How to track and record the work cycle of sterilizable medical products

Abstract

The invention relates to a method for determining and recording a work cycle of a sterilizable medical product (2) preferably held in a holding device (1) in preferably wireless communication with an external data processing device (6) preferably arranged in the holding and / or storage device (1), for this purpose firstly the execution of a process step of the work cycle, or each process step, is determined depending on an output signal of at least one sensor (7; 8), preferably arranged in the holding and / or storage device (1), which output signal is then (further) processed by the data processing device (6) to form cycle information, which cycle information (6) is finally stored in a data chain / data sequence stored in a data memory (9) of the medical product (2), which cycle information being stored in exactly one bit in the data chain.

Description

Technical Field

[0001] The present disclosure relates to a method for detecting and recording the working cycle of a washable / sterilizable medical product, particularly preferably a holding / rinsing and / or storage device, particularly a handpiece held in a motor system or other system and a sieve holder. The medical product is preferably arranged in a holding device or communicates wirelessly with an external data processing device connected to the holding device. For this purpose, first, the individual process steps of the working cycle, or the execution of each individual process step, are preferably detected as a function of the output signal of at least one sensor arranged in the holding device. Then, the output signal is (further) processed by the data processing device to form cycle information, and this cycle information is finally stored in a data chain / data sequence stored in the data memory of the medical product.

Background Art

[0002] In most cases, the detection of the sterilization cycle for medical instruments and tools is based on documentary recording or confirmation at the end of the reprocessing cycle. The problem is that it is impossible to determine whether and how the individual process steps of the sterilization cycle, such as pre-washing, washing and disinfection, maintenance, and sterilization, have been carried out. Effective data is created by documentary recording, but this procedure takes time and is very error-prone. Furthermore, the operating hours of electrical, pneumatic, or hydraulic products cannot be recorded in relation to each tool or product, i.e., at the individual product level. Another problem is the lack of identification of individual instruments and tools, as well as the detection and determination of their service life or traceability.

[0003] For the monitoring and traceability of sterilized products, it must be possible to determine whether medical technology instruments or devices have undergone the entire reprocessing process successfully and whether all necessary maintenance or process steps have been performed. The problem is that sensors can only be housed in large devices, and instruments that are not currently regulated cannot be monitored.

[0004] For this purpose, special holding devices are typically used for cleaning and holding motors and / or handpieces of surgical instruments (as is the case in this disclosure). Such holding devices are described in particular in German Patent Application Publication No. 10 2010 017 624. The holders are placed together with the medical products that are contained within the holding devices in medical cleaning plants, particularly sterilizers and rinsing plants. Furthermore, the holders may be used with and placed inside a sterilization container to ensure that re-contamination of the medical products is effectively prevented after sterilization.

[0005] Furthermore, reusable implants, for example, are typically reprocessed, similar to the surgical instruments mentioned earlier. When there are many such reprocessable implants, especially those made of titanium, frequent reprocessing can lead to a decline in the quality of the medical product. For example, in the case of titanium screws, the thickness of the oxide film protecting the screw from corrosion and biofilm formation decreases with frequent use of strong cleaning agents. Reprocessable implants often come in sets, and the reprocessing process is always carried out together, regardless of whether the individual elements of the set are actually used.

[0006] However, it is currently impossible to count the (fully correct) rework cycles associated with a product and to detect, record, and derive relevant conclusions from this information. In other words, automated recording of rework cycles at the individual product level, or throughout the entire lifecycle of a tool or product, is currently unknown.

[0007] The reprocessing cycle essentially includes a manual pre-cleaning step and / or a mechanical pre-cleaning step in an ultrasonic bath, a cleaning step in a washing and disinfecting unit (WD), maintenance steps such as lubrication if necessary, and a sterilization step.

[0008] Due to a lack of information regarding the (correctly) executed cycle, the following points cannot be stated with certainty: - Overall condition - Service life / Service life deadline - Maintenance interval - Execution and suitability for subsequent operations (as described in the purpose description) - Product maintenance and, if any, reduction of product damage. - Temperature overshoot and undershoot, and, if applicable, product damage.

