Slide 1 Live Demonstration The Auto ID Technologies & In-House Systems for UDI Compliance Brought to you by the AIM North America Healthcare Committee
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Slide 1
Live DemonstrationThe Auto ID Technologies &
In-House Systems for UDI Compliance
Brought to you by the AIM North America Healthcare Committee
Slide 2
AIM represents…Automatic Identification and Data Capture
RFID
Mobile Computing
Bar Code
Other AIDC
Slide 3
AIM and AIDC standardization
• For more than 40 years, AIM has served as the worldwide authority on AIDC (Automatic Identification and Data Collection) technology and standards.
• Draft standards provider to ANSI and ISO
• Supports all technologies to identify “things” that need to have standards for interoperability
• The IT System is the hurdle, not AIDC technology
Slide 4
AIM NA is focusing on related FDA initiatives• UDI: Unique Device Identification (now)
– Medical devices – Patient care, diagnostic, or treatment devices
• SNI: Standardized Numeric Identification (near future)– Prescription drugs – Pharmaceuticals – Biologics – Vaccines
Slide 5
Systems for Data Management and Label Printing
AIM North America Healthcare CommitteeArdi Batmanghelidj
Chairman Healthcare Committee
Slide 6
Components of UDI Compliance• Where is the data? • Getting the data to the GUDID • Labels and Direct Part Marking
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Dusty Files in Storage?
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Spread Sheets?
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Labeling Systems?
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ERP and PLM Systems?SAP
JDE
Oracle
Agile
Documentum
Team Center
BPCS
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Get It All inOne Place
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• Add data elements through configuration not programming
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• Prevent manual entry and retrieve data from other systems
• Allow manual entry when this system is the Single Source of Truth
• Manage row and column level security
• Use drop-downs for accuracy
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• Filtering and adhoc data retrieval is critical
• At the beginning, data cleansing will require bulk action on many items
• Excel is a good second option but it has no audit trail
• Electronic signatures will be required for approval
• Part 11 compliance must be enforced
Slide 15
• Unapproved record
• Protected and system driven Statuses
• Locally maintained data
• Device description retrieved from remote system. On demand or scheduled
• Codes as drop down from other Tables
Slide 16
Communicate Data to FDA GUDID
1. Direct communication using ESG and HL7
2. Upload to a GS1 data pool which will send data to GUDID
3. Use third party GUDID upload providers
4. Plan for other regulatory databases
Slide 17
Master
Data
ERP
Data
M_GTIN L_Exd/YYMMDD
L_Num
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• Configure, don’t program
• Ability to present any data element in the database on a label or Direct Part Marking (DPM)
Slide 19
• HIBC codes are just a different representation of the same type of data
Slide 20
Issuing Agencies for UDI encoding in AIDC
• Each has a system for encoding medical devices’• Device Identifiers• Production Identifiers (may have multiple fields)
• Each assigns Enterprise Identifiers, which are intended to be concatenated with Product Identifiers
or
Slide 21
• GS1-128
• GS1 Data Bar
• GS1 Data Matrix
• RFID EPC Gen 2 UHF Tag
• Code 128 and Code 39
• Data Matrix, QR Code, Aztec Code
• RFID ISO 18000-6c UHF Gen 2 tag
• ISBT128
• Data Matrix
• RFID ISO 18000-3 mode 1 HF tag
Slide 22
Live Demo
Slide 23
Direct Part MarkingAIM North America Healthcare Committee
Peter Ginkel
Slide 24
Direct Part Marking
• Direct Part Marking (DPM) is a process to permanently mark parts with product information including serial numbers, part numbers, date codes and barcodes.
Slide 25
Direct Part MarkingDPM is generally suggested in applications where:
• Traceability is needed after the product is separated from its temporary identification
• The part is too small to be marked with bar code labels or tags• The part is subjected to environmental conditions that preclude the use of add-onidentification data
Slide 26
• Non-Intrusive Marking: A method of marking by adding material to a surface. Nonintrusive marking methods include ink jet, laser bonding, liquid-metal jet, silk screen, stencil, and thin-film deposition.
Direct Part MarkingIntrusive vs. Non-Intrusive Marking
• Intrusive Marking: Any device designed to alter a material surface to form a human- or machine-readable symbol. This marking category includes, but is not limited to, devices that abrade, burn, corrode, cut, deform, dissolve, etch, melt, oxidize, or vaporize a material surface.
