This page is part of the Da Vinci Coverage Requirements Discovery (CRD) FHIR IG (v0.1.0: STU 1 Ballot 1) based on FHIR v3.5.0. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions 
JSON representation of the profile-device-stu3 Profile.
{
"resourceType" : "StructureDefinition",
"id" : "profile-device-stu3",
"text" : {
"status" : "generated",
"div" : "<div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/STU3/help16.png" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="profile-device-stu3-definitions.html#Device">Device</a><a name="Device"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/STU3/help16.png" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>"
},
"url" : "http://hl7.org/fhir/us/davinci-crd/STU3/StructureDefinition/profile-device-stu3",
"version" : "0.1.0",
"name" : "CRD Device",
"status" : "draft",
"date" : "2018-07-25T00:00:00+10:00",
"publisher" : "DaVinci",
"description" : "CRD Device based on US Core Device",
"fhirVersion" : "3.0.1",
"mapping" : [
{
"identity" : "argonaut-dq-dstu2",
"uri" : "http://unknown.org/Argonaut-DQ-DSTU2",
"name" : "Argonaut-DQ-DSTU2"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/w5",
"name" : "W5 Mapping"
},
{
"identity" : "udi",
"uri" : "http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm",
"name" : "UDI Mapping"
}
],
"kind" : "resource",
"abstract" : false,
"type" : "Device",
"baseDefinition" : "http://hl7.org/fhir/us/core/StructureDefinition/us-core-device",
"derivation" : "constraint",
"snapshot" : {
"element" : [
{
"id" : "Device",
"path" : "Device",
"short" : "US Core Implanted Device Profile",
"definition" : "The US Core Implanted Device Profile is based upon the core FHIR Device Resource and created to meet the 2015 Edition Common Clinical Data Set 'Unique device identifier(s) for a patient’s implantable device(s)' requirements.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device",
"min" : 0,
"max" : "*"
},
"constraint" : [
{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"xpath" : "not(parent::f:contained and f:contained)",
"source" : "DomainResource"
},
{
"key" : "dom-1",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain any narrative",
"expression" : "contained.text.empty()",
"xpath" : "not(parent::f:contained and f:text)",
"source" : "DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource",
"expression" : "contained.where(('#'+id in %resource.descendants().reference).not()).empty()",
"xpath" : "not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))",
"source" : "DomainResource"
}
],
"mustSupport" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "rim",
"map" : "Device"
},
{
"identity" : "w5",
"map" : "administrative.device"
},
{
"identity" : "argonaut-dq-dstu2",
"map" : "Device"
}
]
},
{
"id" : "Device.id",
"path" : "Device.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"isSummary" : true
},
{
"id" : "Device.meta",
"path" : "Device.meta",
"short" : "Metadata about the resource",
"definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Meta"
}
],
"isSummary" : true
},
{
"id" : "Device.implicitRules",
"path" : "Device.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.",
"comment" : "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element.
This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"isModifier" : true,
"isSummary" : true
},
{
"id" : "Device.language",
"path" : "Device.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueReference" : {
"reference" : "http://hl7.org/fhir/ValueSet/all-languages"
}
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}
],
"strength" : "extensible",
"description" : "A human language.",
"valueSetReference" : {
"reference" : "http://hl7.org/fhir/ValueSet/languages"
}
}
},
{
"id" : "Device.text",
"path" : "Device.text",
"short" : "Text summary of the resource, for human interpretation",
"definition" : "A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"comment" : "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.",
"alias" : [
"narrative",
"html",
"xhtml",
"display"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Narrative"
}
],
"condition" : [
"dom-1"
],
"mapping" : [
{
"identity" : "rim",
"map" : "Act.text?"
