System and method for automating verification of sterilization compatibility and sterilization cycle selection for medical instruments - Patents.com

Abstract

To provide a sterilization system for a new medical device.SOLUTION: A sterilization system 10 includes a communication hub 20 that is configured to transfer information between devices of the system such as a sterilizing cabinet 100, a biological indicator analyzer 102, and a server 106 in order to allow a user to track a medical device throughout a sterilization process. The server may provide data to the sterilizing cabinet during a sterilization process that may be used to verify that the medical device is compatible with the sterilizing cabinet, and to automatically select a compatible sterilization cycle to perform on the medical device. Automatic selection of sterilization cycles and confirmation of compatibility reduces a possibility for a user error, which could result in contaminated medical devices being placed back into service. Automatic selection of sterilization cycles also allows users to more efficiently configure and perform sterilization cycles while being confident that the medical device will be sterile upon completion.SELECTED DRAWING: Figure 1

Description

Disclosure Contents

[0001] 〔background〕 Reusable medical devices, such as certain surgical instruments, endoscopes, etc., can be sterilized before reuse to minimize the possibility of contaminated devices being used on a patient. A variety of sterilization techniques can be used, such as steam, hydrogen peroxide, and vapor-phase sterilization, with or without gas plasma and ethylene oxide (EtO).

[0002] Sterilization of medical devices can be accomplished in an automated sterilization system such as the STERRAD® system by Advanced Sterilization Products of Irvine, California. Examples of automated sterilization systems are described in U.S. Pat. No. 6,939,519, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma," issued Sep. 6, 2005, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 6,852,279, entitled "Sterilization with Temperature-Controlled Diffusion Path," issued Feb. 8, 2005, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 6,852,277, entitled "Sterilization System Employing a Switching Module Adapter to Pulsate the Low Frequency Power Applied to a Plasma," issued Feb. 8, 2005, the disclosure of which is incorporated herein by reference; and U.S. Pat. No. 6,447,719, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma," issued Sep. 10, 2002, the disclosure of which is incorporated herein by reference. Each different medical device may require a different construction and sterilization process.

[0003] Although various systems and methods have been created and used to sterilize medical devices, it is believed that no one prior to the inventors has created or used the technology as described herein.

[0004] The invention will be better understood from the following description of specific embodiments taken in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0005] [Figure 1] 1 shows a schematic diagram of an exemplary sterilization system. [Figure 2] FIG. 2 shows a schematic diagram of an exemplary sterilization cabinet that may be used with the system of FIG. 1. [Figure 3] 3 shows a high-level flowchart of an exemplary set of steps that the sterilization cabinet of FIG. 2 can perform to sterilize medical devices. [Figure 4] 1 illustrates an exemplary set of steps that may be performed by a sterilization system such as that shown in FIG. 1 to automatically identify a medical device. [Figure 5] An exemplary set of steps that may be performed by a sterilization system such as that shown in FIG. 1 to track medical devices throughout their lifecycle is shown. [Figure 6] 1 illustrates an exemplary set of steps that may be performed by a sterilization system such as that shown in FIG. 1 to automatically verify compatibility of a medical device with one or more components of the system. [Figure 7] 10 illustrates an exemplary interface for viewing device compatibility information for a sterilization cycle. [Figure 8] 10 illustrates an exemplary interface for viewing compatibility information for multiple devices in a sterilization cycle. [Figure 9] 10 illustrates an exemplary interface for viewing a history record of sterilization cycles and medical device compatibility. [Figure 10] 10 illustrates an exemplary interface for configuring one or more alerts associated with a non-compliant sterilization cycle. [Figure 11] 10 illustrates an exemplary interface for selecting a device based on compatibility with a medical device. [Figure 12] 10 shows an exemplary interface for viewing compatibility information for all devices currently in use. [Figure 13] 10 shows an exemplary interface for viewing the overall compatibility level. [Figure 14] 1 illustrates an exemplary set of steps that may be performed by a sterilization system such as that shown in FIG. 1 to automatically select and configure an appropriate sterilization cycle for a device.

[0006] [Detailed explanation] The following description of a particular example of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description, which is, by way of example, one of the best modes contemplated for implementing the technology. As will be appreciated, the technology described herein is capable of other different and obvious aspects without departing from the technology. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0007] Furthermore, it is understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the teachings, expressions, embodiments, examples, etc. described below should not be viewed in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be within the scope of the claims.

[0008] I. Overview of an Exemplary Sterilization System 1 shows a schematic diagram of an exemplary system (10) of interconnected devices that may be configured to perform methods related to sterilization of medical devices (e.g., endoscopes and other medical devices). The system (10) of this example includes a sterilization cabinet (100), a biological indicator analyzer (102), a communications hub (20), a server (106), a user device (108), and a sterilization guide database (110). The communications hub (20) is configured to provide for the transmission of data between the sterilization cabinet (100), the biological indicator analyzer (102), the communications hub (20), the server (106), the user device (108), and the sterilization guide database (110), as described in more detail below.

[0009] FIG. 2 illustrates an exemplary set of components that may be incorporated into a sterilization cabinet (100). The sterilization cabinet (100) may be configured to perform one or more sterilization cycles, with different sterilization cycles being appropriate for different types and quantities of medical devices. The sterilization cabinet (100) of this example includes a sterilization chamber (152) configured to receive one or more medical devices for sterilization. The sterilization cabinet (100) also includes a sterilization module (156), which is operable to receive a sterilant cartridge (158) and dispense sterilant from the cartridge (158) into the sterilization chamber (152). The sterilization cabinet (100) further includes a touchscreen display (160), which is operable to render various user interface display screens and receive user input via user contact with the touchscreen display (160). The sterilization cabinet (100) may include various other types of user input features, including, but not limited to, buttons, keypads, keyboards, mice, trackballs, and the like.

[0010] The sterilization cabinet (100) of this embodiment further includes a processor (162), a communications module (164), a reader (166), and a memory (168). The processor (162) is in communication with various components of the sterilization cabinet (100) and is operable to process data and execute control algorithms that drive the various components of the sterilization cabinet (100). The communications module (164) is configured to enable bidirectional communication between the sterilization cabinet (100) and the communications hub (20). The communications module (164) may also be configured to enable bidirectional communication between the sterilization cabinet (100) and the server (106) and / or the sterilization guide database (110). The reader (166) is operable to read identification tags of biological indicators and / or other devices as described herein. The memory (168) is operable to store control logic and instructions that are executed by the processor (162) to drive the components of the sterilization cabinet (100). Memory (168) may also be used to store results related to sterilization cycle settings, load adjustment cycle performance, sterilization cycle performance, and / or various other types of information. A variety of suitable components and configurations that may be used to form processor (162), communications module (164), reader (166), and memory (168) will be apparent to those skilled in the art in view of the teachings herein.

[0011] In addition to the above, the sterilization cabinet (100) may be constructed and operable in accordance with at least some of the teachings of any of the patent documents cited above in this specification; U.S. Patent Application Publication No. 2017 / 0252473, published September 7, 2017, entitled "Apparatus and Method for Sterilizing Medical Devices," the disclosure of which is incorporated herein by reference; and / or U.S. Patent Application Publication No. 2017 / 0252474, published September 7, 2017, entitled "Method of Sterilizing Medical Devices, Analyzing Biological Indicators, and Linking Medical Device Sterilization," the disclosure of which is incorporated herein by reference.

[0012] In some cases, biological indicators may be included in the sterilization cabinet (100, 150) with the medical devices during the sterilization process. The biological indicators may be activated prior to placement to allow microorganisms contained therein to grow unless they are successfully sterilized during the procedure. After the sterilization process, the number of microorganisms present in the biological indicator may be measured by the biological indicator analyzer (102) to ensure that the sterilization process was successful for the biological indicator, which also indicates that the sterilization procedure was successful for the medical device. The biological indicator analyzer (102) may receive the biological indicator and measure one or more characteristics of the biological indicator to collect data that may be used to determine whether the test result for the biological indicator is positive, indicating the presence of contamination after the sterilization procedure, or negative, indicating the absence of contamination after the sterilization procedure.

