Validating blending in decontamination processes

Abstract

A method for inspecting and validating a decontamination process performed on a medical device using a decontamination system is disclosed. The method involves a user capturing a video stream from a work area where the decontamination process is performed and analyzing the video stream to identify one or more decontamination events within the video stream corresponding to the decontamination process being performed correctly on the medical device. The decontamination event or at least one of the decontamination events comprises using a wipe to apply a decontamination composition of the decontamination system to the medical device. Based on each decontamination event, the method further determines whether the decontamination process has completed, and provides corresponding instructions to the user upon determining that the decontamination process has completed. The method also includes recording data to alert the user to potential errors and / or provide an audit trail.

Description

[Technical Field]

[0001] a. Field of the Invention The present invention relates to a method and apparatus for testing and validating the process of a decontamination system during use. In particular, the present invention is directed to testing and validating disinfection processes for medical instruments, devices, and surfaces in a clinical environment. [Background technology]

[0002] b. Related fields Effective decontamination of medical instruments, surfaces, and other objects in the clinical environment is essential to ensure patient safety. To address this requirement, several highly effective disinfection systems have been developed.

[0003] For example, WO 2005 / 011756 discloses a two-component disinfectant system. This 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. In a preferred embodiment, one of the two components is an acidic solution, and the other is a solution containing sodium chlorite or sodium chlorate. A disinfectant composition containing carbon dioxide is generated upon mixing of the two components. The first component, known as an activator, can be dispensed as a fluid, preferably as a foam, in a pump dispenser, while the second component is absorbed or impregnated into at least one fabric member within a sealed container. To prepare the disinfectant wipes, a user removes the impregnated wipes from the container and adds some of the foam from the sprayer to the wipes. To encourage mixing of the air bubble and the reagent within the tissue, the user may fold the tissue to enclose the air bubble, or may squeeze or rub the folded tissue before opening it.

[0004] WO 2005 / 107823 discloses a decontamination system suitable for the reprocessing of non-lumenized medical instruments using a three-wipe manual disinfection process, as shown in Figure 1. The exemplary system includes a box 10 containing a bag 11 of pre-clean wipes, a disinfection system 12 including a dispenser 14 and a bag 16 of disinfectant wipes as described above, and a box 18 with a bag 20 of sterile rinse wipes. The pre-clean wipes are used to wipe down an instrument, such as an endoscope, to be decontaminated. A two-component disinfection system 12 (using an activated gas foam in the tissue) is used to sterilize or disinfect the instrument, and the sterile rinse wipes are used to remove any chemical residue. All disinfection details are recorded in an accompanying audit trail book, allowing full traceability of the disinfection process.

[0005] To ensure full effectiveness of this type of decontamination system, the user must adhere precisely to a specific sequence of steps, an example of which is shown in Figure 2.

[0006] In step 101, a wipe, such as a pre-use tissue, is removed from its bag 11. In step 102, the pre-use wipe is wiped, starting with the cleanest area (such as the handle) and moving towards the dirtiest or most contaminated area (such as the invasive distal area).

[0007] In step 103, a disinfectant wipe is withdrawn from its bag 16 and unfolded, and then in step 104, a precise amount of activator foam (typically measured by operating the dispenser 14 a preset number of times) is dispensed onto the wipe. In step 105, the wipe is folded to encapsulate the foam and then rolled for a preset time to thoroughly mix the two components of the disinfectant system. In step 106, the device is wiped with the activated disinfectant wipe, again starting with the cleanest area and working towards the dirtiest area.

[0008] At step 107, a rinse wipe is drawn from bag 20 and at step 108 the device is again wiped with the rinse wipe from the clean area towards the dirty area.

[0009] In step 109, the decontaminated devices are diverted to a pre-defined clean area, thereby preventing recontamination of the devices that might otherwise occur.

[0010] Any user error that could lead to failure of the decontamination process would be, for example, selecting the wrong bag 11, 16, 20 in any of steps 101, 103, or 107, wiping in the wrong direction or too quickly in steps 102, 106, or 108, dispensing an insufficient amount of active agent in step 104, and rolling too short in step 105.

[0011] To avoid such errors, audit trail books and software can be used, but these generally rely on user input, making it difficult to directly verify that any part of a process was performed correctly.

[0012] In view of the above background, it would be desirable to solve the technical problem of process validation that is less dependent on user input during the decontamination process and allows for more direct validation of steps in the decontamination process. Summary of the Invention

[0013] A first aspect of the present invention relates to a method for validating a decontamination treatment performed on a medical device using a decontamination system having wipes, in which a user captures a video stream of a work area where the decontamination treatment is being performed, analyzes the video stream to identify one or more decontamination events in the video stream that correspond to the decontamination treatment being correctly performed on the medical device (wherein the decontamination event or events involve applying a decontamination composition of the decontamination system to the medical device using a wipe), determines whether the decontamination treatment is complete based on each identified decontamination event, and provides a corresponding indication to the user upon determining that the decontamination treatment is complete.

[0014] This method provides validation of the decontamination process of a medical device, which can be based on an automatic evaluation of the user's actions through analysis of the video stream, and is highly advantageous in that it can confirm that the user correctly completed the decontamination process. This method provides a reliable indication to the user that the process was successful, thereby ensuring that the device has been effectively decontaminated and increasing user confidence.

