Compliance packaging (medication management packaging) and methods of using it

Abstract

A package for facilitating compliance with a protocol, comprising a first compartment for housing a first component and a second compartment for housing a second component. The first and second components are used when complying with the protocol. The first compartment is attached to the second compartment. The first and second compartments are configured such that access to the second compartment is possible after access to the first compartment.

Description

[Technical Field]

[0001] This application claims priority and benefit from Indian Provisional Patent Application No. 202341061291, filed on September 12, 2023, the entire disclosures of which are incorporated herein by reference in their entirety.

[0002] The present invention generally relates to medical catheter accessories, and more specifically relates to a device for assisting in securing a catheter. [Background Art]

[0003] A catheter is a medical device that can be inserted into the body to treat diseases or perform surgical procedures. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular and ophthalmic procedures. For most applications, the catheter is a thin, flexible tube (flexible tube) (soft catheter), but catheters of various stiffness levels are available depending on the application. A catheter can be inserted into a body cavity, lumen, blood vessel, brain, skin or adipose tissue. Functionally, catheters enable drainage, administration of fluids or gases, access by surgical instruments, and can also perform a wide variety of other procedures depending on the type of catheter.

[0004] When a catheter is to be left in place in a patient for an extended period, fixation techniques are often used to secure the catheter in that position. This is especially true for central venous catheters (CVCs) and peripherally inserted central catheters (PICCs), which are often inserted into the superior vena cava via the patient's neck / chest and upper arm, respectively. Solutions include sutures (Figure 1) and catheter fixation devices (an exemplary catheter fixation device is STATLOCK, available from Becton, Dickinson and Co. (Franklin Lakes, New Jersey)). 商標 The device includes, for example, Figure 3). In any of these techniques, it is typically necessary to change the dressing associated with the catheter insertion site. As can be seen in Figures 2A-2C, cleaning around a catheter secured by sutures results in incomplete (and therefore insufficient) cleaning, which can actually increase the risk of central line-associated bloodstream infection (CLABSI).

[0005] When a catheter is secured with an anchoring device, the anchoring device is typically replaced at the same time as the dressing. During the changing of the dressing, replacement of the anchoring device, and cleaning around the insertion site, the caregiver must avoid excessive movement of the catheter (for example, the catheter tip may move or become dislodged at the insertion site, which could cause the catheter to shift too much and not be properly positioned in the vein or intended anatomical site). This is especially important for certain catheters and sites, such as CVCs and PICCs.

[0006] Adhesive-based fixing devices (e.g., STATLOCK) 商標 Various techniques are currently used to temporarily secure a fixed catheter during dressing changes. In one technique, a caregiver may attempt to hold the catheter in place using their fingers (Figure 4A). However, this method may require a second caregiver to clean the site while a first caregiver holds the catheter in place with one hand and lifts the extension tube with the other after the fixation device is removed. Furthermore, this technique does not conform to the aseptic non-touch technique (ANTT). Alternatively, a rolled-up dressing method may be used to temporarily hold the catheter when the fixation device is replaced (Figure 4B). However, the use of rolled-up dressings can result in inconsistencies (e.g., the amount of dressing for rolled-up use). As a third technique, a secondary fixation component, such as adhesive tape, may be used to temporarily hold the catheter in place during the removal and replacement of the fixation device (Figure 4C). This requires that caregivers be aware of the need to perform this task and adhere to a protocol using adhesive tape during dressing changes. Experience has shown that this protocol is often disregarded due to several constraints. For example, removal of the adhesive tape can be difficult and / or may cause movement of the catheter, and in some cases, the adhesive tape may leave residue on the catheter lumen after removal, thereby attracting contaminants / microorganisms. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] It is desirable to provide technologies that improve adherence to protocols, which may improve patient outcomes. [Means for solving the problem]

[0008] In a first view, embodiments of the present invention are directed toward a package that facilitates compliance with a protocol. The package comprises a first compartment for housing a first component and a second compartment for housing a second component. The first and second components are used when complying with the protocol. The first compartment is attached to the second compartment. The first and second compartments are configured such that the second compartment can be accessed after the first compartment has been accessed.

[0009] In a second view, embodiments of the present invention provide access to a first component and a second component from a compliance acceleration package, wherein the method is (a) To provide a package comprising a first compartment for housing a first component and a second compartment for housing a second component, wherein the second compartment is attached to the first compartment; (b) Open the first compartment and access the first component; then, (c) Open the second compartment and access the second component. Including the process, Here, the first compartment and the second compartment are configured such that the second compartment can be accessed after the first compartment has been accessed. The above method is intended.