[0013] By way of example only, the biological indicator and biological indicator analyzer (102) may be any of the biological indicators and biological indicator analyzers described in U.S. Patent Application Publication No. 2017 / 0253845, published September 7, 2017, and entitled "Self-Contained Biological Indicator," the disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2017 / 0253905, published September 7, 2017, and entitled "Apparatus and Method for Analyzing Biological Indicators," the disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2017 / 0252474, published September 7, 2017, and entitled "Method of Sterilizing Medical Devices, Analyzing Biological Indicators, and Linking Medical Device Sterilization," the disclosure of which is incorporated herein by reference; and / or U.S. Patent Application Publication No. 2017 / 0252474, published March 15, 2018, and entitled "Biological Indicator The present invention may be configured and operable in accordance with at least part of the teachings of U.S. Patent Application Publication No. 2018 / 0071421, entitled "Sensor-Based Electromagnetic Wave Propagation with Variable Resistance."

[0014] The server (106) may include a hospital record server or a hospital local area network server. The server (106) may receive information from the sterilization cabinet (100) regarding the sterilization procedures performed by the sterilization cabinet (100), such as the duration and results of the sterilization procedure; whether a particular sterilization procedure provided a subsequent indication of biological contamination; the identity of the user or technician who initiated, canceled, or completed the sterilization procedure; consumable materials or supplies used during the sterilization procedure; diagnostic information and system errors; and / or other information. The server (106) may also receive data from the biological indicator analyzer (102) via the communications hub (20).

[0015] The user device (108) may include devices such as mobile devices, such as laptop computers, desktop computers, smartphones, tablets, or other mobile computing devices; or dedicated devices with similar functionality, including wired or wireless communication with the communications hub (20), processors and memory, displays, user interfaces, and other features. The user device (108) may be used to access and view information related to one or more components (100, 102, 110, 106) of the system (10) via the communications hub (20); and may also be used to create or change configurations and settings of the communications hub (20) and connected devices. A user of the user device (108) may view information and configure the device via, for example, a desktop software application, a mobile device software application, a web browser, or another software interface that may enable the user device (108) to exchange information with the communications hub (20). 1 as being in communication with the communications hub 20, several user devices 108 may be in communication with the communications hub 20. Similarly, several sterilization cabinets 100, several biological indicator analyzers 102, several servers 106, and several sterilization guide databases 110 may be in communication with the communications hub 20.

[0016] Each of the components (100, 102, 110, 106) of the system (10) may be coupled to the communications hub (20) via any suitable wired and / or wireless communication technology, such as Ethernet, Wi-Fi, Bluetooth, USB, infrared, NFC, and / or other technologies. The communications hub (20) may relay data and the like between the components (100, 102, 110, 106) of the system (10), with the communications hub (20) acting as an intermediary, as described herein. Various suitable components and configurations that may be used to form the communications hub (20) will be apparent to those skilled in the art in view of the teachings herein. By way of example only, communications hub (20) and / or user equipment (108) may be configured and operable in accordance with at least a portion of the teachings of U.S. Patent Application Publication No. 2017 / 0252472, published September 7, 2017, and entitled "Apparatus and Method to Link Medical Device Sterilization Equipment," the disclosure of which is incorporated herein by reference; and / or U.S. Patent Application Publication No. 2017 / 0252474, published September 7, 2017, and entitled "Method of Sterilizing Medical Devices, Analyzing Biological Indicators, and Linking Medical Device Sterilization," the disclosure of which is incorporated herein by reference.

[0017] II. Illustrative Sterilization Process Overview FIG. 3 illustrates an exemplary set of steps the system (10) can perform to sterilize a medical device. Initially, the sterilization cabinet (100) can display one or more sterilization cycles via the touchscreen display (160) and then receive a sterilization cycle selection from the user (block 200). The sterilization cabinet (100) can also display instructions indicating whether a biological indicator should be used in the selected sterilization cycle; it can also receive an identification of the biological indicator (block 202). The biological indicator may be placed in the sterilization chamber (152) before the sterilization cycle begins, or may remain in the sterilization chamber (152) during the sterilization cycle. Thus, the user can identify a particular biological indicator (block 202) before placing the biological indicator in the sterilization chamber (152).

[0018] The selection of a sterilization cycle (block 200) and identification of biological indicators (block 202) may define one or more requirements regarding the configuration and placement of medical devices within the sterilization cabinet (100). The sterilization chamber (152) door may be opened, and instructions may be displayed to guide the user through sterilization cycle preparation (block 204), including placement of biological indicators, placement of medical devices, closing the sterilization chamber (152) door, and / or other preparation changes. Prior to starting the actual sterilization cycle (block 208), the sterilization cabinet (100) may also perform a load adjustment (block 206) of the medical devices to be loaded into the sterilization chamber (152). Such load conditioning (block 206) may include verifying that the sterilization chamber (152) is sealed; verifying the contents of the sterilization chamber (152); checking physical characteristics of the contents of the sterilization chamber (152), such as moisture level, amount of contents, weight of contents, internal temperature, or other characteristics; and / or performing one or more conditioning steps, which may include heat treatment, chemical treatment, plasma treatment, or other types of treatment, to reduce moisture, increase temperature, and / or otherwise prepare the medical devices in the sterilization chamber (152) for the sterilization cycle.

[0019] Once the load adjustment (block 206) is complete, the selected sterilization cycle itself can be performed (block 208). The sterilization cycle (block 208) may include exposing the medical devices in the sterilization chamber (152) to pressurized sterilant gas, further heat treatment, chemical treatment, plasma treatment, vacuum treatment, and / or other types of sterilization treatment. After the sterilization cycle (block 208) is complete, the complete sterilization results may be displayed to the user via the touchscreen display (160); transmitted to the server (106); printed locally; and / or displayed, transmitted, and / or stored via other devices as desired.

[0020] The sterilization cabinet (100) may also provide sterilization cycle results (block 210). This providing of results (block 210) may include results from analysis of the biological indicator via the biological indicator analyzer (102). These results may include a positive or negative indication of contamination present in the biological indicator upon completion of the sterilization cycle (block 208). If the biological indicator suggests contamination is present after completion of the sterilization cycle (block 208), additional actions may be taken, such as alerting the user to a positive test and analysis of the sterilization cycle history to determine whether other past cycles may be the source of the contamination; and / or whether subsequently sterilized medical devices need to be resterilized.

[0021] III. Exemplary Methods for Identifying Medical Devices The sterilization guide database (110) includes a set of records that associate multiple medical devices with multiple sterilization equipment (e.g., sterilization cabinets (100), etc.), sterilization procedures, sterilization cycles, and sterilization materials (e.g., biological indicators, detergents, sterilants, etc.); and indicates for each medical device association whether a particular sterilization equipment, procedure, or material has been validated as compatible or usable to sterilize that particular medical device. The sterilization guide database (110) may include a database, table, file, or other data storage type stored on a computer (e.g., a cloud computer or cloud storage, server (106), or another physical server) and accessible to the communications hub (20). Other locations and forms that the sterilization guide database (110) may take will be apparent to those skilled in the art in light of the teachings herein.

[0022] The exemplary methods described below may be implemented on a system such as system 10 to further mitigate the risk of human or equipment error resulting in failed sterilization of a medical device, damage to the medical device, or waste of sterilization materials and resources. Some of the disclosed methods can benefit from such identification when the sterilization process is initially configured to, for example, automatically select appropriate hardware and process configurations, verify compatibility, and perform other similar steps based on the identification of the medical device. When the description or claims indicate that a step, decision, identification, or other determination or conclusion is "based on" or "based upon" particular inputs, data, or other factors, other factors or inputs may also affect the result. Thus, such descriptions should be interpreted to cover situations in which the result is based solely on or on the stated factors, as well as situations in which the result is based on or on at least the stated factors in addition to others not expressly described or listed.

