|Submitted By: Terrie Reed / Symmetric Health Solutions|
|Data Element Information|
|Rationale for Separate Consideration||The UDI-PI lot is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device to be determined.|
|Use Case Description(s)|
|Use Case Description||Referring to the UDI in USCDI without specifying the separate parts of the UDI has introduced unnecessary confusion for device users that are scanning the UDI. The use of UDI as a full string for documenting UDI is only necessary for data validation, not to add meaning for tracking a device and associating that device with a patient. The UDI-DI and each part of the UDI-PI (lot, serial, expiration date, manufacturing date, and donation identification number) are the values that should be stored and exchanged separately in Health IT systems. The UDI-DI is used as a field in adverse event reporting, recalls, claims, materials management and inventory control to track the device at the model version level. These use cases are currently being documented in the HL7 UDI Implementation Guidance Requirements document. The document was first balloted in September 2020 and is expected to be published by the end of the year.
|Estimated number of stakeholders capturing, accessing using or exchanging||Every stakeholder that would capture access, use or exchange the UDI would more appropriately capture, access, use or exchange the UDI-DI and parts of the UDI-PI.|
|Link to use case project page||https://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1238|
|Use Case Description||Links to additional use cases
UDI: A Roadmap for Effective Implementation by The Brookings Institute https://www.fda.gov/media/91988/download
Implementing Unique Device Identification: Recommendations for Integrating Medical Device Data Throughout the Health Care System by The Pew Charitable Trust https://www.pewtrusts.org/-/media/assets/2015/09/udiimplementation-report.pdf
MDEpINET Building UDI into Longitudinal Data for Device Evaluation Final Summary Report and Roadmap http://mdepinet.org/wp-content/uploads/BUILD-Update.pdf
|Estimated number of stakeholders capturing, accessing using or exchanging||It is estimated that approximately 200 million people would use, be exposed to or derive better data to make decisions about implantable devices after the UDI were separated into discrete fields. This estimate is based upon the following approximations and assumptions that would also be be more accurate if the UDI were split into UDI-DI and UDI-PI and all of this data were available in health records.
Approximately 12 million implant procedures performed in the US per year.
An average implant life of 10 years
100 million people in the US with at least one implant – 20% estimated to have multiple implants – this is equivalent to 1/3 of US population over 50 years old
Average US household of 2-3 people with estimate that at least one other person besides the person with the implant cares about the implant
Approximation - 200 million people would benefit from having UDI or know someone they care about with an implanted device and would benefit from the information.
|Maturity of Use and Technical Specifications for Data Element|
|Applicable Standard(s)||Please see FDA UDI regulation and FDA Data Elements Reference Table - see
Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download
UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20
|Additional Specifications||HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2 (Normative)
Women's Health Technologies (WHT) Coordinated Registry Network (CRN) FHIR Implementation Guide (STU)
HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 - US Realm (STU)
|Current Use||In limited use in production environments|
|Number of organizations/individuals with which this data element has been electronically exchanged||2-3|
|Restrictions on Standardization (e.g. proprietary code)||The UDI-DI and UDI-PI currently exist in human and machine readable format on the label of devices. The UDI-DI are publicly available in AccessGUDID. There are no restriction on the use of this data.
|Restrictions on Use (e.g. licensing, user fees)||No restrictions|
|Privacy and Security Concerns||The UDI-DI can be part of a limited or de-identified data set. See https://www.hhs.gov/hipaa/for-professionals/faq/2071/can-device-identifier-di-portion-unique-device-identifier-udi-be-part-limited-or-de-identified/index.html
The fact that UDI-DI must be separate from the remainder of the UDI to qualify as a limited data set provides more rationale for UDI-DI to be stored separately in HIT.
|Estimate of Overall Burden||To effectively implement UDI in healthcare a system should be storing each of the UDI parts separately. If the system is not, it is adding unecessary burden to the UDI adoption process.
An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.
Information from the submission form
|UDI-Production Identifier-Lot or UDI-PI-Lot||
The number assigned to one or more device(s) that consists of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download