Optimized tracking system, tracking method and computer readable storage medium for sterilized product cycles

Abstract

A computer-implemented tracking method for tracking a sterilization cycle history of a medical device having a motor system, comprising the steps of: acquiring (S1) a unique identification of a medical product (1) by a detection unit (2); reading (S2) a sterilization cycle history counter associated with the medical product (1); detecting ultrasonic treatment of the medical product (1) and / or maintenance (refueling) of the medical product (1) and incrementing (S3) a sterilization cycle history counter associated with the medical product (1); storing (S4) the counter in a storage unit (8) in a transponder (4) of the medical product (1); and determining (S5) that the medical product (1) is in a warning range if the counter exceeds a predetermined limit value associated with the medical product (1), and outputting (S6a) a warning message to a user via a visual display device (10) and / or initiating (S6b) an automatic recovery process to restore functionality of the medical product (1).

Description

[Technical Field]

[0001] The present disclosure relates to a computer-implemented tracking method for tracking the sterilization cycle history of medical products, in particular instruments or medical devices with a motor system. Furthermore, the present disclosure relates to a tracking system, a universal adapter for tracking the sterilization cycle history, an ultrasonic sieve, a computer-readable storage medium, and a computer program according to the preambles of the independent claims. [Background technology]

[0002] Generally, medical products such as surgical instruments or surgical devices have strict reprocessing, maintenance and sterilization requirements and are subjected to so-called sterilization cycles.

[0003] Such a sterile article circle for pharmaceutical / medical products such as surgical instruments or devices with motor systems may in particular comprise or consist of the following processing steps: First processing step: manual or mechanical pre-cleaning of the medical product, especially ultrasonic pre-cleaning. Second processing step: disinfection of medical products. Third process step: Servicing or maintenance of medical products, in particular the refueling of medical products with integrated motors or motor systems. Fourth processing step: Sterilization of medical products. Fifth processing step: Medical application, or the actual use of the medical product, especially during surgical intervention.

[0004] These sterilization circle / sterilization cycles are repeated until the medical product becomes defective or exceeds its intended useful life and requires replacement.

[0005] According to the current situation, some medical products are typically used until they are no longer functional, i.e., until a defect occurs, until the intended maintenance interval is reached, or until they are (subjectively) assessed by the user as no longer functional.

[0006] Until now, it has been impossible for manufacturers of medical products to retroactively determine the useful life of a medical product or collect data on the number of sterilization cycles a used medical product has undergone. Therefore, manufacturers rely on the cooperation and honesty of their customers to obtain relevant data on medical products. Another problem is that it is nearly impossible to ensure that customers actually collect data on each medical product, especially at the serial number level, in order to reliably track or monitor each individual medical product. Summary of the Invention [Problem to be solved by the invention]

[0007] It is therefore an object of the present invention to avoid or at least mitigate the drawbacks of the prior art, and in particular to provide a tracking method, tracking system, universal adapter, ultrasonic sieve, as well as a computer-readable storage medium and computer program that allow efficient and effective tracking of the execution of sterile goods circles, particularly at the level of single individual medical products with unambiguous identification (ID), in particular unique serial numbers.A further partial object is to ensure reliable availability of medical products in sterile goods circles, preferably in operating rooms, to prevent delays and cancellations of surgeries, thereby increasing the safety of interventions and minimizing costs. [Means for solving the problem]

[0008] The object is solved with respect to a tracking method according to the invention according to the features of claim 1, with respect to a tracking system according to the invention according to the features of claim 9, with respect to a universal adapter according to the invention according to the features of claim 10, with respect to an ultrasonic sieve according to the features of claim 12, with respect to a computer-readable storage medium according to the invention according to the features of claim 13 and with respect to a computer program according to the invention according to the features of claim 14.

[0009] Thus, the basic idea of ​​this disclosure is to use "data points" or processing steps in the sterilization item cycle that have the greatest impact on the useful life of a medical product, i.e., its usability, and ultimately to ensure "guaranteed usability," i.e., to have a medical product available for medical intervention and have a sufficient and adequate useful life so that defects do not occur during use. Ultrasonic mechanical pre-cleaning and product care, particularly the lubrication of medical products, were identified as data points associated with a significant impact on product quality, particularly on the motor system of the medical product. By recognizing this processing step, an incremental counter for each medical product, particularly each handpiece, can be incremented step by step (incrementally plus one) via an antenna. If medical product-specific data (down to the serial number) is recorded as the medical product passes through these processing steps, this collected data can be used to make statements about useful life based on already collected data and based on predictive models (e.g., historical data about the useful life of the medical product), and to make statements about future usability and failures. Based on this, warning messages can be issued and automatic repair processes can be initiated. For example, an automatic repair of the medical product's repair system may be initiated. A reorder or repair may trigger a more fully automated action to correct the defect. Thus, to guarantee and ensure guaranteed availability in the customer's clinic, minimum requirements for the useful life of the medical product are defined. This makes it possible to achieve a availability of more than 90%.

