Abstract: A sterilization process is assessed using a test pack having a tube (16) for simulating the difficult to clean areas of instruments, such as lumens. The tube is disposed in a tray (10), and a biological indicator (30) is connected to a tube open end. Additional biological and chemical indicators (42, 24) are inserted in corresponding receiving wells or pockets (40, 22) of the tray. The test pack is covered with a porous wrapping (54) to simulate the challenge of wrapped instruments. The test pack is inserted in a sterilizer along with instruments to be sterilized. The biological indicator (30) will only register effective sterilization if sufficient sterilant flows through the length of the tube to the indicator.

Abstract: A self-venting package (A) contains peracetic acid or other strong oxidants in a unit dose that assures sterilization of instruments and equipment in an automated sterilizing apparatus (FIG. 3) or of biological wastes in a biological waste comminuting apparatus (FIG. 4). The self-venting package is constructed of a cylindrical body having first and second vent apertures (12, 14) 180.degree. offset adjacent a first edge (20) and third and fourth vent apertures (16, 18) 180.degree. offset adjacent a second edge (26). The first and second vent apertures are 90.degree. offset relative to the third and fourth vent apertures. The first edge is flattened and sealed forming a pair of corners (40, 42) such that the first and second vent apertures are disposed closely adjacent the first and second corners. The container is filled with peracetic acid or other liquids which liberate gas or vapors. A second end (26) of the container is flattened and sealed in a direction transverse to the first edge.

Abstract: A decontamination device (10) including a housing (12) and a chamber (16) for receiving articles to be decontaminated by at least one of washing, disinfecting and sterilizing. A control pad (20) for an operator to input control instructions for controlling decontamination cycles to which the articles are subjected. The control pad being disposed adjacent an exterior of the housing and being accessible to the operator through an opening (24) in the housing (12). A door (30) covering the opening (24) and being hingedly attached to the decontamination device by a mechanism (26) disposed entirely within the housing when the door is in a closed position. The mechanism (26) can be a leaf spring (36) having a first end connected with a pivot pin (42) to the door (30) and a second end secured to an internal region (40) of the housing (12).

Abstract: A pressure vessel (12) has a chamber (10) closed by a door (14). Steam, from a steam source (38) is selectively supplied to the interior of the pressure vessel to sterilize received items. The pressure vessel has an electric heater (24) for a steam passage or jacket (50) extending circumferentially therearound to heat the pressure vessel wall above the saturation temperature to prevent condensation within the pressure vessel. A vacuum jacket (20) surrounds the pressure vessel and the heater to provide an annular vacuum insulation region. A vacuum pump (30) is operated, as necessary, to maintain the vacuum between the vacuum jacket and the pressure vessel and is utilized when appropriate to draw a vacuum within the pressure vessel (12).

Abstract: A decontamination apparatus for medical devices includes a decontamination basin (14a, 14b) with a selectively opened and closed cover member (16a, 16b) to provide selective access to the basin (14a, 14b). A mixing chamber assembly (80) selectively dispenses detergent concentrate and decontaminant concentrate into a liquid to form a liquid cleaning solution or a liquid decontaminant solution, respectively. A source of decontaminated rinse liquid, such as a microbe removal filter (54), is in selective fluid communication with the basin (14a, 14b). A source of anti-microbial liquid is in selective fluid communication with the microbe removal filter (54) and rinse liquid flow paths (58) between the microbe removal filter and the basin for decontaminating the filter (54) and the rinse lines (58). Each channel of a medical device (E) being decontaminated is connected to a channel flush line (30) and a channel pump (32) for flushing the channels of the device (E).

Abstract: A countertop decontamination unit (A) has a decontamination chamber (10) for receiving a tray or module (C) which contains items to be sterilized, disinfected, or otherwise microbially decontaminated. The tray or walls of the decontamination chamber itself provide fluid outlets from which an anti-microbial solution is conveyed through tubing (76) to fittings (78). A pump (20) recirculates the anti-microbial fluid. The fittings include a porous sleeve (80, 92) which is received in firm frictional connection with an annular surface of a bore, nipple, or coupler mechanism of the item (86) to be sterilized. The porous sleeve is preferably elastomeric when used for frictional interconnections, but may be rigid when used with threaded or other standardized connectors. The porous sleeve has a porosity of 3 microns or more, sufficient that the anti-microbial fluid penetrates through the porous portion and contacts the immediately contiguous and abutting annular surface.

Abstract: A flow-through vapor phase decontamination apparatus includes at least one isolator unit (14) defining an isolation chamber (16) that receives a load (L) for decontamination. The apparatus includes a vapor phase decontaminant generation system (20) integrally connected to the at least one isolator unit (14). The vapor phase decontaminant generator system (20) includes one or more vaporizers (22) that inject a combination of a carrier gas and a vaporized decontaminant such as H.sub.2 O.sub.2 into the isolation chamber (16). A blower (24) recirculates the carrier gas through the one or more vaporizers (22) for replenishment of the decontaminant vapor. Alternatively, an automated filling system (70a-70c) is provided within the isolation chamber (16) for aseptic filling of containers (C). A conveyor system (68) transports the containers (C) into and out of the isolation chamber (16). The decontamination apparatus includes an electronic control system (26) for controlling decontamination operations.