[0010] From a third perspective, embodiments of the present invention are a method for forming a package to facilitate compliance with a protocol, the method being To form the first compartment; Placing the first component in the first compartment; To form a second compartment attached to the first compartment; Placing the second component in the second compartment; and, To seal the first compartment and the second compartment. Includes, The first compartment and the second compartment are configured such that the second compartment can be accessed through the first compartment after the first compartment has been accessed. The above method is intended.

[0011] In a fourth view, embodiments of the present invention are directed to a package for facilitating compliance with a protocol, comprising a first compartment for housing a first component and a second compartment for housing a second component and attached to the first compartment. A barrier exists between the first compartment and the second compartment. The first and second components are used when complying with the protocol. The second compartment is accessible through the first compartment after the first compartment has been accessed and after the barrier has been breached. [Brief explanation of the drawing]

[0012] [Figure 1] Figure 1 is a top view of a catheter fixed in place with sutures. [Figure 2A] Figures 2A to 2C show attempts to clean around the insertion site of a CVC sutured in place (Figure 2A), the results after cleaning with the CVC still present (Figure 2B), the results after cleaning after the CVC has been removed (Figure 2C), and the skin around areas where cleaning was insufficient. [Figure 2B]Figures 2A to 2C show attempts to clean around the insertion site of a CVC sutured in place (Figure 2A), the results after cleaning with the CVC still present (Figure 2B), the results after cleaning after the CVC has been removed (Figure 2C), and the skin around areas where cleaning was insufficient. [Figure 2C] Figures 2A to 2C show attempts to clean around the insertion site of a CVC sutured in place (Figure 2A), the results after cleaning with the CVC still present (Figure 2B), the results after cleaning after the CVC has been removed (Figure 2C), and the skin around areas where cleaning was insufficient. [Figure 3] Figure 3 is a top view of an exemplary catheter fixation device. [Figure 4A] Figure 4A is a top view showing a caregiver manually holding the catheter in place with gloved fingers during a dressing change and replacement of the catheter fixation device. [Figure 4B] Figure 4B is a top view showing that a caregiver is inserting a rolled-up dressing to temporarily secure the catheter during the dressing change and the replacement of the catheter fixation device. [Figure 4C] Figure 4C is a top view showing the use of adhesive tape as a secondary fixation component between dressing changes and catheter fixation device replacements. [Figure 5] Figure 5 is an exploded view of an assembly comprising a primary catheter fixation device, a secondary catheter fixation device, and a catheter at the catheter insertion site. [Figure 6] Figure 6 is a top perspective view of the secondary catheter fixation device shown in Figure 5. [Figure 7] Figure 7 is a bottom perspective view of the secondary catheter fixation device shown in Figure 6. [Figure 8] Figure 8 is a top-view perspective of the assembly shown in Figure 5 at a predetermined position at the patient's catheter insertion site. [Figure 9A]Figures 9A to 9F are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9B] Figures 9A to 9F are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9C] Figures 9A to 9F are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9D] Figures 9A to 9F are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9E] Figures 9A to 9F are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9F] Figures 9A to 9F are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 10] Figure 10 is a perspective view showing a compliance promotion package that can be used with the assembly of Figure 5 to prompt a user to follow an appropriate dressing replacement protocol. [Figure 11A] Figures 11A to 11D are consecutive perspective views showing the use of the compliance promotion package of Figure 10. [Figure 11B] Figures 11A to 11D are consecutive perspective views showing the use of the compliance promotion package of Figure 10. [Figure 11C] Figures 11A to 11D are consecutive perspective views showing the use of the compliance promotion package of Figure 10. [Figure 11D] Figures 11A to 11D are consecutive perspective views showing the use of the compliance promotion package of Figure 10. [Figure 12]Figure 12 is a perspective view of a compliance-facilitating package according to an alternative embodiment of the present invention. [Modes for carrying out the invention]

[0013] Herein, the present invention is described herein with reference to the accompanying drawings illustrating embodiments of the invention. However, the present invention may be used in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided to ensure that this disclosure is complete and thorough and to fully convey the scope of the invention to those skilled in the art.

[0014] In the drawings, certain layers, components, or features may be exaggerated for clarity, and dashed lines indicate any feature or operation unless otherwise specified.