[0015] Preferably, a trained neural network is used to identify a decontamination event or at least one of a plurality of decontamination events when analyzing the video stream, and with suitable training, the neural network can reliably and quickly identify the decontamination events as they are being performed by the user.

[0016] Determining whether the decontamination process is complete may involve using image analysis to determine the cumulative time that the decontamination composition has been in contact with the medical device and comparing this cumulative time to a predetermined minimum contact time. Alternatively, or in addition, determining whether the decontamination process is complete may involve determining whether the decontamination composition has been applied to the entirety of a predetermined area of the medical device.

[0017] One of the decontamination events can include applying a decontamination composition to a medical device with a wipe. The decontamination composition can be absorbed or impregnated into the wipe. In another embodiment, the decontamination composition can be applied as part of a decontamination process, in which case one of the decontamination events can include applying the decontamination composition to a wipe.

[0018] A medical device may have a distal portion where treatment occurs and a proximal portion, such as a handle. In such cases, cleaning or disinfection typically begins at the proximal portion and proceeds toward the treatment portion (i.e., from the least contaminated portion to the most contaminated portion). Therefore, determining whether a decontamination process is complete may involve determining whether the wipe has moved away from the proximal portion and toward the distal treatment portion. Thus, during a decontamination event or one of multiple decontamination events, the wipe may move away from the proximal portion and toward the treatment portion while in contact with the medical device, and / or may treat the proximal portion with the wipe when it is first applied to the device.

[0019] In some applications, it is not as important to wipe the medical device in a particular direction, for example, determining whether the decontamination process is complete may instead be determined by determining whether the wipe has applied to all of the target areas of the medical device, such as all or a portion of the surface of the device.

[0020] In addition to clearly indicating that the decontamination process has been completed correctly, it also indicates any errors that may have occurred, allowing the user to make corrections or, if the errors are serious, to abandon or restart the process as appropriate.

[0021] Thus, the method of the present invention can further include, upon analysis of the video stream, determining (identifying) one or more alarming events in the video stream that correspond to potential errors occurring during the decontamination process, and upon determining (identifying) the alarming events, issuing a corresponding warning to the user.

[0022] For example, if the alerting event or one of the alerting events is a loss of visibility of the user's hand work area, at least a portion of the decontamination system, and / or at least a portion of the medical device, a warning may be provided to the user to ensure that any processing actions associated with the decontamination process are within the field of view of the video stream.

[0023] In another example, if the medical device has a proximal portion and a distal portion where treatment is performed, and the decontamination system has a wipe, the alert event or one of the alert events is the wipe moving in the wrong direction, i.e., moving from the treatment portion to the proximal portion while in contact with the device. Similarly, the alert event or one of the alert events is the wipe applying to the treatment portion of the wipe when first applying the wipe to the device. Also, the alert event or one of the alert events is the wipe moving at an excessive speed while in contact with the device, which could result in insufficient contact time or transfer of the decontamination composition.

[0024] After decontaminating the device, it may be desirable or necessary to place the device in a designated clean portion of the work area (such as a designated portion of a surface or container). Thus, in an alert event or one of multiple alert events, the device is placed outside the designated clean portion of the work area after the decontamination composition is applied to the device.

[0025] In some cases, validation is based on the verification of a single decontamination event in which a decontamination composition is applied to a device, although preferably two or more decontamination events are verified, with the first decontamination event being the application of the decontamination composition to the device and the second decontamination event being the placement of the device in a designated clean portion of the work area.

[0026] Preferably, a container having at least a portion of the decontamination system is presented at a prior decontamination event, allowing the user to confirm that the correct components have been selected before adding the decontamination composition to the device, or to provide a warning that an incorrect component may have been selected and an error may have occurred.

[0027] The method of the present invention can check compatibility between a decontamination system and a medical device. The method acquires information about the medical device and information about the decontamination system, cross-references the acquired information with a stored dataset, checks compatibility between the decontamination system and the medical device, and notifies a user of compatibility or incompatibility. The method can acquire information about the medical device and / or the decontamination system by analyzing the video stream, for example, to identify components of the medical device and / or the decontamination system, or by reading machine-readable information provided on the device or component. The method can also allow a user to confirm the information obtained by analyzing the video stream. The information about the medical device can include either the device model and / or serial number, and the information about the decontamination system can include one or more of the decontamination system model, lot number or batch number, date of manufacture, and use-by date or expiration date.

[0028] Information about the medical device and / or information about the decontamination system can be used in determining whether the decontamination process is complete.

[0029] The method of the present invention may also employ means for electronically recording information regarding the decontamination process. In particular, the method may electronically record the completion of the decontamination process. Upon determination of an alarming event, confirmation of this event may be electronically recorded, and as information regarding the medical device and / or the decontamination system is obtained, this information may also be electronically recorded.

