Patent Description:
Sterilization of medical devices may be performed with an automated sterilization system such as a STERRAD® System by Advanced Sterilization Products of Irvine, California. Examples of automated sterilization systems are described in <CIT>; <CIT>; <CIT>; and <CIT>.

Each different medical device may require a different arrangement and sterilization process.

Document <CIT> discloses a device for a sterilization system for medical devices, wherein said medical devices are identified to the device using RFID tags only. Additionally, users are enabled to distinguish devices based on a name seal. After the medical devices are identified, a risk mitigation process is configured including a sterilization cycle, sterilizing cabinet and compatibility assurance.

While a variety of systems and methods have been made and used for medical device sterilization, it is believed that no one prior to the inventor(s) has made or used the technology as described herein.

It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:.

Embodiments and descriptions no longer falling under the scope of the appended claims are considered merely as examples suitable for understanding the invention.

Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the art in view of the teachings herein.

<FIG> depicts a schematic view of an exemplary system (<NUM>) of interconnected devices that may be configured to perform methods associated with sterilizing medical devices (e.g., endoscopes and other medical devices). System (<NUM>) of this example includes a sterilizing cabinet (<NUM>), a biological indicator analyzer (<NUM>), a communication hub (<NUM>), a server (<NUM>), a user device (<NUM>), and a sterility guide database (<NUM>). Communication hub (<NUM>) is configured to provide transmission of data between sterilizing cabinet (<NUM>), biological indicator analyzer (<NUM>), communication hub (<NUM>), server (<NUM>), user device (<NUM>), and sterility guide database (<NUM>), as will be described in greater detail below.

<FIG> depicts an exemplary set of components that may be incorporated into sterilizing cabinet (<NUM>). Sterilizing cabinet (<NUM>) may be configured to perform one or more sterilization cycles, with different sterilization cycles being appropriate for different types and quantities of medical devices. Sterilizing cabinet (<NUM>) of the present example includes a sterilization chamber (<NUM>), which is configured to receive one or more medical devices for sterilization. Sterilizing cabinet (<NUM>) also includes a sterilization module (<NUM>) that is operable to receive sterilant cartridges (<NUM>) and dispense a sterilant from a cartridge (<NUM>) into sterilization chamber (<NUM>). Sterilizing cabinet (<NUM>) further includes a touch screen display (<NUM>), which is operable to render various user interface display screens and receive user input in the form of the user contacting touch screen display (<NUM>). Sterilizing cabinet (<NUM>) may include various other kinds of user input features, including but not limited to buttons, keypads, keyboards, a mouse, a trackball, etc..

Sterilizing cabinet (<NUM>) of the present example further includes a processor (<NUM>), a communication module (<NUM>), a reader (<NUM>), and a memory (<NUM>). Processor (<NUM>) is in communication with the various components of sterilizing cabinet (<NUM>) and is operable to process data and execute control algorithms to drive various components of sterilizing cabinet (<NUM>). Communication module (<NUM>) is configured to enable bidirectional communication between sterilizing cabinet (<NUM>) and communication hub (<NUM>). Communication module (<NUM>) may also be configured to enable bidirectional communication between sterilizing cabinet (<NUM>) and server (<NUM>) and/or sterility guide database (<NUM>). Reader (<NUM>) is operable to read an identification tag of a biological indicator and/or other devices as described herein. Memory (<NUM>) is operable to store control logic and instructions and that are executed by processor (<NUM>) to drive components of sterilizing cabinet (<NUM>). Memory (<NUM>) may also be used to store results associated with setup of a sterilization cycle, performance of a load conditioning cycle, performance of a sterilization cycle, and/or various other kinds of information. Various suitable components and configurations that may be used to form processor (<NUM>), communication module (<NUM>), reader (<NUM>), and memory (<NUM>) will be apparent to those skilled in the art in view of the teachings herein.

In addition to the foregoing, sterilizing cabinet (<NUM>) may be configured and operable in accordance with at least some of the teachings of any of the patent references previously cited herein; <CIT>; and/or <CIT>.

In some cases, a biological indicator may be included in sterilizing cabinet (<NUM>, <NUM>) along with the medical device during the sterilization process. The biological indicator may be activated before placement to cause a microorganism contained therein to multiply unless it is successfully sterilized during the procedure. After the sterilization process, the number of microorganisms present in the biological indicator may be determined by the biological indicator analyzer (<NUM>) to ensure that the sterilization process was successful for the biological indicator, which will also indicate that the sterilization procedure was successful for the medical device. Biological indicator analyzer (<NUM>) may receive a biological indicator and measure one or more characteristics of the biological indicator to gather data that may be used to determine whether the biological indicator tests positive, indicating that contamination is present after a sterilization procedure; or negative, indicating that no contamination is present after the sterilization procedure.

By way of example only, the biological indicator and biological indicator analyzer (<NUM>) may be configured and operable in accordance with at least some of the teachings of <CIT>; <CIT>; <CIT>; and/or <CIT>.

