Steris Inc.

Other

Ecomed, Inc.

Innovative Medical Technologies, Ltd.

Raymond C Kralovic

Norman L Siegel

Edward T Schneider

Paul S Malchesky

Lewis I Schwartz

Bill R Sanford

Duncan C Badertscher

Joseph J Switka

Craig M Saunders

Nick E Stanca

Jeffrey S Plantz

John L Beiswenger

Joseph H Wilson

Kathleen M Antloga

David B Mennel

Jeffrey C Rapp

Kenneth R Lamaster

David E Minerovic

Donald J Rebele

Donna M Richardson

Douglas F Marshall

Samuel M Fung

Kenneth E Scheckelhoff

Lorraine D Lindeman

David Z Levin

Gregory A Dale

David C Haeberle

Denis G Dyke

Pamela C Tanner

Medical instruments, such as endoscopes, may be sterilized or disinfected in a liquid chemical sterilant (LCS). The LCS is of sufficient potency to sterilize the contaminated medical device. In addition it is self-degrading, non-contaminating, and non-corrosive. It does not require the addition of chemically contaminating anti-corrosive compounds and detergents. Preferred LCS for use in the invention include peracetic acid, silver activated hydrogen peroxide and acidic sodium hypochloride. A particularly preferred LCS is peracetic acid since it has particular applicability with plastic components of medical devices.

Method of removing microbial contamination

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. Flattening the second edge defines third and fourth corners (44, 46). The third and fourth vent apertures are disposed closely adjacent to the third and fourth corners. Portions of a semi-permeable membrane (32, 34, 36, 38) cover each of the vent apertures. The semi-permeable membrane permits gas or vapor to pass freely therethrough while blocking the passage of liquids.

Light weight vented package for liquids

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). After the microbial decontamination process is complete, the cap is forced toward medium housing causing the rim and the flange to dislodge from their respective detents and lodge in detents (50B) resulting in the puncturing of the foil seal, the sealing of the dart within the medium housing and the immersion of the dart and the challenge spores into the growth medium.

Self contained biological indicator

A lid (10) of a countertop decontamination unit (A) is opened to gain access to a tray (12) for receiving items to be sterilized and a well (16) for receiving a two compartment powdered anti-microbial agent carrying cup (C). The cup includes an outer cup portion (50) and an inner cup portion (70) that have peripheral walls (52, 72) affixed together at flanges (54, 74). The outer cup portion (50) is closed at one end by a first detachable base (58). The inner cup portion (70) is closed by a second detachable base (78). The outer and inner cups (50, 70) define a first powdered reagent receiving chamber (56) therebetween. The inner cup defines a second chamber therein. A permeable sheet (100) is affixed to the inner cup portion flange (74) for ventedly sealing both chambers.

Two compartment cup for powdered sterilant reagent components

A processing chamber for the treatment and decontamination of biological or medical waste includes a rotating waste treatment system carried within an open-top processing chamber, a cap for closing the chamber opening, a gas-pervious liner carried within the chamber for preventing waste from adhering to the underside of the cap as a result of waste-treatment operations, a sealing member disposed at and for sealing the interface of the cap and the processing chamber, and a chemical indicator carried within the interior of the processing chamber for confirming the presence of decontaminant during a waste treatment cycle.

Isolated biological and medical waste processor and lid liner carrying a

A film for releasing at least one of an anti-microbial agent, oxygen, and a medicament includes a flexible, porous layer (18) such as a woven, non-woven, or knitted cloth or a layer of open cell foam. A first dry reagent (12) and a second dry reagent (14) which react in the presence of a dilutant to form the anti-microbial agent, oxygen, or medicament attached to the flexible, porous layer. In one preferred embodiment, the two dry reagents are disposed on opposite sides of the flexible, porous layer such that the flexible porous layer keeps the two apart and prevents a premature reaction. Porous outer layers (20, 22) prevent the powdered reagents from being wiped off while permitting dilutant access. In a preferred embodiment, the powdered reagents include acetylsalicylic acid and a perborate which react in the presence of water to generate peracetic acid (an antimicrobial agent which breaks down in a matter of minutes to hours into oxygen) and salicylic acid (a topical keratotic). The rate at which the reaction occurs and the peracetic acid breaks down into oxygen is controlled by buffering the pH of the powdered reagents, by selectively micro-encapsulating the powdered reagents, by controlling the porosity of the layers, or the like. Optionally, surfactants, detergents, emollients, gels, and the like can be added to the dry reagents. Alternately, a single reagent which releases oxygen or forms a strong oxidant may be used.

