Abstract: A device and method for cleaning and sterilizing tubular structures particularly, long, narrow tubular structures such as lumens of a medical device such as an endoscope by reversing the flow of fluid in interconnected tubular structures. The device comprises a first and second valve in fluid communication with a first and second tubular structure. The valves selectively switch between a first and second position causing a first and second flow path within the tubular structures, at least a part of the second flow path opposite the first flow path.

Abstract: Methods and devices for determining the efficacy of a cleaning, disinfecting, or sterilizing process intended to remove biofilms are provided. The devices involve a biofilm sample, a biofilm indicator, and a simulated endoscope.

Abstract: The present invention relates to a two-part or multi-part concentrate system for preparing an activated solution which can be diluted with water to a use-dilution solution having improved anti-corrosive properties at room temperature. The concentrate system contains a first component containing at least one oxidizing agent, preferably hydrogen peroxide and a second component containing at least formic acid in a concentration of about 25 wt %. At least one corrosion inhibitor and at least one surfactant are also included in the concentrate system. When mixed and diluted, the resulting solution is excellent in its sterilization and anti-corrosive properties.

Abstract: A system for reprocessing and sterilizing a previously used endoscope having at least one lumen is disclosed. The reprocessing system includes a reaction chamber into which individual chemical components of a sterilant are transferred by pneumatic force. The system includes a central processor which controls the asynchronous reprocessing and sterilization of at least two endoscopes. A novel sterilant is also disclosed. Also disclosed is a combination of the sterilization device and the sterilant and methods of using the same.

Abstract: A system for reprocessing and sterilizing a previously used endoscope having at least one lumen is disclosed. The reprocessing system includes a reaction chamber into which individual chemical components of a sterilant are transferred by pneumatic force. The system includes a central processor which controls the asynchronous reprocessing and sterilization of at least two endoscopes. A novel sterilant is also disclosed. Also disclosed is a combination of the sterilization device and the sterilant and methods of using the same.

Abstract: A method for cleaning the lumens of a medical device such as an endoscope by providing a flow and a reverse flow of fluids in interconnected lumens of the medical device.

Abstract: A coupling device that reduces the risk of cross-contamination of dialyzers during reprocessing by providing a reusable, easily disinfected connector for coupling a dialyzer to, e.g., the blood line of a dialyzer reprocessing system. The coupling device is in the form of a one-piece adapter for being screwed to the luer connector of a dialyzer and then axially attached to a blood line of a dialyzer reprocessing device via a quick connect/disconnect coupling. The adapter is reusable and easily disinfected by soaking it in liquid disinfectant.

Abstract: A peracetic acid disinfectant is used to clean particulate inorganic materials such as calcium and magnesium from fibers and filters. The method allows polysulfone filtens in particulate to be reused after soaking for at least about 18 hours, and most preferably at least about 24 hours, in the peracetic acid based solution. The cleaned filters have been shown to have a reuse life of in excess of 30% and up to about 60-80% of the original life of the filter. The peracetic acid solution and method may be used to clean both hollow fiber and pleated polysulfone filters.

Abstract: A hemodialysis acid concentrate which includes, before mixing, sodium chloride powder and sometimes dextrose powder as a powder component, and a liquid component which contains some or all of the following: potassium chloride, magnesium chloride, sodium chloride, dextrose, calcium chloride, and an acid from the group lactic acid, acetic acid, and citric acid. The liquid and powder components are added to a specified volume of water to make a final acid concentrate. The individual components are easily inspected for quality control and the shipping weight is greatly reduced compared to conventional liquid acid concentrates.

Abstract: A method of cleaning precleaning the header of a used dialyzer is provided. The method includes providing a precleaner header selectively coupled to a dialyzer header cap. The precleaner header includes a needle having an inlet in fluid communication with a source of cleaning fluid and an outlet in fluid communication with the header cap. An incoming source of cleaning fluid is introduced into the needle at a pressure above ambient pressure and an incoming source of air is introduced at a pressure above ambient pressure into the incoming cleaning fluid stream. The cleaning fluid containing air is discharged into the dialyzer header and cleans the dialyzer header by circulating therewith in. A waste stream is generated and drained from the dialyzer header through the precleaner header.

Abstract: A system for reprocessing and sterilizing a previously used endoscope having at least one lumen is disclosed. The reprocessing system includes a reaction chamber into which individual chemical components of a sterilant are transferred by pneumatic force. The system includes a central processor which controls the asynchronous reprocessing and sterilization of at least two endoscopes. A novel sterilant is also disclosed. Also disclosed is a combination of the sterilization device and the sterilant and methods of using the same.

