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
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.
More specifically, a medical device must bear a permanent mark with the Unique Device Identifier if all of the following factors apply:
check mark The UDI is required on the device label
check mark The device is intended to be used more than once
check mark The device is reprocessed before each use.
This will enable traceability of these devices after they are separated from their labeling or packaging. Class II and Class I instruments make up the majority of our products that need to be marked. The FDA deadline for Class III instruments is September 2016. Class II products must be compliant by 2018, with Class I devices following in 2020. We have chosen to implement 2D Barcoding with Human Readable text wherever possible.
Smith And Nephew GTINs
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