[0030] According to a second aspect, the present invention can also be extended to an apparatus for verifying a decontamination treatment applied to a medical device using a wipe-based decontamination system. The verification apparatus includes a camera system for capturing a video stream of a work area where a user performs the decontamination treatment; an output device for providing an audio, textual, and / or visual display to the user; an image analysis module configured to receive the video stream and identify one or more decontamination events in the video stream corresponding to the correct implementation of the decontamination treatment, the image analysis module applying a decontamination composition of the decontamination system to the medical device using a wipe at the decontamination event or at least one of the decontamination events; and a validator module for determining whether the decontamination treatment has been completed based on each identified mixing event, and the output device for providing a corresponding indication to the user upon determining that the decontamination treatment has been completed. The image analysis module preferably includes a neural network-based classifier trained to recognize one or more decontamination events in the video stream. The verification apparatus can further include a recording module configured to electronically record the completion of the mixing treatment. More conveniently, the verification apparatus is implemented on a smartphone or tablet computing device.

[0031] Also disclosed herein is the use of the apparatus according to the second aspect to verify the decontamination treatment performed on a medical device using the decontamination system according to the method of the first aspect.

[0032] The present invention can also be used to test and validate disinfection processes using virtually any suitable decontamination system, including systems that require a mixing process to produce an active disinfectant or cleaning composition. In these cases, embodiments of the present invention can extend to verifying that the mixing process was properly completed. Other steps or procedures, such as the use of a pre-use cleaning stage and / or a rinsing stage, can also be performed in the decontamination process, and therefore embodiments of the present invention can extend to verifying one or more of the associated pre-use cleaning and rinsing procedures.

[0033] The present invention is also applicable to a method for verifying a decontamination treatment performed on a medical device using a decontamination system, in which a user captures a video stream of a work area where the decontamination treatment is performed, analyzes the video stream to verify that one or more decontamination events are being performed correctly on the medical device, applies a decontamination composition of the decontamination system to the medical device during the decontamination event or at least one of the decontamination events, determines that the decontamination treatment is complete based on the verified decontamination event or events, and provides a corresponding indication to the user upon determining that the decontamination treatment is complete.

[0034] In other embodiments, the preferred and / or appropriate features of each embodiment of the present invention can be applied alone or in combination as appropriate.

[0035] In the context of this specification, "testing and validating a process" means verifying, by appropriate means, that one or more specific steps or omissions and / or one or more specific ingredients were used in performing the process in question. The process being verified does not necessarily encompass the entire process of decontaminating a device, object or surface, but may be only a small portion of a longer decontamination process.

[0036] Additionally, as used herein, "decontamination process" refers to a series of steps to clean, prepare for cleaning, disinfect, sterilize, wash, etc., an object or surface, including steps to prepare materials and components for use in these treatment operations. As used herein, "decontamination treatment" may refer to a single step in a decontamination process, a combination of these steps as a subset of a longer decontamination process, or all of the steps in a decontamination process, and should be interpreted in context. [Prior art documents] [Patent documents]

[0037] [Patent Document 1] WO 2005 / 011756 [Patent Document 2] WO 2005 / 107823 [Patent Document 3] WO 2006 / 079822 A1 [Brief explanation of the drawings]

[0038] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings in which like reference numerals refer to like parts, and in which: [Figure 1] FIG. 1 shows a known decontamination system to which an embodiment of the present invention may be applied. [Figure 2] FIG. 2 shows the sequence of steps in a decontamination process using the system of FIG. [Figure 3] Figure 3 shows a verification device for the decontamination process. [Figure 4-12] Figures 4-12 show images captured from a video stream illustrating events that occur during the medical device decontamination process. DETAILED DESCRIPTION OF THE INVENTION

[0039] Embodiments of the present invention provide methods and apparatus for automatically or semi-automatically verifying and validating various treatments or steps that a user must perform when performing a decontamination process. An example of a decontamination system and corresponding decontamination process is described below with reference to Figures 1 and 2. However, embodiments of the present invention are equally applicable to other decontamination systems and processes.

[0040] 3 is a schematic diagram of a process verification and validation apparatus. In this embodiment, the validation apparatus comprises a handheld device 30 equipped with a camera system 32 that captures a video stream of a working area 34.

[0041] The camera system 32 outputs a video stream to an image analysis module 36. As described in more detail below, the image analysis module 36 analyzes the video stream to determine when predetermined events or actions occur within the workspace. The image analysis module 36 outputs corresponding event data to a validator module 38.

[0042] Validator module 38 analyzes the received event data and determines whether a given operation completed successfully or whether any potential errors are occurring. After making such a determination, validator module 38 provides corresponding instructions to the user via display 40. Validator module 38 may also provide instructions via an audio output (not shown), such as a loudspeaker output or a headphone output.

[0043] Validator module 38 is also configured to record data in memory 42. In this configuration, validator module 38 can record in memory 42 the successful completion of one or more operations and / or the identification of one or more potential errors in the video stream.

[0044] This recorded event information may be correlated with supplemental information such as the user's name and other user details, patient details, the location where the procedure is being performed, the type of device, the surface or other item being decontaminated, the device serial number, or details about the decontamination system and components such as batch or lot numbers, manufacturing date and time, and expiration date. Such supplemental information may be entered by a user via a suitable interface (not shown), typically a touchscreen, captured by scanning a barcode or matrix code presented to a camera, or determined by analysis of a video stream. In the latter case, for example, validator module 38 may be configured to recognize the containers (i.e., bags 11, 16, 20 and dispenser 14) containing the various components used in the decontamination system, and validator module 38 may be configured to retrieve stored component type information corresponding to each identified container and record this information along with the recorded event information.

