Medical Device Handling AFTER the device's specified lifetime has expired

[Aphel]

Hello.

Actually I have to deal with discussions about complaint handling...

If a medical device is sent back from customer to the manufacturer because of a defect AFTER the device's specified lifetime has expired - is it a requirement to treat this as a complaint acc. §820.198?

If yes - where can i find a corresponding regulatory requirement?
Any comment is appreciated!

Thanks in advance for your feedback and support!

BR
Aphel

 

[MIREGMGR]

Re: Medical Device Handling AFTER AFTER the device's specified lifetime has expired

My understanding is yes...particularly if harm or elevated risk was involved.

Your specified device life affects your obligation to the end user in regard to what you do to make the end user whole, i.e. during device lifetime you might send them a new unit, after device lifetime you might tell them "thank you for the information, here is our price list and ordering information".

Your specified device lifetime also may be part of your documented device performance specification, i.e. this widget will do whatever widgets do with accuracy per ASTM 12345 during its five year specified lifetime from date of sale.

But my understanding is that you have an obligation to record and evaluate the complaint, and report it to FDA if it meets reportability requirements, even if you do not have to take further action.

 

[Ronen E]

In my understanding an evaluation has to take place, because the fact that the complaint was received after the device lifetime expiry doesn't automatically say that the failure occurred at that time (could have gone unnoticed or unreported - for whatever reason - for a while). Even if it failed after expiry, the defect or otherwise the root cause could have been there long before. You have to look into it in order to understand what happened and what are your obligations are as a result.