Confirmation of mixing treatment in decontamination processes

Abstract

A method for inspecting and validating mixing in a process using a two-component disinfectant system is disclosed. The disinfectant system includes a first component having a first reagent in a carrier and a second component miscible with the first component and having a second reagent in a carrier. Upon mixing, the first and second reagents react to produce a disinfectant composition. The validation method of the present invention captures a video stream of a user's mixing area, analyzes the video stream, identifies one or more mixing events in the video stream corresponding to correctly performed mixing, determines that the mixing process is complete based on each identified mixing event, and provides corresponding instructions to the user upon determining that the mixing process is complete. The method can alert the user to potential errors and / or record data to provide an audit trail.

Description

Technical Field

[0001] a. Field of the Invention The present invention relates to a method and apparatus for inspecting and validating a treatment process during the use of a contamination removal system. In particular, the present invention is directed to the inspection and validation of the disinfection process of medical devices, devices and surfaces in a clinical environment.

Background Art

[0002] b. Related Art Effectively removing contamination from medical devices, surfaces and other objects in a clinical environment is essential for ensuring patient safety. To address this essential requirement, several highly effective disinfection systems have been developed.

[0003] For example, WO 2005 / 011756 discloses a two-component disinfectant system. This disinfectant system has a first component having a first reagent in a carrier, and a second component that is miscible with the first component and has a second reagent in the carrier. When mixed, the first reagent and the second reagent react to produce a disinfection composition. In a preferred embodiment, one of these two components is an acidic solution and the other component is a solution containing sodium chlorite or sodium chlorate, and a disinfection composition having chlorine dioxide is generated upon mixing of these two components. The first component, known as an activator, can be dispensed as a fluid, preferably as bubbles, by placing it in a pump dispenser, and the second component is absorbed or impregnated (soaked) into at least one cloth member in a sealed container. To prepare a disinfection tissue, the user removes the impregnated tissue from the container and adds a portion of the bubbles from a nebulizer to the tissue. To facilitate mixing of the bubbles and the reagent in the tissue, the user may fold the tissue to enclose the bubbles or crush or rub the folded tissue before opening it.

[0004] WO 2005 / 107823 discloses a decontamination system suitable for retreatment of non-lumen medical devices using a disinfection process involving three manual wipes, as shown in Figure 1. The system shown as an example comprises a box 10 containing a sachet 11 of pre-clean wipes, a disinfection system 12 containing a dispenser 14 and a bag of disinfectant wipes 16 as described above, and a box 18 having a bag of sterilized rinsing tissues 20. The pre-clean wipes are used to wipe instruments such as endoscopes that need to be decontaminated. The instruments are then sterilized or disinfected using the two-component disinfection system 12 (with activated bubbles in combination with the wipes), and any chemical residues are removed using the sterilized rinsing tissues. All details of the disinfection process are recorded in the accompanying audit trail book, allowing for complete tracking of the disinfection process.

[0005] To ensure that this type of decontamination system is fully activated, the user must strictly adhere to a specific process sequence. An example of such a sequence is shown in Figure 2.

[0006] In step 101, remove a wipe, such as a tissue, from the bag 11. In step 102, wipe with the wipe, starting with the cleanest part (such as the handle) and moving towards the dirtiest or most contaminated part (such as the invasive distal part).

[0007] In step 103, a disinfectant wipe is pulled from its bag 16 and unfolded, and then in step 104, a precise amount of activated foam (generally measured by operating the dispenser 14 a predetermined number of times) is dispensed onto the wipe. In step 105, the wipe is folded to enclose the foam, and then rolled up for a predetermined time to completely mix the two components of the disinfectant system. In step 106, the device is wiped with the activated disinfectant wipe. Again, wiping should begin with the cleanest part and proceed towards the dirtiest part.

[0008] In step 107, pull a rinsing wipe from bag 20, and in step 108, wipe the device again with this rinsing wipe, starting from the clean parts and moving towards the dirty parts.

[0009] In step 109, the decontaminated device is moved to a pre-set clean area, thus preventing recontamination of the device that could otherwise occur.

[0010] Any error by the user can lead to the failure of the decontamination process. Examples of such errors include incorrect selection of bags 11, 16, or 20 in any of steps 101, 103, or 107; incorrect wiping direction or wiping too quickly in steps 102, 106, or 108; insufficient distribution of the active ingredient in step 104; and rounding too short in step 105.

[0011] To avoid such errors, one can use audit trail books or audit trail software, but both generally rely on user input, making it difficult to directly confirm that a part of the process was performed correctly.

[0012] Given the above background, it is desirable to solve the technical challenge of ensuring that the decontamination process has less reliance on user input and that more steps in the decontamination process can be directly verified. [Overview of the project]

[0013] A first aspect of the present invention provides a method for inspecting a mixing procedure in a process using a two-component disinfectant system. The disinfectant system comprises a first component having a first reagent in a carrier, and a second component that is mixed with the first component and has a second reagent in a carrier, wherein the first and second reagents react during mixing to produce a disinfectant composition. In the method of the present invention, a video stream is acquired from the work area where the user performs the mixing procedure, and this video stream is analyzed to identify one or more mixing events in the video stream that indicate the mixing procedure is being performed correctly. Based on each identified mixing event, it is determined whether the mixing procedure has been completed, and when it is determined that the mixing procedure has been completed, a corresponding instruction is shown to the user.

