Medical appliance management system and medical appliance data registration device

Abstract

To provide a medical appliance management system in which fault resistance and robustness are improved, and to provide a medical appliance data registration device.SOLUTION: A medical appliance management system 10 includes a plurality of participation bases 20 sharing a distributed ledger. Each of the participation bases 20 includes: a storage section 45 for storing the distributed ledger; and a data registration device 30. In the distributed ledger, transaction data corresponding to identification information unique to a medical appliance is registered. The data registration device 30 receives an entity of a medical appliance 25, and thereby identifies identification information corresponding to the medial appliance 25. In the case that the data registration device 30 has identified the identification information corresponding to the received medical appliance 25, transaction data corresponding to the identified identification information can be registered in the distributed ledger using the data registration device 30.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a medical instrument management system for managing medical instruments, and a medical instrument data registration device for registering data relating to medical instruments. [Background technology]

[0002] Patent Document 1 describes a management system for surgical instruments that manages data on the surgical instruments using a centralized management device. In the management system described in Patent Document 1, a data carrier is attached to the surgical instrument, and information read from the data carrier is stored in the centralized management device. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2019-88550 A Summary of the Invention [Problem to be solved by the invention]

[0004] However, in the management system described in Patent Document 1, all data is stored in a centralized management device, so if any kind of failure occurs in the centralized management device (e.g., a power outage, congestion due to concentrated access, etc.), users will not be able to use the management system during that time.

[0005] In addition, since all data is collected in the centralized management device, if any unauthorized manipulation such as cracking, which alters stored data into unauthorized data, is carried out at a single location such as the centralized management device, the entire management system can be affected by the unauthorized manipulation.

[0006] In addition, since the centralized control device is generally located away from the site where each surgical instrument is actually handled, the centralized control device cannot directly check whether the data received from the site is related to the surgical instrument actually handled at the site. Therefore, if the user makes an operational error (such as inputting the wrong instrument ID), the data of the surgical instrument actually handled at the site may not be stored correctly.

[0007] In view of the above problems, an object of the present invention is to provide a medical instrument management system and a medical instrument data registration device that are highly fault-resistant and robust. [Means for solving the problem]

[0008] In order to solve the above problem, a medical instrument management system as an example of an embodiment of the present invention is a medical instrument management system that manages a plurality of medical instruments, and includes a plurality of participating locations that share a distributed ledger in which data related to the medical instruments is registered, and each of the participating locations includes a memory unit that stores data of the distributed ledger, and at least one data registration device having a function of registering data in the distributed ledger, and transaction data corresponding to identification information unique to the medical instruments is registered in the distributed ledger, and the data registration device has a function of accepting an entity of the medical instrument and identifying the identification information corresponding to the accepted medical instrument, and when the data registration device identifies the identification information corresponding to the accepted medical instrument, the data registration device is able to register the transaction data corresponding to the identified identification information in the distributed ledger by the data registration device.

[0009] As another example of an embodiment of the present invention, a medical instrument data registration device registers transaction data in a distributed ledger in which transaction data corresponding to identification information unique to a medical instrument is registered, and includes an identification unit, a generation unit, and a registration unit. The identification unit accepts an entity of a medical instrument and thereby identifies the identification information corresponding to the accepted medical instrument. The generation unit generates the transaction data to be registered in the distributed ledger in association with the identification information. When the identification unit has identified the identification information corresponding to the accepted medical instrument, the registration unit is capable of registering the transaction data generated by the generation unit in the distributed ledger in association with the identification information identified by the identification unit. Effect of the Invention

[0010] According to the present invention, since multiple participating sites share a distributed ledger, even if a failure occurs at one of the participating sites, the other participating sites can use the medical equipment management system without any problems, and the system has high fault tolerance. Furthermore, even if unauthorized manipulation is performed at one of the participating sites, it is difficult to tamper with the distributed ledger shared by the multiple participating sites, so the entire medical equipment management system is unlikely to be affected by unauthorized manipulation, and the robustness of the system is high.

[0011] According to the present invention, the data registration device registers transaction data in the distributed ledger when it receives the medical instrument entity, so that the transaction data registered is related to the medical instrument entity that is actually being handled at the participating sites. Therefore, the data of the medical instrument that is actually being handled is registered correctly, and the data is highly reliable. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a schematic diagram showing an overview of a medical instrument management system. [Diagram 2] FIG. 4 is a diagram showing an example of data stored in a storage unit. [Diagram 3]FIG. 11 is a diagram showing an example of matching information. [Figure 4] FIG. 2 is a schematic diagram showing an overview of processing performed by the data registration device. [Diagram 5] FIG. 4 is a schematic diagram showing the correspondence between an appliance ID and transaction data. [Figure 6] A schematic diagram showing the data structure in a blockchain. [Figure 7] FIG. 4 is a diagram showing an example of tool information. [Figure 8] FIG. 4 is a diagram showing an example of transaction data. [Figure 9] FIG. 4 is a diagram showing an example of history data. [Figure 10] FIG. 4 is a flow chart showing a process flow by the medical instrument management system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] A medical instrument management system 10 according to an embodiment of the present invention will be described with reference to the drawings. Fig. 1 is a schematic diagram showing an overview of the medical instrument management system 10. A plurality of locations (nodes) participate in this medical instrument management system 10, and Fig. 1 shows one of these locations, a participating location 20.

