Apparatus and method for sterilizing medical devices

Abstract

To provide a sterilizing cabinet to implement a method of processing a medical device, such as a used medical device or a non-sterile device.SOLUTION: The method includes receiving from a user an input of selecting a sterilization cycle from a plurality of available sterilization cycles. The sterilizing cabinet identifies a biological indicator associated with the selected sterilization cycle. The sterilizing cabinet prompts the user via a touch screen display to place the medical device and the biological indicator in a sterilization chamber of the sterilizing cabinet. The sterilizing cabinet performs load conditioning on the medical device in the sterilization chamber. The sterilizing cabinet then performs the selected sterilization cycle on the medical device in the sterilization chamber after completing the action of the load conditioning.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (Priority) This application claims priority to U.S. Provisional Patent Application No. 62 / 302,257, filed March 2, 2016, entitled "System and Method for Sterilizing Medical Devices," the disclosure of which is incorporated herein by reference.

[0002] This application also claims priority to U.S. Provisional Patent Application No. 62 / 316,722, filed April 1, 2016, entitled "System and Method for Sterilizing Medical Devices," the disclosure of which is incorporated herein by reference.

[0003] This application further claims priority to U.S. Provisional Patent Application No. 62 / 376,517, filed August 18, 2016, entitled "Apparatus and Method to Link Medical Device Sterilization Equipment," the disclosure of which is incorporated herein by reference. [Background technology]

[0004] Some reusable medical devices, such as surgical instruments, endoscopes, etc., may be sterilized before reuse to minimize the likelihood of contaminated devices being used on a patient, potentially leading to patient infection. Various sterilization methods can be used, such as steam, hydrogen peroxide, and vapor-phase sterilization, with or without gas plasma and ethylene oxide (EtO). Each of these methods may depend in part on the rate of diffusion of the sterilizing fluid (e.g., gas) into the medical device being sterilized.

[0005] Prior to sterilization, medical devices may be packaged in containers or pouches that allow the delivery of a sterilizing fluid, also called a sterilant, and that have a semi-permeable barrier that prevents the entry of contaminating microorganisms after sterilization and until the container is opened by a healthcare professional. For a sterilization cycle to be effective, contaminating microorganisms within the container must be killed, as some microorganisms may survive the sterilization cycle and multiply, potentially recontaminating the medical device.

[0006] While packaging can help prevent contamination of medical devices after sterilization, it can also prevent sterilant from reaching the contained medical device, potentially making a successful sterilization cycle more difficult. This can be particularly problematic for medical devices with diffusion-restricted spaces, as these spaces can reduce the likelihood that the sterilization cycle will be effective. For example, some endoscopes have a single, long, narrow lumen through which sterilant must diffuse in sufficient concentration for a sufficient period of time to achieve a successful sterilization cycle.

[0007] Sterilization of medical devices can be performed by an automated sterilization system, such as the STERRAD® system by Advanced Sterilization Products of Irvine, Calif. Examples of automated sterilization systems are described in U.S. Patent No. 6,939,519, issued September 6, 2005, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma," the disclosure of which is incorporated herein by reference; U.S. Patent No. 6,852,279, issued February 8, 2005, entitled "Sterilization with Temperature-Controlled Diffusion Path," the disclosure of which is incorporated herein by reference; and U.S. Patent No. 6,852,279, issued February 8, 2005, entitled "Sterilization System Employing a Switching Module Adapter to Pulsate the Low Frequency Power Applied to a No. 6,852,277, entitled "Sterilization System Employing a Switching Module Adapter for Oscillating Low Frequency Power Applied to a Plasma"; and U.S. Patent No. 6,447,719, issued September 10, 2002, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma," the disclosures of which are incorporated herein by reference. To maintain an environment conducive to effective sterilization, medical devices must be carefully positioned and controlled within the sterilization system. Different medical devices may require different configurations and sterilization processes. This means that use of a sterilization system can remain error-prone and highly dependent on the training and knowledge of the operator and the associated documentation.

[0008] Furthermore, reusing the same sterilization chamber in a sterilization system can lead to cross-contamination, especially if the sterilization system is not operated correctly. Operators may mistakenly return medical devices believed to be decontaminated to service. Ensuring that the sterilization cycle is effective helps healthcare professionals prevent contaminated medical devices from being used on patients. Medical devices may not be checked for the presence of microbial contaminants after sterilization because doing so could introduce additional microbial contaminants onto the medical device, potentially recontaminating the device. Therefore, an indirect check may be performed using a sterilization indicator. A sterilization indicator is a device that can be placed with or near a medical device undergoing a sterilization cycle so that the sterilization indicator undergoes the same sterilization cycle as the medical device. For example, a biological indicator containing a predetermined amount of microorganisms can be placed with the medical device in the sterilization chamber and subjected to the sterilization cycle. After the cycle is complete, the microorganisms in the biological indicator can be cultured to determine whether any microorganisms survived the cycle. Summary of the Invention [Means for solving the problem]

[0009] In light of the above, it would be desirable to provide a sterilization system that reduces the likelihood of operator misinterpretation, thereby increasing the likelihood of a successful sterilization cycle and thereby reducing the risk of patient infection. Although various devices and methods for sterilizing medical devices have been made and used in the past, it is believed that no one prior to the present inventors has made or used the techniques described herein. [Brief explanation of the drawings]

[0010] The invention will be better understood from the following description of several examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [Figure 1] 1 shows a schematic diagram of an exemplary sterilization system. [Figure 2] 2 shows a high-level flow chart of an exemplary set of steps that the sterilization cabinet of the system of FIG. 1 can perform to sterilize medical instruments. [Figure 3] 2 shows a flow chart of an exemplary set of steps that the system sterilizer of FIG. 1 can perform to determine a sterilization cycle and related configurations. [Figure 4] 1 shows a flow chart of an exemplary set of steps that the system sterilizer of FIG. 1 can perform to prepare medical devices for a sterilization cycle. [Figure 5] 1 shows a flow chart of an exemplary set of steps that the system sterilizer of FIG. 1 can perform to complete a sterilization cycle and report the results. [Figure 6] 10 shows a screenshot of an exemplary user interface viewable via the system sterilizer cabinet of FIG. 1 for selecting a sterilization cycle. [Figure 7] 10 shows a screenshot of an exemplary user interface that may be displayed via the sterilization cabinet of the system of FIG. 1 to provide information to a user on configuring a "standard" sterilization cycle. [Figure 8] 10 shows a screenshot of an exemplary user interface that may be displayed via the sterilization cabinet of the system of FIG. 1 to provide information to a user on configuring a "dual" sterilization cycle. [Figure 9] 10A-10C show screenshots of an exemplary user interface that may be displayed via the sterilization cabinet of the system of FIG. 1 to provide information to a user on configuring a "flexible" sterilization cycle. [Figure 10] 10 shows a screenshot of an exemplary user interface that may be displayed via the sterilization cabinet of the system of FIG. 1 to provide information to a user on configuring a "fast" sterilization cycle. [Figure 11] 10 shows a screenshot of an exemplary user interface that can be displayed via the sterilization cabinet of the system of FIG. 1 to provide the user with flexibility in selecting the biological indicator to be used for a specified sterilization cycle. [Figure 12]10 shows a screenshot of an exemplary user interface that may be displayed through the sterilization cabinet of the system of FIG. 1 to guide a user through the placement and configuration of medical instruments for a "fast" sterilization cycle. [Figure 13] 10 shows a screenshot of an exemplary user interface that may be displayed through the sterilization cabinet of the system of FIG. 1 to guide a user through the placement and configuration of medical instruments for a "flexible" sterilization cycle. [Figure 14] 10 shows a screenshot of an exemplary user interface that may be displayed through the sterilization cabinet of the system of FIG. 1 to guide a user through the placement and configuration of medical instruments for a "dual" sterilization cycle. [Figure 15] 10A-10C show screenshots of an exemplary user interface that may be displayed through the sterilization cabinet of the system of FIG. 1 to guide a user through the placement and configuration of medical instruments for a "standard" sterilization cycle. [Figure 16] 10 shows a screenshot of an exemplary user interface that may be displayed via the sterilization cabinet of the system of FIG. 1 to provide results to a user regarding completed sterilization cycles. [Figure 17] 10 shows a screenshot of an exemplary user interface viewable via the sterilization cabinet of the system of FIG. 1 to identify the cycle associated with a positive biological indicator result as communicated from the indicator analyzer of the system of FIG. 1 via the communication hub of the system of FIG. 1. [Figure 18] 2 shows a schematic diagram of an exemplary sterilization cabinet that can be used with the system of FIG. 1; DETAILED DESCRIPTION OF THE INVENTION

[0011] The following description of specific embodiments of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments, and advantages of the present 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 carrying out the present technology. As will be understood, the present technology described herein is capable of various other obvious embodiments, all without departing from the present technology. Therefore, the drawings and description should be regarded as illustrative in nature, and not restrictive.

[0012] It should further be 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. Thus, the teachings, expressions, embodiments, examples, etc. described below are not to be viewed in isolation from one another. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the following claims.

