DE102022128059A1 - Optimized sterile cycle tracking system, tracking procedure and computer-readable storage medium - Google Patents

Abstract

The present disclosure relates to a 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, comprising the steps of: 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 sterile cycle history counter associated with the medical device (1) with identification; detecting (S3) an ultrasound treatment of the medical device (1) and/or 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). In addition, the present disclosure relates to a tracking system, a universal adapter, a computer-readable storage medium and a computer program according to the independent claims.

Description

Technical area

The present disclosure relates to a computer-implemented tracking method for tracking a sterile cycle history of a medical product, in particular an instrument or a medical device with a motor system. In addition, the present disclosure relates to 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.

Background of the revelation

In general, medical devices such as surgical instruments or surgical equipment are subject to strict processing, care and sterilization requirements. They go through a so-called sterile goods cycle.

1. 1. Prozessschritt eine manuelle oder maschinelle Vorreinigung des Medizinprodukts, insbesondere mittels Ultraschall;
2. 2. Prozessschritt eine Desinfektion des Medizinprodukts;
3. 3. Prozessschritt eine Pflege oder Wartung des Medizinprodukts, insbesondere eines Ölens eines Medizinprodukts mit einem integrierten Motor bzw. Motorsystem,
4. 4. Prozessschritt eine Sterilisation des Medizinproduktes, und schließlich
5. 5. Prozessschritt dem medizinischen Einsatz bzw. der eigentlichen Verwendung des Medizinprodukts, insbesondere bei einem chirurgischen Eingriff.

Such a sterile goods circuit for a medical device such as a surgical instrument or device with a motor system has or consists of the following process steps in particular:

1. 1. Process step: manual or mechanical pre-cleaning of the medical device, in particular by means of ultrasound;
2. 2nd process step: disinfection of the medical device;
3. 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. 4. Process step a sterilization of the medical device, and finally
5. 5. Process step the medical application or the actual use of the medical device, especially during a surgical procedure.

Such a sterile goods circuit/sterile goods cycle is repeated until the medical device is either defective or has exceeded its specified service life and must be replaced.

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.

To date, there is no way, particularly on the part of the manufacturer of the medical device, to retrospectively determine the service life of medical devices or to collect data on the medical devices used, in particular on the number of runs through a sterile goods cycle. The manufacturer is therefore dependent on the good cooperation and honesty of the customer in order to obtain the relevant data on the medical device. In addition, there is the problem that it is largely not possible to ensure that the customer actually collects data on each medical device, in particular data at the serial number level, in order to reliably track and trace a single individual medical device.

Summary of Revelation

It is therefore the object of the present disclosure to avoid or at least reduce the disadvantages of the prior art and in particular to provide a tracking method, a tracking system, a universal adapter, an ultrasonic sieve as well as a computer-readable storage medium and a computer program that allows efficient and effective tracking of runs of a sterile goods cycle, in particular at the level of a single, individual medical product that has a unique identification (ID), in particular a unique serial number. A further sub-task is to ensure the guaranteed availability of medical products in the sterile goods cycle, preferably in the operating room, in order to prevent surgical delays and surgical cancellations and thereby increase the safety of an intervention and also minimize costs.

The objects are achieved with regard to a tracking method by the features of claim 1, with regard to a tracking system by the features of claim 9, with regard to a universal adapter by the features of claim 10, with regard to an ultrasonic sieve by the features of claim 12, with regard to a computer-readable storage medium by the features of claim 13 and with regard to a computer program by the features of claim 14.

A basic idea of the present disclosure is to use “data points” or process to use steps in the sterile goods cycle which 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 which 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, in particular in the respective handpieces, can then be increased step by step (plus one), in particular by means of an antenna. If it is recorded on a medical device-related basis, right down to the serial number, whether the medical device or devices have gone through these process steps, then this collected data can be used to make a statement about a service life based on the data already collected and on the basis of predictive models, for example based on historical data on the service life of a medical device, a statement about future availability and possible failures. A warning message can be issued from this 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 a repair or another action to remedy the defect can also be triggered fully automatically. Minimum requirements for a medical device's service life are therefore defined in order to guarantee and ensure guaranteed availability in the customer's clinic. This can achieve an availability of over 90%.

