EP4232977A1

EP4232977A1 - Method, apparatus and system for storing usage data and tracking a medical product

Info

Publication number: EP4232977A1
Application number: EP21794864.5A
Authority: EP
Inventors: Frederick Lenzenhuber
Original assignee: Aesculap AG
Current assignee: Aesculap AG
Priority date: 2020-10-21
Filing date: 2021-10-20
Publication date: 2023-08-30
Also published as: US20240021278A1; WO2022084414A1; CN116419729A; EP3989137A1; JP2023547848A

Abstract

The present invention relates to a computer-implemented tracking method, an apparatus and a tracking system for storing usage data of a medical product, comprising detecting usage of the medical product, creating the usage data which relate to the detected usage of the medical product, and storing the usage data in a data record in a form which cannot be modified retrospectively, specifically in a blockchain. In addition, the present invention relates to a tracking system, an apparatus and a computer-readable storage medium according to the additional independent claims.

Description

METHOD, DEVICE AND SYSTEM FOR STORING USAGE DATA AND TRACKING A MEDICAL DEVICE

FIELD OF THE INVENTION

The present invention relates generally to the use of medical devices. In particular, the storage of data about their use in a forgery-proof manner is described, at least in the currently technically generally possible and economically sensible framework. The present disclosure relates in particular to a tracking system for securely and reliably tracking at least one disposable medical device and a tracking method according to the preambles of the independent claims.

BACKGROUND OF THE INVENTION

The following description of the prior art is intended to provide a better understanding of the invention and in particular the advantages of the invention.

At present, it is difficult to ensure the limited re-use of medical devices, in particular only a single use for reasons of hygiene or contamination, or only a certain number of re-uses for reasons of wear and tear or durability. Accidental use beyond the permitted use may occur inadvertently unless proper label, instructions for use or labeling and other precautions that may be taken for the products are followed.

In addition, with the available state of the art, unintentional or intentional use beyond the permitted use cannot be ruled out and cannot be traced afterwards. Identifying such Unintentional or intentional use beyond the permitted use can only take place on the basis of indications such as signs of wear and customer statements.

Currently existing and used database solutions such as SQL, MYSQL, SAP, Oracle, etc. only insufficiently meet the requirement for the content to be unfalsifiable. The data in such databases can under certain circumstances be changed at will at any time, even if the need for administration rights to make such changes provides a certain level of security, it is not clear from the data whether the stored data is correct.

In addition, the prior art solutions are to some extent vulnerable to attacks by third parties and thus potentially forgeable.

SUMMARY OF THE INVENTION

The object of the invention is to overcome or at least mitigate the above-described disadvantages of the prior art, improve the prior art, and/or at least offer a useful alternative to the existing prior art. In particular, an object of the present invention is to be seen as providing a (tracking) method, a (tracking) device and a (tracking) system for tracking a medical product, which a medical product to be tracked, in particular a disposable medical product, safely and unfalsifiably tracked in order to ensure or at least support a limited number of uses of this medical device, to be able to make a reliable statement about a (usage) condition of a medical device and to increase patient safety. In particular, the historical course of a medical product should be documented with the data being unfalsifiable. Another subtask can be seen in ensuring that a medical product is protected against counterfeiting.

The present invention solves the above problem by the subject matter or by the features of the independent patent claims. The present invention solves the problem with regard to a tracking method according to the invention by the features of claim 1, with regard to a computer-readable storage medium according to the invention by the features of claim 8, with regard to a tracking system according to the invention by the features of claim 9 and with regard to a device according to the invention by the features of claim 15 Advantageous developments can be found in the respective dependent patent claims.

In particular, the present invention achieves the object by detecting use/use of the product, creating usage data/usage data relating to the detected use of the product, and storing the usage data in a data set in a form that cannot be modified later. A “subsequently non-modifiable form” is to be understood in particular as a form of storage that cannot be changed from an economic point of view, for example because the effort involved in making a change is uneconomically large. According to the invention, blockchain technology is used to store the usage data in the data set, which effectively prevents subsequent modification of the data. By storing the data set as a blockchain data set, decentralized storage can be implemented, which means that storage can be secured against the failure of individual servers. Especially in the field of medical products, a high level of reliability is an advantage. In addition, it must be possible to ensure that the storage of the data set and an evaluation of already stored data sets can also be implemented decentrally without a permanent connection to a server. This can be achieved by having the record use the blockchain Technology is used without the risk of subsequent modifications increasing at the same time.

In particular, the object is achieved by providing a medical tracking system for secure tracking of at least one single-use medical device, with: a single-use medical device to be tracked, which has a unique (i.e. only assigned once) identification, in particular a unique serial number and /or has an ID element; at least one detection unit, in particular a reading device, which is adapted to detect the identification of the disposable medical product and to make it available in computer-readable form; a computer network with at least three computers/data processing units/nodes, on each of which a digital tracking book with a directory of blocks of information on the at least one disposable medical device is stored decentrally as/in the form of a blockchain, with at least in a first (genesis) block the unique identification (or identification data) of the at least one disposable medical product and a first (cryptological) hash (in particular as a checksum) are stored; a usage module adapted to send a usage transaction for the single-use medical device to the computer network upon detection of the single-use medical device by the detection unit/device (prior to or upon use); a block generation module adapted to create (based on the usage transaction) a usage block with (the first hash), a timestamp, the usage transaction and a usage s hash and make it available to the computing network to run this usage block on the computers add the computer network to the blockchain; and a tracking (alarm) module, which is adapted to read out the blockchain for the at least one single-use medical device and to detect an existing use block in the blockchain and, in the event of renewed use (i.e. the presence of a use block with

usage transaction for the medical device) to issue an alarm and/or to block the use of the single-use medical device. In this way it can be ensured (particularly by the manufacturer) or at least supported that the single-use medical device is used only once and that a requirement for a sterile standard is complied with, for example. In particular, the output of the alarm is appended as an alarm transaction in the blockchain to ensure secure documentation of a user warning and to have clear evidence.

According to one embodiment, the identification, in particular the serial number and/or a QR code, can be engraved in the disposable medical device, in particular have a laser inscription (be lasered in), and the detection unit can have and/or an optical detection unit, in particular a camera the identification, in particular the serial number, can be stored in a REID tag of the disposable medical device and the

Recording unit have an RFID reader / RFID reader. In this way, the identification is inextricably linked and stored in the single-use medical device and can be read by a compatible reader/reader. In the case of the engraved serial number and an RFID tag, which is preferably sealed off from the environment, a requirement for sterility of the medical product can be ensured and, in particular, read out using a contactless reader. Security is further increased.

According to a further embodiment, the at least one disposable medical product can be a medical, in particular surgical, instrument and/or a perforated basket and/or a holder and/or an electrically operated medical device. A complete and secure follow-up is particularly important in these cases and can be efficiently implemented using the follow-up system. A (disposable) surgical instrument, for example, should be used during the operation and then no longer used. For this purpose, the instrument is recorded by the registration unit before it is used and the usage transaction is added according to the blockchain. In the case of renewed (inadmissible) use of the Instrument by recording via the recording unit, the usage transaction is read in the blockchain and it is determined that the instrument can no longer be used. In a further preferred embodiment, it can be provided that a sterilization transaction is written to the blockchain when the medical device has been sterilized, and the tracking module reads the blockchain and determines that there is no use in a use transaction with a sterilization transaction following the use transaction and a new one Use is permitted without issuing an alert and/or barring use. In this way, the sterility of the medical product is always ensured.