Abstract: A sheet of chemically sensitive paper (54) that exhibits a measurable change in a physical property, such as color, when exposed to a chemical environment is inserted between two sections (20, 22) such that an area of the paper is exposed to the chemical environment through an opening (46) in the upper section. The lower section is connected to a piston (14) that is located in a chamber (10) such that an area at the top of the chamber is sealed by the piston. The piston responds to changes in pressure by moving within the chamber. As it does so, a ratchet mechanism (30) causes the upper and lower sections to rotate one step relative to each other. With each rotational step, a new area of the chemically sensitive paper is exposed to the chemical environment through the opening in the upper section. In this manner, a record of a series of chemical exposures is obtained.

Abstract: The invention is a system and method for real-time monitoring and control of sterilization cycle parameters within a load-simulation device that simulates the same conditions as those within an acceptable standard challenge load to be sterilized. Integration of the device into the sterilizer control system allows critical sterilization parameter levels to be achieved and maintained within the simulated load throughout a sterilization cycle, thus resulting in a significant reduction in the number of unsuccessful cycles. A redundant parameter-monitoring system within the device is included. When acceptable sterilization parameter levels are shown to have been met, the sterile load is automatically released for use immediately upon completion of the cycle, thus eliminating the need for biological indicators and chemical integrators.

Abstract: The invention is directed to the sterilization of bone tissue for transplantation employing a hydrogen peroxide vapor sterilant. The bone tissue is exposed to the sterilant vapor at a pressure, temperature, and concentration, and for a period of time that is sufficient to sterilize the bone tissue, but insufficient to cause substantial physical, chemical and biological damage. The bone tissue is defatted, preferably demineralized, substantially free of moisture and blood, and may be lyophilized prior to sterilization.

Abstract: A vaporizer (48) vaporizes a liquid solution of hydrogen peroxide or other strong oxidants to form a sterilant vapor which is entrained in a flow of sterile air. The sterilant vapor is conveyed to a manifold (12), (36), (40). A plurality of tubes or conduits (14) convey the sterilant vapor from the manifold into a interstitial space (18) between an inner, IV bag (24) and an outer overwrap (22). A vacuum pump (58) draws a negative pressure within an enclosure (42) to draw the sterilant vapor through the manifold, the delivery tubes, and the interstitial space and through the enclosure. The delivery tubes terminate opposite upper corners of the IV bag and are aimed in such a manner that the sterilant vapor gas flows through and contacts all surfaces which define the interstitial space. After sterilization, the sterilant vapor is displaced with sterile air and the IV bag assemblies are removed and the overwrap is sealed to prevent microbial recontamination.

Abstract: A collection vessel (20) is connected with inlet fitting assemblies (12, 14) for receiving waste fluids. The collection vessel is connected by a valve (74) with a drain (70) for selectively draining collected fluids. A fluid inlet (84) that is connected with an exterior water source supplies water through interconnecting tubing to rinse waste residue from the collection vessel. The water flows through a housing member (200) that surrounds a tubular member (214) of the inlet assembly. The housing member is spaced by spacers (216) from the bottom surface (220) of a well (210) surrounding the tubular member such that trapped water is drained through a drain outlet (222). Powdered reagent (170a, 170b) is received in a cup (26) that is carried by a drawer (160) to a position above a fluid mixing reservoir (124). A mechanical actuator (122) lifts a mechanical assembly (124) which defines the reservoir, forcing a cutting blade (180) to pierce and cut open the cup.

Abstract: A washer (10) having prewashing, washing, rinsing, and drying stations (12-18) and a first conveyor (20) which transports animal cages (26) through the washer in an open side down orientation. A bedding dispenser (30) has a bedding dispensing station (32) and a second conveyor (40, 48) for transporting the animal cage (26) through the bedding dispensing station (32) in an open side up orientation. A righting device (60, 90, 100) is interposed between the first conveyor (20) and the second conveyor (40, 48). The righting device includes a counter-rotating flip wheel (64, 80, 106) which receives the animal cages from the first conveyor (20), engages a peripheral flange (28) of the cage with a rung (74, 84, 112) of the flip wheel, and pivots the animal cages from the open side down orientation to the open side up orientation on the second conveyor (40, 48).

Abstract: A bacteria impermeable container or ampule (10) contains a liquid growth medium and a substrate-indicator complex. The complex includes a substrate component, e.g., starch, and an indicator molecule, e.g., a dye, a fluorescent molecule, or the like, which are tightly bound and complexed, but which are cleavable by a preselected enzyme. A sterilant passes over a carrier (20) for microorganisms which, upon germination, are capable of rapidly generating large quantities of the preselected enzyme. Following the sterilization process, the carrier is immersed in the liquid growth medium. Any viable surviving microorganisms grow, generating the preselected enzyme. The enzymes cleave the bound indicator molecule from the substrate, resulting in a measurable property change in a couple of hours. Typical property changes include fluorescence, a color change, a change in pH which triggers a pH indicator color change, and the like.

