Skip to main content

​
Overview

Implantable Device Information addresses: Unique Device Identifier(s) for a Patient’s Implantable Device(s) are recorded in the system using the FHIR Device resource. This profile meets the U.S. Core Data for Interoperability (USCDI) v3 requirements for Unique Device Identifiers. Device is a type of manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. This profile specifically focuses on implantable devices that have been placed in a patient’s body. Each Device has next elements:
  • a code identifying the type of device
  • a patient
Each Implantable Device Must Support:
  • A Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode
  • The Device Identifier (UDI-DI)
  • the manufacture date
  • the expiration date
  • the lot number
  • the serial number
  • the distinct identifier (i.e., the distinct identification code)
Profile specific implementation guidance:
  • This profile supports the requirement to retrieve an 170.315(a)(14) Implantable device list and follows the HL7 Cross Paradigm Implementation Guide: UDI Pattern guidelines for exchanging information about the use of and/or implantation of medical devices in patients.:
    • The AccessGUDID API provides access to device records in GUDID including safety information and UDI. It includes APIs to query and download a complete list of implantable devices registered in GUDID.
    • The Parse UDI API allows users to pass a UDI and return each part of the UDI in a structured format (specifically the serialNumber, lotNumber, expirationDate, distinctIdentifier (returned as donation_id) or manufactureDate).
  • Implantable medical devices that have UDI information SHALL represent this information in either carrierAIDC or carrierHRF. (Note that the UDI may not be present in all scenarios such as historical implantable devices, patient reported implant information, payer reported devices, or improperly documented implants.)
  • For Implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) SHALL be present.
  • Servers SHOULD support query by Device.type to allow clients to request the patient’s devices by a specific type. Note: The Device.type is too granular to differentiate implantable vs. non-implantable devices.
  • Records of implanted devices MAY be queried against UDI data including:
    • UDI HRF string (udi-carrier)
    • UDI Device Identifier (udi-di)
    • Manufacturer (manufacturer)
    • Model number (model)
Implementers MAY also adopt custom SearchParameters for searching by:
  • lot numbers
  • serial number
  • expiration date
  • manufacture date
  • distinct identifier
This resource conforms to USCDI v3 for Unique Device Identifiers - refers to US Core Implantable Device Profile 6.1.0. Device response will be provided in JSON (refers to Capability Statement) format as per FHIR standard R4 version.

​
Must support elements, mandatory and optional search parameters

Devicemust support these elements:
  • udiCarrier
    • deviceIdentifier
    • carrierHRF
  • distinctIdentifier
  • manufactureDate
  • expirationDate
  • lotNumber
  • serialNumber
  • type
  • patient
Each CareTeam Must Have (Mandatory):
  • type
  • patient
The following search parameters and search parameter combinations SHALL be supported: The syntax used to describe the interactions is described here. SHALL support searching for all Devices for a patient using the patient search parameter: GET [base url]/Device?patient={Type/}[id] The following search parameter combinations SHOULD be supported (optional): SHOULD support searching using the combination of the patient and type search parameters: GET [base url]/Device?patient={Type/}[id]&type={system|}[code] SHOULD support searching using the combination of the patient and status search parameters:
  • including support for OR search on status (e.g.status={system|}[code],{system|}[code],…)
GET [base url]/Device?patient={Type/}[id]&status={system|}[code]{,{system|}[code],...} The response to any search operation is always a list of resources in a Bundle or an Operation Outcome.

​
Device By Patient Id

Search for Device by patient. METHOD GET
PARAMS [base url] - FHIR base url {Type/} - Reference type for the patient resource. Example: Patient/ [id] - Id for the Patient HEADERS The Authorization token SHALL be obtained during the Authentication and Authorization process. Go to Authentication and Authorization for further details. RESPONSES The response to any search operation is always a list of resources in a Bundle or an Operation Outcome. EXAMPLE:

​
Device By Id

Fetch a single Device by ID. METHOD GET
or
PARAMS [base url] - FHIR base url {id} - Id for Device resource HEADERS The Authorization token SHALL be obtained during the Authentication and Authorization process. Go to Authentication and Authorization for further details. RESPONSES The response to any search operation is always a list of resources in a Bundle or an Operation Outcome. EXAMPLE:

​
Device by Patient and Type

Search for Devices using combination of patient and type search parameters. METHOD GET
PARAMS [base url] - FHIR base url {Type/} - Reference type for the patient resource. Example: Patient/ [id] - Patient id {system|} - Terminology system for device type. FHIR search token parameter. See Search specification for more information. Example: http://snomed.info/sct| [code] - Device type code. Example: 468063009 (Implantable cardioverter defibrillator) HEADERS The Authorization token SHALL be obtained during the Authentication and Authorization process. Go to Authentication and Authorization for further details. RESPONSES The response to any search operation is always a list of resources in a Bundle or an Operation Outcome. EXAMPLE:

​
Device by Patient and Status

Search for Devices using combination of patient and status search parameters. METHOD GET
PARAMS [base url] - FHIR base url {Type/} - Reference type for the patient resource. Example: Patient/ [id] - Patient id {system|} - Status system. FHIR search token parameter. See Search specification for more information. [code] - Device status code. Example: active, inactive, entered-in-error HEADERS The Authorization token SHALL be obtained during the Authentication and Authorization process. Go to Authentication and Authorization for further details. RESPONSES The response to any search operation is always a list of resources in a Bundle or an Operation Outcome. EXAMPLE: