Abstract: The present disclosure is directed to self-contained biological indicators wherein a single type of indicator is capable of being used for various sterilization conditions, including sterilization with steam and/or ethylene oxide. In some embodiments, a single type of biological indicator is capable of being used for different steam sterilization conditions having varied temperatures and sterilization cycles.

Abstract: A sterilization test pack may include a shell defining an indicator compartment having a volume; a channel extending between a compartment opening and an exterior opening, the channel being in fluid communication with the indicator compartment through the compartment opening and surrounding atmosphere being in fluid communication with the channel through the exterior opening such that the indicator compartment is in fluid communication with the surrounding atmosphere through the channel, the channel having a length measured between the compartment opening and the exterior opening and a hydraulic radius along the length; and an indicator disposed in the indicator compartment, where a ratio of the compartment volume to the channel hydraulic radius may range from 1000 cm2 to 8000 cm2.

Abstract: The present disclosure relates generally to chemical indicators. In particular, the chemical indicators are useful for monitoring sterilization processes. The chemical indicator includes a fluid pathway and a chamber comprises a chemical-indicating composition.

Abstract: The present disclosure is directed to self-contained biological indicators wherein a single type of indicator is capable of being used for various sterilization conditions, including sterilization with steam and/or ethylene oxide. In some embodiments, a single type of biological indicator is capable of being used for different steam sterilization conditions having varied temperatures and sterilization cycles.

Abstract: The disclosed process challenge device is a casing and a self-contained biological indicator operatively connected to the casing. The biological indicator has a housing with an open end and an interior space, a plurality of viable test microorganisms or an active enzyme in the housing, a sterilant pathway extending through the housing to the test microorganisms or the active enzyme, a detection reagent in the interior space, and an aqueous liquid in an openable container. The aqueous liquid is in selective communication with the viable test microorganisms or active enzyme. A first portion of the biological indicator has an open end and is disposed in the casing and a second portion of the self-contained biological indicator is disposed outside the casing. The second portion of the biological indicator comprises a part of the housing through which the aqueous liquid and detection reagent can be observed.

Abstract: A biological sterilization indicator (BI) is provided. The BI can include a housing, and a container positioned in the housing. The BI can further include a first chamber, and a second chamber with a source of biological activity disposed therein. The BI can further include a substrate positioned in the housing between the first chamber and the second chamber. The substrate can be positioned in fluid communication with the first chamber and the second chamber, and the substrate can be further positioned such that the substrate is not in direct contact with the source of biological activity. The substrate can comprise a hydrophobic nonporous film having an aperture. The substrate and the aperture are dimensioned to control fluid flow between the first compartment and the second compartment. The substrate can extend around substantially the entire inner perimeter of the housing between the first compartment and the second compartment.

Abstract: A sensor device. The sensor device includes a sterilant-responsive switch comprising: a circuit; a conductive polymer having a first state and a second state, and a polymeric binder; and wherein the sterilant-responsive switch connects the circuit in the first state and disconnects the circuit in the second state, and wherein the conductive polymer is capable of being converted from being in the first state to being in the second state when in contact with a sterilant.

Abstract: An example sterilization indicator (102) includes a cover (122), an indicator (102), and a seal (142). The cover (122) defines at least a portion of a cavity (138). The indicator (102) is disposed within the cavity (138). The indicator (102) is configured to fluidly couple with an internal cavity (110) of a sterilization package (package) and indicate an exposure to a sterilant. The seal (142) is configured to form a microorganism barrier between an exterior of the cover (122) and an internal cavity (110) of a sterilization package (100).

Abstract: The present disclosure relates to an article for detecting a disinfectant via visual feedback. The article have a first substrate with a first major surface and opposite ends. The article also comprises a process indicator disposed on at least a portion of the first major surface. The process indicator reacts with at least one liquid disinfectant selected from the group consisting of glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, peroxyacetic acid, and combinations thereof. The process indicator can be formed from a synthetic amine-containing polymer derived from polyethylenimine (PEI). The article can have a flow channel that is formed by a portion of the process indicator and that extends between the opposite ends. The disclosure also relates to a kit containing the article as well as a method of using the article in a disinfection process. The article is used to diagnose issues in an automated endoscope reprocessors (AERs).

Abstract: The present disclosure is directed to self-contained biological indicators wherein a single type of indicator is capable of being used for various sterilization conditions, including sterilization with steam, hydrogen peroxide, and/or ethylene oxide. In some embodiments, a single type of biological indicator is capable of being used for different steam sterilization conditions having varied temperatures and sterilization cycles.

