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Traceability
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Traceability is the ability to verify the history, location, or application of an item by means of documented recorded identification.
Value chain
Traceability
Why do we need traceability and why is it important?
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Traceability is important but even more important if human heath is involved.
1. Readiness: In a case of recall or emergency traceability provides the tools and processes to respond swiftly and efficiently.
2. Reaction: When the time to respond is critical, information is readily available to all stakeholders.
3. Regaining: Traceability allows manufacturers to regain control of the company image and product trust.
4. Prevention: The causes of recalls are used for immediate product improvement
Traceability process Medical Devices
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Traceability process
Device Manufacturing
Labelingdevice
Packaging
ShippingHospital
Surgery
Patient
FDA’sGUDID
GlobalUnique Device IdentifierDatabase
ERP
REC
ALL
Recall processValue chain
Available Technologies
5Laser Marking and engravingDot Peening
Ink printing RFID (Radio Frequency IDentification) Tag
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Barcode on label
2D codes onlabel
RFID tag Dot peening Engraved 2D codes on metal
Storage information Low High High Low High
Lifetime/susceptibleto environment
Low Low High High High
Encryption Low High High Low High
Readability/Interface Medium Medium High Low Medium
Security Low High High Low High
Speed Medium Medium High Low Medium
Part of the product Low Low Low High High
Industrial market penetration
Low Low Medium Medium High
Size of the tracker Low high Medium Medium High
Cost Low Medium High Medium High
Comparing Technologies
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Markets vs. Technology
RFID preferred by:
• Retail
• Transportation
• Logistics
• Access control
• Manufacturing
• Large parts
Datamatrix part marking preferred by:
• Industrial manufacturing
• Medical devices
• Automotive parts
• Aerospace components
• Large and small parts
Challenges RFID
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• RFID systems cost generally more than 2D code readers
• RFID technology is typically more complex and requires the right hardware
• Can be susceptible to radio interferences like Wifi or metal components
• RFID tags are generally larger and can be bulky with smaller parts
• Tags are application specific. Not one tag fits all.
• More than one tag can respond at the same time. Can be a disadvantage depending on the application
NFC and RFID
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• NFC is a subset of RFID
• Built-in Secure data exchange
• Most smartphone support NFC • Banking transactions
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Challenges 2D codes
• Curved surfaces• 2D codes must be marked on
relatively flat surfaces
• Surface finish• Dull diffuse surfaces are prefered
• Available mark area getting smaller and smaller
• AIM/DPM standard limits how small 2D codes can be sized
• Readability can be affected by dirt or contaminants
2D code formats
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Matrix size
Number of numerical characters
Number of ASCII
characters Printed area size Area Density = char/area10×10 6 3 3.4 x 3.4 mm 11.56 0.5212×12 10 6 4.1 x 4.1 mm 16.81 0.5914×14 16 10 4.8 x 4.8 mm 23.04 0.6916×16 24 16 5.4 x 5.4 mm 29.16 0.8218×18 36 25 6.1 x 6.1 mm 37.21 0.9720×20 44 31 6.8 x 6.8 mm 46.24 0.9522×22 60 43 7.5 x 7.5 mm 56.25 1.0724×24 72 52 8.2 x 8.2 mm 67.24 1.0726×26 88 64 8.8 x 8.8 mm 77.44 1.1432X32 124 91 10.9 x 10.9 mm 118.81 1.0436X36 172 127 12.2 x 12.2 mm 148.84 1.1640X40 228 169 13.6 x 13.6 mm 184.96 1.2344X44 288 214 15.0 x 15.0 mm 225 1.28
Array Size 10x10 Size 20x20 Size 40x40
Content 123456 123456 123456
Max ASCII 6 31 169
Readability Easy Medium Hard
Why do content and size matter?
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MAP of a 2D code
An example of a Data Matrix code, encoding the text: "Wikipedia"
• Data (green)
• Padding (yellow)
• Error correction (red)
• Finder and timing (magenta)
• Unused (orange).
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Courtesy of Jonathan Laventhol
Example of 2D code VERIFIERS
FOBA Customer Presentation:
Medical Device
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Xaminer eZ-2D
DataMan 2-D Data Matrix VerifierAxicon 12000
LVS-9510 Barcode Verifier
What is GS1 (Wikipedia)
A not-for-profit international organization:
• Develops standards
• Maintains standards
for supply and demand chains across multiple sectors:
• Automotive
• Military
• Medical
• …
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GS1 Format (example of 2D code)
Datamatrix + encoding scheme = GS1.
In MarkUS a GS1 Datamatrix code must start with ~1
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Content Not in GS1:FOBA Same content in GS1:FOBA
Example of GS1 format
FOBA Titel der Präsentation 6.
Oktober 2016
Seite 24
Device Identifier DIProduction Identifier PI
UDI = DI + PI
Microcodes
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Proposed Microcode:
1. UDI codes that would be 10 to 20 times
smaller than current ones
2. A 2D code that fits on the top screw head
3. Readable by a commercial device
0.02” (0.5mm) 2D code on a pacemaker component
12x12 2D code with a 42 micron cell size on a medical device
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0.5mm
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Part with 2D Matrix Code
•2D code (12x12)
•Size 300um (0.012”)
•Dot spacing 28um (0.01”)
•Aligned, Read and Verified with IMP
Curved surface
300um
Conclusion
1. Large components are best tracked using RFID technology
2. Small components like medical implants are generally subjected to extreme
environments and are best laser marked with 2D codes
3. Several organizations provide standards to track or recall product using either RFID
or Datamatrix technologies
4. Both technologies will minimize errors and facilitate recalls
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