[0010] In other words, a computer-implemented tracking method for tracking the sterilization cycle history of a medical product, particularly an instrument or medical device with a motor system, is provided, which comprises the steps of detecting a unique identification of the medical product by a detection unit, particularly an identification number stored in a transponder of the medical product by a transponder read / write device; reading a sterilization cycle history counter associated with the medical product with the identifying information; detecting sonication of the medical product and / or maintenance, in particular refueling, of the medical product and incrementing (incrementally, i.e., plus one) a sterilization cycle history counter associated with the medical product; - storing said counter in a storage unit, in particular in a transponder of a medical product, by means of a transponder read / write device; If the counter exceeds a predetermined limit value associated with the medical product, determining that the medical product is in a warning range and outputting a warning message to a user via a visual display device and / or initiating an automatic recovery process to restore functionality of the medical product. This provides an optimized tracking process in the so-called sterilization article cycle, with the detection of the processing steps being in particular for at least one, in particular all, of the ultrasonic bath, cleaning and disinfection, and / or maintenance processing steps.

[0011] All these measures contribute to a guaranteed availability of medical products and mean that clinics can maintain these processes without interruption. Preferably, the manufacturer also has an overview of the medical products and their condition.

[0012] Advantageous embodiments are set out in the dependent claims and are particularly described below.

[0013] According to a preferred embodiment, in the case of a medical product equipped with a transponder, in the step of reading the sterilization cycle history counter, in addition to reading (reading) the identification number from the transponder, the counter stored in the transponder is also read, and in the step of storing the counter, the counter is stored in a transponder associated with the medical product. The counter associated with the medical product is thus stored directly on the medical product in addition to the identification information. This counter stored in the transponder can be read by various transponder readers, for example before or after surgery, to perform random checks or to determine the status of the medical product.

[0014] In particular, in the reading step, the tracking method may be configured to read a stored counter of the sterilization cycle history associated with the medical product on a central server (e.g., data in a cloud) in the storage unit, and in the counter saving step, the incremented counter is saved in the storage unit of the central server of the medical product together with the identification information, providing centralized data management of the sterilization history of medical products, in particular for a plurality of different medical products. For example, a central database is saved for each individual manufactured medical product, with each database entry including at least an identification number, an associated counter, and a predetermined limit value for the counter, and the execution of the sterilization cycle of each medical product can be detected via the associated counter, and if the counter is equal to or greater than the limit value, a warning message is issued or a recovery process is initiated.

[0015] In particular, the predetermined limit may be defined to be less than the useful life of the number of sterilization article cycles associated with the medical product, so that a warning message is issued to the user and / or an automatic recovery process is initiated before the end of the useful life is reached, thereby providing the user with sufficient lead time or time to reprocess the medical product to restore its functionality or to replace the medical product with a new one, for example in an automated logistics system where the medical product is in inventory.

[0016] According to one embodiment, a medical product may store both an ultrasound counter as a first counter and a maintenance counter as a second counter. When both an ultrasound treatment of the medical product and maintenance of the medical product are detected, both counters are incremented by one. When an ultrasound treatment is detected, only the ultrasound counter is incremented accordingly. When maintenance is detected, only the maintenance counter is incremented accordingly. When at least one counter exceeds a predetermined limit, the medical product is determined to be in a warning range. For this purpose, for a medical product or a class of medical products (e.g., surgical scalpels), a (first) predetermined limit value for ultrasound may be stored, and a (second) predetermined limit value for maintenance may be stored. This allows for a more accurate determination of when the medical product has entered a warning range, for example, when the steps do not necessarily need to be performed together. Alternatively, a sum of the ultrasound counter and maintenance counter may be generated, and when this sum exceeds a predetermined limit, a warning range is determined to exist.

[0017] In particular, if both sonication of a medical product and maintenance of the medical product are detected, the counter may be incremented by just one, ensuring that if only one execution is performed, the counter is incremented by just one. Alternatively, if a read and / or write step is performed by multiple readers in addition to sonication and maintenance of a medical product, the counter may be incremented by exactly one, again recording exactly one execution and incrementing the counter accordingly.

[0018] According to a further embodiment, in the step of detecting ultrasonic treatment, the ultrasonic treatment may be detected by a sensor configured to detect contact with a fluid and / or to detect ultrasonic waves. In other words, for example, immersion in an ultrasonic bath can be detected via a water sensor and / or ultrasonic waves can be detected via an ultrasonic sensor, thereby determining that ultrasonic treatment is being performed. At the same time, quality assurance can be ensured over the treatment time.

