Abstract:
A color coded garment and color coded bedding can be used in a medical setting to identify the location of a medical procedure to take place. A medical patient would wear a specific color coded garment that identifies, through color, the location of a medical procedure to take place. The medical patient&#39;s bedding would also reflect this location using a similar color coded identification mechanism. The combination of the two (garment and bedding) provide unmistakable visual indicia that will help limit or reduce wrong site medical procedures.

Description:
CLAIM OF PRIORITY 
       [0001]    This application claims the priority of U.S. application Ser. No. 62/051,985 filed on Sep. 18, 2014, the contents of which are fully incorporated herein by reference. 
     
    
     FIELD OF THE EMBODIMENTS 
       [0002]    This invention and its embodiments relate to garments and bedding for use in medical environments, namely medical procedures including surgical procedures. In particular, the present invention and its embodiments relate to a color identification and warning system that is prominently displayed on both the patient&#39;s garments and bedding to increase situational awareness of medical facility staff and limit or prevent wrong site medical procedures. 
       BACKGROUND OF THE EMBODIMENTS 
       [0003]    Wrong site surgery is generally defined as an operation or medical procedure performed on the wrong part of the body of a medical patient. Under this definition, there are a number of types of wrong site medical procedures, namely surgeries. For example, surgery performed on the incorrect side of a body of a medical patient, surgery performed on the correct side of the body of a medical patient but at the wrong site (body area), and an incorrect operation performed on the correct side and correct location of the medical patient. 
         [0004]    It is estimated that as many as 40 wrong site surgeries occur each week in this country alone, however, there is limited information as to the exact number of such occurrences due to underreporting by doctors and hospitals. Regardless, this is a very serious matter than can have disastrous outcomes including permanent disfigurement or even the death of a medical patient. 
         [0005]    As such, there have been numerous attempts to remedy the frequency of these occurrences, but these attempts have resulted in little to no impact on the number of such incidents. One such remedy is to have the medical patient and physician mark the site to be subjected to a medical procedure. Another potential remedy involves thorough checklist(s) with a planned “time out” that occurs before the surgery or medical procedure. In this “time out” period, the name, charts, and surgery site (amongst other variables) of the medical patient are to be reviewed. However, these checklists are often only partially performed or performed incorrectly by the medical professionals. 
         [0006]    One major problem plaguing surgical rooms and exacerbating the number of wrong site medical procedures is the lack of a universal standard for prevention of such occurrences. Currently, different medical facilities and establishments follow similar, but not identical guidelines. Further, as mentioned above, there are often breakdowns in these processes. In some instances, time constraints result in rushed or incomplete medical patient assessments and the aforementioned “time outs.” Additionally, similar medical patient names, short hand notation used by hospital staff, and the involvement of multiple individuals all contribute to the lack of cohesion that can result in a wrong site surgery or other medical procedure. 
         [0007]    Thus, there is a need for a simple, yet effective, solution to drastically limit or prevent wrong site surgeries. Such a solution should further be cost-effective and relatively simplistic in nature in order to enable any medical facility or establishment to readily implement the changes necessary to meet these needs. The present invention and its embodiments meet and exceed these objectives. 
       Review of Related Technology: 
       [0008]    U.S. Pat. No. 8,371,306 pertains to a surgical drape and system/method of using a surgical drape having a fenestration to be placed over a surgical site of a medical patient. The surgical drape includes a barrier removably attached to the surgical drape and adapted for placement over a portion of the fenestration to prevent the start of the surgical procedure. Upon verification of a set of predetermined conditions, the barrier is removed by a member of the surgical staff in order to begin the surgical procedure. 
         [0009]    U.S. Pat. No. 7,802,313 pertains to a disposable surgical gown having a neck binding that includes a visual indicator to identify the barrier protection level associated with the disposable surgical gown. In particular, the disposable surgical gown has a neck binding that is color-coded for identifying the barrier protection level associated with the disposable surgical gown for protecting against penetration of body fluids and infectious materials. Also disclosed is a disposable surgical drape having a visual indicator, such as color-coding, to identify the barrier protection level associated with the disposable surgical drape. A surgical kit includes the disposable surgical gown and/or disposable surgical drape having visual indicators, such as color-coding, to identify the barrier protection level. The surgical kit may include other items to be used in a surgical setting which may also have visual indicators, such as color-coding, to identify the barrier protection level associated with the disposable surgical gown and/or disposable surgical drape. 
