Stream: argonaut
Topic: Implantable Device UDI information
Yunwei Wang (Mar 28 2022 at 17:00):
US Core v4.0.0 Implantable Device implementation guidance states that:
Implantable medical devices that have UDI information SHALL represent the UDI code in Device.udiCarrier.carrierHRF.
All of the five UDI-PI elements that are present in the UDI code SHALL be represented in the corresponding US Core Implantable Device Profile element.
Dose this mean that if an implantable device resource has Device.udiCarrier.carrierHRF then it shall has:
manufacture date (UDI-PI element) Device.manufactureDate
expiration dat (UDI-PI elemente Device.expirationDate
lot number (UDI-PI element) Device.lotNumber
serial number (UDI-PI element) Device.serialNumber
distinct identifier (UDI-PI element) Device.distinctIdentifier
If so, why not update uscore-9 to: Device.udiCarrier.carrierHRF.exists() implies (Device.manufactureDate.exists() and Device.expirationDate.exists() and ... )
@Eric Haas
Yunwei Wang (Mar 28 2022 at 20:53):
Eric Haas (Mar 28 2022 at 21:22):
not all that info is present in every UDI - so an invariant is not practicable
Yunwei Wang (Mar 28 2022 at 21:39):
That sentence feels like it requires all of the five be presented. Need to be clarified
Eric Haas (Mar 28 2022 at 21:49):
can you update your Jira ?
Yunwei Wang (Mar 28 2022 at 21:58):
I cannot update my own JIRA ticket. :sad:
So I closed that one and created a new one FHIR-36657 asking for clarification
Yunwei Wang (Mar 28 2022 at 22:00):
Will there be situation that UDI does not contains any of the five PI elements? Or there must be at least one.
Lloyd McKenzie (Mar 29 2022 at 14:13):
You should have an option to edit tickets that have not yet been triaged. (It's a menu item under workflow.)
Last updated: Apr 12 2022 at 19:14 UTC