[0019] The tracking method also preferably further comprises the steps of generating images, in particular by means of a multi-reader camera and / or LIDAR device (Light Detection and Ranging; LADAR), determining the condition of the medical product, in particular the state of the cutting edge quality and / or cutting edge shape of the surgical instrument based on said images, and in case of an unsatisfactory state, outputting a warning message to the user via the visual display device and / or initiating an automatic recovery process of the medical product's functionality. This provides an additional safety mechanism that prevents the medical product from being prepared for surgical intervention even if its state requires replacement. This allows for the evaluation of service life aspects, such as cutting edge quality and cutting edge shape, for example.

[0020] Preferably, in the step of determining the condition, the tracking method may further include a step of sending the image as input data and a condition judgment, in particular a binary condition judgment of ``sufficient''-``inadequate'' (1-0; good condition-inadequate condition), to a trained AI system (artificial intelligence system / AI system) on a central server, which has been trained using the cutting edge quality of the surgical instrument, and performing the condition judgment by the trained AI system, and more preferably performing a step of sending the determined condition to a multi-reader / multi-read / write device.

[0021] Prior to the maintenance processing step, the medical products may be inspected in a sterile goods circle, preferably by employees of the Central Sterile Supply Department (CSSD). The functionality of the medical product may also be evaluated here.

[0022] Data may also be detected, preferably at the customer side of the medical product. This can be done by directly detecting and storing (logging) it in a computer environment (with corresponding computer programs), in particular (in addition to handwriting and then digitizing it, in order to enable its subsequent use). The prerequisite here is that data points must be logged / generated by the customer and made available to the manufacturer for deriving actions based on them. This allows for the derivation of guaranteed usefulness as a service. This is the minimum requirement for data collection from the customer.

[0023] According to a further embodiment of the extended variant, a semi-automated tracking method may be used, which, with the assistance of various electronic assemblies, (automatically) detects at least some, in particular all, of the processing steps of the sterilized article circle.

[0024] The object is solved with respect to a tracking system for tracking the sterilization cycle history of a medical product, in particular an instrument or medical device with a motor system, comprising: a detection unit configured to detect the unambiguous identification of the medical product, in particular the identification number stored in the transponder of the medical product by means of a transponder reading / writing device or by means of a camera and a QR code mounted on the medical product; a sensor configured to detect the ultrasonic treatment of the medical product and / or the maintenance, in particular the refueling, of the medical product; a control unit configured to increment (by one) a sterilization cycle history counter associated with the medical product and to store said counter by means of a transponder read / write device in a storage unit, in particular in a transponder of the medical product, and wherein if said counter exceeds a predetermined limit value associated with the medical product, the control unit is configured to issue a warning message to a user via a visual display device and / or to initiate an automatic recovery process of the functionality of the medical product. The tracking system can thus record and track the operational status of each individual medical product and issue a corresponding warning if necessary, i.e. in the event of entering an alarm range, and can also carry out a recovery process, especially when the required medical product is available again with a sufficient service life for surgical intervention, thus ensuring reliable availability of the medical products.

[0025] In particular, the tracking system may comprise a medical product equipped with a transponder, and the control unit is configured to read a counter in the transponder of the medical product by means of the transponder read / write device, increment it by the transponder read / write device and then (re)store it in the transponder of the medical product.

[0026] Preferably, the tracking system may comprise a sensor configured to detect contact with the fluid and / or to detect ultrasound waves to detect sonication, upon detection of sonication the counter may be incremented accordingly.

[0027] According to one embodiment, the tracking system may comprise a multi-reader equipped with a camera and / or a LIDAR device. In particular, the tracking system may further comprise a trained AI system that is trained using the cutting edge quality of the surgical instrument as input data to make a condition determination, in particular a binary condition determination of satisfactory / unsatisfactory. The control unit may be configured to transmit images to the trained AI system, and after the condition determination by the trained AI system, to issue a warning message to a user via a visual display device in case of an unsatisfactory condition and / or to initiate an automatic recovery process of the medical product's functionality.

[0028] The object is solved with a universal adapter / tracking adapter for connecting an antenna for tracking the sterilization cycle history of medical products. The universal adapter comprises an adapter housing with an antenna contact point, two mutually spaced electrical contact surfaces arranged on the upper side and exposed to the outside of the adapter housing, and having exactly two electrical contact surfaces for a standardized connection structure for a signal-technical wired connection with the antenna; a fastening portion of the adapter housing, particularly in the form of a ring, for fastening the universal adapter to an object, particularly an ultrasonic sieve; and a wired signal interface, particularly a high-frequency coaxial cable, conductively connected to the antenna contact point for passing data signals, particularly high-frequency signals (HF signals). Therefore, a type of extension cable is provided for attaching the antenna for reading the transponder, which has a predetermined connection point, a type of plug, so that the antenna, e.g., a holder with the antenna, can be easily and reliably connected, for example, plugged in via plug-and-play. The universal adapter has such a signal interface, which is precisely configured to transmit high-frequency signals to the antenna for reading and writing the transponder. The antenna is therefore positioned in the vicinity of the medical product equipped with the transponder and can be read in the near field. Preferably, a direct current, e.g., 3 V, 5 V, or 12 V, can also be transmitted via the antenna connection point, e.g., to provide power for the medical product connected within the antenna area. In this way, a standardized interface is created to provide at least one signal line to the transponder of the medical product via a simple and quick connection.