         [0010]    Various devices are known in the art. However, their structure and means of operation are substantially different from the present disclosure. The other inventions also fail to solve all the problems taught by the present disclosure. The present invention and its embodiments provide for a garment and/or bedding that is used to quickly identify the site of a medical procedure to be performed on medical patient using visual indicia. At least one embodiment of this invention is presented in the drawings below and will be described in more detail herein. 
       SUMMARY OF THE EMBODIMENTS 
       [0011]    A medical site identification kit is described and taught having a garment with a color coded identification system, wherein a first color signifies a body area of the medical patient that is subject to a medical procedure and a second color signifies a body area of a medical patient that is a neutral site; at least one layer of fabric for covering a bed and employing a color coded identification system, wherein a first color signifies a body area of a medical patient that is subject to a medical procedure and a second color signifies a body area of a medical patient that a neutral site and wherein there is at least one visual indicia on the at least one layer of fabric; and wherein the position of the site subject to a medical procedure identified on the at least one color coded garment corresponds to the position of the site subject to a medical procedure identified on the at least one color coded layer of fabric. 
         [0012]    In at least one embodiment, the neutral site color is red and the medical procedure site is green. To further reinforce the color scheme, a visual indicia is applied to the medical procedure site side of the bedding or bed covering. For example, the word “yes” may appear on the green side (side of body subject to a medical procedure) which lets a medical patient and medical professional alike know that this is unmistakably the correct side for which the medical procedure is to be performed. 
         [0013]    The garment bears the same color pattern as the bedding which may be the same or different as the red/green color scheme described above. Further the garment may cover the head, neck, torso, arms, hands, legs, feet, or any combination thereof. 
         [0014]    In another aspect of the present invention, there is a method of identifying a medical procedure site, the method having the steps of: identifying a location of at least one medical procedure site on a medical patient; selecting a color coded garment and a color coded bedding combination, wherein the color coded garment and the color coded bedding have a coloration pattern that identifies the location of the medical procedure site; and placing the color coded garment on the medical patient in the correct orientation and the color coded bedding on a bed in the correct orientation. The method may further comprising the step of confirming the correct orientation of the color coded garment and the color coded bedding. 
         [0015]    In the above described methodology, the orientation of the color coded garment is confirmed by establishing the coloration pattern identifies the correct location of a medical procedure site, and the orientation of the color coded bedding is confirmed by establishing the coloration pattern identifies the correct location of a medical procedure site. Further, the color coded bedding may be confirmed to have the correct orientation by establishing the correct orientation and/or location of the visual indicia present on the bedding. 
         [0016]    In general, the present invention succeeds in conferring the following, and others not mentioned, benefits and objectives. 
         [0017]    It is an object of the present invention to provide a medical site identification kit that limits or prevents wrong site surgeries. 
         [0018]    It is an object of the present invention to provide a medical site identification kit that uses an identification system that identifies the left or right side of a medical patient&#39;s body that is subject to a medical procedure. 
         [0019]    It is an object of the present invention to provide a medical site identification kit that is cost effective for medical facilities and establishments. 
         [0020]    It is an object of the present invention to provide a medical site identification kit that can be used for sterile procedures including surgeries. It is an object of the present invention to provide a medical site identification kit that can identify a variety of positions relative to the medical patient&#39;s body. 
         [0021]    It is an object of the present invention to provide a medical site identification kit that creates a universal standard for use in medical facilities and the like to unitize the prevention of medical mishaps. 
         [0022]    It is another object of the present invention to provide a medical site identification kit that may be reusable. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]      FIG. 1A  is a front view of a color coded garment and bedding for a supine right side medical procedure. 
           [0024]      FIG. 1B  is a front view of a color coded garment and bedding for a prone right side medical procedure. 
           [0025]      FIG. 2A  is a front view of a color coded garment and bedding for a supine left side medical procedure. 
           [0026]      FIG. 2B  is a front view of a color coded garment and bedding for a prone left side medical procedure. 
           [0027]      FIG. 3  is a perspective view of a medical patient on a bed with the medical patient wearing a supine left side medical procedure garment and the bed having the correct bedding or fabric covering placed thereon. 
           [0028]      FIG. 4  is a flowchart illustrating an overview of a method of employing the present invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0029]    The preferred embodiments of the present invention will now be described with reference to the drawings. Identical elements in the various figures are identified with the same reference numerals. 
         [0030]    Reference will now be made in detail to each embodiment of the present invention. Such embodiments are provided by way of explanation of the present invention, which is not intended to be limited thereto. In fact, those of ordinary skill in the art may appreciate upon reading the present specification and viewing the present drawings that various modifications and variations can be made thereto. 
