Optimised tracking system in sterile product cycle, tracking method and computer-readable storage medium
Patent Information
- Application Number
- EP2023797720
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-10-24
- Filing Date
- 2023-10-23
- Publication Date
- 2025-09-03
AI Technical Summary
Current medical devices lack a reliable method for tracking their sterile cycle history, leading to uncertain service life and potential operational delays or cancellations, as manufacturers rely on customer data that is often incomplete or inaccurate.
A computer-implemented tracking method and system that uses incremental counters for medical devices to record ultrasound treatment and care processes, linked to unique identification numbers, to predict service life and initiate warnings or automated recovery processes when predefined limits are reached, ensuring guaranteed availability of medical devices.
This approach ensures over 90% availability of medical devices by providing timely warnings and automated recovery processes, preventing operational disruptions and maintaining device quality.
Smart Images
Figure 1.1
Abstract
Description
[0001] Optimized tracking system in the sterile goods cycle, tracking procedure and computer-readable storage medium
[0002] Description
[0003] Technical area
[0004] The present disclosure relates to a computer-implemented tracking method for tracking a sterile cycle history of a medical device, in particular an instrument or a medical device with a motor system. Furthermore, the present disclosure relates to a tracking system, a universal adapter for tracking a sterile cycle history, an ultrasonic sieve, a computer-readable storage medium, and a computer program according to the preambles of the independent claims.
[0005] Background of the Revelation
[0006] In general, medical devices, such as surgical instruments or surgical devices, are subject to strict processing, care, and sterilization requirements. They undergo a so-called sterile supply cycle.
[0007] Such a sterile supply cycle for a medical device such as a surgical instrument or device with a motor system comprises or consists of the following process steps in particular:
[0008] 1. Process step: manual or mechanical pre-cleaning of the medical device, in particular by means of ultrasound;
[0009] 2. Process step: disinfection of the medical device;
[0010] 3. Process step a care or maintenance of the medical device, in particular an oiling of a medical device with an integrated motor or motor system, 4. Process step a sterilization of the medical device, and finally
[0011] 5. Process step the medical application or the actual use of the medical device, especially in a surgical procedure.
[0012] Such a sterile supply cycle is repeated until the medical device is either defective or has exceeded its specified service life and must be replaced.
[0013] According to the current state of affairs, medical devices are usually used until they are no longer functional, i.e. defective, are subject to their intended maintenance interval or are (subjectively) assessed by the user as no longer functional.
[0014] To date, there is no way, especially for the medical device manufacturer, to retrospectively determine the service life of medical devices or to collect data on the medical devices used, especially on the number of cycles through a sterile supply cycle. The manufacturer is therefore dependent on the customer's good cooperation and honesty to obtain relevant data on the medical device. Furthermore, there is the problem that, for the most part, it cannot be guaranteed that the customer actually collects data on each medical device, especially data at the serial number level, in order to reliably track and trace a single medical device.
[0015] Summary of Revelation
[0016] It is therefore the object of the present disclosure to avoid or at least mitigate the disadvantages of the prior art and, in particular, to provide a tracking method, a tracking system, a universal adapter, an ultrasonic sieve, a computer-readable storage medium, and a computer program that allows efficient and effective tracking of runs in a sterile supply cycle, particularly at the level of a single, individual medical device having a unique identification (ID), in particular a unique serial number. A further sub-objective is to ensure the guaranteed availability of medical devices in the sterile supply cycle, preferably in the operating room, in order to prevent surgical delays and interruptions, thereby increasing the safety of an intervention and also minimizing costs.
[0017] The objects are achieved according to the invention by the features of claim 1 with regard to a tracking method, by the features of claim 9 with regard to a tracking system, by the features of claim 10 with regard to a universal adapter, by the features of claim 12 with regard to an ultrasonic sieve, by the features of claim 13 with regard to a computer-readable storage medium and by the features of claim 14 with regard to a computer program.
[0018] A fundamental idea of the present disclosure therefore provides for the use of "data points" or process steps in the sterile supply cycle that have a maximum influence on the service life of a medical device and thus its availability, in order to ultimately ensure "guaranteed availability," i.e., to keep medical devices available for a medical procedure that still have a sufficient service life so that they do not become defective during use. Mechanical pre-cleaning using ultrasound and product care, in particular oiling the medical device, were identified as such relevant data points with a significant influence on product quality, in particular a motor system of a medical device.By detecting this process step, an incremental counter for the respective medical device, particularly in the respective handpieces, can then be increased step by step (plus one), particularly using an antenna. If it is recorded on a medical device-specific basis, down to the serial number, whether the medical device or medical devices have completed these process steps, this collected data can be used to make a statement regarding a service life based on the data already collected and on the basis of predictive models, for example based on historical data on a medical device's service life, a statement about future availability and possible failures. Based on this, a warning message can be issued or an automated recovery process can be initiated. For example, an automated repair of a repair system for the medical device can be started.A reorder or repair can also trigger a further action to remedy the shortage fully automatically. Thus, minimum requirements regarding the service life of a medical device are defined to ensure and ensure guaranteed availability in the customer's hospital. This can achieve availability of over 90%.
