ISO 15223-1 Do Not Reuse and Do Not Resterilize

Kat C

Registered
#1
Hi All,

I was hoping to get input on whether medical devices that are not reusable and have a Do Not Reuse symbol on them also need the Do Not Resterilize symbol. The thinking is that if it's not for reuse, then whether it is resterilizable or not is moot, because resterilizing it would only be associated with reuse. The devil's advocate response is, that conceivably if your sterile barrier is broken before use, if there is no Do Not Resterilize label, someone might subject it to a second sterilization before the single use. For our single-use disposables we are leaning toward just using the Do Not Reuse symbol, but we're not 100% confident. Thoughts? Thanks in advance.
 
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indubioush

Quite Involved in Discussions
#2
If you think there is a risk that someone would accidentally resterilize and reuse, you can add it. If not, leave it off since the do-not-reuse label will suffice.
 

monoj mon

Involved In Discussions
#3
The devil's advocate response is, that conceivably if your sterile barrier is broken before use, if there is no Do Not Resterilize label, someone might subject it to a second sterilization before the single use.
Exactly for this reason I would use the "Do Not Re-sterilize" symbol on my label and IFU based on my risk assessment. Another reason for my decision is that uner MDR 2017/745,
  1. the GSPR 23.3 states "The following particulars shall appear on the sterile packaging: (j) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use"
  2. the GSPR 23.4 states "The instructions for use shall contain all of the following particulars: (l) if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use"
To fulfill the above requirements the first thing I would do is place a symbol and relevant description for "Do Not Re-sterilize".

I am not sure about your target market, but since this type of situation is already mentioned by regulatory authority, I would not take the risk of omitting that particular "Do Not Re-sterilize" symbol.

I hope this will be helpful for you to make a decision.
 

monoj mon

Involved In Discussions
#5
To fulfill these requirements, you can use this symbol:

View attachment 26877
Yes, true. This symbol is the primary one to go on the labeling but my reasoning says this one is not sufficient enough to fulfill the requirements as well as avert any situation like this one as Kat C has mentioned, when someone thinks it's okay to re-sterilize it.
The devil's advocate response is, that conceivably if your sterile barrier is broken before use, if there is no Do Not Resterilize label, someone might subject it to a second sterilization before the single use.
Perhaps I should have said apart from using the "Do not use if package is damaged" symbol as a continuation to this sentence.
To fulfill the above requirements the first thing I would do is place a symbol and relevant description for "Do Not Re-sterilize".
 
#6
Exactly for this reason I would use the "Do Not Re-sterilize" symbol on my label and IFU based on my risk assessment. Another reason for my decision is that uner MDR 2017/745,
  1. the GSPR 23.3 states "The following particulars shall appear on the sterile packaging: (j) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use"
  2. the GSPR 23.4 states "The instructions for use shall contain all of the following particulars: (l) if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use"
To fulfill the above requirements the first thing I would do is place a symbol and relevant description for "Do Not Re-sterilize".

I am not sure about your target market, but since this type of situation is already mentioned by regulatory authority, I would not take the risk of omitting that particular "Do Not Re-sterilize" symbol.

I hope this will be helpful for you to make a decision.
Yes, true. This symbol is the primary one to go on the labeling but my reasoning says this one is not sufficient enough to fulfill the requirements as well as avert any situation like this one as Kat C has mentioned, when someone thinks it's okay to re-sterilize it.


Perhaps I should have said apart from using the "Do not use if package is damaged" symbol as a continuation to this sentence.
Thank you, monoj mon and indubioush, for your discussion. Since you added the "Do not use if package is damaged" symbol to the discussion, I looked up its details in ISO 15223-1, and in the Informative Notes it says: "NOTE This symbol may also mean "Do not use if the product sterile barrier system or its packaging is compromised"." In that case, it seems like this symbol can satisfy GSPR 23.3 and GSPR 23.4 if the IFU defines the symbol as "Do not use if the product sterile barrier system or its packaging is compromised", which should specifically address the situation of someone thinking it's OK to use at all after package damage, resterilization or not.

In the end, my thought is that for a single-use, sterile product the symbols "Do not re-use" and "Do not use if the product sterile barrier system or its packaging is compromised" are sufficient, and cover the two scenarios where there would be forseeable risk of resterilization. The only other scenario where the device could be resterilized would be if the package is not damaged and someone decided to resterilize it for no apparent reason, and I believe that this is an extremely remote possibility and thus does not need to be labeled to address. I welcome comments.
 
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