DE102021133639A1 - Process for the automatic monitoring and/or validation and/or performance qualification of preparation processes and/or disinfection processes of medical devices - Google Patents

Abstract

A method for monitoring and/or validating disinfection processes or sterilization processes of medical cutlery and/or medical instruments is proposed, which can be used in clinics or medical practices or dental practices. The method includes the provision of a server (2) and a mobile measuring case (4) in order to check a processing device (5) arranged in the clinic or the doctor's practice or dentist's practice. A sensor (441, 442) of the measuring case (4) is arranged on the processing device (5) and via the measuring case (4) a data connection via the Internet to the server (2) and a local connection via cable or W-Lan or Bluetooth or ZigBee connected to the sensor (441, 442). During a disinfection process, data are determined by the sensor (441, 442) and transmitted to the server (2) for remote monitoring in order to validate the treatment process.

Description

The invention relates to a method for monitoring and/or validating and/or performance qualification of preparation processes, such as disinfection processes or sterilization processes, of medical products according to the features of the preamble of claim 1.

In medical operations, for example in clinics or dental practices, there are regularly contaminated medical instruments that have to be processed, i.e. cleaned and then sterilized. For example, this is regulated in DIN 17665 - Sterilization of health care products. The devices or devices used for the preparation or sterilization of medical products must be checked and validated or qualified regularly in order to ensure that the medical instruments or medical products can be properly cleaned, disinfected or sterilized. For example, DIN 58341 - Validation of cleaning and disinfection processes.

From the DE 10 2012 004 696 B3 a method for checking cleaning and disinfection devices is known, in which a special sensor is used, which is introduced into the cleaning chamber of a disinfection device in order to collect measured values during the course of the disinfection process and thereby to ensure that the cleaning or disinfection process is running properly check over.

From the DE 10 2017 131 239 A1 a method for the central acquisition of measured values in clinical facilities is known. There, a data communication system with at least two transmitting devices and a central receiving system is described in order to transmit data from sensors to the central receiving point in the clinical environment and thus record it.

From the EP 1 319 411 A1 a cleaning and disinfecting machine is known which has sensors to monitor the cleaning and disinfecting process. As a result, this described cleaning and disinfection machine can be validated.

The present invention relates to the task of providing a method for monitoring and/or validating and/or qualifying the performance of preparation processes, in particular disinfection processes or sterilization processes, of medical products, which requires little personnel expenditure, in particular runs automatically, and at the same time meets a high quality standard. Preferably, the inventive method is a monitoring or validation of the treatment processes such. B. disinfection processes, sterilization processes, cleaning or packaging, contactless, i.e. enable remotely. In particular, the method according to the invention should make it possible for any operator to carry out the method.

According to the invention, this object is achieved by a method for monitoring and/or validating and/or performance qualification of treatment processes, preferably disinfection processes or sterilization processes, according to the features of claim 1 .

• - Bereitstellen eines Servers,
• - Bereitstellen eines mobilen Messkoffers mit wenigstens einem Sensor, wobei der wenigstens eine Sensor von dem Messkoffer abnehmbar und/oder eigenständig transportabel ausgebildet ist,
• - Anordnung des wenigstens einen Sensors in oder an der Aufbereitungsvorrichtung zur Kontrolle eines Aufbereitungsprozesses und/oder Sterilisationsprozesses.

According to the invention, a method for monitoring and/or validation and/or performance qualification of preparation processes, in particular disinfection processes or sterilization processes of medical products or medical instruments, is proposed, which is used in particular in clinics and/or medical practices and/or dental practices. The procedure includes the following steps

• - providing a server,
• - Provision of a mobile measuring case with at least one sensor, wherein the at least one sensor is designed to be removable from the measuring case and/or to be transportable independently,
• - Arranging the at least one sensor in or on the treatment device for controlling a treatment process and/or sterilization process.

It is essential that a data connection is established between the measurement case and the server via the Internet, that a local connection is established between the at least one sensor and the measurement case by means of a cable or W-Lan or Bluetooth or ZigBee, and that the Sensor records the measured values occurring during a preparation process, in particular a disinfection process and/or sterilization process, and transmits them to the server via the measuring case in order to monitor and/or validate and/or qualify the preparation process and/or disinfection process and/or sterilization process.