[0045] So configured, memory 42 may store a partial or complete audit trail of the decontamination process which may then be retrieved and / or transmitted over a suitable communications protocol or network to a record-keeping server or other device.

[0046] The apparatus of the present invention can be configured as a self-contained mobile device 30, such as a smartphone or tablet computer. Commonly used smartphones, tablet computers, and similar devices preferably already include a camera system, data storage, display, audio output, and network-connectable communications devices, along with a processor configured to execute suitable instructions for implementing the methods described herein. Accordingly, the image analysis module 36 and validator module 38 are preferably implemented as software executable by the processor. The software can be embodied as an installable application running within the device's operating system environment. The image analysis module 36 and / or validator module 38 can also be implemented in whole or in part by a cloud-based service with which the device 30 can communicate.

[0047] The camera system may include one or more cameras, and may use non-visible light cameras (such as thermal or depth cameras) to provide supplemental data to the image analysis module 36 .

[0048] Device 30 is preferably mounted on a suitable stand with camera assembly 32 facing work area 34, allowing the user to use both hands freely to perform the decontamination process, although in some cases device 30 may be hand-held throughout some or all of the process.

[0049] While any suitable method for analyzing the video stream can be used for the image analysis module 36, a machine learning approach is preferably used. For example, the image analysis module 36 can utilize a trained artificial neural network (such as a convolutional neural network and / or a recurrent neural network) to identify, classify, or characterize objects and actions that appear or occur in the workspace 34 on a frame-by-frame or across multiple frames. Supervised learning can be readily employed by training the network using video footage and / or multiple versions of images of the event to be identified. Semi-supervised learning, active learning, and user feedback input can also be used to achieve continuous improvement in accuracy. In various embodiments, these approaches can be used to refine the neural network, improving accuracy for specific users and / or specific environments or workspaces.

[0050] Those skilled in the art of machine learning-based video analysis will be familiar with a variety of suitable neural networks, and will not be described in further detail. One suitable neural network architecture is based on MobileNet, which constitutes a convolutional neural network that extracts frame-wise features from a video stream. This can be coupled with an LTSM (long short-term memory) recurrent neural network to aggregate temporal information (i.e., motion between frames). Another possible network is a two-stream convolutional neural network.

[0051] It should be noted that in each embodiment of the present invention, image analysis module 36 only needs to check a relatively small number of different events, allowing validator module 38 to accurately determine whether the target operation was performed correctly or whether a potential error has occurred.

[0052] Some of the events identified by image analysis module 36 may be considered to correspond to a step in a correctly performed decontamination process. Examples of such "decontamination events" include collecting the correct component, correctly mixing the two components of a disinfectant system, and delivering the decontamination components to the device in the correct manner. Other events may correspond to potential errors being made by the user. Examples of such "alert events" include selecting the wrong component for a particular step in the process, washing 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, incorrect mixing of the two components or insufficient mixing time, shaking the dispenser before use, placing the device in a designated clean part of the work area before decontamination or in a designated dirty part of the work area after decontamination, and not wearing gloves and / or other protective equipment.

[0053] The neural network is trained on all the events or tasks to be verified in a multi-task learning environment. The characterization of each event or task can use a hierarchical representation of the results. For example, the task of detecting the type of ingredients in a bag is based on observing the bag. This forces a consensus on the results.

[0054] A training dataset covering all of the events to be verified can be generated from multiple demo videos in which the events are classified, including multiple instances showing the same event with suitable variations that reflect the main sources of variation expected during use. Such variations include camera variation, portrait and landscape orientation variation, camera tilt variation, camera-to-work area distance variation, background color and background material variation, lighting color variation, lighting source variation, lighting intensity variation, lighting direction variation, glove color variation, user skin color variation, gender variation, and variations in handedness and usage efficiency during component use. Additional variations can be synthesized through data augmentation, for example, to introduce variability in brightness, different lighting conditions, horizontal and vertical flips to simulate camera orientation, and shearing and rotation to simulate camera tilt. For subsequent testing, a test dataset can be used in which different demo videos from different users and / or with different settings for the above variations are compared to the demo videos in the training dataset.

[0055] To facilitate learning of unlabeled processes, a self-supervised learning approach can be added. For example, the frame order in a video showing the exact 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 parts of an image and training a network to reconstruct it to learn the structure of an object / medical device) and image recoloring (teaching a model color changes when mixed and / or the expected color of a bag or other container).

[0056] Image analysis module 36 outputs confirmed decontamination events and confirmed alert events to validator module 38. Validator module 38 can determine that each step in a process was performed correctly if the image analysis module 36 output indicates that the required process-specific decontamination event(s) occurred. To do this, validator module 38 can use a finite state machine or hidden Markov model to convert a frame-wise prediction of the events output by image analysis module 36 into a global assessment of the sequence of steps performed in the process. If one or more events are required for the process to be performed correctly, validator module 38 can check that all required events occurred and that they occurred in the correct order. Validator module 38 can also check that no alert events occurred, or that errors corresponding to confirmed alert events were subsequently corrected (e.g., by a subsequent corresponding decontamination event). Some of the events requiring attention include errors that can be corrected immediately, such as selecting an incorrect component, the user's fingers or any part of the decontamination system becoming obscured or out of view, and events such as dispensing the wrong component into the device, which require the decontamination process to be restarted.