[0013] I. Exemplary Sterilization Systems and Apparatus FIG. 1 shows a schematic diagram of an exemplary system (10) of interconnected devices configurable to perform a method for sterilizing medical instruments. This example system (10) includes a sterilization cabinet (100), a biological indicator analyzer (102), a communications hub (104), and a server (106). As described in more detail below, the sterilization cabinet (100) includes a sealable sterilization chamber into which contaminated medical instruments are placed. A user can interact with the sterilization cabinet (100) via a set of user inputs, such as physical buttons, a keyboard, a touchpad, or a mouse, other controls, and / or a touchscreen display interface. The sterilization cabinet's (100) display can provide the user with information, configuration options, the status and duration of sterilization cycles and preparations, and other similar information.

[0014] The sterilization cabinet 100 communicates with a server 106, such as a hospital record server or a hospital local area network server. The server 106 can receive information from the sterilization cabinet 100 regarding the sterilization processes performed by the sterilization cabinet 100, such as the duration and results of the sterilization process; whether a particular sterilization process resulted in new signs of biological contamination; personal information of the user or technician who initiated, canceled, or completed the sterilization process; consumables or materials used during the sterilization process; diagnostic information; and / or other information. Additionally, the server 106 can provide information to the sterilization cabinet 100, such as software updates, configuration updates, user authentication information, biological indicator usage protocols, and other information. Communication between the sterilization cabinet 100 and the server 106 is ,red This may be achieved via any suitable wired and / or wireless communication technology, such as wireline, NFC, and / or other technology.

[0015] In this example system 10, the sterilization cabinet 100 also communicates with a communications hub 104, which itself communicates with one or more biological indicator analyzers 102. As described in more detail below, the biological indicator analyzers 102 may include benchtop or wall-mounted devices that receive the biological indicators and measure one or more properties associated with the biological indicators to gather data that can be used to determine whether the biological indicators test positive, indicating the presence of contamination after sterilization; or negative, indicating the absence of contamination after sterilization.

[0016] In some embodiments, the biological indicator analyzer 102 measures and transmits data to the communications hub 104, which processes the data and determines whether contamination is present. In other embodiments, the biological indicator analyzer 102 itself measures and analyzes the data to determine whether contamination is present, and the communications hub 104 can then be used to receive, collect, and transmit such information to the sterilization cabinet 100 and / or other devices, as described in more detail below. In yet other embodiments, the biological indicator analyzer 102 and the communications hub 104 can be different components of a single device or can be components of the sterilization cabinet 100. Such variations may be desirable depending on the particular implementation and user requirements. This may make a single device incorporating a sterilization cabinet (100), a communications hub (104), and a biological indicator analyzer (102) desirable as a semi-mobile device, while an implementation supporting a one-to-many relationship between sterilization cabinets (100) and biological indicator analyzers (102) may be advantageous for permanent installation within a large hospital with many users.

[0017] As will be explained in more detail below, and as previously alluded to, the communications hub (104) is configured to process and relay information from the biological indicator analyzer (102) to the sterilization cabinet (100). The biological indicator analyzer (102) and the sterilization cabinet (100) are each ,redCommunication with the communications hub 104 can be via any suitable wired and / or wireless communication technology, such as an external line, NFC, and / or other technology. It is further understood that the communications hub 104 can communicate via wired or wireless communication with various other components, including, but not limited to, desktop computers, laptop computers, mobile computing devices, smartphones, etc. Furthermore, the communications hub 104 can communicate with the server 106 via wired or wireless communication. In configurations in which the communications hub 104 communicates with the server 106, the communications hub 104 can relay data, etc., between the sterilization cabinet 100 and the server 106. In this way, the communications hub 104 acts as a relay between the sterilization cabinet 100 and the server 106. Therefore, it is understood that in some configurations, the sterilization cabinet 100 can communicate with the server 106 via the communications hub 104, rather than directly with the server 106. By way of example only, communications hub 104 may be constructed and operated in accordance with at least some of the teachings of U.S. Provisional Patent Application No. 62 / 376,517, entitled "Apparatus and Method to Link Medical Device Sterilization Equipment," filed August 18, 2016, the disclosure of which is incorporated herein by reference. In view of the teachings herein, various suitable components and configurations that may be used to form communications hub 104 will be apparent to those skilled in the art.

[0018] II. Exemplary Sterilization Processes and Interfaces A. Sterilization Process Overview 2 shows a high-level flow chart of an exemplary set of steps that the system 10 can perform to sterilize medical devices. As described in more detail below, a user can interact with the system through a user interface, such as a keyboard or touchscreen, on the sterilization cabinet 100 or through an input device in communication with the sterilization cabinet 100. Initially, the sterilization cabinet 100 can display one or more sterilization cycles via a display and then receive a sterilization cycle selection from the user (block 200). The sterilization cabinet 100 can be configured to perform one or more sterilization cycles, with different sterilization cycles adapted for different types and quantities of medical devices.

[0019] Additionally, the sterilization cabinet (100) can display instructions indicating whether or not to use a biological indicator for a selected sterilization cycle and can receive the biological indicator identification information (block 202). A biological indicator can be placed in the sterilization chamber of the sterilization cabinet (100) before the sterilization cycle begins and can remain in the chamber during the sterilization cycle. Thus, a user can identify a specific biological indicator before placing the biological indicator in the sterilization chamber (block 202). The biological indicator can include a microorganism that responds to a specific sterilization cycle. Upon completion of the sterilization cycle, the biological indicator can be tested for the microorganism to provide a measure of the effectiveness of the sterilization cycle. Biological indicators are not necessarily required for all sterilization cycles and may be required based on hospital rules or local regulations. During use, the biological indicator can be identified by manual entry, such as keyboard entry of the biological indicator type or identifier, or automatically, such as optical scanning of an optical identifier or wireless scanning of an RFID or other unique identifier.

[0020] The selection of a sterilization cycle (block 200) and the identification of biological indicators (block 202) may define one or more requirements for the configuration and placement of medical devices within the sterilization cabinet 100. The sterilization chamber door of the sterilization cabinet 100 may be opened, and instructions may be displayed to guide the user through the preparation of the sterilization cycle (block 204), including placement of biological indicators, placement of medical devices, closing the sterilization chamber door of the sterilization cabinet 100, and / or other changes during preparation.

[0021] Prior to commencing the actual sterilization cycle (block 208), the sterilization cabinet 100 may also perform a load conditioning (block 206) of the medical devices loaded into the sterilization chamber of the sterilization cabinet 100. Such load conditioning (block 206) may include verifying that the sterilization chamber is sealed, verifying the contents of the sterilization chamber, verifying physical characteristics of the contents in the sterilization chamber, such as moisture content, volume, 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 prepare the medical devices in the sterilization chamber for the sterilization cycle.

[0022] 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 device(s) in the sterilization chamber to autoclaved gas, additional heat treatment, chemical treatment, plasma treatment, vacuum treatment, and / or other types of sterilization treatment. Once the sterilization cycle (block 208) is complete, the completed sterilization results can be displayed to the user via the sterilization chamber display; transmitted to the server (106); printed locally; and / or displayed, transmitted, and / or stored via other devices as desired.

[0023] Additionally, the sterilization cabinet (100) may also provide sterilization cycle results (block 210). This may include results from an analysis of the biological indicator via the biological indicator analyzer (102), described below. 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 indicates that contamination is present after completion of the sterilization cycle (block 208), additional actions may be taken, such as notifying the user of the positive test analysis of the sterilization cycle history, to determine whether other previously performed cycles may have contributed to the contamination and / or whether subsequently sterilized medical devices may need to be resterilized.

[0024] B. Exemplary Sterilization Cycle Selection and Biological Indicator Identification Figure 3 illustrates an exemplary set of steps that can be performed by the sterilization cabinet 100 to receive sterilization cycle selection (block 200) and biological indicator identification information (block 202). That is, the method illustrated in Figure 3 can be viewed as illustrating several substeps that can be performed as part of the sterilization cycle selection step (block 200) and biological indicator identification step (block 202) of Figure 2.

[0025] When a user initially interacts with the sterilization cabinet (100), after logging in or authenticating use of the sterilization cabinet (100), the sterilization cabinet (100) may display sterilization cycle selections (block 300) via a graphical user interface such as that shown in FIG. 6. As seen in FIG. 6, the sterilization cycle selection buttons (600) are touchscreen elements that indicate sterilization cycle types such as "standard," "dual," "flexible," and "fast," and may further display additional information for each sterilization cycle selection, such as the sterilization cycle duration, the type of biological indicator associated with the sterilization cycle, and other information, as well as instructions for either selecting a cycle or scanning a biological indicator (601). The sterilization cycle selection screen of FIG. 6 also includes a sterilization cycle information button (602) for each sterilization cycle selection, which can be selected by the user to display additional information that may assist the user in selecting a sterilization cycle. It is understood that the "standard," "dual," "flexible," and "fast" sterilization cycles in this example are for illustrative purposes only. Alternatively, the sterilization cabinet 100 can provide any other suitable number and type of sterilization cycles to select from.