[0023] While manual identification of a medical device by a user of the system 10 may be accurate in some cases, automatic identification may further reduce the risk of human or equipment error resulting in misidentification of a medical device. The identity of a medical device may vary depending on the embodiment, but may include one or more of the device type (e.g., endoscope, cutting instrument, suction instrument, etc.), device manufacturer, semi-unique device model number, unique device serial number, or other information. Figure 4 illustrates an exemplary set of steps 300 that may be performed by or in conjunction with the system 10 to automatically determine the identity of a medical device. Once a medical device is received (block 302) by a user of a system 10 device, such as a sterilization cabinet 100 or user device 108, various options may be available for identifying the medical device using the features and capabilities of the system 10.

[0024] As one example, a user of the sterilization cabinet 100 may identify a medical device (block 303) based on an image capture of the medical device, a portion of the medical device, or identifying symbols, images, or text on the medical device. Image capture may be performed by interacting with features available on the device in use, such as the reader 166 of the sterilization cabinet 100 or an alternate input on the user device 108. This may include, for example, an image capture device capturing image data of an entire medical device profile and identifying it using an image analysis process; capturing image data of an end effector or other portion of a medical device and identifying it using an image analysis process; capturing image data of a serial number or model number present on a medical device, parsing the serial number or model number into text, and then identifying the medical device directly or using a device lookup table stored locally, on the server (106), in the sterilization guide database (110), or on another device or server; capturing image data of a barcode, QR code, or other visual identifier that encodes or otherwise represents data, and using that data to identify the medical device using a device lookup table; and other similar processes.

[0025] Further by way of example only, the sterilization cabinet (100) may automatically identify (block 303) the medical device using advanced optical analysis, including, but not limited to, Fourier transform infrared spectroscopy. As yet another merely illustrative example, the sterilization cabinet (100) may automatically identify (block 303) the medical device using mechanical sensing, including, but not limited to, weight plus dynamic dosing or loading response characteristics (e.g., pressure / peroxide concentration profiles). A variety of suitable hardware components and algorithms that may be used to provide automatic identification (block 303) of the medical device by the sterilization cabinet (100) will be apparent to those skilled in the art in view of the teachings herein.

[0026] Successful identification of the medical device based on image capture (block 303) may be used alone or in combination with the results of other identification attempts to suggest the identity of the medical device to the user (block 312) and receive confirmation from the user that the medical device has been correctly identified, as described in more detail below.

[0027] As another example, a user of the sterilization cabinet 100 can identify a medical device (block 304) based on a device tracking record associated with the medical device and stored on the server 106 or another device in the system 10. Medical devices or other materials can be tracked throughout their lifespan to locate lost or misplaced medical devices, determine a current medical device inventory, audit processes related to the handling of medical devices before and after procedures, and provide tracking information that can be used for other similar uses. Such tracking information can be generated by performing steps 314 as shown in FIG. 5. Whenever a medical device arrives at or departs from a device capable of interacting with the system 10 (block 316) or departs from a user interface with the sterilization cabinet 100 or a user device 108 (block 318), the medical device can be identified manually or automatically using some or all of the steps in FIG. 5 or another identification process. Once identified (block 320), the system (10) may identify (block 322) a set of tracking records or create a new set of tracking records associated with the medical device that are stored on the server (106), the sterilization guide database (110), or another server or location, and update (block 324) the set of tracking records to reflect the current arrival (block 316) or departure (block 318) of the medical device relative to the current contact point.

[0028] When the tracking record is updated (block 324), the information added to the tracking record can include when the device arrives (block 316), where the device arrived, where the device originated, the time of arrival, the user who received the device upon arrival, the state of the device upon arrival (e.g., new, used, sterile, non-sterile), processes or treatments performed on or with the device while it is at its current location, future destinations for the device, and other similar information. When a device departs (block 318), the updated (block 324) information can include the location the device is departing from, the location the device is departing to, the time of departure, the user who received the device when it departed, the state of the device upon departure (e.g., new, used, sterile, non-sterile), processes or treatments performed on the device at the location the device is departing from, and other similar information.

[0029] Returning to FIG. 4 , such tracking information may be used to determine the identity (block 304) of a device arriving at a location such as a sterilization cabinet (100) or a user device (108). For example, tracking information associated with medical device X may indicate that the device departed procedure room A at 1:00 PM and was sent to sterilization cabinet B by technician C. Technician D, located in sterilization cabinet B, may receive an unidentified medical device from technician C at 1:15 PM. Technician D, using sterilization cabinet B, may access the tracking information and identify the medical device as medical device X (block 304) based on the fact that the medical device arrived with technician C at its intended location, sterilization cabinet B, within a reasonable time frame (e.g., 15 minutes) of departure from procedure room A. Other data that may be stored and created as part of the tracking information, and other methods for using such data to identify a medical device (block 304), will be apparent to those skilled in the art in light of the teachings herein.

[0030] As another example, as already described in some detail with respect to identifying a medical device based on image capture (block 303), a user of the sterilization cabinet (100) can identify a medical device based on an optical identifier (block 306). If the sterilization cabinet (100) or user device (108) is capable of capturing and interpreting optical identifiers (e.g., with the reader (166) or an alternative input on the user device (108)), a unique or semi-unique optical identifier can be placed on the medical device, which can be captured and matched against a record lookup table or sterilization guide database (110) on the server (106) to identify the device. This can include using the optical scanner to capture a barcode, QR code, or other visual marking intended to be captured by the optical scanner and configured to encode or otherwise indicate data that can be used to identify the device directly or using a record lookup table.

[0031] As another example, a user of the sterilization cabinet (100) can identify a medical device based on a wireless identifier (block 308). If the sterilization cabinet (100) or user device (108) is capable of capturing and interpreting wireless identifiers (e.g., with a reader (166) or alternative input (194)), a unique or semi-unique wireless identifier can be placed on the medical device, which can be captured and matched against a record lookup table to identify the device. This can include using a combination of RFID transceivers and RFID chips, Bluetooth transceivers and beacons, NFC transceivers and beacons, Wi-Fi transceivers and Wi-Fi antennas, or other wireless communication devices to wirelessly communicate data between the sterilization cabinet (100) and a chip, beacon, or other device placed on or in the medical device or transported with the medical device. Data provided from the medical device to the sterilization cabinet (100) can then be used to identify the medical device directly or using a record lookup table.

[0032] As another example, a user of the sterilization cabinet 100 can identify (block 310) a medical device based on a serial number or other numeric identifier input. The numeric identifier can be entered for the medical device, for example, by manually keying in the numeric identifier using a keyboard or touchscreen display 160, or by connecting a power or data port of the medical device to the sterilization cabinet 100 to automatically retrieve the numeric identifier from a chip or memory on the medical device. As with the previous example, the numeric identifier can be used to identify the medical device directly or using a record lookup table.

[0033] As previously mentioned, after one or more medical device identifications have been made, the sterilization cabinet (100), user device (108), or other device performing the identifications may present the medical device identities to the user via a display or other user interface (block 312); confirmation of the device identity may be received from the user via a keyboard, mouse, touchscreen display (160), or other user interface available on the device. If only a single identification method is used, or if multiple identification methods are used and a common identity is determined, only one option may be presented to the user (block 312).