In other words, a computer-implemented tracking method is provided for tracking a sterile cycle history of a medical device, in particular an instrument or a medical device with a motor system, which has the steps: 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 care, in particular oiling, of the medical device and increasing the sterile cycle history counter associated with the medical device (incrementally, i.e. plus one); storing the counter in a storage 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 when the counter exceeds a predefined limit associated with the medical device, with output of 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 an optimized tracking method in the sterile goods cycle. This detection of a process step would take place in particular in at least one, in particular all, of the following process steps: ultrasonic bath, cleaning and disinfection and/or care (maintenance).

All these measures contribute to the guaranteed availability of medical devices and ensure that clinics can maintain their processes without interruption, while a manufacturer also preferably receives an overview of the medical devices and their condition.

Advantageous embodiments are claimed in the subclaims and are explained in particular below.

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 stored directly in the medical device. This counter stored in the transponder can be read out using various transponder readers, for example before or after an operation, for example to carry out random checks or to determine the condition of the medical device.

In particular, the tracking method can be adapted to read, in the step of reading, a counter of a sterile cycle history stored on a central server (for example data from a cloud) in a storage unit associated with the medical device; and, in the step of storing the counter, the incrementally increased counter in the storage unit of the central server associated with the medical device with the identification is stored in order to provide central data management of the sterile goods history of the medical device, in particular for a large number of different medical devices. If, for example, a central database is stored with each individual medical device manufactured, with each database entry comprising at least one identification number, an associated counter and a predefined limit value for the counter, the runs of the sterile goods 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.

In particular, the predefined limit value can be defined as less than a service life of a number of sterile goods cycles associated with the medical device, so that a warning message is issued to a user and/or the automated recovery process is started before the end of a service life is reached. This gives the user enough lead time to prepare the medical device and restore its functionality or to exchange the medical device for a new one, for example in an automated logistics system with medical devices kept in stock.

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, and in the event that both an ultrasound treatment of the medical device and a care of the medical device are detected, the counters are each increased by one or, if the ultrasound treatment is detected, only the ultrasound counter is increased accordingly and if the care is detected, only the care counter is increased accordingly and it is determined that the medical device is in the warning range if at least one counter exceeds a predefined limit value. For this purpose, a (first) predefined limit value for ultrasound and a (second) predefined limit value for care can be stored for the medical device or a class of a medical device, for example a surgical scalpel. In this way, it can be determined even more precisely when a medical device enters a warning range, for example if the steps do not always have to be carried out together. Alternatively, a sum of the ultrasound counter and the care counter can be created, and if this sum exceeds a predefined limit value, it can be determined that the warning range exists.

In particular, if both an ultrasound treatment of the medical device and a care of the medical device are detected, the counter can only be increased by one. This ensures that the counter is only increased by one in the case of only one run. Alternatively, if in addition to the ultrasound treatment and care of the medical device, a step of reading and/or writing is carried out by a multi-reader, the counter can be increased by exactly one. Here, too, exactly one run is recorded and the counter is increased accordingly.

According to a further embodiment, in the step of detecting an ultrasonic treatment, a sensor that is adapted to detect contact with a fluid and/or to detect ultrasound can detect the ultrasonic treatment. In other words, for example, immersion in an ultrasonic bath can be detected 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 carried out. At the same time, quality assurance can be ensured over the duration.

The tracking method can also preferably further comprise the steps of: creating a recording; in particular via a camera and/or a LIDAR device (light detection and ranging; LADAR) of a multi-reader, determining a condition of the medical device based on the recording, in particular a determination of a condition of a cutting edge quality and/or a cutting edge geometry of a surgical instrument, and, in the case of an inadequate condition, 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. 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.

Preferably, the tracking method in the step of determining the state can further comprise the step of: transmitting the recording to a trained AI system (artificial intelligence system/AI system) of a central server, which 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 carrying out a determination of a state by the trained AI system; wherein further preferably a transmission of the specific state on the multi-reader/multi-reader-writer device.

Before the maintenance process step, the medical devices in the sterile goods cycle can preferably be inspected by an employee of the Central Sterile Supply Department (CSSD). The functionality of the medical device can also be assessed here.

