Create your own symbol?

Jen C

Involved In Discussions
#1
We sterilize our device using a method that is not covered by the symbols provided in ISO 15223-1. We'd prefer not to spell out our sterilization method on the label due to space constraints. For other similar issues we have created our own 'symbols' and defined them in the IFU glossary. Is there anything preventing us from modifying an existing (ISO 15223-1) symbol to indicate the sterilization method?

I.e., we would provide the "Sterile" box with another small box next to it containing an abbreviation (similar to the "A" or "EO" sterilization symbols). Then we'd define this in the IFU glossary.

Is there any issue with doing this - in other words, modifying an existing symbol rather than creating a new one? And do you think it would be acceptable to use ONLY the modified version and not also the original one (the plain "STERILE" in a box)?

Thanks for your thoughts.
 
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Ninja

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#2
Im not in medical...but that sounds like a question for a lawyer in the field...
 

Jen C

Involved In Discussions
#4
Thanks for your replies - we tried what's suggested by craiglab, but we have been requested to add the method of sterilization on the product label. Our options appear to be (a) describe it in words (difficult due to available space), or (b) create a modified symbol and define in the IFU.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
At the very least I would document a risk analysis covering what (and how) could go wrong in case the symbol is misunderstood / misinterpreted. You *might* need to run a usability test to prove that users understand it properly.

As a devil's advocate's argument - if what you'r suggesting is acceptable, what prevents a manufacturer from creating a whole graphic "language" (collection of symbols) and using it across the board, backing it with a paper insert "dictionary"?...
 

craiglab

Involved In Discussions
#6
Thanks for your replies - we tried what's suggested by craiglab, but we have been requested to add the method of sterilization on the product label. Our options appear to be (a) describe it in words (difficult due to available space), or (b) create a modified symbol and define in the IFU.
I don't understand then the sterile symbol since there is always a method.
ER 13.3(m) "The label must bear... where applicable, method of sterilization" I've interpreted "where applicable" to mean a reason for including, based on risk analysis. We use [STERILE][EO] - understandable given possible residuals, and [STERILE][R] - not sure what the risks of gamma are but traditional usage.

You mentioned space constraints - maybe a secondary label?

I agree with Ronen on the risk analysis aspects.

I'm hoping you will post what your notified body ends up accepting.
 

Jen C

Involved In Discussions
#7
Thanks. This is an interesting discussion, because I have always understood that you can, indeed, create your own symbols whenever you want to. The symbols provided in ISO 15223-1 are already approved, which just means you can use those symbols without explaining them (although in practice, I think most people do still provide a glossary). But if you want to create your own symbol, or entirely different ones than those in the standard, I think you can do that - you just need to explain what they mean, and likely do a user/risk assessment to determine whether they might confuse your users. (I should note that our device is for professional use only.)

My concern in creating my own symbol here was mostly that I'm not sure whether modifying an existing symbol is somehow more problematic than creating a new one. Additionally, I'm not sure whether including only the modified symbol would be sufficient, or whether we'd need to include both the "STERILE" and our modified "STERILE-XX" symbols - which is definitely overkill.

Per craiglab's reply, I interpret ER 13.3(m) differently - I believe the "where applicable" means IF your device is sterile. So if you're stating the device is sterile, you need to say HOW it is sterilized. I agree that it then seems redundant to have a "STERILE" symbol, because you're always going to need to specify the type of sterilization. I thought our approach of directing the user to the IFU would be sufficient, but I guess not. Not sure if this is a new MDR-level interpretation, or whether this reviewer is just particular.

As for creating a separate label - the reason for the tight real estate on the label is the size of the container, so there really isn't room for another label either.

It sounds like we just need to propose this and see what they think! Thanks for the interesting discussion.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
(I should note that our device is for professional use only.)
This almost guarantees that users will not consult the IFU/inserts - more the reason to ensure that the new symbol does not confuse (by itself) in a way that might create an unacceptable risk.
My concern in creating my own symbol here was mostly that I'm not sure whether modifying an existing symbol is somehow more problematic than creating a new one.
I guess that generally it increases the risk for confusion - if a user sees something completely new and different from what they know they are (IMO) more likely to stop and think, and maybe look for clarification, if this is significant. If the new symbol is a modification they might not even notice the nuance.
I interpret ER 13.3(m) differently - I believe the "where applicable" means IF your device is sterile. So if you're stating the device is sterile, you need to say HOW it is sterilized. [...] Not sure if this is a new MDR-level interpretation, or whether this reviewer is just particular.
I agree with this interpretation of "where applicable" (in the MDD). The MDR clarifies all that (GSPR 23.2 (l)):
(l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
 
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