The disposable medical product can preferably be an electrically operated medical device and the tracking module can be adapted to interrupt an electrical power supply to the disposable medical product when it is used again or when a usage transaction for this medical product is read out. In this way, unintentional use of a non-sterile single-use product is reliably prevented.

Furthermore, the tracking system can preferably have a display device on which an alarm is output visually as soon as renewed use of the medical product has been detected. In particular, a user must make an entry, in particular on a touch display of the tracking system, in order to be able to continue using the medical product, in particular an electrically operated medical device, contrary to the warning, for example if the medical product is to be used again due to an emergency. A corresponding transaction can be recorded in the blockchain of the computer network. In this way, it is also documented if a single-use medical device is used several times contrary to a specification. In addition to the visual alarm, an acoustic alarm can also be output via a loudspeaker. According to one embodiment, the tracking system has a central database on at least one computer, in which additional entries/data on the at least one single-use medical product are stored. In particular, data such as operating instructions or sterilization instructions for the medical device are stored in the database, with a unique hash value (entry hash) being generated for the entries/data, in particular the operating instructions, which is stored in the blockchain for the medical device in order to ensure that the data stored in the database is protected against forgery. Since only limited amounts of data can be stored in the blockchain, a file (data) such as instructions, an image of the medical device or documentation is stored in a standard database, for example, to this file (as data) using a hash procedure a ( Entry) hash is generated as a type of certificate signature and this unique (entry) hash is stored in the blockchain for the medical device. If, for example, an instruction in the central database is changed (even just a single bit), the entire hash changes and no longer matches the authentic hash of the blockchain. In this way, manipulation can be prevented by appropriate checking. In this way, important data with large file sizes can be stored centrally and protected against falsification via the entries (hashes) of or in the blockchain. A hash value is a short character string that only requires a few bytes of storage space and can be efficiently updated in the blockchain.

Preferably, in addition to the unique identification of the at least one single-use medical device, a best-before date (MHD) can also be stored in the first (genesis) block and the tracking module can be adapted to compare the best-before date with the current date when it is recorded by the recording unit and to issue an alarm and/or to block the use of the medical device if the BBD is exceeded. In addition, an article number for allocation of the medical device can be stored in the (genesis) block. In particular, the use module can be adapted to add a dead-end marker to the corresponding medical device of the blockchain in addition to the use transaction, in order to reliably and quickly recognize that the corresponding medical device can no longer be used when it is used again. In particular, the usage module can add a dead-end marker to the blockchain if the best-before date is exceeded.

According to a further embodiment, a warehouse entry detection device can record the unique identification of the medical device and add a warehouse transaction with a warehouse entry date (as a time stamp) in the blockchain to the medical device in order to document a warehouse entry. In particular, the warehouse entry detection device is adapted to determine that it is a location of a warehouse (rather than a location of use) via a data connection to a warehouse data hotspot.

According to a further embodiment, a sales detection device can capture the unique identification of the medical device and the tracking system can add a sales transaction to the medical device with a sale date (as a time stamp) and also preferably a customer number in the blockchain in order to document a sale of the medical device .

According to a further embodiment, a shipping detection device can capture the unique identification of the medical device and add a shipping transaction with a shipping date (as a time stamp) to the medical device in the blockchain in order to document a shipping of the medical device. With these recording devices and the respective transactions stored in the blockchain, it is possible to securely and clearly document and track the entire path of the medical device from manufacture to use. In particular, the tracking system may be adapted to determine a location of the sensing device in order to perform a transaction corresponding to the location via the location. If, for example, a medical product is scanned by the reader in the warehouse, the reader determines its location in the warehouse (e.g. via a localization system (GPS) or a data connection (WLAN hotspot warehouse)) and then carries out a warehouse access transaction. In this way, the individual stations of the medical product can be recorded with a standardized recording device, with the recording device being assigned as a warehouse entry recording device.

In particular, the tracking system for a temporary interruption in the connection to the computer network with the (main) blockchain can have a side chain in which a usage transaction is temporarily written and when a connection is established to the computer network with the (main) blockchain the stored transactions (with a time delay) in be written to the blockchain.

Furthermore, the object with regard to a (tracking) method is achieved in particular by providing a computer-implemented medical tracking method for reliable tracking of at least one disposable medical device, in particular for a medical tracking system according to the present disclosure, with the steps: detecting a one-to-one Identification of a disposable medical device by a detection device; calculating, based on the unique identifier, a first hash value; storing a first (genesis) block with the detected identification in a blockchain on each computer of a computer network with at least three computers; detecting a usage of the disposable medical device by a detection device and sending a usage transaction to the computing network; Checking whether there is a usage block in the blockchain for the single-use medical device; If there is no usage block yet: Generate based on the usage transaction of a usage block with the first hash, a timestamp, the usage transaction and a usage hash and provide to the computer network to add this usage block in the computers of the computer network respectively to the blockchain; and If there is a block of use: issuing an alarm and/or blocking a functionality of the single-use medical device.

According to a preferred embodiment, an NFT (non-fungible token) can be stored as a digital twin in the blockchain. As soon as an article number and a serial number of the medical device are known, the digital twin can be created and tracked. In a first step, a digital twin is stored in the blockchain, in particular with at least the article number, the serial number and a UID. In particular, a sterilization time stamp can be stored in a sterilization step.

In particular, at least one or a combination of the following time stamps can be stored with the corresponding transaction:

- start of production, - end of production, - quality control, - delivery to the warehouse, - sale, in particular with customer ID, - packaging, - shipping, and/or arrival.

According to a further preferred embodiment, at least one or a combination of the following time stamps can also be stored with the corresponding transaction:

- CSSD supply, - manual pre-cleaning, - cleaning in the RDG care, - packing the sieve, - packaging in the sterile container and/or sterile sieve (basket), - sterilization, - provision of the OP.

According to one embodiment, the tracking system can record the use of the single-use medical product by reading in the unique identification by the registration unit and by a stored association of the registration device as a usage registration device with the use. According to a further embodiment, the tracking method can also have the steps: In addition to the unique identification with a unique serial number: storing a unique control number associated with the serial number in the first block, which was generated as an alphanumeric number code by a specified, non-public algorithm When detecting the use of the disposable medical device: checking the serial number and the control number associated with the serial number and determining that the disposable medical device is counterfeit if the control number does not match the serial number. The serial number is encrypted using a private and publicly unknown algorithm and an associated control number is created, which is also stored in the blockchain. A corresponding test algorithm can be used to check whether the control number actually matches the serial number. This prevents counterfeiting with a consecutive serial number, since an "encrypted" and changing control number is required in addition to the consecutive serial number.

The usage data can also be transferred from the product being used to one or more computers and stored there. A computer is to be understood as meaning any type of data processing device.

In this case, the blockchain data record can be integrated into an existing data construct on the one or more computers, which can also be based on blockchain.

The storage on the product or the computers can be carried out in different ways. It is possible that the storage locations are all non-public, eg within a company or a hospital. However, the computers can also be arranged in a distributed, non-public manner, for example with the manufacturer, service partner and user of the product. Or, the storage is carried out in a publicly accessible DLT. The data transmission used here can be accomplished, for example, by various technologies: Bluetooth, IR, LAN, WLAN, loT, mobile radio, eg 2G, 3G, 4G, 5G, GSM and/or LTE, LoRaWAN (Low Range Wide Area Network). However, other wired or wireless protocols or transmission technologies can also 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.