[0019] In other words, a computer-implemented tracking method for tracking a sterile cycle history of a medical device, in particular an instrument or a medical device with a motor system, is provided, comprising the steps of: detecting a unique identification of the medical device by a detection unit, in particular an identification number stored in a transponder of the medical device by a transponder read / write device; reading in a sterile cycle history counter associated with the medical device with identification; detecting an ultrasound treatment of the medical device and / or a care, in particular oiling, of the medical device and incrementing the sterile cycle history counter associated with the medical device (incrementally, i.e., plus one); storing the counter in a memory unit, in particular in the transponder of the medical device by a transponder read / write device;and determining that the medical device is in a warning range if the counter exceeds a predefined limit associated with the medical device, with outputting a warning message to a user via a visual display device and / or starting an automated recovery process to restore the functionality of the medical device. This provides, so to speak, an optimized tracking method in the sterile supply cycle. This recording of a process step would take place in particular in at least one, but especially all, of the following process steps: ultrasonic bath, cleaning and disinfection, and / or maintenance. All of these measures contribute to the guaranteed availability of medical devices and ensure that clinics can maintain their processes without interruption, whereby a manufacturer preferably also receives an overview of the medical devices and their condition.
[0020] Advantageous embodiments are claimed in the subclaims and are explained in particular below.
[0021] According to a preferred embodiment, in the case of a medical device with a transponder, in the step of reading the sterile cycle history counter, in addition to reading (reading out) the identification number from the transponder, the counter stored in the transponder can also be read; and in the step of storing the counter, the counter is stored in the transponder associated with the medical device. In this way, in addition to the identification, the counter associated with the medical device is also stored directly in the medical device. This counter stored in the transponder can be read using various transponder readers, for example before or after an operation, in order to carry out random checks or to determine the condition of the medical device.
[0022] In particular, the tracking method can be adapted to read in a sterile cycle history counter stored on a central server (e.g., data from a cloud) in a storage unit associated with the medical device in the reading step; and in the counter storing step, the incrementally increased counter is stored in the storage unit of the central server for the medical device with the identification in order to provide central data management of the sterile goods history of the medical device, in particular for a plurality of different medical devices.For example, if a central database is stored with each individual medical device manufactured, with each database entry containing at least an identification number, an associated counter and a predefined limit value for the counter, the runs through the sterile supply cycle of each medical device can be recorded via the associated counter and if the counter is greater than or equal to the limit value, the warning message is issued or the recovery process is started.
[0023] In particular, the predefined limit can be defined as less than the number of sterile cycles associated with the medical device's service life, so that a warning message is issued to the user and / or the automated recovery process is initiated even before the end of the service life is reached. This gives the user sufficient lead time to reprocess the medical device and restore its functionality or even replace the medical device with a new one, for example, in an automated logistics system with medical devices in stock.
[0024] According to one embodiment, both an ultrasound counter as the first counter and a care counter as the second counter can be stored for the medical device. If both an ultrasound treatment of the medical device and care of the medical device are detected, the counters are each incremented by one, or, if the ultrasound treatment is detected, only the ultrasound counter is incremented accordingly, and if care is detected, only the care counter is incremented accordingly, and it is determined that the medical device is in the warning range if at least one counter exceeds a predefined limit. For this purpose, a (first) predefined limit for ultrasound and a (second) predefined limit for care can be stored for the medical device or a class of medical device, for example a surgical scalpel.This allows for even more precise determination of when a medical device enters a warning zone, for example, when the steps don't always need to be performed together. Alternatively, a sum of the ultrasound counter and the care counter can be created, and if this sum exceeds a predefined limit, it can be determined that the warning zone exists.
[0025] In particular, if both ultrasound treatment of the medical device and care of the medical device are detected, the counter can only be incremented by one. This ensures that the counter is only incremented by one for a single pass. Alternatively, if, in addition to the ultrasound treatment and care of the medical device, a reading and / or writing step is performed by a multi-reader, the counter can be incremented by exactly one. In this case, too, exactly one pass is recorded, and the counter is incremented accordingly.
[0026] According to a further embodiment, in the step of detecting an ultrasonic treatment, a sensor adapted to detect contact with a fluid and / or detect ultrasound can detect the ultrasonic treatment. In other words, immersion in an ultrasonic bath can be detected, for example, via a water sensor, and / or ultrasound can be detected via an ultrasonic sensor, so that it can be determined based on this that an ultrasonic treatment is being performed. At the same time, quality assurance can be ensured over time.
