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Relabeling an existing medical device in the field?

kchan

Registered
#1
We have a device in the field that was damaged in shipping and we wish to convert it into a demo unit.

The way we do this is we put NOT FOR CLINICAL USE on the machine and change the device serial number to include a "D" suffix. Then we update the DHR with this information.

Unfortunately, this device is in the middle of nowhere. We don't have any of our company employees in that area to remove the old label and replace the new labels.
We have a distributor in the area, however. With our permission, would they be allowed to relabel this device with the new serial number and not for clinical use sticker?
 
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indubioush

Quite Involved in Discussions
#2
Seems risky to have a demo unit floating out there. However, you have not explained where this unit is. Is it at a distributor facility, clinical site, customer site, etc.? Why not just request that it be shipped back to you? What is the benefit of having a demo unit?
 

cklau

Registered
#3
We have a device in the field that was damaged in shipping and we wish to convert it into a demo unit.

The way we do this is we put NOT FOR CLINICAL USE on the machine and change the device serial number to include a "D" suffix. Then we update the DHR with this information.

Unfortunately, this device is in the middle of nowhere. We don't have any of our company employees in that area to remove the old label and replace the new labels.
We have a distributor in the area, however. With our permission, would they be allowed to relabel this device with the new serial number and not for clinical use sticker?
Thats interesting, but how do you qualified the competency of these "repacker" personnel?
 

kchan

Registered
#4
@indubioush It is at a distributor site. We have many demo units for the purposes of trade shows, so it is not unusual for us to convert a machine to a demo unit. The strangeness here is that it made it to a distributor site, THEN the decision was made to convert it to a demo unit. We don't wish to pay to send it back to HQ to relabel since the shipping costs are astronomical.

@cklau I guess that is our problem! We don't have access to our distributor's training records, nor do we have the authority to force one of our trainings on them. Have you been in this situation before? The change is literally to put a sticker over the old sticker and put a 'not for clinical use' sticker in a noticeable place that we designate. Having the relabeler on a video conference while they do the service, and having our technical support team take responsibility of the service seems like the easiest method. Thoughts?
 

indubioush

Quite Involved in Discussions
#5
Thanks for that info.
You can follow your nonconforming product process where you will justify the disposition of "demo." You will have to train the external individual to the nonconforming product process and any other applicable procedures. You should have a training record from them and they should also sign the nonconforming product report. You can do the relabel through zoom and record the video as evidence that the disposition was performed correctly. The history record of that device should reference the nonconforming product report.
 

cklau

Registered
#7
@indubioush It is at a distributor site. We have many demo units for the purposes of trade shows, so it is not unusual for us to convert a machine to a demo unit. The strangeness here is that it made it to a distributor site, THEN the decision was made to convert it to a demo unit. We don't wish to pay to send it back to HQ to relabel since the shipping costs are astronomical.

@cklau I guess that is our problem! We don't have access to our distributor's training records, nor do we have the authority to force one of our trainings on them. Have you been in this situation before? The change is literally to put a sticker over the old sticker and put a 'not for clinical use' sticker in a noticeable place that we designate. Having the relabeler on a video conference while they do the service, and having our technical support team take responsibility of the service seems like the easiest method. Thoughts?
As per NCR procedure, for this planned deviation, establish a new SOP for the labeling process as per your Change Request Procedure. That can be your CAPA. Hope this help!
 
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