Additional information can also be stored in the stored data sets or data constructs. In particular, information about the article and/or serial number of the product and/or a permitted use, such as an expiry date after which the product may no longer be used, or a permitted number of uses is stored in the data records. This information can either be written into the data construct when the product is manufactured, or it can be recorded when the use is recorded and then saved in the data record. Other information that can be stored is, for example, information relating to dates of manufacture, storage, shipping, sale of the product.

With the additionally stored data, it can be determined when a request is made to use the product whether this requested use is permitted or constitutes unauthorized use. This is done by evaluating the data stored in the data set and/or the data construct. For medical devices, storage in the form of a blockchain is a particularly advantageous embodiment.

If it is determined that further use is unauthorized use, the unauthorized use can be recorded in a forgery-proof manner. Alternatively or additionally, a signal can be output, for example acoustically and/or optically. Furthermore, additionally or alternatively, data can be transmitted at a trigger such a signal or cause a notification there on another device. Furthermore, as an alternative or in addition, a request can be issued and the product can only be released for use after confirmation of the request, for example by a user. This enables emergency use, for example, so that a product that is actually no longer usable can still be used. Reasons for this can be, for example, that there is no unused product or a product that can be used within the usage parameters. Finally, alternatively or additionally, the product can be blocked for the requested further use, so that it cannot be used for the use determined as unauthorized use. This can increase overall safety, since a product can possibly pose a safety risk after reaching the permitted usage times or number of uses, since the cutting edges of cutting tools, for example, can potentially cause damage.

Further advantages of the invention consist in the forgery-proof documentation of the use of products. As a result, unauthorized use can be detected and, by preventing such use, general safety during use can be increased.

Any disclosure related to the (tracking) method of the present disclosure also applies to the (tracking) system according to the present disclosure and vice versa.

BRIEF DESCRIPTION OF THE FIGURES

The above summary, as well as other objects, features and advantages of the present invention are further explained by and with reference to the following drawing figures in order to provide a better understanding of the invention. The same reference symbols denote the same elements therein.

Show it: FIGS. 1 to 4 flow charts of a method according to preferred embodiments;

FIGS. 5 to 8 show schematic views of devices and systems of preferred embodiments;

FIG. 9 shows a flow chart of a method according to a preferred embodiment with additional data.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In order to ensure this limitation for products that are only to be used a certain number of times or only in a certain period of time, or similar, proof of use is required. Ideally, such proof is forgery-proof so that uses cannot be added, deleted or changed afterwards. In order to fulfill the aspect of verified evidence and to be able to publish reliable information as a manufacturer as well as a customer of a product (e.g. quality management in a hospital, materials management in companies, or similar), and thereby increase legal certainty for critical uses, a solution is proposed which ensures that the data cannot be falsified in the form of logs and thus documents the usage historically and reliably. The manufacturer of the product, the user(s) of the product, i.e. those who use it directly, are usually interested in the use of products, but also possibly all those involved in the supply chain between manufacturer and user. These can be dealers, but also possibly intermediate stations such as material storage points and central administration points, e.g. in a hospital association. In the following, manufacturers and users are also covered by the term “participants”.

A so-called distributed ledger technology (short

DLT, English for technology of distributed cash books) is used, which is briefly described below is explained. DLT is used for documenting certain transactions. In contrast to the classic approach, in which a general ledger is usually managed by just one instance, here any number of copies of the ledger, which are in principle equal, are maintained decentrally by different parties. Appropriate measures are taken to ensure that new transactions to be added are adopted in all copies of the ledger and that there is agreement (consensus) on the current status of the ledger.

DLT is a form of blockchain, others are e.g. Tangle. The generic term blockchain is used below, but the invention can also be implemented with any other blockchain technology.

This solution has the following exemplary advantages, among others. By using the blockchain, a user (e.g. manufacturer, user or retailer, etc.) can validly determine and log whether a product has been used more than the specified maximum number of uses. For example, it can be determined whether a single-use item (a product that may only be used once for hygienic reasons, for example) has been used several times. The user can also ensure that the products are only used once. This can be done by blocking (e.g. live devices) or by signals (e.g. acoustic, optical signals) or a prompt in a computer dialog. Such information or signals can, for example, be sent to computers, mobile devices, software that is operated on such (e.g. programs on computers, apps on mobile devices), displays on control devices for the products or other information channels. Various transport protocols can be used for this. For example: SMS, e-mail, TCP/IP etc, or data transmission via Bluetooth, IR, LAN, WLAN, loT, mobile radio, e.g. 2G, 3G, 4G, 5G, GSM and/or LTE, LoRaWAN. Communication can also take place either directly or via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and/or the Internet. By securely logging usage, everyone involved can ensure or even increase their quality and avoid accidental multiple use or too frequent use of products and present valid data and evidence to monitoring institutions or authorities.

Tamper-proof logging is a future-oriented technology and any party using such logging is prepared for the future requirements. Everyone involved can establish themselves as participants in a blockchain and thus increase their reputation with institutions and authorities. This may be decisive for the economic award of orders. A falsification of data can no longer occur through use, since the history is mapped via the respective blocks. In addition, application cycles can also be logged validly and immutably for reusable products.

Previous solutions include logging or logging of usage data in traditional databases such as mysql, sql, etc. Some of these are cloud-based. As a rule, such solutions have no security against forgery. The data may also be entered into such databases by users themselves and are therefore also subject to errors in data acquisition and/or data entry. In addition, data in such databases can be changed by IT administrators (with so-called administration rights, i.e. extended access to the data) or by unwanted access (e.g. attacks) by third parties. Under certain circumstances, such changes can only be noticed relatively late, so that countermeasures can then only be initiated with a time delay. Overall, this leads to a high administration and monitoring effort. Likewise, fraudulent intentions regarding

There are no limits to database changes and data manipulation with sufficient criminal energy. In order to strengthen the integrity of those involved in relation to institutions and authorities, the use of the blockchain is an advantageous approach.

Products with limited use, in particular single-use products, are provided by the customer for the intended, e.g. one-off, use and are usually marked or described accordingly. Single-use products can be marked with a crossed-out number 2, for example.

This symbol can be found, for example, on product packaging, labels, on the products themselves, instructions for use and other suitable places that may be required.

The solution is shown below using a tool as an example, but is not limited to this alone. Rather, the discussion extends to any single use or limited use product.

In general, the invention presupposes that products can be recorded and recognized electronically. This is described in the prior art, e.g

DE 102018133503 A1, DE 102018126969 A1, DE 102018121682 A1

So-called smart hubs, mobile hotspots, data gates, access points, repeaters, etc. are also known from the prior art, which offer a connection between devices and/or to the Internet.

This ensures basic availability and accessibility of services on the Internet and/or for other parties involved. Examples of such devices include mobile hotspots over the mobile network (5G, 4G, 3G, dual-band, etc.), basic devices for loT devices, smartphones or WLAN routers that can establish a hotspot, LoRaWAN that uses a technology that is known alongside 5G as a one of the possible bases for IOT devices to be established, and the like. In addition, the functionality of being able to communicate with at least one blockchain and to carry out transactions or to be able to insert information (in blocks) is described.

In general, the entire life cycle of a product, possibly with sub-process steps, can be logged in the blockchain.

Some possible phases of the life cycle are described below as examples. These are shown in FIG. The content of the stored data is displayed as an example for each phase. The data given in FIG. 9 are for illustration purposes only; further data can be stored, as explained in this description; data can also possibly be omitted, depending on the respective application.