[0014] The medical instrument management system 10 manages a plurality of medical instruments 25 handled at each of the participating sites 20. For the sake of explanation, the shape of each of the plurality of medical instruments 25 is shown as forceps in Fig. 1, but the medical instruments 25 are not limited to forceps.

[0015] The medical instrument management system 10 can handle all so-called steel instruments, such as scissors, scalpels, scalpel holders, tweezers, hooks, needle holders, and thoracotomy instruments, as medical instruments 25. For convenience, the above description refers to steel instruments, but the material of medical instruments 25 is not limited to steel, and medical instruments 25 may include various materials, such as silicon, ceramic, synthetic resin, and natural rubber.

[0016] Furthermore, the medical instrument 25 may be used as a single instrument, or may be an instrument composed of multiple parts. For example, when an instrument is composed of multiple parts, such as a trocar or an irrigation and suction device used in laparoscopic surgery, each part may be treated as an individual medical instrument 25, not just the entire instrument made up of the combined parts. Furthermore, the entire instrument made up of the combined parts may be treated as a single medical instrument 25 separate from the individual parts.

[0017] Each of the multiple participating locations 20 is a location that handles medical instruments 25. For example, the participating locations 20 may be facilities of a medical institution such as a hospital, a facility of a manufacturer that manufactures the medical instruments 25, or a facility of a maintenance company that performs maintenance such as sterilization, cleaning, repair, and part replacement of the medical instruments 25. Maintenance of the medical instruments 25 here refers to all actions performed to maintain the functionality of the medical instruments 25 (to make them usable for medical procedures such as surgery).

[0018] Note that there may be multiple participating locations 20 (nodes) within one facility. For example, in one medical institution (such as a hospital), each of the areas where the medical instruments 25 are handled, such as a surgery area where the medical instruments 25 are used in surgery, a cleaning area where the medical instruments 25 are cleaned, and a storage area where the medical instruments 25 are stored, may be a participating location 20.

[0019] Each participating site 20 of the medical instrument management system 10 includes a data registration device 30 and a memory unit 45. The participating site 20 shown in FIG. 1 includes a management device 40, a display unit 41, and an input unit 42 in addition to the memory unit 45 and the data registration device 30.

[0020] 1, a data registration device 30, a display unit 41, an input unit 42, and a memory unit 45 are connected to a management device 40. The management device 40 is a device (e.g., a computer) for managing the work carried out at the participating locations 20. The display unit 41 is a display device (e.g., a liquid crystal display device) for displaying various information to the user. The input unit 42 is a device (e.g., a mouse and a keyboard) for accepting input operations by the user to the management device 40.

[0021] The memory unit 45 is a storage device (e.g., a storage device such as a hard disk drive or a solid state drive) that stores data of a distributed ledger in which data related to the medical instruments 25 is registered. Note that for the sake of explanation in FIG. 1, the memory unit 45 is illustrated as being included in the participating site 20, but the memory unit 45 does not necessarily have to be located within the participating site 20. The memory unit 45 of the participating site may be a storage device accessible from the participating site 20 that is provided in correspondence with the participating site 20. For example, the memory unit 45 that is accessible from the participating site 20 via a network (e.g., the Internet) may be provided in a facility (e.g., a data center) separate from the participating site 20.

[0022] The distributed ledger stored in the storage unit 45 is a database in which data is held at each of the multiple participating locations 20 (nodes), and the validity of the data is guaranteed by agreement between the participating locations 20. Each participating location 20 records events that occur in each medical device 25 by registering transaction data describing events that occurred in relation to that medical device 25 in the distributed ledger. For example, when the medical device 25 is used in a medical setting for surgery or undergoes maintenance, and the state of the medical device 25 changes, the event that occurred in the medical device 25 is recorded in the distributed ledger as transaction data.

[0023] The data registration device 30 is a device (medical instrument data registration device) for registering transaction data related to the medical instrument 25 in the distributed ledger of the storage unit 45. The data registration device 30 can specify identification information unique to the accepted medical instrument 25 by accepting the entity of the medical instrument 25. The data registration device 30 may include, for example, a camera unit for capturing an image, a management device 40, and a communication unit. The data registration device 30 generates transaction data corresponding to the specified identification information, and registers the generated transaction data in the distributed ledger of the storage unit 45 (via the management device 40 in FIG. 1).

