Method, apparatus, and system for storing usage data and tracking medical products

Abstract

The present invention relates to a computer-implemented tracking method, device, and tracking system for storing usage data of medical products, the method comprising the steps of detecting use of the medical product, creating usage data related to the detected use of the medical product, and storing the usage data in a data record in a format that cannot be retroactively modified, in particular in a blockchain. Additionally, the present invention relates to a tracking system, device, and computer-readable storage medium according to the additional independent claims.

Description

[Technical Field]

[0001] The present invention relates generally to the use of medical products. In particular, the present invention describes the storage of data relating to the use of medical products with at least as much tamper-proofing as is generally technically feasible and economically reasonable at present. In particular, the present disclosure relates to a tracking system and a tracking method for the safe and secure tracking of at least one disposable medical product according to the preamble of the independent claim. [Background technology]

[0002] The following discussion of the prior art provides a better understanding of the present invention, particularly its advantages.

[0003] Currently, it is difficult to ensure limited reuse of medical products, particularly single use for reasons of hygiene or contamination, or reuse only a specific number of times for reasons of wear or shelf life. Failure to follow proper product labeling, precautions, or instructions and other precautions can result in accidental application beyond the permitted use.

[0004] Furthermore, available prior art cannot preclude or trace unintentional or intentional application beyond permitted use, which can be determined solely based on circumstantial evidence, such as the appearance of wear and tear and customer statements.

[0005] Currently available and used database solutions, such as SQL, MYSQL, SAP, Oracle, do not fully meet the requirements for tamper-proof content, and data in such databases can be changed at will at any time under some circumstances, even if a certain level of security is provided by requiring administrative privileges to make such changes, and the accuracy of the data stored cannot be revealed from the data.

[0006] Additionally, prior art solutions are somewhat vulnerable to attacks by third parties and may therefore be falsifiable. Summary of the Invention [Problem to be solved by the invention]

[0007] The object of the present invention is to overcome or at least reduce the above-mentioned drawbacks of the prior art, to improve the prior art, and / or to provide at least one useful alternative to the existing prior art. In particular, the object of the present invention is to provide a (tracking) method, (tracking) device, and (tracking) system for tracking medical products, in particular disposable medical products, in order to track the medical products to be tracked in a tamper-proof and secure manner, to ensure or at least support a limited number of uses of the medical products, to enable reliable statements regarding the (application) status of the medical products, and to increase patient safety. In particular, the object is to document the history of the medical products with tamper-proof data. Another partial object can be understood to be ensuring that medical products are tamper-proof. [Means for solving the problem]

[0008] The present invention solves the above-mentioned objects by the subject matter or features of the independent claims. The invention solves the object relating to the tracking method according to the invention according to the features of claim 1, the object relating to the computer-readable storage medium according to the invention according to the features of claim 8, the object relating to the tracking system according to the invention according to the features of claim 9 and the object relating to the device according to the invention according to the features of claim 15. Further advantageous embodiments can be seen from the respective dependent claims.

[0009] In particular, the present invention solves this problem by detecting product use / application, generating usage / application data related to the detected product use, and storing the usage data in a dataset in a format that cannot be retroactively modified. "In a format that cannot be retroactively modified" is particularly understood as a storage format that cannot be changed from an economic perspective, for example, because the effort required for such changes is uneconomical. According to the present invention, blockchain technology is used to store the usage data in the dataset, which effectively prevents retroactive modification of the data. By storing the dataset as a blockchain dataset, decentralized storage can be achieved, thereby protecting against the failure of individual servers. High reliability is an advantage, especially in the field of medical products. Additionally, it must be ensured that the storage of datasets and the evaluation of already stored datasets can also be achieved decentralized, without a permanent connection to a server. This can be achieved by using blockchain technology for the dataset while at the same time not increasing the risk of retroactive modification.

[0010] In particular, this object is solved by providing a medical tracking system for secure tracking of at least one disposable medical product, comprising: a disposable medical product to be tracked having a bijective identification (i.e., uniquely assigned), in particular a bijective serial number and / or ID element; at least one detection unit, in particular a read-out device, adapted to detect the identification of the disposable medical product and provide said identification in a computer-readable format; and a computer network with at least three computers / data processing units / nodes, in each of which a digital tracking book is decentrally stored in the form of a block chain, with a directory of information blocks relating to the at least one disposable medical product, in particular at least the unique identification (or data of the identification) and a first (cryptographic) hash (in particular a checksum) of the at least one disposable medical product being stored in a first (generated) block; and The system comprises: an application module adapted to send an application transaction for the disposable medical product to the computer network when the disposable medical product is detected (before or during application); a block generation module adapted to create (based on the application transaction) an application block having the (first hash), a time stamp, the application transaction, and the application hash, make the application block available to the computer network, and add the application block to each blockchain in a computer of the computer network; and a tracking (alert) module adapted to read the blockchain for at least one disposable medical product, detect existing application blocks in the blockchain, and issue an alert and / or lock the application of the disposable medical product if application (i.e., the presence of an application block having an application transaction for the medical product) is detected again.In this way, it can be ensured (especially on the manufacturer's side) or at least supported that disposable medical products are used only once, e.g., that requirements for sterilization standards are met. In particular, the issuance of an alarm is added as an alarm transaction in the blockchain to ensure secure documentation of the warning to the user and to provide indisputable evidence.

[0011] According to one embodiment, the identification information, in particular a serial number and / or a QR code, may be printed on the disposable medical product, and in particular the identification information may have a laser marking (e.g., laser processing). The detection unit may comprise an optical detection unit, in particular a camera, and / or the identification information, in particular the serial number, may be stored in an RFID tag on the disposable medical product, and the detection unit may comprise an RFID reader / reading device. In this way, the identification information is stored and inseparably linked to the disposable medical product and can be read by a suitable reader / reading device. In the case of printed serial numbers and RFID tags, which are preferably sealed from the environment, the requirements for sterility of the medical product can be ensured, and they can be read by a contactless reading device, in particular. This further increases security.

[0012] According to a further embodiment, the at least one disposable medical product may be a medical, in particular a surgical, instrument and / or sieve, and / or a holder and / or an electric medical device. In these cases, seamless and secure tracking is particularly important and can be efficiently achieved by a tracking system. Surgical (disposable) instruments are, for example, intended for use during surgery and not to be used again thereafter. For this purpose, the instrument is detected by a detection unit before application, and an application transaction is added to the blockchain accordingly. In the event of repeated (unauthorized) application of the instrument due to detection via the detection unit, the blockchain reads this application transaction and determines that the instrument is no longer usable. In a further preferred embodiment, when the medical product is sterilized, a sterilization transaction is written to the blockchain, and the tracking module reads this blockchain and determines that there is no application in the application transaction, with the application transaction being followed by a sterilization transaction, and that repeated application is permitted without raising an alarm and / or blocking the application. In this way, the sterility of the medical product is always ensured.

[0013] Preferably, the disposable medical product may be an electrically powered medical device, and the tracking module may be adapted to interrupt the power supply to the disposable medical product during repeated applications or while reading out each application transaction to the medical product, in this way reliably preventing unintended use of the non-sterile disposable product.

[0014] Furthermore, the tracking system may preferably be equipped with a display device, which visually outputs an alarm as soon as repeated use of the medical product is detected. In particular, if the medical product should be further used for an emergency, for example, despite the warning, the user must enter an entry, particularly on the tracking system's touch display, to allow the medical product, especially an electrically operated medical device, to continue to be used. The corresponding transaction can be detected in the blockchain of the computer network. In this way, even if a disposable medical product is used more than once against its specifications, it is also documented. In addition to the visual alarm, an acoustic alarm may be generated via a loudspeaker.

[0015] According to one embodiment, the tracking system includes a central database on at least one computer, where additional entries / data related to at least one disposable medical product are stored. In particular, data such as operating instructions or sterilization instructions for the medical product are stored in the database. To ensure that the data stored in the database is tamper-proof, a unique hash value (entry hash) is generated for the entry / data, particularly the operating instructions, stored in the blockchain for that medical product. Because only a limited amount of data can be stored in the blockchain, a file (data) such as instructions, images of the medical product, or documentation is stored, for example, in a standard database. A hashing procedure is used to generate an entry hash for this file (data) as a kind of authentication seal, and this unique entry hash is then stored in the blockchain for the medical product. For example, if an instruction in the central database is changed (even by a single bit), the entire hash changes and no longer matches the tamper-proof hash of the blockchain. In this way, manipulation can be prevented through appropriate verification. In this way, important data, even large file sizes, can be stored centrally and protected from tampering via the blockchain's entries (hashes). A hash value is a short string that requires only a few bytes of storage space and can therefore be efficiently maintained within the blockchain.

