Asset Tracking System with Medical Device Inspection System

Abstract

The asset tracking system includes a medical device inspection system. In some embodiments, the asset tracking system includes asset tracking software and a medical device inspection system that supplements the asset tracking software to provide additional functionality related to inspection of medical devices using the medical device inspection system.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a PCT International patent application filed on October 25, 2023, which claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 380,767, filed on October 25, 2022, entitled "Asset Tracking System with Medical Device Inspection Module," the entire disclosure of which is incorporated herein by reference.

[0002] Healthcare providers utilize many different tools, equipment, and supplies. Asset tracking systems are available that allow healthcare providers to track such assets. Asset tracking is more than just inventory and location tracking; it also involves managing and tracking the status of assets as they progress through various workflows to ensure they are available and ready when needed. Summary of the Invention

[0003] In general terms, the present disclosure is directed to an asset tracking system. In some embodiments, by way of non-limiting example, the asset tracking system includes a medical device inspection system.

[0004] One aspect is an asset tracking system comprising at least one processing device and at least one memory device storing asset tracking software and a medical device inspection system, which when executed by the processing device supplements the asset tracking software to provide additional functionality related to the inspection of medical devices using the medical device inspection system.

[0005] Another aspect is an asset tracking system comprising at least one processing device and at least one memory device, the memory device storing data instructions that, when executed by the processing device, cause the asset tracking system to identify a medical device, obtain a workflow for the medical device, and track progress for the medical device through the workflow, the workflow including at least one inspection step including inspecting the medical device using an inspection instrument.

[0006] A further aspect is a computer-readable storage device storing data instructions related to a medical device inspection system, which, when executed by a processing device, causes the computer-readable storage device to acquire at least one reference image associated with the medical device and generate, within an asset tracking software application, a user interface including the reference image and an inspection image from the medical device inspection instrument.

[0007] Yet another aspect is a method of operating an asset tracking system as disclosed herein. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a schematic block diagram illustrating an example asset management system according to the present disclosure. [Figure 2] FIG. 2 is a schematic block diagram illustrating an exemplary asset tracking system of the asset management system shown in FIG. [Figure 3] FIG. 3 is a schematic block diagram illustrating an exemplary asset tracking software in conjunction with an exemplary medical device inspection system. [Figure 4] FIG. 4 is a flowchart illustrating an exemplary method for tracking assets using a medical device inspection system. [Figure 5] FIG. 5 illustrates an exemplary medical device selection interface for the asset tracking software. [Figure 6]FIG. 6 illustrates an exemplary workflow user interface presented during the exemplary workflow shown in FIG. 3 associated with a medical device. [Figure 7] FIG. 7 illustrates an exemplary user interface of a medical device inspection system. [Figure 8] FIG. 8 illustrates an exemplary computing device. [Figure 9] FIG. 9 is a schematic block diagram illustrating an exemplary medical device inspection system including an exemplary medical device inspection station. DETAILED DESCRIPTION OF THE INVENTION

[0009] Various embodiments will now be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims appended hereto. Moreover, any examples described herein are not intended to be limiting, but merely describe some of the many possible embodiments for the appended claims.

[0010] 1 is a schematic block diagram illustrating an exemplary asset management system 10. In this example, asset management system 10 includes a sterilization processing system 12 and an asset tracking system 100. Multiple assets 114 (including assets 114A and 114B) are shown. The exemplary sterilization processing system 12 includes one or more components 14, such as an inspection system 20 (including an inspection station 22), a cleaning station 24, a reservoir 26, and one or more other processing components 28. The exemplary asset tracking system 100 includes asset tracking software 106, a medical device inspection system 108, and an asset database 110.

[0011] The exemplary asset management system 10 operates to manage multiple assets 114. For example, the asset management system 10 may operate to manage assets for a healthcare facility or group of healthcare facilities. An example of an asset 114 is medical equipment. Managing assets may include a variety of different operations including, for example, tracking the location of the asset, cleaning the asset, managing the status of the asset, and the like.

[0012] In some embodiments, the management system 10 operates to manage assets through workflows. The workflows may be defined by a healthcare facility, healthcare provider, healthcare network, asset manufacturer, asset tracking system 100, or the like, and such workflows may be periodically changed or updated. A workflow may include a series of processes that an asset 114 undergoes within a facility during its operational lifecycle. For example, the asset 114 may need to be inspected by an inspection system 20, cleaned at a cleaning station 24, stored in a reservoir 26, or otherwise processed by one or more other processing components 28. Furthermore, in many embodiments, the asset 114 may be used for its intended purpose at the point of use (e.g., a surgical instrument is used in a surgical procedure, or a medical device is used in a medical procedure). Other processes, such as inspection and / or repair processes, as well as a wide variety of other possible processes, may also be used in various workflows. An exemplary workflow 112 is shown in FIG. 3 .

[0013] The example asset tracking system 100 will now be described in more detail with reference to FIG.

[0014] 2 is a schematic block diagram illustrating an exemplary asset tracking system 100. In this example, asset tracking system 100 includes a server computing environment 101 and multiple client computing devices 104 (including 104A, 104B, and 104C). Server computing environment 101 includes a server computing device 102 along with asset tracking software 106. Asset tracking software 106 includes a medical device inspection system 108. Server computing environment 101 also includes an asset database 110. Several example assets (Assets A and B) are also shown.

[0015] The asset tracking system 100 operates to track assets 114 (which in this example include asset 114A and asset 114B). The asset tracking system 100 may track assets 114 within a healthcare system. A healthcare system may include one or more healthcare providers. In addition to tracking inventory and asset location, the asset tracking system may also track workflows associated with particular assets 114. For example, some medical devices are reusable. However, often such medical devices must go through a particular workflow that includes various processing steps before the medical device can be reused. Examples of such processing steps include cleaning and sterilization. The asset tracking system 100 stores information about such workflows and tracks the asset 114 as it progresses through the process.