[0027] The tracking method can also preferably further comprise the steps of: creating an image, in particular via a camera and / or a LIDAR (light detection and ranging; LADAR) device of a multi-reader, determining a condition of the medical device based on the image, in particular determining a condition of a cutting edge quality and / or a cutting edge geometry of a surgical instrument, and, in the event of an inadequate condition, issuing a warning message to a user via a visual display device and / or starting an automated process to restore the functionality of the medical device. This provides an additional safety mechanism that prevents a medical device from being prepared for a surgical procedure even though its condition requires replacement. This allows an assessment of service life aspects, such as cutting edge quality and cutting edge geometry, to be carried out.
[0028] Preferably, the tracking method may further comprise the step of determining the state: transmitting the recording to a trained AI system (artificial intelligence system) of a central server, which AI system is trained with a cutting edge quality of a surgical instrument as input data and a state determination, in particular a binary state determination "sufficient" - "inadequate" (1 - 0; state good - state insufficient), and performing a determination of a state by the trained AI system; wherein further preferably a transmission of the determined state to the multi-reader / multi-read-write device is performed.
[0029] Before the maintenance process step, medical devices in the sterile supply cycle can preferably be inspected by an employee of the Central Sterile Supply Department (CSSD). This can also assess the functionality of the medical device.
[0030] Data collection can preferably also be carried out by the customer of the medical device. This can be done, in particular (alongside or in addition to manual recording and subsequent digitization for data use) by directly capturing and storing (logging) data in a computer environment (with an appropriate computer program) for subsequent data use. The prerequisite for this is that the data points are logged / generated by the customer and made available to the manufacturer so that actions can then be derived based on them. This allows for guaranteed availability as a service. This represents the minimum requirement for data collection at the customer's site.
[0031] According to a further embodiment of an extended variant, a partially automated tracking method can be used which, with the aid of different electronic components, records at least some of the process steps, in particular all process steps, of the sterile goods cycle (automatically).
[0032] The objects are achieved with regard to a tracking system for tracking a sterile cycle history of a medical device, in particular an instrument or a medical device with a motor system, in that the tracking system comprises: a detection unit adapted to detect a unique identification of the medical device, in particular an identification number stored in a transponder of the medical device by means of a transponder read / write device or by means of a camera and a QR code integrated into the medical device; a sensor adapted to detect an ultrasound treatment of the medical device and / or a care of the medical device, in particular oiling;and a control unit adapted to increase the sterile cycle history counter associated with the medical device (incrementally by one) and to store the counter in a storage unit, in particular in the transponder of the medical device by means of a transponder read-write device;and if the counter exceeds a predefined limit associated with the medical device, to issue a warning message to a user via a visual display and / or to initiate an automated process to restore the functionality of the medical device. In this way, the tracking system can log and track the individual medical device's cycles and, if necessary—namely, upon entering the warning range—issue appropriate warnings or initiate a restoration process, particularly in time for the necessary medical devices with a sufficient service life to be available again for a surgical procedure. In this way, guaranteed availability of the medical device(s) can be guaranteed.
[0033] In particular, the tracking system may comprise a medical device with the transponder, wherein the control unit is adapted to read the counter in the transponder of the medical device by a transponder read-write device and, after incremental incrementation by the transponder read-write device, to store it (again) in the transponder of the medical device.
[0034] Preferably, the tracking system may comprise a sensor adapted to detect contact with a fluid and / or detect ultrasound to detect the ultrasonic treatment. Upon detection of the ultrasonic treatment, the counter may then be incremented accordingly.
[0035] According to one embodiment, the tracking system may comprise a multi-reader with a camera and / or a LIDAR device. In particular, the tracking system may further comprise a trained AI system trained with a cutting edge quality of a surgical instrument as input data and a condition determination, in particular a binary condition determination of "sufficient / insufficient," and the control unit may be adapted to transmit a recording to the trained AI system and, after a condition has been determined by the trained AI system, to output a warning message to a user via a visual display device in the event of an inadequate condition and / or to start an automated process to restore the functionality of the medical device.
[0036] The objects are achieved with regard to a universal adapter / tracking adapter for coupling an antenna for tracking a sterile cycle history of a medical device, in that the universal adapter comprises: an adapter housing with an antenna contact point with two electrical contact surfaces spaced apart from one another, arranged on a top side and exposed to the outside of the adapter housing, in particular with exactly two electrical contact surfaces, for a standardized coupling structure for a signal-related, cable-based connection to an antenna, a fastening section of the adapter housing, in particular in the form of a ring, for fastening the universal adapter to an object, in particular an ultrasonic sieve, and a cable-based signal interface, in particular a high-frequency coaxial cable, which is conductively connected to the antenna contact point in order to transmit a data signal,In particular, a high-frequency signal (RF signal) is to be transmitted. A type of extension cable is provided for connecting an antenna for reading the transponder. However, it has a defined connection point, a type of connector, so that the antenna, for example, a holder with an antenna, can be easily and securely connected, for example, plugged in or inserted, via plug-and-play. The universal adapter has such a signal interface, which is precisely adapted to transmit the high-frequency signals for the antenna for reading and writing the transponder, so that the antenna is located near the medical device with the transponder and can be read in the near field. A direct current, for example, 3V, 5V, or 12V, can also be transmitted, preferably via the antenna contact point, to provide a power supply.For example, for a medical device connected in the antenna area. A standardized interface is thus created to provide at least one signal line to the medical device's transponder via a simple and quick connection.