[0016] Preferably, in addition to the bijective identification information of the at least one disposable medical product, a minimum durability date (MDD) may be stored in the first (origin) block. The tracking module may be adapted to compare the minimum durability date with the current date when detected by the detection unit, and to issue an alarm and / or lock the application of the medical product if the MDD is exceeded. In addition, an item number may be stored in the (origin) block for allocation of the medical product.

[0017] In particular, the application module may be adapted to add a dead-end marker to the corresponding medical product in the blockchain in addition to the application transaction in order to reliably and quickly recognize when the corresponding medical product is no longer usable in the case of repeated applications. In particular, the application module may add a dead-end marker to the blockchain when a minimum endurance date has been exceeded.

[0018] According to a further embodiment, the receipt detection device may detect the unique identification of the medical product and add a warehouse transaction to the blockchain for the medical product along with the receipt date (time stamp) to document the receipt. In particular, the receipt detection device is adapted to determine, via a data connection to a warehouse data hotspot, that it is a warehouse location (e.g., not a location of application).

[0019] According to a further embodiment, a sales detection device may detect the unique identification of the medical product, and a tracking system may add the sales transaction, along with the sale date (time stamp) and, preferably, the customer number, to the blockchain for the medical product to document the sale of the medical product.

[0020] According to a further embodiment, a shipping detection device may detect the unique identification of the medical product and add a shipping transaction along with the shipping date (time stamp) to the blockchain for the medical product to document the shipping of the medical product. With these detection devices and their respective transactions stored in the blockchain, it is possible to securely and bijectively document and track the complete path of a medical product from manufacturing to application.

[0021] In particular, the tracking system may be adapted to determine the location of the detection device and execute a transaction corresponding to the location via that location. For example, if a medical product is scanned by a readout device in a warehouse, the readout device determines its location in the warehouse (e.g., via a location system (GPS) or a data connection (WLAN hotspot warehouse)) and then executes an entry transaction. In this way, standardized detection devices can be used to detect individual stations of the medical product and can be assigned as entry detection devices.

[0022] In particular, the tracking system may have a side chain for temporary interruption of the connection of the (main) blockchain to the computer network, in which the applied transactions are temporarily written, and when the connection of the (main) blockchain to the computer network is established, the deposited transactions are written to the blockchain (with a time delay).

[0023] Furthermore, the objectives relating to the (tracking) method are solved by providing a computer-implemented medical tracking method, in particular a medical tracking system according to the present disclosure, for secure tracking of at least one disposable medical product, the computer-implemented medical tracking method comprising the steps of: detecting a bijective identification of the disposable medical product by a detection device; calculating a first hash value based on the bijective identification; storing a first (generation) block having the detected identification in a blockchain on each computer of a computer network comprising at least three computers; detecting application / usage of the disposable medical product by the detection device and sending an application transaction to the computer network; checking whether an application block for the disposable medical product exists in the blockchain; if an application block does not yet exist, generating an application block having the first hash, a time stamp, the application transaction, and the application hash based on the application transaction, providing the application block to the computer network, and adding the application block to the blockchain in each computer of the computer network; and, if an application block exists, issuing an alarm and / or blocking the functioning of the disposable medical product.

[0024] According to a preferred embodiment, NFTs (non-fungible tokens) can be stored in the blockchain as digital twins. For example, as soon as the article number and serial number of a medical product are known, a digital twin can be created and tracked. In a first step, the digital twin is stored in the blockchain, in particular with at least the article number, serial number, and UID. In particular, a sterilization time stamp may be deposited during the sterilization step. In particular, at least one or a combination of time stamps of the start of production, the end of production, quality inspection, supply to the warehouse, sale, packaging, shipping, and / or receipt, in particular with customer ID, may be stored together with the corresponding transaction.

[0025] According to a further preferred embodiment, at least one or a combination of time stamps of feeding to the CSSD, manual pre-cleaning, cleaning by a washer-disinfector, maintenance, packaging of sieves, packaging of sterile containers and / or sterile sieves (baskets), sterilization, and delivery by the OR may further be stored with the corresponding transaction.

[0026] According to one embodiment, the tracking system may detect application of the disposable medical product by having the detection unit read the unique identification information and store the detection device in association with the application as an application detection device.

[0027] According to a further embodiment, the tracking method may further include storing a unique control number associated with the serial number as an alphanumeric code in a first block generated by a predetermined, private algorithm in addition to the bijective identification information having the bijective serial number; and, upon detecting the application of the disposable medical product, verifying the serial number and the control number associated with the serial number and determining that the disposable medical product is counterfeit if the control number does not match the serial number. The serial number is encrypted using a private, not publicly known, algorithm to create an associated control number, which is also stored in the blockchain. A corresponding verification algorithm can be used to verify whether the control number actually matches the serial number. This prevents tampering with the sequential serial number, since a "cryptographic" changing control number is required in addition to the sequential serial number.

[0028] Usage data may also be transmitted from the product being used to and stored on one or more computers, where computer refers to any type of data processing device.

[0029] In this case, blockchain datasets on one or more computers may be integrated within existing data structures, which may also be based on blockchain.

[0030] Storage for products or computers can be organized differently: the storage location can be entirely private, for example within a company or hospital, but it can also be privately located with computers distributed among, for example, the product manufacturer, service partners, and users, or the storage can be implemented in a publicly accessible DLT.

[0031] The data transmission used in this process may be realized by various technologies, such as Bluetooth, IR, LAN, WLAN, IoT, mobile radio, e.g., 2G, 3G, 4G, 5G, GSM, and / or LTE, LoRaWAN (Low Range Wide Area Network). However, other wired or wireless protocols or transmission technologies may be used. In addition, direct transmission or transmission via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and / or the Internet is possible.

[0032] Additional information may be stored within the stored dataset or data structure. In particular, information regarding the product's item number and / or serial number and / or authorized use, such as an expiration date after which the product cannot be used or the number of authorized uses, is stored within the dataset. This information may be written to the data structure when the product is manufactured or may be detected when use is detected and then stored within the dataset. Other information that may be stored includes, for example, information regarding the product's manufacturing date, warehouse date, shipping date, and sale date.

[0033] The additional stored data may be used to determine, when a use is requested by the product, whether the requested use is permitted or represents an unauthorized use. This is done by evaluating the data stored in the datasets and / or data structures. Therefore, for medical products, storage in the form of a blockchain is a particularly advantageous configuration.

[0034] If further use is determined to be unauthorized, the unauthorized use can be recorded in a tamper-proof manner. Alternatively or additionally, a signal can be sent, for example, acoustically and / or optically. Additionally or alternatively, data can be transmitted, for example, data that triggers such a signal in another device or that causes a notification there. Alternatively or additionally, the request can be sent and the product released for use only after, for example, confirmation of the request by the user. This allows for a product that should no longer be used, for example, to be used for emergency purposes. This is because, for example, unused product or product that should only be used within usage parameters would not be available. Finally, alternatively or additionally, the product can be locked with respect to the requested further use, thereby preventing it from being used for a use determined to be unauthorized. This can increase overall safety because a product may pose a safety risk after reaching the permitted usage time or number of uses, for example, in the case of a cutting tool, the cutting edge may potentially cause damage.

[0035] A further advantage of the present invention is the tamper-proof documentation of product usage, which allows for the detection and prevention of unauthorized use, thereby increasing overall safety during use.

[0036] Any disclosure relating to the (tracking) method of the present disclosure applies equally to the (tracking) system according to the present disclosure, and vice versa.

