Systems and methods for providing sterile medical devices

Abstract

A method of providing sterile medical devices including placing medical devices within a container along with a source of sterilizing gas to define a kit at a kitting facility. Closing the container enables exposure of the medical devices to the sterilizing gas to sterilize the medical devices. The container is opened at a point of use location where the medical devices are removed from the container. The source of sterilizing gas includes a plastic material impregnated with iodine. The medical devices may be selected from a population of received at the kitting facility from one or more medical device companies based on a selected medical procedure. The source of sterilizing gas container and bulk packaging can be reusable. The kit can be provided to the point of use location in a just-in-time fashion.

Description

SYSTEMS AND METHODS FOR PROVIDING STERILE MEDICAL DEVICESPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 634,368, filed April 15, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] The sterile condition of medical devices is paramount to preventing infection risk to patients. Single use medical devices are typically sterilized at the point of manufacture and the shipped to the medical care facility in packaging that maintains the sterility of the medical device inside. Maintaining the sterility of a sterile medical device for a long period of time and during handling between the point of sterilization and use is often complex and expensive. Medical care providers are generally tasked with verifying the absence a sterility breach of the packaging, such as a hole or abrasion of the packaging, prior to using the medical device. Furthermore, short shelf life for a sterile medical device is often defined based a validation testing related to the maintenance of sterility, the short shelf life can result in expiration of the shelf life and discarding of the medical device. As such, there is a need for improved methods and systems of providing sterile medical devices that reduce the infection risk to patients and reduce the cost and labor intense processes of ensuring a medical device is sterile upon use. Disclosed herein are systems and methods that address the forgoing.SUMMARY

[0003] Disclosed herein is a method of providing sterile medical devices that, according to some embodiments, includes (i) placing a number of medical devices within a container; (ii) placing a source of sterilizing gas within the container; (iii) closing the container such that the number of medical devices are exposed to the sterilizing gas so as to transition at least a subset of the number of medical devices from a non-sterile state to a sterile state; (iv) opening the container at a point of use location for the number of medical devices; and (v) removing the number of medical devices from the container.

[0004] In some embodiments, the method further includes waiting a selected sterilizing duration between closing the container and opening the container, where the duration is based on transitioning the subset of medical devices from the non-sterile state to the sterile state.

[0005] In some embodiments, the source of the sterilizing gas includes a plastic material impregnated with a sterilizing agent, and the sterilizing gas is discharged from the plastic material within the container. In some embodiments, the method further includes removing the source of the sterilizing gas from an impregnating environment, where the impregnating environment is configured to impregnate the plastic material with the sterilizing agent. In some embodiments, the method further includes removing the source of the sterilizing gas from the container and replacing the source of the sterilizing gas into the impregnating environment to reimpregnate the plastic material with the sterilizing agent. In some embodiments, the sterilizing agent includes iodine.

[0006] In some embodiments, placing the number of medical devices within the container includes placing a least a first subset of the number of medical devices into a reusable tray and placing the reusable tray into the container. In some embodiments, the container is configured for multiple uses.

[0007] In some embodiments, the container includes a container body and a container lid, and the container lid is selectively transitionable between (i) an open position that enables placement of the number of medical devices within the container and removal of the number of medical devices from the container, and (ii) a closed position defining a seal with the container body.

[0008] In some embodiments, the method further includes manufacturing the number of medical devices at a first location and transporting the number of medical devices from the first location to a second location spaced away a first distance from the first location, and the number of medical devices are placed within the container at the second location. In some embodiments, placing the source of sterilizing gas within the container is performed at the second location. In some embodiments, the point of use location is spaced away a second distance from the second location, where the first distance is greater than the second distance.

[0009] In some embodiments, at least two of the number of medical devices are distinctly different from one another, and in some embodiments, at least a second subset of the number of medical devices is configured for single use.

[0010] In some embodiments, the method further includes selecting the number of medical devices based on a selected medical procedure, and in some embodiments, the number of medical devices are selected from a population of medical devices located at the secondlocation. In some embodiments, the population of medical devices includes medical devices provided by different medical device companies.