[0015] In this specification, the terms “first,” “second,” etc., may be used to describe various elements, components, regions, layers, and / or sections, but it will be understood that these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only to distinguish one element, one component, one region, one layer, or one section from another region, another layer, or another section. Accordingly, the first element, first component, first region, first layer, or first section discussed below may be named the second element, second component, second region, second layer, or second section without departing from the teachings of the present invention. The order of operations (or steps) is not limited to the order presented in the claims or drawings unless otherwise specified.

[0016] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as generally understood by one of the ordinary people skilled in the art to which this invention pertains. Furthermore, unless expressly defined herein, terms as defined in commonly used dictionaries should be interpreted as having the meaning consistent with their meanings in the context of this application and related art, and should not be interpreted in an idealized or overly formal sense. Well-known functions or configurations may not be described in detail for the sake of brevity and / or clarity.

[0017] The terms used herein are intended solely to describe specific embodiments and are not intended to limit the invention. Where used herein, the singular forms “one” (a, an) and “the” are intended to also include the plural form unless the context clearly indicates otherwise. Where used herein, the words “equipped with” and / or “equipped with” indicate the presence of the described feature, integer, step, operation, element and / or component, but it will be further understood that they do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof. Where used herein, the words “and / or” include any and all combinations of one or more of the associated enumerated items.

[0018] When used herein, phrases such as "X to Y" and "about X to Y" should be interpreted as including X and Y. When used herein, phrases such as "from about X to Y" mean "from about X to about Y". When used herein, phrases such as "about X to Y" mean "from about X to about Y".

[0019] Referring to the drawings, the assembly for catheter fixation and replacement is schematically denoted as 10, as shown in Figure 5. The components of the assembly 10 include a primary catheter fixation device 12 and a secondary catheter fixation device 20. The secondary catheter fixation device 20 is used to fix the catheter C (e.g., CVC) at the insertion site (proximal) or distal to the extension line behind the catheter hub when the dressing is replaced, and the primary catheter fixation device 12 replaces the existing primary catheter fixation device.

[0020] The primary catheter fixation device 12 can be any catheter fixation device known to be suitable for fixing a catheter. One example is shown in Figure 5. More specifically, the primary catheter fixation device 12 has a body 13, a pin 14 or other fixation feature for fixing a catheter thereto, and an adhesive lower surface designed to adhere to the patient's skin. Exemplary embodiments of the primary catheter fixation device 12 are described in U.S. Patents 7,223,256, 9,561,348, 8,743,400, and 11,020,565, the disclosures of which are incorporated herein by reference in their entirety.

[0021] The secondary catheter fixation device 20 is shown in Figures 6 and 7. The secondary catheter fixation device 20 comprises a main strip 22. A lumen anchor 24 with clips 25 is attached to the lower central region of the main strip 22. The clips 25 are sized and configured to receive and hold a lumen between them. Adhesive surfaces 26 are located on both sides of the lumen anchor 24 and on the underside of the main strip 22. In some embodiments, the adhesive surfaces 26 may be covered with a backing layer to prevent unintended adhesion of the device 20 before use. Figure 8 shows a catheter C trapped between the clips 25 when the secondary catheter fixation device 20 is attached to the patient's skin.

[0022] The use of the assembly 10 is shown in Figures 9A to 9G. Figure 9A shows the catheter C in place on the patient's skin. The catheter C is secured in place by a pin 14 inserted into a hole H in the catheter C, which holds the wings W of the catheter C. The insertion site for the lumen L of the catheter C is fitted with a small dressing D adapted for the catheter insertion site (an exemplary small dressing is available from Becton, Dickinson and Co., GuardIVa). 商標 It is covered with a dressing. A transparent dressing 50 covers the insertion site, the catheter C, the dressing D, and the primary fixation device 12.

[0023] If dressing D is to be replaced, the transparent dressing 50 is removed, and dressing D is also removed (Figure 9B). Next, the secondary catheter fixation device 20 (Figures 9C and 9D) is applied between the primary fixation device 12 and the insertion site to fix the catheter C in place. The lumen L of the catheter C is received by the clip 25, and the adhesive surface 26 is attached to the skin. Next, the primary fixation device 12 is separated from the catheter C, and the portion previously covered by the transparent dressing 50 is cleaned (Figure 9E).

[0024] Once the cleaning is complete, a new primary fixation device 12' is applied to the skin, and the catheter C is reattached to the new primary fixation device 12'. Next, the secondary catheter fixation device 20 is removed (Figure 9F). A new dressing D' is applied to the insertion site, and when the catheter C is secured in place by the new primary fixation device 12', a new clear dressing 50' is applied over the new dressing D' and the catheter C (Figure 9G).

