US-12616769-B2 - Biological indicator reader with graphical user interface and methods of use

US12616769B2US 12616769 B2US12616769 B2US 12616769B2US-12616769-B2

Abstract

A biological indicator reader is provided for reading a plurality of biological indicators to determine the effectiveness of at least a sterilization process. Each biological indicator is configured to exhibit fluorescence when the sterilization process has failed. Each reader comprises a housing having a plurality of biological indicator holders, a heater coupled to the housing and configured to heat the plurality of biological indicator holders to a preselected temperature to incubate the biological indicators, a UV light emitter configured to emit UV light through a first aperture on the side of each holder and an optical detector positioned under a second aperture on the bottom of the biological indicator holder, the optical detector configured to detect fluorescence intensity indicating the effectiveness of the sterilization process. A method of using the biological indicator reader is provided. A biological indicator system and display are also provided.

Inventors

Keith Hamberg
John C. Houge
Greg Ingersoll
MICHAEL SCHEIDNES
Jeanette Sterner

Assignees

CROSSTEX INTERNATIONAL, INC.

Dates

Publication Date: 20260505
Application Date: 20211222

Claims (20)

1 . A biological indicator reader for reading a plurality of biological indicators to determine an effectiveness of at least one sterilization process, each biological indicator of the plurality of biological indicators is configured to exhibit fluorescence when the at least one sterilization process has failed, the reader comprising: a housing having a plurality of biological indicator holders, each holder configured to receive one of the plurality of biological indicators, each biological indicator holder of the plurality of biological indicator holders having a first aperture and a second aperture; a horizontal circuit board positioned under the plurality of biological indicator holders and a vertical circuit board orthogonal to the horizontal circuit board and proximate to the plurality of biological indicator holders, a heater coupled to the housing and configured to heat the plurality of biological indicator holders to a preselected temperature to incubate the plurality of biological indicators; an UV light emitter mounted on the vertical circuit board and configured to emit UV light through the first aperture of each holder of the plurality of biological indicator holders; an optical detector mounted on the horizontal circuit board and positioned adjacent to the second aperture of each of the plurality of biological indicator holders, the optical detector configured to detect fluorescence intensity indicating the effectiveness of the at least one sterilization process; and a controller coupled to the optical detector, the controller configured to receive an input signal emitted when the optical detector receives light exiting each of the plurality of biological indicator holders and to provide an output signal indicating sterilization process failure or success on a graphical user interface.
2 . The biological indicator reader of claim 1 , further comprising the graphical user interface, wherein the graphical user interface comprises a display indicating sterilization process failure or success of each biological indicator of the plurality of biological indicators disposed in each of the plurality of biological indicator holders.
3 . The biological indicator reader of claim 1 , wherein the first aperture is on a side of each of the plurality of biological indicator holders and the second aperture is on a bottom of each of the plurality of biological indicator holders.
4 . The biological indicator reader of claim 1 , wherein the optical detector comprises a single optical detector configured to detect a presence of a biological indicator of the plurality of biological indicators and the effectiveness of the sterilization process.
5 . The biological indicator reader of claim 2 , wherein the display comprises a graphical screen configured to show a color for each biological indicator of the plurality of biological indicators disposed in each of the plurality of biological indicator holders.
6 . The biological indicator reader of claim 2 , wherein the display is configured to show a virtual keyboard touch screen configured for a user to input data associated with each of the plurality of biological indicators disposed in each of the plurality of biological indicator holders.
7 . The biological indicator reader of claim 1 , wherein the optical detector further comprises a photodiode to detect a fluorescent signal and to send the signal to the controller and/or graphical user interface.
8 . The biological indicator reader of claim 2 , wherein the display is configured to show at least one of a menu, a countdown timer, a date, a time, a well temperature, a view icon or an alarm button.
9 . The biological indicator reader of claim 1 , further comprising the graphical user interface, wherein the graphical user interface is configured to display a home screen configured for a user to access a status of each of the plurality of biological indicators inserted into each of the plurality of biological indicator holders and to enter data associated with each of the plurality of biological indicators.
10 . The biological indicator reader of claim 9 , wherein the graphical user interface is configured to display and update a sterilization status for each of the plurality of biological indicators inserted into each of the plurality of biological indicator holders.