Slide 27
AutomotiveAerospaceMedical Devices
Direct Part Marking
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NASATECHNICALHANDBOOKNASA–HDBK-6003C
NASATECHNICALSTANDARDNASA–STD-6002D
NASA Technical References
Slide 29
Traditional Impact Stamps
Slide 30
Traditional Impact Presses
Slide 31
Computer Controlled Direct Part Marking (DPM)
Dot Peen Marking– Mechanical indentation of surface
Slide 32
Computer Controlled Direct Part Marking (DPM)
Laser Marking– Controlled intense thermal energy
Slide 33
Etching/Engraving
Laser Marking
AnnealingDiscolorationLaser BondingLaser Bondingcompound
Workpiece
Mark
Laser Beam
Slide 34
Typical Laser SystemPopular laser types1. Carbon Dioxide CO2
2. Fiber
3. Green
Slide 35
Cathode
AnodeElectro-etching is a metal etching process that involves the use of a solution of an electrolyte, an anode and a cathode.
Electro-etching
Slide 36
Dot Peen Marking
Slide 37
Dot Peen Marking
Slide 38
Typical Dot Peen SystemPin actuation1. Electric
2. Pneumatic
Slide 39
What is Bar Code Verificationand Why Do I Need It?
AIM North America Healthcare Committee
Tim Lydell
Slide 40
Validationvs
Verification
Slide 41
Validation
Slide 42
Bar Code Scanners will:• Recognize bar code symbology and report the
content of the bar code being scanned• Will the next scanner read it?
– Not all scanners are of equal quality
• Scanning will give no indication of your print quality
Slide 43
Verification
Slide 44
There are Generally Two Types of Bar Code Verifiers
Standard Verifiers Direct Part Mark Verifiers
Slide 45
Bar Code Verifiers Will:Analyze your bar code against a set of International Standards, Application Standards, and Regulatory Requirements and grade the bar code and report defects.
Slide 46
Manufactured to ISO/IEC Standards
15426-115426-2
1541515416
Slide 47
ISO/IEC 15426-1Defines the Test Methods and Minimum
Accuracy Criteria for Linear (1D) Bar Codes
1D Bar Code Example:
Slide 48
ISO/IEC 15426-2Defines the Test Methods and Minimum
Accuracy Criteria for Two-Dimensional (2D) Matrix Symbologies
2D Bar Code Example:
Slide 49
ISO/IEC 15415Specifies the Methodology for Measuring
the Accuracy of Two-Dimensional (2D) and Multi-Row Bar Code Symbologies
2D Bar Code Example Multi-Row Bar Code Example
Slide 50
ISO/IEC 15416Specifies the Methodology for
Measuring the Accuracy of Linear (1D) Bar Code Symbologies
1D Bar Code Example:
Slide 51
All Bar Codes are Defined with Symbology Specifications
There are Approximately 30 Symbology Specifications
Slide 52
Linear (1D) Verification Parameters
Edge Determination Minimum Reflectance Minimum Edge Contrast Decode Contrast
Quiet Zone Modulation Decodability Defects
Slide 53
Two-Dimensional (2D)Verification Parameters
Decode Modulation Decodability Reflectance Margin Axial Non-Uniformity
Grid Non-Uniformity Fixed Pattern Damage Unused Error Correction Along with Other Parameters
Slide 54
What Can Go Wrong with My Print Quality?
Ribbon wrinkle Mismatch of ribbon and substrate Clogged ink jets Overspray of ink Defective areas in the substrate Over or under heated print head
Something on the label Quiet Zone violations Incorrect construction of the
bar code Burned out pixels Misaligned print heads
Slide 55
Are There Other Concerns?
The Correct Symbology for the Application
The Correct Configuration for the Application
Slide 56
Direct Part Mark (DPM) Verification
Slide 57
Different Classifications of DMP Verification
Slide 58
ISO/IEC TR 29158:2011(E)DPM Categories Category 0 Category 1 Category 2 Category 3
Slide 59
Category 0The most stringent marking environment where scanners are expected to read most DPM parts.
Slide 60
Category 1Parts that are easy to read using a specialized DPM type scanner in a field type environment such as a supply depot or an airfield.
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Category 2Parts that are not expected to read in field type situations, but are intended to be read in specialized environments such as a sophisticated repair location.
Slide 62
Category 3
Parts that are not expected to read in open system environments.
Slide 63
How Can I Verify Large Volumes of Bar Codes?
Slide 64
There are In-line Print Quality Systems that Perform Bar Code Verification
Be Sure to Distinguish Between a Vision System and a Print Quality System for Bar Code Verification
The System Must be Able to Calibrate in an Operational Environment
Be Sure to Correlate to an Off-line Bar Code Verifier
Slide 65
Risks of Not Verifying Lost or Misinterpreted
Information Increased Labor Costs High Dollar Re-labeling Costs Incorrect Code Configuration
Product Recalls Rejected Shipments User Dissatisfaction
Slide 66
Standards Available from www.aimglobal.org
• Click “Technologies” tab BarcodeQuality and Verification
• Click “layman’s explanation” link
Slide 67
Remember This
• A Bar Code Verifier Grades and Reports what you printed – Not what you intended to print.
Slide 68
Slide 69
Contact UsAIM North America
20399 Route 19Suite 203
Cranberry Township, PA 16066
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