Commercial resources

Unique Device Identification for medical devices

Unique Device Identifier

Since 2013, Smith+Nephew has embarked on a significant initiative to achieve compliance with the U.S. federal government’s Food and Drug Administration (FDA) rule requiring that most medical devices sold in the U.S. bear a Unique Device Identifier (UDI). Similar to a barcode on consumer products, the UDI is a series of numeric or alphanumeric characters created through a global coding standard which enable the unambiguous identification of a specific medical device. The UDI is required on the label and, in some cases, the actual device and is the responsibility of the labeler of that device to implement.

Compliance

We will achieve compliance by the FDA deadlines on the first two requirements of this rule, which mandate that the UDI be included on the product label and that certain product attributes be submitted to the FDA’s Global Unique Device Identifier Database (GUDID), which serves as a public reference catalog for every device with an identifier.

Smith+Nephew is now focusing its efforts on another mandate for UDI compliance, Direct Part Marking, which requires the UDI to be permanently added to the device at the point of manufacture. This requirement applies only to those devices where the UDI is required on the device label, the device is intended to be used more than once and is reprocessed before each use. The intent is to enable traceability of these reusable devices after they are separated from their labeling or packaging.

Benefits of UDI

While often thought of as another mandatory regulatory requirement, the full electronic product data will provide considerable benefits, not only to hospitals and patients, but also to the industry and Smith+Nephew.

The use of a standardised data model provides a common language to identify, capture and store information about products across the industry

Labelling, GS1 and GDSN Standards

GS1, Global Standards, is a neutral, not-for-profit, international organization that develops and maintains standards for supply and demand chains across multiple sectors.

GS1 introduced the barcode in 1974 and manages the barcode standard used by retailers, manufacturers and suppliers. Industries such as retail and consumer products have used these standards for years, and the healthcare industry is quickly adopting them as well.

Smith+Nephew has adopted the GS1 bar code standard and its GTIN (Global Trade Item Number) identifiers to serve as a foundation for achieving UDI compliance. In fact, some of our customers in the U.S. as well as in countries like France, Spain, Japan and China already require GS1 compliant labels today.

During 2014 and 2015, in order to meet the UDI regulation, Smith+Nephew began the transition from Health Industry Bar Code (HIBCC) barcodes to standard GS1-128 compliant barcodes on all products globally.

Below is an example of an HIBCC bar code label and a corresponding GS1 compliant bar code label:

Current HIBCC Future HIBCC

In addition to adoption of GTIN product identifiers, we are implementing two other parts of the GS1 standards:

Global Location Number (GLN) can be used to identify a company’s physical locations and legal entities, enabling efficiency and accuracy in communicating and sharing location information.

GS1 Global Data Synchronisation Network® (GDSN) enables trading partners to automatically share their business data with each other, ensuring that that the data exchanged between them is accurate and compliant with universally supported standards. The GDSN consists of the GTIN product identifier and the GLN location identifier.

Click here to learn how to construct the UDI from products labeled prior to the UDI deadline

Smith+Nephew is pleased to announce that we have begun publishing product data via the Global Data Synchronisation Network (GDSN). GDSN is a network of interoperable data pools, which enables trading partners to securely synchronise master data. Working from a single source of truth, trading partners gain real-time access to accurate product data and trade item updates, which will enhance both patient safety and improve supply chain efficiencies.

We have partnered with GHX Health ConneXion℠ as our third-party GS1-certified data pool provider. As of December 2017, we have published our GDSN catalog in the United States, United Kingdom and Canada. We will continue to expand our publication to further markets throughout 2018.

Instructions for accessing Smith+Nephew's GDSN catalog:

STEP 1: If you do not already have one, select your own GS1-certified data pool provider here.

STEP 2: Through your data pool provider, subscribe to Smith+Nephew's GDSN catalog utilising our GLN 0885556000007.

STEP 3: Submit the following to GS1Enquiries@smith-nephew.com to ensure your subscription request is received:

Organisation Name
Type of organisation: Hospital, Group Purchasing Organisation, Third-Party Solution Provider, etc.
Primary contact name associated with GDSN, including email address.
Please let us know how your organisation would like to consume our GDSN catalog so we can better adapt our e-commerce strategy with our customers' needs.

Once we receive your request, we will review and notify you whether or not your subscription request has been approved.

We look forward to working with organisations to continue improving patient safety and your supply chain efficiencies through the implementation of GDSN and other GS1 standards.

For further questions regarding Smith+Nephew’s electronic product data GDSN, please contact your local customer service representative

The UDI is composed of a Device Identifier (DI) and one or more Production Identifiers (PI). The DI is found in the Public GUDID database by entering the Catalogue Number found on the product label and the PI(s) are found on the product label. The following steps will illustrate a method of constructing the UDI from a pre-UDI compliant label.

Step 1: Identify the Catalogue (Ref) Number next to a REF symbol - this is generally located in the top left-hand corner of the label. In the above example, the catalog number is 71358003.

Step 2: Identify the Lot or Serial Number next to the corresponding LOT or SN symbols. In the above example, the lot number is SAMPLE.

Step 3: Identify the expiration date next to a USE BY symbol. The expiration date in the UDI will be six numeric characters with the structure YYMMDD. If a label only represents YYYY-MM, use 01 as the day. NOTE: This is only applicable for sterile packaged products.

Step 4: Open the AccessGUDID website.

Step 5: Enter the Catalogue Number into the search field of AccessGUDID and click 'Enter'.

Note: If multiple records are returned, select the one which identifies Smith+Nephew, Inc. as the Company name.

Step 6: Click on the hyperlink to access details for the material in question:

Step 7: The DI is the 14-character series of numbers and can be copied and pasted to another document.

Step 8: The UDI also includes 'Application Identifiers' preceding the DI and the PI(s):
(01) precedes the DI.
(17) precedes the expiration date PI (for sterile products only).
(10) precedes the lot number PI or (21) precedes the serial number PI (one or the other will be present).

Step 9: Based on this example, the UDI is (01) 03596010532701 (17) 211001 (10) SAMPLE. For a non-sterile product, the UDI would only include the DI and the lot number with their respective application identifiers.;

For further questions regarding Smith+Nephew’s electronic product data, please contact your local customer services representative.

Direct Part Marking

Another mandate for UDI compliance, Direct Part Marking, requires the UDI be permanently added to reused and reprocessed devices at the point of manufacture.

Read the FDA Unique Device Identification: Direct Marking of Devices - Guidance for Industry and Food and Drug Administration Staff

More specifically, a medical device must bear a permanent mark with the Unique Device Identifier if all of the following factors apply:

Smith+Nephew GTINs