[0025] As described above, one reality of the process of changing the dressing and the primary fixation device is that caregivers, who are often pressed for time, may not follow the full protocol (for example, the caregiver may find it cumbersome to use adhesive tape to anchor the fixation device due to some of the drawbacks described above). For this reason, it may be beneficial to provide the components of the assembly 10 in a package that promotes adherence to the protocol (and / or prevents non-adherence to the appropriate protocol). One such package is shown in Figure 10 and schematically denoted as 100. As can be seen in Figure 10, the package 100 comprises an upper compartment 101 and a compartment 102. The upper compartment 101 is generally box-shaped and covered by a peelable cover 110. The peelable cover 110 may be transparent or translucent to allow visibility of the items stored in the upper compartment 101. In some implementations, the peelable cover 110 may have a function to indicate whether the peelable cover 110 has been torn or tampered with. Examples of such functions include color-changing sealants, holograms or other image-based indicators, electronic circuits (e.g., RFID antennas), physical seals, or similar devices. As shown in the example in Figure 10, the secondary fixing device 20 is housed in the upper compartment 101. The lower compartment 102 is attached to the upper compartment 101 such that the lower compartment 102 and the upper compartment 101 share at least a portion of a common wall 104 (for example, the bottom of the upper compartment 101 serves as part of the ceiling of the lower compartment 102). The lower compartment 102 is also box-shaped. A barrier 120 is present in the common wall 104 that can be removed (for example, by tearing along one or more score lines) to provide access to the lower compartment 102. The primary fixing device 12 is housed in the lower compartment 102.The barrier 120 may be transparent or partially transparent so that the articles stored in the lower compartment 102 are visible. In some implementations, the barrier 120 may have a function to indicate whether the barrier 120 has been torn or tampered with. Examples of such functions include color-changing sealants, holograms or other image-based indicators, electronic circuits (e.g., RFID antennas), physical seals, or similar devices. In some implementations, the barrier 120 may be formed from the same material as the peelable cover 110. In some implementations, the barrier 120 may be formed from a different material than the peelable cover 110. For example, the barrier 120 may be formed from a material that can support at least the weight of the articles stored in the upper compartment. Furthermore, if the articles in the upper compartment include edges or friction elements, the barrier 120 should be formed from a material that has sufficient strength to withstand tearing that occurs during normal transport of the package 100. The barrier material may, but is not limited to, a variety of materials, including paper (including recycled paper), single-layer or multi-layer polymer films (consisting of polypropylene, polyethylene, nylon, polyethylene terephthalate and one or more tie layers), and thin metal films / foils. Since the packaging material comes into direct contact with the medical device, it is preferable that it be made of an inert material that is biocompatible, non-toxic, and does not leach any harmful trace substances during storage, transport, or use.

[0026] It will be apparent to those skilled in the art that the user can access the components within the package 100 by first removing the peelable cover 110 to open the upper compartment 101, thereby accessing the secondary fixing device 20 located within the upper compartment 101. At this point, the lower compartment remains inaccessible. Next, the user can access the primary fixing device 12 within the lower compartment 102 by removing the barrier 120 from the lower compartment 102. Since the lower compartment 102 is inaccessible until the barrier 120 is removed (or at least partially removed), the user cannot access the primary fixing device 12 without first accessing the secondary fixing device 20 within the upper compartment 101.

[0027] As can be understood from the above description, the configuration of the package 100 facilitates the user following the steps shown in Figures 9A to 9G. Due to the design of the package 10, the user can access the primary fixation device 12 only after first removing the secondary fixation device 20. This reminds the user that (a) the catheter should be anchored using the secondary fixation device 20 before removing the old primary fixation device 12, and (b) that the process should be done in the correct order (i.e., the user should attach the secondary fixation device 20 to the catheter before the primary fixation device 12 is replaced).

[0028] Since the primary and secondary fixation devices 12 and 20 are typically used in a healthcare environment, the package 100 should be configured such that the upper compartment 101 and the lower compartment 102 are uncontaminated (e.g., aseptically packaged). The package 100 also allows the first step of the protocol to be carried out using the first article, while the second article is stored in a sealed container for subsequent protocol steps. This ensures that the second article remains sterile for potential future use, even if any problems occur during the implementation of the first step.