[0024] Here, the data registration device 30 accepting the entity of the medical instrument 25 means that the data registration device 30 reads some information from the entity of the medical instrument 25. The data registration device 30 has a function of reading information from the entity of the medical instrument 25. For example, if some identification index (such as a two-dimensional code) is marked on the medical instrument 25, the data registration device 30 may accept the medical instrument 25 by reading the identification index. If a storage element that stores identification information such as an RFID tag (RFID: Radio Frequency Identification) is attached to the medical instrument 25, the data registration device 30 may accept the medical instrument 25 by reading the information stored in the storage element. If the data registration device 30 has a function of capturing an image of the medical instrument 25, the data registration device 30 may accept the medical instrument 25 by capturing an image of the medical instrument 25.

[0025] Participating locations 20 are connected to other participating locations 20 via a network 50 (a computer network such as the Internet). In Fig. 1, a management device 40 connected to a data registration device 30 and a storage unit 45 is connected to other participating locations 20 via the network 50. The other participating locations 20 also include a storage unit 45 and a data registration device 30. Note that a reference server 29 that allows each participating location 20 to refer to various information may be connected to the network 50 in addition to the participating locations 20.

[0026] Although each of the participating locations 20 includes a storage unit 45, it is sufficient that the participating locations 20 have a storage unit 45 accessible from the participating locations 20, and it is not necessary that each participating location 20 has a separate storage unit 45. That is, one storage unit 45 may be shared by multiple participating locations 20. For example, while the surgery area, cleaning area, storage area, etc. within a single medical institution each serve as a participating location 20, these participating locations 20 within the same medical institution may share the same storage unit 45. Also, a storage unit 45 (such as a shared server) accessible via a network 50, for example, may be shared between multiple participating locations 20 that are separate facilities.

[0027] The storage unit 45 can also store data other than the distributed ledger. An example of data stored in the storage unit 45 is shown in Fig. 2. For example, the storage unit 45 can store management information 46 of the medical device 25 in addition to the distributed ledger 60.

[0028] The management information 46 of the medical instruments 25 is stored in the storage unit 45 as a database separate from the distributed ledger 60. The management information 46 of the medical instruments 25 includes information used to manage the medical instruments 25 in the medical instrument management system 10, which is not registered in the distributed ledger 60. Information on the usage history of the medical instruments 25, i.e., how the medical instruments 25 have been used in the medical field, is registered in the distributed ledger 60 in the form of transaction data, so it is preferable that the management information 46 includes information separate from the usage history of the medical instruments 25. Note that the management information 46 stored in such a database separate from the distributed ledger 60 may be stored in a reference server 29 ( FIG. 1 ) provided in the medical instrument management system 10 as an element that plays a role different from that of the participating sites 20, instead of being stored in the storage unit 45 of each participating site 20.

[0029] 2 includes matching information 47 and instrument information 48. The matching information 47 is data that is matched when the data registration device 30 receives the medical instrument 25 in order to identify the instrument ID 27 (identification information unique to the medical instrument 25) corresponding to the medical instrument 25. The instrument information 48 is information that is determined at the time of manufacture of the medical instrument 25, such as the instrument name and the manufacturer name (name of manufacturer), and is preferably data that does not change regardless of how the medical instrument 25 is used (does not depend on the usage history).

[0030] In this way, at least a part of the information on the medical instrument 25 (here, the management information 46) may be stored in a database separate from the distributed ledger 60. In this case, it is preferable that the transaction data registered in the distributed ledger 60 in correspondence with the instrument ID 27 includes link information to another database in which information on the medical instrument 25 corresponding to the instrument ID 27 is recorded, so that the management information 46 on the medical instrument 25 can be referenced at each participating site 20.

[0031] An example of the matching information 47 is shown in Fig. 3. The matching information 47 in Fig. 3 is information indicating the correspondence between the Fingerprint of Things 26 unique to the medical instrument 25 and the instrument ID 27 (identification information) of the medical instrument 25. The Fingerprint of Things 26 is a surface pattern (such as a fine uneven pattern on the surface) of the medical instrument 25 that is unique to each individual medical instrument 25. Even if the medical instruments 25 are mass-produced using a mold or the like, individual differences in the surface pattern naturally occur during the manufacturing process. By utilizing the individual differences in the surface pattern as the Fingerprint of Things 26, the medical instrument management system 10 can identify each individual medical instrument 25.

[0032] For example, the data registration device 30 may have a function of capturing an image of the medical instrument 25 and a function of extracting the Fingerprint of the thing 26 from the image of the medical instrument 25. When the data registration device 30 extracts the Fingerprint of the thing 26 from the image of the medical instrument 25, it is preferable that a method of acquiring the image and a method of extracting the Fingerprint of the thing 26 from the image are determined in advance, such as under what lighting conditions the image is captured, what image processing is performed on the captured image to extract the Fingerprint of the thing 26, and on which part of the surface pattern of the medical instrument 25 the Fingerprint of the thing 26 is to be extracted based on.

[0033] Furthermore, the captured image does not have to be used as the Fingerprint of the thing 26 as it is, and data calculated based on the image may be used as the Fingerprint of the thing 26. For example, the data registration device 30 may use an AI model (AI: Artificial Intelligence) that performs image recognition processing to extract image features from the image of the medical instrument 25, and use the extracted features as the Fingerprint of the thing 26.

