Iv systems - digital ecosystem for verifying and documenting an infusion specification

WO2025051871A1PCT designated stage expired Publication Date: 2025-03-13B BRAUN MELSUNGEN AG
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Patent Information

Application Number
PCT/EP2024/074855
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-07
Filing Date
2024-09-05
Publication Date
2025-03-13

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Abstract

The present disclosure relates to a method for verifying and documenting an infusion therapy process (S100) having the following steps: receiving a medication prescription from preferably an IT system (8); converting the medication prescription into an instruction; first verification of the medication and / or the preparation by a scanner unit (1); second verification of at least a part of the infusion pump by the scanner unit (1); third verification of a patient by the scanner unit (1); monitoring the infusion administration and fourth verification of the infusion; and documenting the infusion therapy by transmitting all verifications and monitoring data to an IT system (8). Furthermore, the present disclosure relates to an electronic hardware arrangement (5) for verifying and documenting an infusion therapy process, having a user interface (6), a, preferably wireless, data connection (7) to at least one IT system (8), a scanner unit (1) for reading in data, software or a controller (10), and an integrated or separate sensor (2).
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Description

[0001] IV Systems - Digital EcoSystem for the verification and documentation of an infusion statement

[0002] Description

[0003] Technical area

[0004] The present disclosure relates to a method and an electronic hardware arrangement for verifying and documenting an infusion therapy process.

[0005] Background of the invention

[0006] Especially in the medical field, it is particularly important to minimize or eliminate errors in procedures and processes in order to increase the safety of every patient. In this regard, applications using a scanner / scanner unit are known, which makes it possible to establish the connection between prescription, medication, and patient. Furthermore, there are solutions that enable monitoring of infusion administration. Infusion monitoring systems exist that have the option of manually recording prescription and patient data via the user. However, these differ significantly from user-independent electronic verifications.

[0007] State of the art

[0008] US 2010 / 280 486 A1 discloses a method for administering medication to a patient using a dispensable medication delivery system. A first medication to be delivered to the patient is provided. The patient's identity is verified, and the first medication is selected on a user interface to be administered to the patient. The amount of medication to be administered to the patient is entered. The first medication is injected into the patient through a flow-through arrangement. The flow rate and volume of the first medication delivered to the patient are monitored by a flow sensor arrangement during the injection. A visual indicator informs the user of the injection. The method updates the patient's electronic medical record to capture and document information regarding the injection of the first medication.

[0009] However, the current state of the art has the disadvantage that, on the one hand, no electronic verification of the medication, patient, etc. is permitted and / or, on the other hand, the infusion process is not verified and documented.

[0010] In view of the state of the art, the object of the present disclosure is to provide a method that eliminates or at least improves the disadvantages of the prior art. One goal of the present disclosure is to make all aspects of infusion therapy safer in order to prevent errors in the process as best as possible or to detect them when they occur, so that the user is informed of a corresponding error and given the opportunity to correct it.

[0011] The object of the present disclosure is achieved by a method for verifying and documenting an infusion therapy process that can be carried out by means of an infusion system according to the features of claim 1.

[0012] The procedure includes the following steps:

[0013] - In a first step, a medication prescription for a patient is received, preferably from an IT system.

[0014] - In a second step, the medication prescription is converted into a

[0015] converted into an instruction for action.

[0016] - In a third step, a first verification is carried out based on the

[0017] Instructions for use of the medication and / or preparation are carried out by a scanner unit. - In a fourth step, a second verification is carried out based on the

[0018] Instruction for action of at least one component of the infusion system, in particular an infusion pump, an infusion transfer system and / or a syringe, is carried out by the scanner unit.

[0019] - In a fifth step, a third verification of the patient is carried out by the

[0020] scanner unit.

[0021] - In a sixth step, the infusion administration is monitored and a fourth

[0022] Verification carried out based on the infusion / infusion administration instructions.

[0023] - Finally, in a final step, the infusion therapy is documented by transmitting all verifications and monitor data to an IT system via a data connection.