Server (<NUM>) may comprise a hospital record server or hospital local area network server. Server (<NUM>) may receive information from sterilizing cabinet (<NUM>) relating to sterilization procedures performed by the sterilizing cabinet (<NUM>), such as sterilization procedure durations and results; whether a particular sterilization procedure provided a subsequent indication of biological contamination; the identification of a user or technician who initiated, canceled, or complete a sterilization procedure; consumable materials or supplies used during a sterilization procedure; diagnostic information and systems errors; and/or other information. Server (<NUM>) may also receive data from biological indicator analyzer (<NUM>) via communication hub (<NUM>).

User device (<NUM>) may comprise a device such as a laptop computer, a desktop computer, a mobile device such as a smartphone, tablet, or other mobile computing device; or a proprietary device having similar capabilities, such capabilities including wired or wireless communication with devices such as communication hub (<NUM>), a processor and memory, a display, a user interface, and other capabilities. User device (<NUM>) may be used to access and view information associated with one or more components (<NUM>, <NUM>, <NUM>, <NUM>) of system (<NUM>) via communication hub (<NUM>); and may also be used to create or modify configurations and settings of communication hub (<NUM>) and connected devices. A user of user device (<NUM>) may view information and configure devices via, for example, a desktop software application, a mobile device software application, a web browser, or another software interface that may allow user device (<NUM>) to exchange information with communication hub (<NUM>). While only one user device (<NUM>) is shown in <FIG> as being in communication with communication hub (<NUM>), several user devices (<NUM>) may be in communication with communication hub (<NUM>). Similarly, several sterilizing cabinets (<NUM>), several biological indicator analyzers (<NUM>), several servers (<NUM>), and several sterility guide databases (<NUM>) may be in communication with communication hub (<NUM>).

Components (<NUM>, <NUM>, <NUM>, <NUM>) of system (<NUM>) may each be coupled with communication hub (<NUM>) via any suitable wired and/or wireless communication technology, such as Ethernet, Wi-Fi, Bluetooth, USB, infrared, NFC, and/or other technologies. Communication hub (<NUM>) may relay data, etc., between components (<NUM>, <NUM>, <NUM>, <NUM>) of system (<NUM>) as described herein, such that communication hub (<NUM>) serves as an intermediary. Various suitable components and configurations that may be used to form communication hub (<NUM>) will be apparent to those skilled in the art in view of the teachings herein. By way of example only, communication hub (<NUM>) and/or user device (<NUM>) may be configured and operable in accordance with at least some of the teachings of <CIT>; and/or <CIT>.

<FIG> depicts an exemplary set of steps that system (<NUM>) could perform to sterilize a medical device. Initially, sterilizing cabinet (<NUM>) may display one or more sterilization cycles via touch screen display (<NUM>) and then receive a sterilization cycle selection (block <NUM>) from the user. Sterilizing cabinet (<NUM>) may also display instructions indicating whether a biological indicator should be used with the selected sterilization cycle; and receive a biological indicator identification (block <NUM>). A biological indicator may be placed inside sterilization chamber (<NUM>) before the sterilization cycle begins and may remain in sterilization chamber (<NUM>) during a sterilization cycle. The user may thus identify the particular biological indicator (block <NUM>) before the biological indicator is placed the sterilization chamber (<NUM>).

Selection of a sterilization cycle (block <NUM>) and identification of a biological indicator (block <NUM>) may define one or more requirements for the configuration and arrangement of medical devices within sterilizing cabinet (<NUM>). A door of sterilization chamber (<NUM>) may be opened and instructions may be displayed to guide a user through preparation of the sterilization cycle (block <NUM>), including placement of the biological indicator, placement of medical devices, closing the door of sterilization chamber (<NUM>), and/or other changes in preparation. Before initiating the actual sterilization cycle (block <NUM>), sterilization cabinet (<NUM>) may also perform load conditioning (block <NUM>) of the medical devices that are loaded in sterilization chamber (<NUM>). Such load conditioning (block <NUM>) may include verifying that sterilization chamber (<NUM>) is sealed; verifying contents of sterilization chamber (<NUM>); checking physical characteristics of the contents of sterilization chamber (<NUM>) such as moisture levels, content volume, content weight, internal temperature, or other characteristics; and/or performing one or more conditioning steps that may include heat treatment, chemical treatment, plasma treatment, or other types of treatment to reduce moisture, raise temperature, and/or otherwise prepare the medical devices in sterilization chamber (<NUM>) for the sterilization cycle.

Once the load conditioning (block <NUM>) has been completed, the selected sterilization cycle itself may be performed (block <NUM>). The sterilization cycle (block <NUM>) may include exposing the medical device(s) in sterilizing chamber (<NUM>) to pressurized sterilant gas, further heat treatment, chemical treatment, plasma treatment, vacuum treatment, and/or other types of sterilization procedures. After the sterilization cycle (block <NUM>) is completed, the complete sterilization results may be displayed to a user via touch screen display (<NUM>); transmitted to server (<NUM>); printed locally; and/or displayed, transmitted, and/or stored via other devices as may be desirable.

