Device for processing blood containers

Abstract

The present invention relates to a device for processing blood containers. A device for processing blood containers, comprising: a data storage reader unit (20) adapted to read a blood donor identifier from a data storage of a blood container, and a data processing unit (50) adapted to request blood donor-related information from a database (163) based on the read blood donor identifier, in order to allow correct processing of all relevant information regarding the blood donor and the blood recipient, to correctly match the blood and avoid any serious harm on the blood recipient side.

Description

[0001] This application is a divisional application of the invention patent application with the application date of February 27, 2017, the applicant of "Fresenius Kabi Deutschland GmbH", the invention name of "Device for Processing Blood Containers", and the application number of 201780006184.4. Technical Field

[0002] The present invention relates to a device for processing blood containers, in particular to a MultiBag RFID device and software solution, which is particularly compatible with Fresenius Kabi's CompoMat G5 / CompoMasterNet and CompoGuard / DonationMasterNet. Background Art

[0003] RFID technology is becoming important in the field of transfusion technology. The aim is to provide a device that uses RFID, replaces barcodes, and introduces new possibilities in automated processing. The interest from the market is increasing because RFID technology in blood banks and transfusion medicine has the potential to improve operational efficiency and enhance patient safety at the point of care by automatically identifying, regulating, and tracking blood products throughout the blood supply chain. Summary of the Invention

[0004] According to the subject matter of the independent claims, the invention provides a device for processing blood containers and corresponding blood containers. Further embodiments are incorporated into the dependent claims.

[0005] According to an embodiment, there is provided a device for processing blood containers, the device comprising: a receptacle for at least one blood container equipped with a data storage tag, a data storage reader unit for reading data stored in the data storage tag on the blood container, a data storage writer unit for writing data stored in the data storage tag on the blood container, a user interface for inputting blood recipient-related information, a data processing unit having a data storage reader interface, a data storage writer interface, a user input interface, and a database communication interface, wherein the data storage reader unit is communicatively connected to the data storage reader interface, wherein the data storage writer unit is communicatively connected to the data storage writer interface, wherein the user interface is communicatively connected to the user input interface, wherein the data processing unit is communicatively connected to a database in which blood donor-related information is stored, wherein the data storage reader unit is adapted to read a blood donor identifier from the data storage of the blood container, wherein the data processing unit is adapted to request blood donor-related information from the database based on the read blood donor identifier, wherein the data processing unit is adapted to request interrelated blood recipient and donor information from the database based on blood donor-related information and recipient-related information input via the user interface, and wherein the data processing unit is adapted to control the data storage writer unit to write blood donor-related information into the data storage based on the interrelated blood recipient and donor information.

[0006] This allows for the correct processing of all relevant information regarding blood donors and blood recipients. Database information can be used to correctly match blood and avoid any serious harm on the blood recipient side. If the donor and recipient are identified, the matching information can be stored on the container. Any incorrect use can be avoided when storing donors and recipients.

[0007] According to an embodiment, the interrelated blood recipient and donor information is information on whether the donor's blood matches the recipient.

[0008] Therefore, the matching of the donor and recipient can be directly stored on the container.

[0009] According to an embodiment, the data storage unit is an RFID tag.

[0010] Therefore, information can be read non-contactlessly and there is no power supply on the container.

[0011] According to an embodiment, the database for the interrelated blood recipient and donor information is an external database, and the communication connection between the device and the database for the interrelated blood recipient and donor information is a wireless connection.

[0012] Thus, even complex data amounts or computing capabilities of external entities can be used. Additionally, databases regarding information that can be provided externally may be used, which can be used by different users, i.e., different devices for blood container processing at different locations.

[0013] According to an embodiment, the database for blood donor-related information is an external database, and the communication connection between the device and the database for blood donor-related information is a wireless connection.

[0014] Thus, corresponding information can be provided even in very flexible situations and locations of the devices for blood container processing.

[0015] According to an embodiment, the device further includes a first database storage unit storing a database for interrelated blood recipient and donor information.

[0016] Thus, the required information can also be provided locally without external access to the database. In the case where the system does not have an external connection to the database, the system can be protected against external access.