In addition to the at least one sensor, the measuring case can include at least one indicator and/or at least one test body.

The reprocessing process preferably includes all work steps that are required for the reprocessing of medical products. These include at for example cleaning processes with water or ultrasound, and/or sterilization processes, and/or disinfection processes, and/or packaging processes for the medical products.

The advantage here is that a data connection via the Internet to a server is established using a mobile measurement case. As a result, processing devices can be monitored or validated from this server, even over large distances, without a suitably qualified person having to work on site on the processing device.

Advantageously, the mobile measuring case serves as a medium for acquiring sensor data and for transmitting this sensor data to a server via the Internet. The server can then monitor or validate or qualify a preparation process, in particular a sterilization process or disinfection process or cleaning process or packaging process, based on the transmitted measured values of the one sensor or the multiple sensors. This monitoring or validation or performance qualification can be ongoing, i.e. in real time, so to speak. Alternatively, the server can also store the transmitted data in a database so that the monitoring and/or validation and/or qualification can take place at a later point in time.

In particular, when monitoring a treatment process, in particular a disinfection or sterilization process, it is checked whether the data determined by the at least one sensor corresponds to the manufacturer's specifications for a specific treatment device. The validation preferably checks whether the manufacturer's specifications for the processing device are met and whether a processing process or disinfection process has been successfully completed, ie whether the medical product to be disinfected or sterilized has been successfully processed. If the outcome of this monitoring or validation is positive, a certificate can be issued at the end of the validation to confirm the successful validation. This certificate can be issued automatically by the server or manually by a person authorized to validate it.

In particular, a server is understood to mean a computer or a computer center which has an electronic computing unit and one or more electronically rewritable memories connected to it and an interface to the Internet. The server can be installed far away from the processing facilities to be validated, the only requirement is that the server is connected to the Internet.

A preparation device or disinfection device or sterilization device is preferably understood to mean a device for the preparation, disinfection or sterilization of medical products, in particular a corresponding cleaning device and/or an autoclave. Such devices are commercially available, for example a steam sterilizer from Melag, a cleaning and disinfection device from Miele or a sealing seam device from Melag.

In particular, a mobile measuring case is understood to mean a mobile unit that contains the interfaces and sensors or indicators or test objects required for monitoring and/or validating a treatment process or disinfection process. This mobile measuring case is only required during a preparation process or disinfection process or sterilization process in order to monitor and/or validate it. This means that the mobile measuring case can be passed on to another processing device or disinfection device after the preparation process or disinfection or sterilization process has been completed, or transported to the next user.

A user is understood to mean, for example, a doctor's practice or a dentist's practice or a department in a clinic in which one or more treatment devices or disinfection devices are operated, which are to be monitored and/or validated at regular intervals. In this sense, the user is also understood to mean the operator of a processing device who is obliged to validate this processing device.

Preferably, the method can also include the provision of a processing device to be validated and/or monitored.

In particular, a processing process to be validated begins by requesting a mobile measuring case, for example at a control center. This is then delivered to the requesting user. In particular, the processing device to be monitored or validated is uniquely identified, for example by a unique ID. This can be assigned via the server, for example in the form of a QR code that can be printed out by the user and attached to the processing device. Before starting the validation, the user can enter the QR scan code Alternatively, the unique ID can also be in the form of an RFID tag. The RFID tag can be attached to or connected to the processing device in order to read out the ID without contact before the start of the validation process. In order to carry out the preparation process, a user can then remove the at least one sensor from the measuring case, or a test body or an indicator, and arrange it on or in the preparation device. For example, the sensor and/or a test body can be placed in a cleaning chamber of a cleaning or disinfecting device together with the medical product to be processed. The at least one sensor then delivers measurement data to the mobile measurement case at regular intervals while the processing is taking place. Alternatively, the sensor can include a data logger and the measurement data can be temporarily stored in the data logger. After completion of a processing step, the data from the data logger can be transferred to the server via the measuring case. Alternatively, the data logger can also be arranged in the measuring case. Multiple sensors and/or data loggers can be used to measure multiple parameters or increase accuracy. These record or store the measurement data and forward them to the server via the Internet. The measurement data is evaluated on the server side and the processing device is validated depending on the result or error handling is started. This has the advantage that nobody has to be present on site for the evaluation and validation. The measurement can be carried out, for example, by staff in the clinic or doctor's office. Advantageously, this also reduces contacts between people and thus reduces the risk of infection. The risk of contamination of a treatment room in which the treatment processes take place is also reduced. After the evaluation or validation, another validation can be started, or the user sends the mobile measuring case back. A validation process is completed when the measuring case is received by a control center and a test report and/or a certificate of validation is issued.

