Live Demonstration The Auto ID Technologies & In-House Systems for UDI Compliance Brought to you by the AIM North America Healthcare Committee

Transcription

1 Live Demonstration The Auto ID Technologies & In-House Systems for UDI Compliance Brought to you by the AIM North America Healthcare Committee Slide 1

2 AIM represents Automatic Identification and Data Capture Bar Code Mobile Computing Other AIDC RFID Slide 2

3 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

4 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

5 Systems for Data Management and Label Printing AIM North America Healthcare Committee Ardi Batmanghelidj Chairman Healthcare Committee Slide 5

6 Components of UDI Compliance Where is the data? Getting the data to the GUDID Labels and Direct Part Marking Slide 6

7 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

8 Dusty Files in Storage? Slide 8

9 Spread Sheets? Slide 9

10 Labeling Systems? Slide 10

11 ERP and PLM Systems? Agile Documentum Team Center SAP JDE Oracle BPCS Slide 11

12 Get It All in One Place Slide 12

13 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

14 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

15 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

16 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

17 M_GTIN M a s t e r D a t a L_Exd/YYMMDD E R P D a t a L_Num Slide 17

18 Configure, don t program Ability to present any data element in the database on a label or Direct Part Marking (DPM) Slide 18

19 HIBC codes are just a different representation of the same type of data Slide 19

20 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

21 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 c UHF Gen 2 tag ISBT128 Data Matrix RFID ISO mode 1 HF tag Slide 21

22 Direct Part Marking AIM North America Healthcare Committee Peter Ginkel Slide 22

23 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

24 Direct Part Marking DPM is generally suggested in applications where: The Traceability part is subjected too is needed small to after be environmental marked the product with conditions bar is separated code labels that from preclude or its tags temporary the use of add-on identification data Slide 24

25 Direct Part Marking Intrusive vs. Non-Intrusive Marking Non-Intrusive Marking: Marking: Any A device method designed of marking to alter by adding a material material surface to to a surface. form a human- Nonintrusive or machinereadable marking methods symbol. include This marking ink jet, category laser bonding, includes, but liquid-metal is not limited jet, silk to, screen, devices stencil, that abrade, and thin-film burn, corrode, deposition. cut, deform, dissolve, etch, melt, oxidize, or vaporize a material surface. Slide 25

26 Direct Part Marking Medical Automotive Devices Aerospace Slide 26

27 NASA Technical References NASA TECHNICAL HANDBOOK NASA HDBK-6003C NASA TECHNICAL STANDARD NASA STD-6002D Slide 27

28 Traditional Impact Stamps Slide 28

29 Traditional Impact Presses Slide 29

30 Computer Controlled Direct Part Marking (DPM) Dot Peen Marking Mechanical indentation of surface Slide 30

31 Computer Controlled Direct Part Marking (DPM) Laser Marking Controlled intense thermal energy Slide 31

32 Laser Marking Laser Beam Mark Etching/Engraving Discoloration Laser Annealing Bonding Laser Bonding compound Workpiece Slide 32

33 Typical Laser System Popular laser types 1. Carbon Dioxide CO 2 2. Fiber 3. Green Slide 33

34 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

35 Dot Peen Marking Slide 35

36 Dot Peen Marking Slide 36

37 Typical Dot Peen System Pin actuation 1. Electric 2. Pneumatic Slide 37

38 What is Bar Code Verification and Why Do I Need It? AIM North America Healthcare Committee Tim Lydell Slide 38

39 Validation vs Verification Slide 39

40 Validation Slide 40

41 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

42 Verification Slide 42

43 There are Generally Two Types of Bar Code Verifiers Standard Verifiers Direct Part Mark Verifiers Slide 43

44 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

45 Manufactured to ISO/IEC Standards Slide 45

46 ISO/IEC Defines the Test Methods and Minimum Accuracy Criteria for Linear (1D) Bar Codes 1D Bar Code Example: Slide 46

47 ISO/IEC Defines the Test Methods and Minimum Accuracy Criteria for Two-Dimensional (2D) Matrix Symbologies 2D Bar Code Example: Slide 47

48 ISO/IEC 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

49 ISO/IEC Specifies the Methodology for Measuring the Accuracy of Linear (1D) Bar Code Symbologies 1D Bar Code Example: Slide 49

50 All Bar Codes are Defined with Symbology Specifications There are Approximately 30 Symbology Specifications Slide 50

51 Linear (1D) Verification Parameters Edge Determination Minimum Reflectance Minimum Edge Contrast Decode Contrast Quiet Zone Modulation Decodability Defects Slide 51

52 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

53 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

54 Are There Other Concerns? The Correct Symbology for the Application The Correct Configuration for the Application Slide 54

55 Direct Part Mark (DPM) Verification Slide 55

56 Different Classifications of DMP Verification Slide 56

57 ISO/IEC TR 29158:2011(E) DPM Categories Category 0 Category 1 Category 2 Category 3 Slide 57

58 Category 0 The most stringent marking environment where scanners are not expected to read most DPM parts. Slide 58

59 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

60 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

61 Category 3 Parts that are not expected to read in open system environments. Slide 61

62 How Can I Verify Large Volumes of Bar Codes? Slide 62

63 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

64 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

65 Standards Available from Click Technologies tab Barcode Quality and Verification Click layman s explanation link Slide 65

66 Remember This A Bar Code Verifier Grades and Reports what you printed Not what you intended to print. Slide 66

67 Slide 67

68 Contact Us AIM North America Route 19 Suite 203 Cranberry Township, PA info@aim-na.org Slide 68