Method for detecting a disinfection cycle

Abstract

The invention relates to a method for automatically and specifically to a sterile container detecting a sterilization cycle performed by means of the sterile container, wherein a temperature acting on the sterile container is detected by means of a temperature measuring device assigned to the sterile container, wherein the temperature measuring device detects the temperature at a determined first time interval, the temperature values detected after exceeding a predetermined first limit temperature are stored in a memory, the storage of the detected temperature values is set after falling below a predetermined second limit temperature or after a predetermined duration after exceeding the first limit temperature, the stored temperature values are compared with reference temperature values, wherein a deviation of the temperature values from the reference temperature values is determined, and in the case of a deviation within a predetermined tolerance range a counting device and / or a display device are actuated. The invention also relates to a system for performing the method according to the invention.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to a method for automatically and container-specifically detecting a sterilization cycle performed by means of a sterile container, wherein a temperature acting on the sterile container is detected with a temperature measuring device assigned to the sterile container. Furthermore, the present disclosure relates to a system for automatically and container-specifically detecting a sterilization cycle performed by means of a sterile container, the system comprising a sterile container, a temperature measuring device assigned to the sterile container for detecting a temperature acting on the sterile container, a memory and a counting device and / or a display device. BACKGROUND

[0002] From the prior art, different methods are known for automatically or semi-automatically detecting a plurality of sterilization cycles, which a sterile container of medical technology undergoes during its use. Here, the detection of the sterilization cycle can take place, inter alia, by detecting temperature values and / or pressure values and comparing them with defined limit values. For this purpose, either electronic sensors or mechanical components are used. For example, if a previously defined limit temperature is reached, this is displayed in some known methods and systems. It is also known to store the number of limit temperatures reached and to provide the number of limit temperatures reached by reading with a specific reading device.

[0003] Here, common systems with mechanical indicators, for example, use bimetallic elements, which change shape within a certain temperature range. This change in shape is detected with the system and the temperature fluctuations experienced by the sterile container can be inferred. However, bimetallic sensors disadvantageously indicate the number of sterilizations already performed. A further disadvantage is that the detection of individual temperature limit values is not a safe method of confirming the temperature and pressure cycles of the sterilization process. DE 10 2015 112205 A1 discloses a device for counting sterilization cycles when sterilizing medical instruments and devices using bimetallic pairs, the device having a counting mechanism for recording and reproducing a certain number of sterilization cycles, a manipulation device for manipulating the counting mechanism in relation to sterilization parameters, and a locking device for locking the counting mechanism in relation to sterilization parameters, wherein the manipulation device manipulates the counting mechanism when a first threshold sterilization parameter is exceeded, and the locking device locks the counting mechanism after the manipulation and / or after exceeding a second threshold sterilization parameter and unlocks the counting mechanism after falling below a third threshold sterilization parameter.

[0004] EP 1 662 234 A1 discloses a device and a method for electronic monitoring of a disinfection process, wherein measurement value detection is carried out by means of a plurality of sensors inside a closed process chamber having metal walls, the detected measurement values are collected and stored in a plurality of data recorders respectively assigned to the sensors. The stored measurement values are transmitted to a receiving device outside the process chamber by means of radio.

[0005] DE 10 2013 102 277 A1 discloses a system, a measuring device and a method for storing a disinfection cycle, comprising a counter for counting disinfection cycles when a threshold temperature typical for disinfection cycles is exceeded, a memory for storing the number of disinfection cycles and an energy harvesting device for energizing the counter and / or the memory, wherein the energy harvesting device is configured in a self-sufficient manner.

[0006] DE 202 01 752 U1 discloses a measuring device for monitoring disinfection conditions in a disinfection chamber, comprising a data receiver which can be introduced into the disinfection chamber, a data reading device outside the disinfection chamber and an evaluation unit, wherein the data receiver has a housing, a control device, a power supply unit, a data memory and a pressure sensor are located in the housing and the data reading device is provided with a data output, wherein the data receiver is connected to a semiconductor element which can be introduced into the disinfection chamber by means of a sensor cable and stores temperatures measured at a plurality of locations in the disinfection chamber.

[0007] WO 9416299 discloses a device for detecting the number of times a target temperature is reached.