[0026] While FIG. 6 illustrates each sterilization cycle as being associated with a particular type of biological indicator, such as an Apollo Type A or an Apollo Type B, various embodiments can accommodate various configurations of biological indicator types. In some embodiments, each sterilization cycle can include a different type of biological indicator, such that there can be four or more different types of biological indicators for a particular application. However, in other embodiments, a single biological indicator can be adapted for use with any sterilization cycle, such that only one type of biological indicator is required. The number and type of biological indicators required for various sterilization cycles can vary depending on desired cost, shelf life, market, or other factors. While the embodiments illustrated in FIGS. 6-18 call for Type A and Type B indicators, the illustrated technology and interfaces can be modified to accommodate only one type of biological indicator or as many biological indicators as desired.

[0027] 7-11 show examples of sterilization cycle information screens that can be displayed after interacting with the sterilization cycle information button (602). Figure 7 shows an exemplary cycle information screen for a "standard" sterilization cycle, which includes a sterilization cycle description (608); a sterilization cycle duration estimate (614); a list of medical devices suitable for this particular sterilization cycle (610); and a biological indicator visual aid (612) that identifies the type, color, and location of a barcode or identifier consistent with the particular sterilization cycle. In this particular example, the sterilization cycle description (608) indicates that the "standard" sterilization cycle has a cycle time of approximately 47 minutes and is intended for devices including single-channel stainless steel lumens and common medical devices. The medical device list (610) includes examples of arthroscopic and laparoscopic instrument collections, ophthalmic instruments, cystoscopic instruments, rigid and semi-rigid ureteroscopes, camera and optical cords, rechargeable batteries, Doppler cords and defibrillator paddles, orthopedic drills and saws, and ultrasound probes / transducers. The biological indicator visual aid (612) indicates that the biological indicator for a "standard" sterilization cycle is a teal cap "Type A" biological indicator, but it is understood that other types, colors, and configurations may also be displayed.

[0028] Figures 8-10 show similar information regarding a "dual" sterilization cycle (616), a "flexible" sterilization cycle (618), and a "rapid" sterilization cycle (620). In particular, in Figure 8, the sterilization cycle description (616) indicates that the "dual" sterilization cycle has a cycle time of approximately 60 minutes and is intended for devices including single-channel flexible endoscopes, lumenless flexible endoscopes, cameras, and accessory light cords. The list of medical devices for the "dual" sterilization cycle includes examples of bronchoscopes, hysteroscopes, cystoscopes, flexible ureteroscopes, cholangioscopes, thoracoscopes, intubating fiberscopes, light cords, and cameras. The biological indicator visual aid for the "dual" sterilization cycle indicates that the biological indicator for the "dual" sterilization cycle is a teal-cap "Type A" biological indicator, although it is understood that other types, colors, and configurations may be displayed.

[0029] In Figure 9, the sterilization cycle description (618) indicates that the "flexible" sterilization cycle has a cycle time of approximately 42 minutes and is intended for devices including single-channel flexible endoscopes and lumenless flexible endoscopes. The medical device list for the "flexible" sterilization cycle includes examples of bronchoscopes, hysteroscopes, cystoscopes, flexible ureteroscopes, cholangioscopes, thoracoscopes, and intubating fiberscopes. The biological indicator visual aid for the "flexible" sterilization cycle indicates that the biological indicator for the "flexible" sterilization cycle is a teal-cap "Type A" biological indicator, although it is understood that other types, colors, and configurations may be displayed.

[0030] In Figure 10, the sterilization cycle description (620) indicates that the "fast" sterilization cycle has a cycle time of approximately 24 minutes and is intended for general medical devices requiring surface sterilization as well as sterilization of integral stainless steel or titanium surfaces. Examples of medical devices listed for the "fast" sterilization cycle include Da Vinci endoscopes, lumenless rigid or semi-rigid endoscopes, lumenless general surgical devices, rechargeable batteries, lumenless ophthalmic instruments, and ultrasound probes / transducers. The biological indicator visual aid for the "fast" sterilization cycle indicates that the biological indicator for the "flexible" sterilization cycle is a dark gray "Type B" biological indicator, although it is understood that other types, colors, and configurations may be displayed.

[0031] Sterilization cycle information screens such as those shown in Figures 8-10 may display a picture or image of the medical devices that can be sterilized by the sterilization cycle, additional information such as the sterilization method used during the sterilization cycle, the maximum heat or pressure reached in the sterilization chamber during the sterilization cycle, the number of sterilization cycles performed during a period of time, the time the last sterilization cycle was performed, and / or any other information that the user may find useful.

[0032] 3 and 6 together, the sterilization cycle selection screen of FIG. 6 can further prompt the user to manually select a sterilization cycle (block 304) and / or select and scan a biological indicator (block 302). If the user chooses to scan a biological indicator (e.g., by scanning the biological indicator barcode), Do, Instead of displaying a filtered selection of sterilization cycles that can be selected because they match the selected and scanned biological indicator (block 306), this display can be updated (block 302) using an optical or wireless scanner to scan optical identification, RFID, or other wireless identification information (block 302).

[0033] In some embodiments, the interface including the sterilization cycle selection may be filtered (block 306) based on the scanned or selected biological indicator (block 302). For example, one interface screen may show sterilization cycles associated with a "Type B" biological indicator grayed out and unselected. In response to a "Type A" biological indicator being selected or scanned (block 304), this particular screen may be displayed, allowing only that screen to select a filtered sterilization cycle specifically associated with the "Type A" biological indicator. As another example, a screen may include sterilization cycles associated with a "Type A" biological indicator grayed out and unselected. In response to a "Type B" biological indicator being selected or scanned (block 304), this particular screen may be displayed, allowing only that screen to select a filtered sterilization cycle specifically associated with the "Type B" biological indicator. However, in embodiments that support or require only one type of biological indicator, the filtering process by corresponding sterilization cycle type may not be required after the biological indicator is selected.

[0034] 3 and 6, the user may not necessarily scan a biological indicator before selecting a sterilization cycle (block 302). Instead, the user may manually select (block 304) from any of the displayed sterilization cycle selection buttons (600). After manual selection of a sterilization cycle (block 304), if the user also scanned or selected a biological indicator earlier in the process (block 308), the biological indicator may be verified (block 324) for the selected sterilization cycle. Verification (block 324) may include verification of compatibility with the system 10, broadly speaking, with the selected sterilization cycle, verification that the biological indicator has not expired, and / or other verifications.

[0035] Some implementations include a screen that can be used to indicate to the user that there is a warning or error associated with the biological indicator based on validation (block 324). For example, if the compatibility of the biological indicator with the sterilization cabinet 100, the biological indicator analyzer 102, and / or other devices in the system 10 has not been verified or validated, a warning message can be displayed if the biological indicator analyzer is from a third-party manufacturer. The warning message can include a button to cancel use of the biological indicator (block 326) or a button to bypass the warning and continue with the sterilization cycle and indicator selection (block 328) to allow the user to replace the biological indicator with a verified biological indicator.

[0036] If the identified biological indicator is incompatible with the selected sterilization cycle, such as when a "Type A" biological indicator is selected and a "Rapid" sterilization cycle is selected, several warning messages can be displayed. The warning message can be implemented by a button that allows the user to cancel the biological indicator and sterilization cycle selection altogether or to replace the incompatible biological indicator with a new biological indicator that is compatible with the specified sterilization cycle (block 326). Similarly, another warning can be displayed to indicate to the user that the selected "Type B" biological indicator is not suitable for use with the specified "Standard," "Flexible," or "Dual" sterilization cycle. Again, the warning message can be implemented by a button that allows the user to cancel the biological indicator and sterilization cycle selection altogether or to replace the incompatible biological indicator with a new biological indicator that is compatible with the specified sterilization cycle (block 326). However, in embodiments that support or require only a single type of biological indicator, a different warning message to indicate a mismatch between the specified cycle and the selected biological indicator would not be required.

[0037] If the user selects or scans a biological indicator that is incompatible with the sterilization cabinet 100, biological indicator analyzer 102, and / or other equipment, several warning messages can be displayed. These warning messages inform the user that the currently specified biological indicator is clearly incompatible and that they must replace it with a compatible biological indicator before continuing. These messages can be displayed along with buttons that allow the user to either cancel the biological indicator and sterilization cycle selection altogether or replace the current biological indicator with a new biological indicator that is compatible with the specified sterilization cycle (block 326).

[0038] When the user selects or scans a biological indicator that is to be terminated, aborted, or canceled, several warning messages may be displayed. These messages may be accompanied by buttons that allow the user to cancel the biological indicator and sterilization cycle selection altogether or to replace the terminated / aborted / cancelled biological indicator with a new biological indicator (block 326). However, in embodiments that accommodate or require only a single type of biological indicator, the warning messages may be consolidated to require only a single biological indicator type.