[0034] The process for extracting the Fingerprint of the Thing 26 does not necessarily have to be performed within the data registration device 30. The data registration device 30 may transmit a captured image to another device (e.g., the reference server 29 in FIG. 1), and the Fingerprint of the Thing 26 may be extracted (and matched with the instrument ID 27) in the other device that receives the image.

[0035] 3, an instrument ID 27 (identification information) unique to the medical instrument 25 is stored in association with data (image data, feature amount, etc.) of the Fingerprint of Things 26. The instrument ID 27 may be assigned to each individual medical instrument 25, for example, when the medical instrument 25 is manufactured.

[0036] For example, if the facility of a manufacturer of a medical instrument 25 participates in the medical instrument management system 10 as one of the participating locations 20, when the medical instrument 25 is shipped from the manufacturer, the manufacturer may assign a unique instrument ID 27 to the medical instrument 25 and use the data registration device 30 to register transaction data including the instrument ID 27 (identification information).

[0037] In order to make the instrument ID 27 a unique number that does not overlap in the entire medical instrument management system 10, it is preferable that the instrument ID 27 is managed centrally in the medical instrument management system 10. Therefore, for example, a reference server 29 (FIG. 1) that can refer to information from each participating site 20 is provided in the medical instrument management system 10, and the instrument ID 27 is managed centrally as a unique number in this reference server 29. For example, when a medical instrument 25 is shipped from a manufacturer, the data registration device 30 of the manufacturer accesses the reference server 29 and receives a new instrument ID 27. Then, the data registration device 30 of the manufacturer extracts a Fingerprint of Things 26 from an image of the medical instrument 25 to be shipped, and stores in the storage unit 45 the matching information 47 indicating the correspondence between the instrument ID 27 issued by the reference server 29 and the extracted Fingerprint of Things 26. Here, the matching information 47 may be stored in the reference server 29 instead of in the storage unit 45 of each participating site 20. The matching information 47 may also be stored in a database other than the distributed ledger 60.

[0038] When the medical instrument 25 is shipped from the manufacturer, the matching information 47 is stored in the memory unit 45 or the reference server 29, so that the data registration device 30 of a participating site 20 other than the manufacturer can use this matching information 47 to identify the instrument ID 27 (identification information) corresponding to the medical instrument 25.

[0039] The processing by the data registration device 30 will be described with reference to Fig. 4. Fig. 4 is a schematic diagram showing an overview of the processing by the data registration device 30. The data registration device 30 includes an identification unit 35, a generation unit 36, and a registration unit 38. The identification unit 35 in Fig. 4 includes an imaging unit 32 that captures an image of the medical instrument 25, and an extraction unit 34 that extracts the Fingerprint of Matter 26 of the medical instrument 25 from the image of the medical instrument 25. The data registration device 30 includes a calculation unit (processor) such as a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), and an NPU (Neural Processing Unit), and a storage device such as a ROM (Read Only Memory) and a RAM (Random Access Memory), and functions of the identification unit 35, the generation unit 36, the registration unit 38, and the like are realized by the processor executing a program stored in the storage device.

[0040] In the data registration device 30, the identification unit 35 first accepts the entity of the medical instrument 25, thereby identifying the instrument ID 27 (identification information) corresponding to the accepted medical instrument 25. For example, if an identification index (two-dimensional code) indicating the instrument ID 27 is engraved on the medical instrument 25, the data registration device 30 may read the identification index to identify the instrument ID 27. In this case, the identification unit 35 functions as a code reader (barcode reader, two-dimensional code reader, etc.). Also, if a memory element (such as an RFID tag) that stores the instrument ID 27 is attached to the medical instrument 25, the data registration device 30 may read the memory element to identify the instrument ID 27. In this case, the identification unit 35 functions as a memory element reader (such as an RFID reader, etc.).

[0041] 4 shows a form in which the recognition unit 35 identifies the instrument ID 27 by extracting the Fingerprint of the Object 26 from the medical instrument 25. The recognition unit 35 captures an image of the medical instrument 25 using the imaging unit 32 (such as a camera unit), and extracts the Fingerprint of the Object 26 from the captured image using the extraction unit 34 (such as a program for performing image analysis processing).

[0042] The identification unit 35 then compares the Fingerprint of Things 26 extracted by the extraction unit 34 with the matching information 47 stored in the medical instrument management system 10. By comparing the Fingerprint of Things 26 with the matching information 47, an instrument ID 27 (identification information) corresponding to the medical instrument 25 is identified. The identification unit 35 then notifies the registration unit 38 of the identified instrument ID 27.

