RU2683644C2 - Apparatus and method for analysing biological indicators - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: group of inventions relates to monitoring the environment inside a sterilisation system to ensure effective sterilisation of medical devices. Disclosed is a biological indicator analyser, comprising: (a) a plurality of wells, configured to receive a respective biological indicator; (b) a plurality of organism detector features, each configured to detect whether a biological indicator disposed in a corresponding well of the plurality of wells contains a living organism; (c) a touch screen, configured to receive user input and provide information to the user indicating a status of biological indicator analysis; (d) a processor, configured to receive a well selection and an indicator selection from a user; configured to detect whether a control indicator is placed in the well, performing incubation of the control indicator and analysing the control indicator in order to determine the presence of biological contamination; configured to display a notification that a second control indicator from a batch of indicators in another well should be tested, in the absence of biological contamination in the control indicator. Versions of the method for analysing a biological indicator using an indicator analyser are also disclosed.EFFECT: higher efficiency and reliability of the analysis.14 cl, 21 dwg, 26 ex

Description

A PRIORITY

This application claims priority to provisional application for US patent No. 62 / 302,257, entitled "System and Method for Sterilizing Medical Devices", filed March 2, 2016, the description of which is incorporated herein by reference.

This application also claims priority for provisional application for US patent No. 62 / 316,722, entitled "System and Method for Sterilizing Medical Devices", filed April 1, 2016, the description of which is incorporated herein by reference.

This application also claims priority for provisional application for US patent No. 62 / 376,517, entitled "Apparatus and Method to Link Medical Device Sterilization Equipment", filed August 18, 2016, the description of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

Reusable medical devices, such as some surgical instruments, endoscopes, etc., are sterilized before re-use in order to minimize the likelihood of using a contaminated instrument when working with the patient, which can lead to infection of the patient. Various sterilization techniques may be used, such as steam sterilization, hydrogen peroxide sterilization, gaseous sterilization with or without gas plasma, and ethylene oxide (EtO) sterilization. Each of these methods can to some extent depend on the propagation speeds of sterilizing fluids (e.g. gases) through sterilized medical devices.

Before sterilization, medical devices can be packaged inside containers or bags that have a semi-permeable barrier that allows a sterilizing fluid, sometimes called a “sterilizing agent,” to pass through it, but prevents the entry of contaminating microorganisms, especially after sterilization, until the packaging is opened. medical staff. For the sterilization cycle to be effective, it is necessary to destroy the contaminating microorganisms inside the package, since any organisms that survive the sterilization cycle can multiply and re-contaminate the medical device.

Although the package can help prevent contamination of the sterile medical device, the package can make it difficult to complete a successful sterilization cycle because the package can prevent the sterilizing agent from reaching the medical device in the package. This can be especially problematic in the case of medical devices having restricted distribution spaces, since these limited distribution spaces can reduce the likelihood of an effective sterilization cycle. For example, some endoscopes have a long narrow lumen into which the sterilizing agent must spread in sufficient concentration for a sufficient time to ensure a successful sterilization cycle.

Sterilization of medical devices can be performed using an automated sterilization system, such as the STERRAD® system of Advanced Sterilization Products, Irvine, California, USA. Examples of automated sterilization systems are described in US Pat. No. 6,939,519, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma", issued September 6, 2005, the contents of which are incorporated herein by reference; US patent No. 6,852,279, entitled "Sterilization with Temperature-Controlled Diffusion Path", issued February 8, 2005, the description of which is incorporated herein by reference; US patent No. 6,852,277, entitled "Sterilization System Employing a Switching Module Adapter to Pulsate the Low Frequency Power Applied to a Plasma", issued February 8, 2005, the contents of which are incorporated herein by reference; and U.S. Patent No. 6,447,719, entitled "Power System for Sterilization Systems Employing Low Frequency Plasma", issued September 10, 2002, the contents of which are incorporated herein by reference. Medical devices must be carefully placed and monitored inside the sterilization system in order to maintain an environment that provides effective sterilization. For each individual medical device, a separate placement and method of sterilization may be required, that is, errors may occur when using the sterilization system, and its effectiveness largely depends on the training and competence of the operator or on the supporting documentation.

In addition, reuse of the same sterilizing chamber of the sterilization system can cause cross contamination, especially if the sterilization system is not used properly. Operator error can lead to the fact that medical devices that are mistakenly considered cleaned from contamination can be transferred to the work. Confirming the effectiveness of a sterilization cycle can allow medical personnel to avoid using a contaminated medical device when working with a patient. The sterilized medical device itself may not be checked for contaminating microorganisms, since such actions may result in other contaminating microorganisms entering the medical device, as a result of which it is re-contaminated. Therefore, you can perform an indirect check using the sterilization indicator. A sterilization indicator is a device that is placed next to or near a medical device undergoing a sterilization cycle so that the sterilization indicator goes through the same sterilization cycle as the medical device. For example, a biological indicator with a given number of microorganisms is placed in a sterilization chamber near a medical device and a sterilization cycle is started. After completion of the cycle, microorganisms are cultured on a biological indicator to determine if any microorganisms survived the sterilization cycle.

In view of the foregoing, it may be desirable to provide a sterilization system that minimizes the likelihood of operator error, thereby increasing the likelihood of successful sterilization cycles, thereby minimizing the risk of patient infection. Although many systems and methods have been created and used to sterilize surgical instruments, it is believed that no one prior to the inventor (s) has created or applied the technology described in this document.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed that a better understanding of the present invention will serve the following description of specific examples in combination with the attached drawings, in which the same reference numbers denote the same elements and on which:

in FIG. 1 is a schematic diagram of an illustrative sterilization system;

in FIG. 2 shows a high level flow chart of an illustrative series of steps that a sterilizing cabinet of the system of FIG. 1, for sterilizing a medical device;

in FIG. 3 shows a schematic diagram of an illustrative node of a biological indicator that can be used in the system depicted in FIG. one;

in FIG. 4 is a schematic diagram of an illustrative indicator analyzer that can be used to process the biological indicator assembly shown in FIG. 3, as part of the system depicted in FIG. one;

in FIG. 5 is a perspective view of an illustrative form that the indicator analyzer shown in FIG. four;

in FIG. 6 is a flow chart of illustrative steps that the indicator analyzer shown in FIG. 4, in preparation for the analysis of the node of the biological indicator depicted in FIG. 3;

in FIG. 7 is a flow chart of illustrative steps that the indicator analyzer shown in FIG. 4, based on whether the results of the analysis of the node of the biological indicator shown in FIG. Are satisfactory or unsatisfactory. 3;

in FIG. 8 shows a high level flowchart of illustrative steps that the indicator analyzer depicted in FIG. 4, to obtain results for a biological indicator;

in FIG. 9 is a flowchart of illustrative steps that the indicator analyzer depicted in FIG. 4, to force the use of the control indicator before the standard test;

in FIG. 10 is a flowchart of illustrative steps that the indicator analyzer shown in FIG. 4, for incubation and analysis of the test indicator;

in FIG. 11 is a flow chart of illustrative steps that the indicator analyzer shown in FIG. 4, to finalize and display the results of the analysis;

in FIG. 12 is a screen shot of an illustrative user interface that can be displayed on a display of the indicator analyzer shown in FIG. 4, allowing the user to select a cell for analysis;

in FIG. 13 is a screen shot of an illustrative user interface that can be displayed on a display of the indicator analyzer shown in FIG. 4, to accompany the user while scanning the barcode indicator;

in FIG. 14 is a screen shot of an illustrative user interface that can be displayed on a display of the indicator analyzer shown in FIG. 4, to indicate to the user that one or more of the incubation or analysis processes is being performed;

in FIG. 15 is a screen shot of an illustrative user interface that can be displayed on a display of the indicator analyzer shown in FIG. 4, to accompany the user during activation of the indicator;

in FIG. 16 is a screen shot of an illustrative user interface that can be displayed on a display of the indicator analyzer shown in FIG. 4, to display the detailed status of the indicator during incubation and analysis;

in FIG. 17 is a graph depicting relative units of fluorescence over time for several biological indicators containing active enzymes that were detected by the indicator analyzer shown in FIG. four;

in FIG. 18 is a graph showing relative fluorescence units over time for several biological indicators containing inactive enzymes that were detected by the indicator analyzer shown in FIG. four;

in FIG. 19 is a graph showing a change in the slope of the relative fluorescence units for the biological indicators depicted in FIG. 17 and 18;

in FIG. 20 is a graph depicting relative units of fluorescence over time along with a conjugate formula that the indicator analyzer shown in FIG. 4, together with the detection of the presence of an active enzyme in accordance with the first illustrative method; and

in FIG. 21 is a graph depicting relative fluorescence units over time along with a conjugate formula that the indicator analyzer depicted in FIG. 4, together with detecting the presence of an active enzyme in accordance with a second illustrative method.

DETAILED DESCRIPTION

The following description of specific examples of technology should not be used to limit its scope. Other examples, elements, aspects, embodiments and advantages of the technology will become apparent to those skilled in the art from the description below, in which, for illustrative purposes, one of the best methods provided for implementing the technology is proposed. Once implemented, the technology described herein may have various other and obvious aspects, all of which are part of the technology. Accordingly, the drawings and descriptions should be considered as, in fact, illustrative, and not restrictive.

It should also be understood that any one or more of the ideas, expressions, embodiments, examples, etc. described herein may be combined with any one or more of other ideas, expressions, embodiments, examples, etc. d. described in this document. Therefore, you should not consider the ideas described below, expressions, options for implementation, examples, etc., separately relative to each other. In light of the teachings of this document, those of ordinary skill in the art will recognize various acceptable ways in which the ideas of this paper can be combined. It is intended that such modifications and variations be included within the scope of the claims.

I. Overview of illustrative sterilization systems and devices

In FIG. 1 is a schematic diagram of an illustrative system (10) of interconnected devices, which can be configured to implement methods for sterilizing medical devices. The system (10) in accordance with this example includes a sterilizing cabinet (100), a biological indicator analyzer (102), a communication hub (104), and a server (106). In the present example, the sterilizing cabinet (100) includes a sterilizing chamber that is configured to receive one or more of the medical sterilization devices. The sterilizing cabinet (100) also includes a door that opens and closes the sterilizing chamber in response to exposure to the safety plate. Thanks to this, the operator can open and close the sterilizing chamber without the help of hands. The sterilizing cabinet (100) also includes a sterilizing module, which is configured to dose the sterilizing agent into the sterilizing chamber to sterilize medical devices placed in the sterilizing chamber. In the present example, the sterilizing module is configured to receive replaceable cartridges with a sterilizing agent containing a certain amount of sterilizing agent.