[0039] If, after any of the above warnings and error messages, the user elects to continue or bypass the warning, the sterilization cabinet (10) will count the biological indicator as verified despite the warning (block 324), and sterilization cycle selection and biological indicator identification will be complete (block 328). If, after a warning or error, the user elects to replace the previously selected biological indicator with another biological indicator (block 326), this newly selected biological indicator can be verified (block 324). Based on this newly selected biological indicator, and if no warnings or errors exist, sterilization cycle selection and biological indicator identification will be complete (block 328).

[0040] Prior to manual sterilization cycle selection (block 304), if no biological indicators are scanned (block 308), the sterilization cabinet 100 determines whether there are hard requirements (block 310) or soft requirements (block 314) for using biological indicators. The determination of whether there are hard requirements (block 310) or soft requirements (block 314) depends on various configurable factors, which may vary depending on the particular hospital in which the system 10 will be used, the particular geographic region in which the system 10 will be used, the requirements of the user's insurance company, and / or various other factors.

[0041] For example, in some embodiments, there may be hard requirements (block 310) that require the use of biological indicators in certain situations to comply with rules, laws, or other regulations. When such hard requirements are applied to the current sterilization cycle being configured (block 310), the hard indicator requirements may be displayed (block 312) because the user has not yet scanned or selected a biological indicator (308). In some implementations, when hard requirements are applied to a specified sterilization cycle (block 310), a screen may be displayed. For example, a hard requirement description may indicate to the user the circumstances under which the particular hard requirement applies (block 310), and a biological indicator guide may provide a graphical representation of the biological indicators required to continue. This screen may include a button that allows the user to completely cancel the selection process. However, such a screen does not include a button that allows the user to bypass the requirement or continue if no suitable biological indicators are available.

[0042] As another example, a screen may indicate a requirement for a "Type B" biological indicator so that the system can continue the process. The hard requirements screen may display additional information, such as contact information and information regarding individuals who can provide assistance, such as technical support personnel for the sterilization cabinet (100), the biological indicator, the hospital where the sterilization cabinet (100) is located, and / or other individuals who can provide assistance when the user suddenly receives a hard requirement (block 310). However, in embodiments that support or require only a single biological indicator type, only a single interface may be required to display the requirements for a single biological indicator.

[0043] Some hard requirements are "once every 24 hours" requirements, but other requirements may exist. For example, in some embodiments, there may be hard requirements on using a biological indicator per cycle, every other cycle, every X-1 cycles, a certain number of times per day, a certain number of times per time period, and / or other scenarios that may be configured.

[0044] While hard requirements are intentionally designed to appear disallowed without the selection of the appropriate biological indicator, some forms of the system 10 can be further configured to display a set of hard requirement bypass screens that allow a user to bypass (block 320) hard requirements in the event of an emergency or other sufficient need. Such screens may be configured to accept a passcode, provided by support personnel or hospital administrators, that allows the hard requirements to be bypassed. Such screens may be followed by a screen indicating to the user that the passcode was accepted, and may further disable the hard requirements during a sterilization cycle configuration for a certain number of sterilization cycles, such as three, or for a certain period of time.

[0045] Returning to Figure 3, if the hard bypass (block 320) is successful, sterilization cycle selection and biological indicator identification are complete (block 328). Bypassing a hard requirement may result in a new alert or notification being sent to a hospital administrator or other responsible party, and additional information indicating the special circumstances surrounding the hard requirement (block 320) may be sent to the server (106) for later verification of the event. While a code bypass is one example of a hard requirement bypass (block 320), other implementations exist. For example, a hard requirement bypass (block 320) may also be accomplished by scanning an optical bar code, RFID tag, or other indicator that may be carried by a small group of individuals within the hospital, or by scanning a dummy indicator that allows a single bypass or a limited number of bypasses.

[0046] If no hard requirements exist (block 310), the sterilization cabinet 100 determines whether any soft requirements exist (block 314). Soft requirements may be conditionally applicable under similar circumstances to hard requirements, such as every sterilization cycle, intermittent sterilization cycles, intermittent time periods, or other scenarios. If soft requirements exist (block 314), the soft biological indicator requirements may be displayed (block 316) via a screen such as that shown in FIG. 11. FIG. 11 shows a soft requirement description (626), a biological indicator visual guide (622), and a soft bypass (624) button. The soft requirement description (626) indicates that more than 24 hours have passed since the last biological indicator was processed and that a new biological indicator must be scanned to continue. If the user does not want to select a biological indicator, they can abort the cycle or select the soft bypass (624) button. If soft bypass is selected (block 318), the sterilization cycle selection and indicator identification are complete (block 328). Furthermore, if there are no hard requirements (block 310) and no soft requirements (block 314), the user may continue without the need for a biological indicator or bypass, and sterilization cycle selection and biological indicator identification is complete (block 328).

[0047] If no biological indicators were scanned prior to manual selection of a sterilization cycle (block 304), and a hard or soft requirement exists (blocks 310, 314), and no bypass is performed (blocks 318, 320), the user is required to scan a biological indicator (block 308) before the sterilization cabinet (100) will proceed. Once a biological indicator is scanned (block 308), biological indicator verification (block 324) will proceed as previously described. If a soft or hard bypass is used (blocks 318, 320), an additional warning may be displayed to inform the user of the requirement to use a biological indicator.

[0048] C. Exemplary Medical Equipment Placement and Load Balancing Process 4 illustrates an exemplary set of steps that can be performed by the sterilization cabinet 100 to guide a user in placing medical instruments within the sterilization chamber of the sterilization cabinet 100 and prepare the medical instruments for a sterilization cycle. It is understood that the method illustrated in FIG. 4 can be viewed as illustrating several substeps that can be performed as part of the sterilization cycle preparation step (block 204) and the load adjustment step (block 206) of FIG. 2.

[0049] Once a sterilization cycle has been selected (block 200) and biological indicators have been identified (block 202), the sterilization cabinet (100) can display (block 400) a medical device configuration that serves as a visual guide for the user's placement of medical devices within the sterilization chamber of the sterilization cabinet (100) based on the selected sterilization cycle (block 200). Some implementations include a screen that can be used to display (block 400) the medical device configuration.

[0050] Figure 12 shows an interface with a cycle description (650) that characterizes one or more characteristics of the medical sterilization equipment sterilized by the sterilization cycle, the materials sterilized by the sterilization cycle, or the process used during the sterilization cycle. The interface also includes one or more placement instructions (652) that provide the user with instructions (653) regarding where to place the medical instruments to be sterilized (e.g., relative to shelves within the sterilization chamber) and, if applicable to the specified sterilization cycle, where to place biological indicators. The interface also includes a graphical representation (654) of the placement of medical instruments that have a visually similar shape or appearance to the sterilization chamber in the sterilization cabinet (100). Figure 13 shows a similar interface providing visual placement guides for a "flexible" cycle (656), Figure 14 shows a similar interface for a "duplex" cycle (658), and Figure 15 shows a similar interface for a "standard" cycle (660).

[0051] Returning to FIG. 4, once medical device placement is complete (block 402), the user can press a start button or other button indicating medical device placement is complete, and the sterilization cabinet (100) can verify the medical device placement (block 404). Placement verification can be performed in a variety of ways, depending on the particular embodiment. In some forms, placement verification may be as simple as a final display and confirmation of the visual placement guide (654). In other forms, placement verification can be performed by an imaging device or optical sensor, weight sensor, or similar type of sensor capable of detecting the physical presence of an object within a defined space by comparing with two-dimensional or three-dimensional camera image capture, or by recognizing one or more physical characteristics of the presence.

[0052] Additionally, placement verification (block 404) can be performed at either the time of manufacture, the time of use, or the time of sterilization by the placement of wireless RFID or NFC scanners and RFID or NFC chips on the medical devices. One or more wireless scanners can be placed within the walls of the sterilization cabinet (100) and further configured to identify the location of the medical devices within the sterilization chamber and verify that the medical devices are within the configured range of the scanners during verification (block 404). Configurations that include wireless scanners can also be configured to identify the placement of the medical devices as well as the type of medical device, which can be used as additional confirmation that the appropriate sterilization cycle was selected for the type of medical device placed within the chamber.

[0053] If the medical device placement cannot be verified (block 404), the cycle placement guide may be displayed again (block 400). If the medical device placement is verified (block 404), the sterilization cabinet 100 may initiate a load adjustment process (block 406). The load adjustment process (block 406) prepares the sterilization chamber and the medical devices therein for optimal sterilization during the sterilization cycle. Adjustment may involve controlling or optimizing one or more characteristics of the sterilization chamber. For example, during load adjustment, the sterilization cabinet 100 may constantly monitor the moisture content within the sterilization chamber (block 408), reducing the moisture content by, for example, circulating or dehumidifying the air in the sterilization chamber, creating a vacuum within the sterilization chamber, heating the sterilization chamber, and / or otherwise dehumidifying the sealed chamber. This may continue until the sterilization cabinet 100 determines that an acceptable moisture content has been reached (block 410).

