HI, I am about to inspect a Blood Bank that draws some of its own blood. Just wondering about labeling for those hemocromatosis units drawn as therapeutic phlebotomies but which can be used as an allogeneic unit. I can't seem to find any guidelines or standards on how, if at all, the unit has to be labeled to alert someone (?) that the donor has hemochromatosis. Any suggestions?

You didn’t mention what type of inspection you are performing, however see AABB BB/TS Standards 5.6.7.1 and FDA Guidance:  Variances for Blood Collection from Individuals with Hereditary Hemochromatosis, August 22, 2001.  Depending on circumstances, therapeutic collections used for allogeneic use may not need to be labeled with Hemochromatosis disease status.

Those units used to have to have a label stating:  "drawn from a donor with hemochromatosis".  What the standard is now I am uncertain.  Are you sure the place you are inspecting uses blood from such donors?  There are fairly strict rules about such - so much so that I would be surprised if they do . . .

Thanks SMW, its a CAP inspection . I was looking for some official language to use but 5.6.7.1 is way too vague. I am wondering what the label should look like or is a sticker on the bag OK? How detailed should the label be? Maybe the guidance says all this which I will check now.

HI David, just saw your post. I read somewhere that they have these units but I'll be finding out soon when I go there.

You can still get units from the rare donor file that state: drawn from a donor with hemochromatosis.  I'd just look for a sticker as that is all I have seen in the past.

Huh I have never seen that on a unit label. I thought a hemochromatosis unit could be labeled like any other unit as long as donor met criteria and donor center had an FDA variance.

This guidance document provides recommendations to you, blood establishments, that wish to distribute blood and blood components collected from individuals with diagnosed hereditary hemochromatosis without indicating the donor's disorder on the container label.

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080393.pdf

Guidance for Industry

Variances for

Blood Collection from Individuals with

Hereditary Hemochromatosis

Additional copies of this guidance document are available from:

Office of Communication, Training and Manufacturers Assistance (HFM-40)

1401 Rockville Pike, Rockville, MD 20852-1448

(Tel) 1-800-835-4709 or 301-827-1800

(Internet) http://www.fda.gov/cber/guidelines.htm

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research (CBER)

August 2001

Questions about Individuals Diagnosed with Hemochromatosis and Blood Donations

Is it true that individuals diagnosed with hemochromatosis can now donate?

FDA has always allowed individuals diagnosed with hemochromatosis to donate blood. However, FDA is now allowing variances to the requirements that blood establishments 1) label such blood with the donor's disorder, and 2) have a physician examine the donor at the time of donation if less than eight weeks has passed since the previous donation. These variances are specific for individuals with hereditary hemochromatosis.

The existing regulations require that blood establishments using blood collected during therapeutic bleedings label these units with the disease that necessitated the therapeutic bleeding (21 CFR Part 640.3 (d)) and limit the frequency of whole blood collections (21 CFR Part 640.3 (f)). FDA has the authority to permit exemptions to the blood regulations under the provisions of 21 CFR 640.120, Alternative Procedures.

In August 2001, FDA issued Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis providing recommendations to blood establishments that wish to apply for these variances. Refer to the guidance document for the conditions blood establishments must meet in order for us to approve the variance requests. Not all blood establishments have applied for these variances. Ultimately, it is the decision of each blood establishment to apply for any variance.

In summary, when a blood establishment desires to use blood from a therapeutic hemochromatosis bleeding for transfusion purposes, the blood establishment must either 1) label the collected blood with the donor's disorder and have a physician examine the donor on the day of donation if less than eight weeks has passed since the previous donation, or 2) apply for the variances.

From reading the standard 5.6.7 from 28th edition and 29th edition----My understanding is they do not have to be labeled if Blood center have approved variance. 

OK, thanks, I will let this ride until I am on site. I am still not clear  on what the word "label" implies- little sticker on bag? Separate label with all kinds of official sounding words and references to standards??? I'm probably worrying too much about it anyway plus I am 9 plus hours away from a short vacation so my brain is shutting down LOL