The data can preferably also be recorded at the customer's premises. This can be done in particular (in addition to manual notes and subsequent digitization in order to be able to use the data) by directly recording and storing (logging) in a computer environment (with the appropriate computer program) in order to be able to use the data later. The prerequisite for this is that the data points are logged/generated by the customer and must be made available to the manufacturer in order to then derive actions based on them. This can be used to guarantee availability as a service. This represents the minimum requirement for the recording of data at the customer's premises.

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).

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 has: a detection unit which is 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 in the medical device; a sensor which is 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 which is 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 value associated with the medical device, to issue a warning message to a user via a visual display device and/or to start an automated process to restore the functionality of the medical device. In this way, the tracking system can log and track the runs of the individual medical device and, if necessary, namely when the warning range is entered, issue appropriate warnings or have a restoration process carried out, in particular in time so that the necessary medical devices with a sufficient service life are available again for a surgical procedure. In this way, a guaranteed availability of the medical device or devices can be guaranteed.

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 has: 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, wired connection to an antenna, a fastening section of the adapter housing, in particular in the form of a ring, in order to fasten the universal adapter to an object, in particular an ultrasonic sieve, and a wired signal interface, in particular a high-frequency coaxial cable, which is conductively connected to the antenna contact point in order to forward a data signal, in particular a high-frequency signal (HF signal). A type of extension cable is therefore provided for connecting an antenna for reading the transponder, but which has a defined connection point, a type of plug, so that the antenna, for example a holder with an antenna, can be easily and safely connected, for example plugged in or inserted, using 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 arranged 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, in order to provide a power supply, for example for a medical device connected in the area of the antenna. A standardized interface is therefore created in order to provide at least one signal line to the transponder of the medical device using simple and quick coupling.

In particular, the universal adapter can have at least one magnet to provide a force-fitting, detachable coupling with the universal adapter, in particular for a counter adapter designed to complement the universal adapter, wherein the universal adapter preferably has two magnets 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.

In particular, the universal adapter can also have asymmetrically arranged projections on its top to ensure that the mating adapter is aligned in one way. Similar to a USB-A connection, the universal adapter and mating adapter can only be coupled to one another in one orientation. This is particularly important for direct current transmission.

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

The universal adapter can preferably be designed to be waterproof, in particular it can have a fluid-tight housing that encloses an interior and only the electrical contacts are open to the outside in order to ensure continued functionality 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, as this creates a short circuit between the two contact surfaces and this electrical conductivity of the electrical circuit can be used as a parameter.

With regard to an ultrasonic sieve for receiving medical products 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 bowl base, and is connected to a central communication unit via its signal interface, so that an antenna that can be connected via the antenna contact point is used for reading and/or writing a transponder of the medical product. The universal adapter thus connects the connection of the communication unit to the antenna for reading the transponder as a type of extension with a defined interface. In this way, the medical products can be arranged in different positions in the sieve basket and the antennas for reading and/or writing are placed near them and easily connected via the universal adapter. Since HF signals are also transmitted, there is no need for the laborious screwing on of an antenna cable, such as an antenna of a holder, and the antenna can be connected via plug-and-play.

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 large number of medical products, wherein the holder has a counter adapter designed to complement the universal adapter in order to connect the holder centrally to the universal adapter. In this way, the respective transponders of a large number of medical products, for example handpieces with motor systems, 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 medical products equipped with RFID are arranged or mounted. Special electronics, such as an antenna, can be installed underneath the handpieces, which can be adapted using the contact system of the universal adapter and thus plug & play. This transmits the high-frequency signal/HF signal reliably and is particularly functional even under water.

In particular, in addition to the signal, a direct current (DC) can also be transmitted via the signal interface in order to provide electrical energy for the medical device.

• - Detektion eines Ultraschallbades mittels Ultraschallsensor;
• - Detektion einer Reinigung- und Desinfektion mittels eines Temperatursensors und/oder eines Drucksensors;
• - Kommunikationsmodul, insbesondere für eine drahtlose Datenübertragung mittels Bluetooth, besonders bevorzugte mittels Bluetooth low energy (BLE), wireless lan (WLAN) und ähnlichen Übertragungsmodalitäten, um mit einem Lese- und/oder Schreibgerät, insbesondere einem Multireader, kommunizieren zu können; und/oder
• - Detektion der Pflege durch Öl mittels eines Temperatur- und/oder Drucksensors.