[0057] As well as being able to record these results as part of an audit trail in memory 42, device 30 can advantageously provide direct feedback to the user by playing graphical and / or textual displays on display 40 and / or by playing sounds and / or speech via the device's audio output. So configured, when each step of a particular process is performed correctly, an indication can be given to the user confirming both that this step has been completed and that this fact has been recorded by device 30. Similarly, when a potential error has occurred and an event requiring attention has occurred, appropriate indications can be given to the user to take appropriate corrective action.

[0058] Additionally, device 30 can use display 40 and / or audio output to guide the user through the process by providing prompts or instructions regarding the next step to take. For example, validator module 38 can provide instructions regarding the next step in the process to be displayed after confirmation of a particular decontamination process event. Alternatively, if a particular action needs to be performed for a specific amount of time, upon confirmation of an event indicating this action, validator module 38 can display a timer to guide the user.

[0059] To enable operation of the validator module 38 in this manner, suitable process data for each specific process can be stored in the memory 42. This process data can include, for example, a list of required events and the order in which those events must be performed, preset times and other parameters for each step, and a list of possible warning events corresponding to potential errors. The validator module 38 can compare confirmed decontamination events and warning events with the stored process data to determine whether each step of the process was performed correctly or whether an error occurred, retrieve information regarding the expected next step, and trigger the display of instructions or actions, such as starting a countdown timer. The memory 42 can store process datasets for multiple possible processes, allowing the validator module 38 to select which process dataset is appropriate for the process being performed. The process data can include corrections that can adjust parameters to compensate for environmental factors such as temperature and humidity, which may be determined by the device 30 using suitable sensors and / or entered by the user.

[0060] Example 1 The following example illustrates the use of device 30 to validate a decontamination process for a medical device using a decontamination system of the type shown in Figure 1. Examples of medical devices include endoscopes, nasal endoscopes, and transvaginal probes, each having a proximal handle portion and a distal invasive end. Figures 4-12 show exemplary frames captured by camera system 32, where camera 32 is positioned above the working area. To aid in understanding, the output from image analysis module 36 is shown in the upper left corner of each image.

[0061] Process 1 First, the type of medical device to be decontaminated is identified and recorded. This can be done automatically by image analysis of the video stream as the device is placed in the work area, prompting the user to confirm that the medical device type is correctly recognized. Alternatively, the type of medical device can be entered by the user, for example by selecting it from a list of predetermined options.

[0062] Process 2 The device's unique serial number is captured and recorded. As before, this can be done by image analysis, for example by capturing a barcode or matrix (QR) code, or by directly scanning text. Alternatively, the user can enter the serial number. Once captured, the serial number is checked to ensure it is valid for that type of device.

[0063] Process 3 The device 30 will present a prompt to the user to prepare a pre-cleaning wipe.

[0064] Process 4 The device 30 verifies and authenticates that the appropriate pre-use cleaning composition is being used. The image analysis module 36 verifies the presence of an approved pre-use cleaning wipe bag in the work area while it is presented to the camera by the user as a decontamination event. Pre-use cleaning wipe bags are distinguishable by different color indicia from bags used later in the process, allowing the image analysis module 36 to distinguish between different bags. If a bag that does not correspond to the intended pre-use cleaning wipe bag is presented, an alarming event occurs, and the device 30 indicates that an incorrect bag was selected. This identified bag type may be compared to a stock list of suitable pre-use cleaning compositions or a user-entered system. The presence of the pre-use cleaning composition is recorded, along with information such as the composition type, such as the batch number and expiration date, as appropriate.

[0065] Process 5 Image analysis is used to identify the proximal handle portion of the device and the invasive distal end of the device.

[0066] Process 6 The device 30 will prompt the user to begin pre-cleaning the device and then monitor the video stream for any events requiring attention. For example, an error will be displayed if the pre-cleaning begins at the dirtier invasive end rather than the cleaner proximal handle, or if the wipe is moving in the wrong direction. Similarly, an error will be displayed if the user pre-cleans too quickly or does not follow the preset ingredient-specific instructions for the use data.

[0067] Process 7 If the image analysis module 36 determines that the device has cleaned from clean to dirty in accordance with ingredient-specific user instructions without identifying any alarming events, the device 30 provides approval to the user.

[0068] Process 8 The device 30 prompts the user to prepare a disinfectant wipe.

[0069] Process 9 The device 30 verifies and authenticates that the correct disinfectant composition should be used. Similar to step 4 above, the image analysis module 36 verifies the presence of an approved disinfectant wipe bag in the work area while it is presented to the camera by the user as a decontamination event, as shown in FIG. 4. If a bag that does not correspond to the intended disinfectant wipe bag is presented, an alarming event occurs, and the device 30 indicates that an incorrect bag was selected. This identified bag type may be checked against a stored stock list of suitable pre-use cleaning compositions or a user-entered system. The disinfectant composition is further cross-referenced with previously used pre-use cleaning compositions to ensure both are usable. The presence of the disinfectant wipe is recorded, along with information such as the batch number and expiration date, as appropriate, along with information such as the composition type.

