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Irradiate label affixed to the ISBT label

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Hello. I work for a large blood bank in Houston. We do a considerable amount of irradiations daily. In an effort to improve our processes I found this label ---->> https://www.unitedadlabel.com/blood-bank-communication-label-1-1-4-x-5-104 . 

Does anyone who receives and/or irradiates blood components affix this type of label onto their units?  Apparently, this label is non-ISBT compliant and the label is designed to only go onto the base label of the product. 

I am open to suggestions.

 

Thanks, 

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We use the rad sure sticker but when the parent bag is irradiated and we pull a syringe or an aliquot, we use a label similar to the one you referenced.  The nurses are always looking for a sticker.  Of course the product is also labeled with the irradiated product ISBT label from our Hematrax printer.  Curious to hear what others are doing and if this practice is compliant...

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Do you have a product label i could reference for my facility. The one label I found, states "For base label use" only. thanks for your help

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I'm unsure what you are trying to accomplish.  irradiation is a part of the ISBT product code and should be on the base label.  We irradiate about 40,000 products a year.  We use a Radsure on each product and relabel with a new 4x4 base label.  Why are you considering a sticker?

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For a product that is IRRADIATED, that attribute will print on an ISBT 128 label below the product name (see example) using HemaTrax software from Digi-Trax. No need for a separate label.

image001-edit.jpg

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2 hours ago, NLiveris said:

For a product that is IRRADIATED, that attribute will print on an ISBT 128 label below the product name (see example) using HemaTrax software from Digi-Trax. No need for a separate label.

image001-edit.jpg

As an inspector I would be satisfied with this for compliance.  It's always nice to see the RadSure label but I do not believe that it is required.

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Hello Pmanager,

ISBT 128 does not preclude the use of an additional label on top of the ISBT 128 label, such as the “Irradiated” label you referenced, as long as it does not obscure/cover any of the ISBT 128 information.

I hope this helps!

Kind Regards,
Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)

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Right now we are using Radsure but are going to switch to RAD Control(made by TYPENEX). It is a smaller label and stored at room temp rather than the refrigerator. The thing everyone likes about it is the lot number and exp date that we write on the irradiation log is actually a sticker on its own that you peel off and attach to the log. As far as a making doses from the parent bag we use a ISBT based label that has irradiation printed on, like Malcolm's.

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Are you asking about which labels can be placed on the bag and which have to be on the base label??  Some irradiation indicator tags - both Rad-Sure and Rad-Control - have a type of adhesive that can touch the actual bag.  Both can go above or below the base label (or at least that is what I have always been told).  Most little labels/stickers, like the original Irradiation label in this thread, do not have this type of approved adhesive and are not allowed to be placed directly on the bag.  You have to find somewhere to stick it on the base label without covering anything else up.  

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On 10/14/2019 at 10:20 AM, slsmith said:

Right now we are using Radsure but are going to switch to RAD Control(made by TYPENEX). It is a smaller label and stored at room temp rather than the refrigerator. The thing everyone likes about it is the lot number and exp date that we write on the irradiation log is actually a sticker on its own that you peel off and attach to the log. As far as a making doses from the parent bag we use a ISBT based label that has irradiation printed on, like Malcolm's.

Just FYI... RadSure can now be stored @ RT.

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On ‎10‎/‎17‎/‎2019 at 2:08 PM, cswickard said:

Are you asking about which labels can be placed on the bag and which have to be on the base label??  Some irradiation indicator tags - both Rad-Sure and Rad-Control - have a type of adhesive that can touch the actual bag.  Both can go above or below the base label (or at least that is what I have always been told).  Most little labels/stickers, like the original Irradiation label in this thread, do not have this type of approved adhesive and are not allowed to be placed directly on the bag.  You have to find somewhere to stick it on the base label without covering anything else up.  

Piggybacking this comment that yes, the FDA dictates which adhesives can actually touch products meant for human consumption. A wise man once told me of specific CFRs (21CFR175.125 and 21CFR175.105) that detail said restrictions, so it's not as easy as just finding a new sticker that you can just slap on blood products after modifying them, unfortunately ;)

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We do have a label adhesive that can be directly applied to bags and meets FDA requirements.  We can make a custom label if needed for an "IRRADIATED"  label that can be applied to any portion of the bag.

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As noted above, irradiation changes the product code.  For example when E0226 is irradiated it becomes E0224.  

Our computer system changes the product code and prints the appropriate label.  Irradiated is part of the description of the new product code and prints on the new label.

The sticker you asked about is similar to one we used back in the 'Codabar Days.'  However it does not suffice on it's own now.

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On ‎10‎/‎14‎/‎2019 at 10:20 AM, slsmith said:

Right now we are using Radsure but are going to switch to RAD Control(made by TYPENEX). It is a smaller label and stored at room temp rather than the refrigerator. The thing everyone likes about it is the lot number and exp date that we write on the irradiation log is actually a sticker on its own that you peel off and attach to the log. As far as a making doses from the parent bag we use a ISBT based label that has irradiation printed on, like Malcolm's.

slsmith:  do you like the RAD Control stickers?  Just curious after you've actually switched.  Specifically do you feel satisfied by the depth/completeness of the color change and the adhesion quality?

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4 minutes ago, slsmith said:

reply to SusieQ132: yes we our satisfied with the label. Sorry for the delay in my response

No problem!!  Thank you - I appreciate the feedback.  :)

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