[0037] In particular, the universal adapter can have at least one magnet to provide a force-locking, detachable coupling with the universal adapter, in particular for a mating adapter designed complementarily to the universal adapter, wherein the universal adapter preferably has two spaced-apart magnets which are aligned parallel to each other but with opposite magnetic polarity in order to ensure an unambiguous alignment of a connection, in particular to a mating adapter with complementarily arranged magnets.
[0038] In particular, the universal adapter can further have asymmetrically arranged protrusions on its top side to ensure a unique orientation of the mating adapter. Similar to a USB-A connector, the universal adapter and mating adapter can only be connected in one orientation. This is particularly important for DC power transmission.
[0039] In particular, the signal interface may comprise a shielded coaxial cable for transmitting the RF signals.
[0040] The universal adapter can preferably be designed to be waterproof, in particular with a fluid-tight housing enclosing an interior space, with only the electrical contacts exposed to the outside, to ensure continued functionality even during or after immersion in an ultrasonic bath. In particular, immersion in an ultrasonic bath can be detected via the antenna contact point with the two contact surfaces, since this creates a short circuit between the two contact surfaces, and this electrical conductivity of the electrical circuit can be used as a parameter.
[0041] With regard to an ultrasonic sieve for accommodating medical devices and immersing them in an ultrasonic bath, the objects are achieved in that the ultrasonic sieve has at least one universal adapter according to the present disclosure, which is attached to the ultrasonic sieve via its attachment section, in particular to a sieve tray base, and is connected to a central communications unit via its signal interface, so that an antenna connectable via the antenna contact point is used for reading and / or writing a transponder of the medical device. Thus, the universal adapter, as a type of extension with a defined interface, connects the connection of the communications unit to the antenna for reading the transponder.This allows medical devices to be arranged in various positions within the basket, and the antennas for reading and / or writing are placed close to them and easily connected via the universal adapter. Since RF signals are also transmitted, there's no need for the laborious task of screwing on an antenna cable, such as an antenna or a mount, and the antenna can be connected via plug-and-play.
[0042] According to one embodiment, the ultrasonic sieve can further comprise a holder with an antenna, wherein the holder is adapted to accommodate and hold, in particular to fix, a plurality of medical devices, wherein the holder has a mating adapter designed to complement the universal adapter in order to centrally connect the holder to the universal adapter. Thus, for a plurality of medical devices, for example handpieces with motor systems, the respective transponders can be read and / or written using just one universal adapter. In particular, an antenna can be attached to the respective holders on which the RFID-equipped medical devices are arranged or attached. Special electronics, such as an antenna, can be installed beneath the handpieces and can be adapted using the contact system of the universal adapter, thus being plug & play.This transmits the high-frequency signal / HF signal reliably and is particularly functional even under water.
[0043] In particular, a direct current (DC) can be transmitted via the signal interface in addition to the signal to provide electrical energy for the medical device. As a further variant, the ultrasonic sieve can be equipped with an electronic module / electronics that is adapted to detect or exhibit at least one of the following properties:
[0044] - Detection of an ultrasonic bath using an ultrasonic sensor;
[0045] - Detection of cleaning and disinfection using a temperature sensor and / or a pressure sensor;
[0046] - Communication module, in particular for wireless data transmission via Bluetooth, particularly preferably via Bluetooth low energy (BLE), wireless LAN (WLAN) and similar transmission modalities, in order to be able to communicate with a reading and / or writing device, in particular a multi-reader; and / or
[0047] - Detection of oil care using a temperature and / or pressure sensor.
[0048] An ultrasonic sieve can be provided that does not completely complete the sterile goods cycle and thus does not have to undergo the high-temperature and high-pressure sterilization phase, so that the electronics of the ultrasonic sieve are accordingly suitable. In other words, the ultrasonic sieve can, in particular, have an ultrasonic sensor to detect an ultrasonic bath. The ultrasonic sieve can also have a temperature sensor and / or pressure sensor to detect cleaning, disinfection, or care. The ultrasonic sieve can also have a communication module of the communication unit that is adapted for wireless data transmission.
[0049] In one embodiment, the ultrasonic sieve may be equipped with electronics or a detector adapted to detect the immersion of the ultrasonic sieve in an ultrasonic bath as well as the ultrasonic operation itself.
[0050] In particular, the ultrasonic sieve, in combination with the universal adapter or universal interface, can perform an additional function: it can be used to connect to an antenna, allowing data (e.g., the counter) to be written to the transponders (e.g., RFID glass tags). During the oiling process step, the handpieces are simultaneously sprayed with oil. The ultrasonic sieve could also detect the process step in the ultrasonic bath and write the data to the medical devices, especially the handpieces, using the universal adapter and the attached antenna on the holder.