[0070] Process 9A The device 30 verifies and authenticates that the correct disinfectant active should be used, where the image analysis module 36 verifies the presence of an active bubble in the work area of an approved dispenser while the work area is presented to the camera by the user as a decontamination event. As in step 9 above, the same checks may be made on the active ingredients in this step.

[0071] Process 9B The device 30 prompts the user to apply an active agent bubble to the wipe and then monitors the video stream for the following events: (a) Remove the disinfectant wipe from the bag and visualize it in the work area (see Figure 5). (b) Two aliquots of foam have already been added to the wipe (in this example, the two aliquots correspond to the exact amount to be added to one wipe). Figure 6 shows a confirmation of the process of distributing foam from the dispenser to the wipe, and Figure 7 shows the two aliquots of foam on the wipe. (c) The wipe is already folded (FIG. 8) and rolled (FIG. 9) to distribute air bubbles throughout the wipe for at least the minimum time to ensure full activation of the disinfecting composition. (d) The wipe is already open, homogeneous in appearance, and ready for use (Figure 10).

[0072] After each event is confirmed, the device 30 records the event, displays confirmation that the corresponding step was completed correctly, and prompts the user to perform the next step. If any errors occur, such as dispensing an aliquot that is too small or too large, the user is warned. In some cases, the size of each aliquot is verified to ensure that the pump operated correctly each time.

[0073] Step 10 Image analysis is again used to identify the proximal handle portion of the device and the distal invasive end of the device.

[0074] Step 11 The device 30 will prompt the user to begin disinfecting the device and monitor the video stream for any alarming events. Figure 11 illustrates the process of verifying that a disinfecting wipe is placed on the device. An error will be displayed if disinfection begins at the invasive end of the device instead of the proximal handle, 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-set ingredient-specific instructions for the usage data.

[0075] Step 12 The image analysis module 36 determines when the disinfecting wipe has treated all of the medical device. The device 30 then displays a countdown timer and begins counting down the contact time for the disinfection process. If during the wiping process, the wiping stops, pauses, or is not performed at a uniform speed along the length of the device, or if the wipe becomes dislodged from the device, an error will be displayed. Similarly, if the user touches the device or if another item (such as a wipe) touches the device during the countdown, an error will be displayed.

[0076] Step 13 If the image analysis module 36 verifies that the device has been disinfected from clean to dirty in accordance with the specific user instructions for disinfection, and the required contact time is met without any alarming events, the device 30 will authorize the user.

[0077] Step 14 If a final rinse of the disinfectant components used in the pre-use cleaning / disinfection step is not required, the device 30 will indicate that the disinfection process is complete. If the pre-set parameters indicate that a rinse of the disinfectant components used is required, the device 30 will prompt to proceed to step 15.

[0078] Step 15 If rinsing is required, device 30 prompts the user to prepare a rinse wipe.

[0079] Process 16 The device 30 verifies and authenticates that the appropriate rinse wipe should be used. The image analysis module 36 verifies the presence of an authorized rinse wipe bag in 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, an alarm event occurs and the device 30 indicates that an incorrect bag was selected. This confirmed bag type may be checked against a stored stock list of suitable rinse ingredients and user-entered systems, and may also be checked for compatibility with the pre-use cleaning / disinfectant wipe used in the previous step. The presence of the rinse ingredient may be recorded, along with information such as the rinse ingredient type, batch number, and expiration date, as appropriate.

[0080] Process 17 Again, image analysis is used to identify the proximal handle portion of the device and the distal invasion end of the device.

[0081] Process 18 The device 30 will prompt the user to begin rinsing the device and then monitor the video stream for any alarming events, such as an error being displayed if rinsing is initiated from the invasive end rather than the cleaner proximal handle, or if the wipe is traveling in the wrong direction.

[0082] Process 19 If the image analysis module 36 determines that the device has been rinsed from clean to dirty in accordance with the specific user instructions for disinfection without any alarming events being observed, the device 30 provides approval to the user.

[0083] Process 20 At the end of the process, device 30 issues a verification code (if required by the user) that the process was successful and records the details of the process in memory 42. It is also possible for device 30 to record a recommended storage period before re-sterilization is required.

[0084] The image analysis operations in the above steps assume that they are performed within the camera's field of view, so throughout the steps, device 30 will display an error if the user's fingers are not visible in the video stream, either because they are occluded or outside the visible area, as shown in Figure 12.

[0085] In the above process, an "approved" component refers to a component that can be used for its intended use, has been approved by the user's facility for its intended use, and / or has been approved by the medical device manufacturer.

[0086] Example 2 In this example, the two-component disinfectant system 12 has a component in one or both components that undergoes a color change when the two components are mixed. This color change is visible in the video stream, confirming not only that the two components of the disinfectant system 12 have been thoroughly mixed, but also that the physical mixing process described in step 9B of Example 1 has been performed.

[0087] Below are the validation steps involved in the correct preparation of the activated disinfectant wipes in this example.