The sterilizing cabinet (100) according to the present example further includes a touch screen display. A touch screen display is configured to form various user interface display screens. The touch screen display is further configured to receive user input in the form of a user tapping the touch screen display in accordance with conventional sensory-visual technology. The sterilizing cabinet (100) according to the present example further includes a communication module. The communication module is configured to provide two-way communication between the sterilizing cabinet (100) and the communication concentrator (104). In addition or alternatively, the communication module is configured to provide two-way communication between the sterilizing cabinet (100) and the server (106).

The sterilizing cabinet (100) in accordance with this example further includes a reader configured to read the identification tag of the biological indicator, as described herein. By way of example only, the reader may comprise an optical reader configured to read an optical identification tag (e.g., barcode, QR code, etc.) of a biological indicator. In addition or alternatively, the reader may comprise a radio frequency tag (RFID) reader configured to read a radio frequency identification tag (RFID) (e.g., barcode, QR code, etc.) of a biological indicator. Various suitable components and configurations that may be used to make the reader will be apparent to those of ordinary skill in the art in the context of the ideas presented herein. The data obtained using the reader is processed by the processor.

In addition to the foregoing, the sterilizing cabinet (100) can be manufactured and applied in accordance with at least some of the ideas set forth in any of the provisional patent applications of the United States referred to in this document, as well as in US patent No. 6,939,519, the contents of which incorporated herein by reference; US patent No. 6,852,279, the contents of which are incorporated herein by reference; US patent No. 6,852,277, the contents of which are incorporated herein by reference; and / or US Patent No. 6,447,719, the contents of which are incorporated herein by reference.

 The server (106) may include a hospital registration server or a hospital local area network server. The server (106) can receive information from the sterilizing cabinet (100) regarding sterilization procedures performed by the sterilizing cabinet (100), for example, the duration and results of the sterilization procedure; Does the specific sterilization procedure provide a subsequent indication of biological contamination? identification of the user or technician who has started, interrupted or completed the sterilization procedure; supplies or accessories used during the sterilization procedure; diagnostic information and system errors and / or other information. The server (106) can also provide the sterilizing cabinet (100) with information, such as software updates, configuration updates, user authentication information, protocols for using biological indicators, and other information. The connection between the sterilizing cabinet (100) and the server (106) can be established using any suitable wired and / or wireless communication technology, such as Ethernet, Wi-Fi, Bluetooth, USB, infrared, NFC and / or other technologies.

In the system (10) in accordance with the present example, the sterilizing cabinet (100) also exchanges data with a communication concentrator (104), which, in turn, exchanges data with one or more of the biological indicator analyzers (102). As described in detail below, the biological indicator analyzer (102) may comprise a desktop or wall-mounted device that houses a biological indicator and that measures one or more of the characteristics of the biological indicator to collect data that can be used to determine if the biological indicator tests positive, which indicates the presence of contamination after the sterilization procedure, or negative, which indicates the absence of contamination after the sterilization procedure.

In some embodiments, the biological indicator analyzer (102) measures and transmits data to a communication hub (104), which processes the data to determine if there is contamination. In other embodiments, the biological indicator analyzer (102) itself can measure and analyze data, determining the presence of contamination, and the communication hub (104) can be used to receive, collect and transmit such information to the sterilizing cabinet (100) and / or other devices, as will be described in detail below. In other embodiments, the biological indicator analyzer (102) and the communication hub (104) may be various components of a separate device or may be components of a sterilizing cabinet (100). Such options may be desirable depending on the specific application environment and user needs, for example, a separate device combining a sterilizing cabinet (100), a communication concentrator (104) and a biological indicator analyzer (102) may be desirable as part of a semi-stationary unit; whereas in a large hospital with many users, an embodiment supporting the relationship between the sterilizing cabinet (100) and the one-to-many biological indicator analyzer (102) may be more preferable for a stationary installation.

After receiving data from the analyzer (102) of biological indicators used to identify sterilization cycles, the success of which may be in doubt, and therefore medical devices, the sterility of which may be in doubt, the communication concentrator (104) can automatically send notifications to various other devices so that prevent the use of such medical devices before performing another sterilization process. By way of example only, the communication hub (104) can send a notification to the sterilizing cabinet (100) indicating sterilization cycles, the success of which may be in doubt, and therefore medical devices, the sterility of which may be in doubt. The sterilizing cabinet (100) may transmit this notification to the user. In addition or as an alternative, the concentrator (104) may send a notification to the server (106) indicating sterilization cycles, the success of which may be in doubt, and therefore medical devices, the sterility of which may be in doubt. Of course, the communication concentrator (104) can also send a notification to the server (106) indicating that the biological indicator has passed analysis and / or other information related to the operation of the sterilizing cabinet (100) and / or the biological indicator analyzer (102).

In addition or as an alternative, the communication hub (104) may send a notification to one or more of the mobile devices, such as the system operator (10), etc., indicating sterilization cycles whose success may be in doubt, and therefore medical devices whose sterility may be in doubt. In some embodiments, the communication hub (104) sends such notifications to a mobile device associated with a person who has been identified as the user of the sterilizing cabinet (100) and / or with a person who has been identified as a user of the biological indicator analyzer (102). Of course, the communication hub (104) can also send a notification to one or more of the mobile devices indicating that the biological indicator has passed the analysis and / or other information related to the operation of the sterilizing cabinet (100) and / or the biological indicator analyzer (102) .

Both the biological indicator analyzer (102) and the sterilizing cabinet (100) can be connected to the communication hub (104) via any suitable wired and / or wireless communication technology, such as Ethernet, Wi-Fi, Bluetooth, USB, infrared, NFC and / or other technologies. It should also be understood that the communication hub (104) can communicate with various other components via wired or wireless communications, including, without limitation, desktop computers, laptop computers, mobile computing devices, smartphones, etc. In addition, the hub (104) ) communications may communicate with the server (106) via wired or wireless communications. In embodiments in which the communication hub (104) communicates with the server (106), the communication hub (104) can transmit data, etc. between the sterilizing cabinet (100) and the server (106); thus, the communication hub (104) acts as an intermediary between the sterilizing cabinet (100) and the server (106). Therefore, it should be understood that in some embodiments, the sterilizing cabinet (100) can exchange data with the server (106) via a communication hub (104) instead of directly exchanging data with the server (106).

By way of example only, a communication concentrator (104) can be designed and applied in accordance with at least some of the ideas set forth in provisional patent application US No. 62 / 376,517, entitled "Apparatus and Method to Link Medical Device Sterilization Equipment "Filed August 18, 2016, the description of which is incorporated herein by reference. Various suitable components and configurations that may be used to make the communication hub (104) will be apparent to those of ordinary skill in the art in the context of the ideas presented herein.

II. Illustrative sterilization processes and interfaces

 In FIG. 2 shows a high level block diagram of an illustrative series of steps that the system (10) can perform to sterilize a medical device. The user can interact with the system through a user interface such as a keyboard or touch screen of a sterilizing cabinet (100), as described in detail below; or via an input device in conjunction with a sterilizing cabinet (100). First, the sterilizing cabinet (100) may display one or more of the sterilization cycles via a display, and then receive a selection of the sterilization cycle (block 200) from the user. The sterilizing cabinet (100) may be configured to perform one or more of the sterilization cycles, while different sterilization cycles are suitable for different types and numbers of medical devices.

The sterilizing cabinet (100) may also display instructions indicating whether the biological indicator should be used with the selected sterilization cycle and accept the identification of the biological indicator (block 202). The biological indicator is placed inside the sterilizing chamber of the sterilizing cabinet (100) before the start of the sterilization cycle, and the biological indicator remains in the sterilizing chamber during the sterilization cycle. Thus, the user can identify a specific biological indicator (block 202) before placing the biological indicator in the sterilizing chamber. A biological indicator contains microorganisms that respond to a specific sterilization cycle. After the sterilization cycle is completed, the biological indicator is checked for microorganisms in order to measure the effectiveness of the sterilization cycle. A biological indicator may not be necessary for all sterilization cycles, but may be required based on hospital requirements or local regulations. In use, the biological indicator can be identified by entering data manually, for example, by entering the type or identifier of the biological indicator using the keyboard; or can be identified automatically, for example by optical scanning of an optical identifier or wireless scanning of an RFID tag or other unique identifier.

The choice of the sterilization cycle (block 200) and the identification of the biological indicator (block 202) may form one or more of the requirements for the configuration and construction of medical devices inside the sterilizing cabinet (100). The door of the sterilizing chamber of the sterilizing cabinet (100) opens, and the commands that guide the user during the preparation of the sterilization cycle (block 204) are displayed, including placing a biological indicator, placing medical devices, closing the door of the sterilizing chamber of the sterilizing cabinet (100) and / or other changes in the preparation process. Before starting the current sterilization cycle (block 208), the sterilizing cabinet (100) can also prepare when loading (block 206) medical devices loaded into the sterilizing chamber of the sterilizing cabinet (100). Such preparation during loading (block 206) may include monitoring the tightness of the sterilizing chamber; control of the contents of the sterilizing chamber; checking the physical characteristics of the contents of the sterilizing chamber, such as humidity levels, volume of contents, weight of contents, internal temperature or other characteristics; and / or performing one or more of the preparation steps, which may include heat treatment, chemical treatment, plasma treatment or other types of treatment to reduce humidity, increase temperature and / or other preparation of medical devices in a sterilizing chamber for a sterilization cycle.

After completion of the preparation at loading (block 206), the directly selected sterilization cycle can be performed (block 208). The sterilization cycle (block 208) may include exposing the medical device (s) in the sterilizing chamber to a compressed sterilizing gas, subsequent heat treatment, chemical treatment, plasma treatment, vacuum treatment and / or other types of sterilizing procedures. After the sterilization cycle is completed (block 208), all sterilization results can be displayed to the user on the display of the sterilizing cabinet; transmitted to the server (106); print on the spot; and / or displayed, transmitted and / or stored by other devices as desired.

