Live Demonstration
The Auto ID Technologies &
In-House Systems for
UDI Compliance
Brought to you by the
AIM North America Healthcare Committee
Slide 1
AIM represents…Automatic Identification and Data Capture
Bar Code
RFID
Mobile Computing
Other AIDC
Slide 2
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 3
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 4
Systems for Data Management and Label
Printing
AIM North America Healthcare Committee
Ardi Batmanghelidj
Chairman Healthcare Committee
Slide 5
Components of UDI Compliance
• Where is the data?
• Getting the data to the GUDID
• Labels and Direct Part Marking
Slide 6
Single Source of Truth
“Single Source of Truth (SSOT) refers to
the practice of structuring information
models and associated schemata
such that every data element is stored
exactly once.”
- Wikipedia
Slide 7
Dusty Files in Storage?
Slide 8
Spread Sheets?
Slide 9
Labeling Systems?
Slide 10
ERP and PLM Systems?
SAP
Agile
Documentum
JDE
Oracle
Team
Center
BPCS
Slide 11
Get It All in
One Place
Slide 12
•
•
•
•
•
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 13
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 14
•
•
•
•
•
Add data elements
through configuration not
programming
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
Slide 15
•
Unapproved record
•
Protected and system driven
GUDID status
•
Locally maintained data
•
Device description retrieved
from remote system. On
demand or scheduled
•
GMDN or FDA PT codes as
drop down from other
Tables
Slide 16
M
a
s
t
e
r
M_GTIN
D
a
t
a
L_Exd/YYMMDD
E
R
P
D
a
t
a
L_Num
Slide 17
• Configure, don’t
program
• Ability to present any
data element in the
database on a label or
Direct Part Marking
(DPM)
Slide 18
• HIBC codes are
just a different
representation
of the same type
of data
Slide 19
Issuing Agencies for UDI encoding in AIDC
or
• 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
Slide 20
• GS1-128
• Code 128 and Code 39
• ISBT128
• GS1 Data Bar
• Data Matrix, QR Code,
Aztec Code
• Data Matrix
• GS1 Data Matrix
• RFID EPC Gen 2
UHF Tag
• RFID ISO 18000-6c
UHF Gen 2 tag
• RFID ISO 18000-3
mode 1 HF tag
Slide 21
Direct Part Marking
AIM North America Healthcare Committee
Peter Ginkel
Slide 22
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 23
Direct Part Marking
DPM is generally suggested in applications
where:
•• The
part is subjected
toafter
environmental
too
small to
be
marked
with
Traceability
is needed
the product
conditions
that
preclude
the use of add-on
bar
code labels
or its
tags
is separated
from
temporary
identification
identification data
Slide 24
Direct Part Marking
Intrusive vs. Non-Intrusive Marking
• Intrusive
Marking:
Any A
device
designed
to alter
Non-Intrusive
Marking:
method
of marking
by
a
material
surface
form a humanor machineadding
material
to to
a surface.
Nonintrusive
readable
symbol. include
This marking
includes,
marking methods
ink jet,category
laser bonding,
but
is not limited
to, screen,
devicesstencil,
that abrade,
burn,
liquid-metal
jet, silk
and thin-film
corrode,
cut, deform, dissolve, etch, melt, oxidize,
deposition.
or vaporize a material surface.
Slide 25
Direct Part Marking
Medical
Automotive
Devices
Aerospace
Slide 26
NASA Technical References
NASA
TECHNICAL
HANDBOOK
NASA–HDBK-6003C
NASA
TECHNICAL
STANDARD
NASA–STD-6002D
Slide 27
Traditional Impact Stamps
Slide 28
Traditional Impact Presses
Slide 29
Computer Controlled Direct Part
Marking (DPM)
 Dot Peen Marking
– Mechanical indentation of surface
Slide 30
Computer Controlled Direct Part
Marking (DPM)
 Laser Marking
– Controlled intense thermal energy
Slide 31
Laser Marking
Laser Beam
Mark
Annealing
Etching/Engraving
Discoloration
Laser
Bonding
Laser Bonding
compound
Workpiece
Slide 32
Typical Laser System
Popular laser types
1. Carbon Dioxide CO2
2. Fiber
3. Green
Slide 33
Electro-etching
Cathode
Electro-etching is a metal etching
Anode
process that involves the use of
a solution of an electrolyte, an anode
and a cathode.
Slide 34
Dot Peen Marking
Slide 35
Dot Peen Marking
Slide 36
Typical Dot Peen System
Pin actuation
1. Electric
2. Pneumatic
Slide 37
What is Bar Code Verification
and Why Do I Need It?
AIM North America Healthcare Committee
Tim Lydell
Slide 38
Validation
vs
Verification
Slide 39
Validation
Slide 40
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 41
Verification
Slide 42
There are Generally Two Types
of Bar Code Verifiers
 Standard Verifiers
 Direct Part Mark Verifiers
Slide 43
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 44
Manufactured to ISO/IEC
Standards
 15426-1
 15426-2
 15415
 15416
Slide 45
ISO/IEC 15426-1
Defines the Test Methods and Minimum
Accuracy Criteria for Linear (1D) Bar Codes
1D Bar Code Example:
Slide 46
ISO/IEC 15426-2
Defines the Test Methods and Minimum
Accuracy Criteria for Two-Dimensional (2D)
Matrix Symbologies
2D Bar Code Example:
Slide 47
ISO/IEC 15415
Specifies 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 48
ISO/IEC 15416
Specifies the Methodology for
Measuring the Accuracy of Linear (1D)
Bar Code Symbologies
1D Bar Code Example:
Slide 49
All Bar Codes are Defined with
Symbology Specifications
There are Approximately 30
Symbology Specifications
Slide 50
Linear (1D)
Verification Parameters





Edge Determination
Minimum Reflectance
Minimum Edge Contrast
Decode
Contrast




Quiet Zone
Modulation
Decodability
Defects
Slide 51
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 52
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 53
Are There Other Concerns?
 The Correct Symbology for the Application
 The Correct Configuration for the
Application
Slide 54
Direct Part Mark
(DPM) Verification
Slide 55
Different Classifications of
DMP Verification
Slide 56
ISO/IEC TR 29158:2011(E)
DPM Categories




Category 0
Category 1
Category 2
Category 3
Slide 57
Category 0
The most stringent marking
environment where scanners are not
expected to read most DPM parts.
Slide 58
Category 1
Parts that are easy to read using a
specialized DPM type scanner in a
field type environment such as a
supply depot or an airfield.
Slide 59
Category 2
Parts 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 60
Category 3
Parts that are not expected to read in
open system environments.
Slide 61
How Can I Verify Large
Volumes of Bar Codes?
Slide 62
 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 63
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 64
Standards Available from www.aimglobal.org
Click “Technologies” tab  Barcode 
Quality and Verification
• Click “layman’s explanation” link
•
Slide 65
Remember This
• A Bar Code Verifier Grades and Reports
what you printed – Not what you intended to
print.
Slide 66
Slide 67
Contact Us
AIM North America
20399 Route 19
Suite 203
Cranberry Township, PA 16066
+ 1.724.742.4473
www.aim-na.org
info@aim-na.org
Slide 68