AUTOCLAVE SELF-DESTRUCTING MEDICAL DEVICES

Abstract

Single use medical devices that incorporate one or more destruct elements configured to deform during an autoclave cycle, rendering the device visually damaged or unusable. The use of such destruct elements prevents reuse (knowingly or unwittingly) of single use devices on patients after off-label autoclaving.

Description

FIELD

The present disclosure is directed to single-use medical devices and implements (hereafter “devices”). More specifically, the present disclosure is directed to single-use medical devices that, when subjected to autoclave processing for potential reuse, deform, destruct and/or provide a visual indication that the devices are not reusable.

BACKGROUND

Historically, medical devices, such as those utilized in surgery (e.g., scalpels, forceps, spreaders, scrapers, etc.) were reusable. That is, the devices were intended to be re-sterilized/decontaminated and reused after a medical procedure. Such re-sterilization has advanced over time from simply immersing the devices or tools in alcohol to the current practice of autoclave sterilization. In the latter regard, medical devices are inserted into an autoclave chamber where they are subjected to elevated temperatures, pressures and, commonly, steam. By way of example, many autoclaves used for sterilizing medical devices subject those devices to pressurized saturated steam at approximately 121° C. (250° F.) for around 15-20 minutes depending on the size of the load and the contents.

While autoclave sterilization is an industry accepted means for cleaning reusable medical devices, the process is not always one-hundred percent effective. That is, in some cases bacteria, pathogens or other contaminants survive the autoclave process. This is more common for devices that have internal passageways where such contaminants may be partially protected during the autoclave process. The inability to fully sterilize reusable devices can result in infection risks, when utilized with subsequent patients. Accordingly, there has been an ongoing shift in the medical field to single-use medical devices. Such devices are designed to be utilized once in a hospital or clinic and then disposed. In this regard, single-use devices are often delivered in sterilized packages, which are opened shortly before or during a medical procedure. In such an arrangement, no sterilization is required before use. Such single-use devices are intended to eliminate re-sterilization problems sometimes encountered by reusable medical devices. To ensure the single-use devices are not reused, manufacturers often put a single-use labels and warnings on the packaging and/or ISO symbols on the medical device itself alerting medical professionals that the device should be disposed after use.

BRIEF SUMMARY OF THE DISCLOSURE

The present inventor(s) has recognized that many single use devices (SUDs) are erroneously reused. By way of example, during surgery, it is common for all devices or tools used during surgery be placed in a bucket or tray after use. In many instances, reusable devices and SUDs may be comingled. If SUDs are comingled with reusable devices, the SUDs may be erroneously re-sterilized in an autoclave and reused. Further, SUDs may be purposely re-sterilized as a cost saving measure. However, as SUDs are not designed for reuse, operating parts of re-sterilized SUDS can be dull, loose, bent or otherwise out of calibration after autoclaving. The presented systems and methods prevent such unintentional or other off-label reuse of SUDS on patients.

In an arrangement, a destruct element (e.g., thermally deformable element) is incorporated into a SUD that deforms during autoclaving. Most commonly, at least a portion of the destruct element has a melting point below an autoclaving process temperature. That is, the destruct element has a low melting point of less than about 250° F., less than about 230° F. or even less than about 180° F. When subjected to autoclave processing temperatures, the destruct element deforms. Such deformation may provide a visual and/or tactile indication that the device is damaged and not intended for reuse. Size shape and color of the destruct element may be chosen to improve visual discernability. In some arrangements, deformation of the destruct element may prevent operation of a functioning or moving component(s) of the SUD. In any arrangement, a subsequent user of the device has in indication that the SUD has been unintentionally autoclaved in an off-label attempt to sterilize the SUD and that the SUD should not be utilized with a patient.

In an embodiment, a destruct element is disposed on a handle of a SUD. In such an embodiment, the destruct element may provide a visual or tactile indication that the SUD has improperly been exposed to an autoclave process.

In an embodiment, one or more destruct elements form or are disposed against a moving element of a SUD. Such SUDS may include, without limitation, retractable surgical knives and swiveling awls. In such embodiments, the destruct element(s) may prevent ordinary movement of the SUD once the SUD has been exposed to an autoclave process.

The foregoing and other aspects, features, details, utilities, and advantages of the present disclosure will be apparent from reading the following description and claims, and from reviewing the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate perspective and exploded perspective views, respectively of a single use medical device with a destruct element in accordance with the present disclosure.

