Labeling irradiated units

[bmarotto]

If you irradiate a blood product that was received from your blood supplier, do you draw a line through their license/registration number? Do you add your own facility ID and registration to the label, and if so where do you place it?

I understand in ISBT there is a place to put a "further processed by" sticker on the bag label. I was wondering how you do this with Codabar.

[Cliff]

Yes we cross out the license number.

We have a sticker we place on the product that says Irradiated By Our Facility.

[Eagle Eye]

we send our unit to near by hospital for irradiation. After irradiation they have to write their number or put somekind of sticker, Is that true?? In this type of cases supplier is still same as original???

[kate murphy]

We were cited for this issue a few years ago.

We now have labels "Irradiated at BMC".

We do not cross out the original supplier's reg/lic number as they originally drew and processed the unit. We are adding to the unit, not claiming total processing.

[bmarotto]

Kate..that is what we are doing. We add an "Irradiated by....." label but do not cross off the Red Cross license number, which is on the bottom of the blood type label. "U.S. License #190". I am getting conflicting opinions on whether we have to cross the license number off and I have never had an inspector cite us for not doing it....yet.

[MicheleKay]

In addition to the Rad-Sure and the "Irradiated by..." sticker we also have a sticker to place over the original product description. This is done because the unit is being modified. This was brought to our attention a few years ago by one of the many inspections. I don't recall, b/c I'm just the technologist. For example....CPDA1-Leukoreduced Red Cells now becomes Irradiate CPDA1-Leukoreduced Red Cells with the all the same information listed underneath ...."From 450 mL CPDA1 Whole Blood Store at 1-6'C. We by no means CROSS off any supplier information!!

[bmarotto]

Oh, yes we do also change the product label to the irradiated product code label.

[Ellie Ross]

We currently add our own Facility ID and Registration Number label to the unit. it is placed next to but not covering Indicator window of the Irradiation Sticker on the front of the unit above the face label. We leave the original Facility ID/Reg# intacted. We have not made any decision to change this with ISBT128 yet.

[Cliff]

I don't beleive irradiated products are an FDA licensed product.

This is why we started to cross out the original faclities license number.

A few years back an FDA inspector was impressed we were doing this.

[Cliff]

OK, so I just read an Ask the FDA from last years AABB meeting.

Question:

A facility imports a licensed red cell and irradiates it. (The facility is licensed to irradiate.) Does the importing facility place their license label on the irradiated product?

Orton:

If the product is going to be used internally, no, the licensing number of the irradiating facility does not need to go on it. However, if it is being shipped, the labels should have the original collector’s license number and registration, and the irradiating facility would have an additional label stating that the component was irradiated by the facility, and have the facility’s name, the license number and registration number on it.

(Reference - AABB Regulatory Update–Ask the FDA– January 2006)

It looks like we should not be crossing out the license of the original facility.

[bmarotto]

Cliff, That certainly seems to make more sense to me. The license number of the collecting facility refers to the original product as collected.

I have the feeling it is one of those things that if you ask several FDA inspectors you will get answers on both sides. I am going to keep things the way we are doing it now...not crossing off the Red Cross license number, changing the component type label, and adding a label stating "Irradiated by (my facility)"

It is so nice to know I am not alone in my confusion.

[Deb]

I recently asked this question of Dr. Ken Zeeman, CBER, FDA.

He is our Consumer Safety Officer and sits as a liason to the ICCBA committees.

If you are licensed for irradiated products...the license number remains intact.

If the facility irradiating the product is "not" licensed for irradiation, then you must cross out the license number on "any" facility label (including the original facility license)...leave the registration number.

You can add a second facility label indicating the unit was further processed by your facility to the side, below, etc. It just can't obscure the original collecting facility label.

...clear as mud right?