[0037] The foregoing summary, as well as further objects, features, and advantages of the present invention, will be further described by reference to the following drawings, in which like reference numerals refer to like elements, in order to provide a better understanding of the present invention. [Brief explanation of the drawings]

[0038] [Figure 1] 1 shows a flow diagram of a method according to a preferred embodiment. [Figure 2] 1 shows a flow diagram of a method according to a preferred embodiment. [Figure 3] 1 shows a flow diagram of a method according to a preferred embodiment. [Figure 4] 1 shows a flow diagram of a method according to a preferred embodiment. [Figure 5] 1 shows a schematic diagram of a preferred embodiment device and system. [Figure 6] 1 shows a schematic diagram of a preferred embodiment device and system. [Figure 7] 1 shows a schematic diagram of a preferred embodiment device and system. [Figure 8] 1 shows a schematic diagram of a preferred embodiment device and system. [Figure 9] 1 shows a flow diagram of a method according to a preferred embodiment with additional data. DETAILED DESCRIPTION OF THE INVENTION

[0039] To guarantee this restriction on the product, such as that it should only be used a certain number of times or only during a certain period, a proof of use is required. Ideally, such proof should be tamper-proof so that uses cannot be added, deleted, or changed at a later date. To meet the requirements of verified proof and enable product manufacturers and customers to release reliable information (e.g., hospital quality control, corporate material management, etc.), thus increasing legal certainty in critical applications, solutions are proposed that ensure tamper-proof data in the form of logs and thus historically securely document use. Typically, not only the product manufacturer and product user, i.e., the person directly carrying out the use, but also, possibly, all actors in the supply chain between the manufacturer and user, are interested in the use of the product. This may include not only the distributor, but also intermediate stations, such as material storage points and central control points in a hospital network, as the case may be. In the following, manufacturers and users are also encompassed by the term "parties."

[0040] The preferred method for this is known as Distributed Ledger Technology (DLT for short), which is briefly described below. DLT is used for the documentation of specific transactions. In contrast to traditional approaches, where a general ledger is usually managed by only one instance, here any number of copies of the ledger, which are essentially identical, are maintained in a decentralized manner by different parties. New transactions are added to all copies of the ledger, and appropriate measures are taken to ensure that there is agreement (consensus) regarding the current state of the ledger.

[0041] DLT is one form of blockchain, others being the Tangle, and although the generic term blockchain will be used hereafter, the present invention may also be implemented with any other blockchain technology.

[0042] This solution has the following exemplary advantages, among others: Using the blockchain, a user (e.g., a manufacturer, operator, or seller) can effectively determine and record whether a product has been used more than a specified maximum number of times. For example, it can determine whether a single-use item (e.g., a product that can only be used once for hygiene reasons) has been used multiple times. The user can also ensure that the product is used only once. This can be done by a lock (e.g., in the case of an energized device) or a signal notification (e.g., an acoustic or optical signal), or even a request in a computer dialogue. Such a notification or signal can be sent, for example, to a computer for such a product, a mobile device, software running on such a device (e.g., a program on a computer, an app on a mobile device), a display on a control device, or other information channel. For this purpose, various transport protocols can be used, such as SMS, email, TCP / IP, etc., or data transmission via Bluetooth, IR, LAN, WLAN, IoT, mobile radio, e.g., 2G, 3G, 4G, 5G, GSM, and / or LTE, LoRaWAN. Similarly, communication may occur directly or through intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and / or the Internet.

[0043] Securely logging usage allows all parties involved to ensure or further improve quality, avoid accidental multiple or overly frequent use of products, and provide valid data and evidence to oversight bodies or agencies.

[0044] Tamper-proof logging is a technology that prepares any future parties using such a log for future requirements. All involved parties can establish themselves as blockchain stakeholders, thus improving their reputation with organizations and institutions. This can be crucial for the economic allocation of contracts. This implementation makes it impossible to tamper with data, as the history is mapped through each block. Additionally, it also allows for the application cycle to be effectively and immutably logged for reusable products.

[0045] Previous solutions log or record usage data in traditional databases, e.g., MySQL, SQL. These solutions are cloud-based. Such solutions are usually not tamper-proof. Furthermore, because data is entered into such databases by users themselves, there is a possibility that data detection and / or data entry errors may occur. Additionally, data in such databases may be modified by IT administrators (who have so-called administrative rights, i.e., extended access to the data) or through unintended access (e.g., attacks) by third parties. Such modifications may be notified relatively late, and therefore countermeasures can only be initiated after a time delay. Overall, this requires a high level of management and monitoring effort. Furthermore, with sufficient criminal energy, there is no limit to the fraudulent intent involved in modifying databases and manipulating data.

[0046] The use of blockchain is a useful technique for strengthening stakeholder integrity for organizations and institutions.

[0047] Limited-use products, particularly single-use products, are provided to customers for their intended use, e.g., single-use, and are usually marked or labeled accordingly. Single-use products may, for example, be marked accordingly by the number 2 with a strikethrough.

[0048] This symbol may appear, for example, on the product packaging, label, the product itself, instructions for use, and other suitable locations that may be specified.

[0049] By way of example, and not limitation, the following is a tool-based solution, and this description extends to any single-use or limited-use product.

[0050] Generally, the invention requires that products can be detected and recognized electronically, which is described in the prior art, for example, in DE 10 2018 133 503 A1, DE 10 2018 126 969 A1 and DE 10 2018 121 682 A1.

[0051] Also known from the prior art are so-called smart hubs, mobile hotspots, data gates, access points, repeaters etc. which provide connections between devices and / or to the Internet.

[0052] This ensures the basic availability and reachability of services on the Internet and / or other parties. Examples of such devices include mobile hotspots over mobile networks (5G, 4G, 3G, dual band, etc.), IoT devices capable of establishing hotspots, smartphones, or base devices for WLAN routers, LoRaWAN, which uses technology that, together with 5G, is established as one of the possible foundations for IoT devices, etc.

[0053] Furthermore, the functionality is described as being able to communicate with at least one blockchain, execute transactions or insert information (into a block), respectively.

[0054] Generally, the complete life cycle of a product can be recorded, i.e., logged, in the blockchain along with sub-process steps, if applicable.

[0055] Some possible stages of the life cycle are described below by way of example. These stages are illustrated in Figure 9. For each stage, the contents of the stored data are shown as an example. The data shown in Figure 9 is for illustrative purposes only; more data can be stored or data can be omitted depending on the particular application, as explained in this description.

[0056] Stage 1 is the manufacturing of the product. During the manufacturing process, the product is produced and finally loaded with data. This can be done in the form of laser marking or written data memory. Such a process is described, for example, in DE102018125884. According to this description, a log may be obtained, for example, with an article number (e.g., GP111SU), a unique serial number (e.g., SN0001020) possibly including a uniquely assigned data sequence (e.g., NONE COPY IDENTIFICATION), a shortened NCID (which may optionally be encrypted), and / or a minimum endurance date (e.g., 2019-09 for September 2019). One or more of these pieces of information may also indicate, for example, that the product is intended for single use only. This may be indicated, for example, by the letter combination SU in the article number or serial number. Optionally, data indicating characteristics such as single use, reusability, the number of permitted uses, or the permitted period of use may be stored separately. In this way, counting of usage cycles is also possible.

[0057] Phase 2 indicates the warehousing of the product. Here, data indicating, for example, the date of receipt and therefore the saleability are added to the dataset already stored as a log. This data is written to the blockchain in addition to the data packets already present. Further information indicating the product's receipt and the previous route and intermediate stations is also possible, such as the date of shipment from the factory, an indication of the transport stages, the number of intermediate stations, the transport duration, and the distance the product has traveled.

[0058] Stage 3 indicates the sale of a product. Here, data indicating, for example, the time the product was put on the market is added to the data set already stored as a log. Here, it can be added as a date only, or it can be added with additional information such as time, location, or time of day. This data is written to the blockchain in addition to the existing data packet. Additional information is also possible, such as price, number of owners, owner identities, buyer identities, seller identities, etc. In case of desired anonymity, the aforementioned identification information can also be created through encrypted ID data, such as numbers or symbols, known only to a limited scope, for example, the manufacturer or public authorities.

[0059] Stage 4 indicates the shipment of the product. Here, data indicating the time of shipment, for example, is added to the data set already stored as a log. Here, it can be added as a date only, or with additional information such as time, location, or time of day. This data is written to the blockchain in addition to the existing data packet. Additional information, such as the date of the previous shipment, an indication of the transport stages, the number of intermediate stations, the duration of the transport, the distance traveled by the product, the sender's identity, the recipient's identity, transport restrictions such as a no-air transport ban for fragile items or to avoid increased air pressure, etc., are also possible. For the desired anonymity, the aforementioned identification information can also be created through encrypted ID data, such as numbers or symbols, known only to the manufacturer or public authorities.