The sterilizing cabinet (100) may also present the results (block 210) of the sterilization cycle. Such a presentation of the results (block 210) may include the results of the analysis of the biological indicator using the analyzer (102) of biological indicators, as described below. These results may include an indication of the presence or absence of contamination in the biological indicator at the end of the sterilization cycle (block 208). In cases where a biological indicator suggests contamination after the completion of the sterilization cycle (block 208), additional actions can be taken, such as warning the user about a positive history of checking and analyzing the sterilization cycle, to determine if previous cycles could cause contamination and / or whether re-sterilization of later sterilized medical devices is required.

III. Illustrative biological indicator node

As mentioned above, a biological indicator can be placed in a sterilizing cabinet (100) together with a medical device during the sterilization process (block 208) to verify the success of the sterilization process (block 208). In FIG. Figure 3 shows an illustrative form that such a biological indicator can take. In particular, in FIG. 3 shows a biological indicator (700), which includes a housing (710), a cap (720), an ampoule (730), and a carrier (740). The housing (710) is made of a transparent material (e.g., transparent plastic, glass, etc.) and is hollow so that the housing (710) can receive an inserted ampoule (730). The ampoule (730) is also made of a transparent material (for example, transparent plastic, glass, etc.) and contains a fluid (732). By way of example only, fluid (732) may contain a liquid culture medium. Such a liquid culture medium is made with the possibility of stimulation during incubation of the growth of any living microorganisms with which it is in contact. Fluid (732) also includes a fluorophore, the fluorescence of which depends on the amount of microorganisms contained in the medium. The fluid (732) is contained in a hermetically sealed ampoule (730).

Carrier (740) provides a source of microorganisms or active enzymes. By way of example only, the carrier (740) may be impregnated with bacterial spores, bacteria in other forms (e.g., vegetative ones) and / or active enzymes. Only as an example can spores of the species Bacillus, Geobacillus, and Clostridium be used. The carrier (740) may be a water-absorbing material and may be made of filter paper. Sheet materials such as fabric, non-woven polypropylene, hydrated cellulose fiber or nylon, and microporous polymeric materials can also be used to make the carrier (740). Non-water-absorbing materials such as metals (e.g., aluminum or stainless steel), glass (e.g., glass balls or fiberglass), porcelain or plastic can also be used to make the carrier (740). Of course, it is allowed to use combinations of the above materials for the manufacture of media (740).

The ampoule (730) is made in the form of a fragile component of a biological indicator (700) so that the ampoule (730) can break inside the housing with the release of fluid (732) into the housing (710). To facilitate the breaking of the ampoule (730), a set of breaking elements (750) is provided in the lower part of the housing (710). Although in FIG. 3, the breaking elements (750) are shown in the form of teeth, it should be understood that this is purely illustrative. Flaking elements (750) may be of any suitable shape. To facilitate the breaking of the ampoule (730), the cap (720) is configured to slide down along the body (710) to press the ampoule (730) against the debris elements (750). This can be done immediately before inserting the biological indicator (700) into the analyzer (102, 800) of indicators, as described in more detail below. It should be understood that the ampoule (730) remains intact while the biological indicator (700) is in the sterilizing cabinet (100) during the sterilization process.

The cap (720) may include one or more of the openings allowing gases (e.g., air or a sterilizing agent, etc.) to enter the housing (710) before the cap (720) is pressed down relative to the housing (710), to break the ampoule (730). Thus, these openings can contribute to the destruction of microorganisms on the carrier (740) during the sterilization process (block 208). However, after pushing the cap (720) down relative to the housing (710) to break the ampoule (730), these one or more of the openings may be hermetically closed to hold the fluid (732) in the housing (710). When the fluid (732) is released from the ampoule (730), the released fluid eventually reaches the carrier (740), thus initiating the incubation process with any living microorganisms remaining on the carrier (740), as described in detail below.

Although in FIG. 3 not shown, the housing (710) may also include an identification mark. Such an identification mark may include a machine readable element configured to be read by a reader of a sterilizing cabinet (100) and an analyzer (102) of indicators. In other words, the identification tag can be read in the scanning steps (block 302, block 308) of the indicator, as described above with reference to FIG. 3. By way of example only, the identification tag may contain an optical code (for example, a barcode, a QR code, etc.), an RFID tag and / or a machine readable identifier of any other suitable form. In addition, the identification tag may include readable elements such as text, numbers, color code, etc.

Cap (720) may also include a color-changing element. Such a color-changing element can serve as a chemical indicator that changes color when a sterilizing agent of a sterilizing cabinet (100) acts on a biological indicator (700). In some embodiments, the color-changing element simply changes color from one distinctive color to another, where one of the colors indicates no exposure to the sterilizing agent, and the other color indicates at least a slight effect of the sterilizing agent. In some other embodiments, the color-changing element changes color in a range of colors based on the degree of effect of the sterilizing agent on a biological indicator (700). In other words, the color change may be proportional to the degree of exposure to the sterilizing agent.

Additionally or alternatively to the aforementioned, the biological indicator (700) may be designed and operated in accordance with at least some of the ideas set forth in US Patent Application No. 15 / 057,768, entitled "Self-Contained Biological Indicator", filed March 1, 2016, the description of which is incorporated herein by reference. Other suitable forms of such a biological indicator (700) will be apparent to those of ordinary skill in the art in the context of the ideas presented herein.

IV. Illustrative Biological Indicator Analyzer

A. Illustrative material of the biological indicator analyzer

In FIG. 4 shows an illustrative set of components that may be included in the analyzer (102) of biological indicators. The analyzer (800) of biological indicators in accordance with this example contains many cells (810), each of which is configured to insert and receive the corresponding biological indicator (700). Although two cells (810) are shown, it should be understood that any other acceptable number of cells (810) is allowed, including eight cells (810), fewer than eight cells (810), or more than eight cells (810). The analyzer (800) of biological indicators also includes a processor (820), which is used to execute commands and control algorithms, information processing, etc.

Each cell (810) has an associated light source (830) and a sensor (840). Each light source (830) is configured to project light through the housing (710) of the biological indicator (700), which is inserted in the corresponding cell (810); and each sensor (840) is configured to detect the light emitted from the fluid (732) contained in the housing (710). By way of example only, the light source (830) may be in the form of a laser, which is configured to emit ultraviolet light. Various other acceptable forms that a light source (830) may take will be apparent to those skilled in the art in light of the ideas set forth herein. By way of example only, the sensor (840) may comprise a charge coupled device (CCD). Various other acceptable forms that the sensor (840) may take will be apparent to those skilled in the art in light of the ideas set forth herein. As noted above, fluorescence of a fluid (732) will depend on the number of living microorganisms contained in the fluid (732). Thus, the sensor (840) is able to detect the presence of living microorganisms in the fluid (732) based on the degree of fluorescence of the fluid (732) in response to light from a light source (830).

The biological indicator analyzer (800) according to the present example further includes a touch screen display (850). The display (850) with a touch screen is configured to form various user interface display screens related to the operation of the biological indicator analyzer (800). The display (850) with a touch screen is further configured to receive user input in the form of a user tapping the touch screen display (850) in accordance with conventional sensory-visual technology. In addition or alternatively, the sterilizing cabinet (800) may include various kinds of user input elements, including, but not limited to, buttons, keypads, a mouse, trackball, etc. Displays displayed on a touch screen display (850) can be controlled by a processor (820). User inputs received via the touch screen display (850) may be processed by a processor (820).

The analyzer (800) of biological indicators in accordance with this example further includes a communication module (860). The communication module (860) is configured to provide two-way communication between the analyzer (800) of biological indicators and the communication concentrator (104). In addition or alternatively, the communication module is configured to provide two-way communication between the analyzer (800) of biological indicators and the server (106). By way of example only, the communication module (860) is configured to provide wired and / or wireless communication via Ethernet, Wi-Fi, Bluetooth, USB, infrared technology, NFC, and / or other technologies. Various suitable components and configurations that may be used to make the communication module (860) will be apparent to those of ordinary skill in the art in the context of the ideas presented herein. Data transmitted from or received through the communication module (860) is processed by the processor (820).

The biological indicator analyzer (800) in accordance with this example further includes a reader (870) configured to read the identification tag of the biological indicator (700), as described herein. It should be understood that the reader (870) can be used to identify the biological indicator (700) before analysis (block 512) of the biological indicator (700). By way of example only, the reader (870) may comprise an optical reader configured to read an optical identification tag (e.g., barcode, QR code, etc.) of a biological indicator. In addition or alternatively, the reader (870) may include a radio frequency tag reader (RFID) configured to read a radio frequency identification tag (RFID) (e.g., barcode, QR code, etc.) of a biological indicator. Various acceptable components and configurations that can be used to make the reader (870) will be apparent to those of ordinary skill in the art in the context of the ideas presented herein. Data obtained using a reader (870) is processed by a processor (820).

The biological indicator analyzer (800) in accordance with this example further includes a memory (880) configured to store control logic and instructions executed by a processor (820) to control components such as a light source (830), a display (850) ) with a touch screen, a communication module (860) and a reader (870). Memory (880) can also be used to store the results associated with the analysis of biological indicators, and / or various other types of information. The various acceptable forms that memory may take (880), as well as various ways of using memory (880), will be apparent to those skilled in the art in the context of the ideas presented herein.

In FIG. 5 shows an illustrative form that the analyzer (800) of indicators may take. In particular, in FIG. 5 shows an analyzer (950) of indicators, which includes a housing (952) with a set of eight cells (954), a display (956) with a touch screen, and a reader (960). The housing (952) is configured to be mounted on a table surface or other horizontal surface, and comprises a touch screen (956) at an indirect angle with respect to the surface on which the housing (952) rests. Cells (954) are made and function like the cells described above (810). The touch screen display (956) is configured and functions like the touch screen display (850) described above. Various examples of interactive screens that can be displayed on a touch screen display (850, 956) will be described in detail below. The reader (960) is made and functions like the reader (870) described above. It should be understood that the analyzer (950) indicators may additionally include other elements described above in relation to the analyzer (800) indicators, and may further provide the same functionality and ease of use, as described above with reference to the analyzer (800) indicators . Other suitable forms of such analyzer (102, 800, 950) indicators will be obvious to ordinary specialists in this field of technology in the context of the ideas set forth in this application.