[0008] WO 2016 075418 discloses a disinfection container for surgical instruments, comprising an electronic identity device for monitoring and tracking the container and its contents. The electronic identity device comprises a measuring module for measuring parameters representative of environmental conditions and for generating digital measurement data elements from the measurements, a storage module for storing the generated measurement data sets, a communication module adapted to cooperate with the storage module for transmitting the retrieved measurement data sets to an external reading device when the external reading device and the communication module act on each other.

[0009] US 20070160494 discloses a disinfection system having an autoclave and a disinfection container equipped with an RFID tag, wherein the RFID tag contains data relating to the objects to be disinfected contained in the container, which data are read by a control unit of the autoclave and used for controlling disinfection.

[0010] In general, it can be said that the use of the currently known methods for automatic detection of a sterilization cycle generally does not allow a reliable determination of the quantity of treatment, in particular sterilization, of a set of sterile containers and instruments of medical technology.

[0011] It is disadvantageous in the above-mentioned known methods for automatic detection and / or monitoring of a sterilization cycle that the detection of temperature limit values by means of bimetallic technology is generally not precise. The same applies to the methods and systems for identifying a sterilization cycle due to the exceeding of limit values. In part, the adaptation of limit values is only limited or difficult to achieve. A further disadvantage is that in such methods and systems the required holding times for a sterilization in compliance with regulations cannot mostly be detected. SUMMARY

[0012] Starting from the above-mentioned prior art, the task of the present disclosure is to reduce the above-mentioned disadvantages of the prior art and to provide a method and a system with which a sterilization cycle can be reliably and precisely identified automatically and flexibly adapted.

[0013] The task is solved by a method according to the present disclosure, i.e. a method for automatically and sterile container-specifically detecting a sterilization cycle performed by means of a sterile container, wherein a temperature acting on the sterile container is detected with a temperature measuring device assigned to the sterile container, the temperature measuring device detecting the temperature at a determined (first) time interval, the temperature values detected after exceeding a predetermined first limit temperature being stored in a memory, the storage of the detected temperature values being set after falling below a predetermined second limit temperature or after a predetermined duration after exceeding the first limit temperature, the stored temperature values are compared with reference temperature values, wherein a deviation of the temperature values from the reference temperature values is determined, and in the case of a deviation only within a predetermined tolerance range the counting device and / or the display device are actuated.

[0014] Furthermore, the task is solved by a system according to the present disclosure, i.e. by a system which is set up for carrying out a method according to the present disclosure, in particular a method according to the present disclosure or a method described in the present specification. The system is in particular set up for automatically and sterile container-specifically detecting a sterilization cycle carried out by means of a sterile container and comprises a sterile container, a temperature measuring device assigned to the sterile container for detecting a temperature acting on the sterile container, a memory and a counting device and / or a display device. The system is in particular set up for detecting a temperature by means of the temperature measuring device in defined (first) time intervals, for storing temperature values detected after exceeding a predetermined first limit temperature in the memory, for setting the storage of the detected temperature values after a predetermined duration of time after falling below a predetermined second limit temperature but at the latest after exceeding the first limit temperature, for comparing the stored temperature values with reference temperature values and for determining a deviation of the temperature values from the reference temperature values, and for manipulating the counting device and / or the display device only within a predetermined tolerance range in the event of a deviation.

[0015] Within the scope of the present disclosure, the temperature measuring device can preferably be an integral component of the sterile container. Alternatively or additionally, the temperature measuring device can be an integral component of the sterile container, in particular of the sieve basket and / or the outer packaging of the sterile container. In this sense, within the scope of the present disclosure, the sterile container-specific detection can also be understood as a detection in which the sieve basket and / or the packaging to which the sterile container belongs is specifically subjected to the detection. Preferably, the temperature measuring device is a temperature logger which enables simple automatic monitoring and detection of the temperature and / or temperature change profile. The temperature measuring device is preferably programmable, so that the first and second limit temperatures and / or the first and second time intervals can be freely selected and selected / programmed.

[0016] The first limit temperature and / or the second limit temperature can preferably be adapted to requirements in order to cover and take into account different environmental conditions. By selecting two limit temperatures, a region can be defined to a certain extent in the sense of the present disclosure, in which a sterilization process is considered to exist.