The mobile measuring case can preferably include a number of sensors and also an indicator or indicators and/or a test body or a number of test bodies. For example, the measuring case can have one or more temperature sensors and/or one or more pressure sensors and/or one or more humidity sensors and/or one or more PH value sensors and/or PH value indicators and/or one or more conductivity values sensors and/or one or more vapor penetration sensors. This enables a treatment process to be monitored and/or validated using multiple sensors. As a result, the monitoring accuracy can be increased.

Provision can preferably be made for the server to monitor the treatment process in that the server includes a database with device-specific and/or treatment-process-specific target values of the treatment device and compares the transmitted sensor data with the stored target values. For this purpose, the server can have a correspondingly preconfigured database in which the manufacturer-specific parameters are stored for all processing devices to be monitored. The manufacturers specify standard parameters for their devices that they achieve or should achieve during a treatment process. These parameters can be, for example, temperature values and/or pressure values and/or time profiles of temperature and/or pressure values.

It is also possible for a number of sequence programs to be provided for a processing device, with the server then having a number of sequence programs with their associated manufacturer-specific parameters in the database for the respective processing device.

In particular, it can be provided that the server initiates a repetition of the preparation process if the transmitted sensor data deviate beyond a predetermined error limit, and/or that the server initiates maintenance and/or repair of the preparation device if the preparation process is repeated unsuccessfully.

If it turns out that the manufacturer-specific specifications cannot be reached even when the preparation process is repeated, the server reports this as an error and prompts the user to carry out maintenance. The maintenance can be carried out, for example, by appropriate service personnel from the manufacturer of the processing device. After completing a successful maintenance, the validation of the reprocessing process can be repeated.

It is preferably provided that if the values between the transmitted sensor data and the stored target values match, particularly if the deviations are within a predetermined error limit, the server reports proper processing and stores it in a log memory of the server. If the processing is successful, a validation can be confirmed. This confirmation can take the form of a document in paper form or else through a digital certificate. It is advantageous if the server has a corresponding log memory in which the results of a monitored preparation process are permanently stored. This enables a complete documentation of the necessary validation of the processing devices.

A user or operator can countersign the validation certificate or test report by signing the test report or certificate. In order to simplify the process, provision can be made for the user or operator to digitally countersign the test report or the certificate. In particular, the server can have a certification module to enable a digital signature or a digital countersign.

In one embodiment, it can be provided that one or more sensors are logically assigned to a measuring case, and that the sensors each have a unique ID, with the measuring case and/or the server checking whether a sensor belongs to the group of sensors logically assigned to the measuring case. As a result, safety can be increased accordingly, since only sensors that are assigned to a measuring case can be connected to it. The assignment can also include a calibration of the corresponding sensors on the measuring case, for example. This increases reliability and quality by preventing the use of sensors that are not calibrated or sensors that are not intended for a mobile measuring case.

Provision can preferably be made for the mobile measuring case to comprise an operating and/or display device and a data logger, a power supply and at least two interfaces, with a first interface establishing a data connection via the Internet to the server and a second interface establishing a local data connection to the sensor. An operator can operate the measuring case and/or the sensors via the operating and/or display device. For this purpose, the operating and/or display device can comprise a display and a keyboard for entering operating commands.

Provision can be made for the operating and/or display device to enable communication between an operator and the server and/or for the sensor to be controllable via the operating and display device, in particular to be switched on and/or off, and/or for the the data logger can be operated via the operating and display device, in particular to start and/or end a measurement.

It can preferably be provided that an operator dials into a user account of the server via the measuring case and/or via the operating and display device and is thereby uniquely identified by the server and logged into the user account. Several user accounts can be provided on the server, with each user account being uniquely assigned to a medical practice and/or a dental practice and/or a clinical department. Data specific to the user, such as contact persons and/or data on the equipment or on the existing processing devices, can be stored in the user account. The processing programs of the processing devices used by a user can also be stored in the user account on the server. By dialing into a user account, a user can be uniquely identified and access to user-specific data can be unambiguous and protected against misuse.