[0016] Healthcare provider personnel interact with the asset tracking system through client computing devices 104. For example, an application or web interface is provided on the client device that obtains information from server computing device 102. The personnel provide information and updates to the asset tracking system regarding the status of assets 114.

[0017] The asset tracking software 106 and the medical device inspection system 108 are shown and described in further detail with reference to the following figures. While the asset tracking software 106 and the medical device inspection system 108 are shown in FIG. 2 as residing in the server computing environment 101 and the server computing device 102, alternatively, either or both of the asset tracking software 106 and the medical device inspection system 108 may reside on computing devices 104 operated by healthcare provider personnel. Or, in another possible embodiment, aspects of the asset tracking software 106 and the medical device inspection system 108 may reside on both the server 102 and the client computing device 104. Similarly, the asset database 110 may reside on the server 102, another cloud storage device, any one of the computing devices 104, or a combination thereof.

[0018] 2 depicts the medical device inspection system 108 as being a component of the asset tracking software 106. In some embodiments, the medical device inspection system 108 is a plug-in to the asset tracking software 106. Other variations are possible. For example, in some embodiments, the medical device inspection system 108 and the asset tracking software 106 are separate from one another. In some embodiments, the medical device inspection system 108 and the asset tracking software 106 may communicate with one another through data communications, for example, through the server 102 or over a network, such as a local area network or the Internet. In more specific examples, one or more application programming interfaces (APIs) may be used in one or both of the medical device inspection system 108 and the asset tracking software 106 for data communications therebetween or with other computing devices.

[0019] Another embodiment includes medical device inspection software that includes a medical device inspection system 108 and asset tracking software 106. In other words, the medical device inspection software may provide both functions.

[0020] 3 is a schematic block diagram illustrating an example workflow 112 associated with a medical device. In this example, the workflow 112 is managed by an asset tracking system 100, including asset tracking software 106, using a medical device inspection system 108.

[0021] The asset tracking software 106 operates to identify and track specific workflows 112 associated with assets 114 (FIG. 1). One example asset 114 is a medical device. Different workflows are appropriate for different assets 114. Thus, in some embodiments, the asset tracking software 106 may store and manage a healthcare provider's official workflows, which define which steps a medical device should go through. In some embodiments, the operation of the asset tracking software 106 is enhanced by a medical device inspection system 108, which provides extended functionality to the asset tracking software 106 with respect to medical device inspection operations. In some embodiments, the medical device inspection system 108 is or includes an internal inspection system operable to inspect the interior of a medical device.

[0022] As described herein, although the medical device inspection system 108 is shown in FIG. 3 as being separate from the asset tracking software 106, in other configurations the medical device inspection system 108 may be part of the asset tracking software 106, for example, by having the operations of the medical device inspection system 108 incorporated into the asset tracking software 106. In yet another possible embodiment, the workflow 112 may be managed directly by the medical device inspection system 108, such that the operations of the asset tracking software 106 are incorporated into the medical device inspection system 108.

[0023] 3 for a particular asset 114, where the asset 114 is a medical device. As noted, a wide variety of possible workflows 112 may be defined for different assets 114. This example workflow 112 is a cleaning cycle workflow for an exemplary medical device.

[0024] The exemplary workflow 112 includes multiple workflow stages 112A-112J. The exemplary workflow 112 begins with the use of a medical device during a medical procedure 112A, sometimes referred to as the "point of use" or "point of care." One example medical procedure is a surgical procedure, although many medical devices may be used for many other purposes. The use of a medical device in a medical procedure, such as surgery, exposes the medical device to contaminants. Therefore, a cleaning cycle workflow 112 is defined for a medical device in the asset tracking software 106 to clean the medical device before it is used in another medical procedure on a different patient. The medical procedure 112A includes using the medical device for its intended purpose.

[0025] After the medical procedure 112A, the workflow 112 includes a point-of-care processing stage 112B. In this example, the workflow 112 defines some initial processing steps that should be performed while the medical device is still at the point-of-care. One example is wiping the medical device and placing it in some temporary packaging for transport to the next workflow stage.

[0026] The next workflow stage defined by workflow 112 is cleaning stage 112C. In some embodiments, cleaning stage 112C is performed by cleaning station 24 shown in FIG. 1. Cleaning stage 112C involves processing the medical device through a thorough cleaning process. Cleaning stage 112C may involve manual, mechanical, and / or automated cleaning processes, often involving the use of water and detergent. In some embodiments, cleaning stage 112C involves the use of a specific machine or instrument, such as an ultrasonic cleaner, washer-disinfector, cart washer, endoscope washer, or other cleaning machine.

[0027] The workflow 112 then proceeds to a cleaning and inspection stage 112D. During the cleaning and inspection stage 112D, the operations of the cleaning stage 112C are checked to ensure that the operations were successful and thorough. In some embodiments, the medical device inspection system 108 is used during this stage, which may also include the use of the inspection system 20.

[0028] In some embodiments, the exterior of the medical device is inspected. This can be done manually by an operator, for example, by visual inspection, and the results are entered into the asset tracking system 100. The external inspection can also be done using the inspection system 20, for example, using a camera. For example, an external image of the medical device can be captured by a camera and then processed by the medical device inspection system 108 to check for possible anomalies. Some embodiments utilize an external inspection device to inspect the exterior of the medical device. One example external inspection device is described in Applicant's co-pending application entitled "Medical Device Inspection System with External Inspection Device," filed October 25, 2023, which is U.S. Application No. 18 / 494,573, which claims priority to U.S. Application No. 63 / 380,766, filed October 25, 2022, entitled "Medical Device Inspection System with External Inspection Device," the entire disclosure of which is incorporated herein by reference.

