The present disclosure relates generally to stabilized medical devices having immobilized biologically active entities necessary for sterilization. The present disclosure provides a substrate (200) that is at least partially electrically conductive, and a stabilized enzyme layer (220) disposed over at least a portion of a surface of the substrate. The stabilized enzyme layer (220) may include at least one biologically active sensing component (240), such as glucose oxidase in the case of glucose sensors, and at least one stabilizing component (260) non-covalently combined with the biologically active sensing component (240). The present disclosure further provides the biologically active sensing component (240) having a biological activity detection level from about 25 U/cm3 to about 1,000,000 11/ cm3 of the substrate following ethylene oxide sterilization of the biologically active sensing component. The present disclosure further provides methods of making stabilized medical devices having immobilized biologically active entities.

A class 5 chemical indicator color may be imaged such that a color of the indicator may be determined and compared to a color-value threshold indicative of an efficacious sterilization procedure. Color changes of the indicator during a sterilization procedure are typically not uniform. As such, colors on the indicator may be averaged and then compared to the color-value threshold to determine if the procedure has been efficacious or if additional exposure to a sterilant may be desired. Color values and color-value thresholds may be based on, e.g., the L*a*b* color model or a grayscale color model.

A system for recovering a sterilization agent may include a pressure reducing valve for reducing a pressure of a waste gas from a sterilization chamber to a first predefined pressure. The waste gas may include a gaseous mixture of a sterilization agent, nitrogen gas, and water vapor. A first condenser may cool the gaseous mixture to below a boiling point temperature and above a freezing point temperature of the water vapor at the first predefined pressure. A first tank may store the condensed water vapor. A separation pump may raise the pressure of the gaseous mixture to a second predefined pressure. A second condenser may cool the gaseous mixture to below a boiling point temperature and above a freezing point temperature of the sterilization agent at the second predefined pressure causing the sterilization agent to condense into a liquid. A second tank may store the separated sterilization agent.

A metabolic analyte sensor includes a substrate having an electrically conductive surface, an interference layer on the conductive surface, an enzyme layer on the interference layer, and a glucose limiting layer on the enzyme layer. The interference layer or the enzyme layer is configured such that the metabolic analyte sensor has an improved performance characteristic after sterilization compared to before sterilization. A packaged continuous metabolic monitor includes a sealed container; a metabolic sensor in the sealed container for insertion into a patient after the metabolic sensor is removed from the sealed container, the metabolic sensor comprising a conductive surface and an enzyme layer; electronic operating circuitry in the sealed container and coupled to the metabolic sensor; and a residue of a sterilizing gas in the metabolic sensor. The sealed container, the metabolic sensor and the electronic operating circuitry are sterilized together in the sealed container using the sterilizing gas.

A sterilization system comprises a chamber module and an independent pump module that is external to the chamber module in an independent form, is connected to the chamber module, and has a built-in pump, wherein the chamber module comprises a chamber built in the chamber module and storing a target object and a vaporizer built in the chamber module and connected to the chamber to supply a vaporized sterilant, wherein the chamber built in the chamber module is connected to the pump built in the independent pump module and exhausted.

The present disclosure includes and provides for methods of packaging medical devices that are to be treated with a fluorinated liquid to alter their surface properties, packaging systems for such medical devices, and methods of utilizing the packaging systems to treat the medical devices. The packaging systems permit effective storage and distribution of medical devices that upon contact with mammalian blood have limited thrombogenicity or are non-thrombogenic and/or are resistant to adhesion of blood cells or clots.

A method of using a sterilization wrap system including a permeable material having barrier properties and having a first surface and a second opposing surface, the exterior panel being substantially opaque or having a first level of translucence, and an interior panel including a permeable material having barrier properties and having a first surface and a second opposing surface, the interior panel having a level of translucence that is higher than the translucence of the exterior panel, the panels being joined together over at least a portion of their surfaces. Also disclosed is inspection of the sterilization wrap system for exterior panel breaches by looking for light passing through a panel facing the viewer.

A process is presented for determining the effectiveness of sterilization processes for medical devices, with the steps of: providing a data structure, wherein the data structure represents a grid formed of a plurality of three-dimensional cells, recreating the medical device arranged in the sterilizer in the data structure in such a way that a first plurality of cells of the grid represent a body of the medical device and that a second plurality of cells represent an interior of the sterilizer which is not occupied by the body of the medical device, recreating an initial state in the data structure in such a way that each cell of the second plurality of cells is assigned data with respect to the temperature prevailing at the location of the cell, the quantity of a first medium located in the area of the cell and the quantity of a second medium located in the area of the cell, recreating, step by step, changes in the temperature, the quantity of the first medium and the quantity of the second medium occurring in each cell of the second plurality of cells during the sterilization process, and calculating a reduction of a germ load achieved in each cell of the second plurality of cells during the sterilization process taking into account the prevailing temperature, quantity of the first medium and quantity of the second medium in the respective cell in each step. Furthermore, a data processing system as well as a computer program product for carrying out the process are presented.

A kit for performing a medical procedure includes: a closed container; and a plurality of surgical items placed within the closed container. Each of the surgical items is sterilized and the container is closed to maintain sterility of the surgical items placed within. The surgical items include: a plurality of cutting instruments; at least one retractor; an analgesic; an antimicrobial solution; a surgical marker; at least one set of surgical gloves; a surgical drape; at least one length of suture; and a wound dressing.

A multi-chamber package is described including a first and second chamber, the first chamber having a bottom wall and sidewalls defining a cavity, the second chamber having a partially open bottom wall and sidewalls defining a cavity. A first removable seal is positioned over a top surface of the package, fully covering the first chamber and second chamber, and a second seal is positioned over a bottom surface of the partially open floor of the second chamber, fully sealing the second chamber. A method of packaging medical devices is also described.