[0011] Also disclosed herein is a system for providing sterile medical devices that, according to some embodiments, includes (i) a container configured to transition from a closed state to an open state; (ii) a number of medical devices disposed within the container; and (iii) a source of sterilizing gas disposed within the container, where the source of sterilizing gas is configured to discharge the sterilizing gas within the container so as to transition at least a subset of the number of medical devices from a non-sterile state to a sterile state when the container is in the closed state.

[0012] In some embodiments of the system, the source of the sterilizing gas includes a plastic material impregnated with a sterilizing agent, and the sterilizing gas is discharged from the plastic material within the container. In some embodiments of the system, the source of the sterilizing gas is configured for repeated placement into an impregnating environment that is configured to re-impregnate plastic material with the sterilizing agent. In some embodiments of the system, the sterilizing agent includes iodine.

[0013] In some embodiments, the system further includes a reusable tray disposed within the container, where at least a subset of the number of medical devices is disposed in the reusable tray. In some embodiments the container is reusable.

[0014] In some embodiments of the system, the container includes a container body and a container lid, and the container lid is selectively transitionable between (i) an open position that enables placement of the number of medical devices within the container and removal of the number of medical devices from the container, and a closed position defining a seal with the container body.

[0015] In some embodiments of the system, at least one of the number of medical devices is sourced from a first medical device company and at least another one of the number of medical devices is sourced from a second medical device company, where the second medical device company separate from the first medical device company.

[0016] In some embodiments of the system, at least two of the number of medical devices are distinctly different from one another. In some embodiments of the system, at least a subset of the number of medical devices is configured for single use.

[0017] In some embodiments of the system, the number of medical devices are selected from a population of medical devices based on a selected medical procedure.

[0018] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.DRAWINGS

[0019] FIG. 1 is an illustration showing various entities and components of a method of providing sterile medical devices, in accordance with some embodiments.

[0020] FIG. 2 is an exploded view of a kit of medical devices, in accordance with some embodiments.

[0021] FIG. 3 is a block diagram of the method of providing sterile medical devices, in accordance with some embodiments.DESCRIPTION

[0022] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0023] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions.Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0024] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.

[0025] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.

[0026] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and / or use of specific steps and / or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0027] This disclosure is drawn to systems and methods of providing sterile medical devices (e.g., single use devices) to a healthcare facility in a kit form. Currently, medical procedures commonly require the use of multiple medical devices, e.g., syringes, needles, catheters, bandages, etc. Each of the medical devices may be sterile (i.e., pre-sterilized). Insome instances, healthcare persons may define kits that include the medical devices to be utilized when performing selected medical procedures. In such instances, each of the medical devices may include sterile packaging. As such, persons performing the medical procedure (or creating the kit) must check the expiration date for each medical device (which is commonly defined by the sterilization process of the medical device), check each sterile package for a breach of sterility (e.g., shipping damage), remove each medical device from its sterile package, and discard the sterile package at the location of the procedure (e.g., the patient bedside). The system and methods described below address the risks, inefficiencies, package waste, labor, and costs associated with current practice described above.

[0028] FIG. 1 illustrates various aspects and entities of a method 100 of providing medical devices at a point of use location. A first medical device company 110 ships medical devices 115 to a kitting facility 120. The medical device company 110 may include a brand, a manufacturer, and / or a distributor. The medical device company 110 is located a distance 110A from the kitting facility 120. In some instances, the medical device company 110 may be located in a city, state, country, or continent separate from the kitting facility 120. As such, the distance 110A may range from a few miles to a few thousand miles. Consequently, shipping the medical devices 115 from the medical device company 110 to the kitting facility 120 may require significant time period, such as a few days to a few weeks, for example.