11 . The biological indicator reader of claim 1 , wherein the controller comprises a processor having a memory configured to receive, store and transmit data indicative of the fluorescence of each of the plurality of biological indicators based on a fluorescence signal received from the optical detector.
12 . A biological indicator system for detecting an effectiveness of a sterilization process, the system comprising: a biological indicator reader for reading a plurality of biological indicators to determine the effectiveness of at least a sterilization process, each biological indicator of the plurality of biological indicators is configured to exhibit fluorescence when the sterilization process has failed, the reader comprising: a housing having a plurality of biological indicator holders, each holder configured to receive one of the plurality of biological indicators, each biological indicator holder of the plurality of biological indicator holders having a first aperture and a second aperture; a horizontal circuit board positioned under the plurality of biological indicator holders and a vertical circuit board orthogonal to the horizontal circuit board and proximate to the plurality of biological indicator holders; a heater coupled to the housing and configured to heat the plurality of biological indicator holders to a preselected temperature and a preselected period of time to incubate the plurality of biological indicators; an UV light emitter mounted on the vertical circuit board and configured to emit UV light through the first aperture; and an optical detector mounted on the horizontal circuit board and positioned adjacent to the second aperture of each of the plurality of biological indicator holders, the optical detector configured to detect fluorescence intensity indicating the effectiveness of the sterilization process; a controller coupled to the optical detector, the controller configured to receive an input signal emitted when the optical detector receives light exiting each of the plurality of biological indicator holders and to provide an output signal indicating sterilization process failure or success on a graphical user interface; and a selected biological indicator containing spores, growth media containing a fluorescent moiety, and a crushable container, the selected biological indicator being sterilizable and configured to receive UV light from the UV light emitter.
13 . The biological indicator system of claim 12 , wherein the first aperture is on a side of each of the plurality of biological indicator holders and the second aperture is on a bottom of each of the plurality of biological indicator holders.
14 . The biological indicator system of claim 12 , wherein the controller comprises a remote interface configured to connect to a web browser.
15 . The biological indicator system of claim 12 , wherein the controller comprises a diagnostic interface configured to allow one or more settings of the biological indicator reader to be changed by a second controller external to the reader.
16 . The biological indicator system of claim 15 , wherein the second controller is coupled to a connector on a circuit board of the reader.
17 . The biological indicator system of claim 12 , further comprising the graphical user interface, wherein the graphical user interface is configured to display a home screen configured for a user to access a status of each biological indicator of the plurality of biological indicators inserted into each of the plurality biological indicator holders and to enter data associated with each of the plurality of biological indicators.
18 . The biological indicator system of claim 12 , further comprising the graphical user interface, wherein the graphical user interface is configured to display and update a sterilization status for each of the plurality biological indicators inserted into each of the plurality of biological indicator holders.
19 . The biological indicator system of claim 12 , wherein the controller comprises a processor having a memory configured to receive, store and transmit data indicative of the fluorescence of each of the plurality of biological indicators based on a fluorescence signal received from the optical detector.
20 . A method for determining an effectiveness of at least one sterilization process, the method comprising: providing a biological indicator reader for reading a plurality of biological indicators to determine the effectiveness of the at least a sterilization process, each biological indicator of the plurality of biological indicators is configured to exhibit fluorescence when the at least one sterilization process has failed, the reader comprising a housing having a plurality of biological indicator holders, each holder configured to receive one of the plurality of biological indicators, each biological indicator holder of the plurality of biological indicator holders having a first aperture and a second aperture; a heater coupled to the housing and configured to heat the plurality of biological indicator holders to a preselected temperature to incubate the plurality of biological indicators; an UV light emitter configured to emit UV light through the first aperture; an optical detector positioned adjacent to the second aperture, the optical detector configured to detect fluorescence intensity indicating the effectiveness of the at least one sterilization process; providing a selected biological indicator capable of exhibiting fluorescence to indicate the effectiveness of the at least one sterilization process, the selected biological indicator comprising a crushable container; subjecting the selected biological indicator to the at least one sterilization process to obtain a sterilized biological indicator, crushing the crushable container of the sterilized biological indicator to activate the selected biological indicator; incubating the activated biological indicator in one of the plurality of biological indicator holders of the selected biological indicator at a preselected temperature and for a preselected period of time; emitting UV light through the first aperture of each of the plurality of biological indicator holders; detecting fluorescence intensity by the optical detector indicating the effectiveness of the at least one sterilization process, the optical detector coupled to a controller, the controller configured to receive an input signal emitted when the optical detector receives light exiting each of the plurality of biological indicator holders and to provide an output signal indicating sterilization process failure or success on a graphical user interface.