[0009] In the future, issues related to tracking, traceability, and lifecycle management will become increasingly important, as will the submission of evidence when complaints arise. Therefore, as mentioned earlier, hospitals are spending considerable time and effort manually discovering and recording this information in databases.

[0010] Currently, users or customers cannot directly determine how many times a product or tool has been (correctly) reworked, or whether there are defects or abnormalities in the (reworking) process, or whether maintenance may be required. Until now, products had to adhere to prescribed maintenance intervals, even if maintenance was not required based on their condition.

[0011] Conventional technology To track the number of times a medical product, such as a handpiece, has been (correctly) reworked during its service life, it is known that the motor of the medical product may be equipped with an integrated temperature sensor, for example, which includes an independent energy supply unit or energy harvesting unit, thereby detecting the temperature during the rework / cleaning process and storing it in the motor's data memory. A motor with a memory device suitable for this purpose is described, for example, in German Patent Application Publication No. 10 2011 050 192. The inherent drawbacks of such solutions are that they occupy a relatively large installation space on the medical product and increase its weight. These drawbacks are unacceptable, especially for medical products used in neurosurgery, minimally invasive procedures, or similar procedures.

[0012] Furthermore, German Patent Application Publication No. 10 2018 126 969A1 provides a holding device for holding at least one sterilizable medical product, particularly during a cleaning process, and for storing the medical product before and / or after the cleaning process. The holding device comprises a data processing device that is signal-conductively connected to at least one sensor, the sensor being, in particular, a temperature sensor for measuring the temperature during the cleaning process, and / or a pressure sensor for measuring the static and / or dynamic pressure of the cleaning solution during the cleaning process. The data processing device processes the sensor signals into cleaning information. Furthermore, the data processing device may be connected to a data memory of the medical product so that the cleaning information is stored in the data memory. That is, the data processing device can write the determined cleaning information to the data memory of the medical product.

[0013] In other words, the holding device or product detection system of German Patent Application Publication No. 10 2018 126 969A1 allows for the counting of the rework cycles of the entire product in combination with individually performed memory, and enables this information to be stored on the product itself. In particular, it is also possible to see whether all individual process steps have been observed and performed. As mentioned above, the number of rework cycles is a proportional measure of the overall condition, service life or expiration date, maintenance intervals, performance and suitability of follow-up operations, improper care of the product and the resulting product damage, as well as temperature overshoot and undershoot, and product damage.

[0014] This means that traditional solutions for recording sterilization product cycles require a significant amount of manual labor. When packaging products or tools within a medical product reprocessing unit (AEMP), it is often necessary to inspect the products (part number and serial number) and then import the information into the software. This is a manual, error-prone, labor-intensive, and time-consuming handling process.

[0015] The first step towards optimized detection of the sterilization goods cycle is the known detection of barcodes, data matrix codes, or RFID chips. However, sometimes this still requires manual steps such as scanning with additional (reading) devices. Under certain circumstances, this can only be done at one point in the sterilization goods cycle, providing only selective insights into the process.

[0016] However, conventional solutions do not write data related to the service life to data memory. In many cases, only the chip's unique ID (UID) is used to establish a connection ("bridge") to the management software and generate a link. [Overview of the project] [Problems that the invention aims to solve]

[0017] The purpose and objective of this disclosure is to eliminate, or at least reduce, the shortcomings of the prior art. In particular, a method is provided for detecting sterilized product cycles that enables recording of the entire work cycle / reprocessing cycle / sterilization product cycle, preferably over the entire service life of the product, related to the product, i.e., related to individual product levels (e.g., related to lot number, serial number, or GTIN), and thus improves tracking, traceability, and service life management.

[0018] In other words, this disclosure is intended to ensure that, despite very limited memory capacity, the relevant individual steps / process steps of the work cycle can be written directly to the internal data memory of the medical product.