[0060] Stage 5 indicates the actual use of the product. Here, data indicating the duration of use, for example, is added to the data set already stored as a log. This may be added as a date only, or with additional information such as the time, location, or time of day. This data is then written to the blockchain in addition to the existing data packet. Additional information, such as cached usage data written within the device since the last connection to the detection unit, the identity of the person or device that used the product, which can be detected before use via identification information, and further data on use, such as the type of use, duration of use, number of uses, number of power-on and power-off operations, or operations performed during use, are also possible. To achieve the desired anonymity, the aforementioned identification information may also be created via encrypted ID data, such as numbers or symbols, known only to the manufacturer, owner, or official authorities.

[0061] Stage 6 indicates the end of the life cycle. For example, the product itself or another device determines that the end of the product's life cycle has been reached based on previously stored data, such as the number of uses already stored, stored daily data of use, etc.

[0062] The product may then be marked as, for example, invalid or expired, and it may therefore be considered that the product should be discarded and not used again. The time at which the product is marked as "expired" may also be recorded.

[0063] If the corresponding data is stored in the blockchain for the product, the use may be remembered in step 5, in particular by marking it as off-label use, and / or the product may be locked for use if technical possibilities are available. For example, if a product marked as "expired" is detected again in the use environment at a later date or after a defined period of time, off-label use can be determined as described above. This reduces the risk to both the patient and the operator.

[0064] A locking of the product or respectively the intervention of a safety query before use can then be provided for the product: for example, in the case of devices with a power supply, powering on can be technically prevented.

[0065] To nevertheless allow for emergency action, the user can confirm a prompt to intervene and store the prompt in the blockchain via additional data in the dataset in stage 5. Again, this can be done together with the user's identity or device used as described above. Otherwise, a product that has not reached the end of its life cycle would have to be deployed.

[0066] In this case, there are several alternatives.

[0067] The user is not notified. Only off-label use is logged. Applicable parties, such as the company or entity where the product is used, can examine the product data in the blockchain to determine if the product has been used more than once. If so, quality assurance personnel may then intervene and remove the product from the cycle.

[0068] During use, or upon initiation of use of each particular product, the user receives information indicating the end of the life cycle. This may be accomplished via an audio or visual indication on the product or a suitable device involved in the use. Such suitable output devices may include, for example, tablets, control devices, smartwatches, displays, screens within the use space, and any suitable output device. Where appropriate, an indication of permitted use may also be provided along with an indication of whether the product is suitable for the intended use.

[0069] The output of the corresponding notification may be performed elsewhere: it may be performed on an output device at a central monitoring location, or it may also be performed as feedback to the manufacturer, from which a service technician or sales person may then be dispatched to the customer to advise on use.

[0070] Further along the life cycle, such as return, maintenance, reprocessing, recycling, and / or disposal, the same or similar data as described above may be stored within the blockchain.

[0071] In all the exemplary steps described above, the product is generally detected by an electronic reader to store the data. This may be done, for example, by reading a 2D or 3D barcode or an NFC (near field communication) tag on the product, outer packaging, or shipping packaging. Allocation via the shipping packaging is also possible using intermediate database queries.

[0072] This method of using DLT / Blockchain technology provides legal certainty and improves integrity for entities and institutions, as well as enhancing the reputation of all parties using this solution, which improves their reputation with sellers, contractors, and end customers.

[0073] DLT or, respectively, blockchain can be used in different variants. One possibility is the so-called private blockchain. Here, the blockchain operates within a closed network within a company or organization and is possibly maintained redundantly on several servers. These servers are considered so-called nodes / master nodes. Block contents are therefore invisible to other parties outside the private network. Nevertheless, corresponding data transmissions can take place to allow corresponding proofs to be provided.

[0074] Another possibility is a semi-private blockchain. Here, for example, the blockchain is managed and operated jointly by one or more parties, i.e., it may be written to by one or more parties. Alternatively, read-only access for some parties is also possible. An example here is a shared blockchain operation by a consumer and a manufacturer, which may automate the reordering of expired products. Thus, block contents are not visible to other parties outside the semi-private network. Nevertheless, corresponding data transmissions can take place to enable corresponding proofs to be implemented.

[0075] Another possibility is the public blockchain. Here, the blockchain operates publicly, allowing all parties, even non-involved parties, i.e., the public, to inspect transactions, i.e., block contents. The data written therein is stored in plain text or in encrypted form, which allows for a certain degree of anonymity. For this purpose, masternodes, for example, can operate in various company locations around the world. If applicable, customers with their own masternodes are integrated into the network. Furthermore, adaptations to already existing blockchains, such as Ethereum, NEO, or Cardano, can be considered to provide the data to be written there.

[0076] Additionally, product usage may also be detected and recorded if the connection to the used blockchain via the internet is temporarily or permanently absent, for example in the case of an internet outage. This can be achieved, for example, by a so-called sidechain. In this case, a so-called sidechain can be established on the product or on a device communicating with the product, in parallel with the blockchain actually used. This can also be performed ad hoc, i.e., without preparation, when a data communication error is detected. In this way, an independent, continuous blockchain can be operated locally, which first generates blocks locally and locally records, i.e., stores as a log, product usage.

[0077] If a connection is restored after a temporary interruption, or if a connection is permanently lost and a special connection can be established, for example, as part of maintenance, preventive maintenance, the dispatch of a service technician, or another planned data transmission, the connection can be established on the actual blockchain, in this case the main blockchain, and the sidechain's data content can be transmitted to or integrated into the main blockchain. The sidechain's data blocks are then stored, for example, as additional blocks in the main blockchain. This variant also allows products that operate without a data connection, i.e., offline, to be integrated into the blockchain, albeit with a time delay. Therefore, medical products can be used with high availability without sacrificing the aforementioned advantages. Because the sidechain is generated and stored only locally, hardware requirements can be kept low. Complex mechanisms for replicating and synchronizing traditional databases can be dispensed with, meaning high availability can be achieved.

[0078] Another advantage of this solution is improved security regarding counterfeit products. Data such as serial numbers are stored in the blockchain with a unique control number for each product, which is generated via an algorithm and consists of, for example, a unique alphanumeric code. If a counterfeit product with the same serial number and attempted counterfeit control number is later detected, the product is declared counterfeit, and the user, customer, or currently acting party is notified and / or this is logged in the blockchain. This can increase patient safety. Counterfeit products may be detected by checksum comparison or other methods, such as comparing the accompanying encrypted data set (e.g., the control number) with a primary key stored on a server (e.g., in the cloud, i.e., in a remote storage area accessible via data communication). This can be used to determine whether the product is authentic or counterfeit. The encryption used itself can then be compared with a previously stored data set (e.g., from the manufacturer or another party in the supply chain) that can be decrypted using the primary key. In this way, authenticity can be verified, and potentially dangerous use of counterfeit products can be avoided.

[0079] The operation of a database does not preclude the application of blockchain technology. Both technologies can also be used together. Blockchain or DLT, by themselves, are generally relatively unsuitable for storing large amounts of data, as block updates significantly increase data volume. Rather, for large amounts of data, a hybrid database / blockchain solution must be pursued. Here, larger amounts of data are stored and stored within the database. On the other hand, the associated blockchain authenticates the data storage state and therefore guarantees the authenticity and integrity of the data content. For example, a data set is stored within a database. A checksum is generated and stored for that data set. The checksum itself is also logged within the blockchain to immutably record the data integrity. This makes it possible to verify the data stored within the database.

[0080] 1 shows an exemplary method 100 for storing product usage data, where, in a first step 110, usage is first detected. This can be done by the product or a component thereof, or by an external device that detects its use, for example by the product being within detection range of the device, for example via WLAN, Bluetooth, or another wireless technology, or by the product transmitting a corresponding signal to the device. Detection can be done optically, for example by reading a 2D or 3D barcode on the product, or electronically, for example by NFC (Near Field Communication).

[0081] Subsequently, in step 120, data regarding the detected use of the product is created based on the detection of the usage data. As mentioned above, data such as the time of use can be detected here as a date only or with additional information such as time, location, time of day, etc. The usage data may also include the identity of the person or device using the product, which can be detected, for example, by pre-use identification, as well as further data of the use, i.e., the type of use, the time of use, the number of uses, the number of power-on and power-off operations, or the operations performed during use. In the case of desired anonymity, such identification may also be performed via encrypted ID data, such as numbers, symbols, etc., known to a limited scope, for example, only to the manufacturer, owner, or official authorities. Step 120 may be performed by the product or its components, or by an external device that detected or communicated the detection of use.