[0029] In some embodiments, the cleaning and inspection stage 112D includes inspecting the interior of the medical device. In this regard, an internal inspection device is used, such as the exemplary inspection instrument 30 shown in Figure 9. Images of the interior of the medical device are taken by the inspection instrument 30 and then processed by the medical device inspection system 108 to check for possible anomalies.

[0030] If the cleaning check stage 112D determines that the medical device is not sufficiently cleaned, the workflow 112 may then provide that the medical device be returned to the cleaning stage 112C for further cleaning.

[0031] Once the medical device passes the cleaning and inspection stage 112D, the workflow 112 then advances the medical device to a disinfection stage 112E, designed to reduce or eliminate pathogenic microorganisms from the medical device. In some embodiments, the disinfection stage 112E is performed by the cleaning station 24 shown in FIG. 1 . In some cases, the disinfection stage 112E includes manual or mechanical disinfection. Manual disinfection typically involves wiping or soaking the medical device with a liquid chemical, such as a disinfectant solution. Mechanical disinfection involves using a machine to disinfect with water, detergent, and heat. In some workflows, the cleaning and disinfection stages are combined into a single stage. The disinfection stage 112E may also include the use of ultraviolet (UV-C) light or hydrogen peroxide vapor. In some embodiments, UV-C light is utilized using an internal inspection device, such as a borescope, configured to emit UV-C light. In some embodiments, the medical device inspection system 108 is used during the application of UV-C light using the internal inspection device.

[0032] The workflow 112 then proceeds to another inspection stage 112F. During inspection stage 112F, the operations of cleaning stage 112C and disinfecting stage 112E are checked to ensure that the operations were successful and thorough, and may also check for residual moisture or chemicals. Any other abnormalities may also be identified during inspection stage 112F. In some embodiments, the medical device inspection system 108 is used during this stage, which may also include use of inspection system 20. In some embodiments, inspection stage 112F is the same as or similar to that of cleaning inspection stage 112D described above.

[0033] If inspection step 112F determines that the medical device has not been adequately cleaned or disinfected, workflow 112 may then dictate that the medical device be returned to steps 112C and / or 112E for further processing. If any other anomalies are identified, appropriate corrective measures may be dictated by workflow 112.

[0034] Once inspection confirms that the medical device is properly cleaned and disinfected and ready for the next medical procedure 112A, the workflow 112 advances the medical device to a packaging stage 112G. During the packaging stage 112G, the medical device is enclosed in specialized packaging material, such as a sterilization wrap, pouch, or container. The packaging acts as a barrier to protect the medical device from contamination so that the medical device remains sterile until the next medical procedure 112A.

[0035] Next, the workflow 112 proceeds to a sterilization stage 112H. During sterilization, the medical device undergoes further processing to attempt to kill any remaining bacterial organisms, including bacterial spores. The sterilization stage may be performed by a variety of machines or devices, depending on the particular medical device and the particular workflow 112. Exemplary sterilization processes may include the use of an autoclave, an ethylene oxide (EtO) sterilizer, a hydrogen peroxide gas plasma sterilizer, an ozone sterilizer, a dry heat sterilizer, and the like.

[0036] Following the sterilization step 112H, the medical device is then placed into storage 112I. Cleanliness and sterility are maintained through packaging and storage. Even during storage, the asset tracking software 106 can track the status and location of the medical device to ensure it is ready and available for another future medical procedure 112A.

[0037] In the illustrated workflow 112, an additional inspection audit step 112J is performed. In this example, inspection audit step 112J is an additional quality control measure designed to ensure that the medical device remains clean, sterile, and ready for the next medical procedure 112A. Inspection audit step 112J may include, for example, checking the integrity of the packaging (i.e., tears, holes, moisture, etc.), checking sterility indicators, checking storage conditions, checking expiration dates, and the like.

[0038] In some embodiments, workflow 112 includes the use of medical device inspection system 108. Medical device inspection system 108 is utilized during one or more medical device inspection stages of workflow 112. The inspection process may be performed using medical device inspection system 20 to inspect the medical device. For example, the inspection process may check the medical device for anomalies. Anomalies may include, for example, debris, damage (e.g., holes, kinks, tears), discoloration, moisture (e.g., water droplets), contaminants (e.g., biofilm or biological material), and the like. If any anomalies are identified, further inspection or processing of the medical device may be warranted. Additional processing may include, for example, repeating cleaning stage 112C or disinfection stage 112E, obtaining replacement parts, or sending the device for inspection. Numerous other additional stages are possible in other workflows 112.

[0039] An example medical device inspection system is a medical device inspection instrument 30 (FIG. 9). An example inspection instrument is a borescope, such as a fiberscope. Inspection instruments typically include a light source and a camera. An example inspection instrument has a long, thin fiber that can be inserted and removed through the center of the medical device and functions to capture an image of the interior of the medical device. Examples of inspection instruments are disclosed in various patent applications by Clarus Medical, LLC, including U.S. Patent Application Publication No. 2019 / 0224357, filed January 22, 2019; U.S. Patent Application Publication No. 2019 / 0282327, filed February 19, 2019; U.S. Patent Application Publication No. 2022 / 0080469, filed September 10, 2021; and U.S. Patent Application Publication No. 2022 / 0240767, filed February 3, 2022, the entire disclosures of which are incorporated herein by reference.

[0040] 4 is a flow chart illustrating an example method 120 for tracking assets using the medical device inspection system 108. In this example, the method 120 includes operations 122, 124, and 126.

[0041] Operation 122 is performed to identify the medical device, an example of which is shown and described in further detail with reference to FIG.

[0042] Operation 124 is then performed to obtain a workflow for the identified medical device. An exemplary workflow is shown and described in further detail with reference to FIG. 6. One example workflow is an Instructions for Use (IFU). In the United States, the FDA requires that all medical devices have instructions for use. Such instructions often define a workflow, such as a cleaning process, to be used for a particular medical device.

