The Auto ID Technologies & In-House Systems for UDI …...Apr 04, 2016  · Slide 21 • GS1-128 • GS1 Data Bar • GS1 Data Matrix • RFID EPC Gen 2 UHF Tag • Code 128 and Code

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Live DemonstrationThe Auto ID Technologies &

In-House Systems for UDI Compliance

Brought to you by the AIM North America Healthcare Committee

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AIM represents…Automatic Identification and Data Capture

RFID

Mobile Computing

Bar Code

Other AIDC

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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

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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

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Systems for Data Management and Label Printing

AIM North America Healthcare CommitteeArdi Batmanghelidj

Chairman Healthcare Committee

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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

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• 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

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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

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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)

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• HIBC codes are just a different representation of the same type of data

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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

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• 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

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Live Demo

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Direct Part MarkingAIM North America Healthcare Committee

Peter Ginkel

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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.

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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

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• 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.

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AutomotiveAerospaceMedical Devices

Direct Part Marking

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NASATECHNICALHANDBOOKNASA–HDBK-6003C

NASATECHNICALSTANDARDNASA–STD-6002D

NASA Technical References

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Traditional Impact Stamps

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Traditional Impact Presses

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Computer Controlled Direct Part Marking (DPM)

Dot Peen Marking– Mechanical indentation of surface

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Computer Controlled Direct Part Marking (DPM)

Laser Marking– Controlled intense thermal energy

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Etching/Engraving

Laser Marking

AnnealingDiscolorationLaser BondingLaser Bondingcompound

Workpiece

Mark

Laser Beam

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Typical Laser SystemPopular laser types1. Carbon Dioxide CO2

2. Fiber

3. Green

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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

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Dot Peen Marking

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Dot Peen Marking

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Typical Dot Peen SystemPin actuation1. Electric

2. Pneumatic

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What is Bar Code Verificationand Why Do I Need It?

AIM North America Healthcare Committee

Tim Lydell

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Validationvs

Verification

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Validation

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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

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Verification

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There are Generally Two Types of Bar Code Verifiers

Standard Verifiers Direct Part Mark Verifiers

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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.

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Manufactured to ISO/IEC Standards

15426-115426-2

1541515416

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ISO/IEC 15426-1Defines the Test Methods and Minimum

Accuracy Criteria for Linear (1D) Bar Codes

1D Bar Code Example:

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ISO/IEC 15426-2Defines the Test Methods and Minimum

Accuracy Criteria for Two-Dimensional (2D) Matrix Symbologies

2D Bar Code Example:

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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

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ISO/IEC 15416Specifies the Methodology for

Measuring the Accuracy of Linear (1D) Bar Code Symbologies

1D Bar Code Example:

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All Bar Codes are Defined with Symbology Specifications

There are Approximately 30 Symbology Specifications

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Linear (1D) Verification Parameters

Edge Determination Minimum Reflectance Minimum Edge Contrast Decode Contrast

Quiet Zone Modulation Decodability Defects

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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

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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

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Are There Other Concerns?

The Correct Symbology for the Application

The Correct Configuration for the Application

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Direct Part Mark (DPM) Verification

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Different Classifications of DMP Verification

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ISO/IEC TR 29158:2011(E)DPM Categories Category 0 Category 1 Category 2 Category 3

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Category 0The most stringent marking environment where scanners are expected to read most DPM parts.

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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.

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Category 3

Parts that are not expected to read in open system environments.

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How Can I Verify Large Volumes of Bar Codes?

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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

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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

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Standards Available from www.aimglobal.org

• Click “Technologies” tab BarcodeQuality and Verification

• Click “layman’s explanation” link

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Remember This

• A Bar Code Verifier Grades and Reports what you printed – Not what you intended to print.

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Contact UsAIM North America

20399 Route 19Suite 203

Cranberry Township, PA 16066

+ 1.724.742.4473www.aim-na.orginfo@aim-na.org