[0082] In a next step 130, the usage data is then stored in a dataset in a non-retroactively modifiable format, e.g., a DLT such as a blockchain as described above. If applicable, the dataset is written to the blockchain in addition to the already existing data blocks. Writing 130 may also be performed by the product or its components, or by an external device that created or to which the usage data was communicated. Writing may be performed on memory located within the product or in memory associated with the external device.

[0083] 2 shows that after creation 120 and before storing 130, method 100 may include the aforementioned transmission 140 of the usage data to one or more computers, each having a memory. In this case, the storing of step 130 may then be performed by the one or more computers. Again, writing may be performed on memory located within the product or in memory associated with an external device.

[0084] 3 shows that method 100 can be performed such that the storing of step 130 is first performed by the product in its own memory, followed by transmission 150 of the dataset to one or more computers, each having a memory, where the dataset is then stored by the one or more computers in their memory. Here, the dataset already has a format that cannot be retroactively modified from step 130, i.e., exists as a DLT or blockchain, which corresponds, for example, to the above-mentioned sidechain. After transmission 150, it can then be inserted into a data structure already existing on the receiving computer, i.e., on the main blockchain, for example. Alternatively, however, the computer may only have a simple database in which the sidechain is stored for later further use.

[0085] 4 illustrates that the above-described method 100 may be followed by step 170 of determining, in response to a request for further use of the product, that the further use represents unauthorized use. This determination may be performed, for example, by evaluating data stored in datasets and / or data structures, as described above. This step may also be performed within the product or by one of the above-described devices or computers, respectively.

[0086] If unauthorized use is determined in step 170, the method may then perform one or more of the following steps: In step 180, further use or a request for further use may be stored in a dataset and / or data structure. In step 181, a light and / or sound signal may be output. As previously described, this may be performed on the product or remotely from the product. In step 182, data may be transmitted to a computer, such as one of those previously described, which then causes a signal to be sent to or a notification to be triggered on an external device. In step 183, a request may be sent to a user, which must first be confirmed by the user. This results in receipt of a release in step 185, and only then is the release of the product performed in step 184. As previously described, the request and release may be performed by the product itself or by another device, such as a computer, previously described. Finally, in step 186, the product may be locked so that further use is not possible.

[0087] 1-4 involving transmitting data may use one or more of the following technologies: Bluetooth, IR, LAN, WLAN, IoT, mobile radio (e.g., 2G, 3G, 4G, 5G, GSM, and / or LTE), LoRaWAN, etc. These steps may be performed directly or via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and / or the Internet.

[0088] 1-4, each of which may be configured as a DLT or a blockchain, may further store one or more pieces of information, such as the product's serial number and / or information regarding the authorized use of the product, such as an expiration date after which the product should not be used, or the number of authorized uses. This information may be written into the data structure during the manufacture of the product, or detected during detection in step 110 of use, and then stored in the dataset, or such information may include information regarding the date of manufacture, warehouse storage, shipping, or sale of the product.

[0089] Omitted from illustration are systems with processors capable of executing the aforementioned methods, as well as computer program products and / or computer-readable storage media containing instructions that, when executed, implement the aforementioned methods.

[0090] 5 shows an exemplary device 200 for storing usage data 210 of a product 220. The device comprises a detection unit 201, which detects the usage of the product 220 as described above.

[0091] 5, device 200 is a device independent of product 220, while FIG. 6 shows an example configuration in which device 200 is part of product 220. However, the further relationships described above and below generally apply equally to the embodiments of FIGS. 5 and 6.

[0092] If the device 200 represents part of a product, the device 200 detects use, for example, by direct signaling within the product 220 .

[0093] If the device 200 is not part of a product, the use can be implemented, for example, by detecting that the product is within the detection range of the device, for example via WLAN, Bluetooth, or another wireless technology, or by the product transmitting a corresponding signal to the device. Detection may also be performed optically, for example by reading a 2D or 3D barcode on the product, or electronically, for example by NFC (Near Field Communication).

[0094] Furthermore, the device 200 includes a data processing unit 202 that generates usage data 210 related to the detected use of the product 220. The generation may be performed within the product or an external device. As mentioned above, data such as the time of use may be detected here as a date only or together with additional information such as the time, location, or time of day. The usage data may also include the identity of the person or device that used the product, which may be detected, for example, by pre-use identification, as well as further data on the use, i.e., the type of use, the duration of use, the number of uses, the number of power-on and power-off operations, or the operations performed during use. In the case of desired anonymity, the aforementioned identification may also be performed by encrypted ID data, such as numbers, symbols, etc., known to a limited scope, for example, only by the manufacturer, owner, or official authorities.

[0095] The device 200 further comprises a storage unit 203 that stores the usage data 210 in a data set 230 in a non-retroactively modifiable format, for example, a blockchain as described above. If applicable, the data set is written to the blockchain in addition to existing data blocks. The storage unit may be part of the product or part of an external device that created the usage data or to which the usage data was communicated. Storage may be performed on a memory located in the product or in a memory associated with the external device.

[0096] It can further be seen that device 200 can be part of a system 300, which further comprises one or more computers 240, each having a memory 250. Device 200 then comprises a transmission unit 204 for transmitting usage data 210 to one or more of computers 240. The receiving computers then store usage data 210 in their respective memories 250 in a data set 230 in a format that cannot be retroactively modified, i.e. DLT or blockchain, as described above.

[0097] In such a system 300, the device 200 may again be implemented as part of or external to the product 220, as shown in Figure 5 or 6, respectively. The transmission unit 204 may also transmit the dataset 230 created in the device 200 to one or more computers 240.

[0098] In other words, if the device 200 creates the data set 230 from the usage data 210, then the data set 230 may be transmitted from the transmission unit 204 to one or more computers 240 and stored there or elsewhere. However, if one or more computers 240 create the data set 230 from the usage data 210, then the usage data 210 is transmitted from the transmission unit 204 to one or more computers 240 and stored there or elsewhere within the data set 230.

[0099] When the completed dataset 230 is transmitted to one or more computers 240, the one or more computers 240 may include a computation unit 241 that inserts the transmitted dataset 230 into an existing data structure 280 that also cannot be retroactively modified, i.e., also is, for example, a DLT or blockchain.

[0100] 7, device 200 may include a determination unit 320. In response to a request for further use, determination unit 320 may determine that the further use constitutes unauthorized use. This determination may be performed, for example, by evaluating data stored in dataset 230 and / or data structure 280, as described above.

[0101] If the determination unit 320 determines unauthorized use, one or more of the computers 240, as shown in FIGS. 5, 6, and 8, or the device 200, as shown in FIG. 7, may include or be adapted to one or more of the following elements: The device 200 or the system 300 may store further use in the dataset 230 and / or the data structure 280 if unauthorized use is determined by the determination unit 320. The signal sending device 330 may output an optical and / or acoustic signal if unauthorized use is determined by the determination unit 320. As described above, this may be performed on the product or may be performed remotely from the product. The transmission unit 204 may transmit data that causes a signal or notification to be output at the external device 310 if unauthorized use is determined by the determination unit 320. The output device 340 may output a request, and the release device 350 may release the product for the requested further use if unauthorized use is determined by the determination unit 320 in response to receiving user confirmation in response to the request. The locking device 360 ​​may lock the product 220 from further use when unauthorized use is determined by the determining unit 320 .

[0102] 5-8 involving transmitting data may use one or more of the following technologies: Bluetooth, IR, LAN, WLAN, IoT, mobile radio (e.g., 2G, 3G, 4G, 5G, GSM, and / or LTE), LoRaWAN, etc. This may be done directly or via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and / or the Internet.

[0103] 5-8, each of which may be implemented as a DLT or a blockchain, may further store one or more pieces of information, such as the product's serial number and / or information regarding the product's authorized use, such as an expiration date after which the product should not be used, or the number of authorized uses. This information may be written to the dataset when the product is manufactured, or detected when use is detected and then stored in the dataset, or such information may include information regarding the product's manufacturing date, warehouse date, shipping date, and sale date.

[0104] An exemplary embodiment of the device of FIG. a surgical motor system including a handpiece and a control device; and a tool that can be coupled / connected to the handpiece.

[0105] The tool forms the product 220. For example, the tool may be formed as a surgical milling cutter provided for machining bone. The tool is provided with a QR code as an ID element, the QR code including at least an item number and a serial number. Alternatively, the tool may also have an RFID tag, an NFC tag, or a barcode as an ID element. The ID element includes at least one serial number, which in RFID or NFC tag embodiments can be read electronically, or in QR code or barcode embodiments can be read optically.