[0029] The medical devices 115 may include multiple types of medical devices packaged in bulk, e.g., separate cases. By way of example, the medical devices 115 may include a large number (e.g., up to 50, up to 100, up to 500, or more) of medical devices of one type (e.g., needles having a first length) disposed in a bulk package 115A. Similarly, the medical devices 115 may include a large number (e.g., up to 50, up to 100, up to 500, or more) of medical devices of another type (e.g., needles having a second length different from the first length) disposed in a separate bulk or case package. By way of summary, the medical device company 110 may ship multiple cases containing different types of medical devices to the kitting facility 120. In some implementations of the method 100, the bulk packages 115A may be reusable and the bulk packages 115A may be returned to the medical device company 110 for reuse.

[0030] The medical devices 115 may include medical devices that are configured for sterilization before use and that are not yet sterilized. However, in some instances, the medical devices 115 may include medical devices that have been through a sterilization process.Similarly, the medical devices 115 may include medical devices that do not include an individual package. In other embodiments, the medical devices 115 may include medical devices that are each disposed within an individual package, such as a pouch or a box, for example.

[0031] In accordance with another embodiment of the method 100, in addition to the first medical device company 110, a second medical device company 111 ships medical devices 116 to the kitting facility 120. The second medical device company 111 may include a manufacturer, and / or a distributor of the same brand as the medical device company 110. The second medical device company 111 may be located a distance similar to the distance 110A from the kitting facility 120. Similar to the medical devices 115, the medical devices 116 may include multiple types of medical devices packaged in bulk, e.g., separate cases. In some embodiments, a subset of the medical devices 116 may be interchangeable with a corresponding subset of the medical devices 115.

[0032] In accordance with another embodiment of the method 100, in addition to the first medical device company 110, a third medical device company 112 ships medical devices 117 to the kitting facility 120. The third medical device company 112 may be distinctly different from the first and second medical device companies 110, 111. For example, the third medical device company 112 may include a brand different from the first and second medical device companies 110, 111. As such, the medical devices 117 may include medical devices that are not available through the brand of the medical device companies 110, 111. The third medical device company 112 may be located a distance similar to the distance 110A from the kitting facility 120. The the medical devices 117 may include multiple types of medical devices packaged in bulk, e.g., separate cases. In some embodiments, a subset of the medical devices 117 may be interchangeable with a corresponding subset of the medical devices 115, 116. Consistent with the medical devices 115 disposed in a bulk package 115A, the medical devices 116 and / or 117 may be disposed in a bulk package that reusable and the reusable bulk package may be retuned to the respective medical device company for reuse.

[0033] The kitting facility 120 (i) receives the medical devices 115, 116, and / or 117, (ii) processes the medical devices 115, 116, and / or 117, and (iii) delivers the medical devices 115, 116, and / or 117 in the form of a kit to a point of use location 130 in a just-in-time fashion. The point of use location 130 may include a healthcare facility (e.g., a hospital or clinic) or a location within the healthcare facility, such as a pharmacy, an operating room, or nursingstation, for example. In some embodiments of the method, the point of use location 130 may issue an order for the kit 125 to the kitting facility 120, the kitting facility 120 produces the kit 125 or kits 125 (as further described below), and delivers the kit 125 to the point of use location 130 in the just-in-time fashion.

[0034] The just-in-time fashion may be defined herein in accordance with any of the following implementations. The just-in-time fashion may include receiving the order for the kit 125 on one day and delivering the kit 125 to the point of use location 130 in time for the medical procedure to be performed as scheduled the following day. The just-in-time fashion may also include receiving the order for the kit 125 before a selected time, such as before 9 AM, for example, on one day and delivering the kit 125 to the point of use location 130 in time for the medical procedure to be performed as scheduled later on the same day. The just-in-time fashion may also include receiving the order for the kit 125 and delivering the kit 125 to the point of use location 130 within a selected time period (e.g., within two hours) from the time of the order. The just-in-time fashion may include receiving an inventory report (or otherwise assessing the inventory) from the point of use location 130 and delivering a number of kits 125 to the point of use location 130 so as to maintain a selected inventory level of the kits 125 for a selected time period (e.g., a day, three days, a week, two weeks, or a month).