[0029] In particular, the universal adapter may have at least one magnet to provide a force-fit, detachable coupling with the universal adapter, in particular for a counter adapter complementary to the universal adapter, the universal adapter preferably having two spaced apart magnets aligned parallel to each other and with opposite magnetic polarity, in particular using complementary magnets to ensure unique alignment of attachment with the counter adapter.

[0030] In particular, the universal adapter may also have asymmetrically positioned protrusions on its top surface to ensure unique alignment of the counter adapter. As with USB-A connections, the universal adapter and the counter adapter can only be connected in alignment with each other. This is particularly important for DC transmission.

[0031] In particular, the signal interface may comprise a shielded coaxial cable for transmitting RF signals.

[0032] Preferably, the universal adapter has a waterproof design, in particular a liquid-tight housing that encloses the interior and only exposes the electrical contacts to the outside, to ensure continued functionality during and after immersion in the ultrasonic bath. In particular, immersion in the ultrasonic bath can be detected via the antenna contacts with two contact surfaces. This creates a short circuit between the two contact surfaces, and the electrical conductivity of this electrical circuit can be used as a parameter.

[0033] The ultrasonic sieve for receiving medical products and immersing them in an ultrasonic bath is solved by having at least one universal adapter as described in the present disclosure, which is attached to the ultrasonic sieve, particularly to the bottom of the sieve tray, via its fixing portion and connected to a central communication unit via its signal interface, so that an antenna connectable via the antenna contact point is used to read and / or write transponders on the medical products. The universal adapter thus functions as a kind of extension with a predetermined interface that connects the attachment of the communication unit to the antenna for reading the transponders. Thus, medical products can be placed in different positions within the sieve basket, and the reading and / or writing antenna can be placed nearby and easily connected via the universal adapter. Since RF signals are also transmitted, the antenna can be connected via plug and play, eliminating the need for laborious screwing of antenna cables, such as antenna holders.

[0034] According to one embodiment, the ultrasonic sieve may further comprise a holder with an antenna. The holder is configured to receive, hold, and particularly secure multiple medical products. The holder comprises a counter-adapter complementary to the universal adapter, and is centrally connected to the universal adapter. Thus, for multiple medical products, such as handpieces with motor systems, individual transponders can be read and / or written via a single universal adapter. In particular, antennas can be attached to each holder in which RFID-equipped medical products are placed or attached. For example, special electronics, such as antennas, can be installed at the bottom of the handpiece, which can be connected using the universal adapter's contact system, thereby enabling plug-and-play compatibility. This ensures reliable transmission of high-frequency / HF signals, particularly in water.

[0035] In particular, in addition to signals, direct current (DC) may also be transmitted through the signal interface to provide electrical energy to the medical product.

[0036] As a further variant, the ultrasonic sieve may be equipped with an electronic module / electronics configured to be able to detect or indicate at least one of the following characteristics: Ultrasonic bathtub detection using ultrasonic sensors, · Cleaning and disinfection detection by temperature and / or pressure sensors; a communication module for enabling communication with a reading and / or writing device, in particular a multi-reader, in particular a communication module for wireless data transmission via Bluetooth, particularly preferably BLE (Bluetooth low energy), Wireless LAN (WLAN) and similar transmission methods, and / or Detection of maintenance due to refueling using temperature and / or pressure sensors.

[0037] An ultrasonic sieve can be provided that does not completely pass through the sterilization article circle and therefore does not need to go through the high-temperature and high-pressure stage of sterilization. Therefore, the electronics of the ultrasonic sieve are accordingly suitable. In other words, the ultrasonic sieve can have an ultrasonic sensor, particularly for detecting an ultrasonic bath. The ultrasonic sieve can also have a temperature sensor and / or a pressure sensor for detecting cleaning, disinfection, or maintenance. The ultrasonic sieve can also have a communication module of a communication unit suitable for wireless data transmission.

[0038] In one embodiment, the ultrasonic sieve may be equipped with electronics or detectors configured to detect the immersion of the ultrasonic sieve in the ultrasonic bath and the ultrasonic action itself.