[0106] The handpiece includes a detection unit 201. In this example configuration, the detection unit is configured as an optical reader unit provided to read a QR code on the tool. Alternatively, the detection unit may also be configured as an RFID reader or an NFC reader. The detection unit 201 is located within the handpiece. When a tool is inserted into or connected to the handpiece, the detection unit 201 detects the ID element and determines at least the serial number.

[0107] The control device comprises a data processing unit 202, a storage unit 203, and a transmission unit 204. A handpiece is connected to the control device in a ready-to-use state. When a tool is coupled to the handpiece, the detection unit 201 reads the ID element. The data processing unit 202 generates usage data 210 via the serial number determined from the ID element and, if applicable, other data detected during operation. The usage data is then stored in the storage unit 203 as a data set that cannot be retroactively modified.

[0108] The transmission unit 204 is provided to connect the control device to the computer 240. The computer 240 is preferably configured as a local server, for example, an intranet server for a hospital. To connect the control device to the local server, the system 300 includes an access point, not shown in detail. The transmission unit 204 is provided to wirelessly connect to the access point. The computer 240 and the access point may be wired, for example, via a LAN connection, or may be wirelessly connected to the computer 240.

[0109] The server comprises a determination unit 320. The determination of whether use of the product 200 is authorized is made centrally on the server 200. If the determination unit 320 detects unauthorized use, the computer 240 sends corresponding information to the device 200. In an embodiment of the control device, the device 200 comprises a display capable of displaying information. Various functions may be stored in the device to process information regarding unauthorized use. For example, if the determination unit 320 detects that the tool is a single-use tool that has already been used, the control device presents corresponding information. The control device may lock the use of the tool, in which case a function allowing emergency operation may be provided.

[0110] The exemplary embodiment of device 200 of FIG. 6 is a medical pump, e.g., an infusion pump. Usage data 210 is stored in a non-retroactively modifiable format in dataset 230 and may, for example, be information regarding service checks performed. Additionally, each time device 200 is used, dataset 230 including startup-related usage data 210 is created. If determination unit 320 detects that dataset 230 having startup-related usage data 210 belongs to a device for which the last dataset 230 having usage data 210 regarding service checks performed is out of date, device 220 configured as a medical pump may output a signal that a service check is overdue.

[0111] For example, the exemplary embodiment of FIG. 8 is an embodiment of product 220, e.g., as an infusion bag. In such an embodiment, device 200 may be configured as a holder for an infusion bag. However, it is alternatively conceivable that device 200 may be configured as a handheld scanner or the like, for example, for use with goods entering and leaving a warehouse. Device 200 is arranged to detect at least one identification number of product 220, such as a batch number. Depending on the configuration of device 200, different methods can be used. In a handheld scanner embodiment, the device may be arranged for optical recognition of a barcode or a QR code. In a holder embodiment, the device may be arranged to read an NFC or RFID tag.

[0112] For such products, manufacturing, warehousing, and transportation are monitored, among other things. If it is later determined that a situation has occurred in the process that requires the product 220 to be locked, a dataset 230 containing this information about the product is stored in a data structure 280. The device 220 is connected to a computer 240. If the device 220 is a handheld scanner, the computer 240 may be, for example, a computer of a warehouse management system. If the device 220 is a holder, for example, the computer 240 may be part of a patient monitoring system. In particular, in such an embodiment, a device 310 separate from the computer 240 is advantageous to ensure that the user is notified that the product 220 has been locked. For example, the device 310 may be configured as an LED, which signals the lock.

[0113] An alternative tracking system according to a further preferred embodiment may be configured as follows (not shown): The medical tracking system serves to securely track and document the history of a disposable medical product in the form of a scalpel. A QR code with an encoded bijective serial number is printed on the exterior of the scalpel, and the QR code can be detected and read by a reading device in the form of a camera. In a computer network having multiple computers (in this case, more than 20 computers), each digital tracking book with a directory of information blocks related to at least one disposable medical product is decentralized and stored as a blockchain within the computer, where the medical product's serial number, item number, and control number are stored in a first block, and this data is self-contained via a first hash or hash value. The first hash is used, so to speak, to verify the stored data and close the data set / block. If the data in the first block is subsequently changed, the first hash must change as well. When a scalpel is subsequently read via a reading device before use in an operating room, upon detection of the first use, a usage transaction is sent to the computer network, and a usage block having a time stamp, the usage transaction, and a usage hash (recompletion of the block) is created via a block generation module, which is adapted to create this usage block based on the usage transaction and the first hash and make this usage block available to the computer network for adding to the respective blockchain in the computers of the computer network. Contrary to specifications, if a disposable medical product is used again, it must first be read again with the aid of the reading device. The tracking module is adapted to read the blockchain for at least one disposable medical product and detect an existing application block (having a corresponding application transaction) in the blockchain.Then, instead of adding a second application block, the tracking module is configured to output a visual alarm via the OP monitor and also generate an acoustic signal, thus safely preventing repeated use and notifying the user about unauthorized double use.

[0114] In particular, the present invention discloses the following aspects. Aspect 1. A computer-implemented method (100) for storing usage data (210) of a product (220), the method (100) comprising: Detecting (110) the use of a product (220); creating (120) usage data (210) relating to detected usage of the product (220); storing (130) the usage data (210) in a data set (230) in a form that cannot be retroactively modified; Including, The dataset (230) uses blockchain technology. method. Aspect 2. The method (100) includes, after the creating step (120) and before the storing step (130): further comprising the step of transmitting (140) the usage data (210) to at least one computer (240) each having a memory (250); The storing step (130) is performed by at least one computer (240) in a respective memory (250). The method according to embodiment 1 (100). Aspect 3. The storing step (130) is performed by the product (220) in a dedicated memory (245), and the method (100) comprises: transmitting (150) the data set (230) to at least one computer (240) each having a memory (250); and storing (160) the data sets (230) from the at least one computer (240) in a respective memory (250). 3. The method according to claim 1 or 2 (100). Aspect 4. The method (100) of aspect 3, wherein after the data set (230) of the product (220) is transmitted (150) to at least one computer (240), the data set (230) is inserted into an existing data structure (280) that cannot be retroactively modified. Aspect 5. 5. The method (100) of aspect 4, wherein the data structure (280) uses blockchain technology. Aspect 6. Blockchain technology is A blockchain stored only in the memory (250) of a private computer (240) consisting of one group (260), a blockchain stored in a memory (250) of a private computer (240) consisting of at least two groups (260, 270); or a blockchain stored in the memory (250) of a public computer (240); It consists of one of the following forms: 6. The method (100) of any one of aspects 1 to 5. Aspect 7. one or more of the steps of transmitting (140) the usage data and transmitting (150) the dataset (230) use one or more of the following technologies: Bluetooth, IR, LAN, WLAN, IoT, mobile radio, e.g., 2G, 3G, 4G, 5G, GSM, and / or LTE, LoRaWAN; Usage data may be transmitted directly or through intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and / or the Internet; 7. The method (100) of any one of aspects 2 to 6. Aspect 8. One or more pieces of information are further stored in the dataset (230) and / or data structure (280); The information may include the product's serial number and / or information regarding the authorized use, such as an expiration date after which the product may not be used or the number of authorized uses; The information is written into the data structure (280) when the product (220) is manufactured or is detected when use is detected (110) and then stored in the data set (230); 8. The method (100) of any one of aspects 1 to 7, wherein the information includes information regarding the date of manufacture, warehouse storage, shipping, and sale of the product (220). Aspect 9. The product (220) is a medical product; 9. The method (100) of any one of aspects 1 to 8. Aspect 10. and determining (170) in response to a request for further use of the product (220) that the further use constitutes unauthorized use by evaluating data stored in the data set (230) and / or data structure (280) in the product (220) or in the computer (240). 10. The method (100) of any one of aspects 1 to 9. Aspect 11. If unauthorized use is determined in step (170), storing (180) the data set (230) and / or the data structure (280) for further use; emitting (181) an optical and / or acoustic signal; transmitting (182) data that causes a signal or triggers a notification in the external device (310); sending (183) the request and releasing (184) the requested further use only after receiving (185) user confirmation; locking (186) the product (220) so that it cannot be used further;