[0034] If multiple identification methods are used and multiple identities are determined, each option may be presented to the user (block 312); alternatively, the most likely identity may be determined and presented to the user (block 312), with other identities discarded or presented only if the user does not confirm the initial identity (block 312). In some embodiments, the identity is presented (block 312) and may be displayed with additional information, such as a confidence level (e.g., high or low, percentage-based), the source of identification (e.g., identified by audit trail and optical identifier), or other information available to the system (10) that may assist the user in confirming the medical device identity. Confidence levels and other determinations regarding the accuracy of the determined identity are configured by an administrator of the system based on the source of identification (e.g., manually entered serial numbers may be less reliable, while automatically scanned optical identifiers may be more reliable) and may be adjusted over time based on real-world use of the system (e.g., increasing the confidence level of manually entered serial numbers after they are determined to be highly accurate).

[0035] IV. Exemplary Methods for Verifying Medical Device Sterilization Compatibility Different medical devices may have different sterilization requirements, and therefore, the sterilization cabinet (100) can be configured to perform sterilization procedures with different characteristics. The characteristics of the sterilization procedure may be manually configured or selected based on a selected sterilization cycle (block 200). These characteristics may include factors such as the exact placement of the medical devices within the sterilization cabinet (100) (e.g., top, bottom, middle), the number of medical devices that can be placed within the sterilization cabinet (100) at one time, the particular sterilant to be used during the procedure, the total duration of the procedure, the number of different stages of the procedure and the duration of each stage, the appropriate biological indicators to be used and the placement of the biological indicators, and other similar features. A sterilization cycle can combine one or more of these characteristics or other characteristics into a preconfigured process that can be selected to be performed by the sterilization cabinet (100) based on a single user selection.

[0036] Whether the sterilization process is configured manually or by selecting the sterilization cycle to be performed (block 200), there is the potential for user error if the user misunderstands the selection process or misidentifies the medical device, resulting in a sterilization procedure that is not sufficient to completely sterilize the medical device, resulting in an unsterilized medical device being returned to service or a sterilized medical device being unnecessarily resterilized. Even in the absence of true user error (e.g., the user makes an appropriate selection based on their training and the medical device involved), some medical devices may not have a verifiable compatibility with a particular sterilization cycle or sterilization cabinet (100), even if the user and provider believe so.

[0037] For example, an older version of a medical device may have been tested and verified to be compatible with one or more sterilization cycles of the sterilization cabinet 100. A new version of the medical device may be released that is outwardly identical to the older version, but due to internal changes in the device that may be imperceptible to the end user, the new version of the medical device may not be compatible with one or more cycles of the sterilization cabinet 100.

[0038] To address such concerns, the sterilization guide database (110) stores several records linking medical devices to sterilization equipment and processes, such as the sterilization cycle of the sterilization cabinet (100), and provides an indication of conformance. The sterilization guide database (110) may be populated by a single party responsible for maintaining it (e.g., the sterilization cabinet manufacturer or a medical safety association); or, alternatively, it may be populated by multiple users of the sterilization guide database (e.g., medical device manufacturers). Data may be created and populated based on targeted testing of new medical devices, such as testing focused on new devices as they are released to determine whether they can be successfully sterilized by the device or procedure; or it may be created and populated based on similarities with previous devices, simulation models, or other techniques. In effect, the sterilization guide database (110) may be accessed by users to provide assurance that a particular medical device will be sterile after a procedure.

[0039] FIG. 6 illustrates an exemplary set of steps (400) that may be performed using the system (10) to verify compatibility of a particular medical device with a sterilization procedure using the sterilization guide database (110). Once a sterile medical device is received, a user may begin configuring a sterilization cycle for the medical device using the sterilization cabinet (100) (block 402). The steps of FIG. 6 may be performed at the beginning of configuring the sterilization cycle (block 402), or alternatively or additionally, may be performed after the sterilization cycle has been performed, as desired in some embodiments. If the medical device is identifiable (block 404), the sterilization cabinet (100) may automatically receive device identification (block 412) using steps such as those shown in FIG. 5. If the device is not identifiable (block 404), the sterilization cabinet (100) may provide a device input interface to the user (block 406) and receive manual identification of the medical device from the user (block 408).

[0040] The device input interface may include, for example, a set of selection menus, drop-down menus, buttons, boxes, or other interface elements that allow a user to browse a list of medical devices and identify a medical device. This may include, for example, allowing a user to select a manufacturer from a menu and providing a list of device types offered by that manufacturer, allowing a user to select a device type and providing a list of device models included in that device type, and allowing a user to select a device model. This may also include presenting a series of questions to the user regarding the configuration (e.g., "What is the overall length of the device?"), characteristics (e.g., "Does the device have a battery?"), or other aspects of the medical device configured to narrow and identify the device. The interface may be provided by a touchscreen display (160) or in other ways.

[0041] Once the medical device is identified, either automatically (block 412) or manually (block 408), the sterilization cabinet (100) can access the sterilization guide database (100) and receive a set of assurance data associated with the medical device (block 410). The set of assurance data can indicate one or more sterilization cycles, sterilization cabinets such as the sterilization cabinet (100), sterilants, or other equipment or processes that have been validated as compatible with the medical device. The sterilization cabinet (100) can then validate the compatibility of its available sterilization cycles or other characteristics (block 414); if the user performs a validated compatible sterilization cycle, it can update the sterilization cycle results for that sterilization cycle (block 416). The sterilization cycle results are a set of records stored on the server (106) or another device in the system (10) that, for each sterilization cycle performed on that device, indicate the characteristics of the cycle, the medical devices included in the cycle, and the results of the cycle as indicated by the biological indicators used with the cycle. The updated (block 416) cycle results may further include information from the sterilization guide database (110) indicating that the cycle performed was certified compatible with the medical device, further ensuring that the medical device is sterile after the cycle.

[0042] If the user selects a sterilization cycle or process that cannot be verified as compatible with the medical device (block 414), the sterilization cabinet 100 may present the user with a warning or notice of the lack of assurance; asking the user to override the warning (block 418) and continue performing the potentially incompatible sterilization cycle. If the user overrides the notice (block 418) and performs the potentially incompatible sterilization cycle, the sterilization cabinet 100 may provide an override notice (block 420) and update the sterilization cycle results. The override notice may be configured to be provided to the user performing the override, a user responsible for the sterilization cabinet 100 itself or the section of the hospital in which it resides, a user responsible for the hospital's sterilization procedures generally, or another user as desired and may be configured by the system 10 administrator. The sterilization cycle results may be updated to reflect that while biological indicators used with the sterilization cycle may have indicated that the sterilization cycle was successful, the system 10, based on information available via the sterilization guide database 110, was unable to provide assurance that the medical device was compatible with the performed cycle and was successfully sterilized.

[0043] If the user does not override the notification of a potential incompatibility (block 418), the sterilization cabinet (100) may display one or more options for sterilizing the medical device for which a compatibility guarantee is available (block 422), which may include, for example, selecting a different sterilization cycle on the sterilization cabinet (100) or transporting the medical device to another type of sterilization cabinet or equipment.

[0044] 7-13 show screenshots of exemplary interfaces that may be displayed to a user during one or more of the steps of FIG. 6, including during configuration of a sterilization cycle to be performed on a medical device, via the touchscreen display (160) of the sterilization cabinet (100) or via another display or device.

[0045] FIG. 7 shows an interface (500) displaying a set of cycle information (502) related to sterilization cycles that have been configured and are ready to run or have been run on a sterilization cabinet (100). The set of cycle information (502) includes a load description (504) that indicates one or more medical devices that are part of the sterilization cycle's load. A warranty window (506) may be displayed, for example, by hovering over or clicking on a medical device shown in the load description (504). The warranty window (506) includes a list of sterilization cabinets or devices and provides a warranty indication (508) for one or more sterilization cycles available to those sterilization cabinets based on the warranty data received for the medical devices (block 410). The warranty window (506) may also provide a warranty deficiency indication (510) for one or more sterilization cabinets (100) for which the received warranty data (block 410) does not provide a warranty of conformance. The warranty deficiency indication (510) may include instructions for seeking or requesting warranty; or may include a clickable button or other interactive feature that may automatically request warranty from the party responsible for maintaining the sterilization guide database (100).