In particular, it can be provided that the measuring case has a unique measuring case ID and that a measuring case is clearly identified by the server using its measuring case ID, preferably that the measuring case can only be registered on the server if the measuring case with its measuring case ID is associated with a user account. This can effectively prevent a user from using an unintended measurement case to obtain a validation. In this way, the quality of the validation can be further increased.

In particular, provision can be made for the processing device to be monitored and/or validated to be identified before the start of a measurement, and/or for a sequence program to be identified before the start of a measurement, in particular that the processing device and/or the sequence program is/are managed by the server and/or or the measuring case is identified.

In an advantageous embodiment, it can be provided that the measuring case has a display and a loudspeaker and/or a camera in order to display visual and/or acoustic instructions to an operator as an operating aid. This enables a comfortable user guidance. An operator can use the display, for example via short video sequences, to make the necessary actions clear. At the same time, operation can be simplified by means of acoustic announcements or acoustic instructions. This operator assistance can be done step by step to enable even the inexperienced operating persons can use the mobile measuring case and the sensors to initiate a processing process to be validated without errors. The camera can be used to record image material for documentation during the course of the procedure and transmit it to the server. The image material can be stored or documented on the server in order to achieve a high level of security against manipulation.

Furthermore, it can be provided that the measuring case has a real-time clock.

It can further be provided that the measuring case includes a tablet, in particular that the tablet is designed as a camera and as an operating and display device, preferably as a display with a loudspeaker for visual and/or acoustic operating information.

Advantageously, it can be provided that the measuring case is set up to securely transmit the data of the at least one sensor and/or the data logger and/or a start time or stop time or the duration of a preparation process to the server.

In order to further increase the quality of a validation, it can be provided that an operator is identified via the measurement case, in particular by recording a unique operator ID and/or by biometric parameters, in particular by face recognition and/or by fingerprint. This makes it possible in a simple, forgery-proof manner to identify or document an operator.

Another advantage is that no data is stored on the mobile measuring case. The mobile measuring case preferably transmits all of the data determined and/or entered directly to the server. This makes it possible for a mobile measuring case to be used by several users in succession without the risk of user-specific data or sensitive data being exchanged between different users.

In particular, it can be provided that the server is set up to serve a connection to a number of users and/or to a number of measuring cases at the same time. This makes it possible to increase the capacity with regard to the parallel validation processes.

In one embodiment, it can be provided that the server has a database with device-specific target values of a preparation process and/or a database with a number of device-specific target values, with a number of different operational processes being stored for a device.

Furthermore, it can be provided that the server has a log memory for documenting processing processes to be validated, wherein in the log memory at least the user, the processing device, and the start and / or stop time of the processing process, as well as its successful or unsuccessful completion and / or a Batch number of the processing device is stored.

In particular, it can be provided that a separate user account is created on the server for each user. Provision is preferably made for each user account to be assigned a selection of processing devices and/or operating persons. Provision can advantageously be made for a measuring case to be assigned to a user account for the duration of the course of a preparation process. However, the duration of a preparation process does not only include the pure device running time for preparation, but also the time required to bring the mobile measuring case to a user and to send the mobile measuring case back after the preparation process has been completed. A predetermined time window of several days or a week or two weeks can be provided for this and automatically taken into account by the server. The duration of the procedure can also be set variably by the server until the mobile measuring case is sent back by a user and is registered by the server as having arrived.

It can advantageously be provided that the at least one sensor or indicator or test body has an indicator strip, preferably with an optical reference field, and that the camera records the indicator strip in order to check it automatically using the measuring case and/or the server. The indicator strip can be designed to be placed in the cavities of medical instruments in order to be able to demonstrate proper reprocessing even in places that are difficult to access. For this purpose, the indicator strip can be designed as a pH-sensitive and/or as a temperature- and/or moisture-sensitive indicator strip, or it can have different reference proteins in order to demonstrate a correct result during the course of a preparation. The indicator strip preferably undergoes a color change during the preparation process. The color change can be compared with a target value via a colored reference field. This comparison can be done automatically by a camera, with the help of which the Indi cator strip is recorded after a treatment. The actions required for this can be made clear to an operator via the operating and display device of the mobile measuring case.