[0033] Further comprising performing one or more of: The method according to embodiment 10 (100). Aspect 12. 12. A system for processing data, comprising: a processor adapted to perform the method of any one of aspects 1 to 11. Aspect 13. 12. A computer program product comprising instructions that, when executed by a computer, cause the computer to perform the method of any one of aspects 1 to 11. Aspect 14. 12. A computer-readable storage medium comprising instructions that, when executed by a computer, cause the computer to perform the method of any one of aspects 1 to 11. Aspect 15. A device (200) for storing usage data (210) of a product (220), comprising: a detection unit (201) configured to detect use of a product (220); a data processing unit (202) configured to generate usage data (210) related to the detected usage of the product (220); a storage unit (203) configured to store the usage data (210) in a data set (230) in a form that cannot be retroactively modified; A device (200) characterized in that the dataset (230) uses blockchain technology. Aspect 16. A device (200) according to embodiment 15; at least one computer (240) each having a memory (250); The device (200) a transmission unit (204) adapted to transmit the usage data (210) to at least one computer (240); A system (300) in which each memory (250) is adapted to store usage data (210) in a data set (230) in a format that cannot be retroactively modified. Aspect 17. A device (200) according to embodiment 15; at least one computer (240) each having a memory (250); The device (200) is implemented as part of a product (220), a transmission unit (204) configured to transmit the dataset (230) to at least one computer (240); Each memory (250) is configured to store a data set (230); The data structure (280) uses blockchain technology. System (300). Aspect 18. the at least one computer (240) further comprises a calculation unit (241) configured to insert the data set (230) transmitted from the device (200) into an existing data structure (280) that cannot be retroactively modified; 18. The system (300) according to embodiment 17. Aspect 19. DLT is A blockchain stored only in the memory (250) of a private computer (240) consisting of a group; a blockchain stored in the memory (250) of a private computer (240) consisting of at least two groups; or a blockchain stored in the memory (250) of a public computer (240); implemented in one of the following forms: 19. The device (200) or system (300) according to any one of embodiments 15 to 18. Aspect 20. The transmission unit (204) using one or more of the following technologies: Bluetooth, IR, LAN, WLAN, IoT, mobile radio, e.g., 2G, 3G, 4G, 5G, GSM, and / or LTE, LoRaWAN; Transmitting data directly or through intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and / or the Internet; 20. The system (300) of any one of embodiments 17 to 19. Aspect 21. further configured to further store one or more pieces of information within the dataset (230) and / or data structure (280); the information includes the product's commercial serial number and / or information regarding the authorized use, such as an expiration date after which the product should not be used or the number of authorized uses, the information being written into the data structure (280) during manufacture of the product (220) or detected during use detection and then stored in the data set (230); The device (200) or system (300) according to any one of aspects 15 to 20, wherein the information comprises information regarding the date of manufacture, warehouse storage, shipping, and sale of the product (220). Aspect 22. 22. The device (200) or system (300) of any one of aspects 15 to 21, further comprising a determination unit (320) configured to, in response to a request for further use of the product (220), determine that the further use is unauthorized use by evaluating the data stored in the dataset (230) and / or the data structure (280). Aspect 23. The device (200) or system (300) is further configured to store the further use in the dataset (230) and / or data structure (280) if the unauthorized use is determined by the determining unit (320); The device (200) or the system (300) further comprises a signal transmitting device (330) configured to output a visual and / or audible signal when unauthorized use is determined by the determining unit (320); The transmitting unit (204) is further configured to transmit data that causes a signal or triggers a notification at the external device (310) when unauthorized use is determined by the determining unit (320); the device (200) or system (300) further comprises an output device (340) configured to output a request, and a release device (350) configured to release the product for the requested further use in response to receiving a user confirmation in response to the request if unauthorized use is determined by the determination unit (320); and / or The device (200) or system (300) further comprises a locking device (360) configured to lock the product (220) from further use if unauthorized use is determined by the determining unit (320); A device (200) or system (300) according to embodiment 22. The following items are elements that are included in the claims of the international application: (Item 1) A computer-implemented medical tracking method (100) for secure tracking and storage of application data (210) of at least one medical product (220), in particular a disposable medical product (220), said method (100) comprising: Detecting (110) the application of said medical product (220); generating (120) application data (210) relating to the detected application of the medical product (220); storing (130) said application data (210) in a data set (230) in a format that cannot be retroactively modified; The data set (230) uses blockchain technology. A computer-implemented medical tracking method. (Item 2) detecting a bijective identity of said at least one disposable medical product (220); calculating a first hash value based on the bijective identity; storing a first block having the detected bijective identity and the calculated first hash value in a blockchain on each computer of a computer network comprising at least three computers; detecting application of said disposable medical product (220) by a detection unit and transmitting an application transaction to said computer network; checking, by a tracking module, whether there is an application block for the detected disposable medical product (220) in the blockchain; If an application block does not yet exist, generating, by a block generation module, an application block having the first hash value, a time stamp, the application transaction, and an application hash based on the application transaction, and providing the application block to the computer network to add the application block to the blockchain within each of the computers in the computer network; if an application block is present, issuing an alarm and / or inhibiting the function of said disposable medical product (220); characterized in that it comprises Item 1. A computer-implemented medical tracking method according to item 1. (Item 3) The tracking method includes: storing in said first block a minimum durability date of said at least one disposable medical product (220); In addition to the step of detecting the application, the method further includes the step of comparing the time stamp with the stored minimum durability date, and issuing an alarm and / or locking the functions of the disposable medical product (220) when the minimum durability date is exceeded. Item 2. A computer-implemented medical tracking method according to item 2. (Item 4) 4. The computer-implemented medical tracking method according to claim 2 or 3, characterized in that if the disposable medical product (220) is an electrically powered medical device, the tracking method performs locking of the functions of the disposable medical product (220) by interrupting its power supply. (Item 5) The tracking method includes: after issuing the alarm and / or locking the functions of the disposable medical product (220), requesting a user to perform a confirmation input via an input device to confirm that the disposable medical product (220) should be used again; detecting said confirmation input by said user; generating an alert block having a time stamp, an alert transaction, and an alert hash, and providing the alert block to the computer network to add the alert block to the respective blockchains in the computers of the computer network, documenting the repeated application; Further comprising: 5. A computer-implemented medical tracking method according to any one of items 2 to 4. (Item 6) The tracking method includes: storing, in addition to the bijective identification information having a bijective serial number, a unique control number associated with the serial number as an alphanumeric code within the first block generated by a predetermined, private algorithm; Upon detecting the application of the disposable medical product (220), verifying the serial number and the control number associated with the serial number, and determining that the disposable medical product (220) is counterfeit if the control number does not match the serial number; Further comprising: 6. A computer-implemented medical tracking method according to any one of items 2 to 5. (Item 7) The tracking method includes: detecting receipt by detecting the unique identification information of the disposable medical product (220) with an receipt detection device; generating and providing a warehouse block having the warehouse transaction, a time stamp as the receipt date, and a warehouse hash to the computer network, and adding the warehouse block to the respective blockchain in the computer of the computer network to document the receipt; Further comprising: 7. A computer-implemented medical tracking method according to any one of items 2 to 6. (Item 8) 8. A computer-readable storage medium containing instructions that, when executed by a computer, cause the computer to perform the tracking method of any one of items 1 to 7. (Item 9) A medical tracking system for secure tracking of at least one disposable medical product (220), comprising: a disposable medical product (220) to be tracked, having bijective identification information, in particular a bijective serial number; at least one detection unit, in particular a read-out device, adapted to detect said identification information of said disposable medical product (220) and to provide said identification information in a computer-readable format; a computer network having at least three computers, in each of which a digital tracking book having a directory of information blocks related to said at least one disposable medical product (220) is stored in a distributed manner as a blockchain, in particular at least said unique identification information of said at least one disposable medical product (220) and an associated first hash are stored in a first block; an application module adapted to transmit an application transaction for the disposable medical product (220) to the computer network in response to detection of the disposable medical product (220) for application by the detection unit; a block generation module adapted to create an application block having a time stamp, the application transaction, and the application hash based on the application transaction and the first hash, make the application block available to the computer network, and add the application block to the respective blockchain in the computer of the computer network; a tracking module adapted to read the block chain for the at least one disposable medical product (220), detect existing application blocks in the block chain, and, if application is detected again, issue an alarm and / or lock the application of the disposable medical product (220), Medical tracking system. (Item 10) said identification information, in particular said serial number and / or QR code, being printed on said disposable medical product (220); 10. The medical tracking system according to item 9, characterized in that the detection unit comprises an optical detection unit, in particular a camera, and / or the identification information, in particular the serial number, is stored in an RFID tag of the disposable medical product (220), and the detection unit comprises an RFID reader. (Item 11) 11. The medical tracking system according to item 9 or 10, characterized in that the at least one disposable medical product (220) is a medical, in particular a surgical, instrument and / or a sieve, and / or a medical holder and / or a motorized medical device. (Item 12) 12. The medical tracking system according to any one of items 9 to 11, characterized in that in addition to the unique identification information, a minimum durability date for the disposable medical product (220) is also stored in the first block, and the tracking module is adapted to compare the time stamp with the minimum durability date in the case of application of the disposable medical product (220) and to issue an alarm and / or lock the application of the disposable medical product (220) if the minimum durability date is exceeded. (Item 13) the disposable medical product (220) is an electrically powered medical device; the tracking module is adapted to interrupt the power supply to the disposable medical product (220) and lock the application in response to repeated applications or exceeding a minimum durability period of the disposable medical product (220), 13. The medical tracking system according to item 11 or 12. (Item 14) The tracking system further comprises a central database having at least one database entry, in particular a file, particularly preferably medical documentation for the disposable medical product (220), and / or text stored as a database entry, stored for the disposable medical product (220), for which an entry hash is generated; The entry hash is stored in the blockchain to protect the database entry from manipulation via the entry hash. 14. A medical tracking system according to any one of items 9 to 13. (Item 15) A device (200) for storing usage data (210) of a medical product (220), comprising: a detection unit (201) configured to detect application of said medical product (220); a data processing unit (202) configured to generate said application data (210) related to said detected application of said product (220); a storage unit (203) configured to store the application data (210) in a data set (230) in a format that cannot be retroactively modified; The dataset (230) is characterized by using blockchain technology. device.

