Electrosurgical Electrodes - Stability Test

medwise

Involved In Discussions
#1
Hello Experts,

I have undergone an audit and was asked to provide an evidence to demonstrate stability to support the required shelf-life storage requirement of -10 to 55 degrees for 12 months for electrosurgical electrodes (CE marked class IIb medical device). We have conducted cleaning validation test and typically the device is sterilised at 134 degrees. Based on this higher limit temperature exposure we determined that 55 degrees will be the higher limit for storage. Again, we also did shipping stability test as per ISTA. However, our NB is not satisfied and would like a documented justification and or test to demonstrate that our device can be stored at -10 to 55 degrees.

Can this be justified by doing risk assessment only? And as an outcome of that risk based assessment justify that the elements of greatest importance were steam based exposure which is far more challenging on product than low based temperature. Please note device is composed of PVC, Rislan Powder Coating and stainless steel and we can look up the SDS to determine the temperature resistance and 25 years of post-market data.

Look forward to your advise and guidance.

Thanks
medwise
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

Yes, I would start with an engineering assessment. Try to analyse / understand the failure mechanisms in your device that act over time, and see if they're enhanced by low temperatures (-10), high temperatures (55), thermal cycles and generally any temperature profile (common and extreme) that the device is likely to be exposed to during its storage, shipping, shelf-life and use-life. Also pay attention to other relevant environmental factors such as RH, sunlight, chemical exposure etc.

Please note that a short term exposure (eg sterilisation) is not necessarily representative of longer terms exposures, even at lower temperatures (eg 55 deg). Some failure mechanisms take time, and your goal is to establish that a 12 months exposure is safe.

If you have 25 years worth of post-market data (relevant to the current design & materials!) then I guess your job should be much easier.

Please PM me if you want to work on this together.

Cheers,
Ronen.
 
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