[0024] In other words, information regarding a prescription is received from a first computer application of an IT system, such as a patient documentation system, and converted into an instruction by means of a controller / software. Based on the instruction, the controller / software can then verify whether the medication or preparation is correct. Furthermore, other components of the infusion system that serve as aids for infusion administration must be verified, such as an infusion pump, an infusion transfer system, syringes, etc. Furthermore, the method ensures that the correct patient receives the infusion therapy. During the infusion administration, the method provides monitoring of the infusion and enables verification of the infusion by at least one sensor, in particular a flow rate sensor.As a final step, the complete infusion therapy is documented by transmitting all verifications and monitor data to at least one application of the IT system.

[0025] Further aspects of the present disclosure are described in the subclaims. It is preferred if the instruction includes at least one of the following information:

[0026] - Drug name

[0027] - Preparation

[0028] - Flow rate

[0029] - Patient, and / or

[0030] - planned time of infusion.

[0031] It is advantageous if the scanner unit reads information in a barcode, QR code, RFID tag, or NFC tag, or takes a photo and compares this with stored information using image and / or pattern recognition. In other words, this means that the scanner unit scans and reads one of the above-mentioned codes or tags. The read information can then be further processed by the controller / software. This verifies the individual process steps mentioned above.

[0032] It is preferred if, during the first verification, the scanner unit captures the barcode, QR code, RFID tag, or NFC tag on a medication package and reads the information, or takes a photo of the medication package and compares it using image and / or pattern recognition. The read or received information can then be compared with stored information, such as the medication prescription, to ensure that the correct medication or preparation is involved. Verification can include comparing read or compared information with the instructions. Information can, for example, be stored in a patient database. Information can preferably be stored in an IT system.

[0033] It is advantageous if, during the second verification, the scanner unit captures the barcode, QR code, RFID tag, or NFC tag on at least part of a component of the infusion system, in particular part of the infusion pump, and reads the information, or takes a photo of at least part of the component of the infusion system, in particular at least part of the infusion pump, and compares it with stored information using image and / or pattern recognition. In this way, components of the infusion system, such as infusion pumps, infusion transfer systems, and / or syringes, can be verified. The verification can include comparing read or compared information with the instruction. Information can, for example, be stored in a patient database. Information can preferably be stored in an IT system.

[0034] During the third verification, it is preferred that the scanner unit captures a patient's barcode, QR code, RFID tag, or NFC tag and reads the information, or takes a photo of the patient and compares it with stored information using image and / or pattern recognition. This verification ensures that the prepared infusion therapy is administered to the correct patient.

[0035] It is advantageous if incorrect medication and / or incorrect preparation can be detected by means of the first verification, and / or if an incorrect connection of components of the infusion system and / or an occlusion in a component of the infusion system, in particular in at least one part of the infusion pump, can be detected by means of the second verification, and / or if a patient-specific therapy problem can be detected by means of the third verification and / or an incorrect allocation of medication and patient can be detected, and / or if an inaccurate flow rate, an incorrect time or an interruption and / or a delay in the flow can be detected by means of the fourth verification.

[0036] In summary, the verifications are carried out by means of a scanner unit which detects a marking on, for example, packaging, a patient, for example applied to a wristband, or at least one pump part or packaging of at least one pump part and reads out the information contained therein. Alternatively or additionally, the scanner unit can be designed as a camera, in particular as a CCD camera. The verifications can also be carried out by means of this and in combination with image or pattern recognition. Furthermore, the present disclosure relates to an electronic hardware arrangement for verifying and documenting an infusion therapy process with a user interface, a preferably wireless data connection to at least one IT system or data processing system oran application of an IT system, in particular a patient documentation system, a scanner unit for reading in data, a software or controller, and an integrated or separate sensor, preferably a flow rate sensor, wherein the electronic hardware arrangement is designed and provided to carry out the steps according to one of the preceding aspects.

[0037] In other words, this means that the electronic hardware arrangement is an arrangement whose connection to one or more applications on an IT system or computer system is intended and designed to carry out the above method steps.

[0038] Advantageously, the user interface is a display, a keyboard and / or a mouse.

[0039] Accordingly, the electronic hardware arrangement is provided and designed such that the scanner unit can read out or read in data / information according to the above first to fourth verifications, so that the software or the controller is provided and designed to output corresponding data to the user via, for example, the user interface.