[0054] The sterilization chamber (100) may continuously sense the temperature inside the sterilization chamber while heating the chamber (block 412), for example, by the delivery of heated air, conduction through the interior surfaces of the chamber, and / or using other techniques. This may continue until the sterilization chamber (100) determines that an acceptable internal temperature has been reached (block 414). Various adjustment operations, such as temperature and humidity adjustments, may be performed in parallel or sequentially. While one or more adjustment operations are being performed, the sterilization chamber (100) may display an interface indicating to the user the waiting time before the sterilization cycle can begin. Once all load adjustment criteria have been met, the load adjustment is complete (block 416), and the sterilization cycle may then be performed (block 208). It is therefore understood that the sterilization chamber (100) may be configured such that the sterilization cycle (block 208) does not actually begin until the load adjustment process (block 206) is complete.

[0055] Load adjustment (block 206) is not always possible due to system errors, abnormally high humidity, or abnormally low temperatures. Some implementations include an interface that can be displayed if the humidity cannot be reduced or other common failures occur during load adjustment. This interface provides additional guidance to the user so that further adjustment attempts can be made. If the chamber temperature cannot be raised to an acceptable range, another interface can be displayed to instruct the user as to why this failed.

[0056] As described above, the sterilizer cabinet (100) can begin automatically and quickly performing a sterilization cycle (block 208) after completing load adjustment (block 206). During the sterilization cycle (block 208), an interface can be displayed showing the time remaining in the cycle, the total cycle completed, and the current cycle stage, and indicating which portion of the sterilization cycle is currently being performed (e.g., plasma, vacuum, injection, heat, chemical treatment), along with buttons to cancel the sterilization cycle and view more information about the sterilization cycle.

[0057] D. Example Report of Sterilization Cycle Results FIG. 5 illustrates an exemplary set of steps that the sterilization cabinet (100) may perform to conduct a sterilization cycle and, upon completion, report the results of the sterilization cycle (block 208). That is, the method illustrated in FIG. 5 may be viewed as illustrating several substeps that may be performed as part of the results-providing step (block 210) of FIG. 2. If the sterilization cycle is canceled or fails to complete due to a fault or user action (block 500), the sterilization cabinet (100) may remain closed, and may also display an interface (block 502) showing a sterilization cycle canceled message and various details related to the sterilization cycle, such as the date, time, configuration, elapsed time, the operator of the sterilization cycle, the stage at which the sterilization cycle failed, and other information that may be used to identify the reason for the sterilization cycle failure. This display and other information related to the sterilization cycle may be sent to the server (106) or a printer, or both, for further use or analysis (block 504).

[0058] If the sterilization cycle is complete (block 506), the sterilization cabinet (100) may display a sterilization cycle complete (block 508) interface, such as that shown in FIG. 16, which may include information such as a sterilization cycle identifier, sterilization cycle type, start time, duration, operator, and other information (666). If no biological indicators are present during the sterilization cycle (block 510), the displayed information and other information related to the sterilization cycle may be sent to the server (106) or a printer, or both, for further use or analysis (block 504). If a biological indicator was selected and used during the sterilization cycle (block 510), the user may remove the biological indicator and enter it into a biological indicator analyzer (102) to determine the effectiveness of the sterilization process (block 512), as described in more detail below.

[0059] If the data provided by the biological indicator analyzer 102 indicates that the biological indicator test for contamination is negative (block 514), the results of the sterilization cycle and the results of the indicator analysis (block 512) are sent to the server 106, a printer, or both (block 504). If the data provided by the biological indicator analyzer 102 indicates that the biological indicator test for contamination is positive (block 514), the sterilization cabinet 100 can display the sterilization cycle history (block 516) of the sterilization cycles performed prior to the intermediate sterilization cycle to allow the user to determine whether any previously performed sterilization cycles may need to be restarted to ensure the sterility of the associated medical devices. If subsequent sterilization cycles are performed after the sterilization cycle and before the biological indicator analysis (block 512) is complete, these subsequent sterilization cycles may also need to be restarted.

[0060] Figure 17 shows an example of an interface that displays to the user the sterilization cycle history of potentially affected sterilization cycles in the event of a positive biological indicator result (block 514). The example interface in Figure 17 displays the biological indicator result (668), a biological indicator identifier (670) that associates a unique biological indicator with the selected or scanned sterilization cycle, the time the biological indicator was analyzed (672), a past sterilization cycle window (674) that displays a sequential list of previously performed sterilization cycles that may have been affected and goes back at least to the previously performed sterilization cycle that contained a biological indicator, the sterilization cycle completion time (676) for each affected sterilization cycle, the sterilization cycle type (678) for each affected sterilization cycle, and the biological indicator result (680) for each affected sterilization cycle.

[0061] The interface of Figure 17 can be used by a user to identify a set of affected sterilization cycles, which in some cases may be each sterilization cycle performed (i) prior to the sterilization cycle that resulted in a positive contamination reading, and (ii) after the most recent sterilization cycle that resulted in a negative contamination reading. This set of affected sterilization cycles provides a definitive list of each sterilization cycle that may not have been fully effective as a result of a change in the performance of the sterilization cabinet (100), or other faults or contamination that may have currently caused the positive contamination reading. Medical devices that were deemed sterilized during an affected sterilization cycle may be revalidated and / or resterilized to ensure safe use.

[0062] III. Exemplary Sterilization Cabinet FIG. 18 illustrates an exemplary set of components that can be incorporated into the sterilization cabinet (100) of the system (10). In particular, FIG. 18 illustrates an exemplary sterilization cabinet (150) operable to perform the various methods described above and illustrated in FIGS. 2-5. The sterilization cabinet (150) in this example includes a sterilization chamber (152) configured to contain one or more medical instruments for sterilization. Although not shown, the sterilization cabinet (150) also includes a door that opens and closes the sterilization chamber (152) in response to actuation of a kick plate (154). This allows an operator to open and close the sterilization chamber (152) in a hands-free manner. The sterilization cabinet (100) also includes a sterilization module (156) operable to supply a sterilant to the sterilization chamber (152) to sterilize the medical instruments stored therein, as described above. In this example, the sterilization module 156 is configured to receive replaceable sterilant cartridges 158 containing a quantity of sterilant. For purposes of example only, each sterilant cartridge 158 can store enough sterilant to perform five sterilization processes.

[0063] Additionally, the sterilization cabinet (150) of this example also includes a touchscreen display (160). The touchscreen display (160) is operable to display the various user interface display screens described above and shown in Figures 6-18. Of course, the touchscreen display (160) can display various other screens as well. Additionally, the touchscreen display (160) is configured to receive user input in the form of a user contacting the touchscreen display (160) in accordance with conventional touchscreen technology. Additionally or alternatively, the sterilization cabinet (150) can include various other types of user input capabilities, including, but not limited to, buttons, keypads, keyboards, mice, trackballs, etc.

[0064] The sterilization cabinet (150) of this example also includes a processor (162), which is in communication with the sterilization module (156) and the touchscreen display (160). The processor (162) is operable to execute control algorithms that drive the sterilization module (156) according to user input. The processor (162) is also operable to display various screens on the touchscreen display (160) and to execute instructions to process instructions received from a user via the touchscreen display (160) (and / or via other user input functions). As will be described in more detail below and as seen in FIG. 18, the processor (162) is also operable to communicate with various other components of the sterilization cabinet (150) and thereby drive such components and / or process input and / or other data from these components. In view of the teachings herein, various suitable components and configurations that can be used to form the processor (162) will be apparent to those skilled in the art.

[0065] Additionally, the sterilization cabinet (150) of this example also includes a communications module (164). The communications module (164) is configured to enable two-way communications between the sterilization cabinet (150) and the communications hub (104). Additionally or alternatively, the communications module (164) can be configured to enable two-way communications between the sterilization cabinet (150) and the server (106). By way of example only, the communications module (164) can be ,red The communication module 164 may be configured to provide wired and / or wireless communication, such as via an external line, NFC, and / or other technologies. In view of the teachings herein, various suitable components and configurations that may be used to form the communication module 164 will be apparent to those skilled in the art. Communications sent to or received from the communication module 164 are processed via the processor 162.

[0066] Additionally, the sterilization cabinet (150) of this example also includes a reader (166) operable to read the identification tag of the biological indicator as described herein. It is understood that the reader (166) can be used to perform the indicator scanning (blocks 302, 308) steps previously described with reference to FIG. 3. By way of example only, the reader (166) can read the optical identification tag (e.g., a barcode) of the biological indicator. etc. Additionally or alternatively, the reader (166) may be operable to read the RFID identification tag (e.g., barcode) of the biological indicator. etc. ) is also included. In view of the teachings herein, various suitable components and configurations that can be used to form reader 166 will be apparent to those skilled in the art. Data received through reader 166 is processed via processor 162.

[0067] Additionally, the example sterilization cabinet (150) also includes memory (168), which is operable to store control logic and instructions executed by processor (162) to drive components such as sterilization module (156), touchscreen display (160), communication module (164), and reader (166). Additionally, memory (168) may be used to store results related to sterilization cycle settings, load conditioning cycle performance, sterilization cycle performance, and / or various other types of information. In view of the teachings herein, the various suitable forms that memory (168) may take, as well as the various ways in which memory (168) may be used, will be apparent to those skilled in the art.