[0017] According to an embodiment, the device further includes a second database storage unit storing a database for blood donor-related information.

[0018] Thus, the required information can also be provided locally without external access to the database. In the case where the system does not have an external connection to the database, the system can be protected against external access.

[0019] According to an embodiment, the blood donor-related information includes at least one in a group consisting of donor information, blood separation information, and blood component information.

[0020] Thus, relevant information for the compatibility of donors and recipients can be provided directly on the container.

[0021] According to an embodiment, the data storage reader unit has at least one data storage reading element, and the data storage writer unit has at least one data storage writing element, wherein the data storage reading element and the data storage writing element are combined into a single read-write unit for combined reading and writing of data storage on the data storage label of the blood container.

[0022] Thus, a compact read and write unit can be provided for processing reading information from and writing information to the blood container.

[0023] According to an embodiment, the receptacle is adapted to receive a plurality of blood containers in parallel, wherein the data storage reader unit and the data storage writer unit are adapted to read and write the data storage labels of each of the plurality of blood containers in parallel.

[0024] Therefore, parallel processing can be performed. Several read and write elements and / or units can be connected to a bus system for communicating with a data processing unit.

[0025] According to an embodiment, there is provided a blood container including a volume for receiving blood and a data storage tag, wherein the data storage tag includes a read data storage section and a write data storage section.

[0026] Therefore, relevant information can be provided directly at the container such that the information is immediately bound to the container.

[0027] According to an embodiment, the data storage tag is an RFID tag.

[0028] Therefore, contactless reading and writing can be achieved without a power supply at the container.

[0029] According to an embodiment, the read data storage section and the write data storage section are implemented as the same chip.

[0030] Therefore, a compact design and thus a cost-effective chip can be provided.

[0031] According to an embodiment, the read data storage section and the write data storage section are implemented as different chips, wherein the read chip is adapted to prevent writing by a writing mechanism for writing to the write chip.

[0032] Therefore, higher data protection can be achieved. Different chips allow better separation and thus allow different measures for the storage and write chips.

[0033] According to an embodiment, the read data storage section is capable of holding a blood donor identification.

[0034] Therefore, a unique and optionally unmodifiable donor identification can be achieved.

[0035] According to an embodiment, the write data storage section is capable of holding interrelated blood donor and recipient identifications.

[0036] Therefore, relevant information can be provided on the container, which depends on the intended recipient. In the case of a recipient change, updated information can be written to the writable data storage. As an alternative, a "write once" data storage can be provided such that any modification can be avoided after writing recipient-related and relationship-related information to the container. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 The figure shows a collection chamber with CompoGuard and DonationMasterNet SW.

[0038] Figure 2 Illustration of an example of 4 T&B with an RCC InLine filter.

[0039] Figure 3 Illustration of a separation chamber with CompoMat G5 and CompoMasterNet G5 SW.

[0040] Figure 4 Illustration of a device for blood container processing according to an exemplary embodiment of the invention. Detailed Description

[0041] The following abbreviations are used in this specification:

[0042] CG: CompoGuard (mixing metric)

[0043] G5: CompoMat G5 (whole blood separator)

[0044] DMNet: DonationMasterNet (CG data management)

[0045] CMNetG5: CompoMasterNet G5 (G5 data management)

[0046] BBSW: Blood Bank Software - Hospital or Blood Bank Data Management

[0047] MB RFID: MultiBag RFID device

[0048] MB SW: MultiBag RFID device data management

[0049] PLT: Platelet

[0050] BC: Buffy coat

[0051] RCC: Red blood cell concentrate

[0052] DC: Donation code

[0053] HC: Blood component code

[0054] The following reference signs are used in this specification:

[0055] 1 Device for blood container processing

[0056] 10 Receiver

[0057] 20 Data storage reader unit

[0058] 21 Data storage reader interface

[0059] 25 Data storage and reading element

[0060] 30 Data storage writer unit

[0061] 31 Data storage writer interface

[0062] 35 Data storage writing element

[0063] 40 User interface

[0064] 41 User input interface

[0065] 50 Data processing unit

[0066] 60 Data communication unit

[0067] 61 Database communication interface

[0068] 62 First database storage unit for interrelated blood recipient and donor information.