Sterilization cabinet (<NUM>) may also provide results (block <NUM>) of the sterilization cycle. This provision of results (block <NUM>) may include results from analysis of a biological indicator via biological indicator analyzer (<NUM>). These results may include a positive or negative indication of contamination present in the biological indicator at the completion of the sterilization cycle (block <NUM>). In cases where the biological indicator suggests that contamination is present after completion of the sterilization cycle (block <NUM>), additional actions may be taken such as alerting a user of the positive test and analysis of sterilization cycle history to determine if other past cycles may be the cause of the contamination; and/or if subsequently sterilized medical devices may need to be re-sterilized.

Sterility guide database (<NUM>) comprises a set of records that associate a plurality of medical devices with a plurality of sterilization devices (e.g., sterilizing cabinet (<NUM>), etc.), sterilization procedures, sterilization cycles, and sterilization materials (e.g., biological indicators, detergents, sterilant, etc.); and indicate for each medical device association whether the particular sterilization device, procedure, or material has been verified as compatible or usable to sterilize that particular medical device. Sterility guide database (<NUM>) may comprise a database, table, file, or other data storage type stored on a computer (e.g., a cloud computer or cloud storage, server (<NUM>), or another physical server) and accessible to communication hub (<NUM>). Other locations and forms that sterility guide database (<NUM>) may take will be apparent to those skilled in the art in view of the teachings herein.

The exemplary methods described below may be implemented on a system such as system (<NUM>) to further mitigate the risk of human errors or equipment errors resulting in failed sterilization of medical devices, damage to medical devices, or waste of sterilization materials and resources. Several of the disclosed methods may benefit from identification of medical devices when the sterilization process is first configured to, for example, automatically select appropriate hardware and process configurations, verify compatibility, and take other similar steps based upon such an identification. Where the description or claims indicate that a step, determination, identification, or other decision or conclusion is performed "based on" or "based upon" certain input, data, or other factors, other factors or inputs may also influence the outcome. Accordingly, such descriptions should be interpreted to cover situations where the outcome is based only on or upon the described factors, as well as situations where the outcome is based at least on or upon the described factors in addition to others that are not explicitly described or listed.

While manual identification of medical devices by users of system (<NUM>) may be accurate in some cases, automatic identification may further mitigate the risk of human error or equipment error resulting in misidentification of a medical device. The identity of a medical device may vary by implementation but could include one or more of a device type (e.g., an endoscope, a cutting instrument, a suction instrument, etc.), a device manufacturer, a semi-unique device model number, a unique device serial number, or other information. <FIG> shows an exemplary set of steps (<NUM>) that may be performed by or with system (<NUM>) to automatically determine the identity of a medical device. When a medical device is received (block <NUM>) by a user of a device of system (<NUM>), such as sterilizing cabinet (<NUM>) or user device (<NUM>), various options may be available for identifying the medical device using the features and capabilities of system (<NUM>).

As an example, a user of sterilizing cabinet (<NUM>) may identify (block <NUM>) the medical device based upon an image capture of the medical device, portions of the medical device, or identifying symbols, images, or text of the medical device. Image capture may be performed by interacting with features that are available to the device in use, such as reader (<NUM>) of sterilizing cabinet (<NUM>) or an alternate input of user device (<NUM>). This could include, for example, an image capture device capturing image data of a profile of the entire medical device and identifying it using an image analysis process; capturing image data of an end effector or other portion of the medical device and identifying it using an image analysis process; capturing image data of a serial number or model number present on the medical device, parsing the serial number or model number into text, and then identifying the medical device directly or using a device lookup table that is locally stored, or stored on server (<NUM>), stored in sterility guide database (<NUM>), or stored 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 the device lookup table; and other similar processes.

By way of further example only, sterilizing cabinet (<NUM>) may automatically identify (block <NUM>) the medical device using advanced optical analysis, including but not limited to Fourier Transform Infrared Spectroscopy. As yet another merely illustrative example, sterilizing cabinet (<NUM>) may automatically identify (block <NUM>) 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). Various suitable hardware components and algorithms that may be used to provide automated identification (block <NUM>) of the medical device by sterilizing cabinet (<NUM>) will be apparent to those skilled in the art in view of the teachings herein.

A successful identification (block <NUM>) of the medical device based on image capture may be used, by itself or in combination with the results of other attempts at identification, to propose (block <NUM>) a medical device identity to a user and receive confirmation from the user that the medical device was correctly identified, as will be described in more detail below.