Abstract: A dialyzer precleaning system for coupling a source of fluid to a used dialyzer. The precleaning system includes a precleaner header that includes a housing with a needle receiving channel and a connected waste discharge channel, a needle with a plurality of fluid discharge perforations is received within the needle assembly receiving channel, and a coupling arm for attaching the precleaner header to a dialyzer header cap. The needle protrudes into the dialyzer header so that fluid may be discharged through the inside of the needle out the fluid discharge perforations into the dialyzer header. Waste fluid from the dialyzer header is discharged back into the needle assembly receiving channel along the outside the needle into a fluidly connected waste discharge channel and out a waste discharge outlet. The needle may also rotate and retract.

Abstract: A method for improving priming of an integrated oxygenator and heat exchanger which includes pretreating the integrated hollow fiber oxygenator and heat exchanger device with a surfactant. Pretreating the device coats the interior surfaces of the integrated hollow fiber oxygenator and heat exchanger with the surfactant, which facilitates the removal of entrapped air. An integrated hollow fiber oxygenator and heat exchanger having a surfactant coating on the interior surfaces is provided which subsequently allows for more efficient priming with an aqueous priming media.

Abstract: Provided is an anti-microbial composition containing an ester of formic acid, an oxidizer, performic acid and water. Also provided is a premix for making the anti-microbial composition having two parts. One part contains the ester of formic acid and a second part contains the oxidizer. Another method is provided for making the anti-microbial composition in which the ester of formic acid is combined with the oxidizer and water. A further method is provided for sterilizing medical devices, including dialyzer filter modules, wherein the anti-microbial composition is capable of a 1:1 to a 1:12 dilution with water.

Abstract: A combined venous and cardiotomy blood reservoir is provided that includes a rigid shell having a top, a bottom, and a continuous side wall. The top and bottom walls are connected to the continuous side walls so as to define a reservoir for venous and cardiotomy blood. A double column structure is provided within the blood reservoir, the first column for receiving and degassing venous blood, the second for receiving, filtering and defoaming cardiotomy blood. The venous blood filtering and defoaming components can include a top venous screen plate, a bottom venous screen plate or stand and a perforated venous cage captured therebetween. The venous column is of generally D-shape and has a double screen structure including an inner microscreen and an outer microscreen received respectively on the inside and outside of the perforated venous cage.

Abstract: A method is provided for priming a hollow fiber oxygenator which is integrated with a hollow tube heat exchanger. A closed priming circuit is created between a cardiosurgery reservoir, the combined hollow fiber oxygenator and heat exchanger and a vacuum source. Vacuum pressure is applied to the closed priming circuit to evacuate the residual air from the circuit. Priming solution is released from the cardiosurgery reservoir and fills the evacuated closed priming circuit.

Abstract: An asymmetrical, microporous, hollow fiber membrane is made from a polymeric dope mixture of polysulfone and polyvinyl pyrrolidone dissolved in an aprotic solvent. The physical morphology of the hollow fiber membrane, i.e., the asymmetric microporous wall, is rapidly formed by passing the polymeric dope mixture through an outer annular orifice of a tube-in-orifice spinneret while simultaneously passing a precipitating solution through the central tube of the spinneret. The emerging hollow fiber travels substantially downward for about 0.01-10 m before submersion into a quenching bath. The asymmetrical, microporous, hollow fiber membrane is biocompatible and suitable for use in, for example, dialysis, hemodialysis, ultrafiltration, and water filtration applications.

Abstract: A low prime, high heat exchange efficiency oxygenator is provided which includes an oxygenation portion and a heat exchanger portion. Disposed within the heat exchanger portion is a hollow tube heat exchanger wound bundle which includes a plurality of hollow tubes knitted into a mat, the mat wound under tension into a bundle which includes from 16 to 24 layers of the mat. The oxygenator provided permits prime volumes of 180 to 240 mLs.

Abstract: A low prime, high heat exchange efficiency oxygenator is provided which includes an oxygenation portion and a heat exchanger portion. Disposed within the heat exchanger portion is a hollow tube heat exchanger wound bundle which includes a plurality of hollow tubes knitted into a mat, the mat wound under tension into a bundle which includes from 16 to 24 layers of the mat. The oxygenator provided permits prime volumes of 180 to 240 mLs.

Abstract: An asymmetric, microporous hollow fiber membrane comprising a polyimide is disclosed. The hollow fiber membrane is chemically inert to aqueous solutions and/or blood, is immediately rewettable after repeated steam and chemical sterilizations, has superior clearance, sieving, and water permeability characteristics and is usable over a wide range of applications such as dialysis and water filtration. Also disclosed is the process for manufacturing the polyimide hollow fiber membrane.