[0069] 63 Second database storage unit for blood donor-related information

[0070] 162 Database for interrelated blood recipient and donor information

[0071] 163 Database for blood donor-related information

[0072] 200 Blood container

[0073] 210 Volume of the container for receiving blood

[0074] 260 Data storage label on the container

[0075] 262 Data storage reading section

[0076] 263 Data storage writing section

[0077] The present invention provides an apparatus for processing blood containers. The apparatus can be at least partially implemented as a MultiBag RFID reader-writer device (MB RFID) classified as MD according to 93 / 42 / EEC. The apparatus can be further at least partially implemented as a MultiBag RFID device data management solution (MB SW) verified, validated and archived according to MD software and according to rules from the FDA, which will coordinate the read / write functions of the MB RFID device. The CG and G5 devices and their data management solutions DMNet and CMNetG5 may not be modified in any case, for example.

[0078] The MB RFID can be implemented by a desktop device that can read and write multiple bags (bag) with the RFID tag LRI 2K55x55 (embedded 50x50) with an error of <<1% at the same time; for further tags, the % error must be evaluated, but it is always less than 1%. The maximum number of bags (1 bag = 1 TAG) can be, for example, 25 bags. The linear dimension of the MB RFID where the bags can be placed can be, for example, the A3 format (30 cm × 42 cm L × P). The external dimensions of the MB RFID can be designed, for example, not to exceed 51 cm × 65 cm × 42 cm (L × P × H).

[0079] The MB RFID can be linked to a personal computer or laptop, and its data management software (MB SW) is installed. For example, DMNet and CMNet G5 can, for example, not be installed on the same PC or laptop, as Figure 1 and Figure 3 illustrated.

[0080] The MB SW can, for example, be able to communicate with DMNet, CMNet G5, and BB SW. This link can be completed, for example, via a serial port and / or a USB 2.0 / 3.0 port and / or a wireless protocol (WiFi). The communication between the MB RFID and the MB SW can be, for example, two-way. After the read / write function, the MB RFID can, for example, confirm a successful or unsuccessful action. The communication between the MB RFID and the BB SW can be, for example, two-way. The communication between the MB SW and DMNet and CMNet G5 can be, for example, in a one-way mode: only pull data from our DMNet and CMNet G5 to the MB SW. The MB SW must pull ASCII data from DMNet and CMNet G5. At the end of the program, DMNet and CMNet G5 can, for example, automatically create an ASCII file in which the data fields of a constant number of each donation data record are exported. The MB SW can, for example, store these records itself so that the copy-paste of this file can be directly obtained from DMnet or CMNet, or receive this file from the BB SW. For example, this file cannot be deleted or modified from the original folder.

[0081] Figure 1 The collection room with CompoGuard and DonationMasterNet SW is illustrated. The collection room can include a seat called CompoCouch for blood donors. The donated blood can be directly analyzed and monitored. The obtained blood can be packaged and sealed on-site. The blood container can be provided with a unique identifier and a storage tag, which will be relative to later Figure 4It is described. By directly providing an identifier for the container on-site, faults can be reduced, especially misidentification regarding blood.

[0082] Figure 2 An example of 4 T&Bs with an RCC InLine filter is shown. Depending on the corresponding requirements, the filter can provide an appropriate filtering process to filter blood or plasma.

[0083] Figure 3 A separation chamber with CompoMat G5 and CompoMasterNet G5 SW is shown. The separation chamber can have all the required facilities for the correct handling of blood and blood containers.

[0084] The workflow at the collection site can be as follows, for example:

[0085] a. The label is printed by a printer connected to the BB SW in an eye-readable barcode and written into an RFID (at least with DC and HC).

[0086] b. The bag is labeled (see Figure 2 , the TAG is mainly on PLS and RCC bags. BC / PRP bags are an option).

[0087] c. The donation is started using the Fresenius Kabi interface on the CG.

[0088] d. DMNet receives a list of DC and other information and sends it in real-time to all CGs present in the network.

[0089] e. The DC and the CG set itself are simply read on the correct program using the dedicated collection volume, barcode sequence, and alarm settings.

