Is DEVICE_EXPOSURE.unique_device_id only related to the devices regulated by the FDA?

[jiawei-qian]

For the DEVICE_EXPOSURE.unique_device_id field, is it only related to the devices regulated by the FDA?

According to some OHDSI posts and GitHub issue, some people have questions about how to store non-regulated device details into DEVICE_EXPOSURE. They devices are not regulated by FDA. As a result, it is not convenient for them to store their non-FDA regulated device details including those devices ID.

In OHDSI posts, they suggest to use DEVICE_EXPOSURE.device_source_value to store their devices detailed information.

1. https://forums.ohdsi.org/t/adding-manufacturer-and-model-information-to-the-device-exposure-table/16561/6
2. https://forums.ohdsi.org/t/how-to-record-non-regulated-device-details-in-cdm-6-0/18605

In CDM GitHub issue: #353, Vojtech Huser made a full proposal which includes suggesting: remove talking about FDA and make sure wording is in world wide scope. But it seems no further response.

For me, I am in China. If this field is only limited to FDA, I may not be able to use this field to store the ID of devices in China because devices may not be regulated by FDA. I also need to store these information into device_source_value field.

[cgreich]

@jiawei-qian is right, this is not handled correctly. @vojtechhuser's proposal is also no good solution: We generally do not refer to external references, we import into the Vocabularies what we need. There are good reasons for that, like life cycle management, clean up, control over what we want to capture and what is identifiable or irrelevant, Closed World assumption.

I would suggest we take all the FDA talk out of the CDM and start importing the UDIs into the Vocabularies as standard concepts. Problem solved, and solved the standard way we always do it.

Thoughts?

[MelaniePhilofsky]

@cgreich Are there sources for UDIs? Or are they like NDCs, each manufacturer gets to assign as they see fit?

[cgreich]

The FDA keeps the database and lets you search it. No idea if it can be downloaded in full, and whether we should make the UDIs concepts. Something the Device WG should come up with.