Consolidated CDA Release 2.2, published by Health Level Seven. This is not an authorized publication; it is the continuous build for version 2.2). This version is based on the current content of https://github.com/HL7/CDA-ccda-2.2/ and changes regularly. See the Directory of published versions

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Resource Profile: Product Instance

Official URL: http://hl7.org/fhir/cda/ccda/StructureDefinition/2.16.840.1.113883.10.20.22.4.37				Version: 2.2
Active as of 2022-05-13				Computable Name: ProductInstance
Other Identifiers: : urn:oid:2.16.840.1.113883.10.20.22.4.37

This clinical statement represents a particular device that was placed in a patient or used as part of a procedure or other act. This provides a record of the identifier and other details about the given product that was used. For example, it is important to have a record that indicates not just that a hip prostheses was placed in a patient but that it was a particular hip prostheses number with a unique identifier.

The FDA Amendments Act specifies the creation of a Unique Device Identification (UDI) System that requires the label of devices to bear a unique identifier that will standardize device identification and identify the device through distribution and use.

The FDA permits an issuing agency to designate that their Device Identifier (DI) + Production Identifier (PI) format qualifies as a UDI through a process of accreditation. Currently, there are three FDA-accredited issuing agencies that are allowed to call their format a UDI. These organizations are GS1, HIBCC, and ICCBBA. For additional information on technical formats that qualify as UDI from each of the issuing agencies see the UDI Appendix.

When communicating only the issuing agency device identifier (i.e., subcomponent of the UDI), the use of the issuing agency OID is appropriate. However, when communicating the unique device identifier (DI + PI), the FDA OID (2.16.840.1.113883.3.3719) must be used. When sending a UDI, populate the participantRole/id/@root with the FDA OID (2.16.840.1.113883.3.3719) and participantRole/id/@extension with the UDI.

When sending a DI, populate the participantRole/id/@root with the appropriate assigning agency OID and participantRole/id/@extension with the DI. The scopingEntity/id should correspond to FDA or the appropriate issuing agency.

Usage:

• Use this Resource Profile: Procedure Activity Procedure, Planned Supply, Non-Medicinal Supply Activity

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

Path	Conformance	ValueSet / Code
ParticipantRole.classCode	required	Pattern: MANU
ParticipantRole.templateId:primary.nullFlavor	required	NullFlavor
ParticipantRole.code	extensible	RoleCode
ParticipantRole.playingDevice.classCode	required	EntityClassDevice
ParticipantRole.playingDevice.determinerCode	required	Fixed Value: INSTANCE
ParticipantRole.playingDevice.code	extensible	EntityCode
ParticipantRole.playingDevice.manufacturerModelName	extensible	​http://terminology.hl7.org/ValueSet/v3-ManufacturerModelName
ParticipantRole.playingDevice.softwareName	extensible	​http://terminology.hl7.org/ValueSet/v3-SoftwareName
ParticipantRole.scopingEntity.classCode	required	EntityClassRoot
ParticipantRole.scopingEntity.determinerCode	required	Fixed Value: INSTANCE
ParticipantRole.scopingEntity.code	extensible	EntityCode