[0029] Furthermore, those skilled in the art will understand that other "forced-sequence" packaging configurations are also possible. For example, in some embodiments, the barrier 120 may be substantially the bottom of the upper compartment 101 rather than a tear-away panel, and an open window may be located in the ceiling of the lower compartment 102. In such cases, the entire upper compartment 101 (including its bottom) may need to be removed from the lower compartment 102 (by tearing, sliding, or peeling, etc.) to allow the user to access the lower compartment 102.

[0030] As another example, the primary and secondary fixing devices may be located in compartments adjacent to each other (see Figure 12). In such a configuration, the compartment 140 housing the primary fixing device is sealed from the compartment 130 housing the secondary fixing device, and a barrier 135 between these compartments (e.g., on a common side wall of these compartments) prevents access to the primary fixing device compartment. Alternatively, the primary fixing device compartment may be covered with a peelable web, and both the primary-secondary fixing device compartment and the secondary fixing device compartment may be covered with a second peelable web overlapping the first peelable web. In this configuration, the removal of the second peelable web allows access to the secondary fixing device, but the first web remains in place and must be peeled off separately to allow access to the primary fixing device.

[0031] Those skilled in the art will understand that, although a first and second compartment are shown in the drawings and discussed herein, a package according to embodiments of the present invention may include three or more compartments configured to open in a specific order and / or according to a specific protocol. Furthermore, such a package may include both compartments having order-specific components and compartments that are not order-specific. Moreover, the compartments do not have to be rectangular box-shaped configurations as shown herein, but may alternatively be spherical, hemispherical, oval, triangular, hexagonal, etc.

[0032] The upper compartment 101 may also be provided with markings or other indicia on its exterior or interior to guide or instruct the user on how to access the lower compartment 102. Such indicia may be visible before the upper compartment is accessed (e.g., printed on the cover 110), or may be visible only after the upper compartment 101 has been accessed. In some implementations, the compartments of the package 100 (or the majority of the package 100) may be provided with an indicator for identifying a protocol associated with the substance stored in the package 100. The indicator may be a machine-readable indicator for identifying the protocol, e.g., a quick-read code, a barcode, or other scannable element. The indicator may be human-recognizable, e.g., a shape or color. The use of human-recognizable indicators is beneficial in medical settings where an emergency response is required. In such cases, a distinctive color may be associated with a specific emergency protocol to enable either a machine or a human to more quickly identify the appropriate emergency supplies.

[0033] Those skilled in the art will understand that the package 100 can be used in conjunction with various other components. For example, the secondary fastening device 20 shown above may, in some cases, be replaced with adhesive tape. For another example, the protocol may, in some cases, require that the primary fastening be applied first, followed by the application of the secondary component. In such cases, the package is configured such that the secondary component is accessible only after the primary component has been accessed and removed. Numerous different secondary fastening devices are described in Indian Provisional Patent Application No. 202441028018 (filed April 4, 2024) and Indian Provisional Patent Application No. 202441028019 (filed April 4, 2024), the disclosures of which are incorporated herein by reference in their entirety.

[0034] In any of the embodiments described above, the compartments of the package 100 may be made of recyclable materials, such as plastic-based materials or paper-based materials.

[0035] Those skilled in the art will understand that package 100 and other packages described herein may be used to contain other components, whether other medical components or non-medical articles, in which case the user may be prompted to follow certain procedures or a series of steps in order to use such components correctly. Examples include, but are not limited to, disinfectant products for skin or devices, such as wipes (disinfectant applicators) or disinfectant applicators, adhesive removal devices for easily removing IV catheter dressings and / or fixation devices, skin emollients, and tissue adhesives for sealing the entrance location of an IV catheter into the skin.

[0036] A package according to an embodiment of the present invention is typically formed by forming a first compartment; arranging a first component in the first compartment; forming a second compartment attached to the first compartment; arranging a second component in the second compartment; and enclosing the first and second compartments. The first and second compartments are configured such that the second compartment can be accessed through the first compartment after the first compartment has been accessed. In some examples, the first and second compartments (or parts thereof) may be formed and / or enclosed simultaneously, or at different times. In some examples, the formation of the first compartment may be completed by the partial formation of the second compartment (for example, when a barrier is applied to seal the first compartment) (i.e., it may be enclosed). Other variations are also possible.

[0037] The foregoing is illustrative of the present invention and should not be construed as limiting the invention. While several exemplary embodiments of the present invention have been described, those skilled in the art will readily understand that many modifications are possible in the exemplary embodiments without substantially departing from the novel teachings and advantages of the present invention. Accordingly, all such modifications are intended to fall within the scope of the present invention.

