MEDICAL PATIENT VALIDATION FACILITY

Description

Technical area

[0001] The present disclosure relates to a validation system (device) and a control method for ensuring that at least one piece of patient and / or location information is securely assigned to a medical device and that the assignment is verified. Background of the invention

[0002] In clinical practice, medical devices are connected to patients. Both the medical device and the patient are identified using a "reader," and the resulting data packet is sent to a server. The read data contains, in particular, patient and / or location information associated with at least one medical device. The location information is preferably information about the location of the patient's bed or patient room, as well as the medical devices, which are usually located in the patient room or near the patient's bed.

[0003] A data transfer is provided between the server and at least one medical device, such as one or more infusion pumps. This allows the medical device to receive, for example, a prescription and / or medication for a specific patient. During this data transfer, it is important that the data received by the medical device reaches the correct patient.

[0004] Methods for the logical assignment of medical devices to patients are already known. These are used, for example, for the automatic programming of infusion pumps. Current implementations, in which medical devices are logically assigned to patients, are not easily fail-safe with regard to the IEC 60601-1 standard. In clinical practice, this means that the assignment information is not completely trustworthy and requires additional user validation. For example, therapy orders sent to an infusion pump must be validated and confirmed by the user before the infusion begins. State of the art

[0005] According to the current state of the art, the server knows which patient ID belongs to a specific medical device. While the server is capable of forwarding information for this patient ID to the medical device, the process is not fail-safe. An error, such as can occur in existing systems, cannot be detected with this state of the art and could lead to misrouting.

[0006] In other words, current implementations only allow medical devices to be logically assigned to patients. However, validation or verification of this assignment is not provided. Another disadvantage is that locations such as a room or a patient bed ID are not covered.

[0007] US 2005 / 102167 A1 discloses a validation system comprising at least one medical device connected to a patient, and both the medical device and the patient and / or a patient bed are each provided with at least one identification marking. Brief description of the invention

[0008] The present invention is therefore based on the object of providing a validation system for the assignment of at least one medical device to a patient that avoids or at least mitigates the disadvantages of the prior art. The present invention is defined by the appended claims.

[0009] The core of the present invention lies in providing a validation system with at least one medical device, an identification device, and a server that communicates with the at least one medical device and the identification device and is provided and configured to assign the at least one medical device to a corresponding patient and / or patient bed or patient information and / or location information according to an assignment run. The at least one medical instrument is connected or connectable to a patient, and both the medical device and the patient are each provided or can be provided with at least one identification marking. The identification device is provided with a display and is provided and configured to read the identification markings.

[0010] According to the invention, a verification means is additionally arranged which is provided and designed to verify the assignment of the at least one medical device to the corresponding patient and / or patient bed or the corresponding patient information and / or location information in a verification run that is independent / separate from the assignment run by means of a first transaction ID generated by the server.

[0011] In other words, this means that the patient and / or the patient bed and the at least one medical device are each provided with an identification marking, which is read out according to an assignment run using the identification device. The data read out from the identification marking of the patient and / or the patient bed and the at least one corresponding medical device are sent to the server as a data packet. In a verification run, a first transaction ID is then generated based on the data packet received from the server. The generated first transaction ID makes it possible to verify the assignment of the at least one medical device to the corresponding patient and / or patient bed or patient information and / or location information.

[0012] The validation system described above provides the basis for medical server applications that use data from multiple medical devices / medical products linked to a single patient and / or location.

[0013] Since it is further preferred if the identification device is designed as a connecting device, the validation system enables a connection between the server or the server address and the medical device and / or patient and / or patient bed and / or connected systems in order to reliably assign data transmitted from the medical device to the server to the patient and / or the patient bed. This enables a user, in particular a doctor, to make a diagnosis and / or adapt the treatment. In particular, it is preferred if the connection between the server or the server address and the medical device and / or the patient and / or the patient bed is established and used by means of a remote control. It is preferred if the identification device reads the identification markings optically, for example by means of infrared.This offers the advantage that the user / operator of the identification device can / may have a variable distance and / or angle to the identification mark.

[0014] This makes it possible to dynamically ensure a secure, logical assignment and linking of medical devices to patient and / or location information. The patient and / or location information is intended to be contained in technical or medical data reported by at least one medical device / medical device, enabling the linking / assignment of data from a multitude of medical devices / medical devices to a patient and / or location. All data received from a medical device site, such as a therapy prescription for a specific patient, can thus be securely verified to ensure it is sent to exactly the medical device connected to the correct patient and / or location.