[0019] This objective and goal are resolved with respect to the general process by the subject matter of claim 1. [Means for solving the problem]

[0020] Accordingly, the method according to this disclosure is configured such that each individual cycle information / cleaning information is stored / recorded in a data chain as exactly 1 (data) bit (i.e., binary encoded). In other words, each cycle information associated with a single cycle process step is stored as binary data in the medical product's data memory. In other words, the cycle information for individual process steps in a work cycle is stored as a sequence of binary data. Each position in the data chain, i.e., each bit, essentially corresponds to the operation of a single process step or work cycle. Thus, the position in the data chain determines the type of process step, while the binary data or bit value provides information about the successful execution of the process step. Accordingly, according to this disclosure, storing cycle information as a sequence of binary data directly affects the (physical) size of the data memory / storage medium, or the number of cycles that can be stored in a given storage medium. Being able to store a larger number of work cycles in the storage medium reduces the number of handling steps that are prone to manual error for product classification.

[0021] Advantageous embodiments are claimed in the dependent claims and are described below.

[0022] In a preferred modification, the data memory is configured as an RFID chip, particularly an NFC chip, and the housing is preferably made of glass. Alternatively, the data memory may be configured as a UHF chip or a SUHF chip. In this way, the data memory provides storage capacity / storage space while enabling communication with the data processing device. In particular, the data memory or RFID chip can act as a "single trusted source" (SSOT). This means that each data / data element is processed at only one point, particularly a data processing device, to function as a unique key on the one hand and as a data carrier between individual data detection stations on the other hand. This ensures that the current data status is always stored in the chip and that this data can be read at various stations during the process.

[0023] In a preferred embodiment, the work cycle may at least include manual or mechanical pre-cleaning, cleaning and disinfection, maintenance of medical products, and optionally sterilization of medical products, and further process steps of operations (medical / surgical use) using the medical products. As described above, the pre-cleaning can be performed manually or mechanically, for example, in the form of ultrasonic cleaning in an ultrasonic bath. The process step "cleaning and disinfection" may preferably be performed (partially) automatically in a washer-disinfector (WD). Furthermore, the maintenance step may include, for example, lubricating the medical product or parts of the medical product. The medical product can also be sterilized before it can be used, for example, in relation to surgery. In addition, the work cycle may of course include further process steps. For example, a test run can be additionally incorporated into the work cycle. At this point, it is possible to add further process steps at any time.

[0024] Furthermore, it is advantageous if a plurality of work cycles are stored in the data memory and preferably negated binary data is arranged to separate consecutive work cycles. That is, in order to clarify when a work cycle ends and when a further work cycle starts following the first work cycle, additional (single) bits are used between two work cycles to store binary (separator) data. This additional bit (binary data) is preferably negated, that is, when a normally executed (not executed) process step is stored as "1" (or "0"), a single "0" or "1" is prefixed as additional (separator) data, as described in more detail below.

[0025] According to the present invention, the data chain stored in the data memory may further include data for identifying the medical product, particularly the part number, serial number, GTIN (Global Trade Item Number), or further identification characteristics.

[0026] Furthermore, it is particularly preferred that the data chain further includes data for defining the structure of the data chain, especially the protocol version. Such a protocol version can define the structure of the data chain, respectively the structure of the coding of the data chain, i.e., the way of arranging subsequent bits. For example, when the structure changes, such as by adding process steps, the protocol version can be used to easily distinguish this structure.

[0027] As a further preferred development, the data chain may further include data for determining maintenance intervals, especially a maintenance counter / maintenance meter. The maintenance counter can indicate, for example, the number of times a medical product has been maintained and the number of times it has been reset in that context, i.e., the number of times the data memory has been read. This can thus easily prevent subsequent process steps from tampering with the data chain after it has been reset, for example during maintenance or servicing or when the data memory is full.

[0028] In a preferred embodiment, process steps that were executed successfully are stored as "1," and process steps that were not executed successfully are stored as "0." In addition, a complete work cycle in which all process steps were executed successfully can be stored as a single "1," that is, in a complete work cycle, the cycle information of individual process steps, including the aforementioned (delimiter) data, is not stored individually as a sequence / order, but is combined as a single "1." Since such a single "1" requires only one bit, a complete (correct) work cycle can be stored with one bit. Therefore, memory capacity can be used optimally, and the number of work cycles stored can be easily and efficiently increased. An alternative embodiment is characterized in that process steps that were executed successfully may be stored as "0," and process steps that were not executed successfully may be stored as "1." That is, in the alternative embodiment, process steps, or their cycle information, are recorded in a negated form. Here again, it is conceivable and advantageous to store a complete work cycle in which all process steps were executed successfully, including the (delimiter) data, as a single "0."