Phase 1 is the manufacture of the product. During the manufacturing process, the product is manufactured and finally equipped with data. This happens in the form of laser inscription or writing to data storage devices, or something similar. Such processes are described, for example, in DE 102018125884. According to the present description, for example, an article number, e.g. GP111SU, a unique serial number e.g. SN0001020, optionally including a uniquely assigned data sequence, e.g. a NONE COPY IDENTIFICATION, NCID for short, which can optionally also be encrypted and/or a best before date, eg: 2019-09 for September 2019, can be logged. One or more of this information can also indicate, for example, that the product is intended for single use only. This can be indicated, for example, via the letter combination SU in the article or serial number. Optionally, data can also be stored separately, showing the property single use, reusable, the number of permitted uses or the period of permitted use. In this way it is also possible to count the application cycles. Phase 2 describes the warehousing of the product. In this case, data is added to the data record that has already been logged, which, for example, indicates the day of stock entry and thus the salability. This data is written to the blockchain in addition to the already existing data package. Other information describing the access to the warehouse and the previously covered routes and intermediate stations of the product is also possible, e.g. date of dispatch from the factory, indication of the transport phase, number and number of intermediate stations, transport duration, distance traveled by the product, etc.

Phase 3 describes the sale of the product. Here, data is added to the data record that has already been logged, which, for example, shows the time the product was placed on the market. This can be done as just a tag or with additional information such as time, location, time zone, etc. This data is written to the blockchain in addition to the already existing data package. Other information is also possible, e.g. price, number and number of owners, identification of the owner, identification of the buyer, identification of the seller, etc. The identifications described above can also be carried out in the case of desired anonymity via encrypted ID data, e.g. numbers, symbols, and the like that are only known to a limited extent, e.g. only to the manufacturer or only to public authorities.

Phase 4 describes the shipping of the product. In this case, data is added to the data record that has already been logged, which, for example, shows the time of dispatch. This can be done as just a tag or with additional information such as time, location, time zone, etc. This data is written to the blockchain in addition to the already existing data package. Further information is also possible, e.g. day of earlier dispatch, indication of the transport phase, number and number of intermediate stations, transport duration, distance covered by the product, identification of the sender, identification of the recipient, transport restrictions, such as fragile or no air freight increased by a to avoid air pressure, etc. The identifications described above can also be carried out in the case of desired anonymity via encrypted ID data, eg numbers, symbols, and the like, which are only known to a limited extent, eg only to the manufacturer or only to public authorities.

Phase 5 describes the actual use of the product. Here, data is added to the data record that has already been logged, which, for example, shows the time of use. This can be done as just a tag or with additional information such as time, location, time zone, etc. This data is written to the blockchain in addition to the already existing data package. Further information is also possible, e.g. writing out temporarily stored usage data in the device since the last connection to the recording unit, identification of the person or device using, which can be recorded, e.g. via identification before use, further data on use, i.e. type of use, duration of use Usage, number and number of usages, number of switching on and off processes or actions performed during usage. If anonymity is desired, the identifications described above can also be made using encrypted ID data, e.g. numbers, symbols and the like, which are only known to a limited extent, e.g. only to the manufacturer, the owner, or only to public authorities.

Phase 6 describes the end of the life cycle. It is determined, e.g. by the product itself or another device, based on the previously stored data, e.g. number and/or number of uses already stored, daily data of the stored uses, etc. that the end of the product's life cycle has been reached.

The product is thus marked as expired, and it is therefore valid that this product should be disposed of and should not be used again. The time at which the product was marked as "expired" can also be recorded. If corresponding data is stored in the blockchain for the product, the use can also be saved in phase 5 with a special mark, e.g. as off-label use, and/or the product can be blocked for use if the technical possibilities for this are available. For example, if a product marked as "expired" were recorded again in a usage environment on a later day or after a defined period of time, off-label use can be determined as mentioned above. This reduces both patient and user risk.

The blocking of the product or the interposition of a security query before use can now be prescribed for the product. In the case of devices with a power supply, for example, connection can be technically prevented.

In order to still enable emergency operation, a user could confirm the interposed request, which in turn could be stored in phase 5 via additional data in the data record in the blockchain. This can in turn be done with the identification of the user or the device used as described above. Otherwise a product would have to be used whose life cycle has not yet reached the end.

In this case, there are several alternative options:

The user is not informed. Off-label use is only logged. The relevant party, e.g. the company or institution where the product is in use, can view the product data in the blockchain and determine if a product has been used several times. If necessary, a quality assurance officer can then intervene and have the product removed from the cycle.

During use or at the start of use of the specific product, the user receives information that indicates the end of the life cycle. This can be done via an audible or visual display on the product or on a suitable device involved in its use. Such suitable output units can be, for example, the following: tablet, control device, smart watch, display, screen in the usage space and all suitable output devices. If necessary, the reference to permitted use can be made together with an indication of whether the product is at all suitable for the intended use.

A corresponding note can also be output elsewhere. Either on an output device at a central monitoring point or as feedback to the manufacturer. From there, a service technician or sales person can be sent to the customer to advise on the use.

The same or similar data as described above can be stored in the blockchain for the further course of the life cycle, such as return, maintenance, reprocessing, recycling and/or disposal.

For all exemplary phases described above, the product for storing the data is usually read by an electronic reader. This can be done, for example, by reading a barcode, in 2D or 3D, or an NFC (Near Field Communication) tag on the product, the outer packaging or the shipping packaging. Allocation via the shipping packaging via an intermediate database query is also possible.

This method of using DLT/Blockchain technology provides legal certainty and improves integrity towards institutions and authorities. The reputation of everyone involved who uses this solution also increases. This leads to an improved position with dealers, clients and end customers. The DLT or blockchain can be used in different variations. One possibility is a so-called private blockchain. Here, the blockchain is operated within a closed network within a company or institution and possibly kept redundantly on several servers. These servers are considered so-called nodes/masternodes. The block contents are therefore not visible to other parties outside the private network. Nevertheless, a corresponding data transfer can take place in order to be able to provide corresponding proof.

Another possibility is a semi-private blockchain. For example, the blockchain can be managed and operated jointly by two or more participants, i.e. it can be described. Alternatively, read-only access is also possible for some participants. An example here is the operation of the shared blockchain for users and manufacturers, so that, for example, a reorder of expired products can be automated. The block contents are therefore not visible to other parties outside the semi-private network. Nevertheless, a corresponding data transfer can take place in order to be able to provide corresponding proof.

Another possibility is a public blockchain. Here the blockchain is operated publicly and all those involved, possibly even those who are not involved, ie the public, can view the transactions, ie the block contents. The data that is written to it can be stored in plain text or in encrypted form, which in turn can create a certain degree of anonymity. For this purpose, for example: Mastemodes can be operated at the various company locations around the world. If necessary, customers are integrated into the network with their own mastemodes. Furthermore, an adaptation to an existing blockchain such as Ethereum, NEO, Cardano is conceivable in order to feed the data to be written there. There is also the option of recording and storing the use of products if there is no connection to the blockchain used temporarily or permanently, e.g. via the Internet in the event of a failure of the blockchain. This can be done, for example, with a so-called sidechain. A so-called sidechain can be established on the product or on a device that is in communicative connection with the product, parallel to the blockchain actually used. This can also happen ad hoc, i.e. without preparation, if a data communication error is detected. Thus, an independent, continuous blockchain can be operated locally, which first of all generates blocks locally and logs the resulting product uses locally, ie logs them.

