June 2015

Quality of Traceability: Challenges and Solutions

Traceability

2

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?

3

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

4

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

6

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

7

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

Page 8

Laser marked medical devices

Surgical tools

FOBA Presentation 11. November

2011

Electr(on)ic components and housings

Various metal parts

Various plastic parts

ID cards, safety related documents

FOBA Presentation November 2013

Challenges RFID

13

• 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

RFID

14

ReaderChip Antenna Label with built-in RFID

NFC and RFID

15

• NFC is a subset of RFID

• Built-in Secure data exchange

• Most smartphone support NFC • Banking transactions

16

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

17

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?

18

Basic information on a 2D code

Page 19

Clock PatternL Alignment Pattern

Margin or Quiet Zone

Data

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).

20

Courtesy of Jonathan Laventhol

Example of 2D code VERIFIERS

FOBA Customer Presentation:

Medical Device

Page 21

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

• …

Page 22

GS1 Format (example of 2D code)

Datamatrix + encoding scheme = GS1.

In MarkUS a GS1 Datamatrix code must start with ~1

Page 23

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

Video

FOBA Customer Presentation:

Medical Device

Page 25

Microcodes

26

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

UDI Microcodes

27

3mm

2.5mm

1.7mm

1.3mm

Zoom out on 76um

A 2.5 mm UDI marked a read a commercial laser

Technology to mark with built-in reader exists

Technology to mark with built-in reader exists

Support surface can be a challenge

3mm screw head with a UDI

32

0.02” (0.5mm) 2D code on a pacemaker component

12x12 2D code with a 42 micron cell size on a medical device

33

0.5mm

34

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

Microcode UDI readers

35

Pedicle screw marked with a 2D code

36

Tracing medical devices in the OR

37

38

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

39

Thank you!