Abstract: A self-contained biological indicator (“SCBI”) is disclosed. The SCBI may include a first ampule and a second ampule. The first ampule may contain a first volume of a first growth medium, and the second ampule may contain a second volume of a second growth medium. The SCBI is configured such that the first ampule may be broken before the second ampule. The SCBI may be analyzed for changes in fluorescence of the first growth medium. Then, the SCBI may be analyzed for changes in a color of the second growth medium.

Abstract: Biological indicators may be improperly activated. The disclosed subject matter is directed to methods of confirming that a biological indicator having an ampule containing a growth medium has been properly activated such that it may be assayed. The methods may include the steps of measuring a first fluorescence intensity of the biological indicator, heating the biological indicator; quenching the fluorescence intensity of the biological indicator from the first fluorescence intensity to a second fluorescence intensity, measuring the second fluorescence intensity; comparing the second fluorescence intensity and first fluorescence intensity to obtain a comparison value; and determining that the comparison value corresponds to a quenching metric of the liquid growth medium.

Abstract: An apparatus that assists in sterilizing an endoscope inside a sterilizer employing a gaseous sterilant, e.g., hydrogen peroxide, is disclosed. The apparatus may include a dry booster and a flow restrictor that includes two tubes, which may be connected to channels of an endoscope and the dry booster. The flow restrictor may be used to change the flow rates through the channels to assist in delivering sterilant throughout the channels.

Abstract: A sterilization-assistance device is described herein. In some embodiments, the sterilization-assistance device comprises a dry booster and at least one measurement device attached to the dry booster. In various embodiments, the at least one measurement device may include a strain gauge. In various embodiments, the at least one measurement device may include a pressure sensor. In various embodiments, the at least one measurement device may include a pressure sensor and a strain gauge. The sterilization assistance device may also include a communication module. The communication module may be a wireless-communication module. The measurement device may provide indications that the dry booster has become detached from an endoscope during a sterilization procedure.

Abstract: An apparatus that assists in sterilizing an endoscope inside a sterilizer employing a gaseous sterilant, e.g., hydrogen peroxide, is disclosed. The apparatus may include a dry booster and a flow restrictor that includes two tubes, which may be connected to channels of an endoscope and the dry booster. The flow restrictor may be used to change the flow rates through the channels to assist in delivering sterilant throughout the channels.

Abstract: A sterilization-assistance device is described herein. In some embodiments, the sterilization-assistance device comprises a dry booster and at least one measurement device attached to the dry booster. In various embodiments, the at least one measurement device may include a strain gauge. In various embodiments, the at least one measurement device may include a pressure sensor. In various embodiments, the at least one measurement device may include a pressure sensor and a strain gauge. The sterilization assistance device may also include a communication module. The communication module may be a wireless-communication module. The measurement device may provide indications that the dry booster has become detached from an endoscope during a sterilization procedure.

Abstract: A self-contained biological indicator (“SCBI”) is disclosed. The SCBI may include a first ampule and a second ampule. The first ampule may contain a first volume of a first growth medium, and the second ampule may contain a second volume of a second growth medium. The SCBI is configured such that the first ampule may be broken before the second ampule. The SCBI may be analyzed for changes in fluorescence of the first growth medium. Then, the SCBI may be analyzed for changes in a color of the second growth medium.

Abstract: A sterilization package for an endoscope that is described herein. The sterilization package may be used for endoscopes over six feet long. The sterilization package may include a first leg, a second leg connected to the first leg, an opening, and a flap disposed proximate the opening and configured to cover the opening. The package may be 95% by weight of a vapor permeable material. The package, with the endoscope disposed therein, may be coiled and placed into a vacuum chamber of a sterilization system.

Abstract: Biological indicators may be improperly activated. The disclosed subject matter is directed to methods of confirming that a biological indicator having an ampule containing a growth medium has been properly activated such that it may be assayed. The methods may include the steps of measuring a first fluorescence intensity of the biological indicator, heating the biological indicator; quenching the fluorescence intensity of the biological indicator from the first fluorescence intensity to a second fluorescence intensity, measuring the second fluorescence intensity; comparing the second fluorescence intensity and first fluorescence intensity to obtain a comparison value; and determining that the comparison value corresponds to a quenching metric of the liquid growth medium.

Abstract: A chemical vapor sterilization process is enhanced by flowing a portion of the sterilant vapor through an instrument container using a normal portion of the exhaust process. Preferably, an exhaust conduit which draws a vacuum on a sterilization chamber is oriented so that the container is adjacent an inlet to the conduit.

