Digital Autoreader using Electronic Based Sensors for Monitoring of Sterilization Processes

A digital autoreader for determining efficacy of a sterilization process, the digital autoreader comprising:

• a housing comprising an interior and an exterior;
• a well for receiving a process challenge device comprising a first indicator and a second indicator, the well comprising an opening and a block for retaining the process challenge device, wherein the block is located within the interior of the housing;
• a first sensor located within the interior of the housing and positioned adjacent to the block of the well, the first sensor configured to read a variable of the first indicator and determine whether the process challenge device has been adequately sterilized;
• a second sensor located within the interior of the housing and positioned adjacent to the block of the well, the second sensor configured to read a variable of the second indicator and determine whether the process challenge device has been adequately sterilized, wherein the second sensor is located at a location different from where the first sensor is located;
• and
• an interface to alert a user if the process challenge device has been adequately sterilized.

A method of determining efficacy of a sterilization process, the method comprising:

• providing a digital autoreader comprising:
• a housing comprising an interior and an exterior,
• a well for receiving a process challenge device, the process challenge device comprising at least one indicator, the well comprising an opening and a block for retaining the process challenge device, wherein the block is located within the interior of the housing,
• a first sensor located within the interior of the housing and positioned adjacent to the block of the well, the first sensor configured to read a variable of the at least one indicator of the at least one indicator of the process challenge device and determine whether the process challenge device has been adequately sterilized, and
• an interface to alert a user if the process challenge device has been adequately sterilized,
• inserting the process challenge device within the well;
• and
• operating the digital autoreader to determine if the process challenge device has been adequately sterilized.

A system for determining efficacy of a sterilization process, the system comprising:

• an integrated process challenge device comprising:
• a shell comprising an interior and an exterior,
• a compartment defined by the interior and exterior of the shell, the compartment shaped to retain a biological indicator, and
• an opening located on the exterior of the shell adjacent to the compartment, wherein the opening allows a sterilant to enter and exit the compartment;
• and
• a digital autoreader comprising:
• a housing comprising an interior and an exterior,
• a well for receiving the integrated process challenge device, the well comprising an opening and a block for retaining the integrated process challenge device, wherein the block is located within the interior of the housing,
• a biological indicator reader, the biological indicator reader configured to read a variable on the biological indicator and determine whether the integrated process challenge device has been adequately sterilized,
• a crushing mechanism configured to crush a container within the biological indicator, the container having a growth medium housed therein, and
• an interface to alert a user if the integrated process challenge device has been adequately sterilized.