FIGS. 2A and 2B illustrate side views of the single use medical device of FIGS. 1A and 1B before and after an autoclaving process.

FIG. 3A illustrates a perspective view of another single use medical device with a destruct element in accordance with the present disclosure.

FIG. 3B illustrates a top view of a handle of the single use medical device of FIG. 3A,

FIG. 3C illustrates a cross-sectional view of the handle of FIG. 3B.

FIG. 3D illustrates a close-up cross-sectional view of an actuator assembly of the single use medical device of FIG. 3A.

FIG. 4A illustrates another single use medical device with a destruct element in accordance with the present disclosure.

FIG. 4B illustrates the destruct element of the device of FIG. 4A after autoclaving.

FIGS. 5A and 5B illustrate another single use medical device with a destruct element in accordance with the present disclosure.

FIGS. 6A and 6B illustrate another single use medical device with a destruct element in accordance with the present disclosure.

DETAILED DESCRIPTION

Reference will now be made to the accompanying drawings, which at least assist in illustrating the various pertinent features of the presented inventions. The following description is presented for purposes of illustration and description and is not intended to limit the inventions to the forms disclosed herein. Consequently, variations and modifications commensurate with the following teachings, and skill and knowledge of the relevant art, are within the scope of the presented inventions. The embodiments described herein are further intended to explain the best modes known of practicing the inventions and to enable others skilled in the art to utilize the inventions in such, or other embodiments and with various modifications required by the particular application(s) or use(s) of the presented inventions.

Broadly, the present disclosure is directed to single-use medical devices (SUDS) that are configured to deform (e.g., destruct) if re-sterilized in an autoclave process. Generally, each SUD includes a destruct element (e.g., thermally deformable element) that deforms in response to elevated temperatures present during autoclaving. Typically, at least a portion of the destruct element is formed of a material having a melting point below an autoclaving process temperature. That is, at least a portion the destruct element is made of a material having a melting point of less than about 250° F., less than about 230° F. or even less than about 180° F. When subjected to elevated temperature, during an autoclave processing, the destruct element deforms. Preferably, the destruct element grossly deforms. In this regard, materials having a melting point that is significantly less than the autoclaving temperature (e.g., at least 20° F.) may be preferred. However, this is not a requirement. Such deformation may provide a visual indication that the device is damaged and should not be used with a patient. In some arrangements, such deformation may prevent operation of a functioning or moving component(s) of the SUD. In any arrangement, a subsequent user of the device has an indication that the SUD has been unintentionally autoclaved in an off-label attempt to sterilize the SUD and that the SUD should not be utilized with a patient.

FIGS. 1A and 1B illustrate perspective and exploded perspective views, respectively, of one embodiment of a handle 12 of a single use medical device or SUD 10 that includes a destruct element 20. The illustrated SUD 10 does not include a medical implement which may be inserted within a cylindrical recess/aperture 14 formed within a forward/distal end of the handle 12 or otherwise attached to the handle. As will be appreciated, such a handle 12 could be utilized to support a variety of medical implements including, without limitation, retractors, scrapers, etc. Further, the handles of various differently configured SUDS provide a convenient location for incorporating a destruct element as discussed herein. Though presented in an embodiment as incorporating a destruct element on or within a handle of a SUD, the present disclosure is not limited to this location and destruct elements may be incorporated on other portions of a SUD. In the illustrated embodiment, the handle 12 includes a cylindrical recess 16 formed within its rearward/proximal end. In this embodiment, the destruct element 20 is formed with a mating cylindrical end 22 that fits within the cylindrical recess 16. When attached to the handle 12, the destruct element 20 may form a smooth uniform cap (e.g., generally hemispherical, domed, cylindrical, etc.) on the rearward end of the handle 12.

FIGS. 2A and 2B illustrate side views of the handle 12 before and after autoclaving, respectively. As illustrated in FIG. 2A, prior to autoclaving, the destruct element 20 may have a uniform shape on the proximal end of the handle 12. FIG. 2B illustrates a deformed destruct element 20 on the proximal end of the handle 1. That is, FIG. 2B illustrates the destruct element 20 after an elevated temperature is applied during an autoclaving process. As illustrated, the destruct element 20 at least partially deforms when exposed to temperatures above its melting point. In contrast, the handle 12 may be formed of a material having a melting point above autoclaving temperatures. Accordingly, the handle 12 may not experience deformation during the autoclaving process. Likewise, a medical implement attached to the handle (e.g., a metallic implement) would not experience deformation during the autoclaving process. However, due to the deformation of the destruct element 20, a subsequent user of the SUD 10 would have at least a visual indication that the SUD 10 is damaged and should not be re-used.