[0029] According to the present invention, at least one sensor may be a temperature sensor for measuring the temperature during the work cycle, and / or a pressure sensor for measuring the static and / or dynamic pressure of a fluid, particularly a cleaning agent.

[0030] In other words, according to the present invention, data memory in the form of an RFID chip can be incorporated into a medical product or tool, preferably made of glass (as a cast compound or with additional cast compounds) ("glass tag"), and can be sourced in various sizes. In particular, the data memory may be embedded in a glass tube and have a ferrite core with a copper coil encased in epoxy resin. A glass cap is applied to the glass tube and welded (ultrasonically) to the glass tube to hermetically seal it. However, in addition to a glass-sealed assembly, other materials such as ceramics can also be readily considered to seal the assembly. Placed in a predetermined position on a medical product, this chip can be combined with a corresponding holding device for the medical product to always be in a clearly defined relative position to the antenna (of the holding device). This allows electronic devices to access the data content.

[0031] All medical products in a hospital undergo a sterilization cycle and must go through it before being reprocessed. This sterilization cycle includes at least one of the following steps: - Manual or mechanical pre-cleaning (ultrasound) - Cleaning and disinfection ("Disinfection" - D) - Maintenance ("Maintenance" - M) - Sterilization (“sterilization”-S) - Working in the operating room ("Work" - W)

[0032] Information about whether a process (step) was completed or incomplete is stored in data memory. As mentioned earlier, the RFID chip functions as an SSOT, meaning that each data element is processed at only one point between individual data detection stations, acting as a unique key (device + serial number) on the one hand and a data carrier (cycle count + cycle success) on the other. This ensures that the current data status is always stored in the chip and that this data can be read at various stations in the process (for example, to transfer it to an external storage medium such as the cloud).

[0033] All product-related data can also be stored in the data carrier. These include: - Part Number - Serial number / Manufacturer's serial number or LOT number - GTIN (Product Identification Code)

[0034] Preferably, the GTIN may consist of a 14-digit sequence. It is particularly advantageous if the GTIN preferably has a preceding fill position, a two-digit preceding country identifier, a five-to-seven-digit business identification number, a three-to-five-digit part number, and a control digit. In this case, the part number can therefore be integrated into the GTIN.

[0035] Furthermore, the counter readings are stored for handling purposes related to the manufacturer: - Protocol Version: This version defines the structure of the encoding, i.e., how the bits are arranged later. If the structure changes (e.g., an additional process step is added), this version can be used to distinguish it among processing devices. - Maintenance Counter: The reading of this counter indicates the number of times the product has been maintained and the number of times it has been reset as a result. This prevents the sequence from being tampered with in subsequent process steps after a sequence reset (e.g., memory full, maintenance by the manufacturer).

[0036] In other words, such a data chain according to the present invention is configured as follows: Part number + Serial number + GTIN + Protocol version + Maintenance counter + Cycle count.

[0037] The sequence / order of data stored in the data chain is irrelevant here; that is, the order can be swapped as needed and defined all at once. For example, the protocol version can be placed first, and then its order can be mapped via the protocol version.

[0038] In addition, it is conceivable to prefix each piece of data, namely the part number, serial number, GTIN, protocol version, and / or maintenance counter, with an identifier.

[0039] The aforementioned process steps (UDMSW) are necessary to fully describe the reworking cycle. According to the present invention, these are stored in binary format in this sequence, where "1" indicates a complete process step and "0" indicates an incomplete process step. A "0" may be prefixed to distinguish it from the preceding work cycle, which is removed in the next conversion.

[0040] In other words, the present invention relates to a method / process for storing data on a data carrier, making optimal use of a finite / limited memory area, so that processing cycles (consisting of several individual process steps) can be logically detected and the maximum number of cycles can be recorded / detected. In this way, information can be recorded on the product. Furthermore, it is possible to record individual steps of the reworking cycle, as well as to detect defective cycles and / or forgotten process steps. Moreover, since all relevant information is held on the data carrier or RFID chip, transparency can be increased when maintenance is performed. In addition, it is possible to determine usage, resulting in new business models and accurate indication of the lifespan of medical products.