If, in the case of a connection that was only temporarily interrupted, the connection should be restored, or in the case of a permanent missing connection, the connection, e.g. as part of maintenance, preventive maintenance, a service technician assignment, or another planned data transfer, can be established a connection to the actual blockchain, here the main blockchain, can be established and the data content of the sidechain can be transferred to the main blockchain or integrated into it. The data blocks of the sidechain are then stored as further blocks in the main blockchain, for example. This variant also enables products that are operated without a data connection, i.e. offline, to be integrated into the blockchain, albeit with a time delay. As a result, medical products can be used with a high level of availability without having to forego the advantages mentioned. Hardware requirements can be kept low because only one sidechain is generated and stored locally. There is no need for complex mechanisms for replication and synchronization of classic databases, which means that high availability can be achieved.

Another advantage of the solution is the increased security against counterfeit products. Data such as the serial number are combined with a unique control number, which is generated via an algorithm and consists, for example, of a unique alphanumeric number code, is stored for a product in the blockchain. If a counterfeit product with the same serial number and an attempted counterfeit control number is then identified, this product is declared as a counterfeit and the user or customer or the currently acting participant is informed and/or this is logged in the blockchain. Patient safety can be increased. Counterfeit products can also be detected using other methods, such as comparing checksums or comparing an attached encrypted data record (e.g. a control number) with one on a server (e.g. in the cloud, i.e. on a server that can be reached via data communication). remote storage) stored primary key. This can be used to determine whether the product is authentic or a fake. The encryption used can then be decoded with the primary key and compared with the previously stored data record (e.g. with the manufacturer or another participant in the supply chain). In this way, the authenticity can be verified and the potentially dangerous use of counterfeit products can be avoided.

The operation of databases does not exclude the use of blockchain technology. Both technologies can be used together. Blockchain, or more generally DLT, is in itself relatively unsuitable for storing large amounts of data, since the amount of data increases significantly as it is updated in blocks. Rather, a mixed database/blockchain solution should be sought for large amounts of data. Large amounts of data are saved and stored in the database. The associated blockchain, on the other hand, validates the stored status of the data and thus guarantees the authenticity and integrity of the data content. For example, a record is saved in the database. A checksum is generated and saved for the data record. The checksum itself is also logged in the blockchain to keep the data integrity unchangeable. This allows the data saved in the database to be verified. FIG. 1 shows an exemplary method 100 for storing usage data for a product. Here, in a first step 110, the usage is recorded first. This can be done by the product or a component thereof, or by an external device that records usage, e.g. by the product being within the detection range of the device, e.g. by means of WLAN, Bluetooth, or another wireless technology, or by the product the device transmits a corresponding signal. The detection can be done optically, eg by reading a bar code, in 2D or 3D on the product, or electronically, eg by NFC (Near Field Communication).

Subsequently, in step 120, the usage data relating to the recorded use of the product is created based on the recording. As described above, data can be recorded here, such as the time of use, just as a day or with additional information, such as time, location, time zone, etc. The usage data can also identify the person or device using it, e.g identification before use can be recorded, further data on use, i.e. type of use, duration of use, number and number of uses, number of switching on and off processes or actions carried out during use. If anonymity is desired, the identifications described above can also be made using encrypted ID data, e.g. numbers, symbols and the like, which are only known to a limited extent, e.g. only to the manufacturer, the owner, or only to public authorities. Step 120 may be performed by the product or component thereof, or by an external device that has sensed the usage or to which the sensing has been communicated.

In a next step 130, the usage data is then stored in a data set in a form that cannot be modified later. The form that cannot be subsequently modified is, for example, as described above, a DLT such as a blockchain. If necessary, the data record is added to existing ones blocks of data written to the blockchain. The writing 130 can also be performed by the product or a component thereof, or by an external device that created the usage data or to which the usage data was communicated. The writing can be performed on a memory located in the product or in a memory allocated to an external device.

FIG. 2 shows that the method 100 can include the previously described transmission 140 of the usage data to one or more computers, each with a memory, after the creation 120 and before the storage 130 . In this case, the storage in step 130 can then be carried out by one or more computers. Again, the writing can be performed on a memory located in the product or in a memory associated with an external device.

FIG. 3 shows that the method 100 can be carried out in such a way that the product is first saved in step 130 in its own memory and then a previously described method is followed by a transmission 150 of the data record to one or more computers which each have a memory, and then the data set is stored by one or more computers in its memory. Since the data record here already has the form that cannot be subsequently modified from step 130, i.e. it is available as a DLT or blockchain, this corresponds, for example, to the sidechain explained above. After the transfer 150 to an already existing data construct on the receiving computer, i.e. the main blockchain, for example, this could then be inserted. Alternatively, the computer could also only have a simple database in which the sidechain is stored for later use.

Figure 4 shows that the method 100 as previously described, in response to a request for further use of the product, may be followed by a step 170 of determining that the further use constitutes unauthorized use. This determination can be made, for example, by evaluating the data set and/or data stored in the data construct as previously described. This step can also take place in the product or in one of the devices or computers described above.

In the event that unauthorized use was determined in step 170, the method may follow one or more of the following steps. In a step 180, further use or the request for further use can be stored in the data record and/or the data construct. In a step 181, an optical and/or acoustic signal can be output. As previously described, this can be done on the product or at a location remote from the product. In a step 182, data may be transmitted, e.g., to a computer such as those previously described, where the data then causes a signal or notification to an external device. In a step 183, a request can be issued to a user, which the user must first confirm. The receipt of the release again occurs in step 185, and only then in step 184 is the release of the product effected. As previously described, the prompting and enabling may be performed by the product itself or by another device, such as a computer, as previously described. Finally, in step 186, the product can be blocked so that further use is not possible.

The steps described in connection with Figures 1 to 4, which include the transmission of data, can use one or more of the following technologies, for example: e.g. Bluetooth, IR, LAN, WLAN, loT, mobile radio, e.g. 2G, 3G, 4G, 5G, GSM and/or LTE, LoRaWAN, and either directly or via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and/or the Internet.

In the data sets and data constructs described in connection with FIGS. 1 to 4, which can each be implemented as a DLT or blockchain, one or more pieces of information can additionally be stored from: information regarding item, serial number of the product and/or a permitted use, such as an expiry date after which the product may no longer be used, or a permitted number of uses, the information being written into the data construct at the time of manufacture of the product or at the recording in step 110 of the use can also be recorded and then stored in the data record, or information regarding dates of manufacture, storage, shipping, sale of the product.

A system for data processing that includes a processor that can execute the method as described above is not shown. Also not described is a computer program product and/or computer-readable storage medium, each of which includes instructions that, when executed, implement the method as described above.

FIG. 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 use of the product 220 in the manner described above.

While in FIG. 5 the device 200 is a device independent of the product 220, FIG. However, the other relationships described above and below are generally equally applicable to the illustrations in FIGS.

If the device 200 is part of the product, the device 200 records the usage, e.g. by direct signal transmission within the product 220.

If the device 200 is not part of the product, use can be implemented, for example, by recognizing that the product is within the detection range of the device, for example by means of WLAN, Bluetooth, or another radio technology, or by the product of the device sends a corresponding signal. The detection can also be done optically, for example by reading a bar code, in 2D or 3D on the product, or electronically, for example by NFC (Near Field Communication).

Furthermore, the device 200 includes a data processing unit 202 which creates the usage data 210 relating to the recorded usage of the product 220 . Creation can be performed in the product or in an external device. As described above, data can be recorded here, such as the time of use, just as a day or with additional information, such as time, location, time zone, etc. The usage data can also identify the person or device using it, e.g identification before use can be recorded, further data on use, i.e. type of use, duration of use, number and number of uses, number of switching on and off processes or actions carried out during use. If anonymity is desired, the identifications described above can also be made using encrypted ID data, e.g. numbers, symbols and the like, which are only known to a limited extent, e.g. only to the manufacturer, the owner, or only to public authorities.