[0043] Operation 126 is then performed to execute the workflow. In some embodiments, execution of the workflow includes use of the medical device inspection system 108. An example workflow is shown and described in further detail herein with reference to FIG.

[0044] 5 illustrates an example medical device selection interface 128 of the asset tracking software 106. The medical device selection interface is used by an operator to identify medical device records within the asset tracking software 106. For example, when an operator wants to perform a certain stage of a workflow, the operator may use the medical device selection interface to pull up records for a particular medical device in the asset tracking system for review or updating.

[0045] Identification may be performed by entering medical device information, scanning medical device information, or searching for the medical device using one or more search or lookup processes. As one example, an operator may enter a manufacturer and model number and / or a serial number or other medical device identification number. As another example, an operator may scan the medical device with a barcode reader, RFID reader, or digital camera (e.g., reading a QR code or text or performing object recognition). In another example, an operator may perform a search of an asset database to find relevant medical devices. In another example, an operator may search for medical devices associated with a particular case number.

[0046] In this example, once a search is performed or a code is scanned, a resulting list of medical devices is displayed, and the operator can then scroll through the list and select a medical device from the list.

[0047] The asset tracking software 106 may maintain a wide variety of data regarding medical devices. Some exemplary fields of data that may be stored by the asset tracking system include, but are not limited to, one or more of: device manufacturer, device model, serial number, time / date / technician performing each step, status, percent confidence in analysis, device location, procedure for which the device is used, surgeon using the device, patient on whom the medical device was used, date of last repair, device supplier, cleaning completion, inspection completion, sterilization completion, time / date of sterilization, temperature / metadata for previous step, make / model / type of brush (or other cleaning equipment) used during cleaning, soap / chemicals used, concentration of soap / chemicals used, metadata regarding steam sterilization settings, dose of UV-C utilized during inspection or cleaning, images taken at each hot spot and reviewed by staff, and speed / length / quality of inspection. In some embodiments, a medical device selection interface may enable searching, displaying, and identifying medical devices using any one or more of these exemplary fields or various other data fields.

[0048] 6 illustrates an example workflow user interface 129 presented during the example workflow 112 (shown in FIG. 3) associated with a medical device. In some embodiments, the workflow user interface 129 is generated by the asset tracking system 100, for example, by the asset tracking software 106 or the medical device inspection system 108.

[0049] After a medical device is identified in operation 122, for example, using the exemplary user interface 128 shown in FIG. 5, the workflow 112 associated with the medical device may be retrieved. In one example, the workflow 112 is retrieved from the asset database 110 shown in FIG. 2. Each asset (e.g., a medical device) is associated with one or more workflows. In some embodiments, different workflows may be available for different situations of the medical device. For example, after use, the medical device may need to go through a cleaning cycle workflow 112.

[0050] The exemplary user interface 129 includes a workflow preview area that displays a particular stage of the workflow 112 for a selected medical device. In this example, the workflow preview area displays stages 112B-112E of the workflow 112. The workflow preview area provides a brief description and status of the stage. In this example, each stage is associated with a graphical icon that indicates whether the stage is complete. In this example, stages 112B (point-of-care processing) and 112C (cleaning) are complete, and the medical device is currently undergoing the cleaning inspection stage 112D.

[0051] Particular actions are taken and particular data is collected at each stage of the workflow 112. The workflows shown are merely exemplary, and many other workflows are possible.

[0052] The workflow 112 can be displayed by the asset tracking software 106 or medical device inspection system 108 so that personnel can see which steps need to be performed and the current status of the medical device in the workflow. Additionally, the asset tracking software 106 or medical device inspection system 108 can also provide detailed instructions for each stage (e.g., as represented by a list of steps and a description of each step) and collect data about each stage, such as test results and notes. In other embodiments, additional data can be collected and stored, including data from the inspection and images taken during the inspection.

[0053] 7 shows an exemplary user interface 130 for a medical device inspection system 108. In this example, the user interface includes an inspection image display 132, a reference image display 134, a device ID 136, a list of saved images 138, operator annotations or notes 140, a capture button 142, and a settings button 144. This display is for illustrative purposes only; other user interfaces may have more or fewer components than those shown here.

[0054] In some embodiments, interface 130 is a user interface with which an operator may interact while using a medical device inspection system, such as a medical device inspection instrument. In some embodiments, medical device inspection system 108 provides interface 130 that includes images and data from the medical device inspection system.

[0055] For example, the inspection image display 132 shows the most recent image received from the medical device inspection system while inspecting the medical device. The image may be a still image or may be footage from a video feed.

[0056] In some embodiments, the interface 130 also presents one or more reference images to the operator. The reference image may be obtained from an asset database for a particular medical device. The reference image may show, for example, what the original medical device looked like when clean and fully functional (free of any anomalies). In this way, the operator can compare the inspection image 132 with the reference image to check for any anomalies or other differences between the inspection image 132 and the reference image 134. In another possible example, the reference image may show examples of anomalies so that the operator can be alert to such features. In another possible example, the reference image may include previous images from the same medical device currently being processed. This may be useful for comparing the inspection image 132 with a previous set of images taken to see if anything has changed. Similarly, images over a period of time may be viewed to see the progression of anomalies, such as wear, damage, film or contaminant buildup, rust on components, and the like.

[0057] The interface 130 may display information about the medical device currently being processed (eg, device identifier 136) and / or information about the medical device testing system currently being used.

[0058] The interface 130 may include a list 138 of images that have already been saved during the current inspection process. The saved images may be reviewed by the operator if desired.

[0059] The interface 130 may also be configured to receive operator annotations or notes. The operator may provide input identifying any status changes in the medical device, any abnormalities indicated, completion of workflow processing steps, or make any general notes or observations.

[0060] A capture button 142 is provided for the operator to select when an image should be captured and saved. For example, if an abnormality is detected in the inspection image 132, the capture button is selected to save the image. Alternatively, the capture button may be used to capture and save a video recording. In some embodiments, the operator may switch between image or video capture modes.

