Abstract: An intermittent catheter package including a plurality of components and a catheterization tray configured to facilitate a catheterization procedure. The plurality of components include a urinary catheter fluidly connected to a urine-drainage bag and a sampling-port access device configured to fluidly connect to a urine-sampling port of the urinary catheter or the urine-drainage bag for aseptic collection of one or more urine samples. The catheterization tray includes at least a first compartment, a second compartment, and a third compartment configured to hold the plurality of components. The first compartment is configured to hold the urinary catheter. The second compartment is connected to the first compartment by an intercompartment connection. The second compartment is configured to hold the urine-drainage bag. The third compartment is configured to hold the sampling-port access device. Step-by-step instructions are incorporated into the catheterization tray to facilitate the catheterization procedure.

Abstract: The invention relates to a biological indicator for determining the efficacy of a steam or heat sterilization process, and its method. The biological indicator comprises microbial spores (a), at least one sensor protein exogenous to the microbial spores (b), one fluorophore (c), and a culture medium (d). The invention also refers to the method of use of this biological indicator.

Abstract: An improved system, method and interface for automated rapid antimicrobial susceptibility testing (AST) is disclosed which includes, in one aspect, a carrier population station comprising a workstation having a graphic user interface (GUI). The GUI accepts information from a lab technologist, including information related to a scope of testing to be performed on a patient sample. The GUI controls intelligent assignment of patient samples to test panels in a manner that maximize utilization of the test carrier by grouping together samples of similar tests scopes and advantageously testing those samples using one multiplexed test panel. Customizing workflow in accordance with test scope to facilitate parallel processing of multiple samples advantageously reduces laboratory waste, decreases test latencies, increases AST system throughput and efficiency, and thus lowers the costs to the AST lab.

Abstract: A treatment indicator, a method for indicating a level of treatment in a treatment apparatus, and a method of preparing a treatment indicator are provided. The treatment indicator comprises a first body comprising a biological material, a fluid porous body in fluid communication with the first body in a fluid path, and a cleaning test soil disposed in at least a portion of interstitial spaces of the fluid porous body to inhibit traversal of a fluid through the fluid porous body to the first body via the fluid path.

Abstract: A system for real-time detection of airborne pathogens is disclosed. The system includes: an air intake unit defining an inlet and an air inflow channel; a fan configured to cause air in a sampling environment to flow into the air inflow channel via the inlet; a cooling unit for cooling air in the air inflow channel; a collection chamber for collecting liquid water condensed from air in the air inflow channel, the collection chamber including: an active target substrate having a surface that is coated with bioreceptors; and a reference target substrate that is not coated with bioreceptors, and an optical detection unit that is configured to independently illuminate the active target substrate and the reference target substrate with light for detecting presence of an airborne pathogen.

Abstract: A method for cleaning a medical instrument and for detecting residue thereon is provided in which method a non-sterile or conventionally sterilized medical instrument is exposed to pressure below 100 hPa, and, subsequently, exposed to at least one gas reactive to the residue.

Abstract: A sterilization process test device for verifying the efficacy of a sterilization process includes a tubular body defining a chamber for containing at least one sterilization indicator and a cap to sealingly close the tubular body. The tubular body includes at least one hole, which is covered by a gas and steam permeable cover. The only flow path into the chamber is provided through the steam and gas permeable cover and the at least one hole, which when combined are configured to control and restrict a flow of steam or a gaseous sterilization medium from an external environment.

Abstract: An air sampling system is disclosed. The air sampling system includes: an air inflow channel having an air inlet portion at a top end, the air inflow channel being oriented substantially vertically; a fan configured to cause air in a sampling environment to flow into the air inflow channel via the inlet portion; a cooling unit for cooling air in the air inflow channel, the cooling unit disposed downstream of the inlet portion; a collection chamber for collecting liquid water condensed from air in the air inflow channel, the collection chamber being fluidly connected to the air inflow channel; and a sensing unit for determining a volume of liquid in the collection chamber, wherein the cooling unit is controlled in response to signals generated by the sensing unit.

Abstract: An article is provided. The article comprises a nonwoven substrate having a copolymer grafted thereto, and a dried coating adhered to the substrate. The copolymer comprises interpolymerized monomer units of a quaternary ammonium-containing ligand monomer, an amide monomer, and an oxy monomer. The coating comprises a plurality of test microorganisms. Optionally, the coating further comprises a water-soluble or water-dispersible polymeric binding agent. A process challenge device comprising a body having a hollow channel with said article fixed disposed therein is also provided. Methods of using the article or the process challenge device for determining the efficacy of a disinfection process are also provided.

