Abstract: An integrated process challenge device is provided. The integrated process challenge device includes a shell including an interior and an exterior; a first compartment defined by the interior and exterior of the shell, the first compartment shaped to retain a first indicator; a second compartment defined by the interior and exterior of the shell, the second compartment shaped to retain a second indicator; a barrier formed by the shell, the barrier formed between the first compartment and the second compartment to prevent fluid exchange between the first compartment and the second compartment; a first opening located on the exterior of the shell adjacent to the first compartment; and a second opening located on the exterior of the shell adjacent to the second compartment, wherein the first and second openings allow a sterilant to enter and exit the first and second compartments respectively.

Abstract: A digital autoreader is provided. The digital autoreader includes a housing including an interior and an exterior; a well for receiving a process challenge device, the process challenge device including at least one indicator, the well including an opening and a block for retaining the process challenge device, wherein the block is located within the interior of the housing; a first sensor located within the interior of the housing and positioned adjacent to the block of the well, the first sensor configured to read a variable of the at least one indicator of the at least one indicator of the process challenge device and determine whether the process challenge device has been adequately sterilized; and an interface to alert a user if the process challenge device has been adequately sterilized.

Abstract: A biological indicator system for determining the efficacy of a sterilization process is provided. The system includes a radiofrequency identification sensing board having a radiofrequency identification tag, a microcontroller/digital electronics, a sensing pad, and a circuit coupled to the sensing pad that measures an impedance level or a resistance level of the sensing pad upon exposure to a volatile organic compound. The radiofrequency identification tag includes a radiofrequency integrated circuit and an antenna that communicates wirelessly with a radiofrequency identification reader to transmit data associated with the impedance or resistance levels measured from the sensing pad. The data can be transmitted in real-time during incubation, and this data can then be sent to a user interface to determine the efficacy of a sterilization process when the biological indicator system is placed in a sterilization chamber during a sterilization cycle. A method of using the system is also provided.

Abstract: A protective guard is provided for sealing an interface. The protective guard includes a body having a fluid impervious material and proximal and distal segments that may comprise a superabsorbent or a non-superabsorbent material. The proximal and distal segments are positioned on first and second sides, respectively, of the interface. The protective guard extends about the interface to create a fluid barrier. In some embodiments, the non-superabsorbent material may be an elastic material, such as an elastic band, and in particular embodiments, the non-superabsorbent material may be nitrile. In further embodiments, the non-superabsorbent material may be an expandable material that expands upon contact or interaction with a fluid.

Abstract: A pocket and drape system which provides multiple (e.g., at least two) sterile fields and the methodology for employing said pocket and drape system is provided. The system includes a base drape material having an upper edge, lower edge, first side edge, and second side edge to define a perimeter, where the base drape material also includes a first (outer) surface and a second (inner) surface. A first zone of pockets is present on a portion of the first surface and a second zone of pockets present on a portion of the second surface. The manner in which the base drape material is folded at first and second longitudinal fold lines and first and second transverse fold lines during assembly (e.g., prior to sterilization) maintains the sterility of the first zone of pockets and the second zone of pockets until each zone is ready for use during a medical procedure.

Abstract: A folded article formed from a protective garment, and a method of folding a protective garment to prepare the garment for donning, expose sleeve openings of the garment for ease of donning. The protective garment is folded into a folded article that is configured to be grasped by an inner surface of the garment and prevent touching the outer surface of the garment during donning. Thus, the sterility of the protective garment can be maintained during donning. The protective garment may further include a hood and visor, and the folded article formed from the protective garment may have the same size and shape as the visor.

Abstract: A personal protection and ventilation system is provided. The system includes a gown having front and rear panels, a hood, and visor; a fan; an air tube; and a helmet. The fan is positioned between the wearer and a body-facing surface of the rear panel. The front panel and at least a portion of the hood are formed from a first material including a first spunbond layer, a spunbond-meltblown-spunbond laminate, and a liquid impervious elastic film disposed therebetween. The first material has an air volumetric flow rate of less than about 1 standard cubic feet per minute (scfm). The rear panel is formed from a second material including a nonwoven laminate having an air volumetric flow rate of about 20 scfm to about 80 scfm. Therefore, the fan is able to intake a sufficient amount of air from the environment through the rear panel to provide cooling/ventilation to the hood.