B. Illustrative processes and interfaces of a biological indicator

In FIG. 6 shows an illustrative set of steps that can be used to start the analysis cycle of a biological indicator (700) using an analyzer (102, 800, 950) of biological indicators. As a first step, the user can check which cells (810, 954) are free (block 900) and select a free cell (block 902). In some embodiments, a touch-screen display (850, 956) displays a number next to each free cell (810, 954) so that the operator can simply select the free cell by touching the number associated with the selected free cell (810, 954) ( block 902). Then, the screen displayed on the touch screen (850, 956) may invite the user to place the biological indicator identification mark (700) next to the reader (870, 960) so that the reader (870, 960) can read the biological indicator identification mark (700 ) As part of this prompt, a touch screen display (850, 956) may indicate the location of the reader (870, 960) to help the user find the reader (870, 960). The user can then use the reader (870, 960) to read the identification tag of the biological indicator (BI) (700) (block 904).

Then the screen displayed on the touch screen (850, 956) may invite the user to authenticate. After that, the user can be authenticated using the display (850, 956) with a touch screen (block 906). Then, the screen displayed on the touch screen (850, 956) may invite the user to indicate whether the chemical indicator on the cap (720) of the biological indicator (700) has changed color. Then, using the touch screen display (850, 956), the user can indicate whether the chemical indicator on the cap (720) of the biological indicator (700) has changed color (block 908).

Then the screen displayed on the touch screen (850, 956) may invite the user to prepare the biological indicator (700) for loading into the selected cell (810, 954) by breaking the ampoule (730) and shaking the biological indicator (700). After that, the operator can break the ampoule (730) by pressing on the cap (720), then shake the biological indicator (700) (block 910) to ensure proper mixing of the fluid (732) with the carrier (740). The user can then quickly place the biological indicator (700) in the selected cell (810, 954) (block 912). In some cases, it may be desirable to insert a biological indicator (700) into a selected cell (810, 954) (block 912) immediately after breaking the ampoule (730) and shaking the biological indicator (700) (block 910).

In some embodiments, the analyzer (102, 800, 950) of indicators is configured to determine the correctness of the stage of breaking the ampoule (730) and shaking the biological indicator (700) (block 910) before inserting the biological indicator (700) into the selected cell (810, 954) (block 912). By way of example only, this can be determined based on how the sensor (840) detects the light emitted by the light source (830) after inserting the biological indicator (700) into the selected cell (810, 954). If the indicator analyzer (102, 800, 950) detects that the user improperly performed the step of breaking the ampoule (730) and shaking the biological indicator (700) (block 910) before inserting the biological indicator (700) into the selected cell (810, 954) (block 912), a touch screen display (850, 956) may invite the user to remove the biological indicator (700) from the cell (810, 954) and properly perform the step of breaking the ampoule (730) and shaking the biological indicator (700) ( block 910).

If the user properly performed the step of breaking the ampoule (730) and shaking the biological indicator (700) (block 910) and then inserted the biological indicator (700) into the selected cell (block 912), the biological indicator (700) remains in the cell ( 810, 954) for the incubation period (block 914). During the incubation period (block 914), the light source (830) connected to the selected cell (810, 954) is turned on and the sensor (840) monitors the response fluorescence of the fluid (732) in the indicator (700). During the incubation period (block 914), the cell (810, 954) can also heat up (for example, to a temperature of approximately 60 ° C). As indicated above, the fluid (732) includes a fluorophore, the fluorescence of which depends on the number of microorganisms contained in the medium. Thus, the sensor (8400) can detect the presence of live microorganisms (from the carrier (740) in the fluid (732) based on the fluorescence of the fluid (732). It should be understood that after an acceptable incubation period, the analyzer (102, 800, 950) of the indicators concludes whether any of the microorganisms present on the carrier (740) (i.e., before the sterilization cycle in the sterilizing cabinet (100), managed to survive the sterilization cycle in the sterilizing cabinet (100), based on fluorescence of the fluid (732) registered by the sensor (840).

By way of example only, the incubation period (block 914) may be approximately 30 minutes. Alternatively, the incubation period may last substantially longer (for example, one hour or more), less, or have another acceptable duration. During the incubation period (block 914), the touch screen display (850, 956) may provide a graphical representation of the amount of time until the end of the incubation period. If the corresponding biological indicator (700) occupies more than one cell (810, 954), a touch screen display (850, 956) can provide a graphical representation of the amount of time until the end of the incubation period for each occupied cell (810, 954).

In FIG. 7 shows a set of illustrative steps that can be performed after the completion of the incubation period (block 914). As noted above, the analyzer (102, 800, 950) of biological indicators can determine whether any of the microorganisms present on the carrier (740) (i.e., before the sterilization cycle in the sterilizing cabinet (100), managed to survive the sterilization cycle in a sterilizing cabinet (100) based on fluorescence of a fluid (732) detected by a sensor (840). Thus, the analyzer (102, 800, 950) of biological indicators can determine whether the biological indicator (700) passes or does not pass (block 1000). In this sense, the result of the “analysis passed” decree indicates the absence of living microorganisms in the biological indicator (700), which indicates that the sterilization cycle (block 208) in the sterilizing cabinet (100) was successful.The result of the “analysis failed” indicates the presence of living microorganisms in the biological indicator (700) , which indicates that the sterilization cycle (block 208) in the sterilizing cabinet (100) was not completed successfully.

Upon receipt of the result “analysis passed”, the display (850, 956) with a touch screen may offer the user a screen indicating that the biological indicator (700) has passed the analysis (block 1002). A touch screen display (850, 956) may also invite the user to remove the biological indicator (700) from the cell (810, 954) (block 1004) and properly dispose of the used biological indicator (700). As described in detail below, the analyzer (102, 800, 950) of biological indicators can also transmit the result of “analysis passed” (and corresponding data) to the communication concentrator (104) (block 1006) via the communication module (860). In some embodiments, this transmission of the result of “analysis passed” (and corresponding data) to the communication concentrator (104) (block 1006) is performed in response to a request from the communication concentrator (104), so the communication concentrator (104) retrieves the result “analysis passed” from the analyzer (102, 800, 950) of biological indicators. In some other embodiments, the biological indicator analyzer (102, 800, 950) sends the result “analysis passed” (and the corresponding data) to the communication concentrator (104) (block 1006), without requiring a request from the communication concentrator (104).

Upon receipt of the “analysis failed” result, the touch screen display (850, 956) may offer the user a screen indicating that the biological indicator (700) has not passed the analysis (block 1010). The touch screen display (850, 956) may then invite the user to authenticate. Then, the user can interact with the touch screen display (850, 956) through identification (block 1012). A touch screen display (850, 956) may also invite the user to remove the biological indicator (700) from the cell (810, 954) (block 1014) and properly dispose of the used biological indicator (700). As described in detail below, the analyzer (102, 800, 950) of biological indicators can also transmit the result of the “analysis failed” (and corresponding data) to the communication concentrator (104) (block 1016) via the communication module (860). In some embodiments, this transfer of the “analysis failed” result (and the corresponding data) to the communication concentrator (104) (block 1016) is performed in response to a request from the communication concentrator (104), thus, the communication concentrator (104) retrieves the result “analysis is not passed ”from the analyzer (102, 800, 950) of biological indicators. In some other embodiments, the biological indicator analyzer (102, 800, 950) sends the result of the “analysis failed” (and corresponding data) to the communication concentrator (104) (block 1016) without requiring a request from the communication concentrator (104).

In FIG. Figure 8 shows a set of illustrative high-level steps that the analyzer (102, 800, 950) of indicators can perform to apply experimental control when testing a biological indicator (700) after a previously performed sterilization cycle. When a user selects indicator (700) for scanning, the analyzer (102, 800, 950) of indicators will check (block 212) that the control indicator has passed analysis from the same batch or group as the selected indicator (700) by accessing data from the server (106) using the communication hub (104).

The control indicator (700) is a standard biological indicator (700), which was selected from the group of relevant biological indicators (700) and was analyzed without first having to go through a sterilization cycle, and if the group from which the control indicator was selected contains viable indicators (700 ), the control indicator will result in a positive indication of contamination, since it has not been sterilized. By testing a control indicator from a group of indicators (700), the user can minimize the likelihood that a group of incorrectly stored or processed indicators (700) will be inadvertently used in the system. By monitoring to verify (block 212) that the monitoring has been performed for the selected indicator (700), the system can partially automate and enforce the verification test. After checking the control indicator (700) (block 212), the test indicator (700) can be analyzed (block 214) in the analyzer (102, 800, 950) of indicators by placing the indicator (700) in the test cell (810, 954) and execute an analyzer (102, 800, 950) of incubation indicators and an analysis (block 214) of the biological content of the indicator (700) to determine whether the contaminants survived the sterilization cycle. After receiving the test results (block 214), the test can be completed (block 216) by displaying the results on a display (850, 956) with a touch-screen analyzer (102, 800, 950) indicators and issuing a manual or recommendations based on the indicated results and transmitting results through the analyzer hub (104) to the sterilizing cabinet (100), the server (106), or both.

In FIG. 9 shows a set of illustrative steps that the analyzer (102, 800, 950) of indicators can perform to verify and apply a control indicator (700). The user can start configuring the indicator test configuration by making a selection through the user interface, such as a display (850, 956) with a touch-screen analyzer (102, 800, 950) of indicators, which allows cell selection (810, 954) and indicator selection (700 ), while the analyzer (102, 800, 950) of indicators accepts this choice (block 218). As noted above, the analyzer (102, 800, 950) of indicators can have several test cells (810, 954) that can receive the indicator (700) and perform incubation and analysis so that several indicators (700) can be processed simultaneously. The indicator can be selected by scanning or reading a machine-readable code or a unique indicator identifier (700) using a reader (870, 960) or by manually entering information about the indicator (700), which allows the indicator analyzer (102, 800, 950) to identify the indicator ( 700). Identification of the indicator (700) allows the analyzer (102, 800, 950) of indicators to access data on the server (106) through the analyzer hub (104) to determine whether the identified indicator (700) belongs to a batch or group of indicators (700), passed control test; to establish whether the indicator (700) has already been incubated and analyzed, and to prevent a repeated test by mistake; or to identify a sterilization cycle that has been performed using the indicator (700).