[0041] This disclosure is described in more detail below with reference to preferred embodiments using drawings. [Brief explanation of the drawing]

[0042] [Figure 1] This is a perspective view of a holding device for holding a medical product according to a preferred embodiment. [Modes for carrying out the invention]

[0043] The drawings are schematic and merely serve to help understand the present invention. Identical elements are denoted by the same reference numerals. Features of the various embodiments may be interchangeable.

[0044] Figure 1 shows a known cleaning / holding device 1 for holding at least one preferably sterilizable medical product 2 during a cleaning process and storing the medical product 2 before and after the cleaning process. Alternatively, the holding device 1 may be a sterile screen. The medical product 2 is placed in / on the holding device 1 and held by the holding device 1 so that its position relative to the holding device 1 cannot be altered either during the cleaning process or during transport. The illustrated holding device 1 is configured to be placed in a sterile container (not shown here) if necessary, or the sterile container itself is the storage unit.

[0045] For this purpose, the holding device 1 has a platform-like (lattice-like) frame, such as a sheet metal frame, having support legs 3, to which at least one pipeline 4 is fixed, and along this pipeline 4 there are numerous branches 5, which form connection points / connection ports for hollow medical products 2 such as handpieces. In the area of ​​these connection ports, the (sheet metal) frame defines recesses / recesses or grips for stably supporting each medical product 2.

[0046] The illustrated holding device 1 also includes a data processing device 6 and at least one temperature sensor 7 for detecting temperature, located in the area of ​​the connection port. The holding device 1 shown in Figure 1 further includes at least one pressure sensor 8 for detecting the static pressure of the cleaning fluid, and this pressure sensor 8 is also located in the area of ​​the connection port.

[0047] The temperature sensor 7 and pressure sensor 8 enable the determination of whether the process steps of the work cycle undertaken by the medical product 2 have been successfully completed. In other words, the data processing device 6 determines whether the process steps have been successfully completed based on the output signals from the temperature sensor 7 and pressure sensor 8, and processes the output signals into (cycle) information.

[0048] Furthermore, the medical product 2 preferably has an internal data memory 9 so that it can communicate with a data processing device 6 via a wireless communication link and write cycle information to the internal data memory 9 of the medical product 2 after the data processing device 6 has processed the output signal. In other words, the information is stored directly in the data memory 9 of the medical product 2. For this purpose, in a preferred embodiment, the data memory 9 is configured as an RFID chip, which can communicate wirelessly with the data processing device 6 and can also store information.

[0049] In other words, according to the present invention, the medical product 2 incorporates a data memory 9 in the form of an RFID chip, which is preferably housed in a glass housing ("glass tag") and can be sourced in various sizes. However, in addition to the glass assembly, other materials such as ceramics can also be used to seal the assembly.

[0050] In combination with the holding device 1, this chip can be positioned in a location that is always clearly visible relative to the transmitting device / antenna in order to ensure a communication / wireless link between the data processing device 6 and the medical product 2. Thus, the data processing device 6 can access the data stored in the medical product 2 and store the information in the data memory 9 of the medical product 2.

[0051] As described above, medical product 2 is held in and / or on the holding device 1 during both the cleaning process and transport. In order to work with medical product 2, it must ultimately be removed from the holding device 1. The entire sequence, including all cleaning processes leading up to the work step (medical / surgical use / application of the product), is hereinafter referred to as the "work cycle". Throughout its entire service life, medical product 2 goes through numerous work cycles; that is, medical product 2 is reprocessed, and then the medical product is reprocessed again after use. These numerous work cycles are hereinafter referred to as the "sterilization product cycle".

