Example Usage Scenarios:

The following are example usage scenarios for this profile:

• Query for a Patient's Implantable Devices
• Record or update a Patient Implantable Device

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

Each Implantable Device Must Have:

1. a code identifying the type of device
2. a patient

In addition, the following data elements must be supported if the data is present in the sending system (Must Support definition):

Each Implantable Device Must Support:

1. A Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode
2. The Device Identifier (UDI-DI)
3. the manufacture date
4. the expiration date
5. the lot number
6. the serial number
7. the distinct identifier (i.e., the distinct identification code)

Profile Specific Implementation Guidance:

• For non-implantable devices (for example, software or crutches), use the base FHIR Device resource or other use case-specific Device profiles.
• This profile supports the requirement to retrieve a 170.315(a)(14) Implantable device list. It follows the HL7 Cross Paradigm Implementation Guide: UDI Pattern guidelines for exchanging information about the use and implantation of medical devices in patients.

  • A unique device identifier (UDI) is a unique numeric or alphanumeric code. There is a machine-readable version (AIDC - the Automatic Identification and Data Capture) and a human-readable version of the UDI (HRF - Human Readable Form string). This profile specifies that only the HRF must be supported. Considering the complexity of parsing AIDCs, there is no expectation at this time that one converts an AIDC to HRF upon receipt from a FHIR source that is not conformant to this profile or is using another interchange standard (e.g., C-CDA, HL7 v2, etc.). The UDI generally consists of a mandatory Device Identifier (DI) and a conditional Production identifier (PI) that identifies one or more of the five UDI-PI elements. The UDI and its components are mapped to the IE Core Implantable Device Profile elements in the table below:

    UDI component	IE Core Implantable Device Profile element
    UDI HRF string	Device.udiCarrier.carrierHRF
    DI	Device.udiCarrier.deviceIdentifier
    manufacture date (UDI-PI element)	Device.manufactureDate
    expiration dat (UDI-PI elemente	Device.expirationDate
    lot number (UDI-PI element)	Device.lotNumber
    serial number (UDI-PI element)	Device.serialNumber
    distinct identifier (UDI-PI element)	Device.distinctIdentifier

  • Implementers are encouraged to use the EU or FDA Global UDI Database (GUDID) and associated APIs to parse and validate the UDI:

    • 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 with UDI information SHALL represent the UDI code in Device.udiCarrier.carrierHRF. All five UDI-PI elements defined in the UDI code may not always be present in every UDI instance. However, those UDI-PI elements present SHALL be represented in the corresponding IE Core Implantable Device Profile elements.

  UDI may not be present in all scenarios, such as historical implantable devices, patient-reported implant information, payer-reported devices, or improperly documented implants. If UDI is not present and the manufacturer or model number information is available, they SHOULD be included to support historical reports of implantable medical devices as follows:

  data element	IE Core Implantable Device Profile element
  manufacturer	Device.manufacturer
  model	Device.model

• Servers SHOULD support query by Device.type to allow clients to request the patient's devices by a specific type. Note: Device.type is too granular to differentiate implantable vs. non-implantable devices.

• The Quick Start section below describes searching for all 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

Quick Start

Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the IE Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only IE Core Profiles (Profile Only Support) are not required to support these interactions. See the IE Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

• See the Scopes Format section for a description of the SMART scopes syntax.
• See the Search Syntax section for a description of the IE Core search syntax.
• See the General Requirements section for additional rules and expectations when a server requires status parameters.
• See the General Guidance section for additional guidance on searching for multiple patients.

IE Core Scopes

Servers providing access to implantable device data SHALL support these IE Core SMART Scopes:

• resource level scopes: <patient|user|system>/Device.rs

Mandatory Search Parameters:

1. SHALL support searching for all devices for a patient, including implantable devices using the patient search parameter:

   GET [base]/Device?patient={Type/}[id]

   Example:

   1. GET [base]/Device?patient=1137192

   Implementation Notes: Fetches a bundle of all Device resources for the specified patient (how to search by reference)

Optional Search Parameters:

The following search parameter combinations SHOULD be supported:

1. SHOULD support searching using the combination of the patient and type search parameters:

   GET [base]/Device?patient={Type/}[id]&type={system|}[code]

   Example:

   1. GET [base]/Device?patient=1316024&type=http://snomed.info/sct|468063009

   Implementation Notes: Fetches a bundle of all Device resources for the specified patient and type. (how to search by reference and how to search by token)

2. 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]/Device?patient={Type/}[id]&status={system|}[code]{,{system|}[code],...}

   Example:

   1. GET [base]/Device?patient=1316024&status=active

   Implementation Notes: Fetches a bundle of all Device resources for the specified patient and status (how to search by reference and how to search by token)