Controlled oxygen/anti-microbial release films

A bag (86) of medical wastes is inserted into a chamber (12) that contains a grinder (20). A package (48) is placed unopened in the chamber with the medical wastes. A selected volume of a dilutant such as water is added to the chamber (40, 42). The chamber is closed and the grinder operated for a selected duration. The grinder grinds the packaging, disposing of the packaging and permitting contained dry reagents (56, 58) such as acetylsalicylic acid and perborate to react with the dilutant, forming a peracetic acid solution or permitting a sterilant concentrate (70) to form an anti-microbial solution with the dilutant. The grinder continues to grind the packaging and the medical wastes into fine particulates forming a slurry with the peracetic acid solution. The continued operation of the grinder assures that the anti-microbial solution contacts all surfaces of the waste. In this manner, the medical wastes are microbially decontaminated. A color indicator (60, 78) is included with the packaging to provide a color indication as to whether the anti-microbial reaction is complete. For example, a Gentian Violet may be provided which fades to white to indicate completion of the decontamination process. Once decontaminated, the slurry is removed from the chamber and disposed of as non-contaminated waste materials. Optionally, fragrances and deodorants may be included in the package.

Medical waste decontamination

Sodium perborate is mixed with a mixture, preferably a 1:1 mixture, of a rapid acetylating agent, e.g. TAED, and a slow acetylating agent, e.g. acetylsalicylic acid, in water to form a biocidally effective peracetic acid solution. When sodium perborate and TAED alone react in water, peracetic acid is produced quickly but has relatively little stability and a short useful life (curve 10). When sodium perborate and acetylsalicylic acid are mixed in water, the peracetic acid solution takes an extended duration to reach maximum efficacy, but is stable for an extended duration (curve 12). The mixture of rapid and slow acetylating agents quickly produces a stable peracetic acid concentration (curve 14).

Cold sterilant with extended active life

An instrument (28) or other item to be sterilized is supported on a hanger (26) in a decontamination chamber (10). A container such as a sleeve (92), is supported at adjacent ends between supporting rings (90) such that the container surrounds and is displaced from the instrument. A pump (40) recirculates a sterilant or other antimicrobial solution that collects in a lower drain (48) and a reservoir (50) through spray nozzles (70, 96) and connectors (44) which are connected to interior passages of the instrument. In this manner, the internal passages of the instrument are sterilized by the flowing liquid and exterior surfaces are sterilized by sterilant solution mist which condenses on and coats the exterior surface. After the instrument is sterilized, a sterile rinse is sprayed on the instrument and interior of the container. The container and instrument are removed as a unit and the container is closed at its ends to prevent the instrument from becoming microbially contaminated from the ambient air. The instrument may be dried passively by a microbe blocking filter (98) in the container or by using a fan (80) to pump drying air longitudinally through the container.

Medical instrument decontamination and sterilization processor

The body portion (A) of a small portable sterilizer has a face panel (46) against which a door (B) is selectively closed. The face panel defines an access opening for a sterilization chamber (10) which receives a cassette (C), an access opening for an anti-microbial concentrate chamber (20) which receives a powdered or other sterilant concentrate, and an outlet opening (50) from a microbe filter which filters microbes from incoming rinse water. The face plate and the door define fluid flow channels (48, 52) therebetween for selectively directing sterilant solutions and rinse solutions among the anti-microbial concentrate chamber, the sterilization chamber, and the microbial filter. The cassette is configured to assure that it is inserted into the sterilization chamber with a unique orientation such that its fluid inlet apertures (114) and outlet apertures (124) are at preselected locations. The door includes generally U-shaped projections (116) which abut an outer surface of the cassette in the sterilization chamber partially surrounding the fluid inlet apertures. The U-shaped projections assure that the cassette is seated in the sterilization chamber and provide a well which directs the circulating fluids into the cassette inlet apertures. A pair of gaskets (56, 86) surround the active portion of the face panel. A vacuum pump (90) selectively draws a vacuum in an annular region (88) between the gaskets, which vacuum locks the door against the face plate in a sealed, closed position. To assure a fluid tight seal, the gaskets are O-rings which are pressed by the vacuum into V-shaped grooves (82, 84).

