Quality of Traceability: Challenges and Solutions

Transcription

1 Quality of Traceability: Challenges and Solutions June 2015

2 Traceability Traceability is the ability to verify the history, location, or application of an item by means of documented recorded identification. Value chain Traceability 2

3 Why do we need traceability and why is it important? 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 3

4 Traceability process Medical Devices Value chain Recall process Traceability proces Patient Device Manufacturing RECALL Surgery FDA s GUDID Global Unique Device Identifier Database Labeling device Packaging Hospital ERP Shiping 4

5 Available Technologies Ink printing RFID (Radio Frequency IDentification) Tag Dot Peening Laser Marking and engraving 5

6 Comparing Technologies Barcode on label 2D codes on label RFID tag Dot peening Engraved 2D codes on metal Storage information Low High High Low High Lifetime/susceptible Low Low High High High to environment 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 Low Low Medium Medium High penetration Size of the tracker Low high Medium Medium High Cost Low Medium High Medium High 6

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 7

8 Laser marked medical devices Surgical tools Page 8

9 Electr(on)ic components and housings FOBA Presentation 11. November 2011

10 Various metal parts

11 Various plastic parts

12 ID cards, safety related documents FOBA Presentation November 2013

13 Challenges RFID 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 13

14 RFID Chip Antenna Label with built-in RFID Reader 14

15 NFC and RFID NFC is a subset of RFID Built-in Secure data exchange Most smartphone support NFC Banking transactions 15

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 16

17 2D code formats Matrix size Number of numerical characters Number of ASCII characters Printed area size Area Density = char/area x 3.4 mm x 4.1 mm x 4.8 mm x 5.4 mm x 6.1 mm x 6.8 mm x 7.5 mm x 8.2 mm x 8.8 mm X x 10.9 mm X x 12.2 mm X x 13.6 mm X x 15.0 mm

18 Why do content and size matter? Array Size 10x10 Size 20x20 Size 40x40 Content Max ASCII Readability Easy Medium Hard 18

19 Basic information on a 2D code L Alignment Pattern Clock Pattern Data Margin or Quiet Zone Page 19

20 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). Courtesy of Jonathan Laventhol 20

21 Example of 2D code VERIFIERS Axicon DataMan 2-D Data Matrix Verifier Xaminer ez-2d LVS-9510 Barcode Verifier FOBA Customer Page 21 Presentation: Medical Device

22 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

23 GS1 Format (example of 2D code) Datamatrix + encoding scheme = GS1. In MarkUS a GS1 Datamatrix code must start with ~1 Content Not in GS1:FOBA Same content in GS1:FOBA Page 23

24 Example of GS1 format Device Identifier DI Production Identifier PI UDI = DI + PI FOBA Seite Titel der 24 Präsentation 6. Oktober 2016

25 Video FOBA Customer Page 25 Presentation: Medical Device

26 Microcodes 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 26

27 UDI Microcodes 3mm 2.5mm 1.7mm 1.3mm 27

28 Zoom out on 76um A 2.5 mm UDI marked a read a commercial laser

29 Technology to mark with built-in reader exists

30 Technology to mark with built-in reader exists

31 Support surface can be a challenge

32 3mm screw head with a UDI 32

33 0.02 (0.5mm) 2D code on a pacemaker component 0.5mm 12x12 2D code with a 42 micron cell size on a medical device 33

34 Part with 2D Matrix Code 2D code (12x12) Size 300um (0.012 ) Dot spacing 28um (0.01 ) Curved surface Aligned, Read and Verified with IMP 300um 34

35 Microcode UDI readers 35

36 Pedicle screw marked with a 2D code 36

37 Tracing medical devices in the OR 37

38 38

39 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

40 Thank you!