Attribute: Device Identifiers
A Device Identifier is a value issued by GS1 (GTIN) and HIBC (HIBCC) for inventory management and to support clinical documentation with an increased ability to scan items.
Data Sources
The source for Device Identifiers is from multiple sources, such as:
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Manufacturer catalogs
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FDA's AccessGUDID
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Global Data Synchronization Network (GDSN)
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Distributors for white labeled products
Standardization
Device identifiers are reliant on the accuracy of FDA's AccessGUDID-submitted data.
GUDID captures multiple device standards: GTIN (GS1), ICCBBA, HIBCC.
FDA requires that manufacturers submit all UDI information to the GUDID, unless an exception is mentioned otherwise. While GUDID has field-based requirements, they are highly open to interpretation by each submitting organization (e.g. catalog number). There is no audit process in place to validate the accuracy and reliability of said data (e.g. implantable flag, latex, etc).
GTIN and HIBCC codes are broken down as follows:
Primary Device Identifier (DI)
A Primary DI is the lowest packaged DI; the main lookup for a device (e.g. pack of lab test strips).
GHX makes a recommendation based on the comparison of the provider's Primary DI and the GHX Primary DI. A UOM comparison is not needed.
Unit of Use DI
A Unit of Use DI is the identifier assigned to an individual medical device when the Primary DI has a "count of devices" greater than 1 (e.g. individual test strip).
GHX makes a recommendation based on the comparison of the Provider's Unit of Use DI and the GHX Unit of Use DI. A UOM comparison is not needed.
Package DI
A Package DI is the infrequently populated identifier when additional packaging is submitted for a device (e.g. case of test strips).
GHX makes a recommendation based on the comparison of the provider's Package DI and the GHX DI only when a match is found between the provider's Package DI UOM and the GHX DI.
A GHX DI and GHX DI UOM can be added to the customer's ERP system when the provider's Package DI UOM and GHX Device DI UOM does not match, or provider Package DI UOM does not exist.
Considerations
Device Identifiers
GHX recommends up to five Device Identifiers/UOMs per product.
Data comparisons are made depending on how the customer manages Device Identifiers in the ERP for their business processes.
This view will display the item recommendations for the scope of approval – Device Identifiers. (GTIN)
This view will display a single list of Device Identifier recommendations grouped by Buyer Part # and GHX Manufacturer Part #.
Recommendation Management
GHX can work with your organization to set your integration configuration to manage device identifiers for your specific business needs.
In Recommendation Management providers’ administration users can:
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Select to review device identifiers issued by GS1, HIBC (Health Industry Bar Code), or both.
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Select to review only Unit of Use and Primary device identifiers versus all device identifiers which includes packaging device identifiers.