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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 | ||
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 |
* In a foreseeable future, the suggested preferred vocabularies might be superseded or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. 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.
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