The device 200 also includes a memory unit 203, which stores the usage data 210 in a data record 230 in a form that cannot be modified later. The form that cannot be subsequently modified is, for example, a blockchain, as described above. If necessary, the data record is written to the blockchain in addition to existing data blocks. The storage unit can be part of the product or part of an external device that created the usage data or to which the usage data was communicated. The storing may be performed on a memory located in the product or in a memory associated with an external device.

It can further be seen that the device 200 may be part of a system 300, the system 300 further comprising one or more computers 240, one for each Memory 250. The device 200 then has a transmission unit 204 which transmits the usage data 210 to one or more of the computers 240. The receiving computers then store the usage data 210 in a data record 230 in a subsequently non-modifiable form, specifically a DLT or blockchain, in the respective memories 250, as described above.

In such a system 300, the device 200 can again be embodied as part of the product 220, or externally, as can be seen in FIG. 5 and FIG. 6, respectively. The transmission unit 204 can also transmit the data set 230 created in the device 200 to the one or more computers 240 .

In other words, if the device 200 creates the data record 230 from the usage data 210, then this data record 230 can be transmitted from the transmission unit 204 to the computer or computers 240 in order to be stored there or elsewhere. However, if the computer or computers 240 generate the data record 230 from the usage data 210, then the usage data 210 will be transmitted from the transmission unit 204 to the computer or computers 240 in order to be stored there or elsewhere in a data record 230.

If the finished data record 230 is transferred to the computer(s) 240, the computer(s) 240 can have a calculation unit 241, which converts the transferred data record 230 into an existing data construct 280, which is also not subsequently modifiable, i.e. also, for example, in DLT or available as a blockchain.

One of the computers 240 or, as shown in FIG. 7, the device 200 can have a determination unit 320 which, in response to a request for further use, can determine that the further use constitutes unauthorized use. This determination can be made, for example, by evaluating the data stored in the data set 230 and/or the data construct 280, as described above. In the event that the determination unit 320 determines unauthorized use, one or more of the computers 240, as shown in Figures 5, 6 and 8, or the device 200, as shown in Figure 7, can have one or more of the following elements, or be adjusted in the following way. The device 200 or the system 300 may store the further usage in the data set 230 and/or the data construct 280 if unauthorized usage has been determined by the determining unit 320 . A signal device 330 can emit an optical and/or acoustic signal if unauthorized use has been determined by the determination unit 320 . As previously described, this can be done on the product or at a location remote from the product. The transmission unit 204 may transmit data that causes a signal or notification to an external device 310 if unauthorized use has been determined by the determination unit 320 . An output device 340 may issue a request and a release device 350 may, in response to receiving a user confirmation in response to the request, release the product for the requested further use if unauthorized use was determined by the determination unit 320. A blocking device 360 can block the product 220 so that further use is not possible if unauthorized use has been determined by the determining unit 320 .

The elements described in connection with Figures 5 to 8, which include the transmission of data, can use one or more of the following technologies, for example: Bluetooth, IR, LAN, WLAN, loT, mobile radio, e.g. 2G, 3G, 4G, 5G, GSM and/or LTE, LoRaWAN, and either directly or via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and/or the Internet.

In the data records 230 and data constructs 280 described in connection with Figures 5 to 8, which can each be implemented as a DLT or blockchain, In addition, one or more pieces of information can be stored, from: information regarding the article, the serial number of the product and/or a permitted use, such as an expiry date after which the product may no longer be used, or a permitted number of uses, the information Written into the data construct when the product is manufactured or recorded when the use is recorded and then stored in the data record, or information relating to the dates of manufacture, storage, shipping and sale of the product.

An exemplary configuration of the device from FIG

- a surgical motor system with a handpiece and a controller

- and a tool that can be coupled with the handpiece,

The tool forms the product 220 . The tool can, for example, be in the form of a surgical milling cutter intended for processing bones. The tool is provided with a QR code as an ID element, which includes at least an article number and a serial number. Alternatively, the tool can also have an RFID tag, an NFC tag or barcodes as an ID element. The ID element contains at least one serial number, which can be read electronically in an embodiment as an RFID or NFC tag and optically in an embodiment as a QR code or bar code.

The handpiece includes the detection unit 201. In this exemplary embodiment, the detection unit is designed as an optical reading unit that is provided for reading the QR code on the tool. Alternatively, the detection unit can also be in the form of an RFID reader or an NFC reader. The detection unit 201 is arranged in the handpiece. If the tool is inserted into the handpiece or connected to the handpiece, the detection unit 201 records the ID element and determines at least the serial number. The control unit includes the data processing unit 202, the memory unit 203 and the transmission unit 204. The handpiece is connected to the control unit in an operational state. If the tool is coupled to the handpiece, the detection unit 201 reads the ID element. The data processing unit 202 creates the usage data 210 using the serial number determined from the ID element and possibly other data recorded during operation.

The transmission unit 204 is intended to connect the control device to the computer 240 . The computer 240 is preferably designed as a local server, for example as an intranet server for a hospital. In order to connect the control unit to the local server, the system 300 includes access points that are not shown in detail. The transmission unit 204 is provided for a wireless connection to the access points. The computer 240 and the access points can be connected to the computer 240 by wire, for example by means of a LAN connection, or wirelessly.

The server includes the determination unit 320. The determination as to whether use of the product 200 is permitted or not takes place centrally on the server 200. If the determination unit 320 recognizes non-permitted use, the computer 240 sends corresponding information to the device 200. In the configuration as a control unit, device 200 has a display on which the information can be shown. Various functions for processing the information about unauthorized use can be stored in the device. If the determination unit 320 recognizes, for example, that the tool is a single-use tool that has already been used, the control unit displays the relevant information allow emergency operation. An exemplary configuration of the device 200 from FIG. 6 is a medical pump, for example an infusion pump. The usage data 210, which is stored in the data record 230 in a form that cannot be subsequently modified, can be information about service checks that have been carried out, for example. In addition, each time the device 200 is used, a data set 230 is created, which contains usage data 210 about the commissioning. If the determination unit 320 recognizes that the data record 230 with usage data 210 about the commissioning belongs to a device in which the last data record 230 with usage data 210 for a service check carried out has expired, the device 220 embodied as a medical pump can emit a signal, that the service check has expired.

An exemplary configuration for FIG. 8 is, for example, the configuration of the product 220 as an infusion bag. In such a configuration, the device 200 can be embodied as a holder for the infusion bag. Alternatively, however, it is also conceivable for the device 200 to be in the form of a hand-held scanner or the like, such as is used, for example, when goods are received or dispatched in a warehouse. The device 200 is intended to record at least one identification number of the product 220, such as a batch number. Depending on the design of the device 200, different methods can be used. In the configuration as a hand-held scanner, the device can be provided for optical recognition of a barcode or a QR code. In the configuration as a holder, the device can be provided for reading an NFC or RFID tag.

In the case of such products, production, storage and transport are monitored in particular. If it is subsequently determined that a circumstance has occurred which requires the product 220 to be blocked, a data record 230 containing this information for the product is stored in the data construct 280 . The device 220 is connected to the computer 240 . If the device 220 is a hand-held scanner, the processor 240 can be a computer, for example of a warehouse management system. If the device 220 is a holder, the computer 240 can be part of a patient monitoring system, for example.

In such a configuration in particular, the device 310 implemented separately from the computer 240 is advantageous in order to ensure that the user is informed that the product 220 has been blocked. The device 310 can be embodied, for example, as an LED, which signals the blocking.