[0090] f. At the end of the donation, the CG sends the data to the DMNet software, which automatically creates an ASCII file, in which 61 data fields of a constant number of data records per donation are exported. The fields are separated by the semicolon ";" respectively. If no data is stored for a field, the field remains empty. The corresponding field length is zero.

[0091] g. The MB SW stores these records itself so that the copy-paste of the file cannot be deleted from the original folder because it is also required for the interface between DMNet and the BB SW.

[0092] h. There are preset stages in the MB software where, based on the structure of the received ASCII file, it is possible to define which data must be written on the TAG. For example, the data of interest may only be the data in positions 6 / 7 / 11.

[0093] i. When using a plastic pallet to position a defined number of bags on the MB RFID, the device reads the DC code written in the tag and sends the list to the MB SW.

[0094] j. The MB SW replies to the device with the selected corresponding data list as described in stage h for each DC.

[0095] For example: The donation code 202500412536 has the following ASCII output file:

[0096] 1;1Donation;20100509122349;20100513081951;20100521072416;20100522081916;002CGA0277 / V1.4.0.1;0;255;480;481;0;335; 40;0;100;0;106;568;0;0;0;

[0097] 4;ABR,;BAG0,K202500412536;LOT,K7755234;OPE,M0034;TUB,K7755234; CRC,0x0F9A,

[0098] Where the bold positions are the selected positions in stage h (positions 6 / 7 / 11).

[0099] So the MB SW must send the following string to the MB RFID:

[0100] 202500412536,20100522081916:002CGA0277 / V1.4.0.1,481

[0101] This string is the same for each DC present on the MB RFID.

[0102] k. The MB RFID writes the correct string received from the MB SW in each TAG.

[0103] l. When the bags have to be transported to the blood bank, the MB RFID should be used to make a shipping list by RFID bulk reading.

[0104] For example: The shipping box can be positioned on the MB RFID and the device communicates to the MB SW how many bags and which bags are present.

[0105] The workflow in the separation site can be as follows for example:

[0106] Figure 2Diagram of the separation chamber with CompoMat G5 and CompoMasterNet G5 SW:

[0107] a. Use the Fresenius Kabi interface on G5 to start the separation.

[0108] b. CMNet G5 receives the list of DCs and sends them in real time to all G5s present in the network.

[0109] c. Depending on the bag type, donation time, and knowing whether it may produce BCs for pooling or for waste, etc., simply read the DCs on the correct program, the G5 set itself.

[0110] d. At the end of the separation, G5 sends the data to CMNet G5, which automatically creates a.csv file, in which a constant number of 43 data fields per separation data record are exported. The fields are separated by the semicolon ",", respectively. If no data is stored for a field, the field remains empty. The corresponding field length is zero.

[0111] For example: Printed output.csv file:

[0112] "DonationBC", "DummyBC", "7CPT0017", "09:19:18", "09: 20:18", "00:01:00", "09 / 02 / 2009", "ResultBC", "12", "TestProgram12", "Operator1BC", "l", "00:00:01", "001", "002", "003", "004", "005", "201", "202", "203", "204", "205", "l", "ProductBC", "BatchBC", "Operator2BC", "CentrifugeBC", "AdditionalBC", "Incidence1", "Incidence2", "Incidence3", "Incidence4", "Incidence5", "", "", "101", "102", "103", "104", "105", "09:19:18", "09:20:18"

[0113] e. The MB SW can store these records itself, such that copy - paste deletion of the file from the original folder is not possible, as this is also required for the interface between CMNet G5 and BB SW.

[0114] f. There is a preset stage in the MB SW where, based on the structure of the received.csv file, it should be possible to define which data for which blood component must be written in the TAG.

[0115] For example, the data of interest for a plasma bag may only be the data present in positions 7 / 14, and the data of interest for an RCC bag may only be the data in position 7 / 19.

[0116] g. When using a plastic tray to position a defined number of bags on the MB RFID, the device should read the DC and HC codes written in the TAG and send the list to the MB SW.

[0117] h. The MB SW should reply to the device with a list of the corresponding selected data as described in stage f. for each DC and HC.