Abstract: An indicator and method of use thereof, and indicator system and method of use thereof are provided to determine the degree of an oxidative treatment. An indicator is incorporated into the oxidative treatment. The object and the indicator are subjected to the oxidative treatment. A discoloration of the indicator occurs based on an oxidation of the polymer by a process condition of the oxidative treatment oxidizing the polymer. The discoloration of the indicator is measured against a threshold color value to determine the degree of the oxidative treatment.

Abstract: An extraction system for testing microbial contamination includes a biocompatible outer vessel that has a side wall and a biocompatible suspension system that is positionable within an interior of the biocompatible outer vessel. The biocompatible suspension system includes a horizontal member on which a sample may be supported and a securement mechanism that is engagable with the side wall of the biocompatible outer vessel to maintain the suspension system at a desired position within the biocompatible outer vessel.

Abstract: Hearing aid devices, methods of manufacture, methods of use, and kits are provided. In certain aspects, the hearing aid devices comprise an apparatus having a transducer and a retention structure comprising a shape profile corresponding to a tissue of the user, and a layer of elastomer.

Abstract: Disclosed is a catheterization package including catheterization-package components and a catheterization tray configured to facilitate a catheterization procedure. The catheterization-package components include a urinary catheter fluidly connected to a urine-drainage bag and a sampling-port access device configured to fluidly connect to a urine-sampling port of the urinary catheter or the urine-drainage bag for aseptic collection of one or more urine samples. The catheterization tray includes at least a first compartment, a second compartment, and a third compartment configured to hold the catheterization-package components. The first compartment is configured to hold the urinary catheter. The second compartment is connected to the first compartment by an intercompartment connection. The second compartment is configured to hold the urine-drainage bag. The third compartment is configured to hold the sampling-port access device.

Abstract: A reference test body for monitoring and/or verifying test conditions during a test of microbial barrier properties of at least one product, wherein the reference test body has a cavity, a nutrient medium, at least one opening, and at least one cover provided with a number of holes and covering the at least one opening. A constancy of test conditions can be monitored in this way. The invention further relates to an associated use, an associated test chamber, and an associated method.

Abstract: The biological functionality of living microbial spores is modified using phenotypic engineering to endow the resulting modified spores with novel functionality that extends the usefulness of the spores for a variety of practical applications including, for example, sterility testing, the release of active compounds, and cell-based biosensing systems. An embodiment entails engineering Bacillus spores to acquire synthetic new functions that enable the modified spores to sense and rapidly transduce specific germination signals in their surroundings. The newly acquired functions allow the spores to perform, for example, as self-reporters of cellular viability, self-indicating components of cell-based biosensors, and in other analytical systems. Also disclosed are methods for testing adequate sterility of a system by using engineered spores.

Abstract: The present invention relates to moving microorganisms to a surface, where they are grown in the presence and absence of antimicrobials, and by monitoring the growth of the microorganisms over time in the two conditions, their susceptibility to the antimicrobials can be determined. The microorganisms can be moved to the surface through electrophoresis, centrifugation or filtration. When the movement involves electrophoresis, the presence of oxidizing and reducing reagents lowers the voltage at which electrophoretic force can be generated and allows a broader range of means by which the target can be detected. Monitoring can comprise optical detection, and most conveniently includes the detection of individual microorganisms. The microorganisms can be stained in order to give information about their response to antimicrobials.

Abstract: The present application relates to methods for producing materials having viable micro-organisms incorporated therein. More particularly, the materials are produced under high temperature and/or high pressure conditions, and the micro-organisms are incorporated in the material before or during these conditions. Also provided are micro-organisms that remain viable under these conditions and have different applications, depending on the nature of the material.

Abstract: A biological sterilization indicator includes a housing having a first enclosure and a second enclosure, an ampule containing a liquid growth medium, and an insert disposed at least partially in the first enclosure. A portion of the ampule may be disposed inside the first enclosure. The insert may have a platform including a top surface, an abutment surface, and a side surface, as well as a first void disposed in the platform and configured to allow passage of a first volume of the liquid growth medium into the second enclosure and a second void disposed through at least a portion of the side surface and configured to allow passage of a second volume of the liquid growth medium into the second enclosure.