As another example, a user of sterilizing cabinet (<NUM>) may identify (block <NUM>) the medical device based upon device tracking records associated with the medical device and stored on server (<NUM>) or another device of system (<NUM>). A medical device or other material may be tracked throughout its lifetime to provide tracking information that may be used to locate lost or misplaced medical devices, determine current medical device inventory, audit processes related to handling medical devices before and after procedures, and other similar uses. Such tracking information may be generated by performing steps (<NUM>) such as those shown in <FIG>. Whenever a medical device arrives (block <NUM>) or departs (block <NUM>) from a touch-point with a user having a device capable of interacting with system (<NUM>), such as sterilizing cabinet (<NUM>) or user device (<NUM>), the medical device may be identified (block <NUM>) manually or automatically using some or all of the steps of <FIG>, or another identification process. Once identified (block <NUM>), system (<NUM>) may identify (block <NUM>) a set of tracking records or create a new set of tracking records associated with the medical device that are stored in server (<NUM>), sterility guide database (<NUM>), or another server or location, and update (block <NUM>) that set of tracking records to reflect the present arrival (block <NUM>) or departure (block <NUM>) of the medical device from the current touchpoint.

Information added to tracking records when they are updated (block <NUM>) may include, when a device is arriving (block <NUM>), the location the device arrived at, the location the device originated from, the time of arrival, a user that received the device upon arrival, the condition of the device upon arrival (e.g., new, used, sterile, non-sterile), any processes or procedures to be performed on or with the device while at the current location, a future destination of the device, and other similar information. When a device is departing (block <NUM>), updated (block <NUM>) information may include the location the device is departing from, the location the device is departing to, the time of departure, a user that received the device when it departed, the condition of the device upon departure (e.g., new, used, sterile, non-sterile), any processes or procedures performed on the device at the location it is departing from, and other similar information.

Returning to <FIG>, such tracking information may be used to determine the identity (block <NUM>) of a device that is arriving at a location such as sterilizing cabinet (<NUM>) or user device (<NUM>). For example, tracking information associated with Medical Device X may indicate that the device departed Procedure Room A at <NUM>:00PM and is being routed to Sterilizing Cabinet B by Technician C. Technician D, located at Sterilizing Cabinet B, may receive an unidentified medical device at <NUM>:15PM from Technician C. Technician D, using Sterilizing Cabinet B, may access tracking information and identify (block <NUM>) the medical device as Medical Device X based upon the fact that it arrived with Technician C, at its intended location Sterilizing Cabinet B, within a reasonable time frame (e.g., <NUM> minutes) of its 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 (block <NUM>) a medical device will be apparent to one skilled in the art in view of the teachings herein.

As another example, as has already been described in some detail in relation to identifying (block <NUM>) a medical device based on image capture, a user of sterilizing cabinet (<NUM>) may identify (block <NUM>) the medical device based upon an optical identifier. Where sterilizing cabinet (<NUM>) or user device (<NUM>) is capable of capturing and interpreting optical identifiers (e.g., with reader (<NUM>) or an alternate input of user device (<NUM>)), a unique or semi-unique optical identifier may be placed on the medical device that may be captured and checked against a record lookup table on server (<NUM>) or sterility guide database (<NUM>) to identify the device. This could include using an 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 may be used to identify the device directly or using the record lookup table.

As another example, a user of sterilizing cabinet (<NUM>) may identify (block <NUM>) the medical device based upon a wireless identifier. Where sterilizing cabinet (<NUM>) or user device (<NUM>) is capable of capturing and interpreting wireless identifiers (e.g., with reader (<NUM>) or alternate input (<NUM>)), a unique or semi-unique wireless identifier may be placed on the medical device that may be captured and checked against the record lookup table to identify the device. This could include using an RFID transceiver and RFID chip, a Bluetooth Transceiver and beacon, an NFC transceiver and beacon, a Wi-Fi transceiver and Wi-Fi antenna, or other wireless communication device combinations to wirelessly communicate data between the sterilizing cabinet (<NUM>) and the chip, beacon, or other device placed on or within, or transported with the medical device. Data provided from the medical device to the sterilizing cabinet (<NUM>) may then be used to identify the medical device directly or using the record lookup table.

As another example, a user of sterilizing cabinet (<NUM>) may identify (block <NUM>) the medical device based upon a serial number or other numeric identifier input. A numeric identifier may be input for a medical device by, for example, hand-keying with a keyboard or touch screen display (<NUM>), or by connecting a power or data port of the medical device to the sterilizing cabinet (<NUM>) in order to automatically retrieve the numeric identifier from a chip or memory of the medical device. As with prior examples, the numeric identifier may be used to identify the medical device directly or using the record lookup table.

As has been mentioned, after one or more medical device identifications are made, the sterilizing cabinet (<NUM>), user device (<NUM>), or other device performing the identifications may propose (block <NUM>) an identity for the medical device to a user via a display or other user interface; and receive confirmation from the user of the device identity via a keyboard, mouse, touch screen display (<NUM>), or other user interface available to that device. Where only a single identification method is used, or multiple identification methods are used and determine a common identity, only one option may be proposed (block <NUM>) to a user.

