Task 4. Contract No. 223-04-6051, Consolidation of GMDN, UMDNS and CDRH Terminologies
Task 4
White Paper
Automatic Identification of Medical Devices
Final Version
August 17, 2005
Prepared for:
Food and Drug Administration
Center for Devices and Radiological Health
Mailstop HFZ-541
1350 Piccard Drive
Rockville, MD 20850-4307
Project Officer: Brockton Hefflin, MD, MPH
Contract No. 223-04-6051, Consolidation of GMDN, UMDNS and CDRH Terminologies
ECRI
5200 Butler Pike
Plymouth Meeting, PA 19462
Phone (610) 825-6000
Fax (610) 834-1275
Task 4, Contract No. 223-04-6051 Automatic Identification of Medical Devices
Page i
i Task 4 FDA Contract No. 223-04-6051 Automatic Identification of Medical Devices. Prepared by ECRI, July 2005
TABLE OF CONTENTS
1
INTRODUCTION ..............................................................................................................................................2
2 METHODS USED TO IDENTIFY THE LITERATURE...............................................................................3
3 TECHNOLOGY OVERVIEW..........................................................................................................................4
3.1
BAR CODE IDENTIFICATION SYSTEMS...............................................................................................4
3.2
RADIOFREQUENCY IDENTIFICATION SYSTEMS .................................................................................7
3.3
DIFFERENCES BETWEEN BAR CODING AND RADIOFREQUENCY IDENTIFICATION SYSTEMS...............10
4 WHO IS USING AUTOMATIC IDENTIFICATION TECHNOLOGY?...................................................13
5 HOW IS AUTOMATIC IDENTIFICATION TECHNOLOGY BEING USED WITH MEDICAL
DEVICES? .................................................................................................................................................................15
6
POSITION STATEMENTS.......................................................