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.
Context
Parent nodes of template element with id 2.16.840.1.113883.10.20.22.4.37
Classification
CDA Entry Level Template
Open/Closed
Open (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 29 templates, Uses 0 templates
Template Product Instance
Procedure Activity Procedure (V2) (2.1)
Circular reference found with ProcedureActivityProcedureV2, please check
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