FDA Provides New Guidance on Blood Labeling

by Laura Johnson, on January 18, 2017

If your healthcare organization collects blood or blood components for transfusion, the FDA has some new recommendations for labeling that you’ll want to check out.

Just recently the Administration announced the availability of the draft document “Labeling of Red Blood Cell (RBC) Units with Historical Antigen Typing Results,” which as it implies, provides guidance to transfusion services for managing RBC units with legacy antigen typing. The document offers instructions to licensed blood collection establishments when reporting manufacturing and labeling changes under the biologics regulations. It’s worth noting that the guidance does not apply to test results for ABO and Rh(D) antigens.

From a labeling perspective, the FDA recommends that the labels on RBC units clearly indicate results are historical and were obtained using either licensed reagents/approved tests or unlicensed reagents/unapproved tests. The transfusion service receiving the unit can then use this information to determine if further confirmation of the typing is needed. Additional guidance is provided in the document including when to use a container label or a tie-tag and what formatting is required.

Not surprisingly, as with many FDA labeling regulations for the healthcare industry, the Administration recommends a validated process to confirm the donor’s identification along with accurate labeling that links the donated blood to the non-ABO/Rh(D) typing results from earlier donations.

Depending on your current process, now may be a good time to evaluate your own labeling solution to see how it will meet this impending requirement. A tightly integrated, enterprise-class solution that enables labeling within SAP and Oracle—your systems of record—can go a long way to complying with the FDA's evolving regulations while also driving greater efficiency across the healthcare supply chain. Certainly something to think about.

We invite you to learn more and read the brochure Enterprise Labeling for the Medical Device Industry.


Topics:Medical DevicesRegulatory