Packaging for medical devices

Abstract

A package is described that includes a film surrounding a sterile medical device, and includes a tearable feature and a grip feature that enables a user to apply a sufficient tear force using one end of a finger, thumb, or tool, the tearable feature is configured to tear and move the first end of the package away from the second end of the package and expose the sterile medical device for use with only one hand. Methods of packaging sterile medical devices are also described.

Description

Technical Field

[0001] The present disclosure relates to packaging and, more particularly, to a package containing a medical device such as a syringe. Background Art

[0002] Clean or sterile articles used in medical applications are packaged to maintain their sterility. The packaging for these articles is intended to provide a barrier to prevent microorganisms from entering the interior of the package and contaminating the contents of the package. In most cases, the package, such as a blister pack containing a syringe, is opened immediately before the article is used to minimize the time the article is exposed to non-sterile conditions.

[0003] Traditionally, to prevent contamination, medical devices are loosely placed in conventional blister packs. Blister packs provide a housing that is sealed to prevent contaminants from entering and prevent syringes from being contaminated. However, conventional blister packs require two hands and a knuckle-roll-peel technique to open the package.

[0004] This two-handed opening process is cumbersome and time consuming in the challenging environment of a hospital, emergency care center, ambulance, or other medical environment where there is little time to handle syringe packages. Healthcare practitioners, such as doctors, nurses, physician assistants, paramedics, and emergency medical technicians, often multi-task, and due to the design of conventional blister packages, healthcare practitioners must keep both hands free to open the blister package in order to release the medical device from the package.

[0005] In addition, the traditional two-knuckle-roll-peel technique required to open conventional blister packages often compromises sterility. If the package is opened in the wrong direction or opened hastily, the package may tear or break. Such tears can introduce foreign matter into the syringe product, exposing the syringe to non-sterile conditions.

[0006] In addition, conventional blister packages consume a large amount of material because the package requires a peel tab for the user to open the package. This additional packaging material results in an increased cost per syringe product. In addition, the additional packaging material needs to be discarded when the package is opened, thereby increasing the amount of waste material generated in a hospital or other medical environment.

[0007] Fig. 1-4 shows conventional (prior art) syringe packaging and the opening of conventional syringe packaging. Fig. 1 and 2 illustrate conventional syringe packaging. With reference to Fig. 1, packaging 2 comprises syringe 4 and blister packaging 6. Blister packaging 6 comprises a flexible web sealed to a backing, thereby defining a compartment and providing a sealing area 8 for accommodating syringe 4 around the periphery of the backing. The blister packaging also comprises at least one peeling tab 9 for use by a medical practitioner when opening the blister packaging to release the syringe. With reference to Fig. 2, the width of the sealing area 8 is equal around the entire periphery of the backing. In other words, no matter how the sealing mechanism, the sealing area has the same size between the syringe and the edge of the packaging around the entire packaging 6.

[0008] Fig. 3 and 4 illustrate the opening of conventional syringe packaging. With reference to Fig. 3 and 4, by knuckle-rolling motion, the outer packaging material is peeled off with both hands, and the product is released. In other words, the two-handed knuckle-rolling-peeling technique used to open the package 2 needs to place the knuckles of both hands on either side of the peeling tab 9 of the package 2 and use the thumb to roll and peel off the seal, thereby the flexible web is peeled off the backing to expose the syringe 4 separated from the blister pack 6. This two-handed opening method is very troublesome and time-consuming for medical practitioners, because it requires medical practitioners to free both hands to open the package. In addition, the traditional two-handed knuckle-rolling-peeling technique required for opening conventional blister packages usually damages sterility. If the package is opened in the wrong direction or opened in a hurry, the package may tear or break. This fiber tearing is the delamination of the top or bottom web of the blister packaging material. Such tearing can introduce foreign matter into the syringe product, thereby exposing the syringe to non-sterile conditions.