Abstract: A personal protection and ventilation system is provided. The system includes a gown having front and rear panels, a hood, and visor; a fan; an air tube; and a helmet. The fan is positioned between the wearer and a body-facing surface of the rear panel. The front panel and at least a portion of the hood are formed from a first material including a first spunbond layer, a spunbond-meltblown-spunbond laminate, and a liquid impervious elastic film disposed therebetween. The first material has an air volumetric flow rate of less than about 1 standard cubic feet per minute (scfm). The rear panel is formed from a second material including a nonwoven laminate having an air volumetric flow rate of about 20 scfm to about 80 scfm. Therefore, the fan is able to intake a sufficient amount of air from the environment through the rear panel to provide cooling/ventilation to the hood.

Abstract: Closure mechanisms for closing and sealing sterilization containers and indicators for indicating the seal integrity sterilization containers are provided. For example, a container closure mechanism may be configured to distribute a closure force along a gasket to seal a container lid to a container body. Further, a seal indicator may visibly indicate at the container exterior whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is a first state, and if the sterilization container is not sufficiently sealed, the seal indicator is in a second state. Thus, the seal indicator undergoes a state change when the sterilization container transitions from unsealed to sealed or from sealed to unsealed, such that a user can ascertain whether the container is properly sealed to maintain sterility or whether the seal and sterility of the container have been compromised.

Abstract: Closure mechanisms for closing and sealing sterilization containers and indicators for indicating the seal integrity sterilization containers are provided. For example, a container closure mechanism may be configured to distribute a closure force along a gasket to seal a container lid to a container body. Further, a seal indicator may visibly indicate at the container exterior whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is a first state, and if the sterilization container is not sufficiently sealed, the seal indicator is in a second state. Thus, the seal indicator undergoes a state change when the sterilization container transitions from unsealed to sealed or from sealed to unsealed, such that a user can ascertain whether the container is properly sealed to maintain sterility or whether the seal and sterility of the container have been compromised.

Abstract: A wettable SMS material for personal protective equipment, such as a SMS fabric that has been treated to improve the wettability and absorbency properties of the SMS fabric is provided. A treated SMS fabric for personal protective equipment can retain its durability, breathability, and comfort, and may also provide the fabric with wettability and absorption properties. An article for personal protective equipment formed from a wettable SMS fabric is also provided.

Abstract: A folded article formed from a protective garment, and a method of folding a protective garment to prepare the garment for donning, expose sleeve openings of the garment for ease of donning. The protective garment is folded into a folded article that is configured to be grasped by an inner surface of the garment and prevent touching the outer surface of the garment during donning. Thus, the sterility of the protective garment can be maintained during donning. The protective garment may further include a hood and visor, and the folded article formed from the protective garment may have the same size and shape as the visor.

Abstract: A head cover that can be worn by health care professionals is provided. The head cover includes a surgical cap portion and a bouffant cap portion. The surgical cap portion includes a top surface and a side panel secured to the top surface via a seam. Further, the bouffant cap portion is secured to a rear portion of the side panel, where the bouffant cap portion is maintained against the rear portion of the side panel in an undeployed state and is deployable from the rear portion of the side panel to contain a wearer's hair. As such, the head cover enables a wearer to secure his or her hair inside the bouffant cap as needed, yet bouffant cap portion does not cover the wearer's entire head, which minimizes the amount of heat that is trapped within the head cover and increases the level of comfort for the wearer.

Abstract: Sterilization packaging systems with features for sealing a volume against an ingress of contaminants are provided. Such features include a sealing assembly including a gasket and a sheet of filter material. The sealing assembly seals a lid to a seal rim of a base. The gasket has an upper surface, outer edge, and inner edge. The upper surface of the gasket comprises a first row of alternating protrusions and indentations and a second row of alternating protrusions and indentations that define a channel therebetween. The sheet of filter material extends from an inner edge of the gasket. The gasket completely surrounds the sheet of filter material, wherein the indentations and channel facilitate delivery of a sterilization agent through the filter material. A sterilization assembly including a lid having a plurality of protrusions in its upper surface in conjunction with a gasket having a smooth upper surface is also provided.