[0017] According to the present disclosure, the stored temperature values are compared with reference temperature values and a deviation of the temperature values from the reference temperature values is determined. This can take place continuously during the measurement of the temperature in real time or also only after falling below the second temperature limit or the time limit. In particular, the detected values can be compared with a pre-set temperature-time profile and evaluated within a tolerance range.

[0018] Furthermore, it can be preferred that the present disclosure can provide, on the one hand, the possibility of basic monitoring / coarse monitoring and, on the other hand, the possibility of sterilization monitoring / fine monitoring. In the context of basic monitoring / coarse monitoring, the temperature detection is preferably carried out in a first (long) time interval, i.e. at a time distance determined / defined by the first time interval. In the context of sterilization monitoring / fine monitoring, the temperature detection is preferably carried out in a second, short time interval, i.e. at a time distance determined / defined by the second time interval. By correspondingly selecting the length of the first and second time intervals, the coarse monitoring and the fine monitoring can be adapted as best as possible to the respective circumstances.

[0019] By means of the present disclosure, it is possible, inter alia, to continuously monitor the sterile container or to monitor the sterile container continuously over a long period of time via coarse monitoring. For example, the sterile container can be monitored over the entire period of time between two inspection cycles. The first time interval is preferably selected to be relatively long, so that even in the case of a temperature value detected during storage, for example in the context of quality assurance, the amount of data detected does not become too large in the case of continuous monitoring over a long period of time. Almost continuous, complete monitoring is possible during the entire service time and / or service life of the sterile container.

[0020] In the context of fine monitoring triggered by exceeding the first limit temperature, a particularly fine monitoring of the sterilization cycle or possibly existing sterilization cycles is possible. The second time interval is preferably selected to be relatively short, that is to say, shorter than the first time interval, so that a particularly fine / precise monitoring of the sterile container is possible after the first limit temperature has been exceeded. The large amount of data generated in the context of the precise monitoring is relatively unproblematic, since the fine monitoring is usually carried out only over a relatively short period of time until the second limit temperature is undershot or a predetermined duration expires and the recording of the set temperature values is set. Thus, the sterilization process can be monitored particularly finely.

[0021] A particular advantage of the present disclosure is that the changeover from coarse monitoring to fine monitoring is carried out automatically, triggered by exceeding the first limit temperature. Likewise, the switch from fine monitoring to coarse monitoring is carried out automatically, triggered by undershooting the second limit temperature or by a predetermined duration elapsing. Thus, the present disclosure can enable, in an advantageous manner, inter alia, the detection of a sterilization cycle and / or the detection of a temperature profile, the measurement in a defined time interval and the comparison with a preset temperature / temperature profile, in particular automatically. Furthermore, the switching between the measurement intervals can be carried out automatically.

[0022] Furthermore, a deviation of the temperature value from a reference temperature value is determined within the scope of the present disclosure. If the deviation is only within a predetermined tolerance range, it is considered that an actual sterilization process / sterilization cycle exists, and a counting device, in particular in the form of an incremental cycle counter, is used in order to record the sterilization process performed with the sterile container. Thus, the present disclosure can advantageously lead to an automatic detection and display of sterilization cycles performed with the sterile container.

[0023] Advantageous embodiments of the present disclosure are set forth in more detail below.

[0024] An embodiment of the present disclosure is characterized in that the counting device is not manipulated in the case of a deviation outside a predetermined tolerance range. Alternatively or additionally, a fault report can be output and / or stored. Preferably, such an indicator is reversible. In this way, a functional failure in the sterilization process and handling can be determined and displayed simply and reliably by means of the present disclosure.

[0025] In the scope of the method according to the present disclosure, the first intervals in which the temperature to which the sterile container is subjected is measured / detected can have a duration of between approximately three minutes and approximately seven minutes. Preferably, it has a duration of approximately 4 minutes to approximately 6 minutes, more preferably approximately 5 minutes.