[0046] 8 shows an interface (512) that displays a more detailed view of one or more medical devices present in a sterilization cycle load (514). The interface (512) shows a set of rows that show additional information about a first medical device (516) and a second medical device (518), such as the device manufacturer, device name, and model number, and a set of columns that provide warranty indications (520) for one or more sterilization cycles available for those medical devices. The interface (512) can also provide under-warranty indications, if desired.

[0047] 9 shows an interface (522) displaying a view of information related to sterilization cycles (526) performed on a sterilizer (524). The interface (524) also shows an equipment cycle summary (528), which includes a set of aggregate information based on the information related to the sterilization cycles (526), ​​and a warranty percentage (530) indicating the total percentage of cycles that were verified as compliant (block 414) and performed rather than being overridden (block 418).

[0048] 10 illustrates an interface 532 displaying various notification options for different types of alerts 536 that may be provided by the system 10 and different forms of communication 534 that may be used by the system 10 to provide those types of alerts 536 to one or more users of the system 10. An administrator of the system 10 can use the interface 532 to configure various alert scenarios, including configuring the system 10 to provide an alert to one or more users or types of users based on an indication that an unverified sterilization cycle is being run 538. Such alerts may be generated and communicated to a user based on the configured form of communication 534 as part of providing an override notification 420 when the user overrides the notification that the sterilization cycle cannot be guaranteed to be compatible with the medical device 418.

[0049] 11 illustrates an interface (540) that displays a set of sterilization machines available to the user (e.g., the machine the user is currently interacting with, machines available in the same room, and machines available in other areas of the hospital) and indicates whether they are certified compatible with the medical device on which the sterilization cycle will be performed. As can be seen, a first sterilization cabinet (542) and a second sterilization cabinet (544) appear to indicate that they have a compatible sterilization cycle that can be used with the medical device based on the compatibility certification (block 410) received from the sterilization guide database (110). Conversely, a third sterilization cabinet (546) and a sterilization machine (548) appear to indicate that they are not certified compatible with the medical device based on the certification data received (block 410) without any indication of compatibility with the medical device. When the user selects the third sterilization cabinet (546), the interface (540) presents a warning indicating that the user must override the uncertified sterilization cycle (block 418) to continue.

[0050] FIG. 12 illustrates an interface (550) displaying hospital-level instrumentation status (552) showing information about multiple medical devices currently in use at a particular hospital, building, or site and their assurance levels for the sterilization cabinets and sterilization cycles available at that same location. A set of medical devices is displayed in rows containing a first medical device (554) and a second medical device (556), and a first column shows information related to these devices, such as the device manufacturer, device name, model number, and manufacturer notes associated with the device. A set of columns (560) shows, for each sterilization cabinet, a set of sterilization cycles compatible with each of the first medical device (554) and the second medical device (556). The interface (550) can be used by a medical device sterilization manager or administrator to easily view each medical device currently in use at the hospital and the available compliance-assured sterilization resources for each medical device, verifying that all currently used medical devices have some level of compliance-assured sterilization available.

[0051] Figure 13 shows an interface (562) that displays an alternative view of some of the data shown in Figure 12. The alternative view of interface (562) displays information about the set of medical devices (564) currently in use at a particular hospital, site, or other location, as well as the compatibility certification for each medical device as discussed in the context of Figure 12; and further shows a hospital certification rate (566). The hospital certification rate (566) may indicate the percentage of the set of medical devices (564) that are to some extent certified to be compatible with the sterilization equipment present at the hospital; or it may indicate the total percentage of certified compatibility sterilization cycles performed at the hospital during a certain period of time. Additional interfaces and variations on the described interfaces exist and will be apparent to those skilled in the art in view of the teachings herein.

[0052] V. Exemplary Methods for Automated Sterilization Cycle Selection While the disclosed systems and methods reduce the risks associated with sterilization procedures and provide assurance that sterilization will be successful, the methods described below can be implemented individually within system (10) or in combination with these other techniques to further reduce the likelihood of error. Figure 15 shows an exemplary set of steps (600) performed by or in conjunction with system (10) to automatically configure a sterilization cabinet, such as sterilization cabinet (100).

[0053] When a user receives a medical device at the sterilization cabinet (100) and initiates a sterilization cycle configuration (block 602), the medical device can be identified (block 604) by performing the steps shown in Figure 5. If the medical device is successfully identified (block 604) and verified, the sterilization cabinet (100) can automatically receive the medical device identity. If the device cannot be identified (block 604), the sterilization cabinet (100) can provide the user with a device input interface (block 606); and receive a manual identification of the medical device from the user (block 608).

[0054] The device input interface may include, for example, a set of selection menus, drop-down menus, buttons, boxes, or other interface elements that allow a user to browse a list of medical devices to identify a medical device. This may include, for example, allowing a user to select a manufacturer from a menu and providing a list of device types offered by that manufacturer, allowing a user to select a device type and providing a list of device models included in that device type, and allowing a user to select a device model. This may also include presenting a series of questions to the user regarding the configuration (e.g., "What is the overall length of the device?"), characteristics (e.g., "Does the device have a battery?"), or other aspects of the medical device configured to narrow down and identify the device. The interface may be provided by a touchscreen display (160) or in other ways.

[0055] Once the medical device has been identified, either automatically (block 612) or manually (block 608), the sterilization cabinet (100) can select a compatible sterilization cycle based on the medical device identity. This can include, for example, accessing the server (106) to identify a compatible sterilization cycle associated with the medical device, accessing the sterilization guide database (110) to identify a certified compatible sterilization cycle associated with the medical device, or both. In some cases, as previously described, the sterilization cabinet (100) can also select the relevant cycle (block 610) based entirely or in part on tracking information provided with the medical device upon arrival.

[0056] In some scenarios, an identified medical device may not be found in the sterilization guide database (110), but the user reasonably believes that the medical device is actually compatible with the sterilization cabinet (100) (e.g., due to a notice issued by the medical device manufacturer or a notice issued by the manufacturer of the sterilization cabinet (100)). In some such scenarios, the sterilization cabinet (100) can provide a user interface that allows the user to update the sterilization guide database (110) to include the medical device. Thus, the next time the user attempts to sterilize the same medical device in the sterilization cabinet (100), a check of the sterilization guide database (110) will confirm that the medical device is compatible with the sterilization cabinet (100). As another variation on this concept, the sterilization cabinet (100) can provide a user interface that allows the user to compile a separate list of medical devices that are compatible with the sterilization cabinet (100). Such a separate list may be stored elsewhere (i.e., not in the sterilization guide database (110)); or may be stored in the sterilization guide database (110) (e.g., in a list separate from the manufacturer-defined list). In some such versions, the sterilization cabinet (100) may first check the manufacturer-defined list in the sterilization guide database (110); if the medical device is not in the manufacturer-defined list, it may check the user-defined list.

[0057] Whether the medical device identification is performed manually (block 608) or automatically (block 612), the selected (block 610) sterilization cycle is presented to the user via the sterilization cabinet (100) for confirmation (block 614), and if the user confirms that the selected (block 610) cycle should be performed, the cycle may be performed automatically (block 616). If the user does not wish to proceed with the selected (block 610) cycle and does not confirm the sterilization cycle (block 614), the sterilization cabinet (100) may allow a different sterilization cycle to be selected; or may receive a configuration override (block 618) that changes one or more characteristics of the selected sterilization cycle. The sterilization cabinet (100) may provide an override notification (block 620) similar to the previous discussion regarding providing an override notification (block 420); and may perform the override sterilization cycle (block 616).