Abstract: A pocket and drape system which provides multiple (e.g., at least two) sterile fields and the methodology for employing said pocket and drape system is provided. The system includes a base drape material having an upper edge, lower edge, first side edge, and second side edge to define a perimeter, where the base drape material also includes a first (outer) surface and a second (inner) surface. A first zone of pockets is present on a portion of the first surface and a second zone of pockets present on a portion of the second surface. The manner in which the base drape material is folded at first and second longitudinal fold lines and first and second transverse fold lines during assembly (e.g., prior to sterilization) maintains the sterility of the first zone of pockets and the second zone of pockets until each zone is ready for use during a medical procedure.

Abstract: Apparatus, systems, and methods for sealing an interface are provided. For example, a protective guard is provided for sealing an interface. The protective guard comprises a body comprising a fluid impervious material and proximal and distal segments that may comprise a superabsorbent or a non-superabsorbent material. The proximal and distal segments are positioned on first and second sides, respectively, of the interface. The protective guard extends about the interface to create a fluid barrier. In some embodiments, the non-superabsorbent material may be an elastic material, such as an elastic band, and in particular embodiments, the non-superabsorbent material may be nitrile. In further embodiments, the non-superabsorbent material may be an expandable material that expands upon contact or interaction with a fluid.

Abstract: Sterilization packaging systems with features for sealing a volume against an ingress of contaminants are provided. Such features include a sealing assembly including a gasket and a sheet of filter material. The sealing assembly seals a lid to a seal rim of a base. The gasket has an upper surface, outer edge, and inner edge. The upper surface of the gasket comprises a first row of alternating protrusions and indentations and a second row of alternating protrusions and indentations that define a channel therebetween. The sheet of filter material extends from an inner edge of the gasket. The gasket completely surrounds the sheet of filter material, wherein the indentations and channel facilitate delivery of a sterilization agent through the filter material. A sterilization assembly including a lid having a plurality of protrusions in its upper surface in conjunction with a gasket having a smooth upper surface is also provided.

Abstract: A head cover that can be worn by health care professionals is provided. The head cover includes an anterior portion with a height h, a posterior portion with a height h2, at least one side portion or panel which may be shaped and sized so as to connect the anterior portion of the head cover and the posterior portion of the head cover, and where the at least one side portion has a contoured section t that forms all or a portion of a bottom edge of the side portion and that is shaped and sized so as to cover the ears, scalp, and sideburns of a user as required by AORN guidelines while also remaining clear of a user's eyes and field of vision.

Abstract: Sterilization packaging systems with features for sealing a volume against an ingress of contaminants are provided. Such features include a sealing assembly including a gasket and a sheet of filter material. The sealing assembly seals a lid to a seal rim of a base. The gasket has an upper surface, outer edge, and inner edge. The upper surface of the gasket comprises a first row of alternating protrusions and indentations and a second row of alternating protrusions and indentations that define a channel therebetween. The sheet of filter material extends from an inner edge of the gasket. The gasket completely surrounds the sheet of filter material, wherein the indentations and channel facilitate delivery of a sterilization agent through the filter material. A sterilization assembly including a lid having a plurality of protrusions in its upper surface in conjunction with a gasket having a smooth upper surface is also provided.

Abstract: Closure mechanisms for closing and sealing sterilization containers and indicators for indicating the seal integrity sterilization containers are provided. For example, a container closure mechanism may be configured to distribute a closure force along a gasket to seal a container lid to a container body. Further, a seal indicator may visibly indicate at the container exterior whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is a first state, and if the sterilization container is not sufficiently sealed, the seal indicator is in a second state. Thus, the seal indicator undergoes a state change when the sterilization container transitions from unsealed to sealed or from sealed to unsealed, such that a user can ascertain whether the container is properly sealed to maintain sterility or whether the seal and sterility of the container have been compromised.