In particular, it can be provided that the server has a logistics module for planning validation periods and/or for planning the availability of measuring cases. It can be provided that after completion of a preparation process by the logistics module, the mobile measuring case is sent back and prepared, and that the logistics module determines the earliest possible next use date for the measuring case. The logistics module makes it possible to automatically plan and increase the availability of the mobile measuring case. This can, for example, reduce idle times of the mobile measuring case. Future validation processes can also be planned more precisely in terms of timing, since the logistics module can be used to predict the availability of mobile measuring cases.

The invention also includes a mobile measuring case for connection to a server via the Internet in order to carry out the method according to one of the examples described above.

It is preferably provided that the measuring case has a housing in which at least the at least one sensor, an operating and/or display device and a camera are accommodated as components. The housing can preferably be opened and closed. When open, the mobile measuring case allows the at least one sensor to be removed. When closed, the components are surrounded on all sides by the measuring case or the housing. The housing of the measuring case can have several compartments matched to the size and/or shape of the individual sensors. The sensors in the compartments can preferably be charged via a power supply device in the mobile measurement case. The power supply device of the mobile measuring case can work independently of the mains supply, for example by including a rechargeable battery. Alternatively, sensors can be used that have a battery supply, in particular a lifetime battery that makes changing the battery unnecessary.

Advantageously, it can be provided that the housing is designed as shipping packaging by having an address field. As a result, additional outer packaging can be saved when the mobile measuring case is sent to a user or is returned by a user after a disinfection and/or sterilization process has been completed.

The invention also includes an arrangement for carrying out the method according to one of the examples described above, the arrangement including a server and several mobile measuring cases.

The invention also includes a software product comprising an executable program code that is designed for installation on a computer and/or a tablet and/or the mobile measuring case and is set up as an executable program to carry out the method according to the invention according to one of the examples described above, or to assist in execution.

The software product can include a storage medium with the executable program code. It can also be installed on a computer, for example on the tablet in the measuring case. The software product can also be made available for download on the server.

The executable program code of the software product preferably controls the communication between the mobile measuring case and the server and also between the mobile measuring case and the at least one sensor. For this purpose, the executable program code can include drivers for controlling the interfaces of the mobile measurement case. In particular, the executable program code of the software product can also include user guidance and control of data input and data output via a user interface of the operating and/or display device. The executable program code can be designed as an app, for example.

The method according to the invention can be used in the medical environment, for example in clinics, doctors' surgeries, by dentists, podiatrists, veterinarians, ophthalmologists, etc. It can also be used in tattoo and piercing studios, in food processing companies, service providers for medical products and their processing. Also in the pharmaceutical environment, for example in the manufacture and/or packaging of drugs.

• 1: eine Anordnung zur Durchführung des erfindungsgemäßen Verfahrens;
• 2: eine schematische Darstellung eines mobilen Messkoffers zur Durchführung des erfindungsgemäßen Verfahrens;
• 3-5: beispielhafte Einschübe eines Messkoffers.

Further configurations of the method according to the invention are shown in the figures and described below. show:

• 1 : an arrangement for carrying out the method according to the invention;
• 2 : a schematic representation of a mobile measuring case for carrying out the method according to the invention;
• 3-5 : exemplary inserts of a measuring case.

The figures show exemplary examples for carrying out the method according to the invention. These examples are not meant to be limiting. It is clear to the person skilled in the art that he can modify the exemplary embodiments shown in the figures within the scope of protection of the claims or combine them with one another in combinations other than those shown, without departing from the scope of protection of the claims.

In the 1 an arrangement is shown with the aid of which the method according to the invention for monitoring and/or validating preparation processes for medical products can be carried out. The arrangement includes a server 2 with a database 22 and a processing unit, not shown. This server 2 is connected to the Internet 21 via an interface.

A processing device 5 to be validated is installed on site at a user 6 . The user 6 can, for example, be a doctor's office or a clinic or another medical establishment. The user also has a mobile measuring case 4. The mobile measuring case 4 is made available to the user 6 for the duration of a validation process. For this purpose, the mobile measuring case 4 can be requested by the user 6 at a control center 3 and is delivered to the user 6 by means of a parcel service 31, for example. After completion of the validation process, the user 6 can send the mobile measurement case 4 back to the control center 3.

