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Unique Device Identification (UDI)

New FDA Regulations

C15924 UDI Infographic

What products are affected

  • Halyard Health, as a medical device manufacturer, is committed to meeting the deadlines outlined by the FDA and is currently validating and submitting each Class 2 SKU into the GUDID. 
  • Validated SKU’s are being added daily to the database, and will continue to be, until all Class 2 and, subsequently, all Class 1 devices are complete.
  • For data integrity, the AccessGUDID website is your best resource of validated Halyard Health SKU information.

Click here for a complete listing of our codes tied to the UDI barcode change

To find out which SKU's have been accepted by the FDA, visit the AccessGUDID website: https://accessgudid.nlm.nih.gov/.

Submissions may be searched by Catalog Number, Company Name, Product Description, etc. 

What How Why UDI

WHAT IS UDI?

  • A new mandatory FDA initiative
  • A system that identifies and provides data on medical devices from manufacturing all the way through distribution & use
  • One convenient source for fast, accurate device information that's available to everyone
  • The Food and Drug Administration has set the following deadlines for compliance with the UDI directive for Medical Devices:
    • Class 2 Devices: September 24, 2016
    • Class 1 Devices: September 24, 2018

HOW DOES IT WORK? 

  • The public (patients, healthcare providers, etc.) can view device data via the FDA's Access GUDID portal at the click of a button anytime, anywhere
  • Each device label will include a readable UDI code
  • The code may include company ID, device ID, model or version, lot number, serial number, manufacturing or expiration date
  • When the code is entered online, it connects to the FDA Global Unique Device Identification Database (GUDID) where all the information is stored and kept current
  • Manufacturers of Class 1 and 2 Medical Devices, including Halyard Health, are required to submit UDI information to the Global Unique Device Identifier Database (GUDID) by the above deadlines.
  • Submissions to the GUDID include: Package Levels, Contents and the Device Identifiers (Global Trade Identification Numbers (GTIN) for each SKU and package level. 

WHAT ARE THE BENEFITS? 

  • Transfer of information to support decision making at point of care
  • Improve recall management and safety communication
  • More effective supply chain processes
  • Better health care operations management

The ultimate benefit: Improved patient safety!

Where Does Udi Appear

 UDI BARCODE Example

  • On every level of packaging except shipping containers (pallets, cargo transport containers, etc.)
  • On the device itself if it is reusable by different patients (generally not applicable to Halyard devices)

Proactive Udi

  • No supply interruption due to lack of compliance
  • No major quality/regulatory issues (field action, recalls)
  • No lost business due to customer dissatisfaction with implementation schedule
  • It fulfills the Halyard mission of moving CARE FORWARD* because we believe that when you put care first, healthier living is contagious Now it’s time to move forward. We’re bringing that belief with us and focusing on preventing infection, eliminating pain and speeding recovery. 

MAKING UDI HAPPEN AT HALYARD

NOTE: Quality, Labeling, Regulatory, Procurement, Manufacturing teams will play a major role

UDI WILL SUPPLEMENT EXISTING BAR CODE

Are you ready to take advantage of material management benefits and enhanced product information? Let Halyard help you prepare.

  • Quality systems updated to include UDI
  • New procedures and work instructions set up (label inspection, UDI included on MDRs, etc.)
  • Establish “single source of truth” for all product-related data going into GUDID
  • Second deadline to begin compliance is September 24, 2016 for Class II Devices.

QUESTIONS ABOUT UDI?

Contact Customer Service at 1-844-425-9273

You may also visit: http://www.fda.gov/udi