[0052] Medical product 2 is in a work cycle at a medical facility such as a hospital and must undergo this work cycle in order to be reprocessed. This work cycle consists of at least the following steps: - Manual or mechanical pre-cleaning (ultrasonic - "ultrasonic" - U) - Cleaning and disinfection ("Disinfection" - D) - Maintenance ("Maintenance" - M) - Sterilization (“sterilization”-S) - Working in the operating room ("Work" - W)

[0053] In other words, medical product 2 is pre-cleaned manually or in an ultrasonic bath in the first process step (process step U). Subsequently, it is cleaned and disinfected in a washing and disinfecting unit (WD) (process step D). After that, medical product 2 undergoes a maintenance step (process step M). Here, medical product 2 may be lubricated, for example, before being finally sterilized in the next process step (process step S). Once this reprocessing cycle is complete, medical product 2 can be used for operation (process step W).

[0054] After each process step is executed, the data processing device 6 determines whether each process step was executed successfully / completely by evaluating the output signals of, for example, sensor 7 and sensor 8. Accordingly, the data processing device 6 stores the information in data memory 9. In other words, information about whether the process step was executed completely or incompletely is stored in data memory 9.

[0055] In a preferred embodiment, the RFID chip as data memory 9 functions as an SSOT, meaning that each data element is processed at only one point between individual stations of data detection, used on the one hand as a unique key (device + serial number or GTIN) and on the other hand as data memory / data carrier 9 (cycle number + cycle success). This ensures that the current data status is always stored in the chip, i.e., data memory 9, and that this data can be read at various stations in the work cycle (for example, to transfer to an external storage medium such as the cloud).

[0056] All product-related data is stored in the data memory 9 of medical product 2. This includes: - Part Number - Serial number / Manufacturer's serial number or LOT number - GTIN (Product Identification Code)

[0057] In addition to the part number and serial number data necessary to identify medical product 2, counter readings are stored for handling related to the manufacturer. These are as follows: - Protocol Version: This version defines the structure of the encoding, i.e., how the bits are arranged later. If the structure changes (for example, by adding further process steps), this version can be used to distinguish it among processing devices. - Maintenance Counter: The reading of this counter indicates the number of times the product has been maintained and the number of times it has been reset as a result. This prevents the sequence from being tampered with in subsequent process steps after a sequence reset (e.g., memory full, maintenance by the manufacturer).

[0058] Therefore, a data chain consisting of part number, serial number, protocol version, and maintenance counter is stored in data memory 9, and this data chain is extended by the work cycle count, which is described in more detail below. Such a data chain may look like this: GA861 00001345 001 000+ Number of work cycles

[0059] "GA861" is the part number, "00001345" is the serial number, "001" is the protocol version, and "000" indicates the maintenance counter.

[0060] As mentioned above, process steps "UDMSW" are required to fully describe the work cycle. These are then stored in data memory 9 in binary format in this order, with "1" representing a fully or successfully executed process step and "0" representing an incomplete or unsuccessfully executed process step. To distinguish it from previous cycles, the cycle count is further prefixed with "0" as delimiter data, which is removed again between subsequent versions as described in more detail below.

[0061] Thus, the data is stored in data memory 9 in an optimized manner, as shown in the example below: GA861 00001345 001 000 01 Ultrasonic cleaning performed GA861 00001345 001 000 011 Execution of cleaning and disinfection GA861 00001345 001 000 0111 Maintenance performed GA861 00001345 001 000 01111 Sterilization execution GA861 00001345 001 000 011111 Work using medical product 2

[0062] Each process step requires exactly one bit.

[0063] If data is stored as ASCII characters, i.e., a sequence of character symbols UDMSW, as in the conventional method, this requires 6*8 bits, or 48 bits. This is unacceptable due to the limited storage capacity of data memory 9.

[0064] To make more efficient use of the available storage capacity of data memory 9, a fully executed work cycle is stored as a binary "1". This means that a fully executed work cycle requires only one bit. As an example, as explained below, a fully executed work cycle, i.e., the sequence "011111", is converted / combined as a singular "1" and stored. In other words, in the case of a fully executed work cycle, the sequence "011111" (UDMSW) is converted to "1", which is stored in data memory 9. In this relationship, the aforementioned delimiter data is also deleted.