[0026] A further embodiment of the present disclosure is characterized in that, after exceeding the first limit temperature, the temperature measuring device detects the temperature in determined second intervals. These second intervals are preferably shorter than the first time intervals. According to an embodiment of the present disclosure, these second intervals can have a duration of between approximately 20 seconds and approximately 120 seconds, preferably between approximately 40 seconds and approximately 90 seconds, particularly preferably approximately 60 seconds.

[0027] A further embodiment of the present disclosure is characterized in that, below a predetermined second limit temperature, the temperature measuring device again detects the temperature in the determined first intervals. Alternatively, after a predetermined duration has elapsed after exceeding the first limit temperature, the temperature measuring device can again detect the temperature in the determined first intervals. Preferably, the first limit temperature and / or the second limit temperature is settable.

[0028] According to a further embodiment of the present disclosure, a particularly good monitoring of the sterilization process can be achieved by detecting a temperature-specific holding duration after exceeding the first limit temperature and storing this holding duration in a memory. In particular, the stored holding duration can be compared with a reference holding duration, and a deviation of the holding duration from the reference holding duration can be determined. The holding time can be detected particularly well and accurately by means of short measurement intervals in the form of second intervals. Thus, the present disclosure can detect the temperature and recognize sterilization particularly simply in accordance with a preset temperature profile / holding time.

[0029] The present disclosure can particularly achieve the following advantages:

[0030] - automatic variation of the measurement interval time

[0031] - comparison of the disinfection temperature with a preset curve

[0032] - monitoring the entire disinfection rather than considering limit values

[0033] - adaptation of the nominal parameters to the respective application case or to the individual disinfection process

[0034] - reliable detection of the temperature cycle (disinfection)

[0035] - reduction of the energy requirement for autonomous operation

[0036] - adaptation possibility of the parameters to the respective given disinfection conditions

[0037] - measurement interval enabling the identification of the holding time and the start of disinfection

[0038] In general, it can be said that the present disclosure achieves a method and a system for reliably identifying and checking disinfection with minimal energy expenditure. Here, for example, a measurement interval of five minutes can be used to identify disinfection, and an interval of one minute can be used for analysis. The identification, analysis, and mode change can be performed by the system, in particular autonomously, and adapted to different conditions.

[0039] Further features and advantages of the present disclosure will become apparent from the exemplary and non-limiting description of the following drawings. The drawings are merely schematic and serve only for understanding the invention. BRIEF DESCRIPTION OF DRAWINGS

[0040] Herein is shown:

[0041] Figure 1 schematic flow chart showing an embodiment of the present disclosure, and

[0042] Figure 2 schematic diagram showing a system according to the present invention. DETAILED DESCRIPTION

[0043] In Figure 1 The embodiment of the present method shown in Fig. 1 starts with a temperature measurement device 1 in the form of a communication temperature logger detecting the temperature to which the sterile container 2 is subjected with an interval of five minutes (300 seconds) / first interval / first time interval. This monitoring is a kind of rough monitoring. Here, this can involve the temperature of the atmosphere surrounding the sterile container 2, but also the temperature of the atmosphere within the sterile container 2. The temperature detection can take place with one or more temperature sensors.

[0044] The detected temperature is analyzed in the scope of the method and is compared here with a first limit temperature value stored in the storage unit 4. This value can be adapted as required. As long as the temperature value measured in the first time interval does not exceed the first limit value temperature, the method and system remain in the rough monitoring by means of the first interval. As soon as the sterilization is carried out with the sterile container 2, the temperature experienced by the sterile container 2 rises. If the temperature measured during this phase exceeds this predetermined first limit value, the logger 1 automatically switches over to the sterilization mode. This is a fine monitoring of the sterile container 2 and the sterilization process. The system now first assumes that the now detected temperature value is the sterilization temperature and carries out the sterilization process with the sterile container 2.

[0045] After the first limit temperature is exceeded, i.e. in the sterilization mode or in the fine monitoring, the interval time is reduced from the first interval duration to a second interval duration of one minute (60 seconds). As a result of the then more frequent temperature measurements, the holding time and the temperature change can be detected as precisely as possible during the entire phase. In addition, the detected temperature values or time values / holding times are stored in the internal memory 4 in order to be able to evaluate them later.