[0009] It would be advantageous to provide a package for containing a medical device, such as a syringe, that does not require a two-knuckle rolling peel technique to open and does not include a peel tab for opening. Summary of the invention

[0010] Various aspects of the present disclosure relate to medical device packaging and packaged medical devices. In a first aspect, a packaged medical device includes a medical device contained in a package, and the package includes a film surrounding the medical device, the film being sealed at a first end and a second end and defining a housing including a front side, a back side, the first end, and the second end, the film including a tear strength; a tearable feature selected from at least one of a notch and a perforation at a location adjacent to the first end, the tearable feature reducing the tear strength of the film at the location of the tearable feature; and a gripping feature formed in the film between the first end and the tearable feature, the gripping feature being configured to allow a user to apply sufficient tearing force using a finger, thumb, or one end of a tool to cause the tearable feature to tear the first end of the package and move away from the second end of the package and expose the medical device for use using only one hand.

[0011] A second aspect relates to a system comprising a packaged medical device as described herein, such as a medical device according to the first aspect, and a hook tool configured to engage the gripping feature.

[0012] Another aspect relates to a method for packaging a medical device, the method comprising surrounding the medical device with a film and sealing the film at a first end and a second end to define a housing including a front side, a back side, the first end and the second end, the film comprising tear strength; a tearable feature selected from at least one of a notch and a perforation included in the film at a position adjacent to the first end, the tearable feature reducing the tear strength of the film at the location of the tearable feature; and forming a gripping feature in the film located between the first end and the tearable feature, the gripping feature being configured to allow a user to apply sufficient tearing force using a finger, thumb or one end of a tool to cause the tearable feature to tear the first end of the package and move away from the second end of the package and expose the medical device for use using only one hand. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 is a perspective view of a prior art syringe package and a syringe adjacent to the package;

[0014] FIG2 is a top plan view of a syringe package of the prior art;

[0015] FIG3 is a perspective view showing a user / practitioner opening a prior art syringe package;

[0016] FIG4 is a side perspective view showing a user / practitioner opening a prior art syringe package;

[0017] Figure 5Ais a front view of a packaged medical device according to an embodiment of the present disclosure;

[0018] Figure 5B For along Figure 5A A cross-sectional view taken along line BB;

[0019] Figure 5C For along Figure 5A A cross-sectional view taken along line CC;

[0020] Fig. 6A is a front view of a packaged medical device according to an alternative embodiment of the present disclosure;

[0021] Figure 6B is a front view of a packaged medical device according to an alternative embodiment of the present disclosure;

[0022] Figure 7 for Figure 5A A partial front view of the packaging;

[0023] Fig. 8A -E shows an alternative embodiment of the opening shape;

[0024] Fig. 9 A front view illustrating the use of a package according to an embodiment of the present disclosure;

[0025] Fig.10 A front view illustrating the use of a package according to one embodiment;

[0026] Fig.11A - C is a front view showing the use of the package and illustrating how the package may be opened according to an embodiment;

[0027] Fig. 12A - D is a front view showing the use of the package and illustrating how the package may be opened according to an embodiment;

[0028] Fig.13A and 13B illustrates an alternative embodiment of a tool that may be used to open a package according to one embodiment; and

[0029] Fig.14 The following is a flow chart illustrating a method according to an embodiment. DETAILED DESCRIPTION

[0030] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and can be practiced or carried out in various ways.

[0031] With respect to terms used in this disclosure, the following definitions are provided.

[0032] As used herein, the use of "a", "an", and "the" includes both the singular and the plural.

[0033] Reference to "medical device" refers to any device used for medical purposes, such as a syringe. Reference to "syringe" includes syringes for use with needles, nozzles, catheters or for flushing systems. As used herein, the term "syringe" refers to a simple pump-like device that includes a plunger rod that fits tightly in a barrel or tube. The plunger rod can be pulled or pushed in the barrel, allowing the syringe to inhale and discharge liquid or gas through the opening at the open end of the barrel. The open end of the syringe can be equipped with a needle, nozzle or catheter to help guide fluid into and out of the barrel. The syringe can be sterile or non-sterile, depending on the needs of the surgery and medical practitioners.

[0034] As used herein, the term "package" or "packaging" includes any material used to wrap or protect goods or products (such as syringes). Packages can be rigid or flexible. Packages include but are not limited to medical packaging, pharmaceutical packaging, and child-resistant packaging.

[0035] Tyvek® is a synthetic material composed of flash-spun high-density polyethylene fibers (i.e., spunbond olefin fibers). This material is lightweight, strong, and tear-resistant, but can be cut with scissors or a knife. Water vapor and other gases can pass through Tyvek® because the material is highly breathable, but at the same time, the material is impermeable to liquid water and microorganisms.