FIG. 3A illustrates an exploded perspective view of an exemplary single-use retractable surgical knife 30. The retractable surgical knife 30 is a SUD that incorporates one or more destruct elements. In the illustrated embodiment, one or more destruct elements may prevent movement of a component of the SUD after exposure to autoclaving temperatures. As illustrated, the knife 30 includes a blade 32 attached to a distal end of a blade shaft 34. The rearward/proximal end of the blade shaft 34 connects to a slider 36, which can slide linearly within an interior of a handle 38 of the knife 30. When assembled, the blade shaft 34 is disposed within the interior of a hollow shaft 40, which connects to a distal end of the handle 38. Advancement of the slider 36 toward the forward or distal end of the handle 38 advances the blade shaft 34 such that blade 32 extends beyond the distal end of the hollow shaft 40. Likewise, retraction of the slider 36 toward the rearward or proximal end of the handle 38 retracts the blade shaft 34 such that the blade 32 is disposed within an interior of the hollow shaft 40.

FIGS. 3B and 3C illustrates a top view of the handle 38 and a cross-sectional view of the handle taken along a centerline plane A-A′ of the handle, respectively. FIG. 3D illustrates an expanded view of a portion of FIG. 3C. As variously illustrated in FIGS. 3A-3D, a thumb actuator 42 connects to the slider 36, when the slider 36 is disposed within the interior of the handle 38. A user can manipulate the thumb actuator 42 to advance or retract the slider 36 and thereby advance or retract the blade 32. In the illustrated embodiment, studs 44 on the bottom of the thumb actuator 42 extend through a slot 46 in a sidewall of the handle 38 to engage the slider 36. More specifically, the studs 44 extend through the slot and engage mating openings 37 formed into the sider 36. In addition, a biasing pin 48 has a lower end disposed in an opening 39 in the slider 36 and an upper end that engages a bottom surface of the thumb actuator 42. A spring 50 is disposed in the opening 39 below a central collar of the biasing pin 48 and a lower end of the opening in the slider. Collectively, the biasing pin 48 and spring 50 require a user to depress the thumb actuator 42 prior to advancing or retracting the slider 36. However, it will be appreciated that a simple friction slider could be utilized. In addition to the above-noted components, the exemplary knife also includes a distal ferrule 52 on a forward end of the handle 38, which connects the hollow shaft 40 to the handle 38, and a rearward ferrule or cap 54 one a rearward end of the handle 38.

In the illustrated embodiment of the retractable surgical knife 30, various components may be thermally deformable elements (e.g., destruct elements). For instance, the slider 36, thumb actuator 42 and/or the biasing pin 48 may be formed of a material having a low melting point (e.g., below an autoclaving temperature). Accordingly, when subjected to elevated temperatures during autoclaving that exceed the melting point of these component, the components may deform. In the case of the slider 36, thumb actuator 42 and biasing pin 48, such deformation may prevent operation of the retractable knife 30. That is, such deformation may prevent the advancement and retraction of the blade 32 rendering the retractable knife 30 inoperable. For instance, the slider 36 may be a thermally deformable element that may melt to and, for example, adhere to the interior of the handle 38 preventing movement of the blade 32 once the slider 36 has re-solidified (e.g., after cooling). Likewise, additional thermally deformable components may melt and adhere to adjacent components. For instance, the actuator 42 may melt and adhere to the handle 38 and the biasing pin 48 may melt into and adhere with the spring 50. Stated otherwise, one or more components may at least partially melt together and/or adhere to adjacent components preventing subsequent movement. In addition, the knife 30 may include one or more destruct elements that provide a visual indication that the knife has been re-sterilized. For instance, the distal ferrule 52 and/or the proximal ferrule/cap 54 may be formed of a low melting point material that deform during an autoclaving process like the destruct element discussed in FIG. 2B.

