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Healthcare Business Solutions
September 19th, 2016

Learn more about the UDI class II device deadline


Learn more about the UDI class II device deadline

With the recent September 24, 2016 deadline of the FDA unique device identifier (UDI) regulation for class II products, we interviewed our two subject matter experts, Dheepa Lekshmanan, global UDI program manager, and Karen Bradburn, manager of Regulatory Affairs. Dheepa and Karen have been, and will continue to be, focused on the implementation of UDI for all Cook products.

What is a UDI?

UDI stands for unique device identifier and is a numeric code on a device label, on the packaging, or on the device itself that includes the device identifier (DI) and the product identifier (PI). The UDI contains a number unique to the device, a manufacturing number, a date of expiration, and a date of manufacturing.

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When is the UDI class II device deadline and what does it mean?

Full UDI implementation for all classes of medical devices will occur between now and 2020. The classes of medical devices are: class I, class II life-supporting, life-sustaining, and implant, all other class II, and class III. All classes of medical devices have the same regulations and requirements in order to create a common standard.

The next phase of the process, the UDI class II device deadline, was September 24, 2016. For the class II deadline, the labeling and packaging of a medical device has to be aligned with the new UDI regulation. This means that the medical device label should now have the UDI number in human-readable numeric format and updated barcoding on all class II products as of September 24, 2016.

In addition, each DI has been submitted to the FDA’s Global Unique Device Identification Database (GUDID) as a UDI record as of September 24, 2016. The GUDID is a global database that will include a standard set of basic identifying elements for each device with a UDI.

What does this deadline mean for the healthcare industry?

UDIs help provide a common language across the industry. Specifically, the class II device deadline helps the industry reach a critical mass as many more devices become UDI compliant. The next phase of UDI implementation will allow the industry to further operate more efficiently, provide better product traceability, enhance patient safety, and improve outcomes.

Prior to UDI, there was not an industry-wide unique device identifier, which made it difficult for health systems to find and trace products.

What does the adoption of UDI mean for Cook?

We believe the greatest benefits of UDI will not be possible until there is industry-wide adoption. UDIs help to provide a common standard for the industry in terms of product identification.

Ultimately, we want to make decisions based on what is best for the patient. UDIs have helped us better manage our data and have enhanced our ability to identify, at any time, where a product is in the supply chain, ultimately allowing us to identify which patient has which device.

How many Cook products have been uploaded to the GUDID database?

Device class Number of devices uploaded into the FDA’s GUDID system
Class III 370
Class II life-supporting, life-sustaining, and implant 1,585
Class II (all other) 6,500

What does this mean for healthcare professionals?

While September 24, 2016 is the deadline to have UDI-compliant labels, that does not mean that as of September 24 class II device labels on hospital shelves are UDI compliant. There is a three-year grace period for the UDI labeling component for medical device inventory that has already been manufactured.

As a result, after September 24, 2016, stock medical device products will be allowed to be shipped with the current label. However, any products that are manufactured after September 24 should have a UDI-compliant label.

Where can I learn more?

Be a part of the transformation as we work to make healthcare more efficient through data standards to ultimately improve patient outcomes.