Abstract: A sterilization assembly of a mobile device includes a bacteria detection device, a microwave sterilization device, and a processor. The bacteria detection device detects a bacterial count on the mobile device by emitting light waves and receiving reflected light waves and analyzing a wavelength change in the reflected light waves. The microwave sterilization device emits microwaves to kill the bacteria. The processor sends a detection signal to the bacteria detection device to control the bacteria detection device to detect the bacterial count, and sends a sterilization signal to the microwave sterilization device to control the microwave sterilization device to emit the microwaves. The bacteria detection device sends detection feedback information to the processor. The microwave sterilization device sends sterilization feedback information to the processor.

Abstract: A method for rapidly determining effective sterilization, deimmunization, and/or disinfection of equipment and/or supplies by a device. The method includes providing a defined surrogate protein having a predetermined sequence representative of an infectious agent potentially contaminating the equipment and/or the supplies to be sterilized, deimmunized, and/or disinfected by the device. The defined surrogate protein having the predetermined sequence is subjected to sterilization, deimmunization, or disinfection. The effectiveness of the sterilization deimmunization, or disinfection is rapidly determined by determining if the defined surrogate protein has been destroyed.

Abstract: A method for rapidly determining effective sterilization, deimmunization, and/or disinfection of equipment and/or supplies by a device. The method includes providing a defined surrogate protein having a predetermined sequence representative of an infectious agent potentially contaminating the equipment and/or the supplies to be sterilized, deimmunized, and/or disinfected by the device. The defined surrogate protein having the predetermined sequence is subjected to sterilization, deimmunization, or disinfection. The effectiveness of the sterilization deimmunization, or disinfection is rapidly determined by determining if the defined surrogate protein has been destroyed.

Abstract: A method for removing microorganisms from liquid samples and a nanofiber containing liquid filtration medium that simultaneously exhibits high liquid permeability and high microorganism retention. Microorganisms such as bacteria, particularly B. Diminuta, are removed from a liquid by passing the liquid through a porous nanofiber containing filtration medium having a B. Diminuta LRV greater than about 9, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. Another method for removing microorganisms such as bacteria and Mycloplasma, includes passing the liquid through a porous nanofiber containing filtration medium having a microorganism LRV greater than about 8, and the nanofiber(s) has a diameter from about 10 nm to about 1,000 nm. The filtration medium can be in the form of a fibrous electro spun polymeric nanofiber liquid filtration medium mat.

Abstract: Surgical wrappers and related methods are provided. A reusable surgical wrapper can include a first layer that includes a fabric having at least one of synthetic fibers or synthetic yarns. In some embodiments, a surgical wrapper can include a first layer comprising a first fabric that repels fluids forming a first face of the surgical wrapper. A second layer can be provided that includes a second fabric forming a second face of the surgical wrapper. A seam binding can be disposed around at least a portion of an outer edge of the first fabric and an outer edge of the second fabric to join the first layer and the second layer to form a dual layered surgical wrapper.

Abstract: Surgical appliance kit and system for releasably securing a surgical appliance to a surgical field and method of assembling the surgical appliance kit. The surgical appliance kit and system includes a surgical tray having the surgical appliance and a plurality of hook-and-loop attachment members disposed thereon. A cover is attached to the surgical tray and covers the surgical appliance and the plurality of attachment members. In use, a “hook” attachment member is adhesively attached to the surgical appliance and a “loop” attachment member is adhesively attached to the surgical field. The hook attachment member is placed into engagement with the loop attachment member. In this manner, the surgical appliance is releasably secured to the surgical field, so that the surgical appliance will not inadvertently fall from the surgical field.

Abstract: A biological sterilization indicator (BI) system and method. The system can include a BI and a reading apparatus comprising a well. The BI can include a housing, which can include a first portion, and a second portion movable between a first “unactivated” position and a second “activated” position. The reading apparatus can detect at least one of (i) when the well is empty; (ii) when the biological sterilization indicator is positioned in the well with the second portion of the housing in the first position, and (iii) when the biological sterilization indicator is positioned in the well with the second portion of the housing in the second position. The method can include detecting at least one of the above conditions, which can be used to detect an activation status of the biological sterilization indicator.

Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

Abstract: A combined sterilization indicator incubator and reader system, including a sterilization indicator vial containing one of a variety of selected biological indicators and a liquid, at least two incubator blocks, each incubator block independently operable to incubate the sterilization indicator vial at a plurality of independently selectable temperatures, each of the incubator blocks including at least one heating element operable to heat the incubator block to any one of the plurality of independently selectable temperatures; a light source, a photodetector and a control system configured to operate the combined system to determine the efficacy of a variety of sterilization processes. The system calculates and compares a slope to a predetermined threshold slope for the biological indicator, and provides output based only on the comparison of the calculated slope to the predetermined threshold slope without first determining either a baseline or a minimum value of the output from the photodetector.