[0065] Once the work cycle is complete and executed correctly, the data chain will look like this: GA861 00001345 001 000 1

[0066] It should be noted here that the work cycle (UDMSW) can, of course, be extended as desired to include further process steps, such as commissioning (T) in the reworked unit (RUMED) for medical devices. In that case, the fully executed work cycle would look like UDMTSW ("0111111"). This change also uniquely generates a new protocol version assigned to the product, so that, as mentioned above, the structure of the data chain can always be tracked based on the protocol version.

[0067] However, incomplete work cycles are neither summarized nor converted, and therefore remain in binary code, that is, as sequences of binary characters prefixed with "0" in data memory 9. If a process step, such as maintenance M, is not performed or is performed insufficiently due to a lack of lubrication, the data chain in data memory 9 will be as follows: GA861 00001345 001 000 011011 (UDSW)

[0068] Process steps U, D, S, and W that were executed successfully are stored as "1", while maintenance step M that was not executed is stored as "0".

[0069] Each cycle detection is generated as a data chain. For example: GA861 00001345 001 000 1111111UDSW11111DSW111DSW111111 GA861 00001345 001 000 1111111011011111110010111110010111111

[0070] In the example shown above, it can be seen that three incomplete or faulty work cycles were performed. In the first faulty cycle, the process step maintenance M was missing, and in the second and third faulty cycles, the process steps ultrasonic cleaning U and maintenance M were missing. Therefore, the first faulty work cycle is stored as sequence "011011", and the second and third faulty work cycles are stored as sequence "001011", respectively. In this way, it is possible to clearly determine when a faulty work cycle was performed. Therefore, medical technicians or quality control personnel can intervene and, if necessary, train hospital staff to avoid further faulty work cycles.

[0071] After a predetermined interval, and / or during maintenance, and / or when data memory 9 becomes full, data memory 9 is emptied. That is, the data stored in data memory 9 is transferred / loaded to an external storage medium, such as the internal memory of the holding device 1 or a smartphone, where it can be further processed if necessary, and then transferred to an external network, such as a hospital network or a cloud server. After such data transfer, the maintenance counter is incremented and this is communicated to the manufacturer. In this way, it is always possible to clearly determine the total number of reprocessing or work cycles that the medical product 2 has undergone.

[0072] Furthermore, as mentioned above, the data chain may also include GTINs. A GTIN can be structured as follows, for example: 0 40 38653 26855 9

[0073] In other words, in a preferred embodiment, the GTIN consists of a 14-digit sequence. The GTIN has a leading fill digit "0", a two-digit leading country identifier "40", a business identification number "38653", a part number "26855", and a control digit "9". In the above example, the business identification number and part number each have 5 digits. Alternatively, the business identification number may have 6 or 7 digits, and the part number may have 4 or 3 digits.

[0074] In the example above, the data chain consists of part number, serial number, protocol version, maintenance counter, and (optionally) GTIN. However, the sequence / order of the individual components of the data chain can, of course, be changed as desired. That is, the order of the individual components of the data chain can be freely chosen. For example, the protocol version may be placed first.

[0075] Furthermore, the number of characters in each component / information block of the data chain, namely the part number, serial number, protocol version, maintenance counter, or GTIN, can be changed / fixed as needed. The protocol version is responsible for controlling the content and number of characters in each information block.

[0076] In the example above, cycle information is detected in binary format, where "1" represents a successfully executed process step and "0" represents a process step that did not execute successfully. Naturally, it is also possible to execute the process without binary coding, meaning that successfully executed process steps are stored as "0" and process steps that did not execute successfully are stored as "1". Therefore, a "1" is prefixed to each new cycle, and a fully successfully executed work cycle is converted to "0", and thus stored in data memory 9.

[0077] Thus, the data is negated in an optimized manner, as illustrated below, and stored in data memory 9: GA861 00001345 001 000 10 Ultrasonic cleaning performed GA861 00001345 001 000 100 Execution of cleaning and disinfection GA861 00001345 001 000 1000 Maintenance performed GA861 00001345 001 000 10000 Sterilization execution GA861 00001345 001 000 100000 Work using the product

[0078] As described above, the method according to the present invention for detecting and recording work cycles can count and store more work cycles in relation to a product. Calculations by the applicant have shown that when work cycle information (UDMSW) is stored in ASCII format, only 38 cycles can be stored in a conventionally used 1664-bit data memory 9.