FIGS. 4A and 4B illustrate another embodiment of a handle 62 of a SUD 60, which may support any of a variety of medical implements. As above, such a medical implement may be inserted within a cylindrical recess/aperture 64 formed within a forward or distal end of the handle 62 or otherwise attached to the handle. In this embodiment, the SUD 60 includes two side plates 66a, 66b (hereafter 66 unless specifically referenced), which are destruct elements. The plates 66 are formed of a material having a low melting point (e.g., below an autoclaving temperature). As illustrated, the side plates 66 may be attached to the handle 62 utilizing, for example, screws. However, other fasteners may be utilized. To ensure that the side plates 66 (e.g., destruct elements) deform during an autoclaving process, one or more biasing elements 70 (e.g., springs) are secured below the plates 66, when the plates are attached to the handle 62. As illustrated, the biasing elements 70 are coil springs (e.g., compression springs). However, other biasing elements may be utilized (leaf springs, torsion springs, elastomeric blocks, etc.). The biasing elements are partially disposed within recessed openings 68 formed in the handle 62. The biasing elements 70 are compressed when the plates 66 are attached to the handle (not shown). The biasing elements 70 apply an expansive force between the handle 62 and a bottom surface of the plate 66, when the plate is affixed to the handle 62. Prior to experiencing elevated temperatures, the side plates 66 have sufficient rigidity to maintain compression of the biasing elements 70. Once exposed to elevated temperatures during autoclaving (e.g., temperatures above the melting point of the plates 66), the biasing elements 70 may deform the plates 66 (e.g., destruct elements) or even protrude through the surface of the plates 66 as illustrated in FIG. 4B. In either arrangement, a user grasping the handle 62 will have a tactile indication as well as a visual indication that the SUD 60 should not be utilized.

Though discussed above as utilizing a destruct element that deforms in response to elevated temperatures, it will be appreciated that the destruct element may be any component that provides an indication that the SUD should not be reused after exposure to elevated temperatures. FIGS. 5A and 5B illustrate one embodiment of a SUD 80 that utilizes a heat sensitive pop-up indicator 90 as a destruct element. The SUD 80 is again illustrated as a handle 82 that may support any of a variety of medical implements. In this embodiment, the pop-up indicator 90 is at least partially disposed in a recessed opening 86 formed in the proximal end of the handle 82. The pop-up indicator has a biasing pin 92 that includes a lower end disposed within the recessed opening and an upper end, which in the illustrated embodiment, is connected to a plate 96. The biasing pin also includes a central collar 94 having a cross-dimension (e.g., diameter) that is greater than the cross-dimension of the lower end of the pin 92. A biasing element 98 (e.g., coil spring), is disposed between the collar 94 and the bottom end of the recessed opening 86 of the handle 82. Prior to experiencing elevated temperatures, the lower end of the biasing pin 90 is disposed within a rigid potting material 100 and the biasing element is compressed between the collar and the bottom end of the recessed opening. The potting material 100 is made of a material having a low melting point (e.g., below an autoclaving temperature). Accordingly, upon being subjected to elevated temperatures during an autoclaving process, the potting material 100 softens or melts (e.g., deforms) releasing the lower end of the biasing pin 92. Once the potting material softens or melts, the compressed spring 98 expands and lifts the plate 96 above the proximal surface of the handle 82. As above, this provides a visual indication that the SUD should not be re-used. Though illustrated as being placed in the rearward end of the handle, it will be appreciated that the pop-up indicator could be placed at other locations including locations where a user grips the handle 82.

FIGS. 6A and 6B illustrate another SUD 120 in accordance with the present disclosure. In the illustrated embodiment, the SUD 120 is a medical awl having a moveable or swivel end. As illustrated, the SUD 120 includes a handle or shaft 122 a user may grasp to position an awl 132 connected to a forward or distal end of the shaft 122. As best illustrated in FIG. 6B, the awl 132 attaches to the shaft via a housing 130 that that engages a hemispherical ball 124 that is attachable to the distal end of the shaft 122. In the illustrated embodiment, the housing 130 is a generally cylindrical and at least partially hollow element that receives a rearward or proximal end of the awl 132 within its forward or distal end. A first pin 131 may be utilized to connect the awl 132 to the housing 130. Other connection mechanisms are possible. A rearward or proximal end of the housing 130 includes an opening (not shown) that is sized to receive the ball 124 connected to the distal end of the shaft 122. Once the ball 124 is disposed within the housing 130, a second pin 129 passes through the housing 130 and through an aperture 123 extending through the ball 124 to movably connect the housing 130 and awl 132 to the shaft 122.