[0035] The kitting facility 120 is located a distance 120A from the point of use location 130. The distance 120A is defined such that the kit 125 can be delivered to the point of use location 130 in accordance with the just-in-time fashion. The distance 120A may be shorter than the distance 110A. In some implementations, the kitting facility 120 may be located within just a few miles (e.g., up to 10, 20 or 50 miles) of the point of use location 130. In some implementations, the kitting facility 120 may be located substantially adjacent to (e.g., within about 0.25 miles, 0.5 miles, or 1 mile of) the point of use location 130. In some implementations, the kitting facility 120 may be located within the same building as the point of use location 130.

[0036] At the kitting facility 120, a selection of medical devices are chosen from the medical devices 115, 116, and / or 117 to be included within the medical device kit 125. The medical device kit 125 is then delivered to a point of use location 130. The medical device kit 125 (or more specifically, the medical devices included in the kit 125) may be selected based on a selected medical procedure.

[0037] The medical devices 115, 116, and / or 117 are received at the kitting facility 120 from the respective medical device companies and warehoused until they are included in medical device kits such as the kit 125. The kitting facility 120 also receives orders 132 for medical device kits from the point of use location 130. Each of the orders 132 may be based on a selected medical procedure, i.e., to be utilized during the performance of the selected medical procedure. The number of medical devices may include medical devices that are distinctly different from one another. For example, the number of medical devices may include a catheter that is distinctly different from a needle. It is noted that basing each order 132 on a selected medical procedure is not required. In other words, the kit 125 may include a number of medical devices to be used in similar medical procedures that utilize the same medical devices over a time period, such as a day for example. The kit 125 includes a container 126 and in some implementations of the method 100, the container 126 may be retuned to the kitting facility 120 for reuse.

[0038] At the kitting facility 120, a source of sterilizing gas (further described below) is placed within the container 126 along with the selected medical devices. The source of sterilizing gas releases the sterilizing gas within the container 126 so that the selected medical devices are exposed to the sterilizing gas. Exposure of the selected medical devices to the sterilizing gas ensures that the selected medical devices are disposed in a sterile state and / or transitioned from a non-sterile state to the sterile state prior to removal of the selected medical devices from the container 126. In some implementations of the method 100, the source of sterilizing gas is reusable and the source of sterilizing gas is returned to the kitting facility 120 for reuse. As such, the kitting facility 120 may include a system 122 configured for processing the source(s) of sterilizing gas as further described below.

[0039] FIG. 2 is an exploded view of the kit 125 according to some embodiments, where the kit 125 is part of a system for providing sterile medical devices. The kit 125 includes the container 126, the selected medical devices 220, and the source of sterilizing gas 230. In the illustrated embodiment, the container 126 includes a container body 210 and a container lid 212. The selected medical devices 220 and the source of sterilizing gas 230 are placed within an interior of the container body 210 through a top opening 210A. The container lid 212 is configured to close off the top opening 210A such that the container lid 212 forms a fluid seal with the container body 210, where the seal inhibits and / or prevents fluid from entering or escaping the container 126 at the interface of the container lid 212 with the container body 210.The container 126 when disposed in the closed state defines a sterile barrier for the selected medical devices 220 disposed therein.

[0040] According to the illustrated embodiment, the container body 210 is hard-sided so that the container body 210 retains its shape during use. The container body 210 may include a rectangular box shape as illustrated or any other suitable shape, such as cylindrical, oval, or another polygonal shape. The container body 210 may be formed any durable material such as a metal or plastic material. The container lid 212 may be formed similar to the container body 210. In other embodiments, the container 126 may be a soft-sided container such as a pouch or a bag that is configured for sealing via a sealing process, such as heat sealing, for example.

[0041] In some embodiments, the container 126 may include a vent 211 configured to enable an equalization of pressure between the interior and exterior of the container 126. Either the container lid 212 of the container body 211 (as illustrated) may include the vent 211. The vent 211 may include a filter 211 A (e.g., a membrane) extending across the vent 211 such that any fluid passing through the vent 211 passes through the filter 211 A. The filter 211 A may be a sterilizing filter, and as such, a pore size rating of the filter 211 A may be less than or substantially equal to 0.2 microns.