[0014] In this method, confirmation of the mixing process of the two-component disinfectant system is based on automated evaluation of user actions through video stream analysis, making it highly effective in allowing users to accurately confirm that the mixing process is complete. This method reliably demonstrates to the user that the mixing process has been successfully completed, thereby ensuring that the disinfectant composition is optimally effective and increasing user confidence.

[0015] In video stream analysis, it is preferable to use a trained neural network to identify mixed events, or at least one mixed event. With proper training, the neural network can reliably and quickly identify these mixed events while the user is performing them.

[0016] The first and / or second components of the disinfectant system may contain an indicator component that changes color when the first and second components are mixed. In this case, one of the mixing events or multiple mixing events to be confirmed in image analysis will exhibit the aforementioned color change. Therefore, through image analysis, it can be confirmed that the color change occurred completely and uniformly, and that the mixing process was completed successfully.

[0017] In the image analysis process, if a mixed event or one of several mixed events is identified, a preset amount of the first component of the disinfectant system is added to a preset amount of the second component of the disinfectant system.

[0018] The first component of the disinfectant system may be contained in a dispenser and dispensed as a fluid. In this case, the fluid can be dispensed from the dispenser in a mixing event or in one of several mixing events. The second component of the disinfectant system may be absorbed into or impregnated into a wipe. In this case, the wipe may be folded or rolled up after being treated with the first component in a mixing event or in one of several mixing events. With this configuration, the user can accurately and mechanically manipulate the wipe and confirm that the first component is completely distributed and mixed throughout the wipe.

[0019] In another embodiment, the first and second components of the disinfectant system can be dispensed individually or pre-mixed as bubbles, and in one of the mixing events or a combination of mixing events, the bubbles are mixed (by stirring or distributing the bubbles onto a wipe and folding or rolling the wipe, etc.) and / or the mixed bubbles are retained.

[0020] When determining whether the mixing process is complete, the cumulative time of at least one of the mixing events or multiple mixing events may be calculated and compared with a preset minimum mixing time. For example, if the first component of a disinfectant system is contained in a dispenser and the second component is a wipe, when determining whether the mixing process is complete, it is preferable to determine, based on at least two confirmed mixing events, whether (a) a preset amount of the first component of the disinfectant system has been added to the wipe, and whether (b) the wipe has been folded or rolled for at least a preset minimum mixing time. In the method of the present invention, the required minimum mixing time may be determined by searching for a preset mixing time from memory. Depending on the case, when determining the required minimum mixing time, the minimum mixing time may be selected or calculated based on a predetermined ambient temperature or other environmental or system parameters.

[0021] Alternatively, or in addition to the above, when determining whether the mixing process is complete, it may be determined whether a set of different mixing events have occurred in a predetermined sequence. This sequence of different mixing events may include, for example, a sequence in which a predetermined amount of the first component of the bubble system is first distributed onto a wipe of the second component, the wipe is then folded over the entire bubble, and the wipe is then rolled up for a predetermined time. To ensure that the correct reagents are used in the mixing process, a container containing the first component and / or a container containing the second component may be provided in at least one of the mixing events or a set of mixing events.

[0022] In addition to reliably indicating that the mixing process has completed correctly, the present invention can also indicate if an error has occurred, allowing corrective action to be taken if the error is sufficiently serious, and enabling the mixing process to be stopped or restarted as necessary. To this end, the present invention, during video stream analysis, checks for one or more warning events in the video stream that correspond to potential errors during the execution of the mixing process, and after checking for warning events, issues a corresponding warning to the user.

[0023] For example, one event or multiple events requiring attention is vibration of the container holding the first component or the container holding the second component. In particular, when dispensing the first and / or second components as bubbles, if the dispenser vibrates before dispensing the bubbles, it will negatively affect the amount dispensed with each dispensing operation. In this case, the user can be warned to stop the container vibration. Another event or multiple events requiring attention is selecting the wrong component for the process to be performed. In this case, the user can be warned to select the correct component.

[0024] In another embodiment, one of several events requiring attention is that the user's hands obscure the work area, the first component of the disinfectant system, and / or the second component of the disinfectant system. In this case, the user can be instructed to ensure that the mixing process is performed within the field of view of the video stream.

[0025] The present invention may also provide means for electronically recording information related to a mixing process. More specifically, this method can electronically record that the mixing process has been completed. If an event requiring attention is identified, the fact that an event requiring attention has been identified can be electronically recorded. This method can electronically record information related to the first component and / or the second component of the disinfectant system. In this case, when analyzing a video stream, information related to the first component and / or the second component of the disinfectant system can be identified within the video stream. This identification can be done, for example, by reading a machine-readable code after identifying the carrier in use, or by retrieving the information. As information related to the first component and / or the second component of the disinfectant system, at least one of the following can be used: the type of the first or second component, the lot number or batch number, the date and time of manufacture, and the expiration date or expiration date.