The mobile measuring case includes a tablet PC 41, which is designed as an operating and display device. A software 43 is installed on the tablet 41 and takes over the sequence control of the validation process on site, ie at the user 6. The mobile measurement case 4 includes two digital data interfaces 451, 452. The first digital data interface 451 connects the measurement case 4 to the Internet 21. Furthermore, the measuring case comprises at least one sensor 441, 442. In the representation of FIG 1 two sensors 441, 442 are shown as an example. The first sensor 441 is arranged on the processing device 5 . The second sensor 442 is arranged inside the processing device 5 . A connection to the two sensors 441 , 442 can be established via the second data interface 452 of the mobile measuring case 4 in order to read out measurement data determined by the sensors and transmit it to the server 2 via the mobile measuring case 4 and the Internet 21 .

In the 2 a mobile measuring case 4 is shown schematically. The mobile measuring case 4 has a housing in which several inserts 461, 462, 463 are accommodated. The inserts can be removed or pulled out of the housing of the mobile measuring case 4 and each include different functional components.

In the 3 a slot 461 is shown as an example. The slot 461 has an accommodation space for the first sensor 441 and an accommodation space for the second sensor 442 . It is also conceivable that additional receiving spaces for additional sensors are integrated into the slide-in unit 461 . Furthermore, a plurality of test bodies 464 are accommodated in the insert 461 .

In the 4 Another example of a slot 462 is shown. The slot 462 has a receiving space for the tablet 41, for example. The tablet 41 can be removed from the mobile measuring case 4 for the purposes of operation and remains connected to the mobile measuring case 4 via a data connection. The tablet 41 can be inserted into the receiving space of the slide-in unit 462 for transport purposes.

In the 5 Another example of a slot 463 is shown. The slot 463 has, as in the 5 is shown, a data logger 48 and a reading station 47 on. The data supplied by the sensors 441, 442 can be buffered via the data logger 48. The reading station 47 has a preferably contactless data interface in order to read the sensors 441, 442 without contact, ie to determine the data determined by the sensors 441, 442.

In order to carry out the validation of a preparation process, the user 6 first requests the mobile measurement case 4 from the control center 3 . This is then delivered to the user 6 by a parcel service provider 31 . After receiving the mobile measuring case 4 , an operator of the user 6 uses the tablet 41 or the software 43 to dial into a user account which is created on the server 2 for the user. The operator then identifies the type of preparation device 5, for example a specific type of sterilization device, and the preparation or sterilization program to be validated. For this purpose, the operator can receive instructions from the server via the display of the tablet 41 as to how this selection is to be made. It can also be checked via a camera using the mobile measuring case whether the set processing device is identical to the actually existing processing device. In this respect, an optical plausibility check can be carried out automatically. The processing program can also be checked by the mobile measuring case or its camera to determine whether the processing program set by the operator on the operating menu is identical to the processing program actually set on the processing device.

The operator can then remove the sensors 441 , 442 from the mobile measuring case 4 and install them on or in the processing device 5 . After the start of the preparation process, the mobile measuring case 4 uses the sensors 441, 442 to determine the measurement data occurring during the preparation process. These can include, for example, temperature values and/or pressure values and/or humidity values. This list is exemplary and not exhaustive. After completion of the preparation process, the measurement data determined are transmitted to the server 2 via the mobile measurement case 4 . For this purpose, the mobile measurement case can already read the measurement data wirelessly from the sensors 441, 442 during the preparation process, or these are removed from the preparation device 5 after the preparation process is complete and taken to the reading station 47 and read out there.

The server 2 can then carry out a comparison with target values stored in the database 22 of the server 2 on the basis of the measurement data transmitted to it by the sensors. The target values are manufacturer-specific specifications for the respective treatment device or the respective treatment process. If the measured values match the target data, the server 2 can detect proper processing and perform a validation of the processing device. This validation can take place, for example, via a digital certificate. Alternatively, a person who is authorized and qualified for validation can issue a corresponding certificate or arrange for the digital certificate to be issued.

After completion of the preparation process, the user 6 can either initiate a further validation or preparation process of another preparation device or send the mobile measuring case 4 back to the control center 3 via a parcel service provider 31 . A validation period ends when the mobile measuring case 4 arrives at the control center 3 .