[0051] In particular, the ultrasonic sieve can have a self-sufficient energy source and the power supply of the electronics in the ultrasonic sieve can be solved in particular via a primary cell or via an accumulator which can be charged inductively during the process or is charged in the respective process steps by means of energy harvesting.
[0052] In particular, the tracking system of the present disclosure may include a universal adapter and / or an ultrasonic sieve according to the present disclosure.
[0053] In particular, the tracking system may further comprise a medical oil sprayer for spraying a medical device (which comprises an engine system) with oil, wherein the oil sprayer / oil sprayer comprises a universal adapter according to the present disclosure.
[0054] In particular, the multi-reader can be used to identify medical devices. This can be done using a data matrix code (e.g., a QR code) and / or a barcode and / or a transponder, such as an RFID chip. A camera system can also play an important role, both for recognizing a data matrix code (QR code) and, preferably in further steps, for assessing a medical device, such as the cutting edge quality of a cutting instrument. This evaluation can preferably be used in combination with a KL algorithm to determine the remaining service life. The universal adapter or port itself then also reads the individual handpieces and plays the data as an interface into a database, for example, directly into the respective cloud databases.The multi-reader itself would therefore allow data transfer via communication (such as BLE, Wi-Fi, etc.). The data could then be uploaded to a server, cloud, or other programs via the multi-reader, and the lifespan of each individual medical device could be logged.
[0055] The multi-reader can also have the universal adapter to provide batch reading of the holders and the medical devices with transponders held on the holders.
[0056] With regard to a computer-readable storage medium or computer program, the objects are achieved in that it comprises instructions which, when executed by a computer, cause the computer to carry out the method steps of the tracking method according to the present embodiment.
[0057] The universal adapter as a contact system can be adapted in shape and size, whereby the geometric dimensions in length / width / height can be 30mm / 12mm / 7mm in particular and are therefore very small in order to be able to be arranged at different points on an ultrasonic sieve or an oil sprayer, for example.
[0058] The disclosure regarding the tracking method of the present disclosure applies equally to the tracking system, the universal adapter and the ultrasonic sieve of the present disclosure and vice versa.
[0059] Short description of the characters
[0060] The present disclosure will be explained in more detail below using preferred embodiments with reference to the accompanying figures. They show:
[0061] Fig. 1a is a schematic view of a sterile goods cycle in which a tracking method of a preferred embodiment is used, in which a run of the sterile goods cycle is recorded at two stations; Fig. 1b is a flowchart of a tracking method according to a first preferred embodiment, which is used in the sterile goods cycle of Fig. 1a.
[0062] Fig. 2 is a schematic view of another sterile goods cycle of a further variant with a tracking method in which a run is recorded at three stations;
[0063] Fig. 3 is a perspective view of an ultrasonic sieve with a central communication unit and two connected universal adapters for a contact-based connection of instruments according to a preferred embodiment, in particular for a tracking system according to a preferred embodiment;
[0064] Fig. 4 is a perspective view of the sterilization basket of Fig. 3 with two holders in which instruments and handpieces are accommodated, with one antenna in each case in contact with the universal adapter;
[0065] Fig. 5 is a perspective view of a universal adapter according to a preferred embodiment;
[0066] Fig. 6 is a longitudinal sectional view of the universal adapter of Fig. 5;
[0067] Fig. 7 is a perspective view of a multi-reader (reading and writing device) with a centrally arranged universal adapter for contact-based reading and writing according to a preferred embodiment;
[0068] Fig. 8 is a perspective view of an oil sprayer with a universal adapter; and
[0069] Fig. 9 shows a further, more detailed, partial perspective view of the oil sprayer from Fig. 8, taken from a lower side. The figures are schematic in nature and are intended only to aid understanding of the invention. Like elements are designated by the same reference numerals. The features of the various embodiments can be interchanged.
[0070] Detailed description of preferred embodiments
[0071] Fig. 1 shows a schematic sterile goods cycle in which a computer-implemented tracking method is used to track a sterile cycle history of a medical device 1, for example in the form of a surgical instrument or a handpiece with a motor system.
[0072] The sterile goods cycle has five stations or process steps:
[0073] 1. Process step: manual or mechanical pre-cleaning of the medical device 1, in particular by means of ultrasound;
[0074] 2. Process step: disinfection of the medical device 1 ;
[0075] 3. Process step a care or maintenance of the medical device 1 , in particular an oiling of a medical device 1 with an integrated motor or motor system (such as the handpiece with motor),
[0076] 4. Process step a sterilization of the medical device 1 , and finally
[0077] 5. Process step the medical application or the actual use of the medical device 1 , in particular during a surgical procedure.
