Is DEVICE_EXPOSURE.unique_device_id only related to the devices regulated by the FDA?
@clairblacketer is already working on this.
Since Apr 25, 2024.
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Description
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.
- https://forums.ohdsi.org/t/adding-manufacturer-and-model-information-to-the-device-exposure-table/16561/6
- https://forums.ohdsi.org/t/how-to-record-non-regulated-device-details-in-cdm-6-0/18605
In CDM GitHub issue: https://github.com/OHDSI/CommonDataModel/issues/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.
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