An alternative tracking system according to another preferred embodiment can be configured as follows (not shown). The medical tracking system is used to securely track and document the history of a disposable medical device designed in the form of a scalpel. A QR code with an encoded, unique serial number is engraved on the outside of the scalpel, which a reading device in the form of a camera can detect and read. In a computer network with a large number of computers (in this case more than twenty computers), a digital tracking book with a directory of information blocks on the at least one disposable medical device is stored decentrally as a blockchain in the computers, with the serial number, the article number being stored in a first block and a control number of the medical product are stored and these data are self-contained via a first hash or hash value. The first hash is used to control the stored data and, so to speak, closes the data record/block. If the data of the first block were changed later, the first hash would also change. If the scalpel is now read in using the reader before use in an operating room, a use transaction is sent to the computer network when the first use is recorded and a use block with a To create a time stamp, the usage transaction and a usage hash (for a new completion of the block) and to make them available to the computer network in order to add this usage block to the blockchain in the computers of the computer network. Should now If, contrary to the specification, the disposable medical device is used again, it would first have to be read in again with the help of the reader. A tracking module is adapted to read the blockchain for the at least one disposable medical product and to detect an existing use block (with corresponding use transaction) in the blockchain. Instead of adding a second usage block, the tracking module is designed to issue a visual alarm via a surgical monitor and also generate an audible signal. In this way, re-use can be safely avoided and the user informed of the illegal two-way use.

In particular, the following aspects are disclosed according to the present invention:

1. Aspect Computer-implemented method (100) for storing

Usage data (210) of a product (220), the method (100) comprising: detecting (110) usage of the product (220);

Creating (120) the usage data (210) relating to the recorded usage of the product (220); and

Saving (130) the usage data (210) in a data record (230) in a form that cannot be subsequently modified, the data record (230) using blockchain technology.

2. Aspect Method (100) according to aspect 1, wherein the method (100) further comprises after creating (120) and before storing (130):

Transmission (140) of the usage data (210) to at least one computer (240), each comprising a memory (250); and wherein the storing (130) is performed by the at least one computer (240) in the respective memory (250).

3. Aspect Method (100) according to aspect 1 or 2, wherein the storing (130) of the product (220) is carried out in a separate memory (245), the method (100) further comprising:

Transmission (150) of the data set (230) to at least one computer (240), each comprising a memory (250); and Storing (160) the data set (230) from the at least one computer (240) in the respective memory (250). spekt method (100) according to aspect 3, wherein the data record (230) of the product (220) after the transfer (150) of the data record (230) in the at least one computer (240) in an existing data construct (280), which is also not is subsequently modifiable, is inserted. spekt Method (100) according to aspect 4, wherein the data construct (280) uses blockchain technology. spekt method (100) according to any one of aspects 1 to 5, wherein the blockchain technology is embodied in one of the following forms:

Blockchain that is only stored in memories (250) of non-public computers (240) of a network (260);

Blockchain that is stored in memories (250) of non-public computers (240) of at least two networks (260, 270); or

Blockchain stored in memories (250) of public computers (240). spekt Method (100) according to one of aspects 2 to 6, wherein one or more of the steps of transmitting (140) the usage data and transmitting (150) the data set (230) uses one or more of the following technologies, for example: Bluetooth, IR, LAN, WLAN, loT, mobile communications, e.g. 2G, 3G, 4G, 5G, GSM and/or LTE, LoRaWAN, and either directly or via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points, and /or be transmitted over the Internet. spekt Method (100) according to one of aspects 1 to 7, wherein one or more pieces of information are additionally stored in the data set (230) and/or the data construct (280), from:

Information regarding the item, serial number of the product and/or a permitted use, such as an expiry date after which the product may no longer be used or a permitted number of uses, the information being included in the data construct during manufacture of the product (220). (280) to be written or when capturing (110) the usage are also recorded and then stored in the data record (230);

Information regarding dates of manufacture, storage, shipping, sale of the product (220). spekt Method (100) according to any one of aspects 1 to 8, wherein the product (220) is a medical device. . Aspect A method (100) according to any one of aspects 1 to 9, further comprising: in response to a request for further use of the product

(220): Determining (170), in the product (220) or a computer (240), that further use constitutes unauthorized use by evaluating the data stored in the data set (230) and/or the data construct (280). .. Aspect Method (100) according to aspect 10, further comprising: if unauthorized use was determined in step (170), performing one or more of the following steps:

storing (180) the further use in the data set (230) and/or the data construct (280);

Outputting (181) an optical and/or acoustic signal;

transmitting (182) data causing a signal or notification to an external device (310);

Issuing (183) a request and releasing (184) the requested further use only after receiving (185) a user confirmation;

Blocking (186) the product (220) so that further use is not possible. . Aspect A data processing system comprising a processor adapted to perform the method of any one of aspects 1 to 11. Aspect A computer program product comprising instructions which, when the program is executed by a computer, cause the computer to perform the method of any one of aspects 1 to 11. . Aspect A computer-readable storage medium comprising instructions which, when executed by a computer, cause it to perform the method of any one of aspects 1 to 11. . Aspect device (200) for storing usage data (210) of a

Product (220), characterized by: a detection unit (201) which is set up to detect use of the product (220); a data processing unit (202) which is set up to create the usage data (210) relating to the recorded usage of the product (220); and a storage unit (203) which is set up to store the usage data (210) in a data record (230) in a form which cannot be modified subsequently, the data record (230) using blockchain technology. . Aspect System (300) comprising a device (200) according to aspect 15, and at least one computer (240), each comprising a memory (250), wherein the device (200) further comprises: a transmission unit (204) set up for this purpose is to transmit the usage data (210) to the at least one computer (240); and wherein the respective memories (250) are set up to store the usage data (210) in a data record (230) in a form that cannot be modified later. . Aspect System (300) comprising a device (200) according to aspect 15, and at least one computer (240), each comprising a memory (250), wherein the device (200) is embodied as part of the product (220), and further comprises: a transmission unit (204) which is set up to transmit the data set (230) to the at least one computer (240); and wherein the respective memories (250) are configured to store the data set (230), the data construct (280) using blockchain technology. . Aspect System (300) according to aspect 17, wherein the at least one computer (240) further has a calculation unit (241) which is set up to convert the data set (230) transmitted by the device (200) into an existing data construct (280), which is also not subsequently modifiable. . Aspect Apparatus (200) or system (300) according to any one of aspects 15 to 18, wherein the DLT is embodied in one of the following forms:

Blockchain that is only stored in memories (250) of non-public computers (240) of a network;

Blockchain that is stored in memories (250) of non-public computers (240) of at least two networks; or

Blockchain stored in memories (250) of public computers (240). Aspect System (300) according to one of aspects 17 to 19, wherein the transmission unit (204) uses one or more of the following technologies: Bluetooth, IR, LAN, WLAN, loT, mobile communications, e.g. 2G, 3G, 4G, 5G, GSM and/or LTE, LoRaWAN, and either directly or via intermediate stations such as smart hubs, repeaters, routers, switches, mobile hotspots, data gates, access points , and/or Internet transfers data. . Aspect Apparatus (200) or system (300) according to any one of aspects 15 to

20, which are also set up to additionally store one or more pieces of information in the data set (230) and/or the data construct (280), from:

Information regarding the item, serial number of the product and/or a permitted use, such as an expiry date after which the product may no longer be used or a permitted number of uses, the information being included in the data construct during manufacture of the product (220). (280) are written or are also recorded when the use is recorded and are then stored in the data record (230);

Information regarding dates of manufacture, storage, shipping, sale of the product (220). . Aspect Apparatus (200) or system (300) according to any one of aspects 15 to

21, further comprising: a determination unit (320) which is set up to determine, in response to a request for further use of the product (220), by evaluating the data stored in the data record (230) and/or the data construct (280) that the further use constitutes unauthorized use.