[0058] The system (10) and sterilization cabinet (100) may be configured to perform steps as shown in FIG. 6, steps as shown in FIG. 15, or both, as desired. In embodiments that perform steps as shown in both FIG. 6 and FIG. 15, such steps may be performed sequentially or in parallel, as desired. For example, if a sterilization cycle is selected (610) based on data from the sterilization guide database (110), the configured cycle may inherently be associated with a guarantee of compatibility with medical devices from the sterilization guide database (110). Such a guarantee may be presented in addition to other information when the user is prompted to confirm (block 614) the selected (block 610) cycle, and the cycle results may be updated with the guarantee (block 416) after the cycle is run (block 616) and the cycle results are generated.

[0059] VI. Exemplary Combinations The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or any subsequent application hereof. No disclaimer is intended. The following examples are provided solely for illustrative purposes. It is contemplated that the various teachings herein may be configured and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the following examples. Accordingly, none of the aspects or features referred to below should be deemed critical unless later expressly indicated by the inventor or the inventor's assignee. If a claim is presented in this application or any subsequent application related to this application that includes additional features other than those recited below, those additional features will not be presumed to have been added for patentability reasons.

[0060] Example 1 An apparatus usable with a sterilization system for a medical device, the apparatus comprising: (a) a processor and memory; (b) a communication device; (c) a user input; and (d) a display, wherein the processor is configured to: (i) receive a device indicator associated with the medical device; (ii) access a set of medical device records and determine the identity of the medical device based on an association between the device indicator and the set of medical device records; (iii) configure at least one risk mitigation process based on the identity of the medical device; and (iv) configure a sterilization cycle to be performed on the medical device based on the at least one risk mitigation process. Example 2 The apparatus of Example 1, wherein the apparatus is a sterilization cabinet; the communication device is a wireless transceiver configured to connect to the sterilization system via a wireless communication network; the user input includes a touch screen and an optical reader; the identifier is a model number associated with a unique description of the medical device; and the identity is the unique description of the medical device. Example 3 The device described in any one or more of Examples 1 to 2, wherein the device indicator is a set of device tracking information received from the sterilization system; the set of device tracking information indicates a moving medical device starting from an origin and having a destination for the device; the set of medical device records associates the moving medical device with the identity of the medical device; and the processor is further configured to determine that the medical device is the moving medical device. Example 4 The device described in any one or more of Examples 1 to 3, wherein the user input includes an optical reader operable to read data encoded in an optical identifier; the optical reader configured to receive the device indicator after the optical reader reads the optical identifier; and the set of medical device records associates the optical identifier with the identity of the medical device. Example 5 An apparatus described in any one or more of Examples 1 to 4, wherein the user input includes a text input operable to provide a text identifier to the device; the text input configured to receive the device indicator as the text identifier; and the set of medical device records associates the text identifier with the identity of the medical device.

[0061] Example 6 The device of any one or more of Examples 1 to 5, wherein the processor is further configured to: (i) display the identity of the medical device to a user via the display after the identity has been determined; (ii) receive an identity response from the user via the user interface; (iii) if the identity response indicates that the identity is incorrect, provide a manual device input interface via the display, the manual device input interface including a set of prompts for additional information operable by the user to determine a new identity of the medical device; and (iv) configure the at least one risk mitigation process based on the new identity instead of the original identity. Example 7 The device of any one or more of Examples 1 to 6, wherein the at least one risk mitigation process includes a compatibility assurance process, the compatibility assurance process being configured to cause the processor to (i) determine a sterilization cabinet identifier associated with the sterilization cycle, (ii) determine a sterilization cycle type associated with the sterilization cycle, and (iii) receive an equipment assurance indicator from a sterilization guide database of the sterilization system based on the sterilization cabinet identifier, the sterilization cycle type, and the identity of the medical device, the equipment assurance indicator indicating whether the medical device is compatible with the sterilization cabinet associated with the sterilization cabinet identifier and the sterilization cycle associated with the sterilization cycle type. Example 8 The device of Example 7, wherein the processor is further configured to: (i) determine a set of sterilization cabinets present in the sterilization system; (ii) for each sterilization cabinet in the set of sterilization cabinets, determine a set of sterilization cycles that each sterilization cabinet can perform; (iii) receive a set of equipment warranty indicators for each sterilization cabinet in the set of sterilization cabinets from the sterilization guide database and determine a set of compatible sterilization cycle options based on the set of equipment warranty indicators; (iv) display the set of compatible sterilization cycle options via the display; (v) receive a selection associated with an option from the set of compatible sterilization cycle options via the user input; and (vi) configure the sterilization cycle based on the selection. Example 9 The apparatus of any one or more of Examples 7-8, wherein the processor is further configured to, if the apparatus assurance indicator indicates that the medical device is compatible, (i) indicate via the display that the sterilization cycle is compatible with the medical device, and (ii) upon completion of the sterilization cycle, add a compatibility assurance indicator to a cycle results dataset describing performance of the sterilization cycle, wherein the compatibility assurance indicator indicates that the medical device was compatible with the sterilization cycle. Example 10 The device of Example 9, wherein the processor is further configured to, if the device warranty indicator indicates that the medical device is not certified as compatible, (i) display a compatibility warning via the display indicating that the sterilization cycle is not certified as compatible with the medical device; (ii) receive confirmation via the user input to override the compatibility warning and proceed with the sterilization cycle; (iii) provide an unverified cycle warning as an electronic message via the communication device to one or more recipients; and (iv) upon completion of the sterilization cycle, add a warranty warning indicator to a cycle results dataset describing performance of the sterilization cycle and the compatibility warranty indicator indicating that the medical device is not certified as compatible with the sterilization cycle.

[0062] Example 11 The device of any one or more of Examples 7 to 10, wherein the processor is further configured to display an equipment cycle summary interface via the display, the equipment cycle summary interface including: (A) a sterilization cabinet descriptor; (B) a list of cycle results of sterilization cycles performed on a sterilization cabinet associated with the sterilization cabinet descriptor; and (C) a warranty rate indicating a portion of the list of cycle results associated with a compatible equipment warranty indicator. Example 12 The apparatus of any one or more of Examples 7-11, wherein the processor is further configured to cause an instrumentation warranty summary interface to be displayed via the display, the instrumentation warranty summary interface including: (A) a set of medical device descriptors for each medical device in use at a location; (B) a set of sterilization equipment descriptors for sterilization equipment in use at the location; (C) a set of warranty descriptors for each medical device in use at the location indicating which sterilization equipment in use at the location is guaranteed to be compatible; and (D) a warranty rating indicating whether any of the medical devices in use at the location are incompatible with any sterilization equipment in use at the location. Example 13 The device described in Example 12, wherein the instrumentation assurance summary interface further includes a request assurance feature associated with an unverified medical device of the set of medical device descriptors, and the request assurance feature can be interacted with via the user interface to cause an electronic communication to be sent to a recipient associated with the sterilization guide database; the electronic communication describing the unverified medical device and the set of sterilization equipment descriptors. Example 14 An apparatus described in any one or more of Examples 1 to 13, wherein the at least one risk mitigation process includes automatic cycle selection, and the compatibility assurance process is configured to cause the processor to (i) determine an approved cycle configuration based on the identity of the medical device, and (ii) configure the sterilization cycle based on the approved cycle configuration. Example 15 The device described in Example 14, wherein the approved cycle configuration is associated with an equipment warranty indicator, the equipment warranty indicator being configured to be received from a sterilization guide database based on the identity of the medical device, and the equipment warranty indicator is further configured to indicate that the medical device is compatible with the sterilization cycle.