[0061] In some embodiments, the user may adjust one or more settings via settings button 144.

[0062] In some embodiments, the medical device inspection system 108 provides the operator with detailed step-by-step instructions that guide the operator through the completion of the workflow steps. The instructions may also be presented in the interface 130.

[0063] In some embodiments, the asset database may store a list of landmarks, such as a list of hot spots, related to the medical device. The list of hot spots identifies specific parts of the medical device where anomalies are most likely to be found. Hot spots may be components of the medical device that are prone to wear and may need to be replaced. Hot spots may also be locations where contaminants may accumulate. Hot spots may also be locations where damage is more likely to occur, such as points along a flexible member that are more likely to kink or tear. The list of hot spots may be provided as a helpful guide to the operator or may be presented as a mandatory checklist of areas that need to be carefully evaluated by the operator. In such cases, the interface 130 may function to guide the operator through the evaluation of each hot spot and record data regarding each condition (automatically, based on user input, or a combination of both).

[0064] In some embodiments, the interface displays other data, such as the location of medical device inspection equipment within the medical device. Location information can be useful to an operator in locating hot spots and can also help an operator record the location of possible anomalies. Location information can also be stored with the saved image. Similarly, time can be displayed and stored. Data about the image (including anomalies, operator annotations, device ID, location information, time information, etc.) can be stored in a variety of ways, including as data in an asset database, as metadata in the image (or video) file, as part of a file name, or any other way in which data can be associated with an image. Such information can also be stored in the asset database record, for example, as data associated with the completion of a particular workflow step, or to record and verify that such a step has been completed.

[0065] 8 illustrates a preferred structure of a computing device that may be used to implement aspects of the present disclosure, including the server computing device 102 or any of the multiple client computing devices 104 (104A, 104B, or 104C) disclosed herein. The computing device illustrated in FIG. 8 may be used to execute the operating systems, application programs, and software modules (including software engines) described herein. By way of example, the computing device is described below as computing device 104. To avoid undue repetition, this description of the computing device will not be repeated separately herein for each of the other computing devices, including the server computing device 102, although such devices may also be configured as shown and described with reference to FIG. 8.

[0066] In some embodiments, computing device 111 includes at least one processing unit 180, such as a central processing unit (CPU). Various processing units are available from various manufacturers, such as Intel or Advanced Micro Devices. In this example, computing device 111 also includes a system memory 182 and a system bus 184 that connects various system components, including system memory 182, to processing unit 180. System bus 184 may be one of any number of types of bus structures, including a memory bus or memory controller, a peripheral bus, or a local bus using any of a variety of bus structures.

[0067] Examples of computing devices suitable for computing device 111 include a server computer, a desktop computer, a laptop computer, a tablet computer, a mobile computing device (e.g., a smartphone, an iPod® or iPad® mobile digital device, or other mobile device), or other device configured to process digital instructions.

[0068] System memory 182 includes read-only memory 186 and random access memory 188. A basic input / output system 190, containing the basic routines that function to transfer information within computing device 111, for example during start-up, is typically stored in read-only memory 186.

[0069] In some embodiments, computing device 111 also includes a secondary storage device 192, such as a hard disk drive, for storing digital data. Secondary storage device 192 is connected to system bus 184 by a secondary storage interface 194. Secondary storage device 192 and its associated computer-readable media provide non-volatile storage of computer-readable instructions (including application programs and program modules), data structures, and other data for computing device 111.

[0070] Although the preferred environment described herein employs a hard disk drive as secondary storage, in other embodiments, other types of computer-readable storage media are used. Examples of such other types of computer-readable storage media include magnetic cassettes, flash memory cards, digital video disks, Bernoulli cartridges, compact disk read-only memories, digital versatile disk read-only memories, random access memories, or read-only memories. Some embodiments include non-transitory media. Furthermore, such computer-readable storage media may include local storage or cloud-based storage.

[0071] A number of program modules may be stored in secondary storage 192 or in memory 182, including an operating system 196, one or more application programs 198, other program modules 200 (e.g., software engines described herein), and program data 202. Computing device 111 may utilize any suitable operating system, such as Microsoft Windows®, Google Chrome®, Apple® OS, and any other operating system suitable for computing devices.

[0072] In some embodiments, a user provides input to the computing device 111 through one or more input devices 204. Examples of input devices 204 include a keyboard 206, a mouse 208, a microphone 210, and a touch sensor 212 (e.g., a touchpad or touch-sensitive display). Other embodiments include other input devices 204. The input devices are often connected to the processing unit 180 through an input / output interface 214 connected to the system bus 184. The input devices 204 may be connected by any number of input / output interfaces, such as a parallel port, a serial port, a game port, or a universal serial bus. Wireless communication between the input devices and the interface 214 is also possible, and in some possible embodiments includes infrared, BLUETOOTH® wireless technology, 802.11a / b / g / n, cellular, or other radio frequency communication systems.

[0073] In this exemplary embodiment, a display device 216, such as a monitor, LCD display device, projector, or touch-sensitive display device, is also connected to system bus 184 via an interface, such as a video adapter 218. In addition to display device 216, computing device 111 may also include various other peripheral devices (not shown), such as speakers or a printer.

[0074] When used in a local area networking environment or a wide area networking environment (e.g., the Internet), computing device 111 typically connects to the network through network interface 220, such as an Ethernet interface. Other possible embodiments use other communication devices. For example, some embodiments of computing device 111 include a modem that communicates over the network.

[0075] Computing device 111 typically includes at least some form of computer-readable media. Computer-readable media includes any available media that can be accessed by computing device 111. By way of example, computer-readable media includes computer-readable storage media and computer-readable communication media.