[0042] In some embodiments, the kit 125 may include a reusable tray 222 upon or within which all or a subset of the selected medical devices 220 may be placed. A bottom wall 222A of the tray 222 may include a plurality of openings 223 configured to enable fluid (e.g., the sterilizing gas) to pass through the bottom wall 222A. Any of the side walls may also include similar openings. Although not shown, the container body 210 may include a number protrusions extending inward from any of the side walls or the bottom wall of the container body 210, where the protrusions are configured to support the tray 222 spaced away from the bottom wall of the container body 210.

[0043] The source of sterilizing gas 230 may include a substrate material 231 (e.g., plastic) impregnated with a sterilizing agent 232. The sterilizing agent 232 is discharged from the substrate material 231 in a gaseous form to define the sterilizing gas 233. When the source of sterling gas 230 is disposed within the container 126, the sterilizing gas 232A permeates the interior of the container 126 so that the selected medical devices 220 are exposed to the sterilizing gas 232A. In some embodiments, the sterilizing agent 232 includes iodine (e.g., molecular or elemental iodine) and the sterilizing gas 232A includes an iodine gas or vapor.

[0044] It has been shown that iodine can penetrate the cell wall of microorganisms quickly, and the lethal effects are believed to result from disruption of protein and nucleic acid structure and synthesis. Sterilizing medical devices with iodine gas involves exposing the device to iodine gas. The iodine gas can penetrate the surfaces of the devices, effectively neutralizing bacteria, viruses, and other pathogens. One advantage of iodine may be that iodine doesn't leave residue behind that might compromise the integrity or safety of the medical device. Moreover, iodine gas sterilization is known for its rapid sterilization process, typically completing within hours, making it an efficient choice for healthcare facilities.

[0045] Impregnating a plastic material with iodine involves a process wherein the iodine molecules permeate the structure of the plastic, forming a complex intermolecular network. Through this method, the plastic becomes a reservoir for the iodine gas, effectively storing it within its matrix. Thereafter, the iodine gas can be discharged from the plastic material. This discharge occurs as a result of the stored iodine molecules reverting to a gaseous state, escaping from the plastic's surface or pores. The impregnated plastic acts as a controlled- release mechanism, gradually releasing the iodine gas over time. Examples of plastic materials that can used include polyvinyl chloride, polyethylene, polypropylene, polystyrene, and polyurethane.

[0046] In some embodiments, the kitting facility 120 may include a system 122 for processing the sources of sterilizing gas 230. The system 122 may include an impregnating environment such as a chamber, for example, that includes the sterilizing gas 233 in a concentration and at a temperature and pressure, that promotes impregnation of the plastic material 231 with the sterilizing agent 232. As such, the sources of sterilizing gas 230 can be prepared for use by placing the sources of sterilizing gas 230 within the impregnating environment for a selected period of time. The impregnating environment may include storage location, where the sources of sterilizing gas 230 are stored and maintained in the condition for use. As the sources of sterilizing gas 230 may be reusable, the sources of sterilizing gas 230 returned from the point of use location may be placed again with the impregnating environment to re-prepare sources of sterilizing gas 230 for reuse.

[0047] In some embodiments, the kit 125 may include a tamper evident device 240 that is configured to indicate that container 126 has been opened and the sterile barrier has been breached. In such amendments, a person can observe the tamper evident device 240 and determined therefrom that the container 126 has remained closed and that the selected medicaldevices within the container are sterile. The tamper evident device 240 may include a frangible tether extending between the container body 210 and the container lid 212, such as an adhesive label or tape extending across the interface between the container body 210 and the container lid 212. The tamper evident device 240 may be coupled to each of the container body 210 and the container lid 212, such that any separation of the container lid 212 from the container body 210, consistent with breaking the seal, tears or otherwise alters the tamper evident device 240 in a manner that is visibly detectable.

[0048] FIG. 3 is a block diagram of the method 100 according to some embodiments. The method 100 can include all or any subset of the following steps, actions, process or operations. The steps, actions, process or operations may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper performance of the method 100, the order and / or use of steps, actions, process or operations may be modified. Moreover, sub-routines or only a portion of a method 100 may be a separate method within the scope of this disclosure.