In FIG. 12 is a screen shot of an illustrative user interface for selecting a cell (810, 954). In the illustrative interface, eight uniquely numbered cells (810, 954) are presented in numerical form and are configured to select the desired cell (810, 954) by affecting the cell number (418) (for example, by touching the cell number (418)). Some embodiments may include an illustrative user interface for selecting whether a selected cell (810, 954) will receive a control indicator (700) by acting on a button of a “control” indicator; or a test indicator (700), by acting on the button of the "test" indicator. Some embodiments may include an illustrative user interface to provide the user with guidance on scanning machine identification from an indicator (700) using a reader (870, 960) of an indicator analyzer (102, 800, 950).

In FIG. 13 is a screenshot of an illustrative user interface for providing the user (472) with additional guidance on scanning machine identification from an indicator (700) using a reader (870, 960) of an indicator analyzer (102, 800, 950). This manual may include an arrow indicating the location of the reader (960) on the analyzer (950) indicators with text commands for positioning the indicator (700) relative to the reader (870, 960). In some cases, if the analyzer (102, 800, 950) of indicators is used with a setting in which it cannot immediately communicate with the server (106), or if the reader (870, 960) is missing, identification information and information about the sterilization cycle can be entered manually through the user interface, which has manual entry fields for entering information about the indicator (700) and information about the cycle (for example, identification of a specific sterilizing cabinet (100), type of sterilization cycle, sterilization cycle number, time Meni beginning of the sterilization cycle, the end of the sterilization cycle, and so on. p.). This additional information establishes a relationship between a particular indicator (700) and the sterilization cycle previously performed using a sterilizing cabinet (100).

After selecting a cell (810, 954) and selecting the type of indicator (700) (block 218), the analyzer (102, 800, 950) of indicators can request data from the server (106) and identify the party or group associated with the selected or scanned indicator (700 ) to determine if a recent benchmark indicator (700) from this batch or group has been analyzed (block 220). For example, if the indicators (700) arrive in batches of 24 pieces, most likely, each of the 24 indicators (700) in the batch was made at about the same time from the same components and, most likely, its packaging, shipping, storage and transportation carried out equally. Therefore, if one indicator (700) from a batch containing 24 pieces is checked as a control indicator (700) and does not give a positive result for contamination, there is a possibility that other indicators (700) from this batch may also be defective therefore, these indicators (700) must be disposed of in order to eliminate false negative results that would allow us to erroneously assume that the sterilization cycles were successful. The system can be implemented in such a way that the analyzer (102, 800, 950) of indicators requests the analysis of the control indicator (700) for each batch, while the results are stored on the server (106) and linked to the batch so that the system can subsequently check the control indicator (block 220). In some embodiments, a request for a test indicator (700) may be executed once for one batch or once every 24 hours for one batch or any other number of times for one batch with different intervals between repeated tests of the control indicator or other custom test requirement.

If it is established that the control requirements for the party to which the selected indicator belongs are satisfied (block 220), the control indicator is checked and the system can invite the user to continue testing the selected test indicator (700). If it is established that the control requirements for the party to which the selected indicator belongs are not satisfied (block 220), the system will instead notify the user of the requirement for the control indicator that must be met and instruct the user on how to insert the control indicator (700) from selected batch to the selected cell (810, 954). The system can additionally check the chemical indicator (block 224) of the control indicator (700) through the interface screen, which shows a graph, showing the difference in appearance between the unchanged chemical indicator and the changed chemical indicator. The chemical indicator of a biological indicator (700) initially has a first color; but during a sterilization cycle, a chemical reaction to temperatures or substances used during sterilization causes the chemical indicator to change color to a second, providing a visual indication of whether a particular indicator (700) has passed the sterilization cycle. Thus, such an interface allows the user to check and indicates that the chemical indicator of the control indicator (700), which has not undergone a sterilization cycle, still has the original color. If the user makes a different choice, the system may invite the user to select a different control indicator (700), since the previously selected control indicator (700) either contains a defect or was used in the sterilization cycle.

After checking the chemical indicator by the user and the system (block 224), the system begins to incubate the control indicator (block 226) after inserting the control indicator (700) into the selected cell (810, 954). Each cell (810, 954) of the analyzer (102, 800, 950) of indicators can be equipped with a button, photoelectric sensor or other sensor, which allows to determine that the indicator (700) is inserted in the cell (810, 954) so that incubation can start automatically . In some embodiments, in order to determine that an indicator (700) is inserted in the cell (810, 954), a light source (830) and a sensor (840) are used. Various suitable methods in which the presence of an indicator (700) in a cell (810, 954) can be sensed will be apparent to those skilled in the art in accordance with the ideas presented herein.

In FIG. 14 shows a user interface that can show the user updates for each cell (810, 954) of the analyzer (102, 800, 950) indicators. In FIG. 14 shows eight cells (810, 954) with different statuses, and the incubation and analysis in each cell (810, 954) is shown as an increasing sequence of strokes or other characters (429) or as a colored circle or symbol (427) to display recent changes in the status of the cell (810, 954), which recently began to perform incubation or analysis. When selecting a specific cell (810, 954) through the user interface depicted in FIG. 14, the indicator analyzer (102, 800, 950) displays a more detailed status screen for the selected cell (810, 954), which shows the type of test being performed, so the user can determine if the control indicator is being processed in cell (810, 954) (700) or test indicator (700), and a more detailed time status so that the user can get a more accurate idea of the time until the end of the incubation or analysis.

After the incubation and analysis of the control indicator (700) (block 226) is completed, the analyzer (102, 800, 950) of the indicators will determine whether the test results of the control indicator (700) are positive for contamination, indicating that the control indicator has passed the test. If the results of the control indicator (700) indicate that the test has passed (block 228), the results of the control indicator (700) are displayed (block 230) on the display (850, 956) with the touch screen of the analyzer (102, 800, 950) indicators and they are transmitted to the server (106) for comparison with the batch from which the control indicator (700) was selected so that subsequent test indicators (700) from this batch can be analyzed without interrupting the process. If it is determined that the control indicator has not passed the test (block 228), the system will notify the user of the failure, and this notification may indicate the cell (810, 954), in which the control indicator (700), which has not passed the test, is located. If this is the first failure of the control indicator (block 232), the system will indicate that this is the first failure and will invite the user to change cells (810, 954) and test the second control indicator (block 234).

The interface may be displayed in case of a first failure of the indicator (700). Only as an example, such an interface can provide the user with additional guidance on identifying the batch from which a second control indicator must be selected; and also a cell (180, 954), the use of which should be avoided when performing the second control. Performing the test of the second control indicator (700) in another cell (180, 954) allows the system to eliminate the malfunction of the test cell (180, 954).

Another exceptionally illustrative example may be that the interface allows you to identify the user and instructs the user when performing the analysis of the second control indicator. System administrators can use user identification to check the results of the analysis of the control indicator (700) and to verify that in case of failure of the control indicator (700), the appropriate steps are performed. Following the provided instructions, the user can select a new control indicator (700) and return to the stage of checking the chemical indicator (block 224). If the execution of the steps fails the second control (block 228), the system can instead invite the user to dispose of the batch from which previous control indicators that failed the test were selected, and select the control and test indicator (700) from another batch (block 236 ), while the user must repeat the sterilization cycle of the affected medical devices together with a new test indicator (700) from another batch so that reliable batch control can be performed (block 220).

The interface may be displayed in case of failure of the second control indicator (700). By way of example only, such an interface can instruct the user in processing the failure of the second control indicator (700). An additional user interface can be used to identify the user in order to verify and issue additional guidance in case of failure of the second control indicator.

In FIG. 10 shows a set of illustrative steps that the analyzer (102, 800, 950) of indicators can perform to incubate and test (block 214) a test indicator (700) after checking the control indicator (700) (block 212). First, the analyzer (102, 800, 950) indicators checks that the chemical indicator of the test indicator (700) has signs of a sterilization cycle (block 237). In some cases, a touch screen display (850, 956) may display an interface screen that instructs the user as to whether the chemical indicator has an original color or a color that confirms a sterilization cycle; and may accept the user's choice, confirming that the chemical indicator has signs (block 237) of the passage of the sterilization cycle. Such an interface screen may include a graphical representation of an indicator (700) of various colors with corresponding input buttons to indicate which color the user sees.

The analyzer (102, 800, 950) indicators also checks the activation of the indicator (700) by the user (block 238) through a user interface, such as the interface shown in FIG. 15, which provides illustrated instructions (446) for activating and confirming activation of a test indicator (700) before incubation and analysis, as well as for accepting a user selection confirming activation (block 238). After confirming the activation of the indicator (block 238), the indicator (700) can be placed (block 240) in the selected test cell (810, 954). If the sensor of the test cell (810, 954) does not detect the placed indicator (700) (block 240), an interface is displayed to invite the user (block 242) using text and / or graphic instructions (block 242) to place the indicator (700) in the selected test cell (810) 954). When the sensor of the test cell (810, 954), such as a button or photoelectric sensor, detects that the indicator (700) is placed in the cell (block 240), incubation is performed (block 244).

While waiting for the incubation to end (block 246), the analyzer (102, 800, 950) of indicators will constantly update the cell display screens (block 248) so that the user can view information about active cells (810, 954). Some illustrative interfaces can be configured and updated (block 248) so that they reflect current information about the state of the cell (810, 954). In FIG. 16 shows an additional user interface that can be displayed on a display (850, 956) with a touch screen of the analyzer (102, 800, 950) indicators to provide more detailed information (450) about the indicator (700), which is currently undergoing incubation and analysis in the cell (810, 954). Such detailed information may include, for example, the type of biological indicator being analyzed (700), for example, a control indicator (700) or a test indicator (700), the lot number from which the indicator (700) is selected, the serial number, the expiration date, user identification , incubation start time, incubation date, checking the status of the chemical indicator, incubator temperature, incubation and analysis result (if available), sterilization cycle associated with the indicator (700), cycle type, cycle number, start and end time of the cycle and other information that it is desirable to display using the analyzer (102, 800, 950) indicators.

After incubation is completed (block 246), the analyzer (102, 800, 950) of indicators performs an analysis of the incubated indicator (700) and determines the presence of developed or remaining biological contaminants after incubation (block 250). As noted above, in some embodiments, indicator (700) will contain a liquid solution that responds to biological contaminants, so if the first color is shown, there is no contamination, which indicates the success of the sterilization cycle; and if the second color is shown, contamination is present, which indicates a failure of the sterilization cycle. In such embodiments, a positive or negative analysis of the indicator (700) in relation to contamination can be performed using a light source (830) and a sensor (840) to detect fluorescence of the indicator (700), as described above.

