UDI representation | Ed Heierman | IICC introduction on how to communicate equipment information (manufacturer, model, serial number) – is covered s part of LAW supports UDI essentially (in OBX-18)- IICC revisited this as part of the LIVD work related to COVID-19 – establishing the test kit and Connie reached out about understanding how to share instrument UDIs from instruments We know we want to get UDI form test kit and equipment into the IVD datahub – also there is the need to have this information available to folks in LIDR and what is the flow of data from IVD instrument to IVD datahub and all systems in between, so establish the requirements on how the data needs to be represented, need to better understand UDI has different formats across international regions, so need to make sure on how to represent that Are we looking at human readable format, or barcode, how would it be stored in datahub There may be more than on UDI for the system and the test kit UDI has several parts Before trying to push FDA we need to examine what we can do with what we have today US and Europe should address this similarly Reagan Udall or MDIC – whoever developed the Real World evidence requirements – so we can better understand what is needed Affects both us and IVD data hub group – Hung to reach out to Carolyn to give us a starting point Share the potential proposals with this group, with the understanding that this is the starting point, not the final solution - Xavier wil pull this together and send out UDI is not in USCDI Test kit is level 2, instrument is level 1 – we will keep pushing for it May just need to be stored / pass through with the result, anytime it is shared (treat it similar to the LOINC – maintained with the result) – UDI of instrument and maybe reagent – this needs more research Understand the data model around this, then figure out how to properly express in V2, FHIR and CDA Expect that for LIDR capture the device identifier, but leave out the serial number LIVD can capture the device ID now In LAW we require serial number of the instruments The combination of both of these may give you what is needed Have a clear understanding on what is in LIDR, what is the responsibility of the instrument to share
Plan on August 21 for the next discussion
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