[0078] In this case, the passage of Medical Device 1 through the sterile supply cycle is recorded at the pre-cleaning stations in the form of ultrasonic treatment and oil treatment. These two stations are the most relevant stations with regard to the service life of Medical Device 1.
[0079] Specifically, this is realized by the method shown in Fig. 1 b.
[0080] At the pre-cleaning station, in a step S1, a unique identification of the medical device 1 is recorded by a recording unit 2, in particular an identification number stored in a transponder 4 of the medical device 1 by a transponder read-write device 6. Thus, the medical device can be uniquely identified and linked to stored data associated with the medical device 1.
[0081] In step S2, a counter from a sterile cycle history associated with the medical device 1 with identification is read in. After connecting to the relevant data, the corresponding counter is read in.
[0082] In a step S3, an ultrasonic treatment of the medical device 1 of the medical device 1 is detected and, as a result, the counter of the sterile cycle history associated with the medical device 1 is incrementally increased by one.
[0083] In a subsequent step S4, the now increased counter is stored in a memory unit 8, in particular in the transponder 4 of the medical device 1 itself by a transponder read-write device 6
[0084] Finally, in a step S5, it is determined that the medical device 1 is in a warning range, namely when the counter exceeds a predefined limit value associated with the medical device (1). Therefore, if the sterile supply cycle for the individual medical device 1 has been run through too often, the status of the medical device 1 can change from a "green" range to a "yellow" range before it reaches a "red" range of unusability of the medical device 1. In this case, the "yellow" range of a warning is already detected, indicating that the life expectancy may soon be reached, and in a step S6a, a warning message is output to a user via a visual display device 10, for example in the form of a display.
[0085] Alternatively or additionally, an automated recovery process can also be initiated in step S6b to restore the functionality of medical device 1. This sequence of the above steps also occurs at the care station, where the medical device is sprayed with oil. However, this only determines that the counter has already been increased at the ultrasound station, so no further incremental increase of the counter takes place at this station.
[0086] Alternatively, the counter can be incremented only after the medical device has passed through both the pre-cleaning station and the care station. Alternatively, the counter can also be incremented at each of the two stations, although in this case, a cumulative, predefined limit is also applied to account for this. The two critical stations are each marked with an asterisk.
[0087] Fig. 2 shows a schematic view of another variant of a sterile goods cycle with a tracking method in which a run is recorded at three stations. In contrast to the sterile goods cycle in Fig. 1, an additional station is provided at a so-called multi-reader. The multi-reader can also detect a run and can be used instead of or in addition to the other two pre-cleaning and maintenance stations.
[0088] Figs. 3 to 6 show an ultrasonic sieve 101 with a central communication unit 102 and two connected universal adapters 12 for a contact-based connection of instruments, and in Figs. 5 and 6 the universal adapter 12 separately, in particular for a tracking system according to a preferred embodiment with a control unit.
[0089] The ultrasonic sieve 101, shown in Fig. 3 without medical devices 1 and in Fig. 4 with holder and medical devices, is intended and designed to hold medical devices 1 and to be immersed in an ultrasonic bath.
[0090] For this purpose, the ultrasonic sieve 101 has two universal adapters 12 according to a preferred embodiment, each of which is fastened to a sieve tray base 102 via its fastening section 24 and is connected to a central communication unit 104. This communication unit 104 can wirelessly exchange data via WLAN or Bluetooth with a data interface in order to access stored data on the medical devices 1. As described later, a connectable antenna (14) for reading and / or writing a transponder (4) of the medical device (1) can be used via the universal adapter 12. In particular, the ultrasonic sieve has an electronic module with a temperature sensor and an ultrasonic sensor for detecting immersion and ultrasonic treatment.
[0091] The universal adapter 12 is described in more detail with reference to Figs. 5 and 6. The universal adapter 12 serves to couple an antenna 14 for tracking the sterile cycle history of a medical device 1. For this purpose, it has an adapter housing 16 with an antenna contact point 18 with exactly two spaced-apart electrical contact surfaces 22 arranged on a top side 20 and exposed to the outside of the adapter housing 16 in order to be able to establish a standardized coupling structure for a signal-related, cable-based connection to an antenna 14. The universal adapter also has a fastening section 24 of the adapter housing 16 in the form of a (screw-on / fastening) ring for fastening the universal adapter 12 to the sieve tray base 102 of the ultrasonic sieve 101.
[0092] Furthermore, the universal adapter has a wired signal interface 26 in the form of a high-frequency coaxial cable, which is conductively connected to the antenna contact point 18 in order to transmit a high-frequency signal and thus control the antenna 14.
[0093] In addition, the universal adapter 12 has magnets 28 to provide a force-fitting, detachable coupling to the universal adapter 12, in particular for a mating adapter 110 of the holders 106 that is complementary to the universal adapter 12. In this embodiment, the universal adapter 12 has two spaced-apart magnets 28 that are aligned parallel to each other but with opposite magnetic polarity to ensure a unique alignment of a connection, namely to a mating adapter 110 with complementarily arranged magnets. Furthermore, the universal adapter 12 has three asymmetrically arranged projections 30 that prevent incorrect alignment when connected to the mating adapter 110.
