Latex Adhesive Labels used in Medical Device Packaging

Java23

Involved In Discussions
#1
Hi - need help / opinions please.

Discussion going on here - situation is

A specific size label is used in production - printed on zebra printers and then applied to packaging. Found out the adhesive on the label stock contains latex. We have not claimed latex on the label.

There are some that feel that "since the label doesn't come into contact with the patient we are fine using it".

My thought :rolleyes:/suggestion is that we need to:

1. Order new labels without latex.
2. Dispose of the latex roll labels.
3. While using what is in stock until new labels (without latex) are received, we must state the type of latex on the label.

Am I not interpreting 21CFR 810.437 accurately?

Thanks in advance for your many words of expertise!:thanx:
 
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M

MIREGMGR

#2
The rule clearly says in (b)(3):

The term "contacts humans" means that the natural rubber contained in a device is intended to contact or is likely to contact the user or patient.
The highlight above is by me.

Obviously the exposed edge of a label can make contact with a user during pouched-product handling. I don't see any way for the rule to not be applicable to your situation.

Your proposed action plan is correct.
 

Java23

Involved In Discussions
#3
Thank you very much for you thoughts/expertise! Guess I was always taught ANYTHING LATEX needs to be disclosed! I appreciate your input!

:):thanks:
 
M

MIREGMGR

#4
Just to tie up a loose end for any readers that haven't reviewed the rule itself, and are wondering about the quote above seemingly referring only to the product and not to the packaging/labeling...the rule makes clear elsewhere, at least in my reading, that references to "product" are to be read as applying to the associated packaging etc. as well.
 

Java23

Involved In Discussions
#5
Thank you once again for clarifying! When I think about the label being applied to the packaging, my first thought is that anyone coming into contact with the label needs to know that the adhesive contains latex - I consider the "worker" to also be considered a "user". Everyone and Anyone coming into contact with the label should be aware of the latex. As you mentioned above "contacts humans" in section "b".

I am not certain the exact words to be used to notify. Do you feel it is appropriate to use the statements in "f" and "g" (The packaging of this product contains......)? Or, should it state something like, "this label contains........)?

I think the best fix is to destroy the latex labels and only use labels that are "latex free".

Suggestions?? Thank you.
 
M

MIREGMGR

#6
I'd suggest that from a marketing perspective, you want the wording you use to make clear that the latex is present only externally to the sterile barrier packaging, in the label, and therefore will not contaminate the contained medical device in such a way that it could be transferred to the patient.
 

chris1price

Trusted Information Resource
#8
In addition to the above actions, I would also open a CAPA and document a very thorough risk assessment. You should consider whether any of your actions could be considered as a correction.
 
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