[0079] However, if work cycles are recorded using the method of this disclosure, and there are no incomplete process steps, i.e., if all work cycles are executed correctly and completely, 1544 work cycles can be recorded before the storage capacity of data memory 9 is exhausted. Even if 50% of the storage capacity of data memory 9 is occupied by incomplete work cycles, 752 complete work cycles and 125 incomplete work cycles can still be recorded. If complete and incomplete work cycles are distributed 50%-50%, i.e., every other work cycle is incomplete, a total of approximately 420 work cycles can be recorded, and 86% of the storage capacity of data memory 9 is occupied by incomplete work cycles. The following items are elements described in the claims at the time of the international application. (Item 1) A method for detecting and recording the work cycle of a sterilizable medical product (2), wherein the medical product (2) is preferably held in a holding and / or storage device (1), preferably communicating wirelessly with an external data processing device (6) located within the holding and / or storage device (1), and the method is: - Preferably a step of detecting a process step of the work cycle as a function of the output signals of at least one sensor (7;8) located in the holding and / or storage device (1); - The step of processing the output signal by the data processing device (6) in order to form cycle information; - A step of storing the cycle information in a data chain stored in the data memory (9) of the medical product (2), Equipped with, A method characterized in that the cycle information is stored in the data chain as exactly 1 bit. (Item 2) The method according to item 1, characterized in that the work cycle includes at least one of the process steps of manual or mechanical pre-cleaning, washing and disinfection, maintenance, sterilization, and work using the medical product (2). (Item 3) The method according to item 1 or 2, characterized in that multiple work cycles are stored in the data memory (9), and preferably negated bits are arranged to separate consecutive work cycles. (Item 4) The method according to any one of items 1 to 3, wherein the data chain further comprises data for identifying the medical product (2), in particular a part number, serial number, and / or GTIN. (Item 5) The method according to any one of items 1 to 4, wherein the data chain further comprises data, in particular a protocol version, for defining the structure of the data chain. (Item 6) The method according to any one of items 1 to 5, wherein the data chain further comprises data for determining maintenance intervals, in particular a maintenance counter. (Item 7) The method according to any one of items 1 to 6, characterized in that process steps that were successfully executed are stored as "1" and process steps that were not successfully executed are stored as "0". (Item 8) The method according to item 7, characterized in that a work cycle in which all process steps have been successfully executed is stored as "1". (Item 9) The method according to any one of items 1 to 6, characterized in that process steps that were successfully executed are stored as "0" and process steps that were not successfully executed are stored as "1". (Item 10) The method according to item 9, characterized in that work cycles in which all process steps were successfully executed are stored as "0".

Claims

1. A method for detecting and recording the work cycle of a sterilizable medical product, wherein the medical product communicates with an external data processing device, and the method: - A step of detecting a process step of the work cycle as a function of the output signal of at least one sensor; - The steps of processing the output signal by the external data processing device in order to form cycle information; - A step of storing the cycle information in a data chain stored in the data memory of the medical product, Equipped with, The cycle information is stored in the data chain as exactly one bit. The method is characterized in that the data chain further includes data for determining the maintenance interval.

2. The method according to claim 1, characterized in that the work cycle includes at least one of the process steps of manual or mechanical pre-cleaning, washing and disinfection, maintenance, sterilization, and work using the medical product.

3. The method according to claim 1, characterized in that multiple work cycles are stored in the data memory, and bits are arranged to separate consecutive work cycles.

4. The method according to claim 1, wherein the data chain further comprises data for identifying the medical product.

5. The method according to claim 1, wherein the data chain further includes data for defining the structure of the data chain.

6. The method according to claim 1, characterized in that process steps that were successfully executed are stored as "1" and process steps that were not successfully executed are stored as "0".

7. The method according to claim 6, characterized in that a work cycle in which all process steps have been successfully executed is stored as "1".

8. The method according to claim 1, characterized in that process steps that were successfully executed are stored as "0" and process steps that were not successfully executed are stored as "1".

9. The method according to claim 8, characterized in that work cycles in which all process steps were successfully executed are stored as "0".

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