After receipt of a mobile measuring case 4, it is processed and made ready for the next use. After the mobile measuring case 4 has been successfully prepared, it can be made available to the next user by parcel service 31 . The server 2 can operate a large number of mobile measuring cases or processing devices at the same time and can accordingly record a large number of processing processes in parallel. This makes it possible to use the server to carry out a large number of validations within a short period of time. It is also advantageous that the validating person does not have to be on site with the user 6 for the validation itself. This makes it possible for the user to initiate or carry out the validation independently within the validation period, which has the advantage that the device usage times are not adversely affected by the validation. In addition, care is taken to ensure that a high standard of hygiene can be achieved due to the unnecessary on-site contact between the person to be validated and the processing device 5 .

Reference List

1

Arrangement for validation and/or monitoring of treatment processes

2

server

21

Internet

22

Database

3

headquarters

31

parcel shipping

4

mobile measuring case

41

Tablet / operating and/or display device

43

Software app

441

first sensor

442

second sensor

451

internet interface

452

Sensor interface / Bluetooth

461

first slot

462

second slot

463

third slot

464

test body

47

reading station

48

data logger

5

processing device

6

user

QUOTES INCLUDED IN DESCRIPTION

This list of the documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• DE 102012004696 B3 [0003]
• DE 102017131239 A1 [0004]
• EP 1319411 A1 [0005]

Claims (30)

