I will tell you that if females are allowed to donate at lower hemoglobin levels, we would gain FAR more female donors than the males lost by raising the male threshold. In plain English: There are WAY more females with hemoglobin levels between 12.0 and 12.5 than there are males between 12.5 and 13.0!
We know this for sure: On May 23, 2016, all U.S. blood collection centers will lose a small proportion of their male donors who were previously eligible. At the same time, we have an opportunity to develop programs that will potentially make blood donation safer for female blood donors while at the same time increasing our pool of available donors. Certainly, all blood centers (including mine) are evaluating options and creating strategies as I write this.
How do you feel about these changes? Feel free to sound off in the comment section!
- FDA Final Rule, “Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use,”; I dare you!
- Cable, RG et al. Iron Deficiency in Blood Donors: The REDS-II Donor Iron Status Evaluation (RISE) Study. Transfusion 2012;52:702-711