Where multiple identification methods are used, and multiple identities are determined, each option may be proposed (block <NUM>) to a user; or a most likely identity may be determined and proposed (block <NUM>) to the user, with other identities being discarded or only proposed (block <NUM>) if the user does not confirm the first identity. In some implementations, identities may be proposed (block <NUM>) and displayed with additional information such as a confidence level (e.g., high or low, percentage based), a source of the identification (e.g., identified by tracking records and optical identifier), or other information that is available to system (<NUM>) and that may aid user in confirming the medical device identity. Confidence levels and other determinations relating to the accuracy of a determined identity may be configured by an administrator of the system and based upon the source of the identification (e.g., manually input serial number may be a lower confidence while automatically scanned optical identifier may be a higher confidence), and adjusted over time based upon real world use of the system (e.g., raising the level of confidence in manually input serial numbers after they are determined to be highly accurate).

Different medical devices may have different requirements for sterilization, and so sterilizing cabinet (<NUM>) is configurable to perform sterilization procedures having different characteristics. The characteristics of a sterilization procedure may be manually configured or may be selected based upon a selected sterilization cycle (block <NUM>). These characteristics may include such factors as precise placement of a medical device within the sterilizing cabinet (<NUM>) (e.g., top shelf, bottom shelf, middle of shelf), number of medical devices that may be placed within the sterilizing cabinet (<NUM>) at one time, particular sterilant to use during a procedure, the total time of the procedure, a number of different stages of a procedure and a time for each stage, an appropriate biological indicator to use and biological indicator placement, and other similar characteristics. A sterilization cycle may combine one or more of these characteristics or others into a preconfigured process that may be selected to be performed by the sterilizing cabinet (<NUM>) based upon a single user selection.

Whether a sterilization process is manually configured or configured by the selection (block <NUM>) of a sterilization cycle to be performed, there is a possibility for user error resulting in an unsterilized medical device returning to service, or a sterilized medical device being unnecessarily re-sterilized, if a user misunderstands the selection process or misidentifies the medical device and performs a sterilization procedure that is not adequate to completely sterilize the medical device. Even where there is no true user error (e.g., the user makes appropriate selections based upon their training and the medical device involved), some medical devices may not be verifiably compatible with certain sterilization cycles or sterilizing cabinets (<NUM>), even though users and providers believe they are.

For example, an older version of a medical device may have been tested and verified as compatible with one or more sterilization cycles of sterilizing cabinet (<NUM>). A newer version of the medical device may be released that is seemingly identical to the older version, but due to changes on the interior of the device that are imperceptible to the end user, the newer version of the medical device may be incompatible with one or more cycles of sterilizing cabinet (<NUM>).

To address such concerns, the sterility guide database (<NUM>) stores a number of records associating medical devices with sterilization equipment and processes, such as the sterilization cycles of sterilizing cabinet (<NUM>); and provides an indication of compatibility. The sterility guide database (<NUM>) may be populated with data by a single party responsible for maintaining it (e.g., a manufacturer of sterilizing cabinets or a medical safety association); or may be populated by multiple users of the sterility guide database (e.g., medical device manufacturers). Data may be created and populated based upon targeted testing of new medical devices, such as focused testing on new devices as they are released to determine whether they are successfully sterilized by a device or procedure; or may be created and populated based upon similarities to prior devices, simulation models, or other techniques. In effect, the sterility guide database (<NUM>) may be accessed by a user to provide an assurance that a particular medical device is sterile after a procedure.

<FIG> shows a set of exemplary steps (<NUM>) that may be performed with system (<NUM>) to verify the compatibility of a sterilization procedure with a particular medical device using the sterility guide database (<NUM>). When a non-sterile medical device is received, a user may begin (block <NUM>) configuring a sterilization cycle for that medical device using the sterilizing cabinet (<NUM>). While the steps of <FIG> may be performed at the beginning (block <NUM>) of configuration of a sterilization cycle, they may alternatively or additionally be performed after the performance of a sterilization cycle as may be desired in some implementations. If the medical device is identifiable (block <NUM>), using steps such as those shown in <FIG>, the sterilizing cabinet (<NUM>) may receive (block <NUM>) the device identification automatically. If the device is not identifiable (block <NUM>), the sterilizing cabinet (<NUM>) may provide (block <NUM>) a device input interface to a user and receive (block <NUM>) a manual identification of the medical device from the user.

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 through a list of medical devices to identify the medical device. This could include, for example, allowing a user to select a manufacturer from a menu and providing a list of device types provided 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 could also include providing a user with a series of questions about the form (e.g., "What is the total length of the device?"), features (e.g., "Does the device have a battery?"), or other aspects of the medical device that are structured to narrow down and identify the device. The interface may be provided through touch screen display (<NUM>) or otherwise.