[0039] In particular, the ultrasonic sieve can perform further functions in combination with a universal adapter or universal interface, through which an antenna can be connected and data (e.g., a counter) can be written to a transponder (e.g., an RFID glass tag). During the oiling treatment step, the handpiece is simultaneously sprayed with oil. The ultrasonic sieve in the ultrasonic bath can also recognize the treatment step and write data to the medical product, especially the handpiece, using the universal adapter and antenna connected to the holder.

[0040] In particular, the ultrasonic sieve may have a self-sufficient energy source, and the power supply for the electronics in the ultrasonic sieve can be achieved in particular via a primary battery or via a storage battery that can be inductively charged during the process or that is charged at each process step via energy harvesting.

[0041] In particular, the tracking system of the present disclosure may include a universal adapter and / or an ultrasonic sieve according to the present disclosure.

[0042] In particular, the tracking system may further comprise a medical oil sprayer for spraying oil onto the medical product (including the motor system), the oil sprayer comprising a universal adapter according to the present disclosure.

[0043] In particular, the multi-reader / multi-reader may be used to identify medical products. This can be achieved, in particular, via data matrix codes (e.g., QR codes), barcodes, and / or transponders such as RFID chips. A camera system can recognize the data matrix code (QR code) and, preferably, assign important functions to evaluate the medical product, such as the cutting edge quality of a cutting tool, in a further step. This evaluation, preferably in combination with an AI algorithm, can be used to determine the remaining useful life. The universal adapter or port itself can also read the individual handpieces and interface the data to a database, e.g., the cloud, or directly to an individual cloud database. Thus, the multi-reader itself can transfer data using communications (e.g., BLE, WLAN, etc.). The data can then be imported via the multi-reader to a server, cloud, or other program, where the useful life of the individual medical products can be recorded.

[0044] The multi-reader may also have a holder and a universal adapter that provides batch reading of medical products with transponders held in the holder.

[0045] The object is solved by a computer readable storage medium or a computer program comprising instructions which, when executed by a computer, cause the computer to perform the method steps of the tracking method according to the present invention.

[0046] The universal adapter as a contact system can be customized in shape and size, and the geometric dimensions of length / width / height can be specifically 30mm / 12mm / 7mm, and therefore extremely small for placement at various points of, for example, an ultrasonic sieve or oil sprayer.

[0047] The disclosure regarding the tracking method of the present disclosure applies equally to the tracking system, universal adapter, and ultrasonic sieve of the present disclosure, and vice versa. [Brief explanation of the drawings]

[0048] The present disclosure will now be described in more detail with reference to preferred embodiments and with reference to the accompanying drawings, in which:

[0049] [Figure 1a] 1 is a schematic diagram of a sterilization article cycle in which the tracking method of the preferred embodiment is used, where runs of the sterilization article cycle are recorded at two stations. [Figure 1b] 1b is a flow chart of a tracking method according to a first preferred embodiment for use in the sterilization article cycle of FIG. 1a; [Figure 2] 10 is a schematic diagram of a further modified sterilization article cycle using a tracking method in which the cycle is recorded at three stations. [Figure 3] 1 is a perspective view of an ultrasonic sieve with a central communication unit and two connected universal adapters for contact binding mounting of instruments according to a preferred embodiment, particularly for a tracking system according to a preferred embodiment. FIG. [Figure 4] FIG. 4 is a perspective view of the sterilization basket of FIG. 3 with two holders for holding instruments and handpieces, and one antenna in contact with a universal adapter. [Figure 5] FIG. 1 is a perspective view of a universal adapter according to a preferred embodiment. [Figure 6] FIG. 6 is a longitudinal sectional view of the universal adapter of FIG. 5. [Figure 7] 1 is a perspective view of a multi-reader (read / write unit) with a centrally located universal adapter for contact reading and writing according to a preferred embodiment; FIG. [Figure 8] FIG. 1 is a perspective view of an oil sprayer with a universal adapter. [Figure 9] FIG. 9 is a more detailed partial perspective view of the oil sprayer of FIG. 8, seen from below.

[0050] The figures are schematic in nature and are intended to aid in understanding the invention. Identical elements are provided with identical reference numerals. Features of the various embodiments may be interchanged. DETAILED DESCRIPTION OF THE INVENTION

[0051] FIG. 1 shows a schematic sterilization article circle in which a computer-implemented tracking method is used to track the sterilization cycle history of a medical product 1 (eg, in the form of a surgical instrument or handpiece with a motor system).

[0052] The sterilization article circle has five stations or processing steps. First treatment step: manual or mechanical pre-cleaning, in particular ultrasonic pre-cleaning, of the medical product 1. Second processing step: disinfection of medical product 1. Third process step: Servicing or maintenance of the medical product 1, in particular the lubrication of medical products 1 with integrated motors or motor systems (eg motorized handpieces). Fourth processing step: Sterilization of medical product 1. Finally Fifth processing step: medical application, or actual use of the medical product 1, especially during surgical intervention.