[0026] According to a second aspect, the present invention can also be extended to an apparatus for verifying the mixing process in a process using a two-component disinfectant system. This verification apparatus includes a camera system that captures a video stream of the work area where the user performs the mixing process, an output device that provides an audio display, a text display, and / or a visual display to the user, an image analysis module configured to receive the video stream and identify one or more mixing events in the video stream corresponding to the mixing process being accurately performed, and a validator module that determines whether the mixing process has ended based on each identified mixing event and causes the output device to give an instruction corresponding to the user when it is determined that the mixing process has ended. For the image analysis module, it preferably has a classifier based on a neural network and trained to recognize one or more mixing events in the video stream. This verification apparatus can further implement a recording module configured to electronically record that the mixing process has ended. It is more convenient for the verification apparatus to implement a smartphone or tablet computer device.

[0027] In yet another aspect, the present invention also relates to applying the apparatus according to the second aspect to the verification of the mixing process in a process using the two-component disinfectant system according to the method of the first aspect.

[0028] The present invention also relates to a decontamination system having a first component having a first reagent in a carrier, a second component that is miscible with the first component and has a second reagent in a carrier, wherein the first reagent and the second reagent react when the first component and the second component are mixed to produce a chlorine dioxide-based disinfection composition, and the verification apparatus according to the second aspect of the present invention for verifying the mixing process when using the disinfectant system.

[0029] The present invention can be used to verify mixing processes in substantially all contamination removal processes that require mixing to produce active disinfecting and cleaning compositions. In such contamination removal processes, other steps and treatments can be performed, such as using pre-use stages and / or washing stages, and thus embodiments of the present invention can be extended to verify one or more of the associated processes in addition to the mixing process. Using this contamination removal process, contamination removal processes for medical instruments and devices can be carried out, and in this case, embodiments of the present invention can be used to verify accurate cleaning processes for the devices in addition to the mixing process.

[0030] In other aspects, suitable and / or appropriately adopted features of each aspect of the present invention can be applied alone or in appropriate combination.

[0031] For the purposes of the context of this specification, "inspecting and verifying a process" means confirming whether one or more specific steps are employed or not when performing the process in question by appropriate means, and / or whether one or more specific components are used. The process to be verified does not necessarily encompass the entire process of contaminating and removing contaminants from a device, object, or surface, but may be only a small part of a longer contamination removal process.

[0032] Also, as used in this specification, "contamination removal process" refers to a series of steps such as cleaning, preparing for cleaning, disinfecting, sterilizing, and washing an object or surface, and includes steps for preparing the materials and components used in these treatment operations. As used in this specification, "contamination removal treatment" refers to a single step of the contamination removal process, the combined use of these steps as a subset of a longer contamination removal process, or all of the steps of the contamination removal process, and should be determined from the context.

Prior Art Documents

Patent Documents

[0033]

Patent Document 1

[0034] For illustrative purposes only, embodiments of the present invention will be described below with reference to the attached drawings. Note that the same reference numerals in the drawings refer to the same parts. [Figure 1] Figure 1 shows a known decontamination system to which an embodiment of the present invention is applied. [Figure 2] Figure 2 shows a series of steps in a decontamination process using the system shown in Figure 1. [Figure 3] Figure 3 shows the verification device for decontamination treatment. [Figure 4-12] Figures 4 to 12 show images captured from a video stream illustrating events that occur during the decontamination process of medical devices. [Modes for carrying out the invention]

[0035] Embodiments of the present invention provide methods and apparatus for automatically or semi-automatically inspecting and verifying various processes or steps that users need to perform when carrying out a decontamination process. Examples of a decontamination system and corresponding decontamination process are described below with reference to Figures 1 and 2. The embodiments of the present invention are also applicable to other decontamination systems and processes.

[0036] Figure 3 is a schematic diagram showing a processing inspection and verification device. In this embodiment, the verification device has a portable device 30 equipped with a camera system 32 that captures a video stream of the work area 34.

[0037] The camera system 32 outputs a video stream to the image analysis module 36. As will be explained in detail below, the image analysis module 36 analyzes the video stream to determine when a predetermined event or action occurred within the work area. The image analysis module 36 outputs the corresponding event data to the validator module 38.

[0038] The validator module 38 analyzes the received event data and determines whether the predetermined process has been completed correctly or whether any potential error is occurring. After such determination, the validator module 38 provides the user with instructions via the display 40. The validator module 38 may also provide instructions via audio outputs such as loudspeaker output or headphone output (not shown).

[0039] Furthermore, the validator module 38 is configured to record data in memory 42. With this configuration, the validator module 38 can record in memory 42 that one or more processes have completed successfully, and / or that one or more potential errors have been detected during the video stream.

[0040] This recorded event information may be correlated with supplementary information such as the user's name, details of other users, patient details, location of processing, device type, surface or other item being decontaminated, device serial number, or details of the decontamination system and its components, such as batch number or lot number, manufacturing date and time, and expiration date data. Such supplementary information may be entered by the user via a suitable interface (not shown), generally a touchscreen, captured by reading barcodes or matrix codes presented to the camera, or determined and judged by analysis of the video stream. In the latter case, for example, the validator module 38 may be configured to recognize containers containing various components used in the decontamination system (i.e., bags 11, 16, 20 and dispenser 14), and the validator module 38 may be configured to retrieve stored component type information corresponding to each identified container and record this information together with the recorded event information.

[0041] With this configuration, memory 42 can store a partial or complete audit trail of the decontamination process that may be stored therein, and then retrieve and / or transmit it to a server or other device that holds the record via a suitable communication protocol or network.