In FIG. 11 shows a set of illustrative steps that can be performed to display test results and complete the test (block 216). If the analysis of the indicator (block 250) shows that the test indicator (700) is negative with respect to contamination, then the indicator (700) is considered to have passed the test (block 252), and the analyzer (102, 800, 950) of the indicators can update the cell display interface, to show the user that the test indicator (700) has passed the test (block 254). The interface may indicate to the user that the analyzer cell (102, 800, 950) of the indicators has performed a test with a negative result for pollution. The cell indicator may have a certain color to indicate success, for example green; and / or may include a specific symbol for success, for example, a check mark, an asterisk, or other symbol, color, or visual indicator.

The interface may provide the user with a more detailed description and guidance regarding the tested indicator (block 252). Then, the analyzer (102, 800, 950) of indicators can, by means of a sensor located in the test cell (810, 954), detect that the indicator (700) is removed from the test cell (block 256); and also display and transmit the results (block 258) of the analysis of the test indicator. In some embodiments, the results are transmitted (block 258) from the analyzer (102, 800, 950) of the indicators to the communication concentrator (104) in response to a request from the communication concentrator (104), thus, the communication concentrator (104) extracts the results from the analyzer (102, 800, 950) biological indicators. In some other embodiments, the biological indicator analyzer (102, 800, 950) transmits the results to the communication concentrator (104) (block 258) without a request from the communication concentrator (104).

The interface can provide a detailed summary of the test results, for example, which indicator, control indicator (700) or test indicator (700) passed the test, the lot number from which the indicator (700) was selected, the serial number, expiration date and other similar information , which is shown and given in relation to the status interfaces described above. The same interface can offer information about the sterilization cycle, including, without limitation, the identification of the sterilizing cabinet (100) in which the sterilization cycle was performed, the type of sterilization cycle performed, the number of sterilization cycles, the start time of the sterilization cycle, the end time of the sterilization cycle, etc. The results of the analysis of the test indicator can additionally be printed out, stored locally in the analyzer's memory (102, 800, 950) of the indicators, transmitted to the sterilizing cabinet (100) by means of the analyzer concentrator (104) and / or in front of Vat remote server (106) via a hub (104) analyzer.

If instead the analysis of the indicator (block 250) shows that the indicator (700) is positive with respect to contamination, the system determines that the indicator (700) has not passed the test (block 260) and updates the display of the analyzer cell (102, 800, 950) indicators showing failure (block 262). The interface can show the user that the indicator (700) in a particular cell has not passed the test, and receive confirmation or acknowledgment of failure from the user.

After the indicator (700) fails (block 260), the user may be offered an interface for issuing additional information and guidance to the user. Another interface may be offered to the user to accept (block 264) the user's identity for verification and control of actions, and offer (block 266) additional instructions for performing quarantine and re-sterilization of the corresponding equipment. User authentication (block 264) can be useful if the administrator later wants to make sure that the quarantine procedures have been fully followed.

An interface may be displayed to receive user confirmation that quarantine procedures or instructions have been received and read (block 266). The indicator analyzer (102, 800, 950) can then display the user interface to invite the user to retrieve the failed indicator. The analyzer (102, 800, 950) of indicators can register the extraction of the indicator (block 268) using the sensor of the analyzer (102, 800, 950) of indicators and display and transmit the test results in response (block 270). In some embodiments, the results are transmitted (block 270) from the analyzer (102, 800, 950) of the indicators to the communication concentrator (104) in response to a request from the communication concentrator (104), thus, the communication concentrator (104) extracts the results from the analyzer (102, 800, 950) biological indicators. In some other embodiments, the biological indicator analyzer (102, 800, 950) transmits the results to the communication concentrator (104) (block 270) without a request from the communication concentrator (104).

An interface may be displayed to provide a detailed summary of the results, which may include information such as test type, batch number, serial number, batch expiration date, sterilization cycle information, and additional information. Information generated on the basis of an unsatisfactory test can additionally be printed out, stored locally in the analyzer's memory of the indicators (102, 800, 950) or transmitted to one or more of the server (106) and the sterilizing cabinet (100) through the analyzer concentrator (104). A sterilizing cabinet (100), a server (106), or both devices can use the results of an unsatisfactory test to identify medical devices that need to be quarantined or re-sterilized, to identify sterilizing cabinets (100) that are malfunctioning, to identify users who are not perform appropriate sterilization procedures, or to identify other relationships with data stored on the server (106) or in a sterilizing cabinet (100) that can be used to increase the efficiency of ktivnosti subsequent sterilization cycles.

C. Illustrative methods for analyzing enzyme activity

As described above, the analyzer (102, 800, 950) is configured to analyze biological indicators (700) to determine the presence of active enzymes in the fluid (732) by detecting fluorescence of the fluid (732). This is achieved by activating the light source (830) and using a sensor (840) to detect fluorescence in the fluid (732) in response to the illumination provided by the light source (830) during the incubation period in the cell (810, 954). In FIG. 17 shows the fluorescence of the first group (1200) of biological indicators (700) over a period of time (for example, during the incubation period), which was detected by the analyzer (102, 800, 950) indicators. Biological indicators (700) of the first group (1200) underwent an ineffective sterilization cycle in a sterilizing cabinet (100). In FIG. Figure 17 shows fluorescence expressed in relative fluorescence units (OEF), which are recognized units. As shown, the fluorescence intensity decreases during the initial part of the incubation period. By way of example only, this decrease in fluorescence can occur as a result of heating of the fluid (732) in the cell (810, 954) of the analyzer (102, 800, 950) of the indicators. After the initial decrease, the fluorescence intensity increases throughout the remaining time of the incubation period. This increase in fluorescence intensity indicates that each biological indicator (700) of the first group (1200) contains active enzymes. Thus, the sterilization processes to which the biological indicators (700) of the first group (1200) were subjected were unsatisfactory.

In FIG. 18 shows the fluorescence of the second group (1202) of biological indicators (700) over a period of time (for example, during the incubation period), which was detected by the analyzer (102, 800, 950) of indicators. Biological indicators (700) of the second group (1202) underwent an effective sterilization cycle in a sterilizing cabinet (100). In FIG. 18, fluorescence is again expressed in relative fluorescence units (OEF). As shown, the fluorescence intensity decreases during the initial part of the incubation period. As noted above, this decrease in fluorescence can occur as a result of heating of the fluid (732) in the cell (810, 954) of the analyzer (102, 800, 950) of the indicators. After the initial decrease, the fluorescence intensity remains essentially constant throughout the remaining time of the incubation period. This constancy of fluorescence intensity indicates that none of the biological indicators (700) of the second group (1202) contains active enzymes. Thus, the sterilization processes that biological indicators (700) of the second group (1202) underwent were successful.

To determine whether the fluorescence of biological indicators (700) will increase or remain substantially constant after the initial part of the incubation period, during which the fluorescence intensity decreases, it may be desirable to monitor the fluorescence intensity for a significant period of time so that the analysis results are more reliable or reliable. . In other words, it may be desirable to continue to monitor the fluorescence intensity for a substantial period of time after the initial part of the incubation period, during which the degree of fluorescence decreases to determine with sufficient accuracy that the fluorescence intensity has increased to a point indicating the presence of active enzymes (indicating unsatisfactory sterilization process); or that the fluorescence intensity has remained substantially constant, which indicates the absence of active enzymes (indicates the success of the sterilization process). The desire to perform the analysis as quickly as possible in order to provide an acceptable waiting time for the end user is fraught with a conflict of interest. Thus, it may be desirable to ensure that the analysis of biological indicators (700) is performed as quickly as possible, but not to the detriment of the reliability of the results of such an analysis.

To speed up the analysis of biological indicators (700), it may be desirable to find the point at which the product formation rate reaches its maximum, and then compare the maximum speed with a critical value. With a quantitative superiority of the substrate compared to the concentration of enzymes, the indicated maximum rate can be directly related to the number of enzymes present and, thus, to the efficiency of the sterilization cycle.

As shown in FIG. 17 and 18, the slopes of the curves are almost constant after the initial decline. In FIG. 19 shows the change in slope over a 15 minute increment of the data shown in FIG. 17 and 18. As shown in FIG. 19, after 20 minutes the slope reaches maximum speed and then holds there for a two-hour incubation period. Despite the distortion during reading, a significant increase in slope after 20-30 minutes is not observed. In FIG. 19 also clearly shows the difference in maximum slope for the first group (1200) compared with the second group (1202). In particular, the average maximum slope for the first group (1200) is more than 10,000; whereas the average value of the maximum slope for the second group (1202) is approximately 1600. This difference of the slopes is large enough so that it can be easily detected in a reliable way. Moreover, this difference in slopes can be detected quite quickly (for example, about 20-30 minutes).

In view of the foregoing, instead of simply tracking the absolute fluorescence intensity, it may be useful to track the slope associated with changes in fluorescence intensity. Tracking the slope can provide a relatively quick and yet reliable analysis indicating whether the biological indicator (700) has undergone an effective sterilization cycle or an ineffective sterilization cycle. For this purpose, after the start of the incubation period in the analyzer (102, 800, 950) of indicators, the analyzer (102, 800, 950) of indicators can first monitor the fluorescence of the biological indicator (700) and calculate the bias. Then, the analyzer (102, 800, 950) of indicators can compare the slope with a critical value (for example, some number that is more than 1600, such as 2000, 5000, 7500, etc.). If the slope is greater than the critical value, the analyzer (102, 800, 950) of the indicators can conclude that an active enzyme is present in the biological indicator (700) and trigger any of the various notifications of unsatisfactory sterilization processes described in this document. If the slope is less than the critical value, the analyzer (102, 800, 950) of indicators can continue to monitor the slope until the slope reaches its maximum value. By way of example only, it may take approximately 20-30 minutes for the slope to reach its maximum value. If the bias at this stage is still less than the critical value, the analyzer (102, 800, 950) of indicators can conclude that there is no active enzyme in the biological indicator (700) and start any of the various notifications about successful sterilization processes described in this document.

