Medical Device Labels - Use Symbols Not Words

Sam Lazzara

Trusted Information Resource
#1
Here is my theory:
1. Using symbols on medical device labels avoids words.
2. Avoiding words on labels avoids the need to translate those words into the languages required by national regulatory authorities.
3. Avoiding translations reduces clutter and saves valuable label space that can be used for information that matters most to healthcare professionals, thereby improving product usability.

To make this legal, the label symbols must be defined in the Instructions For Use and the IFU must be translated into the required languages. In Europe, symbols that are "harmonised" (published in EN 980) are not required to be translated in the IFU. However, for the sake of worldwide risk reduction I recommend always defining symbol meaning in the IFU. I would not assume that healthcare professionals know what all those harmonised symbols mean.

So do your labels a favor. Use symbols not words, and define them in your multi-language IFU.
 
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pkost

Trusted Information Resource
#3
I will say that I tend to use symbols as much as possible and I agree that it is preferable to text. However, it is important to consider the overall design of the label as well, more so now with the increased focus on ergonomics in the MDD.

What do I mean by this? Well if you have a label bursting at the seams with symbols, it is entirely possible that a user will skim over them and miss a highly relevant one such as single use only or do not resterilise!
 

Michael Malis

Quite Involved in Discussions
#4
Here is my theory:
1. Using symbols on medical device labels avoids words.
2. Avoiding words on labels avoids the need to translate those words into the languages required by national regulatory authorities.
3. Avoiding translations reduces clutter and saves valuable label space that can be used for information that matters most to healthcare professionals, thereby improving product usability.

To make this legal, the label symbols must be defined in the Instructions For Use and the IFU must be translated into the required languages. In Europe, symbols that are "harmonised" (published in EN 980) are not required to be translated in the IFU. However, for the sake of worldwide risk reduction I recommend always defining symbol meaning in the IFU. I would not assume that healthcare professionals know what all those harmonised symbols mean.

So do your labels a favor. Use symbols not words, and define them in your multi-language IFU.
Hi Sam,

Nice idea, however not everyone around the world in agreement with your statements.
FDA is still "adapting" symbols, also required Warnings and Cautions to appear on Label.
The rest of the World, including Europe, is far from harmonizing: Russia, Ukraine, Kazakhstan, Australia, etc. are already implemented their own symbols, certifications, special labeling requirements.

Sorry to burst your bubble, but global harmonization is dead.

Regards,
Michael
 
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Sam Lazzara

Trusted Information Resource
#5
Thanks for the comments everybody. I admit I am an idealist; oh well.

I have seem some companies using symbols with the definition in English (only) next to the symbol. I wonder if this only serves to aggravate non-English language regulatory authorities and health care professionals.
 
#6
Here is my theory:
1. Using symbols on medical device labels avoids words.
2. Avoiding words on labels avoids the need to translate those words into the languages required by national regulatory authorities.
3. Avoiding translations reduces clutter and saves valuable label space that can be used for information that matters most to healthcare professionals, thereby improving product usability.

To make this legal, the label symbols must be defined in the Instructions For Use and the IFU must be translated into the required languages. In Europe, symbols that are "harmonised" (published in EN 980) are not required to be translated in the IFU. However, for the sake of worldwide risk reduction I recommend always defining symbol meaning in the IFU. I would not assume that healthcare professionals know what all those harmonised symbols mean.

So do your labels a favor. Use symbols not words, and define them in your multi-language IFU.
:applause:

Nice idea, however not everyone around the world in agreement with your statements.
FDA is still "adapting" symbols, also required Warnings and Cautions to appear on Label.
The rest of the World, including Europe, is far from harmonizing: Russia, Ukraine, Kazakhstan, Australia, etc. are already implemented their own symbols, certifications, special labeling requirements.

Sorry to burst your bubble, but global harmonization is dead.

Regards,
Michael
That is not correct. Russia, Europe & Ukraine all accept 60601 certification.

I cannot speak for Kazakhstan, but would be grateful if you could you point me in the direction of the evidence for that please?

Australia use a symbol for batch numbers, 'B,' but 60601/980 requirements are also accepted. They also have a minimum font size that would correspond with a requirement I've seen somewhere...specifying a test that font is visible in certain light conditions (somewhere in 60601 I think).
 

Michael Malis

Quite Involved in Discussions
#7
:applause:

That is not correct. Russia, Ukraine all accept...

Joanne,

I strongly disagree.

For example, Russia is still relies on product testing as a tool for determining product safety. Their national standards required testing for products that already possess CE Marking, FDA's clearance, etc. The language requirements and testing are significant barriers for foreign companies to register medical products in this country.

You also need to receive GOST Quality Certificate (the mark of conformity to Russian standards, similar to CE) that is issued to a manufacturer as a confirmation that their product meets Russian quality standards. After certification has been provided, the device must carry the GOST symbol (looks like large C with the small T inside).

In addition, Russian and Ukrainian symbol certificates must carry EXP. date on product packaging (that will change over time, because registration period is different in each country).

Also, Kazakhstan does not accept any more Russian labeling or symbols on products intended for sale in this country.

Regards,
Michael
 
M

MIREGMGR

#8
I have seem some companies using symbols with the definition in English (only) next to the symbol. I wonder if this only serves to aggravate non-English language regulatory authorities and health care professionals.
On our large number of global labels, we use English subtext with all symbols that communicate US-meaningful information, because US FDA formally, generally ignores symbols on non-IVD labeling.

Since we started doing that several years ago, we've had no pushback from non-English-language regulatory authorities regarding the English subtext. We do understand that in theory we aren't complying with EU regs, but it's the best global-label compromise we've been able to develop. Information on many of our labels that is non-symbolic and is EC-meaningful is presented in the full EC language range, so perhaps the regulators' view is that we are demonstrating a best effort.
 
#9
Hello Michael.

The rest of the World, including Europe, is far from harmonizing: Russia, Ukraine, Kazakhstan, Australia, etc. are already implemented their own symbols, certifications, special labeling requirements.
Russia, Ukraine and Europe have accepted our devices to 60601 standard symbols. We have not amended our labeling for any of these countries.
Also we will use 60601 for Australia, using the 980 batch symbol.

the device must carry the GOST symbol
Neither do we, as the manufacturer of medical devices, apply any extra symbols to our devices in Russia.
 
G

geglee

#10
Hi,

Does anyone know about the printing of "Rx only" to the product label and use for all markets? I am not sure is it workable as the tricky issue is CE is not Rx but FDA is. Would there be any issues when entering the CE market/others market? Thanks.
 
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