[0015] Advantageous embodiments are claimed in the subclaims and are explained in more detail below.

[0016] It is preferred if the identification marking is designed as a QR code, barcode, or an identification number and has at least one device ID, a patient ID, and / or a location ID. In other words, this means that the patient wears, for example, a wristband with a corresponding identification marking that has the patient ID. Furthermore, alternatively or additionally, it is provided that the patient bed has an identification marking that outputs the location ID, preferably the patient bed ID and / or the associated room. An identification marking that outputs the device ID is also attached to the at least one medical device. This has the advantage that the identification marking can be easily read using the identification device.The identification device is preferably designed as a QR code reader and / or barcode reader or alternatively as an optical camera system.

[0017] It is preferred that the first transaction ID generated by the server be composed of the device ID, the patient ID, and / or the location ID. The healthcare organization maintains a list of unique identification elements for medical devices, medical equipment, patients, and / or locations. This could be, for example, a patient wristband with a unique identification number or a QR code containing information for identifying the medical devices / medical equipment or location information.

[0018] During the verification run, the medical device is provided and configured to receive the first transaction ID and to send a modified second transaction ID to the server if the first transaction ID contains the device ID. In other words, this means that the server sends the generated first transaction ID to the at least one medical device. The at least one medical device checks whether the first transaction ID contains the device ID corresponding to the at least one medical device. If this is the case, the at least one medical device displays a modified / changed second transaction ID on the screen of the identification device.

[0019] During the verification run, the server is configured and designed to compare the received second transaction ID with the generated first transaction ID stored on the server. In other words, this means that the second transaction ID is sent back to the server from the identification device. The server compares the second transaction ID with the first transaction ID, where the first transaction ID is / was stored on the server.

[0020] It is preferred if, in the event of a positive comparison in the medical device, the identification device is provided and designed during the verification run to visualize the positive assignment of the medical device to the patient and / or to the location in a preferably optical symbol on the display. This means that if the first transaction ID matches the second transaction ID, the assignment of the at least one medical device to the patient and / or location is treated as valid. The valid connection / assignment of the at least one medical device / product to the patient and / or patient bed or to the patient information and / or location information is finally visualized by an optical symbol assigned to the identification device.

[0021] It is preferred if the server is provided and configured during the verification run to change the second transaction ID into a third transaction ID and send it to the medical device. In other words, this means that the second transaction ID received from the server is modified again and sent to the at least one medical device.

[0022] It is preferred if the medical device is provided and configured to compare the received third transaction ID with the stored second transaction ID during the verification run. The at least one medical device compares this modified third transaction ID with the second transaction ID stored in the at least one medical device.

[0023] It is preferred if, in the event of a positive comparison, the identification device is provided and designed during the verification run to visualize the positive assignment of the at least one medical device to the patient and / or to the location in a preferably optical symbol on the display. This means that if the second transaction ID matches the third transaction ID, the assignment of the at least one medical device to the patient and / or patient bed or to the patient information and / or location information is treated as valid. The valid connection / assignment of the at least one medical device / product to the patient and / or location is finally visualized by an optical symbol on the screen of the identification device.

[0024] It is preferred if the validation system is designed and configured to group the patient and / or location information from a plurality of medical devices / products assigned to a single patient or location. In other words, this means that at this point in time, all data sent by the at least one medical device contains / identifies patient and / or location information, which allows data from a plurality of medical devices / medical products to be combined. Furthermore, the at least one medical device is configured / capable of performing independent validation of incoming control requests.

[0025] In summary, the validation system enables verification of the assignment made in the assignment run. This verification, using the verification tool, thus provides a channel independent of the assignment run to protect against individual errors. Thus, the validation system offers the advantage of fail-safe assignment of medical device / equipment data to a patient ID and / or a site ID. The verification run enables the use of data in server applications for therapeutic decisions, the grouping of data from multiple medical devices / equipment belonging to a single patient / site, and the adoption of control data for remote control of medical devices / equipment.

[0026] Furthermore, the present invention relates to a control method for ensuring that at least one patient and / or location information item is assigned to at least one medical device and the assignment is checked, with the following steps.

