4 min reading time

As originally asked by Brenton Cramer.

Hello group,

I am looking for some advise here. I am currently working on a product where several materials have changed; therefore, we are conducting multiple tests to ensure no failures occur. One of these tests is shelf life testing or accelerated age testing. My customer is lead to believe we can sell product with a stated shelf life, for example 8 years, prior to the testing of the product after aging simulation of 8 years and states the risk associated with this is recall if the samples after 8 years of accelerated aging fail. Is this a common thing? I am leaning towards waiting to have all of the testing complete and verified prior to selling it to customers. Any input would be helpful.

Thanks,

Brenton Cramer

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Champa Patel
Regulatory Affairs Specialist at ConvaTec
You need to carry out a risk assessment using the different materials and decide which functional properties will be adversely affected. Following that if you think the new material will be able to withstand the properties for at least 2 years then you could launch the product with 2 year shelf life while carrying out the 2 year shelf life simultaneously. Chances are your two year shelf life test result will be out before the product actually reaches the market and you could breathe a sigh of relief.

At the same time instigate the shelf life for 5 and 8 years. When the 5 year shelf life is complete, label the products with 5 year shelf life and so on until you get to 8 years. I would keep the manufacturing to minimum until 8 years study is complete. If there is still product in the market with 2 year shelf life when the 8 year study is completed then you could send out a special information targeting those customers with the update. This will keep them happy too.

Robert Poyser
QA & RA Manager at Henry Schein
Can you benchmark the shelf life, i.e. are the materials used by you or in some other product, you have tested or in a similar product or environment by a different company, where the shelf life is stated.

This can be part of your risk assessment justification. of course you would need to back this up in the long run, with your own tests as well.

Part of you risk assessment should determine what the outcome would be if the product failed shelf life tests, would the failure be positively detected before use, if not, what would/could the patient outcome be.

What is, or is there a risk benefit for early release, if its only financial then consider being patient.

Each region’s notified bodies (FDA, MHRA, etc.) will/may have a different take on this so keep them in the loop.

Champa Patel
Regulatory Affairs Specialist at ConvaTec
Accelerated aging to achieve 8year shelf life will take a long time even if you consider the temperatures of 60C. It will not be advisable to go beyond this temperature due to the polymers involved in elastomers (their Tg values will play an important role in determining the maximum temperatures you could use.).

Brenton Cramer, ASQ CQE, CQA, CSSGB
Quality Engineering Manager at Biomedical Innovations
Thanks again for all of the comments. With all of the provided feedback, I feel I have enough information to develop a plan and move forward. Thanks again.

Jeanne POUQUET
R&D Manager
Hi Brenton, I am a polymer expert (currently in maternity leave). Accelerated aging usally takes 6 to 8 weeks to complete. Would you like me to recommend a colleague to discuss this further?

Don Ross
Financial Navigator
You would certainly be operating at-risk, if the magnitude of that risk is acceptable to the enterprise then move forward. The risk to the patient and enterprise must be quantified before it can be considered and accepted.

Morgan Tierney
Advanced Engineering at Teleflex Europe
This is a common problem, be careful on the temperature of the accelerated aging, only select temperatures that will not add additional burden – lead to thermal degradation, crossing a transition temperature etc.
The issue here is all about risk.
I would start with the following question ‘Elastic bandage, what can fail due to aging and what is the impact of such a failure in end use’. I would then reach out to a materials engineer and have them review the issues from an engineering aspect, and develop my strategy thereafter!

Star Simkins, RAC (US, EU)
REGULATORY AFFAIRS CONSULTANT – Here to help you with all your European MDR (2020) and IVDR (2022) needs and more.
Typically if critical materials change, accelerated aging is performed with real time in-process & a shelf life in relation to the accelerated aged real time equivalent is the safest route. However, it is very much dependent on the type of material and its function. I’ve seen some companies launch the new material with a shorter shelf life with full accelerated stability data to back it up and others perform a thorough risk assessment and move forward from there if the data are not available prior to marketing. Another approach would be to get information from the vendor on the materials and/or do literature research to support the shelf life of the material.

Brenton Cramer, ASQ CQE, CQA, CSSGB
Quality Engineering Manager at Biomedical Innovations
Thank you all for the comments. To clarify, it is a Class I device and is an elastic bandage, similar to an Ace bandage. 8 years seems like a long time, but given the type of product it is, it may not be used for several used prior to needing to use it.

Robert Barber
Consultant – Medical Device and IVD Regulations and Quality Management
Make sure your accelerated test is a valid predictor of real time shelf life, i.e. based on sound scientific principles (e.g. Arrhenius equation). 8 years seems a very long shelf life, but I’m not sure what your product is. An alternative approach might be to launch with a shorter shelf life claim, say 4 years, and extend this as you successfully reach each time point in the ageing study.

Yi Chen, PhD, RAC
Co-Owner at Xinya S&T Company
It depends upon classification of the medical device. If it’s Class III, or Class II requiring 510(k), accelerated aging validation must be completed to establish a shelf life and to be part of submission, while real time aging is in process to confirm the established shelf life later.

Michael Bagnall
Associate Director at Merck
From my experience it depends on the criticality of the components changed, there innate characteristics and the consequence of failure. If you perform a risk assessment taking this into account and have it informed by the accelerated data you should have a view of what field alert risk you have. Also regulatory will have a view based upon the changes which will impact your timescales.
Hope this helps.