23. Aspect Device (200) or system (300) according to aspect 22, wherein the device (200) or system (300) is further configured to allow further use in the data set (230) and/or the data construct (280). store if unauthorized use has been determined by the determination unit (320); wherein the device (200) or system (300) further comprises a signal device (330) which is set up to emit an optical and/or acoustic signal if unauthorized use has been determined by the determination unit (320); wherein the transmission unit (204) is further configured to transmit data causing a signal or triggering a notification at an external device (310) if unauthorized use has been determined by the determination unit (320); wherein the device (200) or system (300) further comprises an output device (340) arranged to issue a request, and an enabling device (350) arranged to, in response to receiving a user confirmation as responding to the request to authorize the product for the requested further use if unauthorized use has been determined by the determination unit (320); and/or wherein the device (200) or system (300) further comprises a locking device (360) configured to lock the product (220) so that further use is not possible in the event of unauthorized use by the determination unit (320) has been determined.

Claims

PATENT CLAIMS

1. Computer-implemented medical tracking method (100) for secure tracking and storage of usage data (210) from at least one medical product (220), in particular a disposable medical product (220), the method (100) comprising:

detecting (110) a use of the medical product (220);

Creating (120) use data (210) relating to the recorded use of the medical product (220); and

2. Computer-implemented medical tracking method according to claim 1, characterized by the steps:

detecting a unique identification of the at least one disposable medical product (220);

calculating, based on the unique identification, a first hash value;

storing a first block with the detected unique identification and the calculated first hash value in a blockchain on each computer of a computer network with at least three computers;

detecting usage of the single-use medical device (220) by a detection unit and sending a usage transaction to the computer network;

Checking, by a tracking module, whether there is a use block in the blockchain for the recorded single-use medical product (220);

If there is no usage block yet: Generate by a block generation module, based on the usage transaction, a usage block with the first hash, a timestamp, the usage transaction and a usage hash and provide to it

43 computer network to add this usage block in the computers of the computer network to the blockchain respectively; and if there is a usage block: issuing an alarm and/or disabling a functionality of the single-use medical device (220).

3. Computer-implemented medical tracking method according to claim 2, characterized in that the tracking method further comprises the steps of:

storing, in the first block, a best before date of the at least one disposable medical device (220);

In addition to the step of detecting the use, comparing the time stamp with the stored best-before date and, if the best-before date is exceeded: issuing an alarm and/or blocking a functionality of the single-use medical device (220).

4. Computer-implemented medical tracking method according to one of claims 2 or 3, characterized in that in the case of an electrically operated medical device as a disposable medical product (220), the tracking method blocks the functionality of the disposable medical product (220) by interrupting the power supply .

5. Computer-implemented medical tracking method according to any one of claims 2 to 4, characterized in that the tracking method further comprises the steps:

After issuing the alarm and/or blocking the functionality of the disposable medical device (220), prompting a user to perform a confirmation input via an input device and to confirm that the disposable medical device (220) should be used again,

recording the confirmation input by the user,

Generate an alarm block with a timestamp, an alarm transaction and an alarm hash and provide it to the computer network to use it

44 Adding an alarm block in the computers of the computer network to the blockchain and documenting the re-use.

6. Computer-implemented medical tracking method according to any one of claims 2 to 5, characterized in that the tracking method further comprises the steps:

In addition to the unique identification with a unique serial number: storing a unique control number associated with the serial number in the first block, which was generated as an alphanumeric number code by a specified, non-public algorithm,

When detecting the use of the disposable medical device (220): checking the serial number and the control number associated with the serial number and determining that the disposable medical device (220) is counterfeit if the control number does not match the serial number.

7. Computer-implemented medical tracking method according to any one of claims 2 to 6, characterized in that the tracking method further comprises the steps:

Detecting a warehouse entry by capturing the unique identification of the single-use medical product (220) by a warehouse entry detection device,

Generating a storage block with a storage transaction and a time stamp as a storage entry date and a storage hash, and providing it to the computer network in order to add this storage block to the blockchain in the computers of the computer network in order to document a storage entry.

A computer-readable storage medium comprising instructions which, when executed by a computer, cause it to perform the tracking method of any one of claims 1 to 7.

9. Medical tracking system for secure tracking of at least one disposable medical device (220), comprising:

45 a disposable medical device (220) to be tracked, which has a unique identification, in particular a unique serial number; at least one detection unit, in particular a reading device, which is adapted to detect the identification of the disposable medical product (220) and to make it available in computer-readable form; a computer network with at least three computers, on each of which a digital tracking book with a list of blocks of information on the at least one disposable medical device (220) is stored decentrally as a blockchain, with at least the unique identification of the at least one disposable medical device being stored in a first block in particular (220) and an associated first hash is stored; a usage module adapted, upon detection of the disposable medical device (220) by the usage detection unit, to send a usage transaction for the disposable medical device (220) to the computing network; a block generation module, which is adapted to create a usage block with a time stamp, the usage transaction and a usage hash based on the usage transaction and the first hash and to make this usage block available to the computer network in order to use this usage block in the computers of the computer network respectively add blockchain; and a tracking module which is adapted to read the blockchain for the at least one single-use medical device (220) and to detect an existing use block in the blockchain and to issue an alarm if use is detected again and/or use of the single-use medical device ( 220) to lock.

10. Medical tracking system according to spoke 9, characterized in that the identification, in particular the serial number and/or a QR code, is engraved in the disposable medical product (220) and the detection unit is an optical detection unit, in particular a camera and/or the identification, in particular the serial number, is stored in an RFID tag of the disposable medical product (220) and the detection unit has an RFID reader.

11. Medical tracking system according to claim 9 or 10, characterized in that the at least one disposable medical product (220) is a medical, in particular surgical, instrument and/or a perforated basket and/or a medical holder and/or an electrically operated medical device .

12. Medical tracking system according to one of claims 9 to 11, characterized in that in the first block, in addition to the unique identification, a best-before date for the disposable medical device (220) is stored and the tracking module is adapted for this, with a compare the time stamp with the best-before date when the single-use medical device (220) is used and, if the best-before date is exceeded, issue an alarm and/or block use of the single-use medical device (220).

13. Medical tracking system according to claim 11 or 12, characterized in that the disposable medical device (220) is an electrically operated medical device and the tracking module is adapted to provide an electrical power supply to the disposable medical device (220) when it is used again or to interrupt when a best-before date of the single-use medical device (220) is exceeded in order to block use.

14. Medical tracking system according to one of claims 9 to 13, characterized in that the tracking system also has a central database with at least one data entry stored for the disposable medical device (220), in particular a file, particularly preferably medical documentation of the disposable medical device (220) and/or a text is stored as a data entry, with an entry hash being generated for the data entry, and the entry hash is stored in the blockchain to secure the data entry against manipulation via the entry hash.

15. Device (200) for storing usage data (210) of a medical product (220), characterized by: a detection unit (201) which is set up to detect use of the medical product (220); a data processing unit (202) which is set up to create the use data (210) relating to the recorded use of the product (220); and a storage unit (203) that is set up to store the usage data (210) in a data record (230) in a form that cannot be subsequently modified, the data record (230) using blockchain technology.

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