RFID: Experience of a blood bag manufacturer


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RFID tags are useful to ensure traceability, secure processes & improve data acquisition in Transfusion Medicine.

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RFID: Experience of a blood bag manufacturer

  1. 1. RFID Experience of a blood bag manufacturer Bracknell, 12th March 2008 MACO TRACE
  2. 2. Contents <ul><li>MacoPharma overview </li></ul><ul><li>RFID within the Transfusion chain </li></ul><ul><li>MacoPharma RFID Achievements </li></ul>
  3. 4. COMPANY PROFILE <ul><li>French Private company </li></ul><ul><li>Founded in 1977 in Tourcoing near Lille (France) </li></ul><ul><li>More than 1800 employees </li></ul><ul><li>5 manufacturing plants: France – Poland & Tunisia </li></ul><ul><li>International organisation > 55 countries </li></ul><ul><li>ISO 9001 (2000) and ISO 13485 (2004) certified </li></ul><ul><li>CE marked products (Class I, IIb and III) </li></ul><ul><li>FDA approval for blood bags with in-line filter </li></ul>
  4. 5. <ul><li>TRANSFUSION & BIOTHECHNOLOGY </li></ul><ul><ul><li>Filtration </li></ul></ul><ul><ul><li>Safety of Blood Products </li></ul></ul><ul><ul><li>Equipment </li></ul></ul><ul><ul><li>Blood bags </li></ul></ul><ul><ul><li>Biotechnology </li></ul></ul><ul><li>INFUSION </li></ul><ul><ul><li>I.V fluids </li></ul></ul><ul><ul><li>Irrigation </li></ul></ul><ul><ul><li>Chemotherapy </li></ul></ul>3 main activities <ul><li>MASKS </li></ul><ul><ul><li>Respiratory Protection Masks </li></ul></ul><ul><ul><li>Surgical masks </li></ul></ul>
  5. 7. PRODUCT DEVELOPMENT STRATEGY <ul><li> The continuous quest, through partnerships , for improved safety, efficacy and quality of Transfusion, Infusion and Biotherapy. </li></ul><ul><li>The development of integrated closed systems </li></ul><ul><li>To ensure a complete traceability of our products from MacoPharma to end-users </li></ul>
  6. 8. <ul><li>Traceability on a blood bag is done with: </li></ul><ul><li>Reference Number </li></ul><ul><li>Batch Number </li></ul><ul><li>Individual numbers printed on each bag </li></ul><ul><li>Tools codes engraved on plastic parts. </li></ul>A L 12994 18-09-01 18:02 C L L Day From A to C From A to L From A to L Hour Breakdown of the cycles Letter : Identification of the machine
  7. 9. Traceability on a blood bag <ul><li>On a blood pack, you will find a lot of eye-readable traceability data </li></ul><ul><li>Why not having them on an electronic format ? </li></ul><ul><ul><li>RFID could be useful to increase the transfer of traceability </li></ul></ul><ul><ul><li>First development of a RFID chip in 2001 for transfusion </li></ul></ul>
  8. 10. RFID & MacoPharma R adio F requency Id entification in Transfusion Medicine
  9. 11. RFID Tag <ul><li>Chip + antenna </li></ul><ul><li>Transmits data over RF range </li></ul>Antenna Data chip
  10. 12. RFID Validation <ul><li>Internal validation in order to select an appropriate RFID tag for blood bags </li></ul><ul><ul><li>Labelling </li></ul></ul><ul><ul><li>Sterilization </li></ul></ul><ul><ul><li>Pasteurization </li></ul></ul><ul><ul><li>Centrifugation </li></ul></ul><ul><ul><li>Freezing (-30°C & -80°C) & defrosting </li></ul></ul><ul><ul><li>Storage & stability (up to 3 years) </li></ul></ul>
  11. 13. RFID bag <ul><li>Omron Cooper RFID chip (more reliable for our use than Aluminium) </li></ul><ul><li>Withstands sterilisation process and centrifugation </li></ul><ul><li>The RFID Tag used is an I-code2 conform to ISO 15693 </li></ul><ul><li>Memory Capacity - 128 bytes </li></ul><ul><li>Placed under a standard PVC label </li></ul><ul><li>Define a mapping for the use in Transfusion </li></ul>
  12. 14. RFID Chip MacoPharma mapping Product code 12 11 10 9 Donation Number 8         7 Product Reference 6       5   4 Lot Number 3   2 Free Application code 1                                 Smart label Serial Number     Byte 3 Byte 2 Byte 1 Byte 0 Block
  13. 15. RFID within the Transfusion chain Centrifugation Separation Quality Control Hospitals Filtration Collection Distribution Hospital
  14. 16. RFID could be useful in Transfusion <ul><li>To ensure a complete traceability from manufacturer to patient </li></ul><ul><li>To secure a process (viral inactivation, bedside blood match…) </li></ul><ul><li>To speed up data exchange in the different processes of blood transfusion & simplify blood inventory management </li></ul><ul><li>To avoid blood bags to be used on the black market (China) </li></ul>