}
]
},
{
"id" : "Device.contained",
"path" : "Device.contained",
"short" : "Contained, inline Resources",
"definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.",
"comment" : "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.",
"alias" : [
"inline resources",
"anonymous resources",
"contained resources"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Resource"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.extension",
"path" : "Device.extension",
"short" : "Additional Content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.modifierExtension",
"path" : "Device.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"isModifier" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.identifier",
"path" : "Device.identifier",
"short" : "Instance identifier",
"definition" : "Unique instance identifiers assigned to a device by manufacturers other organizations or owners.",
"comment" : "The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For [UDI](device.html#5.11.3.2.2), this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
"alias" : [
"Serial Number"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"mapping" : [
{
"identity" : "udi",
"map" : "The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."
},
{
"identity" : "rim",
"map" : ".id"
},
{
"identity" : "w5",
"map" : "id"
}
]
},
{
"id" : "Device.udi",
"path" : "Device.udi",
"short" : "Unique Device Identifier (UDI) Barcode string",
"definition" : "[Unique device identifier (UDI)](device.html#5.11.3.2.2) assigned to device label or package.",
"comment" : "UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.udi",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() | (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "Element"
}
],
"mustSupport" : true,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : ".id and .code"
},
{
"identity" : "w5",
"map" : "id"
},
{
"identity" : "argonaut-dq-dstu2",
"map" : "Device.udi"
}
]
},
{
"id" : "Device.udi.id",
"path" : "Device.udi.id",
"representation" : [
"xmlAttr"
],
"short" : "xml:id (or equivalent in JSON)",
"definition" : "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.udi.extension",
"path" : "Device.udi.extension",
"short" : "Additional Content defined by implementations",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.udi.modifierExtension",
"path" : "Device.udi.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.",
"comment" : "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"isModifier" : true,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.udi.deviceIdentifier",
"path" : "Device.udi.deviceIdentifier",
"short" : "Mandatory fixed portion of UDI",
"definition" : "The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.",
"alias" : [
"DI"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udi.deviceIdentifier",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"mustSupport" : true,
"isSummary" : true,
"mapping" : [
{
"identity" : "udi",
"map" : "The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."
},
{
"identity" : "rim",
"map" : "Role.id.extension"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.udi.name",
"path" : "Device.udi.name",
"short" : "Device Name as appears on UDI label",
"definition" : "Name of device as used in labeling or catalog.",
"comment" : "Use the `Device.type` for a generic type or kind of device name. Note the [GUDID](http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/globaludidatabasegudid/default.htm) lists the name as the 'Brand Name'.",
"alias" : [
"Brand Name"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udi.name",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"isSummary" : true,
"mapping" : [
{
"identity" : "udi",
"map" : "Propietary/Trade Name of the medical Device as used in the labeling or catalog"
},
{
"identity" : "rim",
"map" : ".displayName"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.udi.jurisdiction",
"path" : "Device.udi.jurisdiction",
"short" : "Regional UDI authority",
"definition" : "The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.",
"requirements" : "Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udi.jurisdiction",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : "Role.scoper"
}
]
},
{
"id" : "Device.udi.carrierHRF",
"path" : "Device.udi.carrierHRF",
"short" : "UDI Human Readable Barcode String",
"definition" : "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.",
"comment" : "If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.",
"alias" : [
"Human Readable Form",
"UDI",
"Barcode String"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udi.carrierHRF",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"mustSupport" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "udi",
"map" : "A unique device identifier (UDI) on a device label in plain text"
},
{
"identity" : "rim",
"map" : "Role.id.extension"
},
{
"identity" : "argonaut-dq-dstu2",
"map" : "Device.udi"
}
]
},
{
"id" : "Device.udi.carrierAIDC",
"path" : "Device.udi.carrierAIDC",
"short" : "UDI Machine Readable Barcode String",
"definition" : "The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 encoded.",
"comment" : "The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.",
"alias" : [
"Automatic Identification and Data Capture",
"UDI",
"Barcode String"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udi.carrierAIDC",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "base64Binary"
}
],
"mustSupport" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "udi",
"map" : "A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."