[0049] The method 100 may further include manufacturing the medical devices at a first location and transporting the medical devices from the first location, such as a medical device company, to a second location, such as a kitting facility (block 305).

[0050] The method 100 may include placing a number of medical devices within a container (block 310). In some embodiments of the method 100, the container includes a container body and a container lid, and the container lid is selectively transitionable between (i) an open position that enables placement of the number of medical devices within the container and removal of the number of medical devices from the container, and (ii) a closed position defining a seal with the container body. In some embodiments of the method 100, the container is configured for multiple uses, i.e., reusable. In some embodiments of the method 100, at least two of the number of medical devices are distinctly different from one another. In some embodiments, all or at least a subset of the medical devices are configured for single use.

[0051] The method 100 may further include placing all or at least a subset of the medical devices into a reusable tray, and placing the reusable tray into the container (block 315).

[0052] The method 100 may further include placing a source of sterilizing gas within the container (block 320). In some embodiments, the source of the sterilizing gas includes aplastic material impregnated with a sterilizing agent, and the sterilizing gas is discharged from the plastic material within the container. Placing the source of sterilizing gas within the container may be performed at the second location.

[0053] The method 100 may further include closing the container such that the medical devices are exposed to the sterilizing gas (block 325), and so that the sterilizing gas is contained within the container. As at least a subset of the medical devices may be non-sterile, exposing the subset of the medical devices to the sterilizing gas can transition the subset of the medical devices from a non-sterile state to a sterile state. In some embodiments, the method 100 may include attaching a tamper evident device to the container after closing the container.

[0054] The method 100 may further include waiting a selected sterilization duration after closing the container and before opening the container (block 330). The duration may be based on the transitioning of the subset of medical devices from the non-sterile state to the sterile state.

[0055] The method 100 may include transporting the container including the number of medical devices and the source of sterilizing gas disposed therein from the second location to the point of use location (block 335). In some embodiments of the method 100, the selected sterilization duration may occur during (e.g., at least partially simultaneous with) transportation of the container from the second location to the point of use location. In some embodiments, the point of use location is spaced away a second distance from the second location, where the first distance is greater than the second distance.

[0056] The method 100 may further include opening the container at a point of use location for the medical devices (block 340) and removing the medical devices from the container (block 345).

[0057] The method 100 may further include steps, actions, process or operations not shown in block diagram of FIG. 3 as described below.

[0058] The method 100 may further include removing the source of the sterilizing gas from an impregnating environment. The impregnating environment is configured to prepare the source of the sterilizing gas for use. The impregnating environment is more specifically configured to impregnate and / or re-impregnate the plastic material with the sterilizing agent.

[0059] The method 100 may further include removing the source of the sterilizing gas from the container and replacing the source of the sterilizing gas back into the impregnating environment.

[0060] The method 100 may further include selecting the medical devices based on a selected medical procedure. The medical devices may be selected from a population of medical devices located at the second location. In some embodiments of the method 100, the population of medical devices includes medical devices provided by different medical device companies.

[0061] The method 100 may further include returning the container from the point of use location to the kitting facility for reuse. As the medical devices may be shipped from the medical device company to the kitting facility within a reusable bulk package, the method 100 may further include retuning the bulk package from the kitting facility to the medical device company for reuse.

[0062] Systems of providing sterile medical devices may be include all or any subset of the entities and components shown and described in relation FIGS. 1 and 2, where the entities and components are used to perform the method 100.

[0063] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A method of providing sterile medical devices, comprising: placing a number of medical devices within a container; placing a source of sterilizing gas within the container; closing the container such that the number of medical devices are exposed to the sterilizing gas to transition at least one of the number of medical devices from a non-sterile state to a sterile state; opening the container at a point of use location for the number of medical devices; and removing the number of medical devices from the container.

2. The method according to claim 1, further comprising waiting a selected sterilization duration between closing the container and opening the container, the duration based on the transitioning the at least one of the number of medical devices from the non-sterile state to the sterile state.

