Unique Device Identification (UDI)
Unique Device Identification, often abbreviated UDI, is a rule created by the U.S. Food and Drug Administration (FDA) that requires medical device manufacturers to label their products with both a unique device identifier and production identifiers (such as expiration date and lot or serial number). The FDA has also created a database called the Global UDI Database (GUDID) to which manufacturers will upload product data and that will be searchable by the public. The FDA’s intent is to reduce medical errors and more quickly identify medical devices in the case of adverse events or recalls, in addition to providing an accessible source of definitive device identification information. Scanning barcodes containing standardized product information not only streamlines recall management, but also offers hospitals the opportunity to better manage inventory and integrate standardized product information into their electronic medical records. The FDA’s timeline for implementation of UDI is:
- Class* III - September 24, 2014
- All Other Implantable, Life Supporting, Life Sustaining Devices - September 24, 2015
- All Other Class II Devices - September 24, 2016
- All Other Class I and Unclassified Devices - September 24, 2018
*Class is the FDA medical device classification
For More information and for the full text of the rule, visit the FDA's website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm
GS1 is a data standards organization that regulates many standards across industries such as UPCs in grocery stores or ISBNs on books. The FDA accredited GS1 as an issuing agency to assign Unique Device Identifiers (UDIs). The standards organizations provide the UDIs and set the rules on how the barcodes containing those UDIs appear on the packaging.
Global Trade Item Numbers (GTINs). GTINs are the device identifier portions of the UDIs. Each device is assigned a GTIN, just as each device is assigned a catalog number, and that GTIN will appear in a barcode on its packaging down to the unit of use level.
Global Location Numbers (GLNs). Each manufacturer will have its own GLN which provides shipping and invoicing accuracy. GLN is part of the GTIN.
Halyard’s barcodes adhere to technical standards and dimensions prescribed by GS1. The application identifiers below are for demonstration purposes only. Bar code content and sequence may vary and will only include the applicable elements.
Due to space constraints, we may use a GS1 DataMatrix on roughly 10% of product codes for all levels of packaging instead of a GS1-128.
For more information, visit the GS1 website: http://www.gs1us.org/healthcare
Halyard evaluated the operational requirements needed to support the major process changes required to implement UDI successfully, and initiated the following:
- Established a formal GS1/UDI Program involving key representatives from every Halyard division
- Invested in technology standardization
- Aligned data definitions across functions to support the program requirements
- Created a barcode standard and a GTIN allocation standard
Here are some frequently asked questions about potential supply chain impact:
Q. How will the package labels change?
The GS1 barcode will be at both the unit of sale and, where applicable, a single unit, or the “each” level. See Label Changes section
Q. Will UDI affect my method of ordering products?
We will continue to use the catalog numbers in addition to GTINs, so you can order as you have been ordering. You will see GS1 barcodes on the packaging and your invoices and packaging slips will start to include GTINs as well as catalog numbers.
Halyard will continue to take orders, manage service requests, and conduct business using product catalog numbers, however, in most cases you may also use the product’s GTIN as a reference if you desire.
Q. Will All Halyard Product Labels Change?
Barcodes associated with global codes are changing in the following product families: surgical drapes and packs, surgical gowns, face masks, digestive health, radiofrequency devices, oral care and acute pain.
Q. Where can I find a list of Halyard GTINs?
Click here to download a list of products where GTINs are changing with UDI implementation
Q. What Should I do if I Can’t Scan my Barcode?
If your scanner could read your bar code before UDI but can’t read the concatenated bar code containing the UDI required data, your software can be updated or reformatted to interpret the scanned data. Please contact your bar code scanner hardware supplier and/or GS1 for support.
Q. What equipment do I need to use the new bar code?
Halyard has elected to use the GS1-128 linear bar code in the belief that most customers currently have capability to read this format. Any bar code reader with GS1 linear bar code capability can scan our bar codes. The processing of the information contained within the bar code depends upon the various capabilities of the software that the customer uses with the scanner. Where space limitations existed on labels and packaging, Halyard adopted GS1’s 2D DataMatrix format. Scanning of 2D DataMatrix bar codes requires an image scanner versus a linear bar code scanner. Halyard changed approximately 10% of its available SKUs to the DataMatrix format at 1 or more levels of packaging. DataMatrix bar code scanners are readily available via your bar code scanning supplier. Please contact your bar code scanner hardware supplier and/or GS1 for support.
Q. What information will a UDI contain?
UDI = DI + PI
- DI: Device Identifier: company ID, device ID for a specific version or model
- PI: Production Identifier: lot number, serial number, manufacture date or expiration date if these are on the label in human readable form, then they must be included in the bar code.
- Must be both human readable and electronically scannable
UDI will also tie in to a publicly available FDA database containing 50-60 product data attributes for each UDI.
Q. How will UDI information be used by the FDA?
FDA intends UDI will be phased in over several years and offer several benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernize device post-market surveillance and clinical registries, and facilitate medical device innovation. It will drive the marketplace to develop practices and technology to realize the potential benefits more fully.
Q. We have products with older packaging- would they be re-packaged or re-labeled to meet his requirement?
The UDI rule allows three years after the compliance date to deplete existing inventory. Inventory on the market after the three-year mark, if any, should be withdrawn from the market.
Q. Who can I contact if I have questions about Halyard’s GS1/UDI initiative?
Please contact your local Halyard representative for more information about UDI.
We recognize that organizations are being challenged to improve patient safety and quality of care while lowering costs, increasing efficiencies, and adapting to new regulations.
To support these initiatives, Halyard is updating our product labels to include barcodes that conform to standards created by GS1. GS1 develops and maintains standards for supply and demand chains across multiple sectors, including the healthcare industry.
This transition will support visibility across the entire supply chain, enabling consistent information transfer from manufacturing sites to hospitals, clinics, and patient treatment centers.
GTIN Only Barcode (Typical Halyard Barcode Prior to UDI)
Concatenated Linear Barcode with UDI required PI
Data Matrix Barcode
If the label contains a 2D bar code that was not on the package before, check the specifications of your scanner. If they show GS1 DataMatrix as a viable format, the scanner may be able to scan the GS1 DataMatrix with some reformatting. If it does not, there are scanners that are specified to scan that barcode type.
Halyard is following the U.S. FDA compliance deadline to assign a Unique Device Identifier to applicable products, which will be incorporated into product label barcodes based on the FDA’s medical device classification.
What is changing?
Until existing product inventory is depleted, there may be Halyard products in circulation with
both the new GS1 standard barcodes and the pre-UDI versions in which bar codes may not contain production information and legacy GTINs. Click here to obtain a list of Halyard products where GTINs are changing with UDI implementation.
Due to space constraints, Halyard may use a GS1 DataMatrix on roughly 10% of product codes for all levels of packaging instead of a GS1-128. Your inventory scanning system may need to be configured to recognize both linear and 2D formats.