[0053] In the present case, the passage of the medical product 1 through the sterilization cycle is detected at the stations of pre-cleaning in the form of ultrasonication and maintenance with oil, these two stations being the most relevant for the useful life of the medical product 1.

[0054] Specifically, this is achieved via the in Figure 1b.

[0055] At the pre-cleaning station, in step S1, the detection unit 2 obtains the unambiguous identification of the medical product 1, in particular the identification number stored in the transponder 4 of the medical product 1 by the transponder read / write device 6. The medical product is thus unambiguously identifiable and can be linked to the stored data associated with the medical product 1.

[0056] In step S2, a counter of the sterilization cycle history associated with the medical product 1 with identification information is read. After connecting with the relevant data, the associated counter is read.

[0057] In step S3, sonication of the medical product 1 is detected and a sterilization cycle history counter associated with the medical product 1 is incremented by one.

[0058] In a next step S4, the now incremented counter is saved, in particular by the transponder read / write device 6, in a storage unit 8 in the transponder 4 of the medical product 1 itself.

[0059] Finally, in step S5, a determination is made that the medical product 1 is in a warning range, i.e., the counter exceeds a predetermined limit value associated with the medical product 1. If sterilization article cycles for an individual medical product 1 are being performed too frequently, the state of the medical product 1 may change from the "green" range to the "yellow" range before reaching the "red" range of unusability of the medical product 1. In this case, the "yellow" range of warning that the end of life may soon be reached is already recognized, and in step S6a a warning message is output to the user via the visual display device 10, for example in the form of a display.

[0060] Alternatively or additionally, in step S6b an automatic recovery process may be initiated to restore functionality of the medical product 1.

[0061] The above sequence is also performed at the maintenance station where oil is sprayed onto the medical product, however this only determines that the counter at the ultrasound station has already been incremented and no further incrementing of the counter occurs at this station.

[0062] Alternatively, the counter may not be incremented until the medical product has passed through both the pre-wash station and the maintenance station. Alternatively, the counter may be incremented at each of the two stations, with a cumulative predetermined limit being used to account for this. In this case, the two critical stations are each marked with an asterisk.

[0063] Figure 2 shows a schematic diagram of another sterilization article cycle with a further variant and a tracking scheme, where passage is detected at three stations. In contrast to the sterilization article cycle of Figure 1, an additional station, the so-called multi-reader, is provided. This multi-reader can also detect the cycle and may be provided instead of or in addition to the other two stations, pre-cleaning and maintenance.

[0064] Figures 3 to 6 show an ultrasonic sieve 101 with a central communication unit 102 and two connected universal adapters 12 for contact-bound mounting of instruments. Figures 5 and 6 show separately the universal adapters 12 for the tracking system according to the preferred embodiment, in particular with the control unit.

[0065] The ultrasonic sieve 101 is shown without the medical product 1 in FIG. 3 and with the holder and medical product in FIG. 4 and is configured to receive the medical product 1 and be immersed in the ultrasonic bath.

[0066] For this purpose, the ultrasonic sieve 101 has, according to a preferred embodiment, two universal adapters 12, each of which is attached to the sieve tray bottom 102 via its fastening part 24 and connected to a central communication unit 104. This communication unit 104 can exchange data wirelessly with a data interface via WLAN or Bluetooth and can access data stored in the medical product 1. As will be explained below, a connectable antenna 14 for reading and / or writing the transponder (4) of the medical product (1) is available via the universal adapters 12. In particular, the ultrasonic sieve has an electronic module with temperature and ultrasonic sensors for detecting immersion and sonication.

[0067] The universal adapter 12 will now be described in more detail with reference to Figures 5 and 6. The universal adapter 12 is used to connect an antenna 14 for tracking the sterilization cycle history of the medical product 1. For this purpose, it has an adapter housing 16 with antenna contact points 18 located on its top surface 20 and exposed towards the outside of the adapter housing 16, on which exactly two electrical contact surfaces 22 are spaced apart, in order to create a standardized connection structure for connecting a signal technology connection cable to the antenna 14. The universal adapter 12 also has a fixing part 24 of the adapter housing 16 in the form of a (screwable / fixed) ring for fixing the universal adapter 12 to the sieve tray bottom 102 of the ultrasonic sieve 101.

[0068] Additionally, the universal adapter has a wired signal interface 26 in the form of a high frequency coaxial cable that is conductively connected to the antenna contacts 18 for transferring high frequency signals and driving the antenna 14 .