As a further variant, the ultrasonic sieve can be equipped with an electronic module/electronics which is adapted to be able to detect or have at least one of the following properties:

• - Detection of an ultrasonic bath using an ultrasonic sensor;
• - Detection of cleaning and disinfection by means of a temperature sensor and/or a pressure sensor;
• - Communication module, in particular for wireless data transmission by means of Bluetooth, particularly preferably by means of 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
• - Detection of oil treatment using a temperature and/or pressure sensor.

An ultrasonic sieve can be provided, which does not completely and thus does not have to pass the high temperature and high pressure phase of sterilization, so that the electronics of the ultrasonic sieve are suitable accordingly. 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 or disinfection or care. The ultrasonic sieve can also have a communication module of the communication unit that is adapted for wireless transmission of data.

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.

In particular, the ultrasonic sieve can perform an additional function in combination with the universal adapter or the universal interface, namely an antenna can be contacted via this and the data (e.g. the counter) can be written into the transponders (e.g. RFID glass tags). During the oiling process step, the handpieces are simultaneously sprayed with oil. The ultrasonic sieve could also recognize the process step in the ultrasonic bath and write the data into the medical products, especially the handpieces, using the universal adapter and the antenna connected to the holder.

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.

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

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 comprises a universal adapter according to the present disclosure.

In particular, the multi-reader can be used to identify medical devices. This can be done in particular via a data matrix code (e.g. QR code) and/or a barcode and/or a transponder, such as an RFID chip. A camera system can also be given an important function, both for recognizing a data matrix code (QR code) and also, preferably in further steps, for assessing a medical device, such as the cutting quality of a cutting instrument. This evaluation can preferably be used in combination with an AI algorithm to determine the remaining service life. The universal adapter or port itself then reads the individual handpieces and plays the data as an interface in a database, for example in the cloud directly into the respective cloud databases. The multi-reader itself could therefore be used to transfer the data via communication (such as BLE, WLAN, etc.). The data could then be played into a server or cloud or other programs via the multi-reader and the service life of each individual medical device could be logged.

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.

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.

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.

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.

Short description of the characters

• 1a eine schematische Ansicht eines Sterilgutzyklus bei dem ein Nachverfolgungsverfahren einer bevorzugten Ausführungsform zum Einsatz kommt, bei dem an zwei Stationen eine Erfassung eines Durchlaufs des Sterilgutzyklus stattfindet;
• 1b ein Flussdiagramm eines Nachverfolgungsverfahrens gemäß einer ersten bevorzugten Ausführungsform, welches bei dem Sterilgutzyklus aus 1a zur Anwendung kommt;
• 2 eine schematische Ansicht eines weiteren Sterilgutzyklus einer weiteren Variante mit einem Nachverfolgungsverfahren, in welchen an drei Stationen eine Erfassung eines Durchlaufs stattfindet;
• 3 eine perspektivische Ansicht eines Ultraschallsiebs mit einer zentralen Kommunikationseinheit und zwei angebundenen Universaladapter für eine kontaktgebundene Anbindung von Instrumenten;
• 4 eine perspektivische Ansicht des Sterilisierkorbs aus 3 mit zwei Halterungen, in der Instrumente und Handstücke aufgenommen sind, wobei jeweils eine Antenne in Kontakt mit dem Universaladapter steht;
• 5 eine perspektivische Ansicht eines Universaladapters gemäß einer bevorzugten Ausführungsform;
• 6 eine Längsschnittansicht des Universaladapters aus 5;
• 7 eine perspektivische Ansicht eines Multi-Readers (Lese- und Schreibgerät) mit einem mittig angeordneten Universaladapter zum kontaktgebundenen Lesen und Schreiben gemäß einer bevorzugten Ausführungsform;
• 8 eine perspektivische Ansicht eines Ölsprühers mit einem Universaladapter; und
• 9 eine weitere, detailliertere perspektivische Teilansicht des Ölsprühers aus 8 von einer unteren Seite.

The present disclosure is explained in more detail below using preferred embodiments with reference to the accompanying figures. They show:

• 1a 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;
• 1b a flow chart of a tracking method according to a first preferred embodiment, which is used in the sterile goods cycle of 1a applies;
• 2 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;
• 3 a perspective view of an ultrasonic sieve with a central communication unit and two connected universal adapters for a contact-based connection of instruments;
• 4 a perspective view of the sterilization basket from 3 with two holders in which instruments and handpieces are accommodated, with one antenna in each case in contact with the universal adapter;
• 5 a perspective view of a universal adapter according to a preferred embodiment;
• 6 a longitudinal section view of the universal adapter 5 ;
• 7 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;
• 8th a perspective view of an oil sprayer with a universal adapter; and
• 9 another, more detailed perspective partial view of the oil sprayer from 8th from a lower side.

