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).

Abstract: Surgically implantable shaped materials, e.g., sheets, are fabricated from elongate bone particles, advantageously those that have been demineralized. The materials when applied to a bone repair site enhance or accelerate new bone ingrowth by any one of a variety of biological and/or mechanical mechanisms.

Abstract: A method and apparatus for evaluating the efficacy of prevacuum steam sterilizers by separating, collecting and detecting the presence of air in association with steam. A receptacle containing an adsorbent directly separates air from steam without changing the physical state of the steam. The apparatus has a portal communicating with the sterilizing environment and a defined path for the steam to traverse from the portal to a distal end of the apparatus. The distal end of the apparatus is attached to an air collection chamber which contains an air indicator. The indicator can be chemical or biological, and indicated whether any air pockets existed in the steam.

Abstract: A device for evaluating the efficacy of prevacuum steam sterilizers by separating, collecting and detecting the presence of air in association with the steam. The device includes a receptacle containing an adsorbent for directly separating air from steam without requiring a change of state, from gas to liquid, of the steam. During sterilizer evacuation, the interstices of the adsorbent and the device offer a challenge to air removal. The receptacle has a portal to provide communication with the sterilizer environment and a defined path for the steam to traverse, in a progressive manner, moving to the distal end of the receptacle. The adsorbent retains the moisture during sterilization. At the distal end of the column is an opening into an air collecting chamber. Within this chamber is located an article that indicates the presence of air in the steam. The indicator can be chemical or biological, and indicates whether any air pockets existed which prevented complete contact between the steam and the indicator.

Abstract: Disposable test packs for monitoring the efficacy of steam or ethylene oxide sterilization cycles includes a fiber board housing for a biological indicator. The housing includes two end sections and a midsection. Each end section includes an outer tube and a longer inner tube. The open end of the outer tubes abut the opposing open ends of the midsection to define a seam or gap. The inner tube extends past the seam and telescopes into the midsection. The seam and the close tolerance between the inner tube and the midsection provide a tortuous path for the entry of sterilant into the interior of the housing. The tortuous path has a moisture absorbent surface and is dimensioned to promote intimate contact between the sterilant and the absorbent surface. A second path of entry is provided in the embodiment adapted for use in monitoring ethylene oxide sterilization processes only. A midsection can be made of a transparent, sterilant impermeable material to permit observation of the interior of the housing.

Abstract: A sterilizable pouch for holding items during sterilization and for storing such items in a sterile condition following sterilization. The pouch includes a first member and a second opposing member. The first member extends outwardly beyond one edge of the second member to define a flap. An opening is defined between the one edge of the second member and the flap. The remaining edges of the first and second members are sealed to one another to define the pouch. An adhesive backed strip having a removable liner over the adhesive is connected along one edge to the second member adjacent to or spaced from the opening and is dimensioned to cover the opening and the flap when the liner is removed and the adhesive backed strip is pressed against the opening and the flap.

Abstract: A disposable test pack for monitoring the efficacy of steam or ethylene oxide sterilization cycles includes a fiber board housing for a bioligical indicator. The housing includes an outer tube and a shorter inner tube. The outer tube has upper and lower portions which define a seam or gap at their adjoining open ends. The inner tube extends past the seam and telescopes into the upper and lower portions. The seam and the close tolerance between the inner tube and the upper and lower portions of the outer tube provide a tortuous path for the entry of sterilant into the interior of the housing. The tortuous path has a moisture absorbent surface and is dimensioned to promote intimate contact between the sterilant and the absorbent surface. The exterior of the housing can be lined with foil to prevent sterilant from permeating the housing, thereby preventing entry of the steam by any path other than through the seam.

Abstract: A device for indicating the presence of unacceptable levels of noncondensable gas, such as air, in a stream sterilization chamber. The device includes an insulated heat sink having an upper end and a lower end. The upper end of the heat sink is in such open communication with the sterilization chamber that the steam enters the heat sink. The device also includes a chamber proximate the lower end of the heat sink. The heat sink defines a path through which the steam travels from the upper end toward the chamber. The path is adapted to provide sufficient exposure of the steam to the heat sink so that the steam condenses within the path, releasing any noncondensable gas associated with the steam and forcing it toward the chamber. The chamber includes means for indicating the presence of noncondensable gas accumulated therein. The device also includes means for preventing the condensate from effecting the indicating means.

Abstract: A receptacle for handling contaminated waste for sterilization and subsequent disposal which is a pore forming sterilization bag made from a thermoplastic resin which has been embedded with either soluble materials or melt materials which respond to the temperature and moisture of steam sterilization to form pores in the bag, thus permitting the entrance of sterilant and the exit of air for sterilization of the waste. The melt materials are low molecular weight polymers such as carbowaxes. The soluble materials can be either organic or inorganic materials such as polyvinyl alcohol, polyvinyl acetate, polyvinyl pyrrolidone and various inorganic salts, such as sodium chloride.

Abstract: Apparatus for rupturing a sealed, frangible container is disclosed. A substantially rigid tubular member, closable at both ends if desired, is provided with a zone of reduced interior cross section. The tubular member is adapted to receive the frangible container and retain it in a position so that an annular space of decreasing dimension is formed adjacent the zone of reduced cross section of the tubular member. Means insertable into the annular space wedgedly engage the frangible container with sufficient force to rupture it.

Abstract: This invention relates to a novel apparatus useful for the gravity fed delivery of a liquid from a first liquid reservoir to a second liquid reservoir. This apparatus is especially useful for the administration of intravenous (I.V.) solutions, where a constant flow, despite varying conditions of pressure in said second fluid reservoir (i.e. the blood-stream of the patient) is desirable if not absolutely required.

Abstract: An all plastic retention catheter of the Foley type having a body of a thermoplastic polyurethane and a balloon of a thermosetting polyurethane. The catheter may be fabricated by a method wherein the thermosetting polyurethane balloon sleeve is molded with integral bands of a thermoplastic polyurethane polymer spaced at either end of the sleeve and subsequently sealed to the catheter body by fusing the thermoplastic bands to the body material with heat or solvent.