Claims

1. A package that promotes compliance with a protocol, the package is A first compartment for housing a first component; A second compartment for housing a second component. It is equipped with, Here, the first component and the second component are used when following the protocol, The first compartment is attached to the second compartment; and, The first compartment and the second compartment are configured such that the second compartment can be accessed via the first compartment and after the first compartment has been accessed. The aforementioned package.

2. The package according to claim 1, wherein a barrier exists between the first compartment and the second compartment, and access to the second compartment requires at least partial removal of the barrier.

3. The package according to claim 2, wherein the first component must be removed from the first compartment in order to access the barrier.

4. The package according to claim 2, wherein the barrier is configured to be torn or peeled away from the second compartment in order to access the second compartment.

5. The package according to claim 1, wherein the first compartment and the second compartment each include a sterile compartment.

6. The package according to claim 1, wherein the first component is a secondary catheter fixation device, and the second component is a new primary catheter fixation device.

7. The package according to claim 6, wherein the secondary catheter fixation device is configured to fix the position of the inserted catheter when a used primary catheter fixation device is replaced with a new primary catheter fixation device.

8. The package according to claim 1, wherein the first compartment is located above the second compartment.

9. The package according to claim 1, wherein the first compartment includes an indicator that instructs the user how to access the second component from the second compartment.

10. A method for accessing a first component and a second component from a compliance promotion package, wherein the method is (a) To provide a package comprising a first compartment for housing a first component and a second compartment for housing a second component, wherein the second compartment is attached to the first compartment; (b) Open the first compartment and access the first component; then, (c) Opening the second compartment and accessing the second component. Including the process, Here, the first compartment and the second compartment are configured such that the second compartment can be accessed after the first compartment has been accessed. The aforementioned method.

11. The method according to claim 10, wherein a barrier exists between the first compartment and the second compartment, and step (c) includes removing at least a portion of the barrier.

12. The method according to claim 11, further comprising step (b) removing the first component from the first compartment before performing step (c).

13. The method according to claim 11, wherein step (c) includes tearing or peeling away the barrier from the second compartment to access the second compartment.

14. The method according to claim 10, wherein the first compartment and the second compartment include a sterile compartment.

15. The method according to claim 10, wherein the first component is a secondary catheter fixation device, and the second component is a novel primary catheter fixation device.

16. To fix the position of the inserted catheter on the patient by applying the aforementioned secondary catheter fixation device; Removing the used primary catheter fixation device from the patient; and, To apply the aforementioned new primary catheter fixation device to the patient. The method according to claim 15, further comprising the step of

17. The method according to claim 10, wherein the first compartment is positioned above the second compartment.

18. The method according to claim 10, further comprising a display that instructs the user how the first compartment accesses the second component from the second compartment.

19. A method for forming a package to facilitate compliance with a protocol, wherein the method is To form the first compartment; Placing the first component in the first compartment; To form a second compartment attached to the first compartment; Placing the second component in the second compartment; and, To seal the first compartment and the second compartment. Includes, The first compartment and the second compartment are configured such that the second compartment can be accessed via the first compartment after the first compartment has been accessed. The aforementioned method.

20. The method according to claim 19, further comprising forming a barrier between the first compartment and the second compartment, and requiring at least partial removal of the barrier to access the second compartment.

21. The method according to claim 20, wherein the first component must be removed from the first compartment in order to access the barrier.

22. The method according to claim 19, wherein the step of forming the second compartment seals the first compartment.

23. The method according to claim 22, wherein the step of forming a barrier seals the first compartment.

24. The method according to claim 19, wherein the sealing step sterilizes the first compartment and the second compartment.

25. The method according to claim 19, wherein the first component is a secondary catheter fixation device, and the second component is a novel primary catheter fixation device.

26. The method according to claim 25, wherein the secondary catheter fixation device is configured to fix the position of the inserted catheter when a used primary catheter fixation device is replaced with a new primary catheter fixation device.

27. The method according to claim 19, further comprising attaching an indicator that instructs the user on how to access the second component from the second compartment.

28. A package for promoting compliance with a protocol, wherein the package is A first compartment for housing a first component; A second compartment that houses a second component and is attached to the first compartment. It is equipped with, Here, a barrier exists between the first compartment and the second compartment; The first and second components are used when following the protocol; After the first compartment is accessed and the barrier is breached, the second compartment becomes accessible through the first compartment. The aforementioned package.

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