[0094] Thus, in particular, the ultrasonic sieve 101 shown in Figs. 3 to 6 already implements a tracking system with a control unit (not shown) according to a preferred embodiment. The detection unit, which is adapted to provide a unique identification of the medical device 1, in particular an identification number stored in a transponder 4 of the medical device 1, is implemented by the transponder read / write device 6. The sensor, which is adapted to detect ultrasonic treatment of the medical device 1, is implemented by the electronic module with a temperature sensor and an ultrasonic sensor for detecting immersion and ultrasonic treatment.A control unit (not shown) of the tracking system is adapted to increase the sterile cycle history counter associated with the medical device 1 (incrementally by one) and to store the counter in a storage unit, in particular in the transponder 4 of the medical device 1 by means of a transponder read-write device; and if the counter exceeds a predefined limit associated with the medical device 1, to issue a warning message to a user via a visual display device 10 and / or to start an automated process for restoring the functionality of the medical device 1.
[0095] Fig. 7 shows a multi-reader for a tracking system, which has a universal adapter 12 centrally located on a base for reading medical devices 1 arranged on a holder with antennas 14, which are designed similarly to the ultrasonic sieve 101 described above. A defined, standardized interface of a recording unit in the form of a transponder read / write device can be provided via the universal adapter 12. The multi-reader is thus adapted to record the unique identification of the medical device 1 or medical devices 1, which is stored as an identification number in a transponder 4 of the medical device 1. A tracking system according to a preferred embodiment, which uses the multi-reader from Fig.7, further comprises a sensor adapted to detect an ultrasound treatment of the medical device 1 and / or a care of the medical device 1, in particular oiling, in particular by a separate oil sprayer 108, as disclosed in the following Figs. 8 and 9. A control unit (not shown), which may be provided, for example, in the multi-reader, is specifically adapted to increase the sterile cycle history counter associated with the medical device 1 (incrementally by one) upon detection and to store the counter in the transponder 4 of the medical device 1 by the transponder read-write device.Furthermore, the control unit is adapted to issue a warning message to a user via a visual display device (not shown here) when the counter exceeds a predefined limit value associated with the medical device 1 and / or to start an automated process of restoring the functionality of the medical device 1.
[0096] Figs. 8 and 9 show an oil sprayer 108 having a counter adapter 110 complementary to the universal adapter 12. This allows the oil sprayer to be connected to the nursing station via a universal adapter, and a counter for the medical device can be increased.
[0097] List of reference symbols
[0098] 1 medical device
[0099] 2 recording unit
[0100] 4 transponders
[0101] 6 Transponder read-write device
[0102] 8 storage unit
[0103] 10 Display device
[0104] 12 universal adapters
[0105] 14 Antenna
[0106] 16 adapter housings
[0107] 18 Antenna contact point
[0108] 20 Top
[0109] 22 Contact surface
[0110] 24 Fastening section
[0111] 26 Signal interface
[0112] 28 Magnet
[0113] 30 lead
[0114] 101 Ultrasonic sieve
[0115] 102 Sieve tray bottom
[0116] 104 Communication unit
[0117] 106 Bracket
[0118] 108 oil sprayers
[0119] 110 counter adapters
[0120] 51 Step Recording an identification of a medical device
[0121] 52 Step Reading a Meter
[0122] 53 Step Detecting a process step
[0123] 54 Step Saving the changed counter
[0124] 55 Step Determine whether medical device in warning area
[0125] S6a Step Output Warning Message
[0126] S6b Step Start Recovery Process
Claims
Claims 1 . Computer-implemented tracking method for tracking a sterile cycle history of a medical device (1 ), in particular an instrument or a medical device with a motor system, characterized by the steps: Detecting (S1) a unique identification of the medical device (1) by a detection unit (2), in particular an identification number stored in a transponder (4) of the medical device (1) by a transponder read-write device (6); Reading (S2) a counter of a sterile cycle history associated with the medical device (1) with identification; Detecting (S3) an ultrasound treatment of the medical device (1) and / or a care, in particular oiling, of the medical device (1) and increasing the sterile cycle history counter associated with the medical device (1); Storing (S4) the counter in a storage unit (8), in particular in the transponder (4) of the medical device (1) by a transponder read-write device (6); and Determining (S5) that the medical device (1) is in a warning range when the counter exceeds a predefined limit value associated with the medical device (1), with outputting (S6a) a warning message to a user via a visual display device (10) and / or starting an automated recovery process (S6b) to restore the functionality of the medical device (1).
2. Computer-implemented tracking method according to claim 1, characterized in that in the case of a medical device (1) with a transponder (4), in the step of reading the counter of the sterile cycle history, in addition to reading (reading out) the identification number from the transponder (4), a reading of the counter stored in the transponder (4) is also carried out; and In the step of storing the counter, the counter is stored in the transponder (4) associated with the medical device (1).
