Medical Device Storage Temperature Tests and Requirements

Ronen E

Problem Solver
Moderator
The proper way would be to build new products with new components from the new supplier, then to invest the necessary thought in preparing a valid accelerated aging protocol, then to run it to validate 5-years shelf life and submit the report for regulatory scrutiny. In my opinion any other patchwork would be too shaky under serious, science-based scrutiny (which, surprisingly, might not be applied by your reviewers!...).

Unfortunately, from a regulatory perspective you can justify no-testing through risk evaluation only where the relevant regulatory clause stipulates that this is an acceptable path. Is it in your case? Is it in any/all the other "countless stories"? "Commensurate with risk" is a general principle in detailing explicit regulations, not a catch-all method for addressing any or all individual issues. You could argue that that principle was not always correctly transposed into individual regulations, however it is what it is and we can only wiggle within the room spelled out for us (or argue for update of the regulations).
 

Bonebuilder

Involved In Discussions
Ronen E,

I'm not advocating a "Canned Solution" as you put it, merely pointing out the limits to which a major component of a large majority of medical device packaging has been tested by its supplier. I agree with you that the specifics of the project at hand always need to be considered, and the packaging is only part of the shelf life equation.

To Marmotte's question again I find myself agreeing with Ronen E. If you want to claim 5 years and only have data for 2 years you need to know and show what's occurring in the additional 3 years!

Is it acceptable to follow the ASTM recommendations with using 25C "storage temp" even though the label says -10 to 40?

Presumably by your labelling you expect your product may have to endure -10° at some stage in its life? How then can testing it at 25° possibly tell you how the modified device with this "new material" will perform at -10°?

Can you demonstrate that it really is "the same" material, if so what validation did your original material supplier provide? What is the material? If its a metal I would think you'll be able to reasonably justify the change, (I'd still run some real time samples ahead of your production to confirm no change) if its any of the exotic polymers well your clock's ticking...!
 
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Pads38

Moderator
For people looking for a standard for testing of (non-sterile) packaging, may I suggest the ASTM D4169 series.

A background article:
https://www.astm.org/SNEWS/OCTOBER_2004/mckinlay_oct04.html

But these do not cover "lifespans" or accelerated ageing - they are more concerned with simulated shipping conditions, with different test levels available dependent upon sensitivity and the number of 'distribution cycles' intended to simulate.
 

marmotte

Diapason Consulting
Thanks all,

My employers are very serious about confidentiality so I will not give more details about my product - but for the sake of the example, I will bounce of one of these countless examples I read about, which is similar in material and function to my product. A cuff sleeve, like they have been made for decades, is made from synthetic fabric.

In my opinion, decades of experience with this kind of products, with hundreds of products in the field and lots of post market data - is WAY more illustrative of the actual aging of a product/material than a Test based on the ASDM standard which everybody agrees is based on one single equation - oversimplifying a complex phenomenom and using ultraconservative hypothesis. This is not exactly what I'd call "good science".

My comment also meant that it appears many regulators (both CE and US sides) are recently requiring a lot more than what they use to just a few years ago - and are very often requiring more now for simple/low risk products than what they used to ask for much more critical products....
 

Ronen E

Problem Solver
Moderator
Thanks all,

My employers are very serious about confidentiality so I will not give more details about my product - but for the sake of the example, I will bounce of one of these countless examples I read about, which is similar in material and function to my product. A cuff sleeve, like they have been made for decades, is made from synthetic fabric.

In my opinion, decades of experience with this kind of products, with hundreds of products in the field and lots of post market data - is WAY more illustrative of the actual aging of a product/material than a Test based on the ASDM standard which everybody agrees is based on one single equation - oversimplifying a complex phenomenom and using ultraconservative hypothesis. This is not exactly what I'd call "good science".

My comment also meant that it appears many regulators (both CE and US sides) are recently requiring a lot more than what they use to just a few years ago - and are very often requiring more now for simple/low risk products than what they used to ask for much more critical products....

No offence but I think you quite missed my point. I wasn't promoting using the ASTM standard in your case. What I was arguing for is a thoughtful, detailed, patient examination of how a specific device fails / might fail over time, and building shelf life validation upon the insights. It has to be engineering/science based, it has to start at the roots and details do matter (so two pressure cuffs are not necessarily the same). It doesn't necessarily have to end up in extensive testing.

Unfortunately I see the above take place very seldom. Instead, often great resources are wasted to establish pseudo-scientific confidence, which, under slightly deeper scrutiny, is actually very little confidence. Then we later hear about catastrophic recalls where everyone is so surprised "how we could have missed it".

If you're interested in going into details in private please send me a PM. I'm happy to sign a NDA.

Cheers,
Ronen.
 
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