[0036] As used herein, the term "sterilization" refers to a method of eliminating or killing microorganisms present on a surface, contained in a fluid or compound (such as a biological culture medium) to achieve an antiseptic or aseptic microbial environment. Sterilization can be achieved by applying heat, chemicals, irradiation / radiation, high pressure, filtration, or a combination thereof. Chemical sterilization includes sterilization with gases such as ethylene oxide, hydrogen peroxide gas, and ozone, such as chlorine bleach, iodine, glutaraldehyde and formaldehyde, o-phthalaldehyde (OPA), hydrogen peroxide, peracetic acid, sodium hydroxide, silver, and cobalt liquids. Radiation sterilization includes the use of radiation, such as electron beams, x-rays, gamma rays, or subatomic particles.

[0037] Embodiments of the present disclosure relate to a package comprising a syringe surrounded by a package, wherein the package contains features for opening the package with only one hand while maintaining the sterility of the syringe. In one or more embodiments, removing a medical device from the package is less cumbersome than removing a medical device from a conventional package. In one or more embodiments, the package is a flow wrap package.

[0038] Reference now Figure 5A -C, one embodiment of the present disclosure relates to a packaged medical device 100, which includes a medical device 190 contained in a package 110. In one or more embodiments, the package 110 includes a film 104 surrounding the medical device 190, the film 104 is sealed at a first end 101 and a second end 102 and defines a shell 113, the shell includes a front side 110F, a back side 110B, a first end 101, a second end 102, a first edge 111, and a second edge, and the film 104 has a tear strength.

[0039] The package 110 further includes a tearable feature 120 selected from at least one of a notch and a perforation 122 at a location on one of the first edge 111 and the second edge 112 and adjacent to the first end 101, the tearable feature 120 reducing the tear strength of the film 104 at the location of the tearable feature 120. The package 110 further includes a gripping feature formed in the film 104 between the first end 101 and the tearable feature 120, the gripping feature being configured to allow a user to apply sufficient tearing force using a finger, thumb, or one end of a tool to cause the tearable feature 120 to tear the first end 101 of the package 110 and move away from the second end 102 of the package 110 and expose the medical device 190 for use using only one hand.

[0040] In one or more embodiments, the medical device 190 includes a syringe as shown, and in some embodiments, the syringe 12 is sterile. In one or more embodiments, the gripping feature 130 is selected from the group consisting of a raised area 130R in the film 104 and an opening 132 through the film 104. The thickness of the raised area 130R is such that the height h of the raised area 130R (in Figure 5B ) is greater than the thickness t of the film 104. In one or more embodiments, the packaging material comprises low density polyethylene having a thickness in the range of 30 to 40 microns, and the film is wrapped around the medical device using a flow wrap process.

[0041] In some embodiments, the height of the raised area 130R is 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 20 times greater than the thickness t of the film 104. The height of the raised area 130R should provide sufficient strength for the gripping feature 130 so that when a user applies a pulling force on the gripping feature 130, the film 104 tears at the tearable feature 120, so that the first end 101 of the package 110 can be torn at the tearable feature to expose the medical device 190 to be removed from the package 110. In some embodiments of the packaged medical device 100, the gripping feature includes a raised area 130R in the film 104, the raised area 130R having a height h greater than the thickness t of the film 104 and providing a surface to allow the user to apply sufficient tearing force to tear the package 110 to allow the medical device 190 to be removed from the package 110.

[0042] In one or more embodiments, the gripping feature 130 includes an opening 132 through the membrane 104. Figure 5A In the embodiment shown in -C, the opening 132 is circular in shape. However, the shape of the opening 132 is not limited to a circular shape. Figures 8A-8E Alternative embodiments are shown as non-limiting examples of alternative shapes. Fig. 8A and 8C In FIG. 1 , the opening 132 is in the shape of a circle including a narrowed top surface 132 e. Figure 8B In the embodiment, the opening 132 is circular or has a circular shape. Fig.8D and 8E In FIG. 1 , the opening 132 is an elliptical shape having a concave bottom surface 132 b, thereby providing an irregularly shaped opening.