[0043] When the data registration device 30 is installed in a facility of a manufacturer, the instrument ID 27 corresponding to the medical instrument 25 may not yet be included in the matching information 47. In the facility of the manufacturer, the data registration device 30 may newly generate an instrument ID 27 corresponding to the Fingerprint of Things 26 (via the reference server 29, etc.) and include it in the matching information 47, instead of matching the Fingerprint of Things 26 with the matching information 47. Then, the data registration device 30 notifies the registration unit 38 of the generated instrument ID 27 as the identified instrument ID 27.

[0044] Meanwhile, the generation unit 36 ​​of the data registration device 30 generates transaction data 62 to be associated with the instrument ID 27 (identification information) and registered in the distributed ledger 60. This transaction data 62 includes data on the work performed on the medical instrument 25 at the participating site 20 where the data registration device 30 is installed.

[0045] The registration unit 38 registers the transaction data 62 generated by the generation unit 36 ​​in the distributed ledger 60 in association with the instrument ID 27 (identification information) identified by the identification unit 35. Here, the registration unit 38 can register the transaction data 62 in the distributed ledger 60 when the identification unit 35 identifies the instrument ID 27 corresponding to the accepted medical instrument 25. That is, the data registration device 30 does not register the transaction data 62 related to the medical instrument 25 in the distributed ledger 60 when the entity of the medical instrument 25 has not been accepted. For example, even if the user of the data registration device 30 knows the data of the instrument ID 27 of the medical instrument 25, the user cannot register the transaction data 62 related to the medical instrument 25 in the distributed ledger 60 when the medical instrument 25 is not at hand. Therefore, the transaction data 62 registered in the distributed ledger 60 is reliably related to the work performed when the medical instrument 25 was actually handled at the site (participating site 20), and the reliability of the data is high.

[0046] In order to limit devices that can register the transaction data 62 to only the data registration device 30, the distributed ledger 60 may be designed such that, for example, an individual device number (ID) is preset for each data registration device 30, and the transaction data 62 cannot be registered from devices other than those with the preset device numbers. As a specific example of a configuration that enables registration of the transaction data 62 when the identification unit 35 identifies the device ID 27 of the medical device 25, the registration unit 38 may be configured to start accessing the distributed ledger 60 on the condition that the identification unit 35 identifies the device ID 27, or the generation unit 36 ​​may be configured to start generating the transaction data 62 on the condition that the identification unit 35 identifies the device ID 27.

[0047] Furthermore, when identifying the instrument ID 27 of the medical instrument 25 using the Fingerprint of Things 26, there is no need to attach a mark indicating the instrument ID 27 or an RFID tag storing the instrument ID to the medical instrument 25, so the operability of the medical instrument 25 is not impaired. Furthermore, the Fingerprint of Things 26 is not damaged by wear caused by normal sterilization and cleaning processes, and identification can be performed without problems even if the medical instrument 25 is used many times.

[0048] The details of the transaction data 62 registered in the distributed ledger 60 vary depending on the participating location 20 where the data is registered. For example, when a medical device 25 is shipped from a manufacturer, the transaction data 62 including at least the device ID 27 of the medical device 25 may be registered using the data registration device 30.

[0049] 5 is a schematic diagram showing the correspondence between the device ID 27 and transaction data 62. For each device ID 27, a series of transaction data 62 corresponding to that device ID 27 is registered in the distributed ledger 60. In the distributed ledger 60, data related to the device ID 27 that has already been registered cannot be directly changed or deleted, and data is updated only by adding new transaction data 62.

[0050] However, for newly manufactured medical instruments 25, data regarding the instrument ID 27 of the medical instrument 25 is not registered in the distributed ledger 60, so it is advisable to register the transaction data 62 including the instrument ID 27 at the time of shipment from the manufacturer.

[0051] The data in the distributed ledger 60 is distributed and stored in the respective memory units 45 of the multiple participating locations 20, and the contents are shared among each participating location 20. Because the distributed ledger 60 is stored in the multiple participating locations 20, even if a failure occurs at one of the participating locations 20, the other participating locations 20 can still use the medical instrument management system 10 without any problems, making the system highly fault-tolerant.

[0052] Furthermore, in order to claim that the data in the distributed ledger 60 stored in the memory unit 45 of any participating location 20 is legitimate, it is necessary to obtain the agreement of the other participating locations 20 (to confirm that the data is consistent with the data stored at the other participating locations 20), so it is difficult to tamper with data that has already been registered, making the system highly robust.

[0053] The distributed ledger 60 is preferably based on blockchain technology. The schematic diagram of Fig. 6 shows a data structure in a blockchain 64. In the blockchain 64, a series of blocks 65 is registered for the instrument ID 27. Each block 65 includes transaction data 62 related to the medical instrument 25. To be precise, transaction data 62 that occurred at the same time is collected into one block 65 (i.e., transaction data 62 related to multiple medical instruments 25 is included in one block 65), but for the sake of explanation, Fig. 6 illustrates one transaction data 62 included in one block 65.

