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| 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 | Snomed CT ger bara en beskrivning av att det finns ett implantat och vilken typ av implantat. Ingenting om identiteten på implantat eller beskrivningar av ett visst implantat | |
| A.2.3.2.2 | Device ID | Normalised identifier of the device instance such as UDI according to REGULATION (EU) 2017/745 | UDI = UDI-DI + UDI-PI | ||
| 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 | ||
* In a foreseeable future, the suggested preferred vocabularies might be superseded or
complemented, as mentioned in Guidelines Article 11(2).
** The Preferred code system(s) has been selected based on adequacy to convey the
information using the methodology of the Subgroup on Semantics. When more alternative
international code systems are available, all are listed when it is assumed to be unlikely that
agreement can be reached short term. Mapping between code systems could be proposed for
specific use cases.
LV: A.2.3.2.3. REGULATION (EU) 2017/745 - pekar på UDI-DI eller på UDI-PI. Produktgrupp eller enskild produkt (Inte "eller" utan "och". dock minst UDI-DI, alltid obligatoriskt). UDI-Di (samt en kod för produktmodell Basic UDI-DI eller BUDI-DI) kommer, förhoppningsvis, att finnas i Eudamed (ev 2Q 2026). UDI-PI finns inte planerad i databasen (Det ska inte in i databasen. Däremot kan tillverkaren ange i databasen vilka ”UDI Production identifiers” som produkten förses med på sin produktetikett, tex batch och utgångsdatum eller tillverkningsdatum och serienummer etc).
PJO: Patient Summary Guideline: Har för lite information som behövs för dela information om insatta implantat, EHDS Logical information Models verkar ha fler och mer relevanta attribut att använda.
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. | Betyder detta vem som använder? | |||||
| EHDSDeviceUse.status | EHDSDeviceUse.status | 0 | 1 | CodeableConcept | C.25.2 - Status | Current status of the Device Usage. | preferred | HL7 device-statement-status | Är detta om produkt är i bruk? | |||
| EHDSDeviceUse.implantDate | EHDSDeviceUse.implantDate | 0 | 1 | dateTime | C.25.3 - Implant date | Date when procedure was performed. | Obligatoriskt | |||||
| 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. | Villkorat obligatoriskt | |||||
| 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. | Obligatoriskt. Vilka detaljer menas? Produktbeskrivning? Annat (modell, längd, storlek, hö/vä, ref nr, mm?) | |||||
| 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. | Obligatoriskt | |||||
| EHDSDeviceUse.bodySite | EHDSDeviceUse.bodySite | 0 | 1 | CodeableConcept | C.25.7 - Body site | Anatomical location of the device. May include laterality. | Obligatoriskt | |||||
| 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. | Vad menas? | |||||
| EHDSDeviceUse.recorded | EHDSDeviceUse.recorded | 0 | 1 | dateTime | C.25.9 - Recorded | Date and time at which the statement was made/recorded. | Samma som C.25.3 - Implant date? | |||||
| 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. | Samma som C.25.1 - Identifier? |
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. | Obligatoriskt om det menas UDI-DI? | |||||
| EHDSDevice.manufacturer | EHDSDevice.manufacturer | 0 | 1 | string | C.12.2 - Manufacturer | Name of device manufacturer | Obligatoriskt | |||||
| EHDSDevice.manufactureDate | EHDSDevice.manufactureDate | 0 | 1 | dateTime | C.12.3 - Manufacture date | The date and time when the device was manufactured | Villkorat obligatoriskt. Kan vara (del av) UDI-PI | |||||
| 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). | Obligatoriskt | |||||
| EHDSDevice.lotNumber | EHDSDevice.lotNumber | 0 | 1 | string | C.12.5 - Lot number | Lot number of manufacture | Obligatoriskt (UDI-PI) | |||||
| EHDSDevice.serialNumber | EHDSDevice.serialNumber | 0 | 1 | string | C.12.6 - Serial number | Serial number assigned by the manufacturer | Villkorat obligatoriskt (UDI-PI) | |||||
| 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 | Obligatoriskt | |||||
| EHDSDevice.modelNumber | EHDSDevice.modelNumber | 0 | 1 | string | C.12.8 - Model number | The manufacturer's model number for the device | Obligatoriskt. Men vad menas med modell nummer? Version? Bara heta modell? | |||||
| EHDSDevice.version | EHDSDevice.version | 0 | 1 | string | C.12.9 - Version | The actual design of the device or software version running on the device | Villkorat obligatoriskt? | |||||
| EHDSDevice.type | EHDSDevice.type | 0 | * | CodeableConcept | C.12.10 - Type | Device type | preferred | SNOMED CT, EMDN | Obligatoriskt. Typ av produkt? Ex Höftprotes, Pacemaker mm? | |||
| EHDSDevice.note | EHDSDevice.note | 0 | * | Narrative | C.12.11 - Note | Device notes and comments |