},
{
"identity" : "rim",
"map" : "Role.id.extension"
},
{
"identity" : "argonaut-dq-dstu2",
"map" : "NA (not Supoorted)"
}
]
},
{
"id" : "Device.udi.issuer",
"path" : "Device.udi.issuer",
"short" : "UDI Issuing Organization",
"definition" : "Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
1) GS1:
http://hl7.org/fhir/NamingSystem/gs1-di,
2) HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI,
3) ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
4) ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di.",
"alias" : [
"Barcode System"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udi.issuer",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"mapping" : [
{
"identity" : "udi",
"map" : "All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.
GS1 DIs:
http://hl7.org/fhir/NamingSystem/gs1
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other"
},
{
"identity" : "rim",
"map" : "Role.id.root"
}
]
},
{
"id" : "Device.udi.entryType",
"path" : "Device.udi.entryType",
"short" : "barcode | rfid | manual +",
"definition" : "A coded entry to indicate how the data was entered.",
"requirements" : "Supports a way to distinguish hand entered from machine read data.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udi.entryType",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "UDIEntryType"
}
],
"strength" : "required",
"description" : "Codes to identify how UDI data was entered",
"valueSetReference" : {
"reference" : "http://hl7.org/fhir/ValueSet/udi-entry-type"
}
},
"mapping" : [
{
"identity" : "rim",
"map" : "NA"
}
]
},
{
"id" : "Device.status",
"path" : "Device.status",
"short" : "active | inactive | entered-in-error | unknown",
"definition" : "Status of the Device availability.",
"comment" : "This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.status",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"isModifier" : true,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "FHIRDeviceStatus"
}
],
"strength" : "required",
"description" : "The availability status of the device.",
"valueSetReference" : {
"reference" : "http://hl7.org/fhir/ValueSet/device-status"
}
},
"mapping" : [
{
"identity" : "rim",
"map" : ".statusCode"
},
{
"identity" : "w5",
"map" : "status"
}
]
},
{
"id" : "Device.type",
"path" : "Device.type",
"short" : "What kind of device this is",
"definition" : "Code or identifier to identify a kind of device.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"mustSupport" : true,
"binding" : {
"strength" : "extensible",
"description" : "Codes to identify medical devices",
"valueSetReference" : {
"reference" : "http://hl7.org/fhir/ValueSet/device-kind"
}
},
"mapping" : [
{
"identity" : "udi",
"map" : "Type description using GMDN or other code system"
},
{
"identity" : "rim",
"map" : ".code"
},
{
"identity" : "w5",
"map" : "what"
},
{
"identity" : "argonaut-dq-dstu2",
"map" : "Device.type"
}
]
},
{
"id" : "Device.lotNumber",
"path" : "Device.lotNumber",
"short" : "Lot number of manufacture",
"definition" : "Lot number assigned by the manufacturer.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.lotNumber",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"mapping" : [
{
"identity" : "udi",
"map" : "The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI."
},
{
"identity" : "rim",
"map" : ".lotNumberText"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.manufacturer",
"path" : "Device.manufacturer",
"short" : "Name of device manufacturer",
"definition" : "A name of the manufacturer.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.manufacturer",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"mapping" : [
{
"identity" : "udi",
"map" : "N/A"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].scoper.name"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.manufactureDate",
"path" : "Device.manufactureDate",
"short" : "Date when the device was made",
"definition" : "The date and time when the device was manufactured.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.manufactureDate",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "dateTime"
}
],
"mapping" : [
{
"identity" : "udi",
"map" : "The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”."
},
{
"identity" : "rim",
"map" : ".existenceTime.low"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.expirationDate",
"path" : "Device.expirationDate",
"short" : "Date and time of expiry of this device (if applicable)",
"definition" : "The date and time beyond which this device is no longer valid or should not be used (if applicable).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.expirationDate",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "dateTime"
}
],
"mapping" : [
{
"identity" : "udi",
"map" : "the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”."
