Changing the Label of a Medical Device product in the field

[shimonv]

Hi Fellows,
Have you had a situation were it become possible to upgrade the hardware of a device or accessory in the field to the extent that you needed to change its part number?

If so, did you do over-labeling or removed the existing label and placed a new one in its place? Or is it better to manage tractability via service operations without actually changing the label in the field.

Also, how does UDI regulation address this?

Thanks in advance.

Shimon

 

[Ronen E]

In what contry the device is placed?

 

[shimonv]

US & EU.

Thanks,
Shimon

 

[Ronen E]

Under US regulation a hardware upgrade that would lead to assigning a new PN might be considered remanufacturing.

Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device's performance, safety specifications, or intended use.

In that case, labeling wouldn't be your only concern.

As far as UDI goes, a new PN would be considered a new version and require a new UDI.

 

[briesmie671]

My company did the same thing - upgraded the external power supply, effectively upgrading the complete system. Since there was a clear difference between the two systems, a new PN was assigned. A notice was sent to all known owners of the V1.0 system that an upgrade was available. If/when the V1.0 device was returned for service (either regular maintenance, or in response to the notice), we re-marked all parts of the system that held the Top Level PN. It was also the company's decision to perform the upgrade across the board, it was not optional. This made it easier for the Service team to manage the Device History Records as the systems are traceable by Serial Number. We did not offer servicing in the field for this system so it was all managed in-house.

 

[shimonv]

Thanks briesmie671; It makes sense.
The fact that you were able to do it in-house made all the difference because it was controlled by your QMS.

From what I could read on the Internet, there is growing regulatory concern ,and potential future regulation, when performing activities such as recondition or re-manufacturing by a third party. I am quoting from the federal register [FR Doc. 2016-04700 Filed 3-3-16; 8:45 am]:

"Stakeholders have expressed concerns that some third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and that the work performed may not be adequately documented. Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation."

Shimon