The aperture 123 extending through the ball 124 is elongated, which allows the housing 130 and attached awl 132 to pivot about the end of the shaft 122 in at least first and second axes. A friction bearing 126 (hereafter “bearing”) and spring 128 provide friction between the housing 130 and the ball 124. More specifically, when assembled, the spring 128 and a generally cylindrical bearing 126 are disposed within the housing 130 such that a proximal end of the bearing 126 is compressed against an outside surface of the ball 124 by the spring 128, which is itself compressed between a distal end of the bearing 126 and an inside surface (not shown) of the housing 130. Once assembled, the friction of the bearing 126 on the outside surface of the ball 124 provides resistance to movement, which allows positioning the awl 132 at a desired angle.

The bearing 126 is a thermally deformable destruct element in accordance with the present disclosure. That is, the bearing 126 has a low melting point of less than about 250° F., less than about 230° F. or even less than about 180° F. When subjected to autoclave processing temperatures, the bearing (e.g., destruct element) deforms or partially melts. Once the bearing 126 has sufficiently softened during an autoclave sanitation process, the spring 128 helps deform the bearing 126 by pushing it into the ball 124. In response to the pressure exerted by the spring 128, the bearing deforms into the functional swivel area (e.g., ball 124 and aperture 123, housing 130 and pin 129). Further, the spring 128 may become disposed within the distal end of the bearing 126. After an autoclaving process and the bearing material has re-solidifies (e.g., once cooled), the awl SUD 120 is inoperable. This is, due to the deformation of the bearing 126 during autoclaving into the functional swivel area, the housing 130 and awl 132 retain a fixed position relative to the shaft.

As noted above, the destruct elements are made of a material having a melting point that is less than a standard medical autoclaving temperature of approximately 121° C. or 250° F. A variety of materials may be utilized so long as those materials can be sterilized prior to the first use of a SUD (e.g., where such sterilization is by means other than elevated temperatures). Most commonly, the destruct material is a polymer. However, this is not a requirement. In one embodiment, the destruct material is Polycaprolactone (PCL), a biodegradable polyester with a low melting point of around 140° F. (60° C.). In another embodiment, paraffin wax may be utilized as the destruct material. Paraffin wax has a low melting point of approximately 154° F. In a further embodiment, the destruct material is a low-density polyethylene having a melting point of less that about 200° F. (90° C.). In a yet further embodiment, the destruct material is Polyethylene Glycol (PEG), which has a melting point of less than about 144° F. (62° C.). In various embodiments, the destruct material may be a material that acts similar to an adhesive when softened or melted. For example, various polymers may become sticky when softened/melted. Such materials tend to adhere to adjacent components when softened/melted. Once cooled (e.g., after autoclaving) such materials effectively bond to adjacent components thereby preventing movement of these components. Other materials are possible and considered within the scope of the present disclosure.

All directional references (e.g., distal, proximal, upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the any aspect of the disclosure. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.

Claims

1. A single use medical device, comprising: a medical implement, at least a portion of the medical implement formed of a material having a melting point of greater than an autoclaving temperature of 250° F.; anda thermally deformable destruct element attached to the medical implement, wherein the thermally deformable destruct element is formed of a material having a melting point of less than 230° F., wherein the thermally deformable destruct element at least partially deforms when exposed to the temperatures in excess of 230° F. during an autoclaving process.

2. The device of claim 1, wherein the thermally deformable destruct element has a melting point of less than about 200° F.

3. The device of claim 2, wherein the thermally deformable destruct element has a melting point of less than about 180° F.

3. The device of claim 1, wherein the medical implement includes: at least one moving component configured to move between at least first and second position;wherein the thermally deformable destruct element is in direct contact with at least one moving component, wherein the thermally deformable destruct element allows the moving component to move prior to partial deformation and prevents the moving element from moving after partial deformation.

4. The device of claim 1, further comprising: a handle, wherein the medical implement is connected to the handle and the thermally deformable destruct element is attached to the handle.

5. The device of claim 1, wherein the thermally deformable destruct element is a polymer material.

6. The device of claim 1, wherein the thermally deformable destruct element comprises: an indicator configured to move from a first position to a second position;a potting material having the melting point of less than 230° F., wherein a portion of the indicator is disposed in potting material in the first position; anda bias force element compressed between the indicator and the potting material, wherein the bias form member is configured to move the indicator from the first position to the second position upon the potting material softening in response to an elevated temperature above the melting point of the potting material.