[0046] After the second limit temperature is undershot or a certain period of time has elapsed, the fine monitoring is ended. In addition, in some embodiments the temperature measurement can be ended. The temperature values detected and stored during the fine monitoring and possibly the time values / holding times are compared with reference values, for example sterilization temperature curves and / or time curves, stored in the system / memory 4. Thereby the time / holding time and the temperature / temperature change curve / temperature change passed in the process can be detected and checked (by means of the computer 6) so that an analysis and control of the sterilization process carried out can be easily realized according to prescribed values / processes (also by means of the computer) and is significantly safer compared to the simple limit value observation according to the prior art.

[0047] If the measured / stored temperature values / time values are within the defined tolerance range, i.e. in accordance with the prescription, the sterilization is classified as successful. In this case either an internal counter in the computer is incremented as a counting means or an indicator is set as a display means 8 so that the successful sterilization is visible to the outside. If the values are not in accordance with the prescription, i.e. outside the tolerance range, this can be visible in a similar way. Alternatively, the system can be reset into the initial mode, i.e. for the temperature monitoring with the first interval duration. After the detection and evaluation, the internal memory 4 is reset and the measurement interval for the ambient temperature is again five minutes.

Claims

1. A method for automatically and specifically detecting a sterilization cycle performed by means of a sterile container, wherein, A temperature measuring device is used to detect the temperature applied to the sterile container, wherein the temperature measuring device is a programmable temperature recorder. The temperature measuring device detects the temperature at a predetermined first time interval. The temperature value detected after exceeding a predetermined first limit temperature is stored in memory. The storage of the detected temperature value is set after the temperature falls below a predetermined second limit temperature or after a predetermined duration has elapsed since the temperature exceeds the first limit temperature. The stored temperature value is compared with a reference temperature value, wherein the deviation between the temperature value and the reference temperature value is determined, and it is determined whether a disinfection cycle has been performed. Operate the counting device and / or display device when the deviation is within a predetermined tolerance range. Its features are, After the first limit temperature is exceeded, the temperature measuring device detects the temperature at a determined second time interval, which is shorter than the first time interval.

2. The method according to claim 1, characterized in that, The counting device shall not be operated and / or the fault report shall not be output and / or the fault report shall be stored when the deviation is outside the predetermined tolerance range.

3. The method according to claim 1 or 2, characterized in that, The first time interval is four to six minutes.

4. The method according to claim 1, characterized in that, The second time interval is 40 to 90 seconds.

5. The method according to claim 1, characterized in that, The temperature measuring device detects the temperature again within the determined first time interval when the temperature is below the predetermined second limit temperature or after a predetermined duration following the temperature exceeding the first limit temperature.

6. The method according to claim 1, characterized in that, The first limit temperature and / or the second limit temperature are settable and can be set.

7. The method according to claim 1, characterized in that, After exceeding the first limit temperature, the temperature-specific holding duration is detected and the holding duration is stored in memory.

8. The method according to claim 7, characterized in that, The stored hold duration is compared with a reference hold duration, wherein the deviation between the hold duration and the reference hold duration is determined.

9. A system for automatically and specifically detecting a sterilization cycle performed by means of a sterile container, the system having - A temperature measuring device for detecting the temperature acting on the sterile container. - Memory, and - Counting device and / or display device in, The system is configured such that, -The temperature is detected by means of the temperature measuring device at a determined first time interval. - The temperature value detected after exceeding a predetermined first limit temperature is stored in the memory. - After exceeding the predetermined first limit temperature, the temperature is detected by means of the temperature measuring device at a determined second time interval, the second time interval being shorter than the first time interval. - Set the storage of the detected temperature value after the temperature falls below a predetermined second limit temperature or after a predetermined duration has elapsed since the temperature exceeds the first limit temperature. - Compare the stored temperature value with a reference temperature value, and determine the deviation between the temperature value and the reference temperature value. - Operate the counting device and / or the display device when the deviation is within a predetermined tolerance range.

10. The system according to claim 9, characterized in that, The temperature measuring device is a temperature recorder.

11. The system according to claim 9, characterized in that... Sterile containers.

12. A machine-readable data storage device, characterized in that, The data storage device stores a method for automatically and specifically detecting a sterilization cycle performed by means of a sterile container, according to any one of claims 1 to 8.

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