Medical container, system and method for tracking data relating to said medical container

1 . A medical container comprising:

a first RFID disposed on a first surface of the medical container, the first RFID tag being operable in a first frequency band and being configured for storing a unique identifier of the medical container, the unique identifier uniquely identifying the container, the first RFID tag configured for long-range interrogation during industrial processing of the medical container; and

a second RFID tag disposed on a second surface of the medical container, the second RFID tag being operable in a second frequency band lower than the first frequency band and configured to store the unique identifier of the medical container, the second RFID tag configured for near-field interrogation at a point of use of the medical container,

wherein, in response to reading the first RFID tag during production or inspection of the medical container, a data storage system is configured to associate the unique identifier with at least one of:

manufacturing parameters, inspection results, or environmental variables recorded during production of the medical container;

wherein the association of the unique identifier with said manufacturing parameters, inspection results, or environmental variables is only performed in response to reading the first RFID tag, and

wherein manufacturing traceability data and point-of-use verification are enforced through different RFID tags operating at different stages of a medical container lifecycle.

2 . The medical container according to claim 1 , wherein the first and second RFID tags are separate physical components mounted at different locations on the container.

3 . The medical container according to claim 1 , further comprising an optical mark selected from at least one of: a tamper-resistant laser-etched mark; a chemically durable mark resistant to sterilization processes; or a redundant unique identifier readable in low-light conditions,

wherein the optical mark comprises at least one of: a one-dimensional mark, a two-dimensional mark or a human readable text.

4 . The medical container according to claim 3 , wherein (i) the first RFID tag and (ii) the second RFID tag or the optical mark are located on different parts of the medical container, and wherein the second RFID tag serves a distinct function, at a different operational stage of the supply or clinical workflow, including at least one of patient-facing authentication, bedside verification, chain-of-custody tracking, or reduced-range secure access, distinct from the industrial tracking functions of the first RFID tag.

5 . A system comprising:

at least one medical container according to claim 1 ; and

a data storage system configured to store the unique identifier of each medical container in compliance with GS1 EPC Gen2 standards to ensure traceability, interoperability, and protection against identifier duplication or tampering.

6 . The system according to claim 5 , wherein the data storage system is further configured to associate each unique identifier with step-specific data recorded during manufacture, the step-specific data including one or more of: forming conditions, annealing parameters, needle assembly data, inspection outcomes, cleaning cycles, or lubrication timing.

7 . The system according to claim 5 , further comprising:

at least one first RFID reader coupled to the data storage system and configured to read the first RFID tag of each medical container; and

at least one of:

(i) a second RFID reader coupled to the data storage system and configured to read the second RFID tag of each medical container, the second RFID reader being optimized for near-field scanning at clinical endpoints; and

(ii) an optical reader coupled to the data storage system and configured to read the optical mark of each medical container, the optical reader comprising a scanner operable in low-light environments.

8 . The system according to claim 5 , wherein the data storage system is configured to automatically update or append process data for each medical container as it progresses through sequential manufacturing stages, thereby enabling continuous traceability.

9 . A method for tracking data relating to at least one medical, comprising:

providing at least one medical container according to claim 1 ;

generating the unique identifier of each medical container;

forming the first RFID tag on each medical container, wherein the first RFID tag stores the unique identifier of the respective medical container;

forming on each medical container at least one of the second RFID tag storing the unique identifier of the respective medical container or the optical mark encoding the unique identifier of the respective medical container, the second RFID tag being configured for storing the unique identifier of the medical container, wherein the second RFID tag is optimized for point-of-use scanning, while the first RFID tag is optimized for industrial tracking;

storing, in a data storage system, the unique identifier of each medical container in association with one or more of manufacturing parameters, inspection results, or environmental variables recorded during production of the medical container.

10 . The method according to claim 9 , wherein forming the first and/or second RFID tag comprises at least one of: labelling, in-mold labelling, screwing, over-molding, or direct antenna printing.

11 . The method according to claim 9 , wherein forming the optical mark comprises at least one of: labelling, in-mold labelling, enamel sintering, inkjet printing, laser marking, including picosecond laser marking or femtosecond laser marking, drop-on demand printing, or dot peen marking.

12 . The method according to claim 9 , further comprising:

(a) providing:

at least one first RFID reader coupled to the data storage system and configured to read the first RFID tag of each medical container; and

at least one of:

(i) a second RFID reader coupled to the data storage system and configured to read the second RFID tag of each medical container; and

(ii) an optical reader coupled to the data storage system and configured to read the optical mark of each medical container; and

(b) reading at least one of the first RFID tag, the second RFID tag and the optical mark of at least one medical container with the first RFID reader, the second RFID reader and/or the optical reader and determining from the data storage system the unique identifier of said at least one medical container.

13 . The method according to claim 9 , further comprising:

using the second RFID tag for point-of-care authentication or patient administration; and using the first RFID tag for logistics or warehouse management.

14 . The medical container of claim 1 , wherein the second RFID tag is positioned on an externally accessible surface of the container to facilitate handheld reader access, and the first RFID tag is located in an embedded or internal region suitable for automated equipment scanning.

15 . The medical container of claim 1 , wherein the near-field environment comprises at least one of: a patient bedside, a nurse station, or a medication dispensing terminal, and wherein the industrial environment comprises at least one of: an automated inventory system, a logistics checkpoint, or a bulk container storage area.

16 . The medical container according to claim 1 , wherein the second RFID tag is embedded within a barrel portion of the container, and the first RFID tag is disposed on an exterior surface of a removable cap of the container.

17 . The medical container according to claim 1 , wherein the data storage system records, in association with the unique identifier, at least one of:

manufacturing station identifiers, process temperature profiles, lubrication parameters, inspection defect data, or cleaning cycle information of the medical container.