-
Type:
Change Request
-
Resolution: Persuasive with Modification
-
Priority:
Highest
-
US Core (FHIR)
-
3.1.1
-
Cross-Group Projects
-
US Core Implantable Device Profile
-
The original tracker request led to a series of changes which include the proposed changes. The statement that the request suggested changing was removed. The following changes should be applied:
1) The HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2 June 2020 HL7 Normative Standard (http://www.hl7.org/documentcenter/private/standards/HL7_IG_UDI_R2_2020JUN.pdf) indicates "Systems SHALL transmit the UDI value, SHALL do so using the Human Readable Form string (HRF) and
SHALL ensure that the OID or URL identifying the UDI assigning system is specified." ... So the expectation would be that if UDI is present, the HRF form is the minimum required.therefore:
a) remove the Device.CarrierAIDC from the profile
b) remove all references to Device.CarrierAIDS from the Introduction
c) remove invariant us-core-12
—
2) remove us-core-9 because is unable to express the intent to represent all PI contained in UDI.
—
3) Update section 18.96.1.1 to read:
Each Device must support:
- A Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode
- The Device Identifier (UDI-DI)
- a manufacture date
- an expiration date
- a lot number
- a serial number
- a distinct identifier (i.e., the distinct identification code)
—
4) Update the Profile specific implementation guidance to express the desired intent to represent all PI elements contained in the UDI
as preapplied - see screenshot:
The original tracker request led to a series of changes which include the proposed changes. The statement that the request suggested changing was removed. The following changes should be applied: 1) The HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2 June 2020 HL7 Normative Standard ( http://www.hl7.org/documentcenter/private/standards/HL7_IG_UDI_R2_2020JUN.pdf) indicates "Systems SHALL transmit the UDI value, SHALL do so using the Human Readable Form string (HRF) and SHALL ensure that the OID or URL identifying the UDI assigning system is specified." ... So the expectation would be that if UDI is present, the HRF form is the minimum required. therefore: a) remove the Device.CarrierAIDC from the profile b) remove all references to Device.CarrierAIDS from the Introduction c) remove invariant us-core-12 — 2) remove us-core-9 because is unable to express the intent to represent all PI contained in UDI. — 3) Update section 18.96.1.1 to read: Each Device must support: A Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode The Device Identifier (UDI-DI) a manufacture date an expiration date a lot number a serial number a distinct identifier (i.e., the distinct identification code) — 4) Update the Profile specific implementation guidance to express the desired intent to represent all PI elements contained in the UDI as preapplied - see screenshot: -
Brett Marquard/Marti Velezis: 8-0-0
-
Enhancement
-
Non-compatible
To clarify this condition, additional text was added.
Existing Wording:
us-core-9: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) SHALL be present.
Proposed Wording:
us-core-9: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) SHALL be present. If the UDI-PI is in the UDI Carrier, it should be provided as its individual element.
(Comment 46 - imported by: Jean Duteau)
- is voted on by
-
BALLOT-14949 Negative - Mitra Rocca : 2021-Jan-FHIR US CORE R1 STU2 STU
- Balloted