Webinar on Traceability and UDI Compliance in Medical Equipment Manufacturing

Introduction

• Host: Peter Hoffman (VP of Marketing, Motion Solutions)
• Presenter: Felix Klebe (Marketing Manager, Omron Automation Americas)

Motion Solutions Overview

• Custom application-specific engineered systems for OEMs in medical, life sciences, semiconductor sectors
• Services: electromechanical design, prototype, and volume manufacturing
• Over 60 years of experience
• Distributor of linear motion and motion control products

Presenter Introduction: Felix Klebe

• Responsible for sensors, barcode readers, verifiers, RFID systems, laser markers, vision systems
• 25 years of product marketing experience
• Previously with Microscan Systems (acquired by Omron in 2017)

Webinar Agenda

1. High-level overview of UDI labeling requirements
2. Best practices for label inspection
3. Benefits of implementing traceability
4. Introduction to Omron's traceability 4.0
5. Omron hardware and software solutions for compliance and traceability

Unique Device Identification (UDI)

• Definition: Unique ID number for medical devices, mandated by FDA in 2014
• Purpose: Centralized identification for recalls and problems
• Requirements: Device identifier (DI) and production identifiers (PIs)
• Labeling Requirements: Human-readable plain text and AIDC technology form on the label/package
• Accepted Forms: Linear barcode, 2D Data Matrix, RFID tags
• Implementing Agency: GS1, an accredited issuing agency

Medical Device Classification & Deadlines

• Different requirements based on class (Class 1, Class 2, Class 3)
• Deadlines have passed for Class 2 & 3; upcoming for Class 1
• EU and Canada have similar regulations with slight variations

Labeling Best Practices

• Verification Points: Initial label design, prototyping, and during production
• Common Causes of Defects: Poor contrast, ribbon issues, substrate inconsistencies, clogged inkjets
• Pitfalls: Fine font, substrate inconsistency, low-resolution printers, over-inspection

Direct Part Marking (DPM)

• Used for reprocessable medical devices
• Data Matrix barcode and laser etching common
• Compliance with ISO 29158 and GS1 Table 7

Traceability 4.0

• Evolution: From basic barcode usage (traceability 1.0) to process visibility (traceability 4.0)
• Integration: Enhanced production efficiency, reduction in errors and non-compliance issues
• Benefits: Beyond regulatory compliance, improves overall business operations

Omron Solutions

• Verification Systems: Handheld and inline systems (e.g., LVS-9585 for direct part marks)
• Print Quality Inspection: Inline inspection systems (e.g., Zebra ZT600 series printers)
• RFID Systems: Not commonly used in unit-level labeling but valuable for traceability
• Vision Inspection Systems: Overall product quality checks beyond labeling
• Laser Markers: High-resolution fiber laser markers for DPM

FAQs

1. Regulations Update: Software updates provided at no charge, hardware updates depend on specific changes
2. EU & US Compliance: Separate compliance processes for FDA and EU regulations
3. Cost of Verification Systems: Inline system ~$20,000, offline handheld system ~$7,000 or less
4. Training: Separate line item, available in person or remotely

Additional Resources

• FDA and GS1 websites
• Omron website for product-specific information
• Support available from Motion Solutions and Omron

Conclusion

• Contact Motion Solutions or Omron for assistance with UDI and traceability implementation
• Webinar will be available on-demand through the Motion Solutions website