Maintaining of Performance during the Lifetime of a IIa Medical Device

[Gawelle]

Dear all,

I am new on this forum and I am working in the quality department of a company which manufactures dental rotary files made with nickel titanium.

It's a class IIa device and it's sold non-sterile.

I need help with the maintaining of performance during the lifetime of the medical device.

As far as I know, there is no guidelines regarding that matter and I have trouble defining what to do.

Thank you in advance for your help,



Gawelle

 

[Ronen E]

Dear all,

I am new on this forum and I am working in the quality department of a company which manufactures dental rotary files made with nickel titanium.

It's a class IIa device and it's sold non-sterile.

I need help with the maintaining of performance during the lifetime of the medical device.

As far as I know, there is no guidelines regarding that matter and I have trouble defining what to do.

Thank you in advance for your help,



Gawelle

Hello Gawelle and welcome to the Cove

I'm not sure what you are referring to in "maintaining of performance". Are you talking about a technical aspect of the device itself or about some documentation / regulatory aspect? If you could describe the situation in more detail and maybe explain how you came to deal with this issue, it might help in directing us.

Thanks,
Ronen.

 

[Gawelle]

Hello Gawelle and welcome to the Cove

I'm not sure what you are referring to in "maintaining of performance". Are you talking about a technical aspect of the device itself or about some documentation / regulatory aspect? If you could describe the situation in more detail and maybe explain how you came to deal with this issue, it might help in directing us.

Thanks,
Ronen.

Hi Ronen,

Thank you for your answer. I am sorry for the lack of clarity of my question, I will try to make it more understandable.
This issue comes from a remark made at the last audit. In the essentiel requirements of the 93/42/CEE directive, section 4 specifies that the characteristics and performances must not be affected during the lifetime of the device in normal conditions of use.
I am wondering how to prove it. Apparently, there is a link between clinical and pre-clinical evaluation and this matter.
The goal is to claim a 2 years lifetime. Technically speaking, I can have samples from 2 years ago for testing but the way to proceed isn't clear for me.
I hope this will clarify my question.

Thank you,

Gawelle

 

[chris1price]

Hi Gawelle, I presume the rotary files are used more than once and then cleaned or sterilised betwen uses. I think you need to show that the performance of the file meets its requirements at the end of its life. This might not be simply time based, but on number of uses, or you might estimate how many uses occur in 2 years, and use that as a time justification.

You will need to decide what testing is required to show this, it might be clinical or bench testing, but essentially repeat the testing performed originally to show the file was effective at day 1.

 

[Gawelle]

Hi Gawelle, I presume the rotary files are used more than once and then cleaned or sterilised betwen uses. I think you need to show that the performance of the file meets its requirements at the end of its life. This might not be simply time based, but on number of uses, or you might estimate how many uses occur in 2 years, and use that as a time justification.

You will need to decide what testing is required to show this, it might be clinical or bench testing, but essentially repeat the testing performed originally to show the file was effective at day 1.

Hi Chris,

Thank you for your answer.
The file is sold as a single use device. In our case, the lifetime in use is within 15 minutes that is why we consider the lifetime of the instrument stored, before use.
I think I should perform the validation tests (mechanical) which currently permit to release a batch.
Is there any other tests I should realise? Such as bioburden or biocompatibility after 2 years of storage.
Regarding clinical testing, we established in the clinical evaluation that clinical investigations don't have to be carried out for this file. Is it advised to realise clinical testing to prove the maintaining of performance during the lifetime anyway ?

Thank you,

Gawelle

 

[Ronen E]

Hi Chris,

Thank you for your answer.
The file is sold as a single use device. In our case, the lifetime in use is within 15 minutes that is why we consider the lifetime of the instrument stored, before use.
I think I should perform the validation tests (mechanical) which currently permit to release a batch.
Is there any other tests I should realise? Such as bioburden or biocompatibility after 2 years of storage.
Regarding clinical testing, we established in the clinical evaluation that clinical investigations don't have to be carried out for this file. Is it advised to realise clinical testing to prove the maintaining of performance during the lifetime anyway ?

Thank you,

Gawelle

Hi Gawelle,

You are on the right track. Repeating you validation (bench) testing on 2-years old devices can support your shelf-life claim, you just need to ensure that the storage conditions the test specimens were exposed to are representative of real life, including worst-case scenarios. On top of that a risk analysis would tell you whether other characteristics need testing as well. For example, if bioburden is an issue (aren't the files cleaned right before use?) and there's a risk that it will exceed safe limits over time, test it. Biocompatibility testing is not likely to be required if you've done your initial biological evaluation properly - it should have already accounted for shelf-life deterioration. You can hypothesise and evaluate the specific risks better than us because you are more familiar with the device and the application.

I don't think that a clinical investigation is required to support your shelf-life claim as long as the literature review establishes that equivalent devices carry similar life claims and are handled (shipped, stored etc.) in a similar manner.