[0068] Additionally, the example sterilization cabinet (150) also includes a printer (170) operable to print information such as results related to sterilization cycle settings, load conditioning cycle performance, sterilization cycle performance, and / or various other types of information. By way of example only, the printer (170) may include a thermal printer, although it will be appreciated that other suitable types of printers may be used. In light of the teachings herein, the various suitable forms that the printer (170) may take, as well as the various ways in which the printer (170) may be used, will be apparent to those skilled in the art. It will also be understood that the printer (170) is merely optional and may be omitted in some embodiments.

[0069] In addition to the above, the sterilization cabinet (150) may be constructed and operable in accordance with at least part of the teachings of U.S. Pat. No. 6,939,519, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,852,279, the disclosures of which are incorporated herein by reference; U.S. Pat. No. 6,852,277, the disclosures of which are incorporated herein by reference; and / or U.S. Pat. No. 6,447,719, the disclosures of which are incorporated herein by reference.

[0070] IV. Exemplary Biological Indicator Structures As described above, to ensure the success of the sterilization process (block 208), a biological indicator is included in the sterilization cabinet (100, 150) along with the medical device during the sterilization process (block 208). An exemplary biological indicator includes a housing, a cap, an ampoule, and a carrier. The housing is made of a transparent material (e.g., clear plastic, glass, etc.) and is hollow so that the housing can insertably receive the ampoule. Furthermore, the ampoule is made of a transparent material (e.g., clear plastic, glass, etc.) and contains a fluid. By way of example only, the fluid may include a liquid growth medium capable of promoting the growth of any viable microorganisms that it comes into contact with by incubation. The fluid may also include a fluorophore whose fluorescence depends on the amount of microorganisms contained in the medium. The fluid is sealed within the ampoule.

[0071] The carrier provides a source of microorganisms or active enzymes. By way of example only, the carrier can be impregnated with bacterial spores, other forms of bacteria (e.g., vegetative forms), and / or active enzymes. By way of example only, spores from Bacillus, Geobacillus, and Clostridium species can be used. In light of the teachings herein, various suitable methods by which the carrier can be constructed will be apparent to those skilled in the art.

[0072] The ampoule is configured as a frangible component of the biological indicator, allowing the ampoule to be fractured within the housing and release the fluid therein. To facilitate fracture of the ampoule, the cap is configured to slide downward along the housing, depressing the ampoule into the fracture structure. This can be done immediately prior to inserting the biological indicator into the indicator analyzer (102). It is understood that the ampoule remains intact while the biological indicator is in the sterilization cabinet (100) during the sterilization process. The cap can include one or more openings for allowing gas (e.g., air or sterilant) to pass through the housing before the cap is pressed downward against the housing to fracture the ampoule. Such openings can thus kill microorganisms on the carrier during the sterilization process (block 208). However, after the cap is pressed downward against the housing to fracture the ampoule, such openings can be sealed to contain the released fluid within the housing. When the fluid is released from the ampoule, it eventually reaches the carrier and the incubation process begins, as described in more detail below, with any live microorganisms remaining on the carrier.

[0073] The housing may further include an identification tag. Such identification tag may include a machine-readable feature that is readable by the sterilization cabinet (100, 150) and the reader (166) of the indicator analyzer (102). That is, it is understood that the identification tag may be used to perform the indicator scanning (blocks 302, 308) steps previously described with reference to FIG. 3. By way of example only, the identification tag may include an optical code (e.g., a barcode) or a Do et al. ), RFID tags, and / or any other suitable type of machine-readable identifier. Additionally, identification tags may also include human-readable features such as letters, numbers, color codes, etc.

[0074] Additionally, or alternatively, the biological indicator may be constructed and operative in accordance with at least some of the teachings of U.S. Patent No. 15 / 057,768, filed March 1, 2016, entitled "Self-Contained Biological Indicator," the disclosure of which is incorporated herein by reference. Other suitable forms that the biological indicator may take will be apparent to those skilled in the art in view of the teachings herein.

[0075] V. Exemplary Biological Indicator Analyzers The exemplary biological indicator analyzer (102) is operable to perform the biological indicator analysis (block 512) previously described with reference to Figure 5. The biological indicator analyzer (102) of this example includes a plurality of wells, each configured to insertably receive a respective biological indicator. The biological indicator analyzer (102) also includes a processor operable to execute command and control algorithms, process information, and the like.

[0076] Each well has an associated light source and sensor. Each light source is configured to project light through the housing of a biological indicator inserted into the corresponding well, and each sensor is operable to detect light emitted by fluorescence from a fluid contained within the housing. As discussed above, the fluorescence of the fluid will depend on the amount of biological microorganisms contained within the fluid medium. Thus, the sensor can detect biological microorganisms within the fluid depending on the degree to which the fluid fluoresces in response to light from the light source.

[0077] The biological indicator analyzer 102 of this example also includes a touchscreen display. The touchscreen display is operable to display various user interface display screens related to the operation of the biological indicator analyzer 102. The biological indicator analyzer 102 of this example also includes a communications module. The communications module is configured to enable bidirectional communication between the biological indicator analyzer 102 and the communications hub 104. Additionally, or alternatively, the communications module can be configured to enable bidirectional communication between the biological indicator analyzer 102 and the server 106. In view of the teachings herein, various suitable components and configurations that can be used to form the communications module will be apparent to those skilled in the art.

[0078] Additionally, the biological indicator analyzer (102) of this example also includes a reader, which is operable to read an identification tag of the biological indicator, as described herein. It is understood that the reader can be used to identify the biological indicator prior to analyzing the biological indicator (block 512). By way of example only, the reader can read the optical identification tag (e.g., a barcode) of the biological indicator. Do et al. Additionally or alternatively, the reader may be operable to read the RFID identification tag (e.g., barcode) of the biological indicator. Do et al. ) are also included. In view of the teachings herein, a variety of suitable components and configurations that can be used to form a reader will be apparent to those skilled in the art.

[0079] Further by way of example only, biological indicator analyzer (102) may be constructed and operate in accordance with at least some of the teachings of U.S. Provisional Patent Application No. 62 / 316,722, entitled "System and Method for Sterilizing Medical Devices," filed April 1, 2016, the disclosure of which is incorporated herein by reference. Other suitable forms that biological indicator analyzer (102) may take will be apparent to those skilled in the art in view of the teachings herein.

[0080] VI. Exemplary Combinations The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It is understood that the following examples are not intended to limit the scope of all claims that may be presented at any time in this or any subsequent application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that some variations may omit certain features referred to in the following examples. Therefore, none of the aspects or features referred to below should be considered essential unless the inventor or the inventor's successor in interest later expressly states otherwise as such. If a claim including new features other than those referred to below is presented in this application or in a subsequent application related to this application, these new features should not be considered added for any reasons related to patentability. [Example]

[0081] (Example 1) The system includes: (a) a sterilization cabinet, the sterilization cabinet including a sterilization chamber and operable to sterilize medical instruments placed within the sterilization cabinet; (b) a biological indicator analyzer operable to detect the presence of a living organism in a biological indicator structure; and (c) a communications hub, the sterilization cabinet in communication with the communications hub, and the biological indicator analyzer also in communication with the communications hub, the communications hub operable to transmit information from the biological indicator analyzer to the sterilization cabinet.

[0082] (Example 2) The system of Example 1 further includes a server, the server in communication with the communications hub.

[0083] (Example 3) In the system of Example 2, the communications hub is operable to transmit information from the biological indicator analyzer to the server.

[0084] (Example 4) In the system of any one or more of Examples 2-3, the communications hub is operable to transmit information from the sterilization cabinet to the server.

[0085] (Example 5) In the system of any one or more of Examples 2-4, the communications hub is operable to transmit information from the server to the sterilization cabinet.

[0086] (Example 6) In the system of any one or more of Examples 2-4, the communications hub is operable to transmit information from the server to the biological indicator analyzer.

[0087] (Example 7) In a sterilization cabinet, the sterilization cabinet includes a sterilization chamber, the sterilization cabinet is operable to sterilize medical instruments placed in the sterilization chamber, and further, the sterilization cabinet is operable to condition the medical instruments prior to sterilizing the medical instruments.

[0088] (Example 8) In Example 7, the sterilization cabinet is operable to detect moisture on the medical device and remove the moisture from the medical device to condition the medical device prior to sterilizing the medical device.

[0089] (Example 9) The sterilization cabinet includes: (a) a sterilization chamber operable to sterilize medical instruments placed in the sterilization chamber; and (b) a reader operable to read an identification tag of a biological indicator.

[0090] (Example 10) In the sterilization cabinet of Example 9, the reader is operable to scan an optical code on the biological indicator.

[0091] (Example 11) The sterilization cabinet of any one or more of Examples 9 to 10 further includes a graphical user interface configured to instruct a user to operate the reader to read the identification tag of the biological indicator.