Abstract: A Method Validation Unit (MVU) for the evaluation of the level of sterilisation in a sterilisation method involving the use of a fluid at or near the supercritical pressure and temperature for that fluid, wherein the MVU comprises a sterilisation indicator housed within a gas-permeable container, wherein the sterilisation indicator comprises an indicator medium and a population of one or more colony forming units (CFUs), and wherein the indicator medium comprises one or more structural features representative of the internal structure of a material to be sterilised in the sterilisation method.

Abstract: The disclosed invention relates to a method of making a sterilization indicator including depositing an electronically conductive material on a substrate using an ink jet printer and depositing a biological indicator on part or all of the electronically conductive material using the ink jet printer, and further relates to a method for monitoring a sterilization process including (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.

Abstract: A biological sterilization indicator, system, and methods of determining the effectiveness of a sterilization process. The biological sterilization indicator can include a locus of spores, a reservoir containing a liquid, and a sterilant path positioned to provide fluid communication between ambience and the locus of spores. The reservoir can have a closed state in which the reservoir is not in fluid communication with the locus of spores and an open state in which the reservoir is in fluid communication with the locus of spores. The biological sterilization indicator system can include the biological sterilization indicator and a detection device adapted to be coupled to the biological sterilization indicator. In some embodiments, the method can include assaying the spores for a detectable change in a characteristic, and detecting substantially all of the detectable change.

Abstract: A protocol process is provided for testing and evaluating Bacillus spores. The process includes isolating a sample of the spores, providing an environmental matrix of exposure condition elements, determining a midpoint for each control range between the low and high extremities, selecting condition elements from the matrix, with each condition element corresponding to a first condition, subjecting the sample to the condition elements from the matrix, counting survival spores for each condition element, performing a response surface methodology (RSM) analysis from the survival spores, and determining coefficients that satisfy a relation for k conditions. The matrix has control ranges of temperature, relative humidity and exposure duration, the control ranges extending from a low extremity to a high extremity. The first condition is one of the low and high range extremities and remaining conditions occupying the midpoint for a corresponding control range. All condition elements are uniquely distinguishable.

Abstract: Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.

Abstract: A sterilization indicator for oxidative sterilants, comprising a first compartment comprising spores of one or more microorganism species, wherein the spores have been pretreated with and comprises a compound comprising a transition metal ion that is reactive with an oxidative sterilant; a second compartment comprising a growth medium and adapted to combine contents of the first compartment with contents of the second compartment for incubation after the sterilization indicator has been exposed to an oxidative sterilant; and an agent disposed in the growth medium and selected to indicate viability of the spores after the sterilization indicator has been exposed to the oxidative sterilant.

Abstract: A sterilization indicator, including a first compartment containing a genetically engineered biological indicator, and a second compartment containing an enzyme substrate, the second compartment adapted to maintain the enzyme substrate separate from the biological indicator during sterilization, and to permit the enzyme substrate to contact the biological indicator after the biological indicator has been exposed to the sterilization medium; in which the genetically engineered biological indicator comprises at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and the test organism is free of any active or activatable repressor gene that would inhibit expression of the reporter gene if present in the test organism or sterilization indicator, and the indicator enzyme and the enzyme substrate are selected such that enzymatic action of the indicator enzyme upon the enzyme substrate yields a detectable signal.

Abstract: The sterilizing effect of particle irradiation on microorganisms for the sterilizing treatment thereof can be evaluated. The evaluation can be done by supplying microorganisms in the space inside a container (8), allowing particles (7) for the sterilizing treatment of microorganisms to irradiate the microorganisms, sampling the microorganisms by a sampling means (6) after the irradiation of the particles (7) and measuring the sampled microorganisms. The microorganisms as the subject for the sterilizing treatment can be a combination of one or more members selected from the group consisting of bacteria, mycete, viruses and allergens. As the particles, for example, positive ions, negative ions, and gases of positive ions and negative ions in mixture, charged particles such as ? rays and ? rays, various plasma gas particles, particles such as ozone and radical particles, and particles of chemical agent can be used.