[0088] Process 1 Identify the disinfectant wipe bag, check for suitability, and authorize the user.

[0089] Process 2 Identify the active foam dispenser, check suitability, and authorize the user.

[0090] Process 3 Check the wipes in a deactivated state upon removal from the bag. If the wipe does not have the correct starting color at this stage, an error is displayed.

[0091] Process 4 Check the delivery of air bubbles to the wipe and, if applicable, verify the correct number of air bubble aliquots.

[0092] Process 5 Make sure the wipe is folded and rolled for the correct amount of time.

[0093] Process 6 After rolling, verify that the disinfecting wipe has the correct post-discoloration color and that this color is uniform throughout the wipe.

[0094] Color change alone can also be used to confirm complete mixing of both components of the disinfectant system, in which case steps 4 and 5 can be omitted.

[0095] It should be noted that not all of the steps described in the above examples need to be confirmed as events by the image analysis module 36, and not all of the processes in the device 30 need to be reliably confirmed by the validation module 38. In some embodiments of the present invention, the validation process can be omitted for some steps. Similarly, additional steps not mentioned in these examples can be confirmed and used in the validation method.

[0096] The above examples are intended only to illustrate the decontamination process that can be established by the present invention and can be expanded in many ways.

[0097] For example, WO 2006 / 079822 A1 describes a disinfection system in which a first and second reagent are carried in an aqueous carrier with the addition of a foam promoter, and the first and second components of the system are dispensed as a first and second foam, respectively. The first and second foams are mixed to generate a disinfecting composition, which is then applied directly to the item or surface to be disinfected or via a wipe. The first and second foams may be dispensed individually, mixed by hand, or dispensed simultaneously from a dispenser that premixes the foam at the time of dispensing. For such systems, the validation process involves verifying each foam dispenser, dispensing the appropriate amount of foam (or premixed foam, if applicable), verifying that the manual mixing process was performed (e.g., by stirring the foam for a preset time or squeezing the foam on a wipe), verifying that the mixed foam has dwelled for a preset time before use, and / or applying the foam individually or in mixed form to a tissue or other substrate. As in Example 2 above, one or both components may contain a component that changes color when the two components are mixed. In this case, the validation process involves verifying that the mixed foam has the correct post-color change color after mixing, and that this color is uniform within the foam.

[0098] As noted above, in the process of Example 1, the rinsing stage can be omitted if not required for the application. In this case, only the pre-use cleaning stage / disinfection stage need be used. It is also possible to use only the disinfection and rinsing stages and omit the pre-use cleaning stage. When at least two stages using two different components are used, the validation process includes steps to verify each component used and to confirm that the stages are used in the correct order.

[0099] The above approach can also be used to validate 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 validation process may focus on determining that the wipe was properly applied to the medical device or other equipment (e.g., as described in steps 10-13 of Example 1). Note that in some cases, the precise application of the wipe may differ. For example, wiping from the proximal handle to the distal working portion may not be necessary; in such cases, the validation process may determine application to the entire surface of the medical device or to a specific area.

[0100] When using a two-component disinfection system, such as the chlorine dioxide-based disinfection system described in WO 2005 / 011756, it is beneficial to validate the process to ensure the correct mixing of the two components of the disinfection system. However, depending on the application, it may be more appropriate to use a single-component disinfectant composition, and other processing steps, such as the correct selection of components and the correct cleaning of the device, may be validated. Single-component disinfectant compositions can include, but are not limited to, hydrogen peroxide, peracetic acid, hypochlorous acid, peroxyacids, quaternary ammonium compounds, etc.

[0101] Virtually any component, such as a foam, liquid, spray composition, or powder, in virtually any combination, can be used in the decontamination process and verified using the methods and apparatus described above. For example, verification can be based on verification of the component container. Image analysis modules can also be trained to verify and verify procedures such as spraying a foam or liquid component onto a medical device or immersing a medical device in a container of liquid.

[0102] While the above examples relate to the decontamination of medical devices, the validation approaches 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, validation can be performed, for example, to select the correct components or component sequence and / or to ensure the correct mixing of a two-component disinfectant system, although this does not form part of the present invention.

[0103] Further modifications not expressly described above may be made without departing from the scope of the invention as defined in the claims. [Explanation of symbols]

[0104] 10 boxes 11 Bags 12 Two-component disinfectant systems 14 Dispenser 16 Bags 18 boxes 20 bags 30 Portable Devices 32 camera system 34 Working area 36 Image Analysis Module 38 Validator Module 40 Display 42 memory 101 processes 102 processes 103 Process 104 Process 105 Process 106 Process 107 Process 108 process 109 Process

Claims

1. 1. A method for verifying a decontamination treatment performed on a medical device using a decontamination system having a wipe, comprising: capturing a video stream of a work area where the decontamination procedure is performed by a user; analyzing the video stream to identify one or more decontamination events in the video stream corresponding to one or more decontamination events using the wipe to apply a decontamination composition of the decontamination system to the medical device, wherein the decontamination process is being performed correctly on the medical device; determining whether the decontamination process is complete based on each identified decontamination event; and Upon determining that the decontamination process is complete, providing corresponding instructions to the user. A verification method characterized by:

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

3. 3. The method of claim 1 or claim 2, wherein when determining whether the decontamination treatment is complete, the cumulative time that the decontamination composition has been in contact with the medical device is determined and this cumulative time is compared with a predetermined minimum contact time.

