Stream: devices
Topic: How to record field safety notices for a device model
François Macary (May 20 2021 at 09:47):
Which resource would you use to record a "Field safety notice", which is a notification (normalized in the Medical Device EU Regulation)
Example: "All devices with lot number XXX of model Y" are recalled by manufacturer. @Marti Velezis ?
Jose Costa Teixeira (May 20 2021 at 11:56):
I'd expect:
Jose Costa Teixeira (May 20 2021 at 11:57):
- a Flag : "the device described by xxxx is not to be used"
Jose Costa Teixeira (May 20 2021 at 11:57):
- a SupplyRequest: "Please send back all devices described by xxxx"
Jose Costa Teixeira (May 20 2021 at 11:58):
does that make sense?
Marti Velezis (May 20 2021 at 15:05):
@François Macary that information is part of the marketing status (in EUDAMED) -- which we currently do not have on the device definition resource. We should discuss -- as there are regional differences and for EU there are 3 levels of information to provide (e.g., no longer on the market --> Recalled-->[by] Lot Number). At the device definition level -- it is just how those things are controlled (e.g., lot or serial number). Therefore, when you are wanting to query for actual recalls of a device instances -- you may have actual production identifiers and that would need to use the device resource as that is where the UDI orUDI-PIs will be available. When do you think we should discuss this? WGM? or next HCP or Catalog call?
François Macary (May 26 2021 at 06:24):
To me a "lot XXX recalled" looks more like some kind of event resource pointing to the DeviceDefinition representing the model. On the other hand, "no longer on the market" should be part of DeviceDefinition. How about next HCP call to discuss these?
Jose Costa Teixeira (May 26 2021 at 07:09):
good to discuss in HCP call
Jose Costa Teixeira (May 26 2021 at 07:10):
lot XXX recalled sounds like pointing to Device (because that's where Lot is)
Jose Costa Teixeira (May 26 2021 at 07:11):
the link to DeviceDefinition would be the usual one - device--> deviceDefinition
Jose Costa Teixeira (May 26 2021 at 07:13):
if the purpose is to see "from the existing instances of DeviceX, flag some of them as not being ready", we could use that as inventory (inventory usually cares about separating those that are OK or recalled)
http://build.fhir.org/inventoryreport has a inventoryListing.status
Last updated: Apr 12 2022 at 19:14 UTC