[0054] In addition to the transaction data 62, a block 65 newly added to the blockchain 64 contains a hash value 66 of the previous block. The hash value 66 of the previous block is data corresponding to the data of the existing block 65, and is data whose validity can be verified by a third party. Note that the data contained in the block 65 and corresponding to the data of the existing block 65 does not necessarily have to be a hash value as long as the data can be verified for validity according to a certain rule, but here it will be described as a hash value.

[0055] The hash value 66 of the previous block included in each block 65 must correctly correspond to the data of the existing block 65. Therefore, if the data of any block 65 is tampered with, the hash value 66 of the previous block included in the next block 65 of that block 65 will no longer be consistent, and the tampering will be easily detected. Therefore, it is difficult to tamper with the data of the blockchain 64, and the robustness of the system is high.

[0056] When the medical instrument 25 is shipped from the manufacturer, the instrument information 48 about the medical instrument 25 may also be recorded. FIG. 7 shows an example of the instrument information 48. The instrument information 48 in FIG. 7 includes information such as the instrument name (the instrument type name or product name), the manufacturer name (the manufacturer name), and special notes (such as the fact that it is a custom-made product and the information of the doctor who made the special order) corresponding to the instrument ID 27. These pieces of information are determined at the time of manufacturing the medical instrument 25, and do not change even if the transaction data 62 is registered thereafter. Therefore, it is preferable that such instrument information 48 is stored in a database other than the distributed ledger 60 rather than being registered in the distributed ledger 60. The database other than the distributed ledger 60 may be stored in the memory unit 45 of each participating site 20, or may be stored in a reference server 29 other than the participating site 20.

[0057] However, when at least a portion of the information about the medical instrument 25 is stored in a database other than the distributed ledger 60, such as the instrument information 48, it is preferable that the transaction data 62 includes link information to the database other than the distributed ledger 60 so that a user can reach the database by following the transaction data 62.

[0058] Next, a description will be given of the transaction data 62 at participating locations 20 other than the facilities of the manufacturer of the medical instrument 25. For example, when the medical instrument 25 arrives at a medical institution (such as a hospital), the medical institution serving as the participating location 20 may use the data registration device 30 to register the transaction data 62 including at least information on the arrival date and time of the medical instrument 25. By including information on the arrival date and time in the transaction data 62, the user can obtain information on when the medical instrument 25 began to be used at the medical institution from the distributed ledger 60.

[0059] When the medical instrument 25 is used in a medical institution, the transaction data 62 may be registered using the data registration device 30, including at least information on the date and time of use of the medical instrument 25.

[0060] Fig. 8 is a diagram showing an example of the transaction data 62. The transaction data 62 in Fig. 8 is data registered in the distributed ledger 60 when (or after) the medical instrument 25 is used in a surgery at a medical institution.

[0061] The transaction data 62 in FIG. 8 includes information such as the date and time of surgery, the site where the surgery was performed (information of the medical institution), the person performing the surgery (information of the doctor), the ID of the data registration device 30 that registers the transaction data 62, the type of work performed (here, surgery), the ID of the instrument for which the transaction data 62 is registered (instrument ID 27, i.e., identification information), and notes (such as the content of the surgery). By including and registering such information in the transaction data 62, the user can obtain information on when, how many times, and for what type of surgery the medical instrument 25 was used from the distributed ledger 60. Although not shown in FIG. 8, the transaction data 62 may also include information on matters requiring management, which are history items of usage that require special attention in managing the medical instrument 25, such as whether or not the medical instrument 25 was used in surgery on a patient with a specific infectious disease. Such information on matters requiring management may be recorded as information on the type of work performed or notes.

[0062] Here, if there is a limit to the amount of information that can be stored in the transaction data 62 at one time, the data registration device 30 may include only the minimum amount of information (such as the date and time of the transaction) and link information to another database in the transaction data 62, and store the other information in a separate database.

[0063] 8 includes the ID of the data registration device 30 to indicate that the data registration device 30 attempting to register the transaction data 62 is a device that has been previously determined as a device capable of registering the transaction data 62 in the distributed ledger 60. However, if the communication protocol used in the medical instrument management system 10 is set to automatically reject registration of transaction data 62 from devices other than those having a specific device ID, the ID of the data registration device 30 does not need to be included in the transaction data 62.

[0064] Furthermore, when the medical instrument 25 arrives at a participating site 20 that performs maintenance on the medical instrument 25, the transaction data 62 may be registered using the data registration device 30, including at least information on the arrival date and time of the medical instrument 25. Furthermore, when the medical instrument 25 is shipped from a participating site 20 that performs maintenance on the medical instrument 25, the transaction data 62 may be registered using the data registration device 30, including at least information on the maintenance status of the medical instrument 25. By including and registering such information in the transaction data 62, the user can obtain information from the distributed ledger 60 regarding where the medical instrument 25 is currently located, and when, how many times, and what type of maintenance (sterilization, cleaning, repair, part replacement, etc.) the medical instrument 25 has undergone.

