Reusable medical devices shelf life

[Maheen Shaukat]

Hello everyone,

I am currently working on technical documentation of Class Ir (EU MDR) and seeking some clarity regarding shelf life.

For non-sterile reusable medical devices, is it mandatory to mention shelf life/expiry date like 2 or 5 years or else just useful life such as reprocessing cycles will suffice by providing reprocessing study and justification for shelf life non-applicability? I have gone through IFUs for different reusable devices and never seen shelf life/expiry date mentioned.

I assume there is also no compulsion of defining shelf life for non-sterile medical devices provided, there are no safety and performance characteristics that could be compromised due to ageing while devices are stored under controlled conditions.

 

[Nichole F]

GSRP 23.2(i) and (j) indicate that a shelf-life is not always required. Not every device is going to have an expiration date. Non-sterile reusable devices likely do not have a shelf-life as their material of construct is intended to be reused over the device's lifetime. That being said, any reprocessing requirements may shorten that lifetime so what may be appropriate for your situation is having a limit on the number of reprocessing cycles. It may be appropriate for you to communicate to the user sign to watch for to indicate premature aging of the device (e.g., cracks, discoloration, etc.) rather than an arbitrary "use by" date.

 

[Maheen Shaukat]

GSRP 23.2(i) and (j) indicate that a shelf-life is not always required. Not every device is going to have an expiration date. Non-sterile reusable devices likely do not have a shelf-life as their material of construct is intended to be reused over the device's lifetime. That being said, any reprocessing requirements may shorten that lifetime so what may be appropriate for your situation is having a limit on the number of reprocessing cycles. It may be appropriate for you to communicate to the user sign to watch for to indicate premature aging of the device (e.g., cracks, discoloration, etc.) rather than an arbitrary "use by" date.

Thanks Nichole F, that makes sense.
However, during my search on reprocessing topic, I noticed some companies mention the maximum number of reprocessing cycles like 50/100 cycles or so whilst others don’t. Rather under title of “Limitation on reprocessing”, they mention the following:
“Repeated processing has minimal effect on these devices.
End of life is normally determined by wear and damage due to use.
Any specific limitations on the number of reprocessing cycles shall be made available with the device.”

So, which is the more accurate approach considering 23.2 (j) as well. Should we not validate the reprocessing cycles ought to be claimed even if the devices do not show any sign of degradation, wear?

 

[Nichole F]

I'd think you'd want to determine how the user can tell that the device is okay to use or if it is at the end of its lifetime. If the device is intended to last indefinitely, this may not be applicable. Some device manufacturers choose to validate a set number of reprocessings allowed while other manufacturers may opt to communicate what the user should look for to know if the device continues to be fit for use. This of course should be addressed in design control and risk management.

 

[Maheen Shaukat]

I'd think you'd want to determine how the user can tell that the device is okay to use or if it is at the end of its lifetime. If the device is intended to last indefinitely, this may not be applicable. Some device manufacturers choose to validate a set number of reprocessings allowed while other manufacturers may opt to communicate what the user should look for to know if the device continues to be fit for use. This of course should be addressed in design control and risk management.

Thanks for your reply.

What I need to know is what would be considered best practice out of the two. If the devices undergo reprocessing validation and can sustain, say 50 cycles, should that be enough and 50 cycles can be claimed or else the cycle study should proceed till end-of-life factors are determined that can be communicated to user. What do you say?

 

[Nichole F]

It is really up to the company to determine strategy. One is heavily quantitative and the other is qualitative. I have seen companies qualify more reprocessings than they label the device for in order to provide some room for error. I prefer the quantitative testing personally, but both are acceptable with the right controls.

 

[Maheen Shaukat]

It is really up to the company to determine strategy. One is heavily quantitative and the other is qualitative. I have seen companies qualify more reprocessings than they label the device for in order to provide some room for error. I prefer the quantitative testing personally, but both are acceptable with the right controls.

Dear Nichole,
Thank you so much for your valuable suggestion.