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FDA Meeting On Unique Identifier for Medical Devices - Panel discussion on Use of Automatic Identification Technologies

FDA Meeting On Unique Identifier for Medical Devices - Panel discussion on Use of Automatic Identification Technologies

James P. Keller
Vice President
Health Technology Evaluation and Safety

October 25, 2006

Introduction

• Background
• ECRI white paper on automatic identification of medical devices
• Some issues to consider
• Including ECRI perspectives
• Panel discussion

ECRI Overview

• World’s most comprehensive source of information on healthcare technology (i.e., medical devices and systems)
• Serves healthcare community with a variety of advisory services, publications, and databases
• Non-profit organization chartered in 1955
• A Collaborating Center of the World Health Organization
• Consumer Reports-like evaluator of Healthcare Technology

Background

• Obvious potential value in using unique identifiers for medical devices
• Patient safety
  • Assisting with recalls
  • Tracking medical device incidents
  • Identifying incompatible or counterfeit devices
• Inventory management
• Cost containment
  

Background …

• Key challenges include
  • Diversity among device types to be identified
  • Diversity among types of identification technologies
  • Nonstandard approach to device identification and inventory management
  • Implementation costs

ECRI’s White Paper

• Extensive overview on automatic identification of medical devices
• Commissioned by FDA
• www.fda.gov/cdrh/ocd/ecritask4.html
• Review of identification technologies
• Analysis of available literature
• ECRI commentary

ECRI’s White Paper …

• Technology overview
  • Bar code identification systems
  • Radio frequency identification systems
• Detailed discussion of automatic identification technologies for medical devices
  • Who is using it
  • How it is being used
  • Potential benefits of the different technologies
• Stakeholders, position statements, standards, existing unique identifiers, nomenclature, etc.
  

Sample White Paper Content

• Bar code identification
  • Line of sight (i.e., limited range) with handheld readers
  • Widely adopted
  • Relatively inexpensive
• Radio frequency identification
  • New and emerging technology
  • Can be used over a wide range within a healthcare facility
  • Costs for tags, readers, and associated software relatively high

Issues to Consider

• Varying sizes of medical devices
• Sterilization and disinfection of reusable medical devices
• Growing number of devices with built-in software and interconnections
• Human readable vs. “machine” readable identifiers
• Rapid evolution of “reader” technologies

ECRI Perspectives

• Automatic identification of medical devices has tremendous potential
• Diversity – on a variety of levels – will make universal implementation very difficult and costly
• Consider addressing high-value technologies first
• Rapid evolution of identification technologies will limit our ability to standardize on one method

Panel Discussion

Thank You!

James P. Keller, Jr., M.S.
Vice President
Health Technology Evaluation and Safety
ECRI
5200 Butler Pike
Plymouth Meeting, PA 19426
(610) 825-6000, ext. 5279
jkeller@ecri.org

Updated October 27, 2006

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