Abstract: Aspects of the present disclosure relate to a system including an image capture device and a computing device configured to receive a test image from the image capture device corresponding to a first surgical instrument, determine an identity type of the first surgical instrument using the test image in a machine vision technique, determine whether the first surgical instrument is flagged, and perform at least one operation in response to whether the first surgical instrument is flagged.

Abstract: The present disclosure provides a monitoring device comprising a test composition, a test element comprising a test portion to which the test composition is releasably adhered, a detection reagent, and a container comprising a first end with an opening and a second end opposite the first end. The test composition comprises a predetermined quantity of tracer analyte. The container is configured to receive the test portion and configured to be operationally coupled to an analytical instrument. The tracer analyte and the detection reagent each are capable of participating in one or more chemical reaction that results in the formation of a detectable product. A method of using the monitoring device to assess the efficacy of a washing process is also provided.

Abstract: A sterilization test pack may include a shell defining an indicator compartment having a volume; a channel extending between a compartment opening and an exterior opening, the channel being in fluid communication with the indicator compartment through the compartment opening and surrounding atmosphere being in fluid communication with the channel through the exterior opening such that the indicator compartment is in fluid communication with the surrounding atmosphere through the channel, the channel having a length measured between the compartment opening and the exterior opening and a hydraulic radius along the length; and an indicator disposed in the indicator compartment, where a ratio of the compartment volume to the channel hydraulic radius may range from 1000 cm2 to 8000 cm2.

Abstract: Aspects of the present disclosure relate to a sensor device having an integrated circuit and a monitoring loop coupled to the integrated circuit. The monitoring loop includes a first conductive trace and a second conductive trace, each having a first end electrically coupled to the integrated circuit and a second end. The monitoring loop includes a sterilant-responsive switch electrically coupling the second ends of the first conductive trace and the second conductive trace. The sterilant-responsive switch has a first impedance state and a second impedance state. The sterilant-responsive switch modifies an electrical connection between the first conductive trace and the second conductive trace based on exposure to an adequate environmental condition in an adequate sterilization process. The sensor device also includes an antenna coupled to the integrated circuit forming an antenna loop that is distinct from the monitoring loop.

Abstract: The disclosed hydrogen peroxide indicator includes a substrate on which is disposed an indicator composition that includes at least one of a select group of indicator compounds and a catalyst. As a result of contact with hydrogen peroxide, the indicator composition changes color, even from colorless to having a visually observable color, thereby providing an indication of the presence of hydrogen peroxide.

Abstract: The disclosed sterilization monitoring device comprises a perfusion channel with a chemical indicating composition disposed in fluid communication with the perfusion channel. Exposure to a sterilant creates a laterally moving front across the chemical indicating composition in the perfusion channel.

Abstract: A microbial indicator device for liquid disinfection comprises a first cavity, a source of biological activity fluidically coupled to the first cavity via a portion of a first fluidic path, a filter membrane positioned in a second fluidic path for a disinfectant, and a first coupling portion fluidically coupled to the source of biologically activity via the second fluidic path. The filter membrane has a first side and a second side, wherein the first side is in fluid communication with the first fluidic path. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity on the first side. The device further comprises a frangible container contained in the first cavity, wherein a liquid in the container is in fluid communication with the first cavity when the container is fractured.

Abstract: The disclosed multilayer test pack comprises a channel lamina to form a recessed channel, and then a seal layer covers the recessed channel to form an embedded channel By providing the recessed channel in a thin-film channel lamina, the recessed channel tolerances are better controlled. Further, using thin films for the channel lamina, which can be formed into a roll, allows for a continuous unrolling and continuous bonding to a seal layer.

Abstract: The present disclosure relates generally to chemical indicators. In particular, the chemical indicators are useful for monitoring sterilization processes. The chemical indicator includes a fluid pathway and a chamber comprises a chemical-indicating composition.

Abstract: A method of verifying the efficacy of a disinfection process is provided. The method includes flowing a liquid disinfectant into an indicator device that has a plurality of indicator microorganisms disposed therein, the indicator microorganisms comprising or capable of producing a detectable enzyme activity; contacting the indicator microorganisms with the liquid disinfectant for a predetermined minimum first period of time at a first temperature; after contacting the indicator microorganisms with the liquid disinfectant for the first period of time at the first temperature, contacting the indicator microorganisms for a second period of time with a detection medium comprising a detection reagent; and during or after the second period of time, detecting a quantity of the detectable enzyme activity that was not inactivated by the contact with the disinfectant. The indicator device is also provided.