The figures are schematic in nature and are intended only to assist in understanding the invention. Identical elements are provided with the same reference numerals. The features of the various embodiments can be interchanged.

Detailed description of preferred embodiments

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.

1. 1. Prozessschritt eine manuelle oder maschinelle Vorreinigung des Medizinprodukts 1, insbesondere mittels Ultraschall;
2. 2. Prozessschritt eine Desinfektion des Medizinprodukts 1;
3. 3. Prozessschritt eine Pflege oder Wartung des Medizinprodukts 1, insbesondere eines Ölens eines Medizinprodukts 1 mit einem integrierten Motor bzw. Motorsystem (etwa des Handstücks mit Motor),
4. 4. Prozessschritt eine Sterilisation des Medizinproduktes 1, und schließlich
5. 5. Prozessschritt dem medizinischen Einsatz bzw. der eigentlichen Verwendung des Medizinprodukts 1, insbesondere bei einem chirurgischen Eingriff.

The sterile goods cycle has five stations or process steps:

1. 1. Process step: manual or mechanical pre-cleaning of the medical device 1, in particular by means of ultrasound;
2. 2nd process step: disinfection of the medical device 1;
3. 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 (e.g. the handpiece with motor),
4. 4. Process step a sterilization of the medical device 1, and finally
5. 5. Process step the medical application or the actual use of the medical device 1, in particular during a surgical procedure.

In this case, the passage of medical device 1 through the sterile goods cycle is recorded at the pre-cleaning stations in the form of ultrasound treatment and care with oil. These two stations are the most relevant stations with regard to the service life of medical device 1.

In concrete terms, this is achieved by 1b realized.

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. The medical device can thus be uniquely identified and linked to stored data associated with the medical device 1.

In a step S2, a counter of a sterile cycle history associated with the medical device 1 with identification is read in. After the connection with the relevant data, the associated counter is read in.

In a step S3, an ultrasound 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.

In a subsequent step S4, the now increased counter is stored in a storage unit 8, in particular in the transponder 4 of the medical device 1 itself by a transponder read-write device 6.

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). If the sterile goods cycle for the individual medical device 1 has been run through too often, the state 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 recognized that the life expectancy may soon be reached and in a step S6a a warning message is issued to a user via a visual display device 10, for example in the form of a display.

Alternatively or additionally, an automated recovery process to restore the functionality of the medical device 1 can also be started in a step S6b.

This sequence of the above steps also takes place at the care station where the medical device is sprayed with oil. However, this only establishes that the counter has already been increased at the ultrasound station, so that no further incremental increase of the counter takes place at this station.

Alternatively, it can be specified that the counter is only increased when the medical device has passed through both the pre-cleaning station and the care station. Alternatively, the counter can also be increased at each of the two stations, although in this case a cumulative predefined limit is also used to take this into account. The two decisive stations are each marked with an asterisk.

2 shows a schematic view of another sterile goods cycle of another variant with a tracking procedure in which a run is recorded at three stations; In contrast to the sterile goods cycle from 1 Another station is provided on a so-called multi-reader. The multi-reader can also detect a run and can be provided instead of or in addition to the other two pre-cleaning and maintenance stations.

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 as well as in the 5 and 6 the universal adapter 12 separately.

The ultrasonic sieve 101, in 3 without medical devices 1 and in 4 with holder and medical devices, is intended and designed to accommodate medical devices 1 and immerse them in an ultrasonic bath.

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 exchange data wirelessly via WLAN or Bluetooth with a data interface in order to be able to access stored data on the medical devices 1. As described later, a connectable antenna (14) can be used via the universal adapter 12 for reading and/or writing a transponder (4) of the medical device (1). In particular, the ultrasonic sieve has an electronic module with a temperature sensor and an ultrasonic sensor in order to detect immersion and ultrasonic treatment.

