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FDA > CDRH > Unique Device Identification > October 25, 2006 Public Meeting

October 25, 2006 Public Meeting on Unique Device Identification

FDA held a public meeting and vendor display on October 25, 2006 to discuss the issues associated with the development, implementation, and use of a unique device identification system and the use of various automatic identification technologies. For additional information about the Unique Device Identification initiative, please contact David Racine or Jay Crowley at CDRHUDI@fda.hhs.gov.

(Presentations are linked to presenter name, and will be added as they are made available.)

Welcome
Dr. Janet Woodcock
Deputy Commissioner for Operations

Introduction and Format of Meeting
Dr. Larry Kessler
Director, Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
Food and Drug Administration

Panel discussion on The Benefits and Costs of a UDI System

Panelists:

Discussion:

  1. What public health and patient safety benefits could be gained from having a standardized UDI system? How would such a system contribute to meeting device recall and adverse event reporting requirements, and to reducing medical error?
  2. What are the setup costs measured in time and other resources associated with the development, implementation, and use of a UDI system? What infrastructure or technological advancements are needed for hospitals and other device user facilities to be able to capture and use UDI for basic inventory control and recall completion purposes? How costly are these advancements?

Panel discussion on Design and Implementation of a System of UDI

Panelists:

Discussion:

  1. How should a UDI system be developed? What attributes or elements of a device should be used to create the UDI? Should unique device identifiers be considered for all devices? At what unit of packaging (that is, unit of use) should UDIs be considered (for example, the unit of use could be a box of examination gloves or an infusion pump)? Should UDIs be considered for different levels of packaging?
  2. What are the incentives for establishing a uniform, standardized system of UDIs? What are the barriers for establishing UDIs? What suggestions would you have for overcoming these barriers?

Panel discussion on The Development, Maintenance, and Use of a Repository for UDI-related Information

Panelists:

2:30 - 3:15 Panel discussion on The Use of Automatic Identification Technologies

Panelists:

Discussions:

  1. Should the UDI be both human readable and encoded in an automatic identification technology? Should a UDI be based on the use of a specific technology (e.g., linear bar code) or be nonspecific?
  2. If a bar code is recommended, is a specific type of symbology preferred? Should the bar code be ``compatible''' with those used for the drug bar code rule? Should the UDI be on the device itself (e.g., laser-etched) for certain devices?

Public Presentations

Wrap Up and Next Steps
Dr. Daniel Schultz
Director, Center for Devices and Radiological Health
Food and Drug Administration

Updated February 26, 2007

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