Although the previous examples are given in the context of tracking the fluorescence of a fluid (732) in a biological indicator (700), it should be understood that similar principles are easily applicable to other recorded parameters (e.g., rainbow, absorption, etc.) that change when active enzyme in the fluid (732). Similarly, although the previous examples are given in the context of biological indicators (700) that have undergone sterilization processes in a sterilizing cabinet (100), it should be understood that similar principles are easily applicable to sterilization methods using an enzymatic reaction and / or various other types of enzyme detection contexts.

In FIG. 20-21 show additional graphs of fluorescence (in OEF) over time for a visual representation of additional illustrative methods for determining the presence of active enzymes in the fluid (732) of a biological indicator (700). As well as the method described above with reference to FIG. 17-19, the methods described below can be implemented using an analyzer (102, 800, 950) indicators. The methods associated with FIG. 20-21 are designed to filter out the fluorescence data associated with the initial part of the incubation process, during which the fluorescence intensity encounters an initial decrease (for example, as a result of heating of the fluid (732) in the cell (810, 954). In both In the following examples, the variable tʹ is used to indicate the time during which the fluorescence intensity completes the initial decrease.

In the graph shown in FIG. 20, curve (1210) is a graph associated with a biological indicator (700) having an active enzyme (indicating an ineffective sterilization cycle); while the curve (1212) is a graph associated with a biological indicator (700) that does not have an active enzyme (which indicates an effective sterilization cycle). The straight line (1214) is a horizontal line drawn parallel to the x axis (which indicates time), with a value associated with the initial fluorescence of the biological indicator (700). As the lower limit t _{1 of the} integral formula shown in FIG. 20, a point is taken at which a straight line (1214) intersects a curve (1210, 1212). The test statistics are represented by the integral, as shown in FIG. twenty.

In the graph shown in FIG. 21, curve (1210) is also a graph associated with a biological indicator (700) having an active enzyme (indicating an ineffective sterilization cycle); while the curve (1212) is also a graph associated with a biological indicator (700) that does not have an active enzyme (which indicates an effective sterilization cycle). The straight line (1214) is also a horizontal line drawn parallel to the x axis (which indicates time), with a value associated with the initial fluorescence of the biological indicator (700). Also, as the lower limit t _{1 of the} integral formula shown in FIG. 21, the point at which the line (1214) intersects the curve (1210, 1212) is adopted. However, in this example, tʹ is defined as the time during which the negative region (1220) (i.e., the region under the line (1214) before t _{1 is} reached) decreases by half; or alternatively in the center of the negative region (1220). For this, it is not necessary to find the exact minimum value on the curve (1210, 1212), but this can give an integration start point at which biologically relevant light intensity or fluorescence begins. Then integration is performed according to the luminous intensity or fluorescence taken from t ₁ to t _f , which represents the end of the incubation period of the analysis cycle, to compile the test statistics. As shown, this defines the area between the curve (1210, 1212) and the new horizontal line (1216). The horizontal line is parallel to the x axis and has a value associated with the minimum fluorescence intensity associated with time tʹ.

Regardless, the test statistics are evaluated using the method described above with reference to FIG. 20, or using the method described above with reference to FIG. 21, test statistics can be compared with a predetermined critical value. The critical value will serve as a threshold indicating whether the biological indicator (700) contains the active enzyme or not. It should be understood that the curve (1210) provides test statistics that exceed the critical value, which indicates the inefficiency of the sterilization cycle; while the curve (1212) provides test statistics that are below the critical value, which indicates the effectiveness of the sterilization cycle. It should be understood that to perform the integration in accordance with the methods described above, the "trapezoidal method" can be used. Various acceptable methods by which a critical value can be identified for the purposes described herein will be apparent to those skilled in the art. It should be understood that the fluorescence of biological indicators (700) can be analyzed using other methods.

V. Illustrative combinations

The following examples relate to various non-exhaustive ways in which the ideas of this document can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or in subsequent documents on this application. Examples do not imply disclaimer. The following examples are provided for illustrative purposes only. It is contemplated that various ideas of this document may be compiled and applied in many other ways. It is also contemplated that some variations may not include certain elements mentioned in the examples below. Therefore, none of the aspects or elements mentioned below should be considered critical, unless otherwise explicitly indicated subsequently by the authors of the present invention or the assignee in the interests of the authors of the present invention. If any claims related to this application are presented in this application or in subsequent documents that include additional elements other than those listed below, these additional elements will not be considered added for any reason relating to patentability.

Example 1

A method for processing a medical device, comprising the steps of: (a) receiving input from a user selecting a specific sterilization cycle from among a plurality of available sterilization cycles; (b) identify a certain type of biological indicator associated with the selected sterilization cycle; (c) the user receives an invitation to place the medical device and the identified biological indicator in the sterilizing chamber of the sterilizing cabinet; (d) performing the selected sterilization cycle of the medical device in the sterilizing chamber; and (e) determining whether the identified biological indicator contains any living organisms after the selected sterilization cycle has been completed.

Example 2

The method of example 1, wherein the step of determining whether the identified biological indicator contains any living organisms comprises evaluating the fluorescence associated with the identified biological indicator.

Example 3

The method according to any one of one or more examples 1-2, in which the action of determining whether the identified biological indicator contains any living organisms, indicates that the identified biological indicator contains a living organism, the method further comprising informing the user that that the identified biological indicator contains a living organism.

Example 4

The method according to example 3, in which the action of informing the user that the identified biological indicator contains a living organism is performed by means of a sterilizing cabinet.

Example 5

The method according to any one of one or more examples 1-4, wherein the step of determining whether the identified biological indicator contains any living organisms is performed using a biological indicator analyzer, the biological indicator analyzer being separated from the sterilizing cabinet.

Example 6

An biological indicator analyzer comprising: (a) a plurality of cells, each cell configured to receive a corresponding biological indicator; (b) a plurality of elements for detecting organisms, each element for detecting organisms is configured to detect whether a biological indicator located in a corresponding cell of the plurality of cells contains a living organism, and (c) a touch screen, wherein the touch screen is configured to receive user input and providing the user with information indicating the status of the analysis of the biological indicator.

Example 7

The biological indicator analyzer of Example 6, wherein the elements for detecting organisms comprise: (i) light sources configured to emit light to biological indicators located in the cells, and (ii) sensors configured to detect fluorescence emanating from biological indicators located in cells.

Example 8

The biological indicator analyzer according to any one of one or more examples 6-7, further comprising a communication port, wherein the communication port is configured to transmit the results of the biological indicator analysis to a device located at a distance from the biological indicator analyzer.

Example 9

The biological indicator analyzer according to any one of one or more examples 6-8, further comprising a plurality of indicator sensors, wherein each indicator sensor is configured to determine whether the indicator is placed in a corresponding cell from a plurality of cells.

Example 10

The biological indicator analyzer according to any one of one or more examples 6-9, further comprising: (a) a processor configured to receive a cell selection from the user and select an indicator and respond to the remote server to determine whether the control indicator has passed from the indicator batch associated with with the choice of an indicator, a test, and with the possibility of issuing to the user via the touch screen a control notification if the control indicator has not been tested; and (b) memory communicating with the processor.

Example 11

The biological indicator analyzer of example 10, in which the processor is further configured to detect that the control indicator is placed in the cell, incubate the control indicator and analyze the control indicator to determine the presence of biological contamination, and, in the case of biological contamination, display by touch a notification screen indicating that the test indicator test was successful and that the indicator is linked to indicator selection.

Example 12

The biological indicator analyzer according to example 11, in which the processor is additionally configured to display a notification that it is necessary to test the second control indicator from a batch of indicators in another cell, in the absence of biological contamination in the control indicator.

Example 13

The biological indicator analyzer according to any one of one or more examples 6-12, further comprising (a) a processor further configured to display a chemical indicator guide via a touch screen in response to receiving a signal indicating a user’s intention to place the indicator in a cell; moreover, the manual regarding the chemical indicator is configured to display the initial chemical indicator and chemical indicator after sterilization; moreover, the processor is additionally configured to receive a user’s choice indicating whether the chemical indicator of the indicator corresponds to the original chemical indicator or chemical indicator after sterilization; and (b) memory communicating with the processor.

Example 14

The biological indicator analyzer according to any one of one or more examples 6-13, further comprising (a) a processor further configured to display, by means of a touch screen, an indicator activation guide in response to receiving a signal indicating a user’s intention to place the indicator in a cell; moreover, the indicator activation guide is configured to display a set of commands for breaking the glass ampoule of the indicator and mixing the chemical solution from the ampoule with biological material; moreover, the processor is additionally configured to receive from the user a choice indicating whether the glass ampoule was broken and whether the chemical solution was mixed; and (b) memory communicating with the processor.

Example 15

The biological indicator analyzer according to any one of one or more examples 6-14, further comprising: (a) a processor configured to display, by touch screen, a graphical representation of each cell, the graphical representation being configured to indicate the presence of an indicator in the corresponding cell, time to end the test performed for the indicator in the appropriate cell, and an indication of whether the test performed in the corresponding cell was successful or unsatisfactory; and (b) memory communicating with the processor.

Example 16

The biological indicator analyzer according to any one of one or more examples 6-15, further comprising: (a) a processor configured to receive identification of the indicator analyzer from the user, receiving recognition of the unsatisfactory result from the user, issuing a set of quarantine instructions to the user via the touch screen, access to a remote server to identify one or more of the surgical instruments associated with the unsatisfactory indicator, and create a notification containing a description of one or more surgical instruments associated with poor indicator in response to the unsatisfactory test indicator; and (b) memory communicating with the processor.

Example 17

The biological indicator analyzer according to any one of one or more examples 6-16, further comprising an indicator scanner, wherein the indicator scanner is configured to read an identification from a biological indicator and determine an indicator data set based on an indicator identification, wherein the indicator data set contains a unique identifier and indicator history .

Example 18

The biological indicator analyzer of Example 17, wherein the indicator scanner is selected from the group consisting of an optical reader and a wireless radio reader.

Example 19

The biological indicator analyzer according to any one of one or more examples 17-18, further comprising a processor and a communication port, the processor being configured to transmit a set of analysis results to the server via a communication port, wherein the analysis result contains a set of results data and a unique identifier.

Example 20

The biological indicator analyzer according to any one of one or more examples 6-19, further comprising a housing having cells and containing elements for detecting organisms, the housing providing a base configured to support the housing to the surface, the touch screen being oriented at an angle to the base.