[0042] The apparatus of the present invention can be configured as a self-contained portable device 30, such as a smartphone or tablet computer. It is preferable that commonly used smartphones, tablet computers, and similar devices already implement a camera system, data storage device, display, audio output device, and network-connectable communication device, along with a processor configured to execute suitable instructions for carrying out the method described herein. Therefore, it is preferable that the image analysis module 36 and the validator module 38 be implemented using software that can be executed by the processor. The software can be incorporated as an installable application that operates within the device's operating system environment. The image analysis module 36 and / or the validator module 38 can also be entirely or partially configured by a cloud-based service configured to communicate with the device 30.

[0043] In the case of a camera system, it can be equipped with one or more cameras, and it is conceivable that supplemental data can be sent to the image analysis module 36 using a non-visible light camera (such as a thermal camera or depth camera).

[0044] Regarding device 30, it is preferable to mount it on a suitable stand with the camera device 32 facing the work area 34, allowing the user to perform the decontamination process with both hands free. Depending on the circumstances, it is also possible to hold device 30 by hand throughout part or all of the process.

[0045] In the case of the image analysis module 36, any suitable method can be used to analyze the video stream, but a machine learning approach is preferred. For example, in the case of the image analysis module 36, a trained artificial neural network (such as a convolutional neural network and / or a recurrent neural network) can be used to identify, classify, or characterize what appears or happens in the work area 34 frame by frame or across multiple frames. Supervised learning can be easily utilized by training the network with video footage and / or multiple versions of images of the events to be identified. Continuous improvement in accuracy can also be achieved using semi-supervised learning, active learning, and user feedback input. In several embodiments, these approaches can be used to refine the neural network and improve accuracy according to the specific user and / or specific environment or work area.

[0046] Those skilled in the art, working in the field of machine learning-based video analysis, are familiar with various suitable neural networks and will not elaborate further. One suitable neural network architecture is based on MobileNet, which constitutes a convolutional neural network that extracts frame-wise features from a video stream. Combining this with an LTSM (Long-Term Memory) recurrent neural network allows for the aggregation of temporary information (i.e., motion between frames). Another possible network is a two-stream convolutional neural network.

[0047] In each embodiment of the present invention, the image analysis module 36 is only necessary when confirming a relatively small number of different events, and the validator module 38 can accurately determine whether the target process was performed correctly or whether a potential error occurred.

[0048] Some of the events identified by the image analysis module 36 can be considered to correspond to a single step in a properly executed decontamination process. Examples of such “decontamination events” include sampling the correct components, accurately mixing the two components of a disinfectant system, and supplying the decontamination components to the device in the correct manner. Other events are considered to correspond to potential errors being made by the user. Examples of such “events requiring attention” include selecting the wrong component at a specific stage of the process, cleaning the device too quickly or in the wrong direction, distributing the wrong amount of one component of a two-component disinfectant system to the other, inaccurate mixing of the two components or insufficient mixing time, vibrating the dispenser before use, placing the device in a designated clean area of ​​the work area before decontamination or in a designated contaminated area of ​​the work area after decontamination, and not wearing gloves and / or other protective equipment.

[0049] For neural networks, training is performed on all events and tasks that need to be examined in a multi-task learning environment. A hierarchical representation of the results can be used to characterize each event and task. For example, the task of detecting the types of components in a bag is based on observation of the bag. This ensures that the results are forced to match.

[0050] A training dataset covering all phenomena to be examined can be generated from multiple demo videos in which phenomena are classified, including multiple examples of the same phenomenon with suitable variability that reflects the main causes of variability expected during use. Such variability includes camera variability, portrait and landscape orientation variability, camera tilt variability, distance between the camera and the work area variability, background color and background material variability, lighting color variability, lighting source variability, lighting intensity variability, lighting direction variability, glove color variability, user skin color variability, gender variability, and handedness and usage efficiency variability when using the component. Further variability can be synthesized through data augmentation to simulate camera orientation by introducing variability in brightness, different lighting conditions, horizontal and vertical flips, and camera tilt by introducing variability in shearing and rotation. For subsequent testing, a test dataset can be used, for example, comparing different demo videos with different users and / or different settings of the above variability to the demo videos in the training dataset.

[0051] To facilitate learning unlabeled processes, a self-supervised learning approach can be added. For example, the frame order of a video demonstrating an accurate process can be shuffled, and then the network can be trained to recognize the original frame order. Other examples of self-supervised learning include image inpainting (taking a portion of an image and training a network to reconstruct it, learning the structure of an object / medical device) and image recoloring (training a model to learn color changes during mixing and / or the expected colors of bags or other containers).

[0052] The image analysis module 36 outputs confirmed decontamination events and confirmed events requiring attention to the validator module 38. When the validator module 38 indicates that specific decontamination events (sometimes multiple) have occurred in the process for which the output from the image analysis module 36 is required, it can determine that each step in the process was performed correctly. To this end, the validator module 38 can use a finite state machine or a hidden Markov model to convert the frame-wise prediction of the events output from the image analysis module 36 into a global evaluation of the process sequence executed in the process. If one or more events are required to perform the process correctly, the validator module 38 can check that all necessary events have occurred and that these events occurred in the correct order. In the case of the validator module 38, it can also check that no events requiring attention occurred, or that errors corresponding to confirmed events requiring attention were subsequently corrected (for example, by the corresponding decontamination event immediately following). Some of the events requiring attention include errors that can be corrected immediately, such as the selection of the wrong ingredient, or the user's hands or parts of the decontamination system becoming invisible or going out of field of view. In the event of events such as the supply of the wrong ingredient to the device, the decontamination process needs to be restarted.