Once the medical device is identified, whether automatically (block <NUM>) or manually (block <NUM>), the sterilizing cabinet (<NUM>) may access the sterility guide database (<NUM>) and receive (block <NUM>) a set of assurance data associated with the medical device. The set of assurance data may indicate one or more sterilization cycles, sterilizing cabinets such as sterilizing cabinet (<NUM>), sterilants, or other devices or processes that have been verified as being compatible with the medical device. Sterilizing cabinet (<NUM>) may then verify (block <NUM>) the compatibility of its available sterilization cycles or other features; and, where the user performs a verified compatible sterilization cycle, update (block <NUM>) the sterilization cycle results for that sterilization cycle. Sterilization cycle results are a set of records stored on server (<NUM>) or another device of system (<NUM>) that indicate, for each sterilization cycle performed on that device, the characteristics of the cycle, the medical devices included in the cycle, and the results of the cycle as indicated by a biological indicator used with the cycle. The updated (block <NUM>) cycle results may additionally include information from the sterility guide database (<NUM>) indicating that the performed cycle has been assured as being compatible with the medical device, which provides further assurance that the medical is sterile after the cycle.

Where a user selects a sterilization cycle or process that cannot be verified (block <NUM>) as being compatible with the medical device, sterilizing cabinet (<NUM>) may present the user with a warning or notification of the lack of assurance; and ask the user to override (block <NUM>) the warning to continue performing the possibly incompatible sterilization cycle. Where the user overrides (block <NUM>) the notification and performs the possibly incompatible sterilization cycle, the sterilizing cabinet (<NUM>) may provide (block <NUM>) an override notification and update the sterilization cycle results. The override notification may be configured to be provided to the user performing the override, to users responsible for the sterilizing cabinet (<NUM>) itself or the section of the hospital where it is present, to users responsible for sterilization procedures for the hospital generally, or other users as may be desired and configured by an administrator of system (<NUM>). Sterilization cycle results may be updated to reflect that, while a biological indicator used with the sterilization cycle may have indicated that it was successful, system (<NUM>) was unable to provide an assurance that the medical device was compatible with the performed cycle and successfully sterilized, based upon the information available via sterility guide database (<NUM>).

Where the user does not override (block <NUM>) the notification of possible incompatibility, the sterilizing cabinet (<NUM>) may display (block <NUM>) one or more options for sterilizing the medical device for which assurance of compatibility is available. This could include, for example, selecting a different sterilization cycle on sterilizing cabinet (<NUM>), or transporting the medical device to another type of sterilizing cabinet or device.

<FIG> show screenshots of exemplary interfaces that may be displayed to a user via touch screen display (<NUM>) of sterilizing cabinet (<NUM>), or via another display or device, during one or more of the steps of <FIG>, including during configuration of a sterilization cycle to be performed with a medical device.

<FIG> shows an interface (<NUM>) that displays a set of cycle information (<NUM>) associated with a sterilization cycle that is configured and ready to be performed, or that has been performed on sterilizing cabinet (<NUM>). Set of cycle information (<NUM>) comprises a load description (<NUM>) indicating one or more medical devices that are part of the load of the sterilization cycle. An assurance window (<NUM>) may be displayed by, for example, hovering over or clicking on a medical device shown in load description (<NUM>). Assurance window (<NUM>) comprises a list of sterilizing cabinets or devices and provides an assurance indication (<NUM>) for one or more sterilization cycles available to those sterilizing cabinets, based upon assurance data received (block <NUM>) for the medical device. Assurance window (<NUM>) may also provide a lack of assurance indication (<NUM>) for one or more sterilizing cabinets (<NUM>) for which the assurance data received (block <NUM>) does not provide assurance of compatibility. Lack assurance indication (<NUM>) may comprise instructions for seeking or requesting assurance; or may include a clickable button or other interactive feature that may automatically request assurance from a party responsible for maintaining the sterility guide database (<NUM>).

<FIG> shows an interface (<NUM>) that displays a more detailed view of one or more medical devices present in a sterilization cycle load (<NUM>). Interface (<NUM>) shows a set of rows showing additional information on a first medical device (<NUM>) and a second medical device (<NUM>) such as device manufacturer, device name, and model number, and a set of columns providing an assurance indication (<NUM>) for one or more sterilization cycles available to those medical devices. Interface (<NUM>) may also provide a lack of assurance indication where appropriate.

<FIG> shows an interface (<NUM>) that displays a view of information associated with sterilization cycles (<NUM>) performed with a sterilization device (<NUM>). Interface (<NUM>) also shows a device cycle summary (<NUM>) comprising a set of aggregate information based upon information associated with sterilization cycles (<NUM>), and an assurance rate (<NUM>) indicating an aggregate percentage of cycles that were verified (block <NUM>) as compatible rather than being overridden (block <NUM>) and performed.