Claims

1. 1. A computer-implemented medical tracking method executed by a computer for secure tracking and storage of application data of at least one disposable medical product, said tracking method comprising: Detecting application of the at least one disposable medical product, wherein the bijective identification information of the at least one disposable medical product is detected; creating application data relating to the detected application of the at least one disposable medical product, the application data comprising: calculating a first hash value based on the bijective identification information; Storing the application data in a data set using blockchain technology in a format that cannot be retroactively modified, wherein a first block having the detected bijective identification information and the calculated first hash value is stored in a blockchain on each computer of a computer network comprising at least three computers; detecting application of the disposable medical product by a detection unit and transmitting an application transaction to the computer network; Checking by a tracking module whether there is an application block for the detected disposable medical product in the blockchain; If an application block does not yet exist, generating, by a block generation module, an application block having the first hash value, a time stamp, the application transaction, and an application hash based on the application transaction, and providing the application block to the computer network to add the application block to the blockchain within each of the computers in the computer network; if an application block is present, issuing an alarm and / or inhibiting the function of said disposable medical product; characterized in that it comprises A computer-implemented medical tracking method.

2. The tracking method includes: storing in said first block a minimum durability date of said at least one disposable medical product; In addition to the step of detecting the application, the method further includes a step of comparing the time stamp with the stored minimum durability date, and issuing the alarm and / or inhibiting the function of the disposable medical product when the minimum durability date is exceeded.

10. The computer-implemented medical tracking method of claim 1.

3. 3. The computer-implemented medical tracking method of claim 1 or 2, wherein the tracking method comprises, if the disposable medical product is an electrically powered medical device, interrupting the function of the disposable medical product by interrupting its power supply.

4. The tracking method includes: after issuing the alarm and / or inhibiting the function of the disposable medical product, requesting a user to perform a confirmation input via an input device to confirm that the disposable medical product should be used again; detecting said confirmation input by said user; generating an alert block having a time stamp, an alert transaction, and an alert hash, and providing the alert block to the computer network to add the alert block to the respective blockchains in the computers of the computer network, documenting the repeated application; Further comprising: A computer-implemented medical tracking method according to any one of claims 1 to 3.

5. The tracking method includes: storing, in addition to the bijective identification information having a serial number, a unique control number associated with the serial number as an alphanumeric code within the first block generated by a predetermined, private algorithm; When detecting the application of the disposable medical product, verifying the serial number and the control number associated with the serial number, and determining that the disposable medical product is counterfeit if the control number does not match the serial number; Further comprising: A computer-implemented medical tracking method according to any one of claims 1 to 4.

6. The tracking method includes: detecting an entry by detecting the bijective identification information of the disposable medical product with an entry detection device; generating and providing a warehouse block having the warehouse transaction, a time stamp as the receipt date, and a warehouse hash to the computer network, and adding the warehouse block to the respective blockchain in the computer of the computer network to document the receipt; Further comprising: A computer-implemented medical tracking method according to any one of claims 1 to 5.

7. 1. A medical tracking system for secure tracking of at least one disposable medical product, comprising: a disposable medical product to be tracked having bijective identification information; at least one detection unit adapted to detect the bijective identification information of the disposable medical product and provide the bijective identification information in a computer readable format; a computer network having at least three computers, in each of which a digital trackbook having a directory of information blocks related to the at least one disposable medical product is decentralized and stored as a blockchain; an application module adapted to transmit an application transaction for the disposable medical product to the computer network in response to detection of the disposable medical product for application by the detection unit; a block generation module adapted to create an application block having a time stamp, the application transaction, and an application hash based on a first hash value calculated based on the application transaction and the bijective identity, make the application block available to the computer network, and add the application block to the respective blockchain in the computer of the computer network; a tracking module adapted to read the block chain for the at least one disposable medical product, detect existing application blocks in the block chain, and issue an alarm and / or prevent application of the disposable medical product if application is detected again; Medical tracking system.

8. the bijective identification information is printed on the disposable medical product; 8. The medical tracking system of claim 7, wherein the detection unit comprises an optical detection unit, and / or the bijective identification information is stored in an RFID tag of the disposable medical product, and the detection unit comprises an RFID reader.

9. 9. The medical tracking system according to claim 7 or 8, characterized in that the at least one disposable medical product is a medical instrument and / or a sieve, and / or a medical holder and / or a powered medical device.

10. 10. The medical tracking system according to claim 7, wherein in addition to the bijective identification information, a minimum durability date for the disposable medical product is also stored in the first block, and the tracking module is adapted to compare the time stamp with the minimum durability date in the case of application of the disposable medical product, and to issue an alarm and / or prevent application of the disposable medical product if the minimum durability date is exceeded.

11. the disposable medical product is an electrically powered medical device; The tracking module is adapted to interrupt the power supply to the disposable medical product to prevent application in response to repeated applications or exceeding a minimum durability date of the disposable medical product. A medical tracking system according to claim 9 or 10.

12. The tracking system further comprises a central database having at least one database entry stored for the disposable medical product, an entry hash being generated for the database entry; The entry hash is stored in the blockchain to protect the database entry from manipulation via the entry hash. A medical tracking system according to any one of claims 7 to 11.

13. A device for storing application data for at least one disposable medical product, comprising: a detection unit configured to detect application of the at least one disposable medical product, the detection unit detecting bijective identification information of the at least one disposable medical product; a data processing unit configured to generate application data related to the detected application of the at least one disposable medical product, the data processing unit calculating a first hash value based on the bijective identification information; a storage unit configured to store the application data in a data set using blockchain technology in a format that cannot be retroactively modified, the storage unit storing a first block having the detected bijective identification information and the calculated first hash value in a blockchain on each computer of a computer network comprising at least three computers; an application module that detects application of the disposable medical product by a detection unit and transmits an application transaction to the computer network; a tracking module that checks whether an application block for the detected disposable medical product exists in the blockchain; a block generation module that, if an application block does not yet exist, generates an application block having the first hash value, a time stamp, the application transaction, and an application hash based on the application transaction, and provides the application block to the computer network to add the application block to the blockchain within each of the computers in the computer network; Equipped with the tracking module issues an alarm and / or prevents the disposable medical product from functioning if an application block is present; device.

14. 13. The medical tracking system of claim 7, wherein at least the bijective identification information of the at least one disposable medical product and the associated first hash value are stored in a first block.

15. The medical tracking system of claim 8 , wherein the bijective identification information is a serial number and / or a QR code.

16. 13. The medical tracking system of claim 12, wherein the at least one database entry for the disposable medical product is a medical document for the disposable medical product.

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