[0053] Not only can these results be recorded in memory 42 as part of the audit trail, but device 30 is also advantageous in that it can provide direct feedback to the user by playing graphical and / or text displays on display 40 and / or playing sound and / or speech via the device's audio output. With this configuration, if each step of a particular process is performed correctly, the user can be instructed to confirm both that the step has been completed and that device 30 has recorded this fact. Similarly, if a potential error occurs and an event requiring attention arises, the user can be prompted to take appropriate corrective action with appropriate instructions.

[0054] Furthermore, device 30 can guide the user through the process by providing prompts or instructions regarding the next steps to be taken using the display 40 and / or audio output. For example, the validator module 38 can provide instructions regarding the next steps to be displayed after confirming a specific decontamination event. Alternatively, if a specific action needs to be performed for a certain period of time, the validator module 38 can display a timer to guide the user when confirming the event indicating this action.

[0055] To enable the operation of the validator module 38 in this way, suitable processing data for each specific process can be stored in the memory 42. This processing data may include, for example, a list of required events and the order in which these events are performed, pre-set times and other parameters for each process, and a list of possible warning events corresponding to potential errors. The validator module 38 compares the confirmed decontamination events and warning events with the stored processing data to determine whether each process was performed correctly or whether an error occurred, retrieves information about the expected next process, and triggers the display of instructions or actions, such as starting a countdown timer. Since the memory 42 can store processing datasets for multiple possible processes, the validator module 38 can select which processing dataset is appropriate for the process being performed. The processing data may include corrections that allow adjustment of parameters to compensate for environmental factors such as temperature and humidity, and these parameters may be determined by the device 30 using suitable sensors, and / or entered by the user. Example 1

[0056] The following examples illustrate the use of device 30 to verify a decontamination process for medical devices using the type of decontamination system shown in Figure 1. Examples of medical devices include endoscopes, nasal endoscopes, and transvaginal probes, all of which have a proximal handle and a distal invasive end. Figures 4 to 12 show exemplary frames captured by the camera system 32. In this case, the camera 32 is positioned above the work area. For illustrative purposes, the output from the image analysis module 36 is shown in the upper left corner of each image.

[0057] Process 1 First, the model of the medical device to be decontaminated is identified and recorded. This can be done automatically by image analysis of the video stream when the device is placed in the work area. In this case, the user is prompted to confirm that the medical device model has been correctly identified. Alternatively, the user may input the medical device model by selecting it from a predetermined list of options.

[0058] Process 2 Capture and record the device's unique serial number. This can be done, as described above, by image analysis, for example, by capturing a barcode or matrix (QR) code, or by directly reading text. Alternatively, the user may input the serial number. Once captured, the serial number is checked to confirm its validity for the device model.

[0059] Process 3 Device 30 prompts the user to prepare pre-cleaning wipes.

[0060] Process 4 Device 30 verifies and authenticates that the appropriate pre-use cleaning component is being used. The image analysis module 36 verifies that an approved pre-use cleaning wipe bag is present in the work area as a contamination removal event while it is presented to the camera by the user. The pre-use cleaning wipe bag can be identified by a different colored indicia than the bags used later in the process, allowing the image analysis module 36 to identify the different bags. If a bag that does not correspond to the planned pre-use cleaning wipe bag is presented, it is considered an event requiring attention, and device 30 displays that the wrong bag has been selected. The type of bag identified may be compared with a suitable pre-use cleaning component or a stock list stored in the user input system. The presence of the pre-use cleaning component is recorded, along with information such as the batch number and expiration date, as well as the type of component, if applicable.

[0061] Process 5 Image analysis is used to identify the proximal handle portion of the device and the invasive distal end of the device.

[0062] Process 6 Device 30 prompts the user to begin pre-use cleaning of the device, and then monitors the video stream to monitor for any events requiring attention. For example, an error will be displayed if the pre-use cleaning is started from the dirtier invasive end instead of the cleaner proximal handle, or if the wipe is moving in the wrong direction. Similarly, an error will be displayed if the user performs the pre-use cleaning too quickly or does not follow the pre-configured component identification instructions for the usage data.

[0063] Process 7 If the image analysis module 36 confirms that the device has been cleaned from clean to dirty areas according to the user's instructions specific to the components, without the device detecting any alarming events, the device 30 grants approval to the user.

[0064] Process 8 Device 30 prompts the user to prepare disinfectant wipes.

[0065] Process 9 Device 30 verifies and authenticates that the appropriate disinfectant should be used. Similar to step 4 above, the image analysis module 36 verifies that an approved disinfectant wipe bag is present in the work area as a contamination removal event while it is presented to the camera by the user. This is shown in Figure 4. If a bag that does not correspond to the planned disinfectant wipe bag is presented, it is considered an event requiring attention, and device 30 displays that the wrong bag has been selected. The type of bag confirmed may be compared with a suitable pre-use cleaning component or a stock list stored in the user input system. Furthermore, the disinfectant component is cross-referenced with a previously used pre-use cleaning component to ensure that both are usable. The presence of disinfectant wipes is recorded, if necessary, along with information such as the batch number and expiration date, as well as the type of component.