4. The method according to any one of claims 1 to 3, wherein when determining whether the decontamination process is completed, it is determined whether the decontamination composition has been applied to the entire predetermined area of the medical device.

5. The method of any one of claims 1 to 4, wherein the decontamination composition is absorbed or impregnated into the wipe.

6. The method of any one of claims 1 to 5, wherein the decontamination composition is applied to the wipe as a foam, and the foam is applied to the wipe during the decontamination event or one of the decontamination events.

7. 7. The method of claim 1, wherein the medical device has a distal treatment portion and a proximal portion, and determining whether the decontamination process is complete comprises determining whether the wipe has moved away from the proximal portion toward the distal treatment portion.

8. 8. The method of claim 7, wherein during the decontamination event or events, the wipe moves in contact with the medical device in a direction away from the proximal portion toward the distal treatment portion.

9. 9. The method of claim 7 or claim 8, wherein the wipe is applied to the proximal portion during the first use of the wipe on the medical device during the decontamination event or one of the decontamination events.

10. The method of any one of claims 1 to 9, wherein determining whether the decontamination process is complete comprises determining whether the wipe has been applied to the entire target area of the medical device.

11. further, upon analyzing the video stream, identifying one or more alarming events in the video stream corresponding to potential errors that may occur during the performance of the decontamination process; and A method according to any one of claims 1 to 10, wherein upon confirmation of an alarming event a corresponding alert is provided to the user.

12. 12. The method according to claim 11, when dependent on any one of claims 7 to 9, wherein the wipe moves in a direction from the treatment portion towards the proximal portion while in contact with the medical device during the alert event or one of a plurality of alert events.

13. A method according to claim 11 or claim 12 when dependent on any one of claims 6 to 8, wherein the wipe is applied to the treatment area when the wipe is first used on the medical device during the alert event or one of a plurality of alert events.

14. 14. A method according to any one of claims 11 to 13, wherein in the alert event or one of a plurality of alert events, the speed of movement of the wipe while in contact with the medical device becomes excessive.

15. 15. The method of any one of claims 11 to 14, wherein during the alert event or one of a plurality of alert events, the working area of the user's hands, at least a portion of the decontamination system, and / or at least a portion of the medical device are obscured from view.

16. 16. The method of any one of claims 11 to 15, wherein during the alert event or one of a plurality of alert events, the medical device is positioned outside a designated clean portion of the work area after application of the decontamination composition to the medical device.

17. The method of any one of claims 1 to 16, wherein two or more decontamination events are identified and the decontamination composition is applied to the medical device during one of the decontamination events.

18. 18. The method of claim 17, wherein during a subsequent one of said decontamination events, said medical device is placed in a designated clean portion of said work area.

19. 19. The method of claim 17 or claim 18, wherein in a prior one of the decontamination events, a container containing at least a portion of the decontamination system is presented.

20. obtaining information about the medical device; obtaining information about the decontamination system; Checking whether the decontamination systems and medical devices are compatible by cross-referencing the acquired information with stored data sets; and A method according to any one of the preceding claims, further comprising providing a corresponding indication to the user of compatibility or incompatibility.

21. 21. The method of claim 20, further comprising analyzing the video stream to obtain information about the medical device and / or information about the decontamination system.

22. 22. The method of claim 21, wherein a user confirms the information obtained by analyzing the video stream.

23. the information about the medical device is one or two of a device model and a serial number; The method of any one of claims 20 to 22, wherein the information about the decontamination system is one or more of the decontamination system model, lot or batch number, manufacturing date, and use by date or expiration date.

24. The method according to any one of claims 20 to 23, wherein information about the medical device and / or information about the decontamination system is used when determining whether the decontamination treatment is complete.

25. The method of any one of claims 20 to 24, further comprising electronically recording information about the medical device and information about the decontamination system.

26. The method according to any one of claims 1 to 25, wherein the completion of the decontamination treatment is electronically recorded.

27. 1. An apparatus for verifying a decontamination treatment performed on a medical device using a decontamination system having wipes, comprising: a camera system that captures a video stream of a work area where the decontamination process is performed by a user; an output device that outputs an audio, textual, and / or visual display to the user; an image analysis module configured to receive the video stream and identify one or more decontamination events within the video stream corresponding to the decontamination process being performed correctly, the image analysis module using the wipe during the decontamination event or at least one of the decontamination events to apply a decontamination composition of the decontamination system to the medical device; a validator module that determines whether the decontamination process is complete based on each confirmed decontamination event, and that causes the output device to provide a corresponding indication to the user upon determining that the decontamination process is complete; An apparatus comprising:

28. 28. The apparatus of claim 27, wherein the image analysis module comprises a neural network-based classifier trained to recognize the one or more decontamination events in the video stream.

29. 29. The apparatus of claim 27 or claim 28, further comprising a recording module for electronically recording that the decontamination process has been completed.

30. 30. The apparatus of any one of claims 27 to 29, comprising a smartphone or tablet computing device.

Images