[0118] For example: The code 202500412536 has the following.csv output file:

[0119] “K202500412536”, “”, “B”, “12:00:52”, “12:03:16”, “00:02:24”, “30 / 07 / 2008”, “”, “3”, “CQ32250”, “Operator1”, “0”, “00:00:00”, “302”, “”, “”, “”, “”, “344”, “”, “”, “”, “”, “0”, “KR8344”, “K08F06L51”, “”, “”, “”

[0120] Where the bold positions are the selected positions (positions 7 / 14 / 19).

[0121] So the MB SW must send the following string to the MB RFID:

[0122] 202500412536, 30 / 07 / 2008; 302; 344

[0123] This string is the same for each DC present on the MB RFID

[0124] i. The MB RFID should write the correct string received from the MB SW that differentiates between plasma and RCC bags in each TAG.

[0125] For example:

[0126] Plasma bags with DC 202500412536 and HC 7 must be received only on 30 / 07 / 2008; 302. RCC bags with DC202500412536 and HC 25 must be received only on 30 / 07 / 2008; 344

[0127] j. When bags have to be transported to the hospital, MB RFID shall be used to make a shipping list by means of RFID bulk reading.

[0128] For example, the shipping box may be located on the MB RFID, and the device shall communicate to the MB SW how many RCC or PLS bags there are and which RCC or PLS bags.

[0129] For back - lab operations, the MB RFID may be able to receive data regarding, for example, also the BC pooling process from the BB SW.

[0130] a. The MB SW shall receive from the BB SW a list that includes data such as pooling barcodes, assembled BC barcodes, and assembly dates.

[0131] For example:

[0132] I201425236985; 202500412536; 202500412537; 202500412538; 202500412539; 202500412540; 30 / 11 / 2015

[0133] where the BC barcodes are written in bold.

[0134] b. When the pooling bag that will contain the final PLT pool is located on the MB RFID, the barcode identifying the bag is scanned, and the data in the list shall be written in the previously applied TAG.

[0135] Figure 4 Schematic construction of a device according to an embodiment of the invention is illustrated. The device 1 for blood container processing has one or more receivers 10 for receiving one or more blood containers 200. A typical blood container 200 has a volume 210 for receiving blood. A typical blood container has a label 260 for data storage. The label 260 may have a reading part 262 and / or a writing part 263. These two parts may be implemented in a single chip or may be implemented in separate chips. The reading part 262 may contain blood donor - related information. This part may be implemented as a read - only part so that the information cannot be manipulated. The writing part 263 may contain information according to the relationship between the donor and the recipient. Figure 4The device 1 in [description] has a data storage reader unit 20, which may have a reading element 25. The reading element 25 may be arranged such that it can read donor-related information in the data storage 262 on the container 200. The device may also have a data storage writer unit 30 with a data writing element 35. The writing element may be adapted to write information (e.g., according to the mutual relationship between the blood donor and the blood recipient) onto the corresponding storage 263 of the container 200. The device 1 may have a data processing unit 50, which has a data storage reader interface 21, a data storage writer interface 31, a user input interface 41, and a database communication interface 61. The data storage reader interface 21 is connected to the data storage reader 20, and the data storage writer interface 31 is connected to the data storage writer 30. The user input interface 41 may be connected to a user input device 40, which may be a keyboard or any other device for inputting recipient-related information. The database communication interface 61 may be connected to a data communication unit 60, which may be adapted to connect to an external database 162 or 163 or an internal database 62, 63 through a wireless or wired bounded database connection. The database memory unit 62 may be used for the mutually related blood recipient and donor information. The database storage unit 63 may be used for blood donor-related information. Correspondingly, the database 162 may be used for the mutually related blood recipient and donor information, and the database 163 may be used for blood donor-related information.

