Från eHealth Network guidelines
| Data | Element | Description | Preferred Code Systems | Pågående arbeten | |
|---|---|---|---|---|---|
| * ** A.2 Patient summary body data elements | |||||
| A.2.3.2 | Medical devices and implants | En informell arbetsgrupp arbetar med medicintekniska produkteroch implantat, där Läkemedelsverket och andra aktörer (bl.a.Region Västerbotten) är involverade. Det framkom att det ärviktigt att separera behovet av strukturerad dokumentation fördessa produkter från behovet av nationella databaser, som UDI(Unique Device Identification). | |||
| A.2.3.2.1 | Device and implant description | Describes the patient's implanted and external medical devices and equipment upon which their health status depends. Includes devices such as cardiac pacemakers, implantable fibrillator, prosthesis, ferromagnetic bone implants, etc. of which the HP needs to be aware. | SNOMED CT GPS* EMDN | ||
| A.2.3.2.2 | Device ID | Normalised identifier of the device instance such as UDI according to REGULATION (EU) 2017/745 | |||
| A.2.3.2.3 | Implant date | Date when procedure was performed | ISO 8601 | ||
| A.2.3.2.4 | End date | Date when the device was explanted from the patient or the external device was no longer in use; likewise when the device is planned to be explanted | ISO 8601 | ||
LV: A.2.3.2.3. REGULATION (EU) 2017/745 - pekar på UDI-DI eller på UDI-PI. Produktgrupp eller enskild produkt. UDI-Di (samt en kod för produktmodell Basic UDI-DI eller BUDI-DI) kommer, förhoppningsvis, att finnas i Eudamed (ev 2Q 2026).
Exporterat från logisk modell "Device use model" (under arbete)
Device use model - EHDS Logical Information Models v0.1.0
| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | Region Västerbotten | Inera | E-hälso-myndigheten |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EHDSDeviceUse | EHDSDeviceUse | 0 | * | Device use model | C.25 - EHDS refined base model for Device Use | |||||||
| EHDSDeviceUse.identifier | EHDSDeviceUse.identifier | 0 | * | Identifier | C.25.1 - Identifier | An identifier for this statement. | ||||||
| EHDSDeviceUse.status | EHDSDeviceUse.status | 0 | 1 | CodeableConcept | C.25.2 - Status | Current status of the Device Usage. | preferred | HL7 device-statement-status | ||||
| EHDSDeviceUse.implantDate | EHDSDeviceUse.implantDate | 0 | 1 | dateTime | C.25.3 - Implant date | Date when procedure was performed. | ||||||
| EHDSDeviceUse.endDate | EHDSDeviceUse.endDate | 0 | 1 | dateTime | C.25.4 - End date | Date when the device was explanted from the patient or the external device was no longer in use; likewise when the device is planned to be explanted. | ||||||
| EHDSDeviceUse.device | EHDSDeviceUse.device | 1 | 1 | Reference (https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice) | C.25.5 - Device | The details of the device used. | ||||||
| EHDSDeviceUse.subject | EHDSDeviceUse.subject | 1 | 1 | Reference (https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSPatient) | C.25.6 - Subject | The patient using the device. | ||||||
| EHDSDeviceUse.bodySite | EHDSDeviceUse.bodySite | 0 | 1 | CodeableConcept | C.25.7 - Body site | Anatomical location of the device. May include laterality. | ||||||
| EHDSDeviceUse.note | EHDSDeviceUse.note | 0 | * | Narrative | C.25.8 - Note | Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement. | ||||||
| EHDSDeviceUse.recorded | EHDSDeviceUse.recorded | 0 | 1 | dateTime | C.25.9 - Recorded | Date and time at which the statement was made/recorded. | ||||||
| EHDSDeviceUse.source | EHDSDeviceUse.source | 0 | 1 | Reference(https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSPatient|https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSHealthProfessional|https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSRelatedPerson) | C.25.10 - Source | Who reported the device was being used by the patient. |
Exporterat från logisk modell "Device model" (under arbete)
Device model - EHDS Logical Information Models v0.1.0
| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | Region Västerbotten | Inera | E-hälso-myndigheten |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EHDSDevice | EHDSDevice | 0 | * | Device model | C.12 - EHDS refined base model for Device information | |||||||
| EHDSDevice.identifier | EHDSDevice.identifier | 1 | * | Identifier | C.12.1 - Identifier | An identifier of the device which is unique within in a defined scope. Multiple identifiers can be used. | ||||||
| EHDSDevice.manufacturer | EHDSDevice.manufacturer | 0 | 1 | string | C.12.2 - Manufacturer | Name of device manufacturer | ||||||
| EHDSDevice.manufactureDate | EHDSDevice.manufactureDate | 0 | 1 | dateTime | C.12.3 - Manufacture date | The date and time when the device was manufactured | ||||||
| EHDSDevice.expiryDate | EHDSDevice.expiryDate | 0 | 1 | dateTime | C.12.4 - Expiry date | The date and time beyond which this device is no longer valid or should not be used (if applicable). | ||||||
| EHDSDevice.lotNumber | EHDSDevice.lotNumber | 0 | 1 | string | C.12.5 - Lot number | Lot number of manufacture | ||||||
| EHDSDevice.serialNumber | EHDSDevice.serialNumber | 0 | 1 | string | C.12.6 - Serial number | Serial number assigned by the manufacturer | ||||||
| EHDSDevice.name | EHDSDevice.name | 0 | * | string | C.12.7 - Name | The name and name type of the device as known to the manufacturer and/or patient | ||||||
| EHDSDevice.modelNumber | EHDSDevice.modelNumber | 0 | 1 | string | C.12.8 - Model number | The manufacturer's model number for the device | ||||||
| EHDSDevice.version | EHDSDevice.version | 0 | 1 | string | C.12.9 - Version | The actual design of the device or software version running on the device | ||||||
| EHDSDevice.type | EHDSDevice.type | 0 | * | CodeableConcept | C.12.10 - Type | Device type | preferred | SNOMED CT, EMDN | ||||
| EHDSDevice.note | EHDSDevice.note | 0 | * | Narrative | C.12.11 - Note | Device notes and comments |