3. The method according to either claim 1 or 2, wherein: the source of the sterilizing gas includes a plastic material impregnated with a sterilizing agent, and the sterilizing gas is discharged from the plastic material within the container.

4. The method according to any of the preceding claims, further comprising removing the source of the sterilizing gas from an impregnating environment configured to impregnate the plastic material with the sterilizing agent.

5. The method according to claim 4, further comprising removing the source of the sterilizing gas from the container, and replacing the source of the sterilizing gas into the impregnating environment to reimpregnate the plastic material with the sterilizing agent.

6. The method according to either claim 4 or 5, wherein the sterilizing agent includes iodine.

7. The method according to any of the preceding claims, wherein placing the number of medical devices within the container includes:placing a least a first subset of the number of medical devices into a reusable tray, and placing the reusable tray into the container.

8. The method according to any of the preceding claims, wherein the container is reusable.

9. The method according to any of the preceding claims, wherein Ithe container includes a container body and a container lid, and wherein the container lid is selectively transitionable between an open position enabling placement of the number of medical devices within the container and removal of the number of medical devices from the container, and a closed position defining a seal with the container body.

10. The method according to any of the preceding claims, further comprising: manufacturing the number of medical devices at a first location; and transporting the number of medical devices from the first location to a second location spaced away a first distance from the first location, wherein the placing the number of medical devices within the container is performed at the second location.

11. The method according to claim 10, wherein placing the source of sterilizing gas within the container is performed at the second location.

12. The method according to either claim 10 or 11, further comprising transporting the container including the number of medical devices and the source of sterilizing gas from the second location to the point of use location, wherein the point of use location is spaced away a second distance from the second location, and the second distance is less than first distance.

13. The method according to any of the preceding claims, wherein at least two of the number of medical devices are distinctly different from one another.

14. The method according to any of the preceding claims, wherein at least a second subset of the number of medical devices are configured for single use.

15. The method according to any of the preceding claims, further comprising selecting the number of medical devices based on a selected medical procedure.

16. The method according to any of the preceding claims, wherein the number of medical devices are selected from a population of medical devices located at the second location.

17. The method according to claim 16, wherein the population of medical devices includes medical devices provided by at least two distinctly different medical device companies.

18. A system for providing sterile medical devices, comprising: a container configured to transition from a closed state to an open state; a number of medical devices disposed within the container; and a source of sterilizing gas disposed within the container, the source of sterilizing gas configured to discharge the sterilizing gas within the container to transition at least a subset of the number of medical devices from a non- sterile state to a sterile state when the container is in the closed state.

19. The system according to claim 18, wherein the source of the sterilizing gas includes a plastic material impregnated with a sterilizing agent, and wherein the sterilizing gas is discharged from the plastic material within the container.

20. The system according to claim 19, wherein the source of the sterilizing gas is configured for repeated placement into an impregnating environment configured to reimpregnate the plastic material with the sterilizing agent.

21. The system according to either claim 19 or 20, wherein the sterilizing agent includes iodine.

22. The system according to any of claims 18-21 , further comprising a reusable tray disposed within the container, wherein at least a subset of the number of medical devices are disposed in the reusable tray.

23. The system according to any of claims 18-22, wherein the container is reusable.

24. The system according to any of claims 18-23, wherein the container includes a container body and a container lid, and wherein the container lid is selectively transitionable between an open position enabling placement of the number of medical devices within thecontainer and removal of the number of medical devices from the container, and a closed position defining a seal with the container body.

25. The system according to any of claims 18-24, wherein at least one of the number of medical devices is sourced from a first medical device company and at least another one of the number of medical devices is sourced from a second medical device company, the second medical device company separate from the first medical device company.

26. The system according to any of claims 18-25, wherein at least two of the number of medical devices are distinctly different from one another.

27. The system according to any of claims 18-26, wherein at least a subset of the number of medical devices are configured for single use.

28. The system according to any of claims 18-27, wherein the number of medical devices are selected from a population of medical devices based on a selected medical procedure.

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