[0043] In some embodiments, the raised area 130R includes a reinforcement member surrounding the opening 132, the height h of the reinforcement member is greater than the thickness of the film 104 surrounding the opening, and the tear strength of the reinforcement member is greater than the tear strength of the film 104. According to one or more embodiments, the tear strength of the reinforcement member is at least 1.5 times, at least 2 times, at least 3 times, at least 4 times, at least 5 times, at least 6 times, at least 7 times, at least 8 times, at least 9 times, at least 10 times, or at least 20 times the tear strength of the film 104. The tear strength of the reinforcement member should provide sufficient strength so that when a user applies a pulling force on the reinforcement member, the film 104 is torn at the tearable feature 120, so that the first end 101 of the package 110 can be torn at the tearable feature to expose the medical device 190 to be removed from the package 110.

[0044] In one or more embodiments, the front side 110F of the housing 113 includes an inner surface 110i in contact with the medical device 190 and an outer surface opposite to the inner surface of the front side 110F, and the rear side 110B of the housing 113 includes an inner surface in contact with the medical device 190 and an outer surface 110o opposite to the inner surface of the rear side 110B. In one or more embodiments, the tearable feature 120 includes a notch 120n and a perforation 122.

[0045] In some embodiments, the notch 120 n is u-shaped, and in some embodiments, the notch 120 n is v-shaped, as shown. In one or more embodiments, the housing 113 includes a flow-wrapped membrane 104 .

[0046] Fig. 6A An alternative embodiment of a packaged medical device 100 is shown that includes a package 110 containing a medical device in which a gripping feature 130 in the form of an opening is not located centrally between the first edge 111 and the second edge (as shown in FIG. 5A ), but is positioned closer to the first edge 111 . Figure 6B An alternative embodiment of a packaged medical device 100 is shown, which includes a package 110 containing a medical device, wherein the gripping feature 130 in the form of an opening is not located centrally between the first edge 11 and the second edge (eg, Figure 5A ), but is positioned closer to the first edge 111. In addition, the opening 132 is elliptical in shape.

[0047] Reference now Figure 7 In an exemplary embodiment, the inner diameter of the opening 132 through the membrane 104 is 20 mm or greater, or Figure 7 The opening size allows the opening 132 to be sized so that a user's finger or thumb having an average thumb or finger size can be inserted through the opening 132, or a tool having a hook can be inserted through the opening 132. Figure 7 In FIG. 1 , for an overall package width W of 30 mm, the notch has a depth of 5 mm. Figure 7 Other exemplary dimensions are shown, including an overall package width W of 60 mm ( Figure 7The width of the notch is shown to be 5 mm, and the distance from the edge of the notch to the center is 25 mm, and the total package width W will be 2×30 mm). Angle θ is the angle between a line extending from the top of the opening 132 to the edge of the notch and a diameter line of a circle extending vertically from the top of the opening 132. In one or more embodiments, the tear strength at the tearable feature 120 is greater than 0.1 Newton and less than or equal to 1.3 Newton. Taking into account the presence of two layers of film 104, the total tear strength of the package 110 is 2.6 Newtons or less. When the thumb is extended away from the index finger, the thumb of an average user can apply a force of 9.7 Newtons. Therefore, when the thumb is extended away from the index finger, the thumb force acting on the notch V is equal to Fcosθ=7.46 Newtons, which is sufficient to tear the package at the tearable feature 120. In one or more embodiments, the width of the notch 102n is such that the force to tear the package open is less than 9.7 Newtons.

[0048] In one or more embodiments, the packaged medical device 100 includes a stretchable web 133 attached to an opening 132 through the film 104 (at Figure 8B and 8C ). The stretchable web 133 is configured to allow a user to insert a finger, thumb, or one end of a tool into the opening 132, and to limit the finger, thumb, or one end of the tool from piercing the stretchable web, and to allow the user to apply sufficient tearing force and tear the first end 101 of the package 110 with only one hand and move away from the second end 102 of the package 110. In other words, the stretchable web 133 has puncture resistance and strength to prevent the user's finger or thumb from being entangled in the opening, and the stretchable web allows the user to apply a tearing force to tear the first end away from the package 110 so as to expose the medical device 190 and allow the medical device 190 to be removed from the package 110.

