Order Catalog Implementation Guide
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Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

Resource Profile: DeviceModel - Mappings

Draft as of 2022-02-20

Mappings for the DeviceModel resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

DeviceModel
DeviceDefinitionadministrative.device
   identifierFiveWs.identifier
   partNumberFiveWs.what[x]
   manufacturerFiveWs.what[x]
   deviceName
      typeFiveWs.what[x]
   modelNumberFiveWs.what[x]
   version
      componentFiveWs.what[x]
   ownerFiveWs.source
   contactFiveWs.source

Mappings for RIM Mapping (http://hl7.org/v3)

DeviceModel
DeviceDefinitionEntity, Role, or Act
   textAct.text?
   containedN/A
   modifierExtensionN/A
   udiDeviceIdentifier
      idn/a
      extensionn/a
      modifierExtensionN/A
      marketDistribution
         idn/a
         extensionn/a
         modifierExtensionN/A
         marketPeriod
            idn/a
            extensionn/a
            start./low
            end./high
   regulatoryIdentifier
      idn/a
      extensionn/a
      modifierExtensionN/A
   partNumber.playedRole[typeCode=MANU].id
   manufacturer.playedRole[typeCode=MANU].scoper.name
   deviceName
      idn/a
      extensionn/a
      modifierExtensionN/A
      type.playedRole[typeCode=MANU].code
   modelNumber.softwareName (included as part)
   classification
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
   classification (gmdn)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         text./originalText[mediaType/code="text/plain"]/data
   classification (snomed)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         text./originalText[mediaType/code="text/plain"]/data
   classification (emdn)
      idn/a
      extensionn/a
      modifierExtensionN/A
      type
         idn/a
         extensionn/a
         codingunion(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         text./originalText[mediaType/code="text/plain"]/data
   conformsTo
      idn/a
      extensionn/a
      modifierExtensionN/A
   hasPart
      idn/a
      extensionn/a
      modifierExtensionN/A
   packaging
      idn/a
      extensionn/a
      modifierExtensionN/A
      distributor
         idn/a
         extensionn/a
         modifierExtensionN/A
      udiDeviceIdentifier
         idn/a
         extensionn/a
         modifierExtensionN/A
         marketDistribution
            idn/a
            extensionn/a
            modifierExtensionN/A
            marketPeriod
               idn/a
               extensionn/a
               start./low
               end./high
   version
      idn/a
      extensionn/a
      modifierExtensionN/A
   property
      idn/a
      extensionn/a
      modifierExtensionN/A
   owner.playedRole[typeCode=OWN].scoper
   contact.scopedRole[typeCode=CON].player
   link
      idn/a
      extensionn/a
      modifierExtensionN/A
   note.text
   material
      idn/a
      extensionn/a
      modifierExtensionN/A
   guideline
      idn/a
      extensionn/a
      modifierExtensionN/A
   correctiveAction
      idn/a
      extensionn/a
      modifierExtensionN/A
   chargeItem
      idn/a
      extensionn/a
      modifierExtensionN/A

Mappings for Europe Union EUDAMED (https://ec.europa.eu/tools/eudamed)