[0076] Computer-readable storage media include volatile and nonvolatile, removable and non-removable media implemented in any device configured to store information such as computer-readable instructions, data structures, program modules, or other data. Computer-readable storage media include, but are not limited to, random access memory, read-only memory, electrically erasable programmable read-only memory, flash memory or other memory technology, compact disc read-only memory, digital versatile disk or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the desired information and that can be accessed by a computing device 111. Computer-readable storage media does not include computer-readable communication media.

[0077] Computer-readable communication media typically embodies computer-readable instructions, data structures, program modules, or other data in a modulated data signal, such as a carrier wave or other transport mechanism, and includes any information delivery media. The term "modulated data signal" refers to a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal. By way of example, computer-readable communication media includes wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, radio frequency, infrared and other wireless media. Combinations of any of the above are also included within the scope of computer-readable media.

[0078] The computing device shown in FIG. 8 is also an example of a programmable electronic device that may include one or more such computing devices, and when multiple computing devices are included, the computing devices may be connected together with a suitable data communications network to collectively perform various functions, methods, or operations disclosed herein.

[0079] 9 is a schematic block diagram illustrating an exemplary medical device inspection system 20 including an exemplary medical device inspection station 22. The exemplary inspection system 20 includes a computing device 104 and an inspection assembly 231. The exemplary computing device 104 includes a medical device inspection system 108. In this example, the medical device inspection system 108 includes an inspection analyzer 228 having an anomaly detector 230. The exemplary computing device 104 also includes a display device 216 that displays a user interface 224. The exemplary inspection assembly 231 includes an inspection instrument 30 that includes a support structure 233, an advancement system 234, a position tracking device 238, and a camera 240. The inspection assembly 231 is shown supporting a medical device M thereon. Inspection data 232 can be generated by the inspection system and communicated between the inspection assembly 231 and the computing device 104.

[0080] In some embodiments, inspection station 22 is used as part of method 120 shown and described with reference to Figure 4. Examples of user interface 224 are shown and described with reference to Figures 5-7. In some embodiments, computing device 104 includes some or all of the components shown and described with reference to Figure 8. In some embodiments, computing device 104 communicates over a network with other computing devices, such as computing device 102 of server computing environment 101 shown and described with reference to Figure 2.

[0081] This example shows medical device inspection system 108, test analyzer 228, and anomaly detector 230 residing on computing device 104. However, as shown in FIG. 2, in other embodiments, medical device inspection system 108 may also reside in a server computing environment (or other computing device). Furthermore, in some embodiments, multiple computing devices (i.e., 104 and 102) may cooperate to collectively perform the functions of medical device inspection system 108. It was also previously described that medical device inspection system 108 (shown in FIG. 9 as including test analyzer 228 and / or anomaly detector 230) may be part of asset tracking system 100 and software 106, and in other embodiments, asset tracking system 100 and software 106 may be incorporated into medical device inspection system 108.

[0082] In some embodiments, the inspection assembly 231 includes a support structure 233 that supports the inspection instrument 30 and the medical device M. The support structure 233 can take a variety of possible forms and typically includes at least a frame or other housing that supports and optionally guides movement of the various components of the inspection station 22 relative to one another. In some embodiments, the support structure 233 is a vertical support structure that can support one or more or portions of the medical device M or the inspection instrument 30 in a vertical orientation. An advantage of a vertical support structure configuration is, for example, that it can reduce table or floor space. In other embodiments, the support structure 233 includes a horizontal support structure that supports in a horizontal orientation.

[0083] In some embodiments, the inspection instrument 30 includes a camera 240 for visually inspecting the medical device M. In some embodiments, the inspection instrument 30 transmits the inspection data 232 to the computing device 104.

[0084] As described herein, in some embodiments, the inspection assembly 231 further includes an external inspection device that may be supported by the support structure 233 and movable relative to the medical device by the advancement system 234.

[0085] The advancement system 234 is configured to move the inspection instrument 30 relative to the medical device M. In some embodiments, the advancement system 234 is motorized to move the inspection instrument 30 or the medical device M.

[0086] As mentioned above, in some embodiments, the advancement system 234 is configured to operate automatically. For example, the advancement system 234 may include a robotic arm or an automated feeder that advances the inspection instrument 30 through the medical device M. Other motorized, mechanical, and manual methods may be used in different embodiments and are disclosed herein. In some embodiments, the inspection instrument 30 of the advancement system 234 captures inspection data that is processed by a machine learning model to provide real-time feedback to automatically control the advancement system 234. For example, the machine learning model may analyze the captured image data to determine how the inspection instrument 30 should be advanced through the medical device M. In some embodiments, the machine learning model may output outcomes that are verified / approved by a user before being reported and / or stored in a database.

[0087] In some embodiments, a user manually advances inspection instrument 30 through medical device M. Examples of inspection instrument 30 are disclosed herein. For example, inspection instrument 30 may be a borescope, such as a fiberscope. In some embodiments, inspection instrument 30 includes one or more fiber optic elements (which may include one or more optical fibers, such as a fiber bundle) that carry light from a light source to the tip of inspection instrument 30. In other embodiments, the light source (e.g., a light emitting diode (LED)) is located at or near the tip. Additionally, in some embodiments, the fiber optic elements carry light returning from the tip to a camera 240 (or other light sensor) located away from the tip.

[0088] The camera 240 operates to capture images of the medical device M. The images may be individual images or videos. The videos may be made up of multiple images. The image and video data are included with the examination data 232 that is transmitted (via a wired connection or wirelessly) to the computing device 104. The examination data may also include a timestamp identifying the date and / or time the image was taken. In some embodiments, the examination data 232 also includes operational data. Examples of examination data are disclosed herein.

[0089] Medical device M can be one of a variety of different types of medical devices and can include an elongated, flexible body with one or more internal openings. Examples include endoscopes, fiberscopes, catheter-based medical / surgical instruments, and other reusable devices.