[0063] Example 16 1. A method of configuring a sterilization system for sterilizing a medical device, comprising: A method comprising: (a) receiving a device indicator associated with the medical device; (b) accessing a set of medical device records; (c) determining the identity of the medical device based on an association between the device indicator and the set of medical device records; (d) configuring at least one risk mitigation process based on the identity of the medical device; and (e) configuring a sterilization cycle to be performed on the medical device based on the at least one risk mitigation process. Example 17 The method of example 16, wherein the step of configuring the at least one risk mitigation process includes: (i) determining a sterilization cabinet identifier associated with the sterilization cycle; (ii) determining a sterilization cycle type associated with the sterilization cycle; and (iii) receiving an equipment warranty indicator from a sterilization guide database of the sterilization system based on the sterilization cabinet identifier, the sterilization cycle type, and the identity of the medical device, wherein the equipment warranty indicator indicates whether the medical device is compatible with the sterilization cabinet associated with the sterilization cabinet identifier and the sterilization cycle associated with the sterilization cycle type. Example 18 The method of example 17, further comprising: (a) determining a set of sterilization cabinets present in the sterilization system; (b) for each sterilization cabinet in the set of sterilization cabinets, determining a set of sterilization cycles that each sterilization cabinet is capable of performing; (c) receiving a set of equipment warranty indicators for each sterilization cabinet in the set of sterilization cabinets from the sterilization guide database and determining a set of compatible sterilization cycle options based on the set of equipment warranty indicators; (d) displaying the set of compatible sterilization cycle options to a user of the sterilization system; (e) receiving a selection from the user, the selection associated with an option from the set of compatible sterilization cycle options; and (f) configuring the sterilization cycle based on the selection. Example 19 The method of any one or more of Examples 16 to 18, wherein the step of configuring at least one risk mitigation process includes the steps of: (i) accessing a database and searching a set of medical device records; (ii) determining an approved cycle configuration based on the identity of the medical device and the set of medical device records; and (iii) configuring the sterilization cycle based on the approved cycle configuration. Example 20 A sterilization system comprising: (a) a sterilization cabinet operable to perform a sterilization cycle on a medical device; (c) a sterilization guide database including a set of warranty indicators indicating a plurality of sterilization cabinets that are certified to be compatible with a plurality of medical devices; and (d) a communications hub configured to provide communications between the sterilization cabinet and the sterilization guide database; the sterilization cabinet configured to (i) receive a device indicator associated with the medical device, (ii) access a set of medical device records and determine the identity of the medical device based on an association of the device indicators with the set of medical device records, (iii) determine a sterilization cabinet identifier associated with the sterilization cabinet and a sterilization cycle type associated with the sterilization cycle, (iv) receive a warranty indicator from the sterilization guide database based on the sterilization cabinet identifier, the sterilization cycle type, and the identity of the medical device, and (v) configure the sterilization cycle to be performed on the medical device based on the warranty indicators.

[0064] VII. Other It should be understood that all or part of a patent, publication, or other disclosure material said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosure material set forth in this disclosure. Thus, to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, said to be incorporated by reference herein but which contradicts existing definitions, descriptions, or other disclosure material set forth herein is incorporated only to the extent that no contradiction arises between the incorporated material and the existing disclosure material.

[0065] While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Some of these possible variations have been mentioned above, but other variations will be apparent to those skilled in the art. For example, the examples, embodiments, shapes, materials, dimensions, proportions, steps, etc. described above are illustrative and not required. Accordingly, it is understood that the scope of the present invention should be considered in light of the following claims and is not limited to the details of structure and operation shown and described in the specification and drawings.

[0066] [Embodiment] (1) An apparatus usable with a sterilization system for medical devices, (a) a processor and memory; (b) a communications device; (c) user input; (d) a display; Including, The processor: (i) receiving a device indicator associated with the medical device; (ii) accessing a set of medical device records and determining the identity of the medical device based on an association between the device indicator and the set of medical device records; (iii) configuring at least one risk mitigation process based on the identity of the medical device; (iv) configuring a sterilization cycle to be performed on the medical device based on the at least one risk mitigation process; The apparatus is configured to: (2) The device is a sterilization cabinet; the communication device is a wireless transceiver configured to be connected to the sterilization system via a wireless communication network; The user input includes a touch screen and an optical reader; the identifier is a model number associated with a unique description of the medical device; The device of embodiment 1, wherein the identity is the unique description of the medical device. (3) the device indicator is a set of device tracking information received from the sterilization system; the set of device tracking information indicating a medical device in motion originating from an origin and having a destination for the device; the set of medical device records associating the medical device in transit with the identity of the medical device; 2. The device of claim 1, wherein the processor is further configured to determine that the medical device is the moving medical device. (4) the user input includes an optical reader operable to read data encoded in an optical identifier; the optical reader is configured to receive the device indicator after the optical reader reads the optical identifier; 2. The device of claim 1, wherein the set of medical device records associates the optical identifier with the identity of the medical device. (5) the user input includes a text input operable to provide a text identifier to the device; the text input is configured to receive the device indicator as the text identifier; 2. The device of claim 1, wherein the set of medical device records associates the text identifier with the identity of the medical device.

[0067] (6) The processor: (i) after the identity of the medical device is determined, displaying the identity to a user via the display; (ii) receiving an identity response from a user via the user interface; and (iii) if the identity response indicates the identity is incorrect, providing a manual device input interface via the display, the manual device input interface including a set of prompts for additional information operable by the user to determine a new identity for the medical device; (iv) configuring the at least one risk mitigation process based on the new identity instead of the identity; and 2. The apparatus of claim 1, further configured to: (7) The at least one risk mitigation process includes a conformance assurance process; The conformance assurance process includes: (i) determining a sterilization cabinet identifier associated with the sterilization cycle; (ii) determining a sterilization cycle type associated with the sterilization cycle; (iii) receiving a device assurance indicator from a sterilization guide database of the sterilization system based on the sterilization cabinet identifier, the sterilization cycle type, and the identity of the medical device; It is configured as follows: 2. The device of claim 1, wherein the device warranty indicator indicates whether the medical device is compatible with the sterilization cabinet associated with the sterilization cabinet identifier and the sterilization cycle associated with the sterilization cycle type. (8) The processor: (i) determining a set of sterilization cabinets present in the sterilization system; (ii) for each sterilization cabinet in the set of sterilization cabinets, determining a set of sterilization cycles that each sterilization cabinet is capable of performing; (iii) receiving a set of equipment warranty indicators for each sterilization cabinet in the set of sterilization cabinets from the sterilization guide database; and determining a set of compatible sterilization cycle options based on the set of equipment warranty indicators; (iv) displaying the set of compatible sterilization cycle options via the display; (v) receiving via the user input a selection associated with an option from the set of compatible sterilization cycle options; (vi) configuring the sterilization cycle based on the selection; 8. The device of claim 7, further configured as follows: (9) if the device warranty indicator indicates that the medical device is compliant, the processor: (i) indicating via the display that the sterilization cycle is compatible with the medical device; (ii) upon completion of the sterilization cycle, adding a compliance assurance indicator to a cycle results dataset, the cycle results dataset describing the performance of the sterilization cycle, and the compliance assurance indicator indicating that the medical device was compatible with the sterilization cycle; 8. The apparatus of claim 7, further configured to: (10) if the device warranty indicator indicates that the medical device is not certified as compatible, the processor: (i) displaying a compatibility warning via the display indicating that the sterilization cycle is not certified as compatible with the medical device; (ii) receiving confirmation via the user input to override the compatibility warning and proceed with the sterilization cycle; and (iii) providing the unverified cycle alert as an electronic message to one or more recipients via said communication device; (iv) adding a warranty warning indicator to a cycle results data set upon completion of said sterilization cycle; further configured to: The apparatus of embodiment 9, wherein the cycle result dataset describes the performance of the sterilization cycle and the compatibility assurance indicator indicates that the medical device is not guaranteed to be compatible with the sterilization cycle.