With reference to the 5 and 6 the universal adapter 12 is described in more detail. The universal adapter 12 is used for coupling an antenna 14 for tracking a 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 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 order to be able to produce a standardized coupling structure for a signal-technical, 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 in order to fasten the universal adapter 12 to the sieve tray base 102 of the ultrasonic sieve 101.

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 forward a high-frequency signal and thus control the antenna 14.

In addition, the universal adapter 12 has magnets 28 to provide a force-fitting, detachable coupling with the universal adapter 12, in particular for a counter adapter 110 of the holders 106 that is designed to complement the universal adapter 12. In this embodiment, the universal adapter 12 has two magnets 28 that are spaced apart from one another and are aligned parallel to one another but with opposite magnetic polarity in order to ensure a unique alignment of a connection, namely to a counter adapter 110 with complementarily arranged magnets. The universal adapter 12 also has three asymmetrically arranged projections 30 which prevent incorrect alignment when connected to the mating adapter 110.

7 shows a multi-reader which has a universal adapter in the middle of a base in order to be able to read medical products 1 arranged on a holder with antennas 14, which are designed similarly to the ultrasound sieve 101 above. A defined standardized interface can be provided via the universal adapter 12.

8th and 9 show an oil sprayer 108, which has a counter adapter 110 that is complementary to the universal adapter 12. This allows the oil sprayer to be connected to the care station via a universal adapter and a counter for the medical device to be increased.

List of reference symbols

1

Medical device

2

Registration unit

4

Transponder

6

Transponder reader/writer

8th

Storage unit

10

Display device

12

Universal adapter

14

antenna

16

Adapter housing

18

Antenna contact point

20

Top

22

Contact surface

24

Mounting section

26

Signal interface

28

magnet

30

head Start

101

Ultrasonic sieve

102

Sieve tray bottom

104

Communication unit

106

bracket

108

Oil sprayer

110

Counter adapter

S1

Step 1: Entering an identification of a medical device

S2

Step Reading a meter

S3

Step Detecting a process step

S4

Step Save the modified counter

S5

Step Determine whether medical device is in warning range

S6a

Step Output Warning Message

S6b

Step Start recovery process

Claims (14)

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 sterile cycle history counter associated with the medical device (1) with identification; detecting (S3) an ultrasound treatment of the medical device (1) and/or 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) by 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). Computer-implemented tracking procedure 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 carried out; and in the step of storing the counter, the counter is stored in the transponder (4) associated with the medical device (1). 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 step of storing the counter, 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 goods history of the medical device (1), in particular for a large number of different medical devices (1). Computer-implemented tracking method according to one of the preceding claims, characterized in that the predefined limit value is defined as smaller than a service life of a number of sterile goods 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 an end of a service life is reached. 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. 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. Computer-implemented tracking method according to one of the preceding claims, characterized in that the tracking method further comprises the steps of: 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). Computer-implemented tracking procedure according to Claim 7 , characterized in that in the step of determining the state, it further comprises the step of: transmitting 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 state determination, in particular a binary state determination sufficient-inadequate, and carrying out a determination of a state by the trained AI system; wherein further preferably a transmission of the determined state to the multi-reader is carried out. 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 has: 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 which is 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 which 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 value associated with the medical device (1), to issue 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). Universal adapter (12) for coupling an antenna (14) for tracking a sterile cycle history of a medical device (1), comprising: an adapter housing (16) with an antenna contact point (18) with two spaced-apart antennas (12) arranged on an upper side (20) and for Electrical contact surfaces (22) exposed on the outside of the adapter housing (16), in particular with exactly two electrical contact surfaces, for a standardized coupling structure for a signal-related, wired 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 wired signal interface (26), in particular a high-frequency coaxial cable, which is conductively connected to the antenna contact point in order to forward a signal, in particular a high-frequency signal. Universal adapter (12) to Claim 10 , characterized in that the universal adapter (12) has at least one magnet (28) to provide a non-positive, detachable coupling with the universal adapter, in particular for a counter adapter designed to be complementary to 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. Ultrasonic sieve (101) for receiving medical products (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 via its fastening section to the sieve (101), in particular to a sieve bowl base (102), and is connected via its signal interface (26) to a central communication unit (104), 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). Computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to perform the method steps according to one of the Claims 1 until 8th to execute. Computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method steps according to one of the Claims 1 until 8th to execute.

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