[0049] Fig.13A and 13B Examples of tools 250 and 260 are shown, which can be used to insert into the opening 132 to tear the package 110 open so as to remove the medical device 190. Fig.13A In the embodiment of the present invention, tool 25 includes hook 252 and mounting member 254, which allows the tool to be mounted to a wall surface of a room, or a bed or wall surface of an ambulance, and the tool can be conveniently placed in the patient treatment area. Similarly, tool 260 includes hook 252 and mounting member 254, which allows the tool to be mounted for use. Alternatively, the hook can be placed on an IV bag pole. The hook provides leverage when the user grasps the package and tears the top of the package at the tearable feature.

[0050] Thus, one aspect of the present disclosure encompasses a system comprising a packaged medical device 100 as described herein and a hook tool ( 250 or 260 ) configured to engage the gripping feature 130 .

[0051] Reference now Fig.14 , a method 300 for packaging a medical device 190 in a package 110 includes surrounding the medical device 190 with a film 104 at operation 301, and sealing the film at a first end 101 and a second end 102 to define a housing 113, the housing including a front side 110F, a back side 120B, a first end 101, a second end 102, a first edge 111, and a second edge 112, the film 104 having a tear strength. At operation 302, the method 300 involves including in the film 104 at least one of a notch 120n and a perforation 122 at a location adjacent to the first end 101 on one of the first edge 111 and the second edge 112, the tear feature 120 reducing the tear strength of the film at the location of the tear feature 120. At operation 303, the method includes forming a gripping feature 130 between the first end 101 and the feature 120 that can be torn apart in the film 104, and the gripping feature 130 is configured to allow the user to apply enough tearing force using one end of a finger, thumb or tool, so that the feature 120 that can be torn apart with only one hand will tear the first end 101 of the package 110 and move away from the second end 102 of the package 110 and expose the medical device 190 for use. In some embodiments, at operation 304, the method includes forming a reinforcement feature that surrounds the gripping feature. Therefore, in some embodiments of method 300, the gripping feature 130 includes at least one of the raised area in the film and the opening through the film, and the method also includes sealing one of the first edge and the second edge. In some embodiments of method 300, the gripping feature includes the raised area in the film, and the raised area has a thickness greater than the thickness of the film and provides a surface that allows the user to apply enough tearing force. In some embodiments of the method, the gripping feature includes an opening through the film, and the opening extends through the front side and the back side.

[0052] In embodiments of the method comprising a reinforcement member surrounding the opening, the thickness or height of the reinforcement member is greater than the thickness of the film surrounding the opening, and the tear strength of the reinforcement member is greater than the tear strength of the film. In one or more embodiments, the method comprises a flow wrap process, and the housing comprises a flow wrap film. In some embodiments, the opening in the film 104 has an inner diameter of 20 mm or greater.

[0053] Some embodiments of the method include attaching a stretchable web to an opening through a film, wherein the stretchable web is configured to allow a user to insert a finger, thumb, or end of a tool into the opening and to restrict the finger, thumb, or end of the tool from penetrating the stretchable web and allowing the user to apply sufficient tearing force to tear a first end of a package and move away from a second end of the package using only one hand.

[0054] In some embodiments, the film 104 is a flow wrap film. Flow wrap (also known as fin seal wrapping, horizontal bagging, or pillow bag wrapping) is a fast and economical packaging method. In the flow wrap process, the medical device passes through a flow wrap machine, which precisely places the polymer-based packaging film 104 around the medical device and seals the package 110. The flow wrap contains three unique seals, including two crimps at both ends (the first end 101 has a seal 101s and the second end 102 has a seal 102s) and a longitudinal fin seal extending along the back of the package or along one edge (the first edge 111 contains a seal 111s, however, the second edge 112 can have a seal without the first edge 111 being sealed). It should be understood that the unsealed edge (in the illustrated embodiment, the second edge 112) is simply folded and wrapped around the medical device 190.

[0055] Flow wrapping machines have various forms, and flow wrapping machines usually include feed conveyor belts, film feed components, forming areas, and discharge areas. Medical devices are usually placed on feed conveyor belts, which transport products to the forming area. At the forming area, the machine wraps a layer of sealing material around the product, wherein the two outer edges of the material are matched at the bottom. Then, the edges of the matching pass through a pair of rotating fin sealing wheels, which utilize heat, pressure, or a combination of the two to form a longitudinal seal. Then, the packaged medical device 109 moves through a series of rotating cutting heads or end seal crimping machines, and the front and rear ends of the sealed products separate the adjacent products into separate packages simultaneously. After the process, the machine delivers the packaged medical device to the discharge area, where they are piled up for storage or further packaging.