<FIG> shows an interface (<NUM>) that displays various notification options for different types of alerts (<NUM>) that may be provided by system (<NUM>) and different forms of communication (<NUM>) that may be used by system (<NUM>) to provide the types of alerts (<NUM>) to one or more users of system (<NUM>). An administrator of system (<NUM>) may use interface (<NUM>) to configure various alert scenarios, including configuring system (<NUM>) to provide alerts to one or more users or types of users based upon an indication of an unverified sterilization cycle being performed (<NUM>). Such an alert may be generated and communicated to users based upon the configured forms of communication (<NUM>) when a user overrides (block <NUM>) a notification that a sterilization cycle cannot be assured as being compatible with a medical device, as part of providing (block <NUM>) override notification.

<FIG> shows an interface (<NUM>) that displays a set of sterilization devices available to a user (e.g., a device the user is presently interacting with, devices available in the same room, devices available in other areas of a hospital) and whether they have been assured as being compatible with the medical device for which the sterilization cycle will be performed. As can be seen, a first sterilizing cabinet (<NUM>) and a second sterilizing cabinet (<NUM>) appear in a manner that indicates they have compatible sterilization cycles that may be used with the medical device based upon an assurance of compatibility received (block <NUM>) from the sterility guide database (<NUM>). Conversely, a third sterilizing cabinet (<NUM>) and a sterilizing device (<NUM>) appear in a manner that indicates they have not been assured as compatible with the medical device, based upon the received (block <NUM>) assurance data lacking any indication of compatibility with the medical device. A user selection of the third sterilizing cabinet (<NUM>) may result in interface (<NUM>) presenting a warning indicating that the user must override (block <NUM>) the unassured sterilization cycle to continue.

<FIG> shows an interface (<NUM>) displaying a hospital level instrumentation status (<NUM>) showing information on a plurality of medical devices currently in use at a particular hospital, building, or site, and their assurance level for sterilizing cabinets and sterilization cycles available at that same locale. A set of medical devices are displayed in rows, including a first medical device (<NUM>) and a second medical device (<NUM>), and a first column presents information associated with those devices such as device manufacturer, device name, model number, and manufacturer's notes related to the device. A set of columns (<NUM>) show for each sterilizing cabinet a set of sterilization cycles that are compatible with each of the first medical device (<NUM>) and the second medical device (<NUM>). Interface (<NUM>) may be used by an administrator or person responsible for medical device sterilization to easily view each medical device currently in use at the hospital, and the compatibility assured sterilization resources available for each medical device, to verify that all presently used medical devices have some level of compatibility assured sterilization available.

<FIG> shows an interface (<NUM>) displaying an alternate view of some of the data shown in <FIG>. The alternate view of interface (<NUM>) displays information on a set of medical devices (<NUM>) currently in use at a particular hospital, site, or other location, as well as the compatibility assurances for each medical device as discussed in the context of <FIG>; and additionally shows a hospital assurance rate (<NUM>). Hospital assurance rate (<NUM>) may indicate a percentage of the set of medical devices (<NUM>) that have some assured compatibility with sterilizing devices present at the hospital; or may indicate an aggregate percentage of compatibility assured sterilization cycles performed at the hospital during a period of time. Additional interfaces and variations on the described interfaces exist and will be apparent to one skilled in the art in view of the teachings herein.

While the disclosed systems and methods mitigate risks associated sterilization procedures and provide assurances of successful sterilization, the below described method may be implemented in system (<NUM>) individually or in combination with these other techniques to further reduce the chance of error. <NUM> shows an exemplary set of steps (<NUM>) that may be performed by or with system (<NUM>) to automatically configure a sterilizing cabinet such as sterilizing cabinet (<NUM>).

When a user receives a medical device at sterilizing cabinet (<NUM>) and begins (block <NUM>) the sterilization cycle configuration, the medical device may be identified (block <NUM>) by performing steps such as those shown in <FIG>. If the medical device is successfully identified (block <NUM>) and confirmed, the sterilizing cabinet (<NUM>) may automatically receive the medical device identity. If the device is not identifiable (block <NUM>), the sterilizing cabinet (<NUM>) may provide (block <NUM>) a device input interface to a user; and receive (block <NUM>) a manual identification of the medical device from the user.

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 through a list of medical devices in order to identify the medical device. This could include, for example, allowing a user to select a manufacturer from a menu and providing a list of device types provided 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 could also include providing a user with a series of questions about the form (e.g., "What is the total length of the device?"), features (e.g., "Does the device have a battery?"), or other aspects of the medical device that are structured to narrow down and identify the device. The interface may be provided through touch screen display (<NUM>) or otherwise.

Once the medical device is identified, whether automatically (block <NUM>) or manually (block <NUM>), the sterilizing cabinet (<NUM>) may select a compatible sterilization cycle based upon the medical device identity. This could include, for example, accessing server (<NUM>) to identify compatible sterilization cycles associated with the medical device, accessing the sterility guide database (<NUM>) to identify compatibility assured sterilization cycles associated with the medical device, or both. In some cases, the sterilizing cabinet (<NUM>) may also select (block <NUM>) an associated cycle based entirely upon or in part upon tracking information provided with the medical device upon arrival, as has been described.