7. The device of claim 1, further comprising: a bias force element, wherein the thermally deformable destruct element at least partially biases the bias force element prior to exposure to the autoclaving temperature and wherein the bias force element at least partially expands when exposed to the autoclaving temperature deforming the thermally deformable destruct element.

8. A single use medical device, comprising: a handle;a medical implement attached to the handle; anda thermally deformable destruct element attached to the handle or the medical implement, wherein the thermally deformable destruct element is made of a material having a melting point of less than an autoclaving sterilization temperature, wherein the thermally deformable destruct element at least partially deforms when exposed to the autoclaving sterilization temperature.

9. The device of claim 8, further comprising: a movable part for moving the medical implement between a first position and a second position.

10. The device of claim 9, wherein the thermally deformable destruct element is in direct contact with or forms a portion of the movable part, wherein deformation of the thermally deformable destruct element prevents the movable part from moving between the first position and the second position.

11. The device of 9, further comprising: a bias force element, wherein the thermally deformable destruct element at least partially biases the bias force element prior to the autoclaving process and wherein the bias force element at least partially expands when the thermally deformable destruct element is exposed to the autoclaving sterilization temperature thereby deforming the thermally deformable destruct element.

12. The device of claim 11, wherein: the bias force element is disposed in a recessed opening in the handle; andthe thermally deformable destruct element is disposed over the recessed opening.

13. The device of claim 9, wherein the thermally deformable destruct element is a first thermally deformable destruct element, further comprising: at least a second thermally deformable destruct element made of a material having a melting point of less than the autoclaving sterilization temperature, wherein the second thermally deformable destruct element at least partially deforms when exposed to the autoclaving sterilization temperature and wherein the first thermally deformable destruct element and the second thermally deformable destruct element at least partially melt together when exposed to the autoclaving sterilization temperature.

14. A single use retractable surgical knife, comprising: a handle;a blade;a slider movably connected to the handle, wherein the slider is configured to move between a first position and a second position relative to the handle, wherein a proximal end of the blade is connected to the slider; anda thermally deformable destruct element made of a material having a melting point of less than an autoclaving sterilization temperature, wherein the thermally deformable destruct element at least partially deforms when exposed to the autoclaving sterilization temperature, wherein partial deformation prevents movement of the slider between the first position and the second position.

15. The device of claim 14, further comprising: an actuator connected to the slider, wherein a user engages the actuator to move the slider between the first position and the second position,wherein at least one of the actuator and the slider is the thermally deformable destruct element.

16. The device of claim 15, wherein at least one of the actuator and the slider adhere to an adjacent component when exposed to the autoclaving sterilization temperature.

17. A process for use with a single-use medical device, comprising: attaching a thermally deformable destruct element having a melting point that is less than an autoclaving sterilization temperature to a single use medical device;exposing the single use medical device to an autoclaving sterilization process where the autoclaving sterilization temperature of the autoclaving sterilization process exceeds the melting point of the thermally deformable destruct element, wherein the thermally deformable destruct material at least partially deforms to provide at least one of: a visual indication the single use medical device has been exposed to the autoclaving sterilization process;a tactile indication the single use medical device has been exposed to the autoclaving sterilization process; andadherence of a first component of the single use medical device to a second component of the single use medical device, wherein the adherence prevents movement of a movable part of the single use medical device.

18. The process of claim 17, wherein the autoclaving sterilization temperature of the autoclaving sterilization process exceeds the melting point by at least 20° F.

19. The process of claim 17, wherein the autoclaving sterilization temperature of the autoclaving sterilization process exceeds the melting point by at least 40° F.

20. The process of claim 17, wherein exposing the single use medical device to an autoclaving sterilization process allows a bias force element to at least partially deform the thermally deformable destruct element.

21. A single use medical awl, comprising: a shaft having a proximal end and a distal end;a swivel housing attached to a hemispherical ball disposed on the distal end of the shaft, wherein the swivel housing is able to pivot relative the ball about at least a first axis;a friction bearing disposed within the housing, wherein the bearing is made of a material having a melting point of less than an autoclaving sterilization temperature, wherein the bearing at least partially deforms when exposed to the autoclaving sterilization temperature;a spring disposed within the housing, wherein the spring compresses the friction bearing against an outside surface of the ball; andan awl attached to a distal end of the housing.

22. The single use medical awl of claim 21, wherein upon being exposed to the autoclaving sterilization temperature, the friction bearing prevents movement of the housing relative to the ball.