[0056] Flow wrapping is primarily performed via a horizontal or vertical process. As the name implies, vertical flow wrapping packages the medical device vertically, and horizontal flow wrapping wraps the product horizontally.

[0057] In a particular embodiment of the manufacturing method, the medical device 190 (such as a syringe) and the reinforcement are pre-manufactured and enter as raw material input for packaging and are placed at a predetermined position on the conveyor belt using a separator. According to the current process, a roll of laminated material enters and is placed on a roller. The laminated material is placed above and below each unit in a line. Adhesive is placed on the laminated material section where the reinforcement is located, and the reinforcement is sealed to the film 104. The opening 133 passes through the film 104. Then, each package is cut into a predetermined length, and a notch is added in an additional notch cutting process. In some embodiments comprising a stretchable web, the stretchable web comprises a thin LDPE film, which is attached to the reinforcement using an adhesive or heat sealing process. Alternatively, the stretchable web may include any other plastic or rubber that meets the requirements of opening the package and preventing the user's thumb or fingers from being entangled.

[0058] Fig. 9 and Fig.10 An example of a user opening a package 110 using a single hand 200 is shown. Fig. 9 , the user grasps the package 110 in the hand, wrapping the user's fingers 220 around the package 110 to firmly grasp the package 110 in the hand 200. Then, in the starting position, the user's thumb 210 is shown at 210s, and the user inserts their thumb into the opening 135 and moves the thumb away from the grasped portion of the package, where the thumb is shown in the finished position 210f. Fig.10 The user is shown grasping the package 110 and placing an index finger 220 in the opening 135 of the package.

[0059] Fig. 12A -D shows another embodiment of the opening sequence of the package 110. Fig. 12A In FIG. 1 , the user places the package 110 in the user's hand 200 , wherein the package 110 enclosing the medical device 190 is grasped between the thumb 210 and the finger 220 . Fig. 12B In FIG. 12 , the user (e.g., a medical practitioner) inserts thumb 210 into opening 135 of package 110, wherein package 110 is firmly grasped in the user's hand. In FIG. 12 , the user applies upward force on the opening with thumb 210 until the top of package 110 tears away from the rest of the package. Fig.12D In FIG. 1 , the medical device 190 has been exposed and can be removed from the packaging.

[0060] Only opening the package 110 with one hand is less troublesome for the medical practitioner, and enables the medical practitioner to complete other tasks with his / her other hand. Therefore, the present disclosure provides significant progress relative to the current practice of medical device packaging. The current practice for opening the package requires the participation of two hands. This practice presents a series of challenges of its own (for example, for nursing staff or emergency medical technicians or nurses) in an emergency, and there may be time constraints or spatial challenges or both in an emergency. In this case, the one-handed operation used to open the package provides simple and fast access to the product. The packaging that can be opened with one hand allows users (such as medical practitioners) to do other things with their other hand simultaneously. In one or more embodiments, packaging and medical devices can be sterilized and / or be sterile.

[0061] Although the present disclosure includes descriptions of specific embodiments, it should be understood that these embodiments are only used to illustrate the principles and applications of the present disclosure. Therefore, it should be understood that various modifications can be made to the illustrative embodiments and other arrangements can be designed without departing from the spirit and scope of the disclosed present disclosure.

Claims

1. A packaged medical device comprising: A medical device contained in a package, the package comprising: a film surrounding the medical device, the film sealed at a first end and a second end and defining a housing including a front side, a back side, a first end, a second end, a first edge, and a second edge, the film having a tear strength; a tearable feature 120 selected from at least one of a notch and a perforation at a location on one of the first edge and the second edge and adjacent to the first end, the tearable feature reducing the tear strength of the film at the location of the tearable feature; and A gripping feature formed in the film between the first end and the tearable feature, the gripping feature being configured to allow a user to apply sufficient tearing force using a finger, thumb, or end of a tool to cause the tearable feature to tear the first end of the package and move away from the second end of the package and expose the medical device for access for use using only one hand.

2. The packaged medical device according to claim 1, wherein: The medical device includes a syringe 190 .

3. The packaged medical device of claim 2, wherein: The gripping feature includes at least one of a raised area in the membrane and an opening through the membrane.