Abstract: A washing chamber (10) is surrounded by corner manifolds (14) and interconnecting conduits (16) extending along top, bottom, and side walls of the washing chamber. The conduits have nozzles (12) therein for spraying washing and rinsing liquids into the washing chamber. A central header assembly (40) includes a conduit (42) extending from one of the headers to a terminal end adjacent a central plane of the washing chamber. The central header assembly includes a header (46) with a manifold portion (48) and a plurality of extending arms (50) with nozzles on opposite sides. The header manifold portion is connected with the terminal end of the conduit (42). In one embodiment, a pivotal fluid connection and valve (44) enables the header to pivot between a position in the vertical plane and a stowed position parallel to the top of the washing chamber. In another embodiment, a quick-connect coupler system (100) interconnects the header with an outlet at the terminal end of the conduit (42).

Abstract: A countertop decontamination unit (A) has a decontamination chamber (10) which contains items to be sterilized, disinfected, or otherwise microbially decontaminated. A catheter (60) has an initial curve shape (62A). However, the catheter (60) is straightened in use and returns to a shape (62B). During a decontamination cycle, one or more porous clips (64) are disposed into frictional contact with the catheter. The clip (64) holds the catheter in the initial or undersized shape (62A) during the decontamination process. In the decontamination process, the decontamination fluid is heated at least to a temperature that resets the shape memory of the catheter (e.g., 40.degree.-60.degree. C.). The clip (64) has a sufficient porosity that microbial decontamination fluid penetrates through the clip to wet portions of the item surface in frictional contact with the clip assuring total microbial decontamination of the catheter.

Abstract: A plurality of spray arms (26, 28) are rotatably supported in a washing chamber (14) for spraying a washing and rinsing fluid. An instrument basket (32) is positioned within the washing chamber for retaining instruments or equipment (44) to be washed. An instrument holder (38) associated with the instrument basket loosely holds an instrument (44). The instrument holder includes a tube body (74) having a cavity (80) for receiving an end portion of the instrument (44) and a flange (86) positioned on an external surface of the tube body (74). A retainer cap (76) has an outer wall (116) biased resiliently outwardly over the flange (86) and resilient end wall (118) covering an open end portion of the cavity (80). The end wall has a central aperture (120) which resiliently yields to the end portion of the instrument (44) when inserted in the cavity (80) and which loosely retains the end portion of the instrument in the cavity (80) during a washing and rinsing operation.

Abstract: Medical and other instruments and devices (16, 44) may have a build-up of biological residue film, even after sterilizing. Dead cell membranes in this film can give off endotoxins. To check for the presence of biological residue film, light from a source (10, 40) travels along optical fibers (12, 42) and is focused by a lens (24) on a surface (26) to be examined. Reflected or transmitted light is conveyed by optical fibers (46) to an opto-electrical analyzing device (30, 48). In one embodiment, the opto-electrical device (30) senses the intensity of reflected light to provide an indication of reflectivity attributable to the biological film build-up. In another embodiment, a spectrophotometer (48) converts the returned light into an indication of the reflected spectrum which is analyzed (50) to determine the nature of the material which reflected the light, in particular the type of protein or other biological residue found on the examined surface.

Abstract: A vessel (20) which is divided into compartments (22, 24) receives medical and biological fluid wastes through inlet fitting (12, 14). As the fluid is received, air in the vessel is displaced and is discharged through a vent line (32), either to atmosphere or to a vacuum source. When a level sensor (34) senses that a level of fluid in the vessel is approaching a preselected maximum, a control circuit (40) closes a valve (30) in the vent line, blocking the discharge of air from the vessel and creating a backpressure that stops the receipt of further fluid. Tubing connected to the fittings (12, 14) is disconnected from the patient or other source of fluid and a valve (64) is manually opened to vent the vessel, allowing any residual fluid in the tubing to be drained into the vessel. A drain valve (74) is opened to drain the vessel and the cleaning cycle is commenced.

Abstract: A self contained biological indicator (A) determines an effectiveness of a microbial decontamination process. A dart (68) has a seal (80) engaged by rim (58) in detents (50C) in fins (36A-36F) of a cap (C). The dart has a cutting edge (76) aligned just above a foil seal (86) sealing a growth medium (F) in a medium housing (D). The dart has a chamber (72) in which challenge spores or other microorganisms on a paper disk (74) are housed. A microporous membrane (G) traps the challenge spores in the chamber while allowing a microbial decontamination fluid to flow through to contact the spores. The housing is lodged by a flange (56) in detents (50A) in fins (36A-36F).