How to best prioritize Medical Device Label Contents

Mark Meer

Trusted Information Resource
#11
In previsous editions, this was not very clear so people understand that every time you had to put this symbol, which is stupid ("read the whole manual" is not a good reminder of risks). This also could cause even more risks.
I see. I guess I'm one of those referencing a previous edition (2005).

But although I appreciate the intent, in practice this does not make much sense.

First, there is no way to indicate the "specific" risk using the symbol. Regardless of the developer's risk-files, to the user the symbol still basically means "read the whole manual".

Second, it'd imagine that nearly every device has labelling risk-control at some level. Contraindications come to mind...
 
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Mark Meer

Trusted Information Resource
#12
I ended up with all labelling on the primary packgaing and the LOT number on the device itself
To confirm: you have a medical electrical device with nothing but the LOT number on the device itself (all other info on the packaging)? No issues from your NB?

...I'm going to presume you did not have to certify to 60601-1 or -1-11?

It?s more related to liability than anything else.
Hmmm... My suspicion is that most test labs would equate liability and safety and would not accept the exclusion of, for example, the Applied Part symbol....
 

Marcelo

Inactive Registered Visitor
#13
First, there is no way to indicate the "specific" risk using the symbol. Regardless of the developer's risk-files, to the user the symbol still basically means "read the whole manual".
Sure there is, and I?ve seen it lots of times, you can, for example, put the symbol on the manual next to the specific risk you want to point to.

Second, it'd imagine that nearly every device has labelling risk-control at some level. Contraindications come to mind...
Contraindications are not "RISK CONTROL measure for a specific RISK" as this symbols is to be used, they are more general controls in this case.
 

Marcelo

Inactive Registered Visitor
#14
I see. I guess I'm one of those referencing a previous edition (2005).
The 2005 edition has the rationale I mentioned. You should probably read the whole standard. And I don?t say this as an offense, but mainly because you seem not to be aware of some of the requirements and rationales. Another example:

Quote:
I ended up with all labelling on the primary packgaing and the LOT number on the device itself
To confirm: you have a medical electrical device with nothing but the LOT number on the device itself (all other info on the packaging)? No issues from your NB?

...I'm going to presume you did not have to certify to 60601-1 or -1-11?

IEC 60601 says in 7.2.1 :

If the size of the ME EQUIPMENT, an ME EQUIPMENT part or an ACCESSORY, or the nature of its ENCLOSURE, does not allow affixation of all markings specified in 7.2.2 to 7.2.20 (inclusive), then at least the markings as indicated in 7.2.2, 7.2.5, 7.2.6 (not for PERMANENTLY INSTALLED ME EQUIPMENT), 7.2.10 and 7.2.13 (if applicable) shall be affixed and the remaining markings shall be recorded in full in the ACCOMPANYING DOCUMENTS. Where no marking of the ME EQUIPMENT is practicable, these markings may be affixed to the individual packaging.
So, yes, you can have an equipment complying with the standards with only the LOT number, as mentioned.

Hmmm... My suspicion is that most test labs would equate liability and safety and would not accept the exclusion of, for example, the Applied Part symbol....
They would, pif not possible, as mentioned above.
 

Mark Meer

Trusted Information Resource
#15
The 2005 edition has the rationale I mentioned.
Apologies. I was reading the main text and not Annex A. I've found it now...

So, yes, you can have an equipment complying with the standards with only the LOT number, as mentioned.
Apparently the Applied Part symbol is still required regardless...

...but more generally, as is the subject of this thread, is how to prioritize contents given limited space.

Caveats for limited label space are subjective, and so depending on the requirements of regulator or test-lab, I could easily imagine a situation where a test-lab says "there is space for the required applied part symbol...if you just removed the UDI", or the FCC saying "sure there's space for the FCC ID...it's more important than the Applied Part symbol...".

Sure there is, and I?ve seen it lots of times, you can, for example, put the symbol on the manual next to the specific risk you want to point to.
I guess... but it somehow seems inappropriate to use the "refer to instructions manual/booklet" symbol IN the instructions manual...

I suppose, when defining the symbol, you'd have to describe what the symbol means on the device label (i.e. "refer to instructions") and what it means in the instructions itself (i.e. "this is a mandatory risk-control action").

Contraindications are not "RISK CONTROL measure for a specific RISK" as this symbols is to be used, they are more general controls in this case.
Hmmm... I'm not sure I'm getting the distinction between risk control for a specific risk versus general controls.

As far as our risk-analysis, we've identified "person with (specific contraindication) using the device" as a potential risk, and the only mitigating measure is to provide a contraindication warning in the instructions. Is this not a specific risk?

More generally, are not all stated warnings tied to risks? Otherwise why would they be stated? ...ah yes, liability...

P.S. thanks for good discussion and enlightening me! :thanks:
 

Mark Meer

Trusted Information Resource
#16
This symbol, <consult instructions>, is to be used when there?s a link to a specific risk control measure for a specific risk, as defined in the rationale...
A bit off topic of this thread, but doesn't this conflict with EN ISO 14971:2012?

I'm still using the 2007 version, but from what I gather from various discussion, one change was the addition of Annex Z, which no longer recognizes labelling as an effective risk-control measure?

If this is the case, then isn't there a conflict between IEC 60601-1:2005 (which supports the use of a symbol to inform user of risk-control actions/warnings in the instructions) and EN ISO 14971:2012 (which restricts use of labelling as risk-control).
 

Edward Reesor

Trusted Information Resource
#17
I am having the same issue with label cramming and the recommendation to place information that is on the IFU on the label itself. One example is the temperature ranges for storage and operation respectively. The device I have is made of plastic and therefore operates under a very wide (but not infinite) temperature range..almost at the limits if not exceeding the environmental conditions where they would be used.

We have placed the temp ranges on the IFU but are now being questioned as to why they do not exist on the already overcrowded labels. Human factor engineering may suggest that effort to provide maximum information may lead to increased errors.

Anyone's thoughts on this would be greatly appreciated.
 
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