In some scenarios, the identified medical device may not be found in the sterility guide database (<NUM>), yet the user reasonably believes that the medical device is in fact compatible with sterilizing cabinet (<NUM>) (e.g., due to a notice published by the manufacturer of the medical device or a notice published by the manufacturer of sterilizing cabinet (<NUM>), etc.). In some such scenarios, sterilizing cabinet (<NUM>) may present the user with a user interface that enables the user to update the sterility guide database (<NUM>) to include that medical device. Thus, the next time a user tries to sterilize the same medical device in sterilizing cabinet (<NUM>), a check of sterility guide database (<NUM>) will confirm that the medical device is compatible with sterilizing cabinet (<NUM>). As another variation of this concept, sterilizing cabinet (<NUM>) may present the user with a user interface that enables the user to compile separate listings of medical devices that are compatible with sterilizing cabinet (<NUM>). Such separate listings may be stored elsewhere (i.e., not in sterility guide database (<NUM>)); or may be stored in sterility guide database (<NUM>) (e.g., in a listing that is separate from manufacturer-defined listing(s)). In some such versions, sterilizing cabinet (<NUM>) may first check the manufacturer-defined listing(s) in sterility guide database (<NUM>); and if the medical device is not found in the manufacturer-defined listing(s), then check the user-defined listing(s).

Regardless of whether the medical device identification is performed manually (block <NUM>) or automatically (block <NUM>), the selected (block <NUM>) sterilization cycle may be presented to a user via the sterilizing cabinet (<NUM>) for confirmation (block <NUM>), and, where a user confirms that the selected (block <NUM>) cycle should be performed, the cycle may be automatically performed (block <NUM>). Where the user does not wish to proceed with the selected (block <NUM>) cycle and does not confirm (block <NUM>) the sterilization cycle, the sterilizing cabinet (<NUM>) may receive (block <NUM>) a configuration override that causes a different sterilization cycle to be selected; or that modifies one or more characteristics of the selected sterilization cycle. The sterilizing cabinet (<NUM>) may provide (block <NUM>) an override notification, similar to prior discussion of providing (block <NUM>) override notifications; and may perform (block <NUM>) the override sterilization cycle.

System (<NUM>) and sterilizing cabinet (<NUM>) may be configured to perform steps such as those shown in <FIG>, or steps such as those shown in FIG. <NUM>, or both, as may be desirable. In implementations performing steps such as those shown in both <FIG> and FIG. <NUM>, such steps may be performed in series or in parallel as may be desirable. For example, where the sterilization cycle is selected (<NUM>) based upon data from the sterility guide database (<NUM>), the configured cycle may be inherently associated with an assurance of compatibility with the medical device from the sterility guide database (<NUM>). Such an assurance could be presented in addition to other information when a user is prompted to confirm (block <NUM>) the selected (block <NUM>) cycle, and cycle results may be updated (block <NUM>) with the assurance after the cycle is performed (block <NUM>) and the cycle results are generated.

Claim 1:
A first device (<NUM>) usable with a sterilization system for a second medical device, the first device comprising:
(a) a processor and a memory;
(b) a communication device;
(c) a user input; and
(d) a display;
wherein the processor is enabled to use multiple identification methods to determine associated device indicators (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>), wherein
the multiple identification methods are chosen among image capture of the medical device, portions of the medical device, or optical identifier; identifying symbols, images, or text of the medical device; advanced optical analysis; mechanical sensing; device tracking records; identification based upon a wireless identifier, serial number, or numeric identifier input; and is configured to:
(i) receive one or more device indicator(s) associated with the medical device;
(ii) determine if one identification method has been used to obtain the device indicator or if multiple identification methods have been used to obtain the device indicators;
(iii) access a set of medical device records and determine an identity of the medical device based upon an association of the device indicator with the set of medical device records, wherein when multiple identification methods are used, and multiples identities are determined, each option is proposed to a user, or a most likely identity is determined and proposed to the user (<NUM>);
(iv) once the identity is confirmed by the user (<NUM>), configure at least one risk mitigation process based upon the identity of the medical device, and
(v) configure a sterilization cycle to be performed on the medical device based upon the at least one risk mitigation process;
wherein the at least one risk mitigation process comprises a compatibility assurance process, wherein the compatibility assurance process is configured to cause the processor to:
(A) determine a sterilizing cabinet identifier associated with the sterilization cycle,
(B) determine a sterilization cycle type associated with the sterilization cycle, and
(C) receive a device assurance indicator from a sterility guide database (<NUM>) of the sterilization system (<NUM>) based upon the sterilizing cabinet identifier, the sterilization cycle type, and the identity of the medical device;
wherein the device assurance indicator indicates whether the medical device is compatible with a sterilizing cabinet associated with the sterilizing cabinet identifier and a sterilization cycle associated with the sterilization cycle type.