},
{
"identity" : "rim",
"map" : ".expirationTime"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.model",
"path" : "Device.model",
"short" : "Model id assigned by the manufacturer",
"definition" : "The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.model",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].code"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.version",
"path" : "Device.version",
"short" : "Version number (i.e. software)",
"definition" : "The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.version",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : ".softwareName (included as part)"
},
{
"identity" : "w5",
"map" : "what"
}
]
},
{
"id" : "Device.patient",
"path" : "Device.patient",
"short" : "Patient to whom Device is affixed",
"definition" : "Patient information, If the device is affixed to a person.",
"requirements" : "If the device is implanted in a patient, then need to associate the device to the patient.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.patient",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : "http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient"
}
],
"mustSupport" : true,
"mapping" : [
{
"identity" : "rim",
"map" : ".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"
},
{
"identity" : "w5",
"map" : "who.focus"
},
{
"identity" : "argonaut-dq-dstu2",
"map" : "Device.patient"
}
]
},
{
"id" : "Device.owner",
"path" : "Device.owner",
"short" : "Organization responsible for device",
"definition" : "An organization that is responsible for the provision and ongoing maintenance of the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.owner",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : "http://hl7.org/fhir/StructureDefinition/Organization"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : ".playedRole[typeCode=OWN].scoper"
},
{
"identity" : "w5",
"map" : "who.source"
}
]
},
{
"id" : "Device.contact",
"path" : "Device.contact",
"short" : "Details for human/organization for support",
"definition" : "Contact details for an organization or a particular human that is responsible for the device.",
"comment" : "used for troubleshooting etc.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.contact",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactPoint"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : ".scopedRole[typeCode=CON].player"
},
{
"identity" : "w5",
"map" : "who.source"
}
]
},
{
"id" : "Device.location",
"path" : "Device.location",
"short" : "Where the resource is found",
"definition" : "The place where the device can be found.",
"requirements" : "Device.location can be used to track device location.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.location",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : "http://hl7.org/fhir/StructureDefinition/Location"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : ".playedRole[typeCode=LOCE].scoper"
},
{
"identity" : "w5",
"map" : "where"
}
]
},
{
"id" : "Device.url",
"path" : "Device.url",
"short" : "Network address to contact device",
"definition" : "A network address on which the device may be contacted directly.",
"comment" : "If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.url",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : ".telecom"
},
{
"identity" : "w5",
"map" : "where"
}
]
},
{
"id" : "Device.note",
"path" : "Device.note",
"short" : "Device notes and comments",
"definition" : "Descriptive information, usage information or implantation information that is not captured in an existing element.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.note",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Annotation"
}
],
"mapping" : [
{
"identity" : "rim",
"map" : ".text"
}
]
},
{
"id" : "Device.safety",
"path" : "Device.safety",
"short" : "Safety Characteristics of Device",
"definition" : "Provides additional safety characteristics about a medical device. For example devices containing latex.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.safety",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceSafety"
}
],
"strength" : "example",
"description" : "Codes used to identify medical devices safety characterics. These codes are derived in part from the [United States Food and Drug Administration recommendations](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example.",
"valueSetReference" : {
"reference" : "http://hl7.org/fhir/ValueSet/device-safety"
}
},
"mapping" : [
{
"identity" : "rim",
"map" : "NA"
}
]
}
]
},
"differential" : {
"element" : [
{
"id" : "Device",
"path" : "Device",
"mustSupport" : false,
"isModifier" : false
},
{
"id" : "Device.udi.deviceIdentifier",
"path" : "Device.udi.deviceIdentifier",
"min" : 0,
"max" : "1",
"mustSupport" : true,
"isModifier" : false
}
]
}
}
CRD Version: 0.1.0 ®© 2018+ FHIR Version: 3.0.1 generated on Tue, Aug 21, 2018 16:01+1000.
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