Abstract: The effectiveness of an oxidative sterilization process is determined by exposing a substrate having a known amount of a primary amine or aldehyde indicator chemical to an oxidative germicide. The oxidative germicide reacts with the indicator chemical. The amount of indicator chemical remaining after exposure to the germicide is determined by reacting the indicator chemical with a dye precursor chemical to form a colored product. The amount of indicator chemical remaining on the substrate is determined from the intensity of the color of the colored product. The amount of indicator chemical remaining on the substrate is a measure of the effectiveness of the germicidal treatment. The dye precursor is an aldehyde when the indicator chemical is a primary amine and a primary amine when the indicator chemical is an aldehyde. An integrator for determining the effectiveness of the germicidal process includes a substrate and an indicator chemical, where the indicator chemical is a primary amine or an aldehyde.

Abstract: A chemical vapor sterilization process is enhanced by flowing a portion of the sterilant vapor through an instrument container using a normal portion of the exhaust process. Preferably, an exhaust conduit which draws a vacuum on a sterilization chamber is oriented so that the container is adjacent an inlet to the conduit.

Abstract: The present invention relates to a process for sterilization of medical instruments by concentrating a sterilant such as hydrogen peroxide from a vaporizer, which is connected to the sterilization chamber through the same port as the pump, and sterilizing articles therewith. The sterilant is concentrated by removing more water from the vaporizer than peroxide.

Abstract: A method monitors the concentration of an oxidative gas or vapor during a sterilization process in a sterilization chamber. A sensor formed of a chemical reactive with the oxidative gas or vapor coupled to a temperature probe is positioned inside of an enclosure containing an item to be sterilized. The enclosure is defined by a barrier impermeable to contaminating microorganisms and having at least a portion thereof which is permeable to the oxidative gas or vapor. The sensor is electrically connected through the barrier to contacts located exterior of the enclosure and connected to a control system thereby.

Abstract: An apparatus for monitoring the concentration of an oxidative gas or vapor includes a chemical substance which reacts with the oxidative gas or vapor to produce a heat change. A temperature probe is coupled to the chemical substance and adapted to respond to the heat change. The temperature probe can be coupled to the chemical substance by a carrier, and can include a reference temperature probe. Additionally, a method of using the apparatus is described, as well as a sterilization system which utilizes the apparatus.

Abstract: A monitor of the concentration of an oxidative gas or vapor comprises a chemical coupled to a temperature probe, such as by a carrier. Addtionally, the monitor is used in a method of monitoring the concentration of an oxidative gas or vapor and in a sterilization system operated by a user. By utilizing an output signal from the temperature probe to measure the heat produced in an exothermic reaction between the monitored oxidative gas or vapor and the chemical of the monitor, the concentration of the monitored oxidative gas or vapor can be determined. The present invention represents an improvement over the monitors described in the prior art since it is more simplified, and can provide information on the local concentration of an oxidative gas or vapor at various positions within a chamber, and can be operated in size-restricted volumes. Additionally, a method of using the monitor is described, as well as a sterilization system which utilizes the monitor.

Abstract: An apparatus for monitoring the concentration of an oxidative gas or vapor includes a first thermocouple junction and a chemical substance coupled to the first thermocouple junction. The chemical substance is reactive with the oxidative gas or vapor to produce heat. The apparatus further includes a second thermocouple junction coupled in series to the first thermocouple junction. A net voltage is generated across the first and second thermocouple junctions upon exposure of the chemical substance to the oxidative gas or vapor. The net voltage corresponds to the concentration of the oxidative gas or vapor.

Abstract: A method monitors a concentration of an oxidative gas or vapor in a diffusion-restricted region in fluid communication with a sterilization chamber during a sterilization process. The method includes providing a concentration monitor responsive to the oxidative gas or vapor by generating a parameter corresponding to the concentration of the oxidative gas or vapor. The concentration monitor includes a temperature sensing device coupled to a chemical substance reactive with the oxidative gas or vapor to produce heat. The method further includes placing at least a portion of the concentration monitor comprising the chemical substance within the diffusion-restricted region. The method further includes introducing the oxidative gas or vapor into the sterilization chamber. The method further includes monitoring the parameter generated by the concentration monitor during the sterilization process.

Abstract: An apparatus for monitoring the concentration of an oxidative gas or vapor includes a chemical substance which reacts with the oxidative gas or vapor to produce a heat change. A temperature probe is coupled to the chemical substance and adapted to respond to the heat change. The temperature probe can be coupled to the chemical substance by a carrier, and can include a reference temperature probe. Additionally, a method of using the apparatus is described, as well as a sterilization system which utilizes the apparatus.