Unique device identifier (UDI) FAQs

Q.

What is unique device identification?

A.

In 2013, the U.S. Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also need to be directly marked on a device intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format consistent with international standards and international practice.

A UDI is a unique numeric or alphanumeric code that consists of the following two parts:

  1. A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device
  2. A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following details when included on the label of a device:
    • The lot or batch number a device was manufactured within
    • The serial number of a specific device
    • The expiration date of a specific device
    • The date a specific device was manufactured on
    • The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular- and tissue-based product (HCT/P) regulated as a device1

Q.

Why did the FDA implement unique device identification?

A.

This final rule will substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. By making it possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use, the rule will reduce medical errors that result from the misidentification of a device or confusion concerning its appropriate use. The identification system established under this rule will lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. It will allow the FDA, healthcare providers and the industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby, gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to conform to a standard format to ensure those dates are unambiguous and clearly understood by device users.2

Q.

Why is BD changing its packaging to include a UDI?

A.

In 2013, the FDA released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a UDI on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI is also required to be directly marked on a device intended for more than one use and intended to be reprocessed before each use.

Q.

Will BD discontinue the use of catalog numbers?

A.

No, BD will continue to use catalog numbers in addition to GS1 Global Trade Item Numbers (GTINs) for device identification.

Q.

Can customers and distributors continue to use the current BD catalog numbers for orders?

A.

Yes. BD ordering processes will continue to utilize the current BD catalog numbers―the ordering process will remain unchanged if you prefer to order by BD catalog numbers.

If you are interested in using the DI (GTIN) for your electronic data interchange (EDI) ordering processes, contact your BD representative.

Q.

Will my invoices or packing slips look different?

A.

Yes. In addition to using the BD catalog number, BD has started enhancing invoices or packing slips to include both DI and PI information.

Q.

How can customers obtain additional UDI information for specific BD products?

A.

Contact your BD representative for specific information or visit AccessGUDID.

Q.

Which classes of medical devices does BD manufacture?

A.

BD produces all classes of medical devices. We also manufacture products that are exempt from the FDA UDI regulation, such as pharmaceutical products and research use only (RUO) products.

Q.

Will BD be providing product information online?

A.

Yes. BD has already started the process of populating the FDA Global Unique Device Identification Database (GUDID), which is a repository for product information. BD Class III products are already in the GUDID. Additional products will be added to the GUDID on or before the FDA UDI timeline.

Q.

Should I expect any disruptions while scanning BD products at the point of care and as part of my supply chain processes?

A.

Generally, you will find that new BD labels will be enhanced with additional data and will continue to function in your scanning processes. In the event that a DI or PI (and the associated catalog number and barcode) change as result of BD UDI implementation, you will be notified.


References
  1. UDI basics. U.S. Food and Drug Administration Web site. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIBasics/default.htm. Updated May 6, 2015. Accessed January 11, 2017.
  2. Unique Device Identification System. Federal Register Web site. https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system#h-7. Updated September 18, 2013. Accessed January 11, 2017.

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