[0069] Additionally, the universal adapter 12 has magnets 28 that provide a press-fit, detachable connection with the universal adapter 12, and particularly with the counter adapter 110 of the holder 106 that is complementary to the universal adapter 12. In this embodiment, the universal adapter 12 has two spaced apart magnets 28 with opposite magnetic polarities aligned parallel to one another to ensure positive alignment of attachment to the counter adapter 110 with the complementary positioned magnets. Additionally, the universal adapter 12 has three asymmetrically positioned protrusions 30 that prevent improper alignment when connecting to the counter adapter 110.

[0070] Thus, in particular, the ultrasonic sieve 101 shown in Figures 3 to 6 already implements a tracking system with a control unit (not shown) according to a preferred embodiment. The detection unit, configured to provide an unambiguous identification of the medical product 1, in particular the identification number stored in the transponder 4 of the medical product 1, is realized by the transponder reading / writing device 6. The sensor configured to detect the sonication of the medical product 1 is realized by an electronic module with a temperature sensor and an ultrasonic sensor for detecting immersion and sonication. The control unit (not shown) of the tracking system is configured to increment (by one) a sterilization cycle history counter associated with the medical product 1 and store this counter by the transponder reading / writing device in a storage unit, in particular in the transponder 4 of the medical product 1, and issue a warning message to the user via the visual display device 10 and / or initiate an automatic function recovery process for the medical product 1 if the counter exceeds a predetermined limit value associated with the medical product 1.

[0071] 7 shows a multi-reader for a tracking system, which has a universal adapter 12 in the center of its base in order to be able to read medical products 1 placed in a holder (similar to the ultrasonic sieve 101 described above) with an antenna 14. Via the universal adapter 12, a predetermined standardized interface for a detection unit in the form of a transponder read / write device can be provided. The multi-reader is thus configured to detect the unambiguous identification information of the medical product 1, which is stored as an identification number in the transponder 4 of the medical product 1.

[0072] The tracking system according to a preferred embodiment, including the multi-reader of Figure 7, further comprises a sensor configured to detect ultrasonic treatment of the medical product 1 and / or maintenance of the medical product 1, in particular oiling (in particular by a separate oil sprayer 108, as disclosed in Figures 8 and 9 below). A control unit (not shown), which may for example be provided in the multi-reader, is particularly configured to increment (by one) a sterilization cycle history counter associated with the medical product 1 upon detection and to store the counter in the transponder 4 of the medical product 1 by means of the transponder reading / writing device. Furthermore, if the counter exceeds a predetermined limit value associated with the medical product 1, the control unit is configured to output a warning message to the user via a visual display device (not shown) and / or to initiate an automatic recovery process of the functionality of the medical product 1.

[0073] 8 and 9 show an oil sprayer 108 having a counter adapter 110 that is complementary to the universal adapter 12. This allows the oil sprayer to connect to a service station via the universal adapter and raise the counter for medical products.

[0074] (Reference List) 1. Medical Products 2 Detection Unit 4 transponders 6 Transponder Read / Write Device 8 Storage Units 10 Visual display devices 12 Universal Adapters 14 Antenna 16 Adapter housing 18 Antenna Contact Point 20 Top side 22 Contact surface 24 Fixed part 26 Signal Interface 28 Magnet 30 protrusions 101 Ultrasonic sieve 102 Sieve tray bottom 104 Communication Unit 106 Holder 108 Oil Sprayer 110 Counter adapter S1. Obtaining medical product identification information Steps to read the S2 counter S3 Discover Processing Steps S4 Step to save the changed counter S5 Step to determine if the medical product is within the warning range S6a Step to output a warning message S6b Steps to start the recovery process

Claims

1. 1. A computer-implemented tracking method for tracking the sterilization cycle history of a medical product (1), in particular an instrument or medical device with a motor system, comprising: obtaining (S1) by means of a detection unit (2) the unique identification information of the medical product (1), in particular the identification number stored in the transponder (4) of the medical product (1) by means of a transponder reading / writing device (6); reading (S2) a sterilization cycle history counter associated with a medical product (1) with identification information; detecting ultrasonic treatment of the medical product (1) and / or maintenance, in particular lubrication, of the medical product (1) and incrementing a sterilization cycle history counter associated with the medical product (1); storing (S4) said counter in a storage unit (8) in particular in the transponder (4) of the medical product (1) by means of a transponder reading / writing device (6); If the counter exceeds a predetermined limit value associated with the medical product (1), determining (S5) that the medical product (1) is in a warning range, and outputting (S6a) a warning message to a user via a visual display device (10) and / or initiating (S6b) an automatic recovery process to restore functionality of the medical product (1).

2. In the case of a medical product (1) equipped with a transponder (4), the step of reading the counter of the sterilization cycle history includes reading the counter stored in the transponder (4) in addition to reading the identification number from the transponder (4), 2. The computer-implemented tracking method of claim 1, wherein in the step of storing the counter, the counter is stored in a transponder (4) associated with the medical product (1).