[0027] In a first step, an identification marker is read and a device ID, patient ID, and / or location ID is output as a data packet by an identification device. In a second step, this read data is sent to a server as a data packet. The server generates a first transaction ID from the device ID, patient ID, and / or location ID and sends the generated first transaction ID to the at least one medical device. In a further step, the first transaction ID is changed / modified into a second transaction ID if the first transaction ID contains the device ID. This means that the at least one medical device checks whether its device ID is contained in the first transaction ID. If this is the case, the first transaction ID is modified and displayed on the identification device's display.

[0028] In a subsequent step, the second transaction ID is sent back to the server, and the second transaction ID received at the server is compared with the first transaction ID stored on the server. If the comparison is consistent, a visual symbol is displayed on the identification device's display, and the second transaction ID is changed to a third transaction ID on the server.

[0029] The third transaction ID is sent to the at least one medical device, and the received third transaction ID is compared with the stored second transaction ID. In a final step, a visual symbol is visualized and displayed on the screen of the identification device if the comparison is consistent.

[0030] After successfully completing the above steps, the logical link / assignment of medical device / medical device to patient and / or location is validated on both the server and medical device side.

[0031] By repeating this process, a plurality of different medical devices, such as multiple infusion pumps, dialysis machines, ventilators, physiological sensors and / or the like, can be linked or assigned to a single patient and / or location.

[0032] The present invention provides for data transfer between medical devices and applications, for example, two medical devices, Pump 1 and Pump 2, which communicate with each other via a server. During certain short interruptions / pauses in the process, the system continues running, and during long interruptions / pauses, the assignment process is initiated again. Short description of the figure

[0033] Fig. 1 is a schematic diagram illustrating a validation system and a control method according to the embodiment of the present disclosure. Description of the embodiment

[0034] A preferred embodiment of the present disclosure is described below based on the accompanying figure. The figure is merely schematic in nature and serves to facilitate understanding of the invention. The same elements are designated by the same reference numerals.

[0035] Fig. 1 is a diagram illustrating a validation system 1 according to the embodiment of the present disclosure. Fig. 1The arrows labeled S10 to S15 represent communication connections / data paths, which are referred to as steps S10 to S15 in the following description. The validation system 1 according to Fig. 1 has, among other things, a medical device 2. The medical device 2 is in Fig. 1 exemplified by several infusion pumps. The medical device 2 and a depicted patient (patient arm) 3 or a depicted patient bed 11 each have an identification marking 4 as a further part of the validation system 1, designed as a QR code. During operation, the medical device 2 is connected to the patient 3 (not depicted) or is located near the patient bed.

[0036] Furthermore, the validation system 1 has an identification device 5. The identification device 5 is configured to read the identification markings 4 of the medical device 2 and the patient 3 and / or the patient bed 11. The identification device 5 reads a device ID, a patient ID, and / or a location ID / patient bed ID from the identification markings 4. The identification device 5 has a display 6 configured to display / visualize information and / or symbols.

[0037] In Fig. 1 A server 7 is also shown, which communicates with both the medical device 2 and the identification device 5.

[0038] According to an assignment run, the identification device 5 reads the identification markings 4 of the medical device 2 and the patient 3 and / or the patient bed according to step S10. The read device ID, patient ID, and / or location ID are transmitted / sent to the server 7 as a data packet in a step S11.

[0039] The subsequent steps are performed according to a verification run. In step S12, the server 7 generates a first transaction ID 8 from the received device ID, patient ID, and / or location ID and sends this first transaction ID 8 to the medical device 2. The medical device 2 checks whether the device ID corresponding to the medical device 2 is contained in the received first transaction ID 8.

[0040] If this is the case, the display of the medical device 2 shows a modified second transaction ID 9 according to step S13. The modification ensures that the transaction ID 8 was routed via the medical device 2. This modified second transaction ID 9 is read by the identification device 5.

[0041] In step S14, the second transaction ID 9 is sent back to the server 7 and compared with the first transaction ID 8 stored in the server 7. If the comparison of the second transaction ID 9 with the first transaction ID 8 is positive, the identification device 5 is configured to visualize the positive assignment of the medical device 2 to the patient 3 and / or the patient bed 11 according to the location in an optical symbol on the display 6 and to designate the assignment as valid.

[0042] In a step S15, the server 7 modifies the second transaction ID 9 into a third transaction ID 10 and sends the third transaction ID 10 to the medical device 2. The medical device 2 compares the received third transaction ID 10 with the stored second transaction ID 9. If the comparison between the third transaction ID 10 and the second transaction ID 9 is positive, the identification device 5 is designed to visualize the positive assignment of the medical device 2 to the patient 3 and / or the patient bed 11 according to the location in an optical symbol on the screen / display of the medical device 2 and to designate the assignment as valid.