[0090] Some embodiments include a position tracking device 238. The position tracking device 238 is configured to detect and monitor the position of the inspection instrument 30 relative to the medical device M during medical device inspection. Examples of position tracking devices are described herein.

[0091] The computing device 104 operates a medical device testing system 108. In one example, the medical device testing system 108 includes a test analyzer 228 and an anomaly detector 230, examples of which are disclosed herein.

[0092] The computing device includes a display device 216 that presents a user interface 224. In some embodiments, output from the medical device inspection system 108 is presented on the display device 216. The user interface 224 may display images from the examination along with additional information, such as operational or analytical data, or other displays based thereon. Examples of the user interface 224 are shown and described with reference to FIGS. 5-7. Other examples are described herein. In some embodiments, the user interface allows a user to view a series of images in the order of the examination (e.g., from the distal end or from the proximal end).

[0093] In some embodiments, the inspection system 20, including the medical device inspection system 108 and the inspection assembly 231, operates to inspect one or more landmarks, e.g., specific points of interest, on a medical device. The inspection can be automatic, or in other embodiments, the inspection station 22 can provide instructions or otherwise guide an operator to inspect the landmarks. One example landmark is a hotspot. A hotspot is a point or area on a medical device that is prone to having anomalies. In some embodiments, the hotspot is predetermined. The hotspot may be based on physical or visually identifiable features, such as connections, transitions, or intersections between two parts or materials, depressions or pits, openings, surface textures, and the like. In some embodiments, the hotspot is identified from research or literature analysis indicating spots that are most likely to contain anomalies. In some embodiments, the hotspot is identified by data updated from the inspection software. For example, the hotspot may be provided by another party (or other system), e.g., the FDA, a manufacturer, a third-party repair specialist, a device cleaning specialist, etc. In some embodiments, the hotspots are updated in real time.

[0094] In some embodiments, one or more landmarks may be identified. The landmarks may be predefined and stored in a database, for example, associated with a type of medical device. For example, a landmark may be linked to a particular medical device (serialization), a make / model year, a category of device, etc.; landmarks may also be manually defined by an operator. For example, an operator may identify a particular point on a medical device as a landmark or hotspot.

[0095] Various user interface configurations may be used to receive identification of landmarks from the operator, for example, by receiving input into an image of the medical device M, input into a diagram of the medical device M, or by providing location information (e.g., a length of 10 cm from the front end of the medical device or a range of 5 cm to 15 cm from the front end of the medical device). In some embodiments, landmarks are identified by image recognition or specific locations identified by the end user. For example, channel junctions, lifting mechanisms, and distal tips may be recognized and identified from captured images.

[0096] In yet another embodiment, the landmarks can be determined automatically, for example, by computer analysis of historical data to determine the most common areas where anomalies have previously been identified for this type or model of medical device. The computer analysis can also occur in-situ, for example, using artificial intelligence to automatically predict and identify landmarks for medical device M, for example, current image data, knowledge of the medical device's structure, and / or historical data regarding this or other similar medical devices.

[0097] In some embodiments, once the medical device M is identified, the inspection system 20 is configured to present the operator with landmark instruction for the selected medical device M. The instruction may include training presentations that guide the operator through one or more landmarks, one or more diagrams of the medical device M with the identified landmarks, an image of an example inspection instrument that shows the operator what it will look like during the inspection, or a variety of other possible training presentations or visual displays.

[0098] In some embodiments, the inspection system 20 is configured to store and present or otherwise provide or create available historical records, for example, for a particular medical device M, make / model, device category, and / or device age. For example, historical photographs of the medical device M or medical device inspections may be shown to the operator or incorporated into the report. This may help the operator learn of any known or previous anomalies that have been identified and may provide a reference image that the operator can use to compare previous conditions to current conditions. The historical records may include whether the device is new, the age of the device, the number of times the medical device has been used, recent or previous damage, recent or previous repairs, or other information.

[0099] In some embodiments, the information may also include patient data, such as information regarding which patient the medical device M was previously used on (e.g., the patient's name or patient identification number), which procedure was performed, medical outcome or diagnosis (e.g., to record whether the medical device may have been exposed to a particular biohazard, chemical, radiation, or the like), or other patient-related data (with or without patient identification information). The information may also include healthcare provider information, such as information regarding the healthcare professional who last used the medical device M. The information may also include information about previous (past) patients or healthcare providers.

[0100] In some embodiments, medical device inspection system 108 operates to coordinate medical device inspection. For example, medical device inspection system 108 may automatically control inspection assembly 231 (including advancement system 234 and inspection instrument 30) to perform the medical device inspection, e.g., using control signals 236. Medical device inspection system 108 may use the acquired information to identify landmarks within the medical device for inspection and control advancement system 234 so that camera 240 acquires images of that area. As discussed herein, other options are possible as well, e.g., a complete inspection of medical device M. The resulting inspection data 232, including the images, may then be stored by medical device inspection system 108, e.g., in asset database 118.

[0101] In another example, the medical device inspection system 108 assists an operator in performing a medical device inspection. In this example, a user interface may be presented to guide the operator through the inspection. Certain operations may still be automatically controlled by the medical device inspection system 108 even when an operator is involved. As described in further detail herein, various information, guidance / instructions, reference images, etc. may be presented during the inspection to assist the operator.

[0102] In some embodiments, analysis of the test data is then performed utilizing test analyzer 228 and anomaly detector 230. Test analyzer 228 may process the test data and generate analysis results. In some embodiments, test analyzer 228 operates to identify landmarks on the medical device. In some embodiments, test analyzer 228 utilizes location data generated by position tracker 238. In some embodiments, for example, the test analyzer utilizes one or more machine learning models to perform object recognition and identify landmarks on the medical device.