  15. 17. Target of the RFID Traceability manufacturer Traceability Hospitals Traceability Blood banks <ul><li>Lot Number </li></ul><ul><li>Product reference </li></ul><ul><li>Expiry Date </li></ul><ul><li>… </li></ul><ul><li>Blood group </li></ul><ul><li>Donation Data </li></ul><ul><li>Process Data </li></ul><ul><li>Temperature </li></ul><ul><li>… </li></ul><ul><li>Data Storage </li></ul><ul><li>Blood Type </li></ul><ul><li>- Temperature </li></ul><ul><li>… </li></ul>
  16. 18. Blood Bags Manufacturer <ul><li>Initialization </li></ul><ul><li>Lot number </li></ul><ul><li>Product Reference </li></ul><ul><li>Expiry Date </li></ul><ul><li>Goods Release </li></ul><ul><li>Logistics Control </li></ul>RFID Tunnel for multi-reading
  17. 19. Receipt of goods in a blood bank <ul><li>Control and release </li></ul><ul><li>of medical devices </li></ul><ul><li>Logistics and storage </li></ul><ul><li>Traceability of temperature </li></ul><ul><li>and humidity in storage </li></ul>
  18. 20. Processes <ul><li>Control of Donation </li></ul><ul><li>Control of Transport </li></ul><ul><li>Control of Separation </li></ul><ul><li>Control of Filtration </li></ul><ul><li>Control of Centrifugation </li></ul><ul><li>Control of Inactivation </li></ul>
  19. 21. Storage <ul><li>Receipt of blood products </li></ul><ul><li>Release of blood products </li></ul><ul><li>Control of transport conditions </li></ul><ul><li>Delivery of blood products </li></ul><ul><li>Control of storage conditions </li></ul><ul><li>Random storage </li></ul>
  20. 22. Plasma Storage <ul><li>Random storage possible </li></ul><ul><li>(Every unit is equipped with RFID and can be found with a mobile Reading Device) </li></ul><ul><li>Selection of the right product by RFID </li></ul><ul><li>Cluster-reading of incoming systems </li></ul><ul><li>Goods income inspection for fractionation </li></ul>
  21. 23. Hospital <ul><li>Bedside cross matching with wristband </li></ul><ul><li>Temperature Monitoring (from Blood Bank to patient) </li></ul>
  22. 24. MacoPharma RFID Achievements
  23. 25. MacoPharma RFID Blood Bags <ul><li>RFID chips (13.56 MHz) integrated to blood bag systems : under PVC label, tamper proof – irremovable </li></ul><ul><li>RFID chip can be integrated to any of our blood bags depending on the customer request (WB, Plasma, RBC…) </li></ul><ul><li>RFID bag systems provided with : </li></ul><ul><ul><li>pre-registered manufacturer information (product reference, lot number, expiry date…) </li></ul></ul><ul><ul><li>RFID tags functionality 100 % controlled </li></ul></ul><ul><ul><li>global system qualified as non toxic product </li></ul></ul>
  24. 26. RFID options within MacoPharma Equipment RFID reader/writer integrated within the ABC machine Whole Blood Collection RFID reader integrated within the MacoTronic system with 4 multiplexed antennae (one under each bag location) Theraflex Methylene Blue Plasma Treatment
  25. 27. <ul><li>Macotrace  Editor </li></ul><ul><li>Reading and writing station for controlling RFID tags at different stages of the process </li></ul><ul><li>Used to describe the mapping of the RFID tag memory (MacoTronic, ABC…) </li></ul>MacoTrace System
  26. 28. Technology used  Reading  Writing  Modification of data by R /W devices  Erasure  Saving RFID Gate/Tunnel Read more than 50 bags at the same time Web pad version Hand version
  27. 29. MacoPharma RFID Experience <ul><ul><li>Experience with different blood centers within different European countries (Spain, England, France, Austria, Italy…) </li></ul></ul><ul><ul><li>Experience with several 13.56Mhz RFID tag manufacturers (different standards, size, memory capacity…) </li></ul></ul><ul><ul><li>More than 10 000 RFID blood bag systems manufactured </li></ul></ul>
  28. 30. RFID Pilot Studies <ul><li>Implementation of pilots application with RFID technology in order to : </li></ul><ul><ul><li>Evaluate the reliability of different RFID tags through the blood processes: sterilization, pasteurization, centrifugation, freezing (-40°C) </li></ul></ul><ul><ul><li>Secure and trace blood components treatment process : viral inactivation of plasma by TheraFlex-MB Plasma  system </li></ul></ul><ul><ul><li>Perform traceability and data transfer on MacoPharma ABC  blood collection device with RFID technology </li></ul></ul><ul><ul><li>- Secure autologuous transfusion (routine use) </li></ul></ul><ul><ul><li>- Evaluate the interest of using an active RFID tag to monitor temperature of red blood cells. </li></ul></ul>