[0065] Furthermore, when the medical instrument 25 is disposed of by a waste disposal company, the transaction data 62 may be registered using the data registration device 30, including at least the disposal certification information of the medical instrument 25. In the distributed ledger 60, even when the medical instrument 25 is disposed of, the data of the medical instrument 25 is not deleted, and information that the medical instrument 25 has been "discarded" (discarding certification information) is registered in the distributed ledger 60. By including the disposal certification information in the transaction data 62 and registering it, the user can obtain information regarding whether the medical instrument 25 brought to the waste disposal company has been properly disposed of from the distributed ledger 60.

[0066] At each participating site 20, a user can obtain history data 90 related to the medical instruments 25 from the distributed ledger 60. For example, a user can access the storage unit 45 and obtain data stored in the distributed ledger 60 by operating the management device 40 ( FIG. 1 ) of the participating site 20 via the input unit 42. The data stored in the distributed ledger 60 is processed for display by the management device 40 and displayed on the display unit 41.

[0067] 9 is a diagram showing an example of the history data 90. The history data 90 is information obtained by the management device 40 integrating the transaction data 62 corresponding to the device ID 27 of the medical device 25, and including information such as the management information 46 stored in a database different from the distributed ledger 60 as necessary (depending on the link information).

[0068] 9 includes information such as the instrument name, manufacturer name, number of uses, last use date and time, number of sterilizations, and last sterilization date and time, corresponding to the instrument ID 27. As described above, the instrument name, manufacturer name, and the like may be stored as instrument information 48 in a database different from the distributed ledger 60, and if link information to that database is included in the transaction data 62 of the distributed ledger 60, the management device 40 can also acquire the instrument information 48.

[0069] Although the number of uses and the number of sterilizations may not be directly included in the transaction data 62, the management device 40 can count up the number of pieces of data indicating that the medical instrument 25 has been used or sterilized among the transaction data 62 corresponding to the instrument ID 27, thereby including and indicating the number of times such work has been performed in the history data 90. Similarly, for the last use date and time and the last sterilization date and time, the management device 40 can check the date and time of the latest data among the transaction data 62 indicating that the same type of work was performed, thereby including and indicating the date and time when the corresponding work was last performed in the history data 90.

[0070] This history data 90 can also be viewed at participating locations 20 that do not currently handle the medical instrument 25. In other words, registration of new transaction data 62 related to the medical instrument 25 cannot be performed unless the actual medical instrument 25 is in the user's possession, but if the user simply wishes to view information related to the medical instrument 25, it is possible even if the actual medical instrument 25 is not in the user's possession.

[0071] 1 is shown as a server separate from each participating site 20, multiple servers separate from each participating site 20 may be provided. For example, the server that issues the instrument ID 27, the server that stores the matching information 47, and the server that stores at least a portion of the information related to the medical instrument 25 (such as the instrument information 48) separate from the distributed ledger 60 may each be separate servers.

[0072] Next, the flow of processing in the medical instrument management system 10 will be described with reference to Figures 1, 4 and 10. Figure 10 is a flow diagram showing the flow of processing in the medical instrument management system 10.

[0073] Processing begins (START) when a medical instrument 25 is brought into a participating site 20 (node) participating in the medical instrument management system 10. First, the data registration device 30 accepts the entity of the medical instrument 25 (step S11). That is, the data registration device 30 reads some information from the medical instrument 25 by reading an identification index marked on the medical instrument 25, reading a memory element attached to the medical instrument 25, capturing an image of the medical instrument 25, or the like.

[0074] The data registration device 30, which has received the medical instrument 25, identifies the instrument ID 27 (identification information) corresponding to the medical instrument 25 based on the information read from the medical instrument 25 (step S11). The data registration device 30 can directly read the instrument ID 27 from an identification index marked on the medical instrument 25 and a memory element attached to the medical instrument 25. When the Fingerprint of Things 26 of the medical instrument 25 is used, the data registration device 30 identifies the instrument ID 27 corresponding to the medical instrument 25 by matching the Fingerprint of Things 26 extracted from the image of the medical instrument 25 with the matching information 47.

[0075] Once the instrument ID 27 corresponding to the medical instrument 25 has been identified, the data registration device 30 acquires history data 90 relating to the instrument ID 27 via the management device 40, the storage unit 45, etc. (step S13). The acquired history data 90 is displayed on the display unit 41. The user checks from the contents of the history data 90 whether the state of the medical instrument 25 is compatible with the current participating site 20 (for example, whether the medical instrument 25 has been sterilized, cleaned, etc., in the prescribed order before being brought into the surgery area, etc.). Note that step S13 may be skipped when there is no need to check the history data 90, such as when the medical instrument 25 is shipped from the manufacturer.

[0076] By identifying the instrument ID 27 corresponding to the medical instrument 25, the data registration device 30 becomes capable of recording the transaction data 62 corresponding to the instrument ID 27 in the distributed ledger 60. Then, the generation unit 36 ​​of the data registration device 30 generates the transaction data 62 to be associated with the instrument ID 27 and registered in the distributed ledger 60 (step S14). For example, in a surgery area, the generation unit 36 ​​generates transaction data 62 indicating that surgery has been performed using the medical instrument 25.