[0040] The sensor can be designed as a flow rate sensor, for example in the form of a drop counter or an infusion pump, and is intended and designed to detect, for example, the start and end of the infusion. The sensor can be part of the remaining hardware consisting of the user interface and the scanner unit, or alternatively, it can be designed separately from the remaining hardware. This means that the components of the user interface, the scanner unit, and the wireless data connection can be installed in one system. The sensor can be designed as a separate electronic device, which then has a data connection to the remaining components or to at least one application of the EDP / IT system, which then establishes the logical connection.

[0041] It is preferred if the sensor is designed to be connectable to the user interface and the scanner unit or at least an IT system via the data connection. This ensures data transmission and thus documentation with both the integrated sensor and the separate sensor.

[0042] It is advantageous if the scanner unit is provided and designed to read a barcode, a QR code, an RFID tag or an NFC tag or if the scanner unit is designed as a camera, in particular a CCD camera.

[0043] Short description of the characters

[0044] Fig. 1 is a diagram illustrating an infusion therapy process according to the present disclosure;

[0045] Fig. 2 is a diagram illustrating the electronic hardware arrangement according to the present disclosure; and

[0046] Fig. 3 is a diagram illustrating various flow rate sensors that can be used.

[0047] Hereinafter, embodiments of the present disclosure will be described based on the accompanying figures.

[0048] Fig. 1 is a diagram illustrating an infusion therapy process S100 according to the present disclosure. The infusion therapy process S100 includes a first prescription step S1, a second medication preparation step S2, a third patient access step S3, a fourth application / infusion administration step S4, and a final disposal step S5.

[0049] During the first step S1 and the second step S2, a medication order / prescription is received by an IT system 8, in particular a data documentation system. The information contained therein is converted into an instruction, and the medication is prepared according to the received information. These two steps S1 and S2 are ensured by an initial verification. Thus, the use of an incorrect medication or incorrect preparation of the medication can be detected at this stage, and there is an opportunity for correction.

[0050] In a third step (S3), it is ensured that the prepared medication corresponds to the correct patient's prescription. If verification is successful, the patient is given access for their infusion therapy.

[0051] In the fourth step S4, the infusion therapy / infusion administration is carried out. Here, it is first ensured that the medication or drug has been assigned to the correct patient S41 . If this is the case, the process continues. If the assignment is incorrect, an indication of incorrect medication is given. The infusion is then administered with a prescribed flow rate and control / monitoring (S42). During this process, components of the infusion system, such as the infusion pump, the infusion transfer system and / or syringes, are verified. If verification is not carried out, the following errors may be documented: faulty connection, occlusion / blockage / closure, inaccurate flow rate or incorrect infusion time.In a further step S43, identifying incompatibilities, therapy-related problems, as well as interruptions and delays, can be detected and documented. Subsequently, in a further step S44, the infusion therapy S100 is documented. Documentation is performed by transmitting all previous verifications and data output during the infusion therapy process S100 to a first or subsequent application of an IT system. If the documentation is incorrect or missing in step S44, the user is notified accordingly.

[0052] In a final step S5, the infusion is stopped and the corresponding disposable components of the infusion therapy process S100 are disposed of.

[0053] Fig. 2 is a diagram illustrating the electronic hardware arrangement 5 for verifying and documenting an infusion therapy process S100 according to the present disclosure. The electronic hardware arrangement 5 has a user interface 6, a preferably wireless data connection 7 to at least one IT system 8, a scanner unit 1 for reading in data, software or controller 10, and an integrated or separate sensor 2, preferably a flow rate sensor. The dashed line in Fig. 2 indicates the possibility of a separate sensor 2. In this case, a further transmission 9 of data for the communication of the sensor 2 with the remaining hardware is shown. Alternatively, a direct transmission of the data from the sensor 2 to the IT system 8 is also conceivable / intended.

[0054] The scanner unit 1 is capable of reading a barcode 3, QR code 3, RFID tag 3, or NFC tag 3. Furthermore, the scanner unit 1 can be configured as a camera. In this case, the scanner unit 1 captures a photo / image, which can be compared using image or pattern recognition 4, and the object or medication or drug or at least a part of the infusion pump or the patient can be identified. The comparison can be performed using stored information. This information can be stored, for example, in the IT system 8.