4. The packaged medical device of claim 3, wherein: The gripping feature comprises a raised area in the film having a height greater than the thickness of the film and providing a surface that allows a user to apply sufficient tearing force.

5. The packaged medical device of claim 3, wherein: The gripping feature includes an opening through the membrane.

6. The packaged medical device of claim 5, wherein: The opening has a circular shape.

7. The packaged medical device of claim 5, wherein: The opening has an oval shape.

8. The packaged medical device of claim 5, wherein: The opening has an irregular shape.

9. The packaged medical device of claim 5, further comprising a reinforcement member surrounding the opening, the reinforcement member having a height greater than a thickness of the film surrounding the opening, the reinforcement member having a tear strength greater than a tear strength of the film.

10. The packaged medical device of claim 1, wherein: The front side of the housing includes an inner surface in contact with the medical device and an outer surface opposite to the inner surface of the front side, and the rear side of the housing includes an inner surface in contact with the medical device and an outer surface opposite to the inner surface of the rear side.

11. The packaged medical device of claim 10, wherein: The tearable features include both notches and perforations.

12. The packaged medical device of claim 11, wherein: The notch is U-shaped.

13. The packaged medical device of claim 11, wherein: The notch is V-shaped.

14. The packaged medical device of claim 2, wherein: The housing includes a flow wrap membrane.

15. The packaged medical device of claim 5, wherein: The opening through the membrane has an inner diameter of 20 mm or more.

16. The packaged medical device of claim 9, further comprising a stretchable web attached to the opening through the membrane, wherein the stretchable web is configured to allow a user to insert a finger, thumb, or end of a tool into the opening and to restrict the finger, thumb, or end of the tool from piercing the stretchable web and to allow the user to apply sufficient tearing force with only one hand to tear the first end of the package and move away from the second end of the package.

17. A system comprising: The packaged medical device according to claim 1; as well as A hook-shaped tool is configured to engage the gripping feature.

18. A method of packaging a medical device, the method comprising: surrounding the medical device with a film and sealing the film at a first end and a second end to define a housing including a front side, a back side, a first end, a second end, a first edge, and a second edge, the film having a tear strength; a tearable feature comprising at least one of a notch and a perforation in the film at a location on one of the first edge and the second edge and adjacent to the first end, the tearable feature reducing the tear strength of the film at the location of the tearable feature; as well as A gripping feature is formed in the film between the first end and the tearable feature, the gripping feature being configured to allow a user to apply sufficient tearing force using a finger, thumb, or end of a tool to cause the tearable feature to tear one end of the package and move away from the second end of the package and expose the medical device for access for use using only one hand.

19. The method according to claim 18, wherein: The medical device comprises a syringe.

20. The method according to claim 19, wherein: The gripping feature includes at least one of a raised area in the film and an opening through the film, and the method further includes sealing one of the first edge and the second edge.

21. The method according to claim 20, wherein: The gripping feature comprises a raised area in the film having a height greater than the thickness of the film and providing a surface that allows a user to apply sufficient tearing force.

22. The method according to claim 21, wherein: The gripping feature includes an opening through the membrane, the opening extending through the front side and the back side.

23. The method according to claim 22, further comprising including a reinforcement member surrounding the opening, the reinforcement member having a height greater than a thickness of the film surrounding the opening, the reinforcement member having a tear strength greater than a tear strength of the film.

24. The method according to claim 18, wherein: The front side of the housing includes an inner surface in contact with the medical device and an outer surface opposite to the inner surface of the front side, and the rear side of the housing includes an inner surface in contact with the medical device and an outer surface opposite to the inner surface of the rear side.

25. The method according to claim 24, wherein: The tearable features include both notches and perforations.

26. The method of claim 19, wherein: The housing includes a flow wrap membrane.

27. The method according to claim 23, wherein: The opening through the membrane has an inner diameter of 20 mm or more.

28. The method of claim 27, further comprising attaching a stretchable web to the opening through the film, wherein the stretchable web is configured to allow a user to insert a finger, thumb, or one end of a tool into the opening and to restrict the finger, thumb, or one end of the tool from piercing the stretchable web and to allow the user to apply sufficient tearing force to tear the first end of the package and move away from the second end of the package using only one hand.

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