The U.S. Food and Drug Administration (FDA) created unique device identification, often abbreviated UDI, a rule that requires medical device manufacturers to update their products with a unique device identifier that includes both device and production identifiers (such as expiration date and lot or serial number).
Download all items (Excel file of Stryker's Global Trade Item Numbers, new GTINs updated daily as new GTINs are registered with the FDA), ortho kit scan sheets (updated daily as GTINs are registered with the FDA), ortho kit list cover sheet (updated quarterly) and patient label list (updated quarterly). For questions regarding the GTIN download file, please email GTINDownloadReport@stryker.com.
The U.S. Food and Drug Administration (FDA) created unique device identification, often abbreviated UDI, a rule that requires medical device manufacturers to label their products, and in some cases, direct product markings, 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 upload product data and that is 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 timeline for our implementation of GS1 barcodes on labels is in line with the FDA’s timeline for UDI:
*Class is the FDA medical device classification
For more information and for the full text of the rule, visit the FDA’s web site: 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 also set the rules on how the barcodes containing those UDIs appear on packaging.
Three key aspects of GS1 include:
We conducted a survey of our customers globally and determined that the industry was moving toward the GS1 standard. We evaluated whether we should keep both existing HIBC codes and new GTINs on the labels, but based on input from customers and key stakeholders, we determined that it was confusing to have multiple barcodes on packaging. Through this initiative, we will transition our labels from HIBC to GS1.
For more information, visit the GS1 website: http://www.gs1us.org/healthcare
We evaluated the operational requirements to support the major process changes required to implement UDI successfully and initiated the following:
Here are some frequently asked questions about how the project may impact providers.
No. All products manufactured after the UDI dates provided by the FDA will have GS1 barcodes; however, there will still be HIBC-labeled product in inventory.
We are currently evaluating several GDSN data pools and plans to move forward with publishing product data to a GDSN. We will communicate the timelines for GDSN after we establish them.
Some products may be ordered by GTINs. EDI orders for products that have a GTIN assigned must have both the GTIN and catalog number. We will also maintain the option for you to order by catalog number.
You will see our labels transition from a stacked HIBC linear barcode to a concatenated GS1-128 linear barcode.
On a few packages where a concatenated GS1 barcode will not fit, you may see 2 GS1 barcodes carrying the same content.
In addition, you may also see a 2D (or data matrix) barcode.
The GS1 barcode will be at both the unit of sale and, where applicable, a single unit, or the “each” level.
Some products also are required to be directly marked with the UDI. In general, this applies to products that are reused and processed (sterilized, disinfected) between uses.
We will continue to use the catalog numbers in addition to GTINs, so you can order as you have been ordering. Nothing will change except that you will see GS1 barcodes on the packaging and your invoices and packaging slips will start to include GTINs as well as catalog numbers.
Yes. By the end of the project, all medical devices we sell globally will have a GS1 label.
You can download the list on here: stryker.com/gtin.
Email questions to UDIquestions@stryker.com.
For questions regarding the GTIN download file, please email GTINDownloadReport@stryker.com.
We recognize that organizations need to improve patient safety and quality of care while lowering costs, increasing efficiencies, and adapting to new regulations. To support these initiatives, we updated our product labels to include barcodes that conform to standards created by GS1. More information can be found in the brochure at the link below.
SYK CORP 2017-08-36