Office size instrument sterilization system

A front door (B) of a countertop decontamination unit is opened to gain access to a chamber (10) for receiving a cartridge (C) containing items to be sterilized and a chamber (12) for receiving a two compartment powdered anti-microbial agent carrying cup (D). The cup includes an outer cup portion (60) and an inner cup portion (70) that have peripheral walls (62, 72) affixed together at flanges (64, 74) and abutting base walls (66, 76). At least one of the base walls has a domed portion (68) constructed of plastic, whose plastic resiliency functions as a spring to urge the base walls continuously into engagement. The inner and outer cup portions peripheral walls define an annular chamber (86) therebetween. Preferably, the inner peripheral wall is generally conical to reinforce the outer cup base wall to prevent it from collapsing on impact with a cutting blade (14). The inner wall has a longitudinally elongated recess (80) which interacts with a filling aperture (84) surrounded by a flange portion (82). The longitudinal recess and filling aperture are configured such that a filling tube (92) is selectively insertable through the filling aperture and along the recess for filling the annular compartment with a powdered reagent. A permeable sheet (102) is affixed to the second cup portion flange for sealing both compartments.

Medical instruments, which may include brass, copper, aluminum, stainless steel, carbon steel, or plastic parts are microbially decontaminated (sterilized or disinfected) in an antimicrobial solution. To provide a long shelf life, premeasured doses of powdered reagents are sealed in an ampule until ready for use. The powdered reagents are selected such that they react in the presence of water to form a strong oxidant solution in an appropriate concentration to be effective as an antimicrobial. The preferred powdered reagents include acetylsalicylic acid and sodium perborate which react in the presence of water to form a peracetic acid solution. Moreover, these dry reagents form sodium metaborate and salicylic acid, both corrosion inhibitors to inhibit corrosion of metal parts of the medical instruments. The ampule may also hold a preselected dose of phosphate or other water soluble corrosion inhibitors and a wetting agent.

Powdered anti-microbial composition

A liquid sterilizing system (A) defines a basin (10) in which a container (B) is removably disposed. The liquid sterilizing system selectively pumps sterile rinse liquids from a supply (24) and liquid sterilant solutions from a supply (70) into the basin filling the basin and the container. The container includes a lower shell having a bottom wall (34) that defines an aperture (32) for receiving sterilant and sterile rinse liquids. A nozzle plate (44) is mounted close to but spaced from the shell bottom wall to define a tortuous liquid distribution path (40) between the inlet aperture and nozzle plate apertures (90). A barrier (96) divides the liquid receiving portion and a drain portion of the liquid distribution path between the shell bottom surface and the nozzle plate. A cover (80) has a downward depending peripheral wall (82) which is offset from the shell peripheral wall (86) by the spacers (88) to define a tortuous vent path (48) therethrough. The container is lifted out by handles (100) which enable the container to be removed without disturbing the transparent cover, hence, without disturbing the sterile condition of the items within the container. In this manner, the sterilized items can be inventoried and maintained sterilized in the container for an extended duration.

Container for holding equipment during sterilization

Medical instruments, which may include brass, copper, aluminum, stainless steel, carbon steel, or plastic parts are sterilized or disinfected in an anti-microbial solution. The anti-microbial effect of a strong oxidizing agent, such as peracetic acid, is improved with a wetting agent. The solution further includes a triazole or other component for inhibiting the corrosion of copper and brass. Phosphates or other buffering agents adjust the oxidizing agent generally to a neutral pH for preventing the corrosion of steel. Molybdates or analogous compounds also buffer the pH and inhibit corrosion of aluminum by the oxidizing agent. The corrosion inhibiting is enhanced by the wetting agent. Optionally, a sequestering agent is provided for inhibiting hard water precipitation.

Anti-microbial composition

A tubing system (18) connects a source (10) of tap water with a container (20) holding an item to be sterilized. Powdered buffers, detergents, and corrosion inhibitors are deposited in a well (34) along with an ampule (46) containing a sterilant, such as peracetic acid. The ampule includes an exterior wall (80) which defines an interior volume (82) and a linear vent passage (84) extending from the exterior wall to a central region of the interior volume. A gas permeable liquid impermeable membrane (100) is mounted across a vent aperture (86) which is disposed adjacent the geometric center of the interior volume. The volume is filled less than half way full with the liquid sterilant such that in all orientations of the ampule (FIGS. 4A-C), an upper surface (98) of the sterilant remains below the vent aperture. A pump (50) recirculates the water through the container, the tubing system, and the well to dissolve the powdered reagents. A tubular needle (70) of an aspirator system (42) is moved along the vent passage and through the vent aperture such that its free end is immersed in the sterilant. An aspirator (44) draws the sterilant from the ampule into the tubing system, mixing it with the recirculating water.

Growing community of inventors

Austinburg, OH, United States of America

Raymond C Kralovic