[0068] (11) The processor is further configured to cause a device cycle summary interface to be displayed via the display; The device cycle summary interface includes: (A) Sterilization Cabinet Descriptor, (B) a list of cycle results for sterilization cycles performed on the sterilization cabinet associated with the sterilization cabinet descriptor; and (C) a warranty rate indicating a portion of said list of cycle results associated with a compatible device warranty indicator; 8. The device of embodiment 7, comprising: (12) the processor is further configured to cause an instrumentation assurance summary interface to be displayed via the display; The instrumentation assurance summary interface: (A) a set of medical device descriptors for each medical device in use at a location; (B) a set of sterilization equipment descriptors for the sterilization equipment in use at said location; (C) for each medical device in use at the location, a set of warranty descriptors indicating which sterilizers in use at the location are certified as compliant; and (D) a warranty rate indicating whether any of the medical devices in use at the location are incompatible with any sterilization equipment in use at the location; 8. The device of embodiment 7, comprising: (13) The instrumentation assurance summary interface further includes a claim assurance feature associated with an unverified medical device in the set of medical device descriptors; the claim assurance feature is configured to be interacted with via the user interface to cause an electronic communication to be sent to a recipient associated with the sterilization guide database; 13. The device of claim 12, wherein the electronic communication describes the unverified medical device and the set of sterilization equipment descriptors. (14) The at least one risk mitigation process includes automatic cycle selection; The conformance assurance process includes: (i) determining an approved cycle configuration based on the identity of the medical device; and (ii) configuring the sterilization cycle based on the approved cycle configuration; The device of embodiment 1, configured as follows: (15) The device of embodiment 14, wherein the approved cycle configuration is associated with an equipment warranty indicator, the equipment warranty indicator being configured to be received from a sterilization guide database based on the identity of the medical device, and the equipment warranty indicator is further configured to indicate that the medical device is compatible with the sterilization cycle.

[0069] (16) A method of configuring a sterilization system for sterilizing a medical device, comprising: (a) receiving a device indicator associated with the medical device; (b) accessing a set of medical device records; (c) determining the identity of the medical device based on an association of the device indicator with the set of medical device records; (d) configuring at least one risk mitigation process based on the identity of the medical device; (e) configuring a sterilization cycle to be performed on the medical device based on the at least one risk mitigation process; A method comprising: (17) The step of configuring the at least one risk mitigation process comprises: (i) determining a sterilization cabinet identifier associated with the sterilization cycle; (ii) determining a sterilization cycle type associated with the sterilization cycle; (iii) receiving a device assurance indicator from a sterilization guide database of the sterilization system based on the sterilization cabinet identifier, the sterilization cycle type, and the identity of the medical device; Including, 17. The method of claim 16, wherein the device warranty indicator indicates whether the medical device is compatible with a sterilization cabinet associated with the sterilization cabinet identifier and a sterilization cycle associated with the sterilization cycle type. (18) (a) determining a set of sterilization cabinets present in the sterilization system; (b) for each sterilization cabinet in the set of sterilization cabinets, determining a set of sterilization cycles that each sterilization cabinet is capable of performing; (c) receiving a set of equipment warranty indicators for each sterilization cabinet in the set of sterilization cabinets from the sterilization guide database and determining a set of compatible sterilization cycle options based on the set of equipment warranty indicators; (d) displaying the set of compatible sterilization cycle options to a user of the sterilization system; (e) receiving a selection from the user, the selection relating to an option from the set of compatible sterilization cycle options; (f) configuring the sterilization cycle based on the selection; 18. The method of embodiment 17, further comprising: (19) The step of configuring the at least one risk mitigation process includes: (i) accessing a database and retrieving a set of medical device records; (ii) determining an approved cycle configuration based on the identity of the medical device and the set of medical device records; (iii) configuring the sterilization cycle based on the approved cycle configuration; 17. The method of embodiment 16, comprising: (20) In a sterilization system: (a) a sterilization cabinet operable to perform a sterilization cycle on a medical device; (b) a sterilization guide database including a set of warranty indicators, the set of warranty indicators indicating a plurality of sterilization cabinets that are certified to be compatible with a plurality of medical devices; and (c) a communications hub configured to provide communications between the sterilization cabinet and the sterilization guide database; Including, The sterilization cabinet comprises: (i) receiving a device indicator associated with the medical device; (ii) accessing a set of medical device records and determining the identity of the medical device based on an association between the device indicator and the set of medical device records; (iii) determining a sterilization cabinet identifier associated with the sterilization cabinet and a sterilization cycle type associated with the sterilization cycle; (iv) receiving a warranty indicator from the sterilization guide database based on the sterilization cabinet identifier, the sterilization cycle type, and the identity of the medical device; (v) configuring the sterilization cycle to be performed on the medical device based on the assurance indicator; 1. A sterilization system configured to:

Claims

1. 1. A sterilization system for sterilizing a medical device, comprising: a reader for reading a device indicator associated with the medical device; a set of medical device records associated with the device indicator; a processor operably connected to a display and to the reader; the processor: determining an identity of the medical device based on the device indicator; displaying the determined identity to a user via the display; providing, in response to user input that the displayed identity is incorrect, a manual device input interface on the display including a set of prompts for receiving additional information from the user; determining a revised identity of the medical device based on the additional information; recommending, via an interface on the display, a sterilization cycle compatible with the revised identity of the medical device based on the revised identity of the medical device. The system is configured as follows:

2. the device indicator is a set of device tracking information received from the sterilization system; the set of device tracking information indicating a medical device in motion originating from an origin and having a destination for the device; the set of medical device records associating the medical device in transit with an identity of the medical device; The system of claim 1 , wherein the processor is further configured to determine that the medical device is the mobile medical device.

3. the processor (i) determining an approved cycle configuration for the identity of the medical device; and (ii) configuring the sterilization cycle to the approved cycle configuration; The system of claim 1 , configured to:

4. A method for configuring a sterilization system, comprising: the processor reading an indicator associated with the object to be sterilized; the processor determining the identity of the object based on the reading of the indicator; the processor displaying the identity of the object to a user via a display; the processor, in response to user input that the identity is correct, determining a sterilization cycle compatible with the object's identity, and displaying the sterilization cycle compatible with the object's identity via an interface on the display; Including, method.

5. The method of claim 1, further comprising: the processor accessing a set of medical device records; The method of claim 4 , wherein the processor determines the identity of the object based on an association between the reading of the indicator and the set of medical device records.

6. (a) the indicator comprises a set of device tracking information received from the sterilization system; (b) the set of device tracking information indicates a moving object originating from an origin and having a destination for the device; (c) the set of medical device records associates the moving object with the object's identity; The method of claim 5 , further comprising: (d) the processor determining that the object is the moving object.

7. The method includes automatic cycle selection; The automatic cycle selection includes: (a) causing the processor to determine an approved cycle configuration for the identity of the object; (b) causing the processor to configure the sterilization cycle to the approved cycle configuration; The method of claim 4, comprising:

8. The method of claim 7, wherein the processor is configured to associate the approved cycle configuration with an equipment assurance indicator and to receive the equipment assurance indicator from a sterilization guide database for the identity of the object; 8. The method of claim 7, wherein the device assurance indicator is configured to indicate whether the object is compatible with the sterilization cycle.

9. The method comprises: (i) the processor determining a sterilization cabinet identifier associated with the sterilization cycle; (ii) the processor determining a sterilization cycle type associated with the sterilization cycle; (iii) the processor receiving an equipment assurance indicator from a Sterilization Guide database of the sterilization system for the sterilization cabinet identifier, the sterilization cycle type, and the identity of the object; Including, 5. The method of claim 4, wherein the equipment warranty indicator indicates whether the object is compatible with a sterilization cabinet associated with the sterilization cabinet identifier and a sterilization cycle associated with the sterilization cycle type.

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