[0055] Fig. 3 is a diagram illustrating various usable flow rate sensors. In the present disclosure, the flow rate sensors depicted serve to monitor 11 the infusion administration according to step S4. Reference numerals

[0056] 1 scanner unit

[0057] 2 sensors

[0058] 3 Code, Day

[0059] 4 Image / pattern recognition

[0060] 5 Electronic hardware arrangement

[0061] 6 User interface

[0062] 7 Data connection

[0063] 8 IT system

[0064] 9 Transmission

[0065] 10 Control / Software

[0066] 11 Monitoring

Claims

Claims 1. Method for verifying and documenting an infusion therapy process (S100) using an infusion system, comprising the following steps: - Receiving a medication prescription for a patient, preferably from an IT system; - Converting the medication prescription into an instruction for action; - first verification based on the instructions for use of the medicament and / or the preparation by a scanner unit (1) (S1, S2); - second verification based on the instruction of at least one component of the infusion system, in particular an infusion pump, an infusion transfer system and / or a syringe, by the scanner unit (1) (S4); - third verification of the patient by the scanner unit (1) (S41); - monitoring the infusion administration and fourth verification based on the infusion action instruction (S42, S43) by a sensor (2); and - Documentation of infusion therapy by transmitting all verifications and data to an IT system (8) via a data connection (9) (S44).

2. Method according to claim 1, characterized in that the instruction comprises at least one of the following information: - Drug name - Preparation - Flow rate - Patient, and - planned time of administration.

3. Method according to one of the preceding claims, characterized in that information in a barcode (3), QR code (3), RFID tag (3) or NFC tag (3) is read out by the scanner unit (1) or a photo created and this is compared with stored information using image and / or pattern recognition (4).

4. Method according to one of the preceding claims, characterized in that during the first verification the scanner unit (1) detects the barcode (3), QR code (3), RFID tag (3) or NFC tag (3) on a packaging of the medication and reads out the information or takes a photo of a packaging of the medication and compares it with stored information by means of image and / or pattern recognition (4), wherein the read out or compared information is compared with the instruction during the verification.

5. Method according to one of the preceding claims, characterized in that during the second verification the scanner unit (1) detects the barcode (3), QR code (3), RFID tag (3) or NFC tag (3) on at least part of a component of the infusion system, in particular the infusion pump, and reads out the information or takes a photo of the at least part of a component of the infusion system, in particular the infusion pump, and compares it with stored information by means of image and / or pattern recognition (4), wherein the read out or compared information is compared with the instruction during the verification.

6. Method according to one of the preceding claims, characterized in that during the third verification the scanner unit (1) detects the barcode (3), QR code (3), RFID tag (3) or NFC tag (3) of a patient and reads out the information or takes a photo of the patient and compares it with stored information by means of image and / or pattern recognition (4).

7. Method according to one of the preceding claims, characterized in that by means of the first verification an incorrect medication and / or an incorrect preparation can be detected, and / or the second verification reveals a faulty connection of components of the infusion system and / or an occlusion in at least part of the infusion pump, and / or the third verification reveals a patient-specific therapy problem and / or an incorrect allocation of medication and patient, and / or the fourth verification reveals an inaccurate flow rate, an incorrect time or an interruption and / or a delay in the flow.

8. Electronic hardware arrangement (5) for verifying and documenting an infusion therapy process (S100) with a user interface (6), a preferably wireless data connection (7) to at least one IT system (8), a scanner unit (1) for reading in data, a software or controller (10), and an integrated or separate sensor (2), preferably a flow rate sensor, characterized in that the electronic hardware arrangement (5) is designed and provided to carry out the steps according to one of claims 1 to 7.

9. Electronic hardware arrangement (5) according to claim 8, characterized in that the sensor (2) is designed to be connectable to the user interface (6) and the scanner unit (1) or at least one IT system (8) via the data connection (9).

10. Electronic hardware arrangement (5) according to one of claims 8 or 9, characterized in that the scanner unit (1) is provided and designed to read a barcode (3), a QR code (3), an RFID tag (3) or an NFC tag (3) or the scanner unit (1) is designed as a camera, in particular as a CCD camera.

Citation Information

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