Used active medical devices

[Developer_Germany]

Dear all,

I am struggling with one principle topic around active medical devices, like e.g. ECGs, dialysis machines, x-ray devices.

If they are returned by customers back to the manufacturer I assume it is no problem to clean and check them, update them to the newest valid configuration (in compliance with the latest serial release configuration) and sell them again as "used devices". Am I right?

But how shall the manufacturer label such devices? Is it necessary to place a "used device" label on it? If not: what is your practical suggestion to handle such devices? I know that some manufactures change the article number and also the type label to create a variant of the original device with the only differnce that it is a used device. So also the registration in US is doubled to distinguish between "new" and "used" devices. This could be necessary because otherwise the manufacturer has problems to handle those devices in the ERP system and warehouses.

Does that make sense? How do you handle this topic in your field?

Thanks for any comment in advance.

Best regards
Chris

 

[shimonv]

Hi Chris,
To the best of my knowledge there is no specific regulation for "refurbish" devices. You can sell used devices and you don't need to place a "used device" label on it.
From operation standpoint you probably need to setup a different part number to manage prices and inventory.

The real challenge is about quality assurance.
You need to develop manufacturing work instructions to recondition used devices that come in different models and state from the field.
You will face issues of compatibility between different software and hardware components, obsolete parts, etc.
You may need to do some process validation and repeat some design verification.
The refurbished devices must meet the same performance and safety specs as the cleared device.


Cheers,
Shimon

 

[LostLouie]

Hi, that's interesting. I've read that the FDA are increasingly adopting the stance that refurbished means "reworked" or "remanufactured" and so all the demonstrated compliance to ISO 13485 needs to be met. Can you confirm this? (We are having to deal with a supply issue which will necessitate recovering some motherboards from our customers in the field).

 

[Mark Meer]

Hi, that's interesting. I've read that the FDA are increasingly adopting the stance that refurbished means "reworked" or "remanufactured" and so all the demonstrated compliance to ISO 13485 needs to be met. ...

This would be odd, as "rework" has a very specific definition - process of making nonconforming product conforming. This is not necessarily the case with refurbishing, as the units may not be nonconforming. If a unit is lightly used and there is nothing wrong with it, then "refurbishing" may simply be a process of testing to ensure that the unit still meets all requirements.

Regardless, however, all these activities (rework, refurbish,..) should always take place under ISO 13485 processes if they are dealing with devices under the QMS scope.

 

[LostLouie]

Thank you Mark, in our case (due to a supplier shortage foreseen in a couple of years) it would be refurbishment as they are conforming parts on site installed products (that we've maintained under ISO 13485 compliance, and have their history).