  29. 31. Secure a process TheraFlex Viral inactivation of Plasma Using Methylene Blue & Light
  30. 32. Theraflex MB Plasma
  31. 33. TheraFlex Process GMP Compliance <ul><li>Light exposure stage critical to activation of Methylene Blue </li></ul><ul><li>Not possible to use light sensitive indicators to confirm illumination </li></ul><ul><li>Light exposure system must be a GMP compliant controlled process </li></ul><ul><li>Development of RFID chip technology was done to increase security and confirmation of illumination </li></ul>
  32. 34. The RFID/Macotrace Process Plasma Pack User Donation No Prod Code Theraflex Pack Manufacture Product Ref Lot No Macotronic Illumination Status Serial No User Name Energy Illumination duration Maximum temperature User Check on successful illumination
  33. 35. RFID/Macotrace Validation Protocol (England) <ul><li>Validation of Macotrace system </li></ul><ul><li>Verification of chip functionality </li></ul><ul><li>Validation of Theraflex packs with chips/Macotrace </li></ul><ul><ul><li>Normal run </li></ul></ul><ul><ul><li>Interrupted run </li></ul></ul><ul><ul><li>On top of illumination lid </li></ul></ul>
  34. 36. RFID/Macotrace Validation Protocol Theraflex Pack Macotrace Macotronic Password protection Product code entry Donation No Entry Correct Information Chip readability entry Entry overwrite Illumination status PASS FAIL NO DETAILS Web Pad Detection Pad
  35. 37. A simple system to Control inactivation
  36. 38. From donor to patient Vein to vein RFID system
  37. 39. RFID Pilot Study in Valencia Evaluation of RFID data transfer between collection, blood component separation & inactivation
  38. 40. Collection Bag <ul><li>Quadruple Top & Bottom Bag with 2 RFID chip integrated on the RCC & plasma bags </li></ul><ul><li>Production of one Leucoreduced Red Cell Concentrate & one Fresh Frozen Plasma </li></ul>
  39. 41. Pilot Study Valencia (Spain) <ul><li>Traceability </li></ul><ul><li>Securization </li></ul><ul><li>Automation </li></ul><ul><li>Donation data : Donation Number, ABO group, Nurse ID, Donor Number, ABC SN, Date, Time, Duration, Errors… </li></ul><ul><li>Data Control </li></ul><ul><li>Sterile docking : Data Transfer </li></ul><ul><li>Illumination Data Illumination Status, MacoTronic SN, User, Energy, Date, Time, Duration… </li></ul>
  40. 42. RFID Pilot Study in Graz Evaluation of RFID data transfer between collection, blood component separation & transfusion to patient
  41. 43. Pilot Studies Graz (Austria) <ul><li>Test on 1500 blood bags equipped with passive RFID labels from blood donation to red cells transfusion. </li></ul><ul><ul><li>13 defective labels after centrifuge without specific folding. </li></ul></ul><ul><ul><li>No defective bags after training </li></ul></ul><ul><li>Test on active RFID </li></ul>
  42. 44. Tests with passive RFID at UBT/LKH Graz From donation to the hospital 13/1466 failures = 0,88% 1 bar code scanning ~ 40 sec 10 scanning steps x 40 sec x 1500 systems = 167 h <ul><li>Control points: </li></ul><ul><li>- Good incoming/distribution to mobile team </li></ul><ul><li>before centrifugation </li></ul><ul><li>after centrifugation, separation & filtration </li></ul><ul><li>after labeling </li></ul><ul><li>after cross match before distribution </li></ul><ul><li>withdrawal </li></ul>
  43. 45. Discard of blood products in austrian Hospitals 1996-2001 (Öbig Study) transfusion medicine today: 10,56% 4,82% 4,98% 6,26% 2,12% 6,65% 3,26% 5,87% 2,45% 8,73% 7,23% 6,03% 7,51% 7,35% 7,32% 7,70% 7,36% 3,46% 0,00% 2,00% 4,00% 6,00% 8,00% 10,00% 12,00% 1996 1997 1998 1999 2000 2001 Thrombocytes Erythrocytes Plasma
  44. 48. transfusion medicine in/of the future: IB IM IT AMB O&INS
  45. 50. Conclusion <ul><li>RFID tags could be easily included to blood bags. </li></ul><ul><li>RFID tags are useful to ensure traceability, secure processes & improve data acquisition </li></ul><ul><li>Large scale use should confirm the Return Over Investment for passive and active RFID tags in Transfusion Medicine </li></ul>
  46. 51. Thank you for your attention