[0043] Furthermore, it is preferred if, in a further step S16, the positive assignment or validation is additionally displayed on the display of the identification device 5. This information regarding the positive validation is reported back to the user via the identification device 5, for example, in an optical, acoustic, or haptic / vibratory manner.

[0044] After performing these above steps S10 to S15 or S16, all data sent by the medical device / product 2 contain patient and / or location information that allows a plurality of medical devices 2 to be combined, and the medical device 2 is also intended to perform an independent validation of incoming control orders.

[0045] In particular, it is intended that the assignment run can be carried out independently of the verification run. List of reference symbols

[0046] 1.Validation system 2.Medical device 3.Patient 4.Identification marker 5.Identification device 6.Display 7.Server 8.First transaction ID 9.Second transaction ID 10.Third transaction ID

Claims

1. A validation system (1), with at least one medical device (2) which is connected to a patient (3) and both the medical device (2) and the patient (3) and / or a patient's bed are each provided with at least one identification marker (4), an identification device (5) which is provided with a display (6) and is provided and configured to read out the identification markers (4), and a server (7) which communicates with the at least one medical device (2) and the identification device (5) and is provided and configured to assign the at least one medical device (2) to a corresponding patient (3) according to an assignment process, characterized in that a reviewing means is provided and configured to review the assignment of the at least one medical device (2) to the corresponding patient (3) in a reviewing process independent of the assignment process via a first transaction ID (8), composed of a device ID and a patient ID, and / or a location ID and generated by the server (7), and the medical device (2) in the reviewing process is provided and configured to receive the first transaction ID (8) and to send a modified second transaction ID (9) to the server (7) if the first transaction ID (8) comprises the device ID, and the server (7) in the reviewing process is provided and configured to compare the received second transaction ID (9) with the generated first transaction ID (8) stored in the server (7).

2. The validation system (1) according to claim 1, characterized in that the identification marker (4) is configured as a QR code or an identification number and comprises at least a device ID and a patient ID, and / or a location ID.

3. The validation system (1) according to claim 1, characterized in that in the event of a positive comparison, the identification device (5) in the reviewing process is provided and configured to visualize the positive assignment of the medical device (2) to the patient (3) and / or to the location in a preferably optical symbol on the display (6).

4. The validation system (1) according to claim 1, characterized in that the server (7) in the reviewing process is provided and configured to change the second transaction ID (9) to a third transaction ID (10) and to send it to the medical device (2).

5. The validation system (1) according to claim 4, characterized in that the medical device (2) in the reviewing process is provided and configured to compare the received third transaction ID (10) with the stored second transaction ID (9).

6. The validation system (1) according to claim 5, characterized in that in the event of a positive comparison in the medical device (2), the identification device (5) and / or the medical device (2) in the reviewing process is provided and configured to visualize the positive assignment of the at least one medical device (2) to the patient (3) and / or to the location in a preferably optical symbol on the display of the medical device (2) and / or the identification device (5).

7. The validation system (1) according to one of the preceding claims, characterized in that the validation system (1) is provided and configured to group the patient information and / or location information from a plurality of medical devices / products (2) associated with a single patient (3) or location.

8. A controlling method for ensuring that at least one piece of patient information and / or location information is assigned to at least one medical device (2) and that the assignment is reviewed, comprising the following steps: reading (S10) an identification marker (4) and outputting a device ID, patient ID, and / or location ID as a data packet by an identification device (5), sending (S11) the data packet to a server (7), generating (S12) a first transaction ID (8) from the device ID, patient ID, and / or location ID, and sending the generated first transaction ID (8) to the medical device (2), changing the first transaction ID (8) to a second transaction ID (9) if the first transaction ID (8) has the device ID, sending (S14) the second transaction ID (9) to the server (7) and comparing the second transaction ID (9) received at the server (7) with the first transaction ID (8) stored in the server (7).

9. The controlling method according to claim 8, comprising the further steps of: changing (S15) the second transaction ID (9) to a third transaction ID (10) in the server (7) and sending the third transaction ID (10) to the medical device (2) and comparing the received third transaction ID (10) with the second transaction ID (9), and visualizing and displaying an optical symbol on the display of the medical device (2) if the comparison matches.