Method for monitoring and/or validating and/or performance qualification of preparation processes, preferably disinfection processes or sterilization processes, of medical products and/or medical instruments, in particular in clinics and/or medical practices and/or dental practices, comprising the steps - providing a server (2), - Provision of a mobile measuring case (4) with at least one sensor (441, 442), wherein the at least one sensor (441, 442) can be removed from the measuring case (4) and/or is designed to be transportable independently, - Arrangement of the at least one sensor ( 441, 442) in or on a processing device (5) to be validated or monitored for controlling a processing and/or sterilization process, characterized in that a data connection is established between the measuring case (4) and the server (2) via the Internet (21). , and that a local connection is established between the at least one sensor (441, 442) and the mobile measuring case (4) by means of a cable, or W-Lan, or Bluetooth, or ZigBee, and that the sensor (441, 442) the measured values occurring during a preparation process and/or disinfection process and/or sterilization process are recorded and transmitted to the server (2) via the measuring case (4) in order to monitor and/or validate the preparation process and/or disinfection process and/or sterilization process and /or to qualify. procedure after claim 1 , characterized in that the server (2) monitors the treatment process and/or disinfection process and/or sterilization process by the server (2) creating a database (22) with device-specific and/or treatment-process-specific and/or disinfection-process-specific and/or sterilization-process-specific Target values of the processing device (5) includes and compares the transmitted sensor data with the stored target values. procedure after claim 2 , characterized in that the server (2) triggers a repetition of the preparation process if the transmitted sensor data deviate beyond a predetermined error limit, and/or that the server (2) initiates maintenance of the preparation device if the preparation process is repeated unsuccessfully. procedure after claim 2 or 3 , characterized in that the server (2), if the values between the transmitted sensor data and the stored target values match, in particular if the deviations are within a predetermined error limit, reports proper processing and stores it in a log memory (22) of the server. Method according to one of the preceding claims, characterized in that a measuring case (4) is or are logically assigned a sensor or several sensors (441, 442) and that the sensors (441, 442) each have a unique ID, with the measuring case (4) and/or the server (2) is checked to see whether a sensor (441, 442) connected to the measuring case (4) belongs to the group of sensors (441, 442) logically assigned to the measuring case. Method according to one of the preceding claims, characterized in that the measuring case (4) comprises an operating and/or display device (41) and a data logger (48), a power supply and at least two interfaces (451, 452), with a first interface (451) establishes a data connection via the Internet (21) to the server (2) and a second interface (452) establishes a local data connection to the at least one sensor (441, 442). procedure after claim 6 , characterized in that the operating and/or display device (41) allows an operator to communicate with the server (2), and/or that the at least one sensor (441, 442) can be controlled via the operating and display device (41). can in particular be switched on and/or switched off, and/or that the data logger (48) can be operated via the operating and display device (41), in particular to start and/or end a measurement. Method according to one of the preceding claims, characterized in that an operating person dials into a user account of the server (2) via the measuring case (4) and/or via the operating and display device (41) and thereby from the server (2) is uniquely identified and booked into the user account. Method according to one of the preceding claims, characterized in that the measuring case (4) has a unique measuring case ID and that the server (2) uniquely identifies a measuring case (4) using its measuring case ID, preferably that the measuring case (4 ) can only be registered on the server (2) if the measurement case (4) is assigned to a user account with its measurement case ID. Method according to one of the preceding claims, characterized in that before at the start of a measurement, the processing device (5) to be monitored and/or qualified and/or validated is identified, and/or that a processing program is identified before the start of a measurement, in particular that the processing device (5) and/or the processing program is identified by the server (2) and/or the measuring case (4). Method according to one of the preceding claims, characterized in that the measuring case (4) has a display and a loudspeaker and/or a camera in order to display visual and/or acoustic instructions to an operator as an operating aid and/or to create image documentation . Method according to one of the preceding claims, characterized in that the measuring case (4) has a real-time clock. Method according to one of the preceding claims, characterized in that the measuring case (4) comprises a tablet (41), in particular that the tablet acts as a camera and/or as an operating and display device (41), preferably as a display with a loudspeaker for visual and/or or acoustic operating information is formed. Method according to one of the preceding claims, characterized in that the measuring case (4) is set up to store the data from the at least one sensor (441, 442) and/or the data logger (48) and/or a start time or stop time or the Duration of a disinfection process or sterilization process secured to the server (2) to transmit. Method according to one of the preceding claims, characterized in that an operator is identified via the measuring case (4), in particular by recording a unique operator ID and/or by biometric parameters, in particular by face recognition and/or by fingerprint. Method according to one of the preceding claims, characterized in that the server (2) is set up to operate a connection to a number of users and/or to a number of measuring cases (4) at the same time. Method according to one of the preceding claims, characterized in that the server (2) has a database (22) with device-specific target values of a processing process, and/or has a database (22) with a plurality of device-specific target values of a processing process, such that for a processing device ( 5) several different treatment processes are stored. Method according to one of the preceding claims, characterized in that the server (2) has a log memory (22) for documenting treatment processes, wherein in the log memory (22) at least the user, the treatment device, and the start and / or stop time of the disinfection process or sterilization process, as well as its successful or unsuccessful completion, and/or a batch number is stored. Method according to one of the preceding claims, characterized in that a separate user account is created on the server (2) for each user. procedure after claim 19 , characterized in that each user account is assigned a selection of processing devices (5) and/or operating persons. Method according to one of the preceding claims, characterized in that a measuring case (4) is assigned to a user account for the duration of a preparation process. Method according to one of the preceding claims, characterized in that the at least one sensor (441, 442) is designed as a temperature sensor and/or as a pressure sensor and/or as a moisture sensor. Method according to one of the preceding claims, characterized in that an indicator strip is provided and/or that the at least one sensor (441, 442) and/or that a test body has an indicator strip, preferably that the indicator strip is provided with an optical reference field and that the camera records the indicator strip and the optical reference field in order to automatically check the indicator strip using the measurement case (4) and/or the server (2). Method according to one of the preceding claims, characterized in that the server (2) has a logistics module for planning validation periods and/or for planning the availability of measuring cases (4). procedure after Claim 24 , characterized in that after completion of a processing process by the logistics module, a return and processing of the mobile measuring case (4) is initiated, and that the logistics modul determines the earliest possible next application date for the mobile measuring case (4). Measurement case (4) for connection to a server (2) via the Internet (21), set up to carry out a method according to one of the preceding claims. measurement case Claim 26 , characterized in that the measuring case (4) is designed as a mobile measuring case and has a housing in which the at least one sensor (441, 442), a camera, an operating and/or display device (41) are accommodated as components, preferably that the housing can be opened and closed and in the open state allows removal of the at least one sensor (441, 442) and encloses the components in the closed state. measurement case Claim 27 , characterized in that the housing is designed as a shipping package by having an address field. Arrangement for carrying out the method according to one of Claims 1 until 25 , comprising a server (2) and several mobile measuring cases (4), one or more of these mobile measuring cases (4) being connected to the server (2) via the Internet (21) by a method according to one of Claims 1 until 25 to perform. Software product (43) comprising an executable program code which is designed for installation on a computer and/or a tablet (41) and/or the mobile measuring case (4) and is set up as an executable program to implement a method according to one of Claims 1 until 25 to perform.

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