Shelf Life Testing of a Sterile Medical Device

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A

arrabellaangel

#32
OK let say sterilizatio process has been validated, bioburden load has been determined and what left is accelerated aging test which includes sterility testing. thanks for the helps guys
 
D

DesiQE

#33
Hello covers, once again I turn to you for advice.

For medical devices:

Expiry date of final product must be ≤ shelf-life of critical components. Is this right?

A supplier gives us a shelf life of 2 years for their component which is the most critical in our final product. Now we keep it on the shelf for about a year or so. Then we add our component, sterilize and give it a shelf life of 2 years (because we have aging study for 2 years).

Component shelf life: 2 years (mfd in: jun 2012; exp date: june 2014)
At our firm, we leave it on shelf for 1 year (until june 2013)
shelf life of final product per aging study : 2 years
Shelf life given to final product: 2 years (june 2015)

Is this right? I don't think so. But the company has been doing this and has CE for its products.

This is in Europe. Only CE marked device. No US FDA approval.

Thanks in advance.
 
M

MIREGMGR

#34
Expiry date of final product must be ≤ shelf-life of critical components. Is this right?
Yes, unless something about your storage and application conditions is less challenging to the component than the possibly-conservative assumptions made by the component maker. If however you utilize such an analysis, you should document a evidenced rationale for both your knowledge of how and why the component maker's assumptions are overly conservative, and why your longer-life analysis is valid.

Obviously it would not be acceptable to in effect state, "the component life is longer because we need it to be longer". It's also unacceptable to merely state "the life is longer because we haven't had any field failures yet", unless your field population is very large in statistical terms and you can show that all of the fielded units are stored and used under the worst case conditions that are allowed by your instructions for storage and use.

(...) the company has been doing this and has CE for its products.
The fact of a CE Mark does not establish that there is nothing wrong with the holder's operations and products. It only means that the auditors have not noticed any such problem yet.
 
D

DesiQE

#35
Thank you. That was my understanding too. But it's just shocking to me that the auditors haven't looked at such a basic item.

On the other hand, if I use the component at the end its shelf life or accelerate age it to end of its shelf life and then use it in my shelf life study, then I could justify using it beyond it's manufacturer stated shelf life. Do you think that would work?
 
M

MIREGMGR

#36
if I use the component at the end its shelf life or accelerate age it to end of its shelf life and then use it in my shelf life study, then I could justify using it beyond it's manufacturer stated shelf life. Do you think that would work?
Yes, if one of two cases is true:

1. You test a representative sample size and conduct an engineering analysis of the relevant characteristics and factors, and show that your analysis is at least as capable as the component maker's original analysis and your conclusion of a longer life has an objective basis, such as that you can assure that the component always will be subject to less stress than the component maker assumed.

2. You test a statistically valid sample size to achieve a high confidence level. What confidence level would be acceptable would have to be determined. I'd guess that this requirement will depend on the device risk, with a moderate or high risk device requiring a quite high confidence level in this kind of study. This approach, being entirely dependent on testing, also would require a rationale to justify that the testing conditions are representative of all of the worst cases that are allowed by your instructions for storage and use, your worst case manufacturing stresses, and so forth.
 

Ronen E

Problem Solver
Staff member
Moderator
#37
...and you can show that all of the fielded units are stored and used under the worst case conditions that are allowed by your instructions for storage and use.
In determining the device's life one should also take into account foreseeable misuse, e.g. storage conditions outside those allowed by the IFU, that might occur due to mistakes, slips, lapses etc.
 

Ronen E

Problem Solver
Staff member
Moderator
#38
Yes, if one of two cases is true:

1. You test a representative sample size and conduct an engineering analysis of the relevant characteristics and factors, and show that your analysis is at least as capable as the component maker's original analysis and your conclusion of a longer life has an objective basis, such as that you can assure that the component always will be subject to less stress than the component maker assumed.

2. You test a statistically valid sample size to achieve a high confidence level. What confidence level would be acceptable would have to be determined. I'd guess that this requirement will depend on the device risk, with a moderate or high risk device requiring a quite high confidence level in this kind of study. This approach, being entirely dependent on testing, also would require a rationale to justify that the testing conditions are representative of all of the worst cases that are allowed by your instructions for storage and use, your worst case manufacturing stresses, and so forth.
IMO option #2 above (i.e. empirical demonstration with no/little engineering backing) would require huge sample sizes and a rigorous statistical analysis, if it is to be acceptable at all. I find it hard to imagine a competent auditor accepting such an approach otherwise.

I believe that between the two options, #1 would be the way to go.
 
D

DesiQE

#39
Yes, if one of two cases is true:

1. You test a representative sample size and conduct an engineering analysis of the relevant characteristics and factors, and show that your analysis is at least as capable as the component maker's original analysis and your conclusion of a longer life has an objective basis, such as that you can assure that the component always will be subject to less stress than the component maker assumed.

2. You test a statistically valid sample size to achieve a high confidence level. What confidence level would be acceptable would have to be determined. I'd guess that this requirement will depend on the device risk, with a moderate or high risk device requiring a quite high confidence level in this kind of study. This approach, being entirely dependent on testing, also would require a rationale to justify that the testing conditions are representative of all of the worst cases that are allowed by your instructions for storage and use, your worst case manufacturing stresses, and so forth.
Thank you MIREGMGR & RONEN. I agree that # 1 is the better option.
 
S

snakepitt

#40
Thanks to Michael and Ajit.
The guidance document on ECG electrodes is helpful by inference. I reviewed subsequent discussion in this thread and did not see something relevant to my question.

I am familiar with the concept of using accelerated aging data for initial 510(k) submission, while putting product aside for real time aging tests.

Lately I have heard rumblings that the FDA is requiring real time aging data as a component of the initial product shelf life submission. For example, if I wish to submit my 510(k) application for a 2-year product shelf life using accelerated aging data, the product cannot have been exposed to ONLY accelerated conditions. It must have had say, 12 months real time plus time in the oven representing another 12 months (or maybe 6 months real + oven time equal to 18 months) prior to testing.

Any recent experience along these lines?
:thanks:
 
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