Just wanted to know if anyone has ever heard of food graded transfusion labels. We have been using the same blood tags for last 3 years, they have these green labels which we peel off and put on the unit itself. These green labels are all of a sudden considered not food graded????? Not sure what that means. We had two inspectors come into our facility and told us that we are no longer allowed to put place these green labels directly onto the unit. We can however put it on the ISBT label but typically there is no space on these labels. We are trying to come up with a solution. It would be a real pain to put tie tags on these units since we have large volume of transfusions.

Please advise on this situation. Any recommendation would be greatly appreciated.

Thanks,

Sha Shah

Sounds like your FDA inspector was a Food inspector with no knowledge of blood bank. Did you contact the FDA for clarification?

It could well be that the adhesive on the back of the labels has not been proven to be safe. By this, I mean that some adhesives have been shown to migrate through the plastic of the bag and leech into the blood.

We had this problem in the UK.

We had to get labels with an adhesive that was proven not to go through the plastic, or did not affect the blood if it did (I think the former).

Contact your label manufacturer to see what they say. If they are OK to apply to the unit, they should be able to provide you with documentation.

The adhesive on the label must meet FDA requirements.

Linda Frederick

Contact your label manufacturer to see what they say. If they are OK to apply to the unit, they should be able to provide you with documentation.

The adhesive on the label must meet FDA requirements.

Linda Frederick

I talked to someone at Shamrock labels who knew all about FDA requirements for labels, very helpful. 800-323-0249.