3. In the reading step, a stored counter of the sterilization cycle history associated with the medical product (1) is read on a central server in the storage unit; 3. The computer-implemented tracking method according to claim 1 or 2, characterized in that in the step of saving the counter, the incremented counter together with the identification information is saved in a storage unit of a central server of the medical product (1), providing a centralized data management of the sterilization history of the medical product (1), in particular for a plurality of different medical products (1).

4. 4. A computer-implemented tracking method according to any one of claims 1 to 3, characterized in that the predetermined limit value is defined to be less than the useful life of the number of sterilization article cycles associated with the medical product (1), so that a warning message is issued to the user and / or an automatic recovery process is initiated even before the end of the useful life is reached.

5. In the medical product (1), both an ultrasound counter as a first counter and a maintenance counter as a second counter are stored; 6. A computer-implemented tracking method according to any one of claims 1 to 5, characterized in that if both ultrasonic treatment of the medical product (1) and maintenance of the medical product (1) are detected, both counters are increased by one each, and if at least one of the counters exceeds a predetermined limit value, the medical product (1) is determined to be within a warning range.

6. 6. A computer-implemented tracking method according to any one of claims 1 to 5, characterized in that in the step of detecting ultrasonic treatment, the ultrasonic treatment is detected via a sensor configured to detect contact with a fluid and / or to detect ultrasonic waves.

7. The tracking method further comprises the steps of generating images, in particular by a multi-reader camera and / or LIDAR device; - determining the condition of the medical product (1), in particular the cutting edge quality condition and / or cutting edge shape of the surgical instrument, based on the image; In case of an unsatisfactory state, outputting a warning message to the user via a visual display device and / or initiating an automatic recovery process of the functionality of the medical product (1).

8. The step of determining the state further includes: transmitting the image as input data and a condition judgment, in particular a binary condition judgment of satisfactory / inasufficient, to a trained AI system on a central server, the trained AI system having been trained using cutting edge qualities of surgical instruments, and performing the condition judgment by the trained AI system; 8. A computer-implemented tracking method according to claim 7, characterized in that sending certain status to multiple readers is also preferably performed.

9. A tracking system for tracking the sterilization cycle history of a medical product (1), in particular an instrument or medical device with a motor system, comprising: a detection unit configured to detect the unique identification of the medical product (1), in particular the identification number stored in the transponder (4) of the medical product (1) by means of a transponder reading / writing device (6); a sensor configured to detect the ultrasonic treatment of the medical product (1) and / or the maintenance, in particular the refueling, of the medical product (1); a control unit configured to increment (by one) a sterilization cycle history counter associated with the medical product (1) and to store said counter in a storage unit, in particular in a transponder (4) of the medical product (1), by means of a transponder read / write device, and to issue a warning message to a user via a visual display device and / or to initiate an automatic recovery process of the functionality of the medical product (1) if said counter exceeds a predetermined limit value associated with the medical product (1).

10. A universal adapter (12) for connecting an antenna (14) for tracking the sterilization cycle history of a medical product (1), in particular in a computer-implemented tracking method according to any one of claims 1 to 8 or in a tracking system according to claim 9, an adapter housing (16) with an antenna contact point (18), with two mutually spaced electrical contact surfaces (22) arranged on the upper side (20) and exposed to the outside of the adapter housing (16) for a standardized connection structure for connecting a signal technology cable to the antenna, in particular with exactly two electrical contact surfaces; a fixing part (24) of the adapter housing, in particular in the form of a ring, for fixing the universal adapter (12) to an object, in particular to an ultrasonic sieve; A universal adapter (12) comprising a wired signal interface (26), in particular a high frequency coaxial cable, conductively connected to an antenna contact point for passing signals, in particular high frequency signals.

11. The universal adapter (12) has at least one magnet (28) for providing a force-fit, detachable coupling with the universal adapter (12), particularly for a counter adapter complementary to the universal adapter (12); 11. The universal adapter (12) according to claim 10, characterized in that the universal adapter (12) preferably comprises two spaced magnets (28) aligned parallel to each other and with opposite magnetic polarity, in particular by using complementary arranged magnets to ensure one-to-one alignment of attachment with the counter adapter.

12. An ultrasonic sieve (101) for receiving medical products (1) and immersing them in an ultrasonic bath, comprising: The ultrasonic sieve (101) has at least one universal adapter (12) according to claim 10 or 11, which is attached to the sieve (101), in particular to the sieve tray bottom (102), via its fixing part, and is connected to a central communication unit (104) via its signal interface (26), so that an antenna (14) connectable via the antenna contact point (18) is used for reading and / or writing the transponder (4) of the medical product (1).

13. A computer readable storage medium comprising instructions that, when executed by a computer, cause the computer to perform the method steps according to any one of claims 1 to 8.

14. A computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method steps according to any of claims 1 to 8.

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