[0066] Process 9A Device 30 verifies and certifies that the appropriate disinfectant active agent should be used. Here, the image analysis module 36 verifies that, as a decontamination event, the active agent bubbles are present in the work area of ​​the approved dispenser while the work area is presented to the camera by the user. Similar to step 9 above, the same verification may be performed on the active agent component in this step as well.

[0067] Process 9B Device 30 prompts the user to treat the active bubbles with a wipe, and then monitors the video stream for the following events: (a) Remove the disinfectant wipes from the bag and make them visible in the work area (see Figure 5). (b) Two aliquots of bubbles have already been added to the wipe (in this embodiment, the two aliquots correspond to the exact amount added to one wipe). Figure 6 shows the verification process of distributing bubbles from the dispenser to the wipe, and Figure 7 shows the two bubble aliquots on the wipe. (c) The wipe is already folded (Figure 8) and rolled up (Figure 9), and air bubbles are distributed throughout the wipe for at least the shortest time necessary to ensure that the disinfectant composition is fully activated. (d) The wipe is already open, looks uniform, and is ready for use (Figure 10).

[0068] After confirming each event, device 30 records the event, displays a confirmation that the corresponding process has been completed correctly, and prompts the user to proceed to the next step. If any error occurs, such as dispensing too few or too many aliquots of bubbles, the user is warned. Depending on the case, the size of each aliquot is checked to confirm that the pump has operated correctly each time.

[0069] Step 10 Image analysis is used again to identify the proximal handle portion of the device and the distal invasive end of the device.

[0070] Step 11 Device 30 prompts the user to begin disinfecting the device, monitors the video stream, and checks for any events requiring attention. Figure 11 shows the process of verifying that the disinfectant wipe is placed on the device. An error will be displayed if disinfection starts from the invasive end instead of the proximal handle portion of the device, or if the wipe is moving in the wrong direction. Similarly, an error will be displayed if the user disinfects too quickly or does not follow the pre-configured ingredient identification instructions for usage data.

[0071] Step 12 The image analysis module 36 confirms when the disinfectant wipe has treated the entire medical device. The device 30 then displays a countdown timer and begins counting down the contact time for the disinfection process. If the wiping process stops or is interrupted, or if it is not performed at a uniform speed along the length of the device, or if the wipe comes off the device, an error will be displayed. Similarly, an error will be displayed if the user touches the device or if another item (such as a wipe) touches the device during the countdown.

[0072] Step 13 The image analysis module 36 confirms that the device has been disinfected from clean to dirty parts according to the specific user instructions for disinfection, and if no incidents requiring attention occur and the necessary contact time is observed, the device 30 grants authentication to the user.

[0073] Step 14 If no final rinse of the disinfectant used in the pre-use cleaning / disinfection stage is required, device 30 will indicate that the disinfection process is complete. If a pre-set parameter indicates that rinsing of the disinfectant used is required, device 30 will prompt to proceed to step 15.

[0074] Step 15 If rinsing is necessary, device 30 prompts the user to prepare rinsing wipes.

[0075] Process 16 Device 30 verifies and authenticates that the appropriate rinse wipes should be used. The image analysis module 36 confirms the presence of an authenticated rinse wipe bag within the work area while it is presented to the camera by the user as a disinfection event. If a bag that does not correspond to the expected rinse wipe bag is presented, it is considered an event requiring attention, and device 30 displays that the wrong bag has been selected. The type of bag confirmed is compared with suitable rinse components and a stock list stored in the user input system, and its compatibility with pre-use cleaning / disinfectant wipes used in the previous step may also be checked. The presence of rinse components can be recorded, if applicable, along with information such as the type of rinse component, batch number, and expiration date.

[0076] Process 17 Again, image analysis is used to identify the proximal handle portion of the device and the distal invasive end of the device.

[0077] Process 18 Device 30 prompts the user to begin rinsing the device and then monitors the video stream for any events requiring attention. For example, an error will be displayed if rinsing begins from the invasive end instead of the cleaner proximal handle, or if the wiping is proceeding in the wrong direction.

[0078] Process 19 If the image analysis module 36 confirms that no alarming events have been detected and that the device has been rinsed from clean to dirty parts in accordance with the specific user instructions for disinfection, the device 30 grants approval to the user.

[0079] Process 20 At the end of the process, device 30 issues a verification code indicating the process was successful (by the user if necessary) and records the process details in memory 42. Device 30 can also record a recommended retention period before re-disinfection is required.

[0080] The image analysis operations in the above process are assumed to be performed within the camera's field of view. Therefore, throughout the entire process, as shown in Figure 12, if the user's fingers are hidden or outside the visible area and thus become invisible in the video stream, device 30 will display an error.

[0081] In the process described above, an “approved” ingredient means an ingredient that can be used for its intended purpose, is approved by the facility of the user of that intended purpose, and / or is approved by the medical device manufacturer. Example 2

[0082] In this embodiment, the two-component disinfectant system 12 has one or both components that exhibit a discoloration when these two components are mixed. This discoloration can be observed in the video stream, which not only confirms that both components of the disinfectant system 12 are completely mixed, but also confirms the physical mixing process described in step 9B of Example 1.