Example 21

A method for analyzing a biological indicator using an indicator analyzer, comprising the steps of: (a) providing instructions to the user through the touch screen of an indicator analyzer; (b) accepting the biological indicator into a cell selected from a plurality of cells in the indicator analyzer; (c) analyzing the biological indicator in the selected cell, the analysis comprising evaluating the fluorescence associated with the biological indicator in the selected cell; (d) display the results of the analysis on a touch screen; and (e) initiate a quarantine procedure if the results of the analysis indicate that the biological indicator is non-sterile.

Example 22

The method of example 21, wherein checking the control status of the analysis of the biological indicator comprises the steps of: (i) identifying the batch associated with the biological indicator, (ii) determining whether the batch was monitored, and (iii) if the control not performed, perform the following actions: (A) displaying instructions to the user regarding the placement of the control indicator in the cell of the analyzer of biological indicators, (B) performing a control analysis using the control indicator, (C) if a follow-up analysis is unsatisfactory for the first time, showing the user instructions for re-checking the control status of the biological indicator using a different cell, and (D) if the control analysis is unsatisfactory for the second time, showing the user instructions for re-checking the control status of the biological indicator using another batch .

Example 23

The method of any one of one or more examples 21-22, wherein the analysis of the biological indicator comprises the steps of: (i) displaying instructions to the user to verify whether the biological indicator has undergone a sterilization cycle, (ii) displaying instructions to the user regarding checking the chemical activating the biological indicator, (iii) determine whether the biological indicator has been placed in the cell of the indicator analyzer, (iv) incubate the biological indicator, (v) emit light to the biological indicator from the source ika analyzer and light indicators (vi) show the fluorescence emanating from the biological indicator by indicators analyzer sensor.

Example 24

The method of any one of one or more examples 21-23, wherein the quarantine procedure comprises: (i) identifying a set of potentially contaminated medical devices and (ii) notifying the party responsible for the potentially contaminated medical device for each potentially contaminated medical device from the set potentially contaminated medical devices.

Example 25

The method of claim 16, further comprising the steps of: (a) displaying instructions to the user to scan the biological indicator using the indicator scanner of the indicator analyzer, (b) receiving the identification of the indicator from the biological indicator, and (c) determining the indicator data set based on the identification indicator, and the indicator data set contains a unique identifier and indicator history.

Example 26

A method for analyzing a biological indicator using an indicator analyzer, comprising the steps of: (a) checking the control status of the analysis of the biological indicator by: (i) identifying the batch associated with the biological indicator, (ii) determining whether the specified batch was monitored, and ( iii) performing the following actions if the control was not carried out: (A) displaying instructions to the user regarding the placement of the control indicator in the cell of the analyzer of biological indicators, (B) performing the control test lysis using a control indicator, (C) if the control analysis is unsatisfactory for the first time, showing the user instructions to re-check the control status of the biological indicator using another cell, and (D) if the control analysis is unsatisfactory for the second time, showing the user instructions re-checking the control status of the biological indicator using a different batch; (b) analyze the biological indicator by: (i) showing the user instructions to verify whether the biological indicator has undergone a sterilization cycle, (ii) showing the user instructions to check the chemical activation of the biological indicator, (iii) determining whether the biological indicator has been placed in a cell of the indicator analyzer, (iv) incubation of the biological indicator, (v) light emission to the biological indicator from the light source of the indicator analyzer, and (vi) detection of fluorescence emanating from the bio ogicheskogo indicator by indicators analyzer sensor; (c) return the results of the analysis of the biological indicator and (d) initiate the quarantine procedure if the results of the analysis of the biological indicator indicate that the biological indicator is non-sterile.

VI. other information

It should be borne in mind that any patent, publication or other description material, fully or partially incorporated herein by reference, is included in it only to the extent that the material included does not contradict the existing definitions, claims or other description materials presented in the present description . Thus, the description, expressly presented in this document, to the extent that it is necessary, prevails over any information that contradicts the material included in this document by reference. Any material or part thereof, indicated as incorporated herein by reference, but contrary to existing definitions, provisions, or other description material presented herein, will be included in this document only to the extent that between the included material and the existing description material no contradictions arise.

A person of ordinary skill in the art can implement the various shown and described embodiments of the present invention, further adapting the methods and systems described herein by appropriate modifications without departing from the scope of the present invention. Some of these possible modifications have been mentioned, while others will be apparent to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, sizes, coefficients, steps, etc. described above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in the light of the claims presented below, and it should be understood that it is not limited to the detailed design and operation information shown and described in the description and figures.

Claims (53)

1. An analyzer of biological indicators, containing: (a) a plurality of cells, each cell being configured to receive an appropriate biological indicator; (b) a plurality of elements for detecting organisms, each element for detecting organisms is configured to detect whether a biological indicator located in a corresponding cell from a plurality of cells contains a living organism; and (c) a touch screen, wherein the touch screen is configured to receive user input and provide the user with information indicating a status of analysis of a biological indicator; (d) a processor, the processor being configured to receive a cell selection from the user and select an indicator and a response request to the remote server to determine whether the control indicator from the batch of indicators associated with the selection of the indicator has passed the test, and with the possibility of issuing to the user a touch screen notifications if the test indicator has not been tested; moreover, the processor is configured to detect that the control indicator is placed in the cell, perform incubation of the control indicator and analyze the control indicator to determine the presence of biological pollution, and, in the case of biological pollution, display through the touch screen a notification indicating that the control indicator is tested successful, and establishing a link between the control indicator and indicator selection; moreover, the processor is configured to display a notification that it is necessary to test the second control indicator from a batch of indicators in another cell, in the absence of biological contamination in the control indicator. 2. The analyzer according to claim 1, in which the elements for detecting organisms contain: (i) light sources configured to emit light to biological indicators located in the cells, and (ii) sensors configured to detect fluorescence emanating from biological indicators located in the cells. 3. The analyzer according to claim 1, further comprising a communication port, the communication port being configured to transmit the results of the analysis of the biological indicator to a device located at a distance from the analyzer of biological indicators. 4. The analyzer according to claim 1, further comprising a plurality of indicator sensors, wherein each indicator sensor is configured to determine whether an indicator is placed in a corresponding cell from a plurality of cells. 5. The analyzer according to claim 1, further comprising a memory interacting with the processor. 6. The analyzer of claim 1, wherein the processor is further configured to display, by means of a touch screen, a guide for activating an indicator in response to receiving a signal indicating a user’s intention to place the indicator in a cell; moreover, the indicator activation guide is configured to display a set of commands for breaking the glass ampoule of the indicator and mixing the chemical solution from the ampoule with biological material; wherein the processor is further configured to receive a selection from the user indicating whether the glass ampoule has been broken and whether the chemical solution has been mixed. 7. The analyzer according to claim 1, wherein the processor is further configured to display, by means of a touch screen, a graphical representation of each cell, wherein the graphical representation is configured to indicate the presence of an indicator in the corresponding cell, the time until the end of the test performed for the indicator in the corresponding cell, and an indication of whether the test performed in the appropriate cell was successful or unsatisfactory. 8. The analyzer according to claim 1, further comprising an indicator scanner, wherein the indicator scanner is configured to read an indicator identification from a biological indicator and determine an indicator data set based on an indicator identification, wherein the indicator data set contains an indicator identifier and an indicator history. 9. The analyzer according to claim 8, in which the indicator scanner is selected from the group consisting of an optical reader and a wireless radio reader. 10. The analyzer according to claim 1, further comprising a communication port, wherein the processor is configured to transmit a set of analysis results to the server via the communication port, wherein the analysis result contains a set of results data and an indicator identifier. 11. The analyzer according to claim 1, further comprising a housing having cells and containing elements for detecting organisms, the housing providing a base configured to support the housing to the surface, the touch screen being oriented at an angle to the base. 12. A method for analyzing a biological indicator using an indicator analyzer, comprising the steps of: (a) instructions are provided to the user through the touch screen of an indicator analyzer; (b) accepting the biological indicator into a cell selected from a plurality of cells in the indicator analyzer; (c) analyze the biological indicator in the selected cell, and the analysis includes steps in which: (i) the user is instructed to check whether the biological indicator has undergone a sterilization cycle, (ii) the user is shown instructions for checking the chemical activation of the biological indicator, (iii) determine whether the biological indicator was placed in the cell analyzer indicators, (iv) incubating the biological indicator, (v) emit light to the biological indicator from the light source of the indicator analyzer, and (vi) detect fluorescence emanating from a biological indicator using an indicator analyzer sensor; (d) displaying the results of the analysis on a touch screen; and (e) initiate a quarantine procedure if the results of the analysis indicate that the biological indicator is non-sterile. 13. The method of claim 12, further comprising the steps of: (a) the user is instructed to scan the biological indicator using the indicator scanner of the indicator analyzer; (b) accepting the identification of the indicator from a biological indicator; and (c) determining the indicator data set based on the identification of the indicator, wherein the indicator data set contains an indicator identifier and an indicator history. 14. A method for analyzing a biological indicator using an indicator analyzer, comprising the steps of: (a) checking the status of the analysis of the biological indicator by: (i) identification of a batch associated with a biological indicator, (ii) determining whether control of the batch has been conducted, and (iii) performing the following actions if control has not been carried out: (A) displaying instructions to the user regarding the placement of the control indicator in the cell of the analyzer of biological indicators, (B) performing a control analysis using control, (C) if the control analysis is unsatisfactory for the first time, showing the user instructions to re-check the status of the biological indicator using a different cell, and (D) if the follow-up analysis is unsatisfactory a second time, showing the user instructions to re-check the status of the biological indicator using a different batch; (b) perform a biological indicator analysis by: (i) showing the user instructions to check whether the biological indicator has undergone a sterilization cycle, (ii) displaying to the user instructions for verifying the chemical activation of the biological indicator, (iii) determining whether a biological indicator has been placed in the cell of the indicator analyzer, (iv) incubation of a biological indicator, (v) radiation of light to the biological indicator from the light source of the indicator analyzer, and (vi) detecting fluorescence emanating from a biological indicator using an indicator analyzer sensor; (c) provide the results of the analysis of the biological indicator; and (d) initiate a quarantine procedure if the results of the analysis of the biological indicator indicate that the biological indicator is non-sterile.

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