[0092] (Example 12) In Example 11, the sterilization cabinet is further configured to prompt the user to select a sterilization cycle from a plurality of available sterilization cycles.

[0093] (Example 13) In Example 12, the sterilization cabinet is configured to identify a particular type of biological indicator associated with a particular sterilization cycle selected by the user, and the graphical user interface is further configured to instruct the user to operate the reader to read an identification tag of the particular type of biological indicator associated with the particular sterilization cycle selected by the user.

[0094] (Example 14) A method for processing medical devices, the method comprising: (a) receiving input from a user selecting a particular sterilization cycle from a plurality of available sterilization cycles; (b) identifying a particular type of biological indicator associated with the selected sterilization cycle; (c) instructing the user to place the medical devices and the identified biological indicators into a sterilization chamber of a sterilization cabinet; (d) performing a load adjustment of the medical devices in the sterilization chamber, whereby moisture is removed from the medical devices; and (e) performing the selected sterilization cycle on the medical devices in the sterilization chamber after completing the load adjustment operation.

[0095] (Example 15) The method of Example 14 further includes instructing the user to scan an identification tag of the identified biological indicator before instructing the user to place the medical device and the identified biological indicator into the sterilization chamber.

[0096] (Example 16) The method of Example 15 further includes evaluating facility policies regarding use of biological indicators, and the operation of instructing the user to scan an identification tag of the identified biological indicator is performed based on the evaluation of the facility policies regarding the user of the biological indicator.

[0097] (Example 17) In one or more of the methods of Examples 15 to 16, the sterilization cabinet includes a graphical user interface, and the step of instructing the user to scan the identification tag of the identified biological indicator is performed via the graphical user interface.

[0098] (Example 18) In one or more of the methods of Examples 14-17, the sterilization chamber includes a touch screen.

[0099] (Example 19) In the method of Example 18, the input from the user selecting the particular sterilization cycle is received via the touchscreen.

[0100] (Example 20) In one or more of the methods of Examples 18 to 19, the step of instructing the user to place the medical device and the identified biological indicator into a sterilization chamber of a sterilization cabinet is performed via the touch screen.

[0101] (Example 21) The method of any one or more of Examples 18-20 further includes presenting information regarding each of the available sterilization cycles to the user via the touch screen.

[0102] (Example 22) The method of any one or more of Examples 18 to 21 further includes, after performing the selected sterilization cycle on the medical device, presenting information regarding the completed sterilization cycle to the user, wherein the step of presenting information regarding the completed sterilization cycle to the user is performed via the touch screen.

[0103] (Example 23) A method for processing a medical device, the method comprising: (a) receiving input from a user selecting a particular sterilization cycle from a plurality of available sterilization cycles; (b) identifying a particular type of biological indicator associated with the selected sterilization cycle; (c) instructing the user to use a reader in a sterilization cabinet to read an identification tag of the identified type of biological indicator; (d) receiving information from the reader based on the user's use of the reader to read the identification tag of the biological indicator; (e) instructing the user to place the medical device and the identified biological indicator into a sterilization chamber of the sterilization cabinet; and (f) performing the selected sterilization cycle on the medical device in the sterilization chamber.

[0104] (Example 24) The method of Example 23 further includes performing a stress conditioning on the medical devices within the sterilization chamber, the stress conditioning including removing moisture from the medical devices.

[0105] (Example 25) In the method of Example 24, the selected sterilization cycle is performed after the load adjustment operation is completed.

[0106] (Example 26) The method of any one or more of Examples 23 to 25 further includes determining whether the information received from the reader indicates that the user has selected the particular type of biological indicator associated with the selected sterilization cycle.

[0107] (Example 27) In the method of Example 26, the determining operation indicates that the user did not select the particular type of biological indicator associated with the selected sterilization cycle, the method further including the step of notifying the user that the user did not select the particular type of biological indicator associated with the selected sterilization cycle.

[0108] (Example 28) A method for processing a medical device, the method comprising the steps of: (a) receiving input from a user selecting a particular sterilization cycle from a plurality of available sterilization cycles; (b) identifying a particular type of biological indicator associated with the selected sterilization cycle; (c) instructing the user to place the medical device and the identified biological indicator into a sterilization chamber of the sterilization cabinet; (d) performing the selected sterilization cycle on the medical device in the sterilization chamber; and (e) determining whether the identified biological indicator contains any living organisms after performing the selected sterilization cycle.

[0109] (Example 29) In the method of Example 28, determining whether the identified biological indicators include any living organisms includes assessing fluorescence associated with the identified biological indicators.

[0110] (Example 30) In one or more of the methods of Examples 28 to 29, the operation of determining whether the identified biological indicators include any living organism indicates that the identified biological indicators include a living organism, and the method further includes a step of notifying the user that the identified biological indicators include a living organism.

[0111] (Example 31) In the method of Example 30, the act of notifying the user that the identified biological indicator contains a living organism is performed via the sterilization cabinet.

[0112] (Example 32) In one or more of the methods of Examples 28 to 31, the operation of determining whether the identified biological indicator contains any living organisms is performed using a biological indicator analyzer, and the biological indicator analyzer is independent of the sterilization chamber.

[0113] (Example 33) A method for processing medical devices, the method comprising the steps of: (a) receiving an input from a user selecting a sterilization cycle from a plurality of available sterilization cycles; (b) identifying a biological indicator associated with the selected sterilization cycle; (c) instructing the user via a touch screen display to place the medical device and the biological indicator into a sterilization chamber of a sterilization cabinet; (d) performing a load adjustment of the medical device in the sterilization chamber; and (e) performing the selected sterilization cycle on the medical device in the sterilization chamber after completing the load adjustment operation.

[0114] (Example 34) The method of Example 33 further includes presenting information regarding each of the available sterilization cycles to the user via the touch screen.

[0115] (Example 35) The method of any one or more of Examples 33-34 further includes receiving an indicator data set from the reader based on the user's use of a reader of the sterilization cabinet to read the identification tag of the biological indicator.

[0116] (Example 36) In Example 35, the method includes the indicator data set including an indicator type, and further includes limiting the plurality of available sterilization cycles based on the indicator type.

[0117] (Example 37) In one or more of the methods of Examples 35-36, the indicator data set includes an indicator end date, and the method further includes a step of instructing the user to obtain a new biological indicator when the indicator end date indicates that the biological indicator has expired.

[0118] (Example 38) In the method of any one or more of Examples 35 to 37, the indicator data set includes an indicator cancellation status, and the method further includes a step of instructing the user to obtain a new biological indicator when the indicator cancellation status indicates that the biological indicator has been cancelled by the provider.

[0119] (Example 39) In the method of any one or more of Examples 35-38, the indicator dataset includes an indicator source, and the method further includes prompting the user to obtain a new biological indicator if the indicator source is not within a set of approved indicator sources.

[0120] (Example 40) The method of any one or more of Examples 33 to 39 further includes instructing the user via the touchscreen display to read the identification tag of the biological indicator using a reader in the sterilization cabinet.

[0121] (Example 41) The method of Example 41 further includes displaying soft indicator requirements on the touchscreen display if (i) the sterilization cabinet does not read the identification tag of the biological indicator, and (ii) the sterilization cabinet receives an indication from the user that the sterilization cycle should be initiated.

[0122] (Example 42) The method of any one or more of Examples 40 to 42 further includes a step of displaying a hard indicator requirement on the touchscreen display if (i) the sterilization cabinet does not read the identification tag of the biological indicator, and (ii) the sterilization cabinet receives an indication from the user that the sterilization cycle should be initiated, the hard indicator requirement preventing the sterilization cycle from being performed.

[0123] (Example 43) The method of Example 42 further includes removing the hard indicator requirement if (i) the sterilization cabinet reads the identification tag of the biological indicator, or (ii) the sterilization cabinet receives a bypass code from the user.

[0124] (Example 44) The method of any one or more of Examples 33 to 43 further includes a step of displaying a load placement image via the touchscreen display, the load placement image including (i) the position of one or more surgical instruments and (ii) the position of the biological indicator.

[0125] (Example 45) In one or more of the methods of Examples 33 to 44, the operation of performing load adjustment includes one or more of the following steps: (i) removing moisture from the medical device; and (ii) increasing the temperature within the sterilization chamber.

[0126] (Example 46) The method of any one or more of Examples 33 to 45 further includes (a) receiving a set of position data from a position sensor of the sterilization cabinet, the set of position data indicating the positions of the medical device and the biological indicator, and (b) determining whether to perform the sterilization cycle based on the set of position data.

[0127] (Example 48) A sterilization cabinet for sterilizing medical instruments includes a processor, a sterilization chamber, and a touchscreen display, the processor configured to execute instructions to: (a) display a set of sterilization cycles; (b) receive a sterilization cycle selection; (c) display a biological indicator type based on the sterilization cycle selection, the biological indicator type indicating a biological indicator associated with the sterilization cycle selection; (d) display a set of placement instructions, the set of placement instructions including a location of the medical instrument and a location of a biological indicator; (e) perform a load adjustment of the medical instrument within the sterilization chamber; and (f) perform a sterilization cycle on the medical instrument within the sterilization chamber based on the sterilization cycle selection.

