John Rhoads (acting as chair on behalf of HCD WG)
Seek final approval of Device(Definition) and Device FHIR resource specifications
The group discussed a final addition to the DeviceDefinition part of the working spreadsheet proposed in an email yesterday by Marti Velesiz of a field "controlledBy" defined as "The identifier that is to appear on the device label. Serial number | Lot/Batch | Expiration Date | Manufacture Date | Distinct Identification Code (DIC)". The name controlledBy, while perhaps confusing, it the one used by regulatory agencies in IMDRF for the concept.
Since it is potentially dependent on jurisdiction, it was suggested and accepted by the proposer that the field be moved within the Backbone element udiDeviceIdentifier.
The group was then asked whether anyone had any remaining concerns with the contents of the spreadsheet. None were raised.
Bob Dieterle proposed a motion, seconded by Brain Reinhold, that the contents of the spreadsheet as revised in this meeting be accepted as final for proposing a new FHIR DeviceDefiniton resource and changed Device resource (representing also the deletion of the former DeviceComponent resource) for the current FHIR specification ballot round.
The motion was passed with all present voting positive with no negative votes and no abstentions.
Reference: final spreadsheet Device(Definition)_20180731.xslx
This completed the planned actions for this meeting. The meeting was adjourned.
Minutes and final spreadsheet to be emailed to Hans Buitendijk.
It was understood that the changes to the resource definitions will be made by Jose Costa Teixiera