3. Computer-implemented tracking method according to one of the preceding claims, characterized in that in the reading step, a counter of a sterile cycle history stored on a central server in a storage unit associated with the medical device (1) is read in; and in the storing step, the incrementally increased counter is stored in the storage unit of the central server for the medical device (1) with the identification in order to provide central data management of the sterile histones of the medical device (1), in particular for a plurality of different medical devices (1).
4. Computer-implemented tracking method according to one of the preceding claims, characterized in that the predefined limit value is defined as less than a service life of a number of sterile cycles associated with the medical device (1), so that a warning message is issued to a user and / or the automated recovery process is started even before the end of a service life is reached.
5. Computer-implemented tracking method according to one of the preceding claims, characterized in that both an ultrasound counter as a first counter and a care counter as a second counter are stored for the medical device (1), and in the event that both an ultrasound treatment of the medical device (1) and a care of the medical device (1) are detected, the counters are each increased by one and it is determined that the medical device (1) is in the warning range if at least one counter exceeds a predefined limit value.
6. Computer-implemented tracking method according to one of the preceding claims, characterized in that in the step of detecting an ultrasonic treatment, the ultrasonic treatment is detected via a sensor which is adapted to detect contact with a fluid and / or to detect ultrasound.
7. Computer-implemented tracking method according to one of the preceding claims, characterized in that the tracking method further comprises the steps: Creating a recording; in particular via a camera and / or a LIDAR device of a multi-reader, Determining a state of the medical device (1) on the basis of the recording, in particular a determination of a state of a cutting edge quality and / or a cutting edge geometry of a surgical instrument, and, in the case of an inadequate state, issuing a warning message to a user via a visual display device and / or starting an automated process for restoring the functionality of the medical device (1).
8. A computer-implemented tracking method according to claim 7, characterized in that in the step of determining the state, it further comprises the step of: Transferring the recording to a trained AI system of a central server, which is trained with a cutting edge quality of a surgical instrument as input data and a condition determination, in particular a binary condition determination sufficient-insufficient, and performing a determination of a condition by the trained AI system; Furthermore, the specific state is preferably transmitted to the multi-reader.
9. Tracking system for tracking a sterile cycle history of a medical device (1), in particular an instrument or a medical device with a motor system, characterized in that the tracking system comprises: a detection unit which is adapted to detect a unique identification of the medical device (1), in particular an identification number stored in a transponder (4) of the medical device (1) by means of a transponder read-write device (6); a sensor adapted to detect an ultrasound treatment of the medical device (1) and / or a care of the medical device (1), in particular oiling; a control unit adapted to increase the sterile cycle history counter associated with the medical device (1) (incrementally by one) and to store the counter in a memory unit, in particular in the transponder (4) of the medical device (1) by means of a transponder read / write device; and if the counter exceeds a predefined limit value associated with the medical device (1), to output a warning message to a user via a visual display device and / or to start an automated process for restoring the functionality of the medical device (1).
10. A universal adapter (12) for coupling an antenna (14) for tracking a sterile cycle history of a medical device (1), in particular in a computer-implemented tracking method according to one of claims 1 to 8 or in a tracking system according to claim 9, comprising: an adapter housing (16) with an antenna contact point (18) with two electrical contact surfaces (22) spaced apart from one another, arranged on a top side (20) and exposed to the outside of the adapter housing (16), in particular with exactly two electrical contact surfaces, for a standardized coupling structure for a signal-related, cable-based connection to an antenna, a fastening section (24) of the adapter housing, in particular in the form of a ring, for fastening the universal adapter (12) to an object, in particular an ultrasonic sieve, and a cable-based signal interface (26), in particular a high-frequency coaxial cable,which is conductively connected to the antenna contact point in order to transmit a signal, in particular a radio-frequency signal.
11. Universal adapter (12) according to claim 10, characterized in that the universal adapter (12) has at least one magnet (28) to provide a force-locking, releasable coupling with the universal adapter, in particular for a counter-adapter designed to complement the universal adapter (12), wherein the universal adapter (12) preferably has two magnets (28) spaced apart from one another, which are aligned parallel to one another but with opposite magnetic polarity in order to ensure an unambiguous alignment of a connection, in particular to a counter-adapter with complementarily arranged magnets.
12. Ultrasonic sieve (101) for receiving medical devices (1) and immersing them in an ultrasonic bath, characterized in that the ultrasonic sieve (101) has at least one universal adapter (12) according to claim 10 or 11, which is fastened to the sieve (101) via its fastening section, in particular to a sieve tray base (102), and is connected to a central communication unit (104) via its signal interface (26), so that an antenna (14) which can be connected via the antenna contact point (18) is used for reading and / or writing a transponder (4) of the medical device (1).
13. A computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to carry out the method steps according to 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 one of claims 1 to 8.