[0128] (Example 49) The sterilization cabinet of Example 48 further includes a reader, and the processor is further configured to receive an indicator data set from the reader when a user uses the reader to read an identification tag of the biological indicator.

[0129] (Example 50) In the sterilization cabinet of Example 49, the indicator data set includes an indicator expiration date, and the processor is further configured to execute instructions to, when the indicator expiration date indicates that the biological indicator has expired, display information indicating that the biological indicator has expired.

[0130] (Example 51) In the sterilization cabinet of any one or more of Examples 49 to 50, the indicator data set includes an indicator cancellation status, and the processor is further configured to execute instructions to display information indicating that the biological indicator is defective when the indicator cancellation status indicates that the biological indicator has been cancelled by a provider.

[0131] (Example 52) In the sterilization cabinet of any one or more of Examples 49 to 51, the indicator data set includes an indicator source, and the processor is further configured to execute instructions to display information indicating that the biological indicator is non-compliant if the indicator source is not within a set of approved indicator sources.

[0132] (Example 53) The sterilization cabinet includes (a) a sterilization chamber, (b) a touch screen display, (c) a biological indicator reader, and (d) means for guiding a user through a sterilization cycle selection process, selecting a verified biological indicator, placing a medical instrument in the sterilization chamber, placing the biological indicator in the sterilization chamber, and initiating the sterilization cycle.

[0133] VII. Other It will be understood that all patents, publications, or other disclosures set forth herein as being incorporated by reference are incorporated herein in whole or in part, unless the incorporated content conflicts with existing definitions, presentations, or other disclosures set forth in this disclosure. Accordingly, to the extent necessary, the disclosures expressly set forth herein take precedence over all conflicting content incorporated by reference herein. Unless a conflict arises between the incorporated content and the existing disclosures, all content, or portions thereof, set forth herein as being incorporated by reference that conflicts with existing definitions, presentations, or other disclosures set forth in this disclosure is incorporated.

[0134] While various embodiments of the present invention have been shown and described above, appropriate modifications may be made by those skilled in the art to further adapt the methods and systems described herein without departing from the scope of the present invention. While some of such contemplated modifications have been described, other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, structures, materials, dimensions, proportions, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should not be understood to be limited to the details of structure and operation shown and described in the specification and drawings.

[0135] [Embodiment] (1) A method for treating a medical device, said method comprising: (a) receiving an input from a user selecting a sterilization cycle from a plurality of available sterilization cycles; (b) identifying a biological indicator associated with the selected sterilization cycle; (c) instructing the user via a touch screen display to place the medical device and the biological indicator in a sterilization chamber of a sterilization cabinet; (d) adjusting the load on the medical devices in the sterilization chamber; (e) after completing the load adjustment operation, subjecting the medical instruments in the sterilization chamber to the selected sterilization cycle. (2) The method of claim 1, further comprising the step of presenting information regarding each of the available sterilization cycles to the user via the touchscreen. (3) The method of embodiment 1, further comprising receiving an indicator data set from the reader based on the user's use of a reader of the sterilization cabinet to read the identification tag of the biological indicator. (4) The method of claim 3, wherein the indicator data set includes an indicator type, and further comprising limiting the plurality of available sterilization cycles based on the indicator type. (5) The method of embodiment 3, wherein the indicator dataset includes an indicator end date, and the method further includes the step of instructing the user to obtain a new biological indicator when the indicator end date indicates that the biological indicator has expired.

[0136] (6) The method of embodiment 3, wherein the indicator data set includes an indicator cancellation status, and the method further includes a step of instructing the user to obtain a new biological indicator when the indicator cancellation status indicates that the biological indicator has been cancelled by the provider. (7) The method of embodiment 3, wherein the indicator dataset includes an indicator source, and the method further includes the step of instructing the user to obtain a new biological indicator if the indicator source is not within a set of approved indicator sources. (8) The method of claim 1, further comprising the step of instructing the user via the touchscreen display to read the identification tag of the biological indicator using a reader in the sterilization cabinet. (9) (i) the sterilization cabinet does not read the identification tag of the biological indicator; and (ii) when the sterilization cabinet receives an indication from the user that the sterilization cycle should be initiated, displaying soft indicator requirements on the touchscreen display. (10) (i) the sterilization cabinet does not read the identification tag of the biological indicator; and (ii) when the sterilization cabinet receives an indication from the user that the sterilization cycle should begin, displaying a hard indicator requirement on the touch screen display; 9. The method of claim 8, wherein the hard indicator requirement prevents the sterilization cycle from being performed.

[0137] (11) (i) The sterilization cabinet reads the identification tag of the biological indicator, or 11. The method of claim 10, further comprising the step of: (ii) removing the hard indicator requirement if the sterilization cabinet receives a bypass code from the user. (12) The method further includes displaying a load placement image via the touch screen display, wherein the load placement image is (i) the location of one or more surgical instruments; and (ii) the location of the biological indicator. (13) The operation of performing load adjustment includes: (i) removing moisture from the medical device; and (ii) elevating the temperature within the sterilization chamber. (14) (a) receiving a set of location data from a location sensor in the sterilization chamber, the set of location data indicating the location of the medical device and the biological indicator; (b) determining whether to perform the sterilization cycle based on the set of configuration data. (15) A sterilization cabinet for sterilizing medical equipment, comprising: a processor; a sterilization chamber; and a touch screen display, wherein the processor: (a) displaying a set of sterilization cycles; (b) receiving a sterilization cycle selection; (c) displaying a biological indicator type based on the sterilization cycle selection, the biological indicator type indicating a biological indicator associated with the sterilization cycle selection; (d) displaying a set of placement instructions, the set of placement instructions including a location for the medical device and a location for a biological indicator; (e) performing a load balancing process for the medical devices in the sterilization chamber; (f) performing a sterilization cycle on the medical instruments in the sterilization chamber based on the sterilization cycle selection.

[0138] (16) The sterilization cabinet of claim 15, further comprising a reader, wherein the processor is further configured to receive an indicator data set from the reader when a user uses the reader to read an identification tag of the biological indicator. (17) The sterilization cabinet of embodiment 16, wherein the indicator data set includes an indicator end date, and the processor is further configured to execute instructions to display information indicating that the biological indicator has ended when the indicator end date indicates that the biological indicator has ended. (18) The sterilization cabinet of embodiment 16, wherein the indicator data set includes an indicator cancellation status, and the processor is further configured to execute instructions to display information indicating that the biological indicator is defective when the indicator cancellation status indicates that the biological indicator has been canceled by a provider. (19) The sterilization cabinet of embodiment 16, wherein the indicator data set includes an indicator source, and the processor is further configured to execute instructions to display information indicating that the biological indicator is incompatible if the indicator source is not within a set of approved indicator sources. (20) A sterilization cabinet, (a) a sterilization chamber; (b) a touchscreen display; and (c) a biological indicator reader; (d) a sterilization cabinet including means for performing the steps of guiding a user through a sterilization cycle selection process, selecting a verified biological indicator, placing a medical instrument in the sterilization chamber, placing the biological indicator in the sterilization chamber, and initiating the sterilization cycle.

Claims

1. 1. A system comprising: (a) a sterilization cabinet operable to sterilize medical devices; (b) a biological indicator analyzer operable to detect the presence of a living organism within the biological indicator structure; (c) a communications hub in communication with the sterilization cabinet and the biological indicator analyzer, the communications hub operable to transmit information from the biological indicator analyzer to the sterilization cabinet; a server in communication with the communication hub; the communications hub is operable to transmit information from the sterilization cabinet to the server; The information from the sterilization chamber is the duration and results of the sterilization procedure, whether a particular sterilization procedure provided new indications of contamination of biological indicators; Identification of the user or technician who initiated, cancelled or completed the sterilization procedure; Consumable materials or supplies used during the sterilization procedure; and / or diagnostic information and system errors, Including, the system.

2. The system of claim 1 , wherein the communication hub is operable to transmit information from the biological indicator analyzer to the server.

3. 3. The system of claim 2, wherein the biological indicator analyzer comprises a tabletop or wall-mounted device that receives the biological indicator.

4. The system of claim 1 , wherein the information from the biological indicator analyzer includes data regarding contamination of a biological indicator.

5. The system of claim 1 , wherein the communications hub is operable to transmit information from the server to the sterilization vault.

6. The system of claim 5 , wherein the information from the server includes software updates, configuration updates, user authentication information, and / or biometric usage protocols.

7. 10. The system of claim 1, wherein the communication hub and the biological indicator analyzer are components of the sterilization cabinet.

8. 10. The system of claim 1, wherein the sterilization cabinet comprises a sterilization chamber sized and shaped to sterilize the medical device placed within the sterilization chamber.

9. 10. The system of claim 1, wherein the communication hub is operable to transmit information from the biological indicator analyzer to the sterilization cabinet via wired and / or wireless communication techniques.

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