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application with Ser. No. 63/134,433 filed, Jan. 6, 2021, and claims priority to U.S. Provisional Patent Application with Ser. No. 63/134,432 filed Jan. 6, 2021, and claims priority to U.S. Provisional Patent Application with Ser. No. 63/134,429 filed Jan. 6, 2021. These applications are incorporated herein by reference, in their entireties. BACKGROUND Sterilization is a process conducted in a specially designed chamber or sterilizer that results hopefully in a complete eradication of all viable microorganisms that may be living on medical, dental or surgical instruments. Sterilization techniques have evolved over time from the traditional methods employing saturated steam at elevated temperature and ethylene oxide gases to more modern techniques such as those employing liquid, vapor, and plasma. The effectiveness of the sterilization process must be evaluated regardless of the technique used especially when a medical, dental or surgical instrument is going to be used on or in the human body. Biological indicators are devices that are used to test the efficacy of sterilization chambers such as those employed in healthcare facilities and laboratories for sterilizing medical, dental or surgical instruments. A biological indicator provides information on whether necessary conditions were met to kill a specified number of microorganisms for a given sterilization process, which provides the user a certain level of confidence in their particular sterilization process. A typical biological indicator being used today is a self-contained biological indicator (SCBI), which contains, among other things, microorganisms, culture medium, carrier, and a crushable container (e.g., vial). After the biological indicator is exposed to a sterilization process, the crushable container of the biological indicator is crushed or activated and placed in a biological indicator reader, which has, among other things, an incubator, a UV light emitter and an optical detector. Any microorganism remaining in the biological indicator, after the sterilization process, is incubated in the culture medium after the indicator is activated. Metabolism of the culture medium by viable microorganisms surviving in the medium will cause a fluorescent signal on exposure of the medium to UV light. This fluorescent signal, if intense enough, will be detected by the optical detector indicating a sterilization failure during the sterilization process, where the proper conditions (e.g., time, temperature, position in the sterilizer, etc.) for sterilization were not met. Medical, dental or surgical instruments not properly sterilized can potentially contaminate patients if used. Unfortunately, some biological indicator readers currently available provide inaccurate results on whether the proper conditions were met to kill a specified number of microorganisms for a given sterilization process. These biological indicator readers fail to provide the user with confidence that the proper sterilization process has occurred. Thus, there is a need for an improved biological indicator reader, system, and method, which reduce inaccurate results of the sterilization process. SUMMARY A biological indicator reader for reading a plurality of biological indicators to determine the effectiveness of at least a sterilization process is provided. Each biological indicator is configured to exhibit fluorescence when the sterilization process has failed, the reader comprising a housing having a plurality of biological indicator holders, each holder configured to receive one of the plurality of biological indicators, each biological indicator holder having a first aperture and a second aperture; a heater coupled to the housing and configured to heat the plurality of biological indicator holders to a preselected temperature to incubate the biological indicators; a UV light emitter configured to emit UV light through the first aperture of each holder; an optical detector positioned adjacent to the second aperture of the biological indicator holder, the optical detector configured to detect fluorescence intensity indicating the effectiveness of the sterilization process; and a controller coupled to the optical detector, the controller configured to receive an input signal emitted when the optical detector receives light exiting each biological indicator holder and to provide an output signal indicating sterilization process failure or success on a graphical user interface. A biological indicator system for detecting the effectiveness of a sterilization process is provided. The system comprises a biological indicator reader for reading a plurality of biological indicators to determine the effectiveness of at least a sterilization process, each biological indicator configured to exhibit fluorescence when the sterilization process has failed, the reader comprising a housing having a plur