Abstract: A sterilization indicator for oxidative sterilants, comprising a first compartment comprising spores of one or more microorganism species, wherein the spores have been pretreated with and comprises a compound comprising a transition metal ion that is reactive with an oxidative sterilant; a second compartment comprising a growth medium and adapted to combine contents of the first compartment with contents of the second compartment for incubation after the sterilization indicator has been exposed to an oxidative sterilant; and an agent disposed in the growth medium and selected to indicate viability of the spores after the sterilization indicator has been exposed to the oxidative sterilant.

Abstract: The present invention relates to a wound dressing or a wound swab, which allows the detection of at least three enzymes selected from the group consisting of lysosyme, elastase, cathepsin G and myeloperoxidase using colored substrate agents for these enzymes. These enzyme substrates can be bound to medically acceptable polymers or fibers.

Abstract: A biological indicator for determining the effectiveness of a sterilization process is disclosed having a package and carrier integral therewith. The package includes a first sheet and a second sheet having a bottom portion, side portions and a top portion. The first and second sheets are joined together generally along a periphery of the first and second sheets by a peelable adhesive. A carrier having a plurality of spores thereon for determining the effectiveness of a sterilization process is attached to the package between the first and second sheets and at least a portion of the resealable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier.

Abstract: The present invention provides method of detecting a predetermined biological activity. The method includes using an aqueous mixture comprising a first indicator reagent with a first absorption spectrum and a second indicator reagent. The second indicator reagent is converted by the predetermined biological activity to a second biological derivative with a second emission spectrum. The first absorbance spectrum includes detectable absorbance in at least a portion of wavelengths present in the second emission spectrum. The first indicator reagent is received and concentrated from an aqueous liquid by a substrate, facilitating the detection of the second biological derivative.

Abstract: The invention aims at providing an adsorbent for bacterial toxins, a method for removal of such toxins by adsorption, and an adsorber packed with said adsorbent. Provided are an adsorbent for bacterial toxins, which comprises a water-insoluble porous material having a mode of pore radius of 20 angstroms to 1,000 angstroms, a method for removal of bacterial toxins using said adsorbent, and an adsorber packed with said adsorbent.

Abstract: A sterility test method includes: selecting strain and culture medium, preparing bacterial cultures, transcribing fingerprint characteristics in thermograms as indices to verify the characteristics, drawing the thermodynamic parameters of the thermogram, determining the positive judgment index and performing sterility test for the samples. A fully-enclosed bacteria collecting ampoule incubator includes bacteria collecting ampoule system, sample and liquid feeding system and peristalsis liquid discharge system. The sample and liquid feeding system is connected with the bacteria collecting ampoule system by the liquid intake tube; and the bacteria collecting ampoule system is connected with the peristalsis liquid discharge system by the liquid drainage tube. The invention is characterized by short inspection time, high sensitivity, high automation and accurate test results on microbial contamination. It can also provide the overall process curve on the growth conditions.

Abstract: A biological indicator for determining the effectiveness of a sterilization process is disclosed having a package and carrier integral therewith. The package includes a first sheet and a second sheet having a bottom portion, side portions and a top portion. The first and second sheets are joined together generally along a periphery of the first and second sheets by a peelable adhesive. A carrier having a plurality of spores thereon for determining the effectiveness of a sterilization process is attached to the package between the first and second sheets and at least a portion of the resealable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier.

Abstract: The present invention provides aryl- or heteroaryl-diketo acid compounds effective to inhibit an activity of a Mycobacterial malate synthase enzyme or to inhibit a malate synthase activity in other bacteria having the enzyme. The compounds may be phenyl- naphthyl-, or thienyl-substituted diketo acids and carboxylate derivatives thereof. Also provided are methods of treating tuberculosis or other pathophysiological conditions associated with a malate synthase enzyme with the inhibitory compounds and methods of in silico design of the inhibitory compounds. In addition, the present invention provides the inhibitory compounds designed by this method. Furthermore, three-dimensional X-ray crystal structures of the Mycobacterial malate synthase complexed with the inhibitory compounds are provided. Further still a method for stabilizing an aromatic or heteroaromatic diketo acid or its prodrug or close analog in solution by derivatizing at least the ortho position on the aromatic ring is provided.

Abstract: The disclosed invention relates to a method of making a sterilization indicator including depositing an electronically conductive material on a substrate using an ink jet printer and depositing a biological indicator on part or all of the electronically conductive material using the ink jet printer, and further relates to a method for monitoring a sterilization process including (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.

Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

Abstract: A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

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.