[0083] The following are the verification steps related to the accurate preparation of the activated disinfectant wipes in this embodiment.

[0084] Process 1 Check the disinfectant wipe bags, verify their suitability, and then authorize the user.

[0085] Process 2 The activated foam dispenser is inspected, its suitability is checked, and then authentication is granted to the user.

[0086] Process 3 Check that the wipes are in an inactive state when removed from the bag. If the wipes do not have the correct initial color at this stage, an error will be displayed.

[0087] Process 4 Verify the supply of bubbles to the wipe and, if necessary, check the exact number of bubble aliquots.

[0088] Process 5 Ensure the wipes are folded and rolled up for the correct amount of time.

[0089] Process 6 After rolling, verify that the disinfectant wipe has the correct color after discoloration and that this color is uniform throughout the wipe.

[0090] Furthermore, the color change alone can be used to confirm that both components of the disinfectant system are completely mixed. In this case, steps 4 and 5 can be omitted.

[0091] It is not necessarily required that all of the steps described in the above embodiments be confirmed as events by the image analysis module 36, nor is it necessary to confirm each process in the device 30 with high reliability by the verification module 38. In embodiments of the present invention, some steps can be omitted from the verification process. Similarly, supplementary steps not mentioned in these embodiments can be confirmed and used in the verification method.

[0092] The above embodiments are intended solely to illustrate the decontamination processes that can be confirmed by the present invention and can be extended in many forms.

[0093] For example, WO 2006 / 079822 A1 describes a disinfection system in which a foam accelerator is added to support a first reagent and a second reagent on an aqueous carrier, and the first and second components of the system are dispensed as first bubbles and second bubbles, respectively. The first and second bubbles are mixed to generate a disinfection composition, which is then supplied directly to the item or surface to be disinfected, or supplied by a wipe. The first and second bubbles may be dispensed individually or mixed by hand, or they may be dispensed simultaneously from a dispenser that premixes the bubbles at the time of dispensing. In such a system, the confirmation process involves checking each bubble dispenser, dispensing a suitable amount of bubbles (or premixed bubbles, if applicable), confirming that the manual mixing process has been carried out (by stirring the bubbles for a predetermined time or by crushing the bubbles on a wipe), confirming that the mixed bubbles have remained for a predetermined time before use, and / or applying the bubbles individually or in mixed form to a tissue or other substrate. Similar to Example 2 above, one or both components may contain a component that changes color when mixed. In this case, the verification process confirms after mixing that the mixed bubbles have the correct color after the color change, and that this color is homogeneous within the bubbles.

[0094] As previously described, in the process of Example 1, the rinsing stage can be omitted if it is not necessary depending on the application. In this case, only the pre-use cleaning / disinfection stage should be used. It is also possible to use only the disinfection and rinsing stages and omit the pre-use cleaning stage. When using at least two stages that use two different components, the verification process includes steps to confirm each component used and steps to confirm that these stages are used in the correct order.

[0095] The above approach can also be used to verify a single-stage disinfection or decontamination process. For example, in some applications, the required level of decontamination can be achieved using only cleaning or disinfecting wipes. In such cases, the verification process may focus on determining that the wipes have adhered precisely to the medical device or other equipment (e.g., as described in steps 10-13 of Example 1). In some cases, precise adherence of the wipes may differ from those described above. For example, it may not be necessary to wipe from the proximal handle towards the distal part where the work is performed, in which case the verification process may determine that the wipes have adhered to, for example, the entire surface of the medical device or to a specific area.

[0096] When using a two-component disinfection system, such as the chlorine dioxide-based disinfection system described in WO 2005 / 011756, it is beneficial to ensure that the two components of the disinfection system are accurately mixed. While not essential to the present invention, it is also possible to ensure other processing steps, such as accurate component selection and precise device cleaning, depending on the application, as a single-component disinfection composition may be more appropriate. Single-component disinfection compositions are not limited to but may contain hydrogen peroxide, peracetic acid, hypochlorous acid, peroxy acid, quaternary ammonium compounds, and the like.

[0097] The methods and apparatus described above are not limited to confirming decontamination processes using wipes. Substantially all components, such as bubbles, liquids, spray compositions, and powders, can be used in substantially any combination in the above decontamination processes and can be confirmed using the methods and apparatus described above. For example, confirmation based on verification of component containers is also possible. Furthermore, an image analysis module can be trained to verify and confirm procedures such as spraying bubbles or liquid components onto medical devices or immersing medical devices in liquid containers.

[0098] While the above examples relate to the decontamination of medical devices, the confirmation approach described herein can also be applied to the decontamination of surfaces or items that cannot be easily placed within the field of view of a camera system. In such cases, confirmation can be performed, for example, to select the correct components or component sequences and / or to ensure the correct mixing of a two-component disinfectant system.

