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FDA Unique Identification system (UDI) For Medical Devices

FDA UNIQUE IDENTIFICATION SYSTEM (UDI) FOR MEDICAL DEVICES

FDA PUBLIC MEETING
OCTOBER 25, 2006

WHAT IS NEMA ?

• NEMA is the primary standards-development organization for medical imaging and therapy systems equipment
• Diagnostic Imaging and Therapy Systems Division members manufacture over 90% of the market for:
  • X-Ray (incl. mammography) and CT
  • Radiation Therapy
  • MR
  • Nuclear Medicine Imaging
  • Diagnostic Ultrasound
  • Medical Imaging Informatics (PACS)

UDI SYSTEM FOR MEDICAL DEVICES

• NEMA supports a practical, cost-effective UDI system which improves patient safety
• NEMA is ready to work with FDA and all key stakeholders to achieve this goal
• NEMA believes all key stakeholders must become involved in this process to ensure success

PROBLEMS, ISSUES

• Problem definition – What problem(s) are we trying to solve ? What is the scope of the problem(s) ?
  • Problem must first be specifically defined before manufacturers can begin to develop a “fix”
• Existing tools to address recalls – capital equipment already marked with serial numbers that are used to track product for recalls and adverse events. Tracking begins in manufacturing through installation
• Existing identification systems -Rad. Health Act requires identifiers on X-Ray components – new UDI system would conflict with existing requirements – 21 CFR 1010
• Same regulations need to apply to both users and manufacturers

PROBLEMS, ISSUES (cont’d.)

• Who will train users
• Cost impacts of increases in user/manufacturer infrastructure must be made known
• Electronic medical records - preserving privacy
• What kind(s) of identification technologies should be employed
• How should software revisions to devices be recognized

ESSENTIAL REQUIREMENTS FOR A UDI SYSTEM

• MUST Enhance patient safety,
• FDA must harmonize with existing systems/regulations- goal is global harmonization of requirements – one worldwide system
• MUST Provide only essential information related to patient safety to users and regulators - HIPAA
• Satisfy needs of FDA, manufacturers, users
• Require compliance from both manufacturers and users
• Provide flexibility – adapt to changes in technology
• Achieve “least burdensome” system which does not impose onerous regulatory or financial burdens

NEXT STEPS

• Form interdisciplinary Task Force representing hospital users, industry and FDA to define specific problem(s) to be solved
• Develop potential approaches, discuss with stakeholders
• Formally identify the process and next steps through the Task Force and/or Fed. Register
• FDA should publish meeting minutes and a cumulative summary from today’s meeting

CONCLUSION

• NEMA supports a practical, cost-effective UDI system which enhances patient safety
• Phase-in process must be gradual – e.g. 5 years
• Critical details, issues must be resolved
• “Grandfather” existing devices in the field
• Establish mechanism to periodically evaluate UDI system with all key stakeholders involved and revise system if needed – Linkage to performance goals – e.g. recalls, adverse event reporting – How is system working ?

CONTACT INFORMATION

• Richard Eaton, Industry Manager
• National Electrical Manufacturers Association
• 1300 N. 17th Street – Suite 1752
• Rosslyn, VA 22209
• Tel. (703) 841 – 3248
• Fax. (703) 841 – 3348
• E-mail: ric_eaton@nema.org

Updated October 26, 2006

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