Device Profile

Scope and Usage

This Device profile is part of the Point-of-Care Device General Implementation Guide. The Device resource contains administrative information about a medical device, whereas DeviceComponent and DeviceMetric represent the physical or logical structure.

Any compliant device representation shall have one Device resource according to the PoC Device profile, which defines the following rules:

  • If there is an Unique Device Identifier (UDI) assigned, it should be mapped to resource elements as described in the Device UDI Mapping.
  • If the device has a serial number or EUI-64, these should be encoded in Device.identifier as defined in the profile. For EUI-64, either base-16 or hex representation (octets separated by hyphens) shall be used. See IEEE Guidelines for Use of EUI, OUI, and CID for details.
  • Device.type shall be present and have a coding from the ISO/IEEE 11073 MDC device nomenclature. The Rosetta Terminology Mapping Management System (RTMMS) lists available codes. Device.type.coding allows additional coding from other code systems.

Content

StructureDefinition Description Example
PoC Device Profile Administrative information about a point-of-care device Physio Monitor Device

PoC Device Profile

Canonical URL

http://devices.fhir.org/StructureDefinition/PoCDevice

Profile Definition

useΣ ?!0..1codeBinding
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1codeFixed Value
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
systemΣ0..0uri
valueΣ1..1string
periodΣ0..1Period
assignerΣ0..1Reference(Organization)
useΣ ?!0..1codeBinding
typeΣ0..0CodeableConceptBinding
systemΣ1..1uriFixed Value
valueΣ1..1string
periodΣ0..1Period
assignerΣ0..1Reference(Organization)
deviceIdentifierΣ0..1string
nameΣ0..1string
jurisdiction0..1uri
carrierHRFΣ0..1string
carrierAIDCΣ0..1base64Binary
issuer0..1uri
entryType0..1codeBinding
statusΣ ?!0..1codeBinding
systemΣ1..1uriFixed Value
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
lotNumber0..1string
manufacturer0..1string
manufactureDate0..1dateTime
expirationDate0..1dateTime
model0..1string
version0..1string
patient0..1Reference(Patient)
owner0..1Reference(Organization)
contact0..*ContactPoint
location0..1Reference(Location)
url0..1uri
note0..*Annotation
safetyΣ0..*CodeableConcept

Example (XML view)

Example of a Physio Monitor Device

<Device xmlns="http://hl7.org/fhir">
    <id value="72" />
    <meta>
        <profile value="http://devices.fhir.org/StructureDefinition/PoCDevice" />
    </meta>
    <identifier>
        <type>
            <coding>
                <system value="http://hl7.org/fhir/identifier-type" />
                <code value="SNO" />
            </coding>
        </type>
        <value value="DE35115712" />
    </identifier>
    <identifier>
        <system value="urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680" />
        <value value="00-09-FB-FF-FF-A0-F4-CA" />
    </identifier>
    <udi>
        <deviceIdentifier value="00884838038752" />
        <jurisdiction value="http://hl7.org/fhir/NamingSystem/fda-udi" />
        <carrierHRF value="(01)00884838038752(21)DE35115712" />
        <issuer value="http://hl7.org/fhir/NamingSystem/gs1-di" />
    </udi>
    <status value="active" />
    <type>
        <coding>
            <system value="urn:iso:std:iso:11073:10101" />
            <code value="69965" />
            <display value="MDC_DEV_MON_PHYSIO_MULTI_PARAM_MDS" />
        </coding>
        <text value="Patient Monitor" />
    </type>
    <manufacturer value="Philips" />
    <model value="MX400 - MX550" />
    <patient>
        <reference value="Patient/371" />
    </patient>
    <location>
        <reference value="Location/46" />
    </location>
</Device>

Example (JSON view)

Example of a Physio Monitor Device

{
    "resourceType": "Device",
    "id": "72",
    "meta": {
        "profile":  [
            "http://devices.fhir.org/StructureDefinition/PoCDevice"
        ]
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "system": "http://hl7.org/fhir/identifier-type",
                        "code": "SNO"
                    }
                ]
            },
            "value": "DE35115712"
        },
        {
            "system": "urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680",
            "value": "00-09-FB-FF-FF-A0-F4-CA"
        }
    ],
    "udi": {
        "deviceIdentifier": "00884838038752",
        "jurisdiction": "http://hl7.org/fhir/NamingSystem/fda-udi",
        "carrierHRF": "(01)00884838038752(21)DE35115712",
        "issuer": "http://hl7.org/fhir/NamingSystem/gs1-di"
    },
    "status": "active",
    "type": {
        "coding":  [
            {
                "system": "urn:iso:std:iso:11073:10101",
                "code": "69965",
                "display": "MDC_DEV_MON_PHYSIO_MULTI_PARAM_MDS"
            }
        ],
        "text": "Patient Monitor"
    },
    "manufacturer": "Philips",
    "model": "MX400 - MX550",
    "patient": {
        "reference": "Patient/371"
    },
    "location": {
        "reference": "Location/46"
    }
}