- A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and
- A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- the lot or batch number within which a device was manufactured;
- the serial number of a specific device;
- the expiration date of a specific device;
- the date a specific device was manufactured;
- the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device."
- Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Enhance analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- Lead to the development of a medical device identification system that is recognized around the world.
- The ability to see all packaging units of measure in which the base item is available e.g. EA, BX/5, CA/50 (each, box of 5, case of 500, etc.) - this appears to be supported by the GUDID.
- The ability to get all necessary item attributes from one source of truth. The GUDID is initially mandating a limited number of item attributes (see chart above), for example the presence of latex or natural rubber in a product, its MRI safety status, etc. There are so many other possible attributes that would be useful, it would be nice if the FDA could start off with a much larger initial set, understanding that going back and adding them later will overall end up to be more onerous than including them from the outset. Examples of other useful attributes could include the presence of DEHP, BPA, etc,: safety-related attributes (e.g. hazardous status, flammability, active or passive safety system if it includes 'sharps.' etc.); usage-associated attributes (e.g. the maximum number of permitted reuses for a 'reposable', etc.); environmental-related attributes (e.g. special disposal requirements, if recyclable, if green or containing recycled product, etc.); and so on...
- The ability to 'trace' predecessor or successor items. The GUDID requires that a device get a new UDI if the product is changed or if certain attributes change (e.g. if the item goes from containing latex to not, if an item goes from non-sterile to sterile, etc., since such changes essentially result in a new product). When a new UDI is obtained and the 'old' product is no longer manufactured, the old UDI is "retired" - the 'package Discontinue Date' is entered and the 'Package Status' field value is changed from 'In Commercial Distribution' to 'Not in Commercial Distribution.' However, if the item is still being manufactured in a new version with a new UDI it does not appear that you can pull up the discontinued item in the GUDID and see the successor (new) product UDI number... Conversely, you apparently cannot go back and see predecessor version UDI. With changes and improvements occurring at a fairly rapid pace for some devices this would be an important ability, as a provider could have items on its shelf past a 'Discontinue Date'. Also related to this is the fact that some device manufacturers have a habit of changing their catalog numbers... This blogger is not aware if a good (i.e. "real") business reason exists for such a practice, and like others has wondered if this is being done uniquely to impede the ability of providers or third parties to develop cross-references between 'equivalent' products made by different manufacturers! At the 2013 UDI Conference one manufacturer attendee asked if they were allowed to change the UDIs on items even if they were not modified or new (the answer was 'yes')! 'Tracer' functionality in the GUDID would go a long way to help in ensuring transparency.
- The ability to either see or link to the device's recall history. The GUDID is designed to only contain Device Identifier information and not Production Identifier information. Given that one of the major benefits of UDI implementation is to make recalls easier, one would hope that as vendors inform the FDA of recalls (which would include both DI and PI information) the corresponding historical recall PI information can be pulled up via the DI in the GUDID when researching an item. This would be invaluable in multiple instances, for example when a provider is choosing between a number of items (UDIs) to carry one input could be the items' recall histories; or if a patient is researching potential implants; etc. It is not clear that this will be possible with the GUDID as currently envisaged.
- The ability to look up the UDIs of all the items present in a custom pack or convenience kit (for when they are individually available commercially that is...). For convenience kits or custom packs where the constituent items are also in commercial distribution, it would be most beneficial to pull up a kit DI and see the DIs of the constituent items!
FDA UDI page
GS1 and UDI
HIDA UDI page
Premier UDI page
AHRMM UDI page
AdvaMed UDI page
A simple guide to UDI
HIBCC UDI Resource page
The Healthcare Hub (GHX) UDI page
Brookings Roadmap for UDI Implementation
Note; All slides (except the "GUDID scorecard") courtesy of FDA, GS1, HIBCC handouts from the 2013 FDA UDI Conference.