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1. (WO2008051551) SYSTÈME DE SUIVI DE SACS ET ARTICLES JETABLES STÉRILISÉS AUX RAYONS GAMMA
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

CLAIMS
What is claimed is:
1. A tracking system for ionizing radiation irradiated lots of items, comprising:
a tracking tag assembly including a memory storage component, that is either not adversely affected by ionizing radiation or encapsulated in an ionizing radiation resistant holder;
the memory storage device including a unique identification and a memory, and at least one trackable event being writable to the memory;
a memory reader which is usable by a user to obtain the identification from the memory storage component after it has been ionizing irradiated and which can read the at least one trackable event stored in the memory.

2. The tracking system of claim 1, wherein the tracking tag assembly further includes a dosimeter that records a level of ionizing radiation to which the tag is exposed.

3. The tracking system of claim 2, wherein the memory storage component is an RF ID tag that is not adversely effected by gamma radiation, and the at least one trackable event comprises at least one of a sterilization certification, a radiation level or a dosimetry record.

4. The tracking system of claim 3, wherein additional trackable events are stored in the memory including at least one of a manufacturing date, a batch number, a lot number, material specifications, material lot number, certifications for sterility, certificates of compliance, size specifications, functional specifications, description, customer data, or customer application associated with the identification.

5. The tracking system of claim 3, wherein the RF ID tag is manufactured with FRAM (Ferroelectric Random Access Memory) based memory.

6. The tracking system of claim 1, wherein the memory reader is a RF ID tag reader that is connectable to PC, internet accessible device or internet for communication of data to a centralized database.

7. The tracking system of claim 1, wherein the at least one trackable event includes at least one of a manufacturing date, a batch number, a lot number, material specifications, material lot number, certifications for sterility, certificates of compliance, size specifications, functional specifications, description, dosimetry records, sterilization certifications, customer data or customer application associated with the identification.

8. The tracking system of claim 3, wherein the tracking tag assembly comprises an external pouch, molded strap or laminations surrounding the RF ID tag.

9. The tracking system of claim 8, wherein the laminations comprise layers of a bag or pouch and the RF ID tag is sealed between the laminations in a seam area of the bag or pouch.

10. The tracking system of claim 3, wherein the tracking tag assembly comprises a holder formed from two pieces of laminate that are made of a polymeric material with the RF ID tag sandwiched between the laminates.

11. The tracking system of claim 1, wherein the tracking tag assembly is integrally molded onto an item to be tracked.

12. The tracking system of claim 1, further comprising a local tracking history database in which data from the memory reader can be stored and tracked for each of the items being tracked.

13. The tracking system of claim 1, further comprising a history analysis and reorder system that analyzes the local history databases to determine a shelf life of the item being tracked or its contents.

14. A method of tracking items to be ionizing radiation irradiated using a tracking system, comprising.
affixing a tracking tag assembly with a memory storage component that is not adversely effected by ionizing radiation or encapsulated in an ionizing radiation resistant holder on the item to be irradiated;
subjecting the item to ionizing irradiation;
writing data to the memory storage component;
providing information relating to the irradiated item to a data base correlated to the identification; and
a user reading the memory storage component on the item with a memory reader.

15. The method of claim 14, further comprising:
the user inputting at least one trackable event regarding the irradiated item into the memory reader;
the memory reader writing the information back on the memory storage device; and
uploading data from the memory reader to a PC or an internet accessible device or connecting the memory reader to an internet;
accessing the data base;
retrieving data relating to the irradiated item from the data base; and uploading data on the at least one trackable event to the data base to build the data base.

16. The method of claim 15, wherein the memory storage device is an RF ID tag, and the memory reader is an RF ID tag reader that can read the RF ID tag without physical contact therewith.

17. The method of claim 16, wherein the tracking tag assembly further includes a dosimeter that records a level of radiation; and the method further includes reading the radiation level recorded by the dosimeter; and writing radiation level data to the RF ID tag or adding the radiation level data to the data base correlated to the RF ID tag for the item.

18. The method of claim 14, wherein the item is a bag or pouch, and the method further comprises sealing the tracking tag assembly into a seam of the bag or pouch.

19. A method of tracking gamma radiation sterilized lots of items using a tracking system, comprising:
positioning at least one tracking tag assembly including an RF ID tag that is either resistant to ionizing radiation or encapsulated in an ionizing radiation resistant holder and a dosimeter in a lot of items;
determining gamma radiation exposure using the dosimeter; and
writing sterilization data determined from the dosimeter to the RF ID tag or to a data base correlated with the RF ID tag identification.

20. The method of claim 19, further comprising:
providing a plurality of the tracking tag assemblies;
locating the tracking tag assemblies according to a set pattern or based on a predetermined map in the lot of items;
determining sterilization data from each of the dosimeters of the tracking tag assemblies to provide a dose map for the lot of items.

21. The method of claim 20, further comprising:
writing the locations of the tracking tag assemblies to the respective RF ID tags of the tracking tag assemblies.

22. The method of claim 20, further comprising:
writing the sterilization data to the respective RF ID tags of the tracking tag assemblies.

23. The method of claim 20, further comprising:
loading the location data for the tracking tag assemblies and the sterilization data to the database.