[0077] Then, the registration unit 38 of the data registration device 30 associates the transaction data 62 generated by the generation unit 36 ​​with the appliance ID 27 identified by the identification unit 35, and registers the data in the distributed ledger 60 (step S15).

[0078] Once the transaction data 62 is registered in the distributed ledger 60, the process for the currently accepted medical instrument 25 is completed (END), and the medical instrument management system 10 goes into a standby state until the next medical instrument 25 is brought in.

[0079] The present invention is not limited to the above-mentioned embodiment, and can be implemented in various forms. In addition, the attached drawings merely show each component in a schematic manner for easy understanding, and the dimensions, number, etc. of each component shown in the drawings may differ from the actual dimensions. In addition, the shape, properties, etc. of each component shown in the above-mentioned embodiment are merely examples, and are not limited to the above-mentioned form, and various changes are possible within the scope of the spirit of the present invention. [Explanation of symbols]

[0080] 10 Medical equipment management system 20 Participating Locations 25 Medical Equipment 26 Object fingerprint 27 Equipment ID 29 Reference Server 30 Data registration device 32 Imaging unit 34 Extraction part 35 Identification section 36 Generation part 38 Registration Department 40 Management device 41 Display section 42 Input section 45 Storage section 46 Management information 47 Matching Information 48 Equipment Information 50 Network 60 Distributed Ledgers 62 Transaction Data 63 Medical equipment data 64 Blockchain 65 blocks 66 Hash value of previous block 90 Historical Data

Claims

1. In a medical instrument management system for managing a plurality of medical instruments, A plurality of participating locations sharing a distributed ledger in which data relating to the medical device is registered; Each of the participating locations includes a storage unit that stores data of the distributed ledger, and at least one data registration device that registers data in the distributed ledger; The distributed ledger registers identification information unique to the medical device and corresponding transaction data; The data registration device receives the entity of the medical instrument, and thereby specifies the identification information corresponding to the received medical instrument; A medical equipment management system in which, when the data registration device identifies the identification information corresponding to a received medical equipment, the data registration device is able to register the transaction data corresponding to the identified identification information in the distributed ledger.

2. The medical instrument management system of claim 1 , wherein the distributed ledger is a distributed ledger based on blockchain technology.

3. Verification information indicating a correspondence relationship between the Fingerprint of a thing unique to the medical instrument and the identification information of the medical instrument is stored; the data registration device includes an imaging unit that captures an image of the medical instrument, and an extraction unit that extracts the Fingerprint of the medical instrument from the image of the medical instrument, The medical instrument management system according to claim 1 , wherein the identification information corresponding to the medical instrument is specified by matching the Fingerprint of Object extracted by the extraction unit with the matching information.

4. The medical instrument management system of claim 3 , wherein the matching information is stored in a database separate from the distributed ledger.

5. At least a portion of the information about the medical device is stored in a database separate from the distributed ledger; The medical device management system according to claim 1 , wherein the transaction data registered in the distributed ledger corresponding to the identification information includes link information to the database in which information about the medical device corresponding to the identification information is recorded.

6. The medical instrument management system according to claim 1 , wherein the transaction data including at least the identification information of the medical instrument is registered using the data registration device when the medical instrument is shipped from a manufacturer.

7. The medical instrument management system according to claim 1 , wherein the transaction data including at least information on the arrival date and time of the medical instrument is registered by the data registration device when the medical instrument is delivered to the medical institution.

8. The medical instrument management system according to claim 1 , wherein the transaction data including at least information on a date and time of use of the medical instrument is registered by the data registration device when the medical instrument is used in a medical institution.

9. 2. The medical instrument management system according to claim 1, wherein the transaction data is registered using the data registration device when the medical instrument arrives at a participating site where maintenance of the medical instrument is performed, and includes at least information on the arrival date and time of the medical instrument, and when the medical instrument is shipped from a participating site where maintenance of the medical instrument is performed, the transaction data is registered including at least information on the maintenance status of the medical instrument.

10. The medical instrument management system according to claim 1 , wherein the transaction data including at least disposal certification information of the medical instrument is registered by the data registration device when the medical instrument is disposed of by a disposal company.

11. A medical instrument data registration device that registers transaction data corresponding to identification information unique to a medical instrument in a distributed ledger, the transaction data being registered, the medical instrument data registration device comprising: The apparatus includes an identification unit, a generation unit, and a registration unit, The identification unit receives an entity of a medical instrument, and thereby identifies the identification information corresponding to the received medical instrument; The generation unit generates the transaction data to be registered in the distributed ledger in association with the identification information, When the identification unit identifies the identification information corresponding to the medical instrument accepted by the identification unit, the registration unit is capable of registering the transaction data generated by the generation unit in the distributed ledger in association with the identification information identified by the identification unit. Medical equipment data registration device.

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