[0103] To aid in the analysis, in some embodiments, the test analyzer 228 utilizes an anomaly detector 230. The anomaly detector 230 operates to evaluate the medical device to assess whether an anomaly may exist. In some embodiments, the anomaly detector 230 may utilize human input, for example, by displaying corresponding images for particular landmarks along with reference images and prompting a user to provide input regarding whether an anomaly exists at the landmark. In another example, the anomaly detector 230 utilizes a machine learning model to automatically analyze one or more images of the medical device to determine or predict whether an anomaly may exist.

[0104] In some embodiments, anomaly detector 230 is or includes a neural network, such as a convolutional neural network (CNN), that operates to process image data from medical device examinations and extract features from the images.

[0105] In some embodiments, the anomaly detector 230 includes an input layer that accepts medical device images from a medical device inspection. In some embodiments, the images are preprocessed. Preprocessing may include, for example, one or more of resizing, normalization, upscaling, grayscale conversion, or noise reduction. Such preprocessing may improve the quality of subsequent machine learning operations by providing consistent input to the model.

[0106] In some embodiments, the anomaly detector 230 includes multiple convolutional layers. For example, the layers are configured to detect patterns, textures, and features in an image. Multiple layers may be combined with pooling layers to improve the ability of the anomaly detector 230 to understand different aspects of the image.

[0107] In some embodiments, the anomaly detector 230 includes one or more fully connected (FC) layers. An FC layer is an example of a dense layer. One or more dense layers may be used to help the anomaly detector 230 make a classification decision. For example, one or more FC layers may be used to combine extracted features to make a final classification.

[0108] In some embodiments, the anomaly detector 230 includes an output layer that provides an output of the machine learning model. For example, the output layer may output a determination as to whether the medical device has an anomaly. One example output is "normal" or "abnormal." As another example, the output may include a probability (i.e., that the medical device is normal or abnormal), e.g., in the form of a percentage or a number between 0 and 1. In some embodiments, the output is binary (i.e., a binary classification by a binary classifier), while in other embodiments, the output may have multiple outputs (i.e., a multi-class classification by a multi-class classifier).

[0109] In some embodiments, the anomaly detector 230 is trained using a labeled training set. In one example, the training includes a training algorithm, such as a gradient descent algorithm, that adjusts the weights of the neural network to minimize the difference between its predictions and the actual labels.

[0110] Additionally, in some embodiments, anomaly detector 230 utilizes one or more reference images that allow it to compare the medical device test data image to a reference image. In some embodiments, anomaly detector 230 utilizes image difference, where a reference image (of a normal device without anomalies) is subtracted from the test image to highlight the differences. In some embodiments, anomaly detector 230 utilizes thresholding to convert the difference image to binary (black and white) to highlight significant differences. In some embodiments, the binary image can then be used as an additional input to a neural network to help the anomaly detector more fully focus on differences.

[0111] In some embodiments, the anomaly detector 230 may include continuous learning, e.g., a feedback loop and retraining. The feedback loop allows additional images (e.g., those containing anomalies or both normal and abnormal images) that are collected to be added to the training set. The model may then be retrained on the updated dataset to improve its accuracy.

[0112] In some embodiments, the output of anomaly detector 230 is presented to an operator for review. The operator may make the final determination as to whether an anomaly exists. In some embodiments, the operator provides user input to update the anomaly determination. In some embodiments, user input overrides (or confirms) the automatic anomaly determination by anomaly detector 230. Additionally, in some embodiments, user input can be provided to manually identify anomalies in the medical device that were not detected by anomaly detector 230, which are then recorded.

[0113] The various embodiments described above are provided merely as examples and should not be construed to limit the scope of the claims appended hereto. Those skilled in the art will readily appreciate that various modifications and changes may be made without following the exemplary embodiments and applications shown and described herein and without departing from the full scope of the following claims.

Claims

1. at least one processing unit; at least one memory device storing asset tracking software and a medical device inspection system; The medical device inspection system, when executed by the processing device, supplements the asset tracking software to provide additional functionality related to the inspection of medical devices using the medical device inspection system.

2. The asset tracking system of claim 1 , wherein the medical device inspection system is connected to the asset tracking software.

3. 10. The asset tracking system of claim 1, wherein the medical device inspection system is in data communication with an inspection system including at least an inspection instrument, and the medical device inspection system receives and stores at least one image of the interior of the medical device taken by the inspection instrument.

4. The asset tracking system of claim 1 , wherein the medical device testing system further comprises a test analyzer that analyzes test data from the testing instrument.

5. The asset tracking system of claim 1 , wherein the memory further stores medical device inspection software, the medical device inspection software including the medical device inspection system and the asset tracking software.

6. The asset tracking system of claim 1 , wherein the asset tracking software and the medical device inspection system are separate, and the asset tracking software and the medical device inspection system are configured to communicate with each other.

7. at least one processing unit; at least one memory device; The memory device stores data instructions that, when executed by the processing unit, cause the asset tracking system to: Identifying medical devices, obtaining a workflow related to the medical device; tracking progress of the medical device through the workflow; The workflow includes at least one inspection step that includes inspecting the medical device using an inspection instrument.

8. The asset tracking system further comprises: acquiring at least one reference image associated with the medical device; The asset tracking system of claim 7 , further comprising generating a user interface that displays the reference image and the inspection image from the inspection instrument.

9. 1. A computer readable storage device storing data instructions for a medical device inspection system, the data instructions, when executed by a processing device, causing the computer readable storage device to: acquiring at least one reference image associated with the medical device; A computer readable storage device for generating, within an asset tracking software application, a user interface including the reference image and an inspection image from a medical device inspection instrument.

10. The user interface includes: (i) historical data relating to the medical device; (ii) the location of the medical device; (iii) an abnormality detected during testing of the medical device; (iv) the severity of the anomaly detected during testing of the medical device; (v) the status of the medical device; (vi) a device identifier; (vii) operator notes from the inspection regarding the medical device; and (viii) The computer-readable storage of claim 9, comprising one or more of any combination of (i) through (viii).

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