Generated Narrative: StructureDefinition ProductInstance Name Flags Card. Type Description & Constraints ParticipantRole ParticipantRole XML Namespace: urn:hl7-org:v3 Instance of this type are validated by templateId Logical Container: ClinicalDocument (CDA Class) #xD; Slices for templateId 1..* II Slice: Unordered, Open by value:root #xD; templateId:product-instance 1..1 II #xD; @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.37 #xD; @extension 0..0 #xD; @classCode 1..1 cs Fixed Value: MANU #xD; id 1..* II #xD; playingDevice C 1..1 Device Constraints: should-code #xD; code 0..1 CE #xD; scopingEntity 1..1 Entity #xD; id 1..* II #xD; Documentation for this format
HL7 International - Structured Documents
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.
Defines the basic properties of every data value. This is an abstract type, meaning that no value can be just a data value without belonging to any concrete type. Every concrete type is a specialization of this general abstract DataValue type.
playingDevice and playingEntity are mutually exclusive
(playingDevice | playingEntity).count() <= 1
If a value is an exceptional value (NULL-value), this specifies in what way and why proper information is missing.
When valued in an instance, this attribute signals the imposition of realm-specific constraints. The value of this attribute identifies the realm in question
When valued in an instance, this attribute signals the imposition of constraints defined in an HL7-specified message type. This might be a common type (also known as CMET in the messaging communication environment), or content included within a wrapper. The value of this attribute provides a unique identifier for the type in question.
An II instance must have either a root or an nullFlavor.
A human readable name or mnemonic for the assigning authority. The Assigning Authority Name has no computational value. The purpose of a Assigning Authority Name is to assist an unaided human interpreter of an II value to interpret the authority. Note: no automated processing must depend on the assigning authority name to be present in any form.
Specifies if the identifier is intended for human display and data entry (displayable = true) as opposed to pure machine interoperation (displayable = false).
Identifies the type as an HL7 Registered model
A character string as a unique identifier within the scope of the identifier root.
When valued in an instance, this attribute signals the imposition of a set of template-defined constraints. The value of this attribute provides a unique identifier for the templates in question
A unique identifier that guarantees the global uniqueness of the instance identifier. The root alone may be the entire instance identifier.
SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: HL7RoleClass urn:oid:2.16.840.1.113883.5.110 STATIC) (CONF:81-7900).
SHALL contain at least one [1..*] id (CONF:81-7902).
SHALL contain exactly one [1..1] playingDevice (CONF:81-7903).
This playingDevice SHOULD contain zero or one [0..1] code (CONF:81-16837).
SHALL contain exactly one [1..1] scopingEntity (CONF:81-7905).
This scopingEntity SHALL contain at least one [1..*] id (CONF:81-7908).