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Unique Device Identification

 

 

What is Unique Device Identification?

 

U.S. Food and Drug Administration (FDA) has established a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in a human and machine-readable format. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public can search and download information from the FDA at AccessGUDID.

 

The UDI system, which is being phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. FDA states UDI implementation will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.

Philips recognizes and supports the MHS mission—which extends beyond combat medicine to healthcare delivery, education, public health, R&D and private sector partnerships to advance health for the Defense community.

 

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How is Philips implementing UDI labeling?

 

Philips is introducing UDI labeling across our products intended for distribution in the US, over the course of several years.

 

In accordance with FDA’s staggered compliance dates, Philips is, and will continue to, implement new UDI labeling over the next few years for our Medical Device. We have adopted 1D GS1-128 barcode and 2D GS1 DataMatrix barcode to comply with UDI requirements from the FDA.

 

UDI Wisp
UDI Diagram

Barcodes

 

2D barcodes require an image scanner that can read text both vertically and horizontally, which allows them to store more information.

1D barcode scanners can only read text horizontally.

IMPORTANT: 2D barcode scanners can scan both 2D and 1D barcodes; however, 1D barcode scanners cannot read 2D barcodes.

What are the GS1 standards?

 
  • GS1 is the most widely used supply chain standards system in the world.
  • The GS1 Standards are used globally by manufacturing companies to ensure data captured from GS1 barcodes are unambiguous, and can electronically communicate this data to inventory management systems.
  • The GTIN and other key product identifiers are automatically identified when the barcode is scanned. For example, when scanning a serial number/barcode, a “(21)” will appear before the actual serial number. This notifies any GS1 compliant scanner or system that the numbers after the “(21)" are a serial number and not a random set of numbers.
  • To learn more about GS1 Healthcare, please visit www.gs1.org/healthcare

When will UDI be implemented?

 

Labels and packages must bear UDI for devices manufactured after the relevant compliance dates except where the rule provides for an exception or alternative.

Timeline

September 24, 2014

Class III Medical Devices (majority of Personal Care products)

September 24, 2015

Class II implants and life-supporting/sustaining devices

September 24, 2016

All other Class II devices (majority of Philips Heathcare products)

September 24, 2018

Class I devices (majority of Personal Care products)

What does it mean to the customer?

 

The UDI system offers a number of benefits that will be more fully realized with the adoption and integration of unique device identifiers into the healthcare delivery system.

 

  • You will start to see either GS1 compliant linear or 2D barcode on Philips medical devices and packaging.
  • Standalone Software medical devices will also contain a UDI on the ‘About’ or ‘Splash’ screens
  • Integrating UDI into your inventory may lead to efficiencies. To learn more about the potential benefits of UDI labeling, visit the FDA website.

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