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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.
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Template Product Instance
Circular reference found with 2.16.840.1.113883.10.20.22.4.14, please check
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