Claims

1. An apparatus for processing blood containers, wherein, The device comprises: a plurality of receptacles (10) for receiving at least one blood container (200), said at least one blood container (200) being equipped with a data storage tag (260), a data storage reader unit (20) for reading the data storage of the data storage tag on the blood container; a data storage writer unit (30) for writing the data storage of the data storage tag on the blood container; wherein, the data storage reader unit (20) has a plurality of data storage reading elements (25), wherein each of the plurality of receptacles (10) is associated with one of the plurality of data storage reading elements (25), each data storage reading element (25) being arranged such that it can read the donor-related information in the data storage of the data storage tag (260) of at least one blood container (200) received in the associated receptacle (10), and the data storage writer unit (30) has a plurality of data storage writing elements (35), wherein each of the plurality of receptacles (10) is associated with one of the plurality of data storage writing elements (35), wherein, the data storage reading element (25) and the data storage writing element (35) associated with the same receptacle (10) are combined into a single read-write unit for reading and writing the combined read and write data storage of the data storage tag (260) on the blood container (200); a user interface (40) for inputting blood recipient-related information; a data processing unit (50) having a data storage reader interface (21), a data storage writer interface (31), a user input interface (41) and a database communication interface (61); wherein, the data storage reader unit (20) is communicatively connected to the data storage reader interface (21); wherein, the data storage writer unit (30) is communicatively connected to the data storage writer interface (31); wherein, the user interface (40) is communicatively connected to the user input interface (41); wherein, the data processing unit (50) is communicatively connected to a database in which blood donor-related information is stored; wherein, the data storage reader unit (20) is adapted to read a blood donor identifier from the data storage of the blood container; wherein, the data processing unit (50) is adapted to request blood donor-related information from the database (163) based on the read blood donor identifier; wherein, the data processing unit (50) is adapted to request mutually related blood recipient and donor information from another database (162) based on the blood donor-related information and the recipient-related information input via the user interface (40); Wherein, the data processing unit (50) is adapted to control the data storage writing unit (30) based on the interrelated blood recipient and donor information so as to write the blood donor-related information into the data storage.

2. The apparatus for processing blood containers according to claim 1, wherein, The interrelated blood recipient and donor information is information on whether the donor's blood matches the recipient.

3. The apparatus for processing blood containers according to claim 1 or 2, wherein, The data storage tag (260) is an RFID tag.

4. The apparatus for processing blood containers according to claim 1 or 2, wherein, The other database (162) for the interrelated blood recipient and donor information is an external database, and the communication connection between the device and the other database for the interrelated blood recipient and donor information is a wireless connection.

5. The apparatus for processing blood containers according to claim 1 or 2, wherein, The database (163) for the blood donor-related information is an external database, and the communication connection between the device and the database for the blood donor-related information is a wireless connection.

6. The apparatus for processing blood containers according to claim 1 or 2, wherein, The device further includes a first database storage unit (62), in which the other database for the interrelated blood recipient and donor information is stored.

7. The apparatus for processing blood containers according to claim 6, wherein, The device further includes a second database storage unit (63), in which the database for the blood donor-related information is stored.

8. The apparatus for processing blood containers according to claim 1 or 2, wherein, The blood donor-related information includes at least one of the following groups, the group consisting of donor information, blood separation information, and blood component information.

9. The apparatus for processing blood containers according to claim 1 or 2, wherein, The receptacle (10) is adapted to receive a plurality of blood containers in parallel, wherein, the data storage reader unit (20) and the data storage writing unit (30) are adapted to read and write the data storage tags of each of the plurality of blood containers in parallel.

10. The device for processing a blood container according to claim 1 or 2, further comprising the at least one blood container (200), wherein the at least one blood container (200) comprises: Volume (210) for receiving blood; Data storage tag (260); Wherein, the data storage tag includes a read data storage part (262) and a write data storage part (263).

11. The device for processing a blood container according to claim 10, wherein, The data storage tag (260) is an RFID tag.

12. The device for processing a blood container according to claim 10, wherein, The read data storage part (262) and the write data storage part (263) are implemented as the same chip.

13. The device for processing a blood container according to claim 10, wherein, The read data storage part (262) and the write data storage part (263) are implemented as different chips, wherein, the read chip is adapted to be prevented from being written by the writing mechanism, and the writing mechanism is used for writing to the writing chip.

14. The device for processing a blood container according to claim 10, wherein, The read data storage part (262) is capable of holding the blood donor identification.

15. The device for processing a blood container according to claim 10, wherein, The write data storage part (263) is capable of holding the interrelated blood donor and recipient identification.

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