[0099] Further modifications not explicitly described above can also be implemented without departing from the scope of the present invention as described in the claims. [Explanation of symbols]

[0100] 10 boxes 11 bags 12. Two-component disinfectant system 14 Dispensers 16 bags 18 boxes 20 bags 30 Portable Devices 32 Camera System 34 Working area 36 Image Analysis Module 38 Validator Modules 40 displays 42 memory 101 process 102 processes 103 Process 104 Process 105 Process 106 Process 107 Process 108 process 109 Process

Claims

1. A first component having a first reagent in a carrier, and The first component is miscible with the second component, and the second component has a second reagent in the carrier. A method for confirming a mixing process in a process using a two-component disinfection system in which the first reagent and the second reagent react during mixing to produce a disinfectant composition, The method involves the user capturing a video stream from a work area where the mixing process is performed. The video stream is analyzed to identify one or more mixed events within the video stream that correspond to the mixed process being performed accurately. Based on each confirmed mixing event, it is determined whether the mixing process has finished, and A confirmation method characterized by providing the user with a corresponding instruction when determining the completion of the mixing process.

2. The method according to claim 1, wherein a trained neural network is used to identify at least one of the mixed events or a plurality of mixed events when analyzing the video stream.

3. The method according to claim 1 or 2, wherein the first component and / or second component of the disinfection system have an indicator component that changes color when the first component and the second component are mixed, and the mixing event or one of the multiple mixing events exhibits this color change.

4. The method according to any one of claims 1 to 3, wherein a predetermined amount of the first component of the disinfection system is added to a predetermined amount of the second component of the disinfection system in the aforementioned mixing event or one of a plurality of mixing events.

5. The method according to any one of claims 1 to 4, wherein the first component of the disinfection system is contained in a dispenser so as to be distributable as a fluid, and the fluid is distributed from the dispenser in the mixing event or one of a plurality of mixing events.

6. The method according to any one of claims 1 to 5, wherein the second component of the disinfection system is absorbed into or impregnated into a wipe, and after adding the first component to the wipe in the mixing event or one of the mixing events, the wipe is folded or rolled up.

7. The method according to any one of claims 1 to 6, wherein, when determining whether the mixing process has been completed, the cumulative time during which the mixing event or at least one of the mixing events has been performed is determined, and this cumulative time is compared with a predetermined shortest mixing time.

8. A method according to claim 7, dependent on claim 6, wherein in determining whether the mixing process is completed, a method for determining whether (a) the predetermined amount of the first component of the disinfection system has been added to the wipe, based on at least two confirmed mixing events, is to determine whether the wipe has been folded or rolled up for at least the predetermined minimum mixing time.

9. The method according to any one of claims 1 to 8, wherein when determining whether the mixing process has been completed, it is determined whether a plurality of different mixing events have occurred in a predetermined sequence.

10. The method according to any one of claims 1 to 9, which provides a container containing the first component and / or a container containing the second component in at least one of the mixing events or a plurality of mixing events.

11. Furthermore, when analyzing the video stream, one or more attention-grabbing events within the video stream that correspond to potential errors occurring during the execution of the mixing process are identified. The method according to any one of claims 1 to 10, wherein a corresponding warning is provided to the user when an event requiring attention is identified.

12. The method according to claim 11, wherein one of the events requiring attention or a plurality of events requiring attention is vibration of a container containing the first component or vibration of a container containing the second component.

13. The method according to claim 11 or claim 12, wherein one of the events requiring caution or a plurality of events requiring caution is an event in which the user's hands, the first component of the disinfection system, and / or the second component of the disinfection system become invisible in the work area.

14. Furthermore, the method according to any one of claims 11 to 13, wherein the confirmation of an event requiring attention is electronically recorded.

15. The method according to any one of claims 1 to 14, wherein the completion of the mixing process is recorded electronically.

16. The method according to any one of claims 1 to 15, comprising electronically recording information relating to the first component and / or the second component of the system.

17. The method according to claim 16, wherein, when analyzing the video stream, the information relating to the first component and / or the second component of the system is confirmed within the video stream.

18. The method according to claim 16 or claim 17, wherein the information relating to the first component and / or the second component of the system relates to at least one of the type of the first or second component, lot number or batch number, manufacturing date, and expiration date or expiration date.

19. A device for confirming mixing in a process using a two-component disinfection system, A camera system that captures the video stream of the workspace where this mixing process is performed by the user, This user has an output device that outputs audio, text, and / or visual displays, An image analysis module configured to receive the aforementioned video stream and to identify one or more mixed events within the video stream corresponding to the accurate execution of the mixed process, A validator module that determines whether the mixing process has been completed based on each confirmed mixing event, and when it is determined that the mixing process has been completed, the output device issues a corresponding instruction to the user. An apparatus characterized by having the following features.

20. The apparatus according to claim 19, wherein the image analysis module has a classifier based on a neural network trained to recognize one or more mixed events in the video stream.

21. Furthermore, the apparatus according to claim 19 or claim 20, further comprising a recording module for electronically recording that the mixing process has been completed.

22. The apparatus according to any one of claims 19 to 21, comprising a smartphone or tablet computer device.

23. Use of the apparatus according to any one of claims 19 to 22 for confirming a mixing process in a process using a two-component disinfection system according to any one of claims 1 to 18.

24. A disinfectant system comprising a first component having a first reagent in a carrier, and a second component that is miscible with the first component and has a second reagent in a carrier, wherein the first and second reagents generate a disinfectant composition when mixed, and The apparatus according to any one of claims 19 to 22 for ensuring the mixing process when using this disinfectant system. A decontamination system having the following features.

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