maps DeviceDefinition elements to EUDAMED UDI data dictionary field IDs|labels

DeviceModel
DeviceDefinitionEUDAMED data dictionary field IDs/labels
   descriptionFLD-UDID-175|Additional product description
   identifierFLD-UDID-136|Secondary UDI - DI code [use = secondary, type = DISTID]; FLD-UDID-138|Direct Marking UDI-DI code [type = DIRECT-MARKING]; FLD-UDID-135|Unit of Use DI code [type = SINGLE-ITEM]
   udiDeviceIdentifier
      deviceIdentifierFLD-UDID-178|UDI-DI code
      issuerFLD-UDID-291|Issuing Entity UDI-DI
      jurisdictionhttps://ec.europa.eu/health/medical-devices-sector_en
      marketDistribution
         marketPeriod
            startFLD-UDID-250|Start date
            endFLD-UDID-251|End date
         subJurisdictionFLD-UDID-141|Countries were the devices is made available
   partNumberFLD-UDID-163|Reference / Catalogue Number
   manufacturerFLD-UDID-10|Legal Manufacturer SRN
   deviceName
      nameFLD-UDID-22|Device Name
      type[registered-name]
   modelNumberFLD-UDID-20|Device Model
   classification
      type
   classification (gmdn)
      type
         coding
   classification (snomed)
      type
         coding
   classification (emdn)
      type
         coding
            systemurn:oid:1.2.250.1.213.2.68
            code[EMDN code]
            displayEMDN name
   packaging
      countFLD-UDID-121|Quantity of item(s)
      udiDeviceIdentifier
         deviceIdentifierFLD-UDID-120|Package UDI-DI
   safetyFLD-UDID-212|Critical Warnings type: {CW025:MR SAFE, CW026:MR CONDITIONAL, CW027:MR UNSAFE, CW023:Consider hazards from magnetic fields, CW024:Do not store near magnets or magnetic devices},FLD-UDID-156|Containing latex (Boolean)
   propertyFLD-UDID-16|Risk Class: {Medical Devices: CLASS_I, CLASS_IIa, CLASS_IIb, CLASS_III} {In Vitro Diagnostic Devices: CLASS_A, CLASS_B, CLASS_C, CLASS_D},FLD-UDID-18|Tissues and cells - Presence of animal tissues or Cells, or their derivates (Boolean),FLD-UDID-34|Tissues and cells - Presence of cells or substances of microbial origin (Boolean),FLD-UDID-23|Tissues and cells - presence of human tissues or cells, or their derivates (Boolean),FLD-UDID-28|Active Device (Boolean),FLD-UDID-29|Device Intended to administer and/or Remove medicinal product (Boolean),FLD-UDID-30|Implantable (Boolean),FLD-UDID-31|Measuring Function (Boolean),FLD-UDID-32|Reusable Surgical Instruments (Boolean),FLD-UDID-33|Companion Diagnostic (Boolean),FLD-UDID-35|Near Patient Testing (Boolean),FLD-UDID-36|Patient Self Testing (Boolean),FLD-UDID-155|Presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or plasma (Boolean),FLD-UDID-158|Presence of substance which, if used separately, may be considered to be a medicinal product (Boolean),FLD-UDID-262|Reagent (Boolean),FLD-UDID-263|Professional Testing (Boolean),FLD-UDID-264|Instrument (Boolean),FLD-UDID-356|Kit (Boolean),FLD-UDID-12|Device, Procedure pack or System {SYSTEM, PROCEDURE_PACK, DEVICE},FLD-UDID-167|Labelled as single use (Boolean),FLD-UDID-169|Device labelled Sterile,FLD-UDID-170|Need for sterilisation before use,FLD-UDID-146|Clinical Sizes {Angle, Diameter, Gauge, Inflation volume, Length, Pressure, Size, Volume, Width, Weight, Heigth, Wavelength, Frequency,...},Handling Environment Temperature
   contactFLD-UDID-354|Contact Details

Mappings for US GUDID (https://accessgudid.nlm.nih.gov/)

maps DeviceDefinition elements to AccessGUDID section titles and field labels

DeviceModel
DeviceDefinitionAccessGUDID section titles and field labels
   descriptionDevice Description
   identifierSecondary DI Number [use = secondary, type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]
   udiDeviceIdentifier
      deviceIdentifierPrimary DI Number
      issuerPrimary DI Number - Issuing Agency
      jurisdictionurn:oid:2.16.840.1.113883.3.150
      marketDistribution
         marketPeriod
            startDEVICE RECORD STATUS - DI Record Publish Date
            endCommercial Distribution End Date
         subJurisdictionurn:oid:2.16.840.1.113883.3.150
   partNumberCatalog Number
   manufacturerCompany Name
   deviceName
      nameBrand Name
      type[registered-name]
   modelNumberVersion or Model
   classification
      type
   classification (gmdn)
      type
         coding
            systemhttp://terminology.hl7.org/CodeSystem/GMDN
            code[GMDN code]
            displayGMDN Preferred Term Name
   packaging
      typePackage Type
      countQuantity per Package
      udiDeviceIdentifier
         deviceIdentifierPackage DI Number
         jurisdictionurn:oid:2.16.840.1.113883.3.150
         marketDistribution
            marketPeriod
               endPackage Discontinue Date
            subJurisdictionurn:oid:2.16.840.1.113883.3.150
   safetyWhat MRI safety information does the labeling contain?,Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437),Device labeled as "Not made with natural rubber latex"
   propertyFor Single-Use,Prescription Use (Rx),Over the Counter (OTC),Kit,Combination Product,Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P),Device Packaged as Sterile,Requires Sterilization Prior to Use,Storage Environment Temperature,Handling Environment Temperature,Size - Length,Size - Width,Size - Heigth,Size - Angle
   contactCUSTOMER CONTACT
   productionIdentifierInUDIPRODUCTION IDENTIFIER(S) IN UDI