         [0031]    Referring now to  FIGS. 1A-2B , there is a garment  100  and a bed covering  115  displaying multiple color schemes and combinations of such schemes. Generally, the garment  100  as shown has a color identification system, however, other symbols, characters, words, phrases and the like may be used singularly or in any combination. In a preferred embodiment, the color identification system is used to signify the location of a medical procedure and the location of a neutral site or non-medical procedure site. 
         [0032]    As used herein a “medical procedure site” is a location on a body, preferably mammalian, that is subject to an invasive or non-invasive medical procedure to be performed with the intent of determining, measuring, diagnosing, or treating a condition associated with a subject or medical patient. 
         [0033]    As used herein a “neutral site” is a location on a body, preferably mammalian, that is not subject to an invasive or non-invasive medical procedure to be performed with the intent of determining, measuring, diagnosing, or treating a condition associated with a subject or medical patient. 
         [0034]    The garment  100  may have a trim  111  that extends around a periphery of the garment  100 . This trim  111  contains the color identification system which preferably has at least two colors. The two colors, a first color  105  and a second color  110  are used to determine the side of a body, either left or right, that is subject to a medical procedure. Each of the first color  105  and the second color  110  are disposed on either side of the midline (M) of the garment  100 . 
         [0035]    Typically a first color  105  is a color that signifies that side of the body is subject to a medical procedure. As such, the color used is preferably green to signify “go” or “ok” thus verifying in the affirmative the side of the body subject to a medical procedure. Typically a second color  110  is a color that signifies the side of the body that is a neutral site. As such, the color used is preferably red to signify “stop” or “danger” thus alerting any individual that the side is not subject to a medical procedure. 
         [0036]    The garment  100  may be a standard hospital gown given to medical patients during their stay or in preparation of a medical procedure. Further, the garment  100  may be any garment employing the principles described herein and may cover any of the head, neck, facial region, torso, arms, legs, hands, feet, or any combination thereof. For example, two arm sleeves bearing the color identification system could be used with one arm sleeve having a first color  105  and the other arm sleeve having a second color  110 . Thus, in some instances, the garment  100  may not be a unitary item but may comprise multiple parts that can be applied to multiple areas of the body of the medical patient simultaneously. 
         [0037]    A bed covering or bedding  115  is used in conjunction with the garment  100  in order to complete a medical site identification system. The bed covering  115  comprises at last one layer of color coded fabric, and the color coding preferably matches that of the garment  100 . The bed covering  115  may be sized to cover a particular size bed (i.e. twin, queen, etc.) or may be sized to only partially cover the bed. The bed covering  115  is preferably divided into two halves down the midline (M′) of the covering. This creates a two section bed covering with one section having a first color  120  and a second section having a second color  125 . The first color  120  corresponds to a side of the body that is a site subject to a medical procedure and the second color  125  corresponds to a side of the body that is a neutral site. 
         [0038]    On the side of the bed covering  115  having a first color  120 , there may be at least one visual indicia  130  disposed on the at least one layer of fabric. This visual indicia  130  may be any form of warning including characters, words, images and the like or any combination thereof. As shown, the visual indicia  130  is the word “yes” which further signifies that this is the correct side of the body for the medical procedure to be performed. Additionally, this visual indicia  130  supplies a visual indication that not only is the correct side identified, but that the bed covering  115  is oriented correctly. The visual indicia  130  must have the correct orientation to be read, viewed, etc. from the foot of the bed with the visual indicia  130  present at the foot of the bed as well (see  FIG. 3 ). 
         [0039]    Thus, the garment  100  and bed covering  115  shown in  FIG. 1A  are positioned from the point of the wearer to be positioned in a supine position. In turn, the garment  100  and bed covering  115  in  FIG. 1A  signify a medical procedure that is to be performed on the right side of a body. However, in  FIG. 1B  the bed covering  115  has an opposite orientation. The bed covering  115 , as shown, has a first color  120  and visual indicia  130  on the opposite side of the midline (M′) when compared to that shown in  FIG. 1A . The garment  100 , however, still has the same color layout as shown in  FIG. 1A . Here, in  FIG. 1B , the garment  100  and bed covering  115  are for a medical patient who is going to receive a medical procedure on the right side of their body but must be in a prone position in order to do so. A prone position is when a medical patient is laid face down on a medical procedure or operating table. Such a position may be used in orthopaedic procedures on the spine. 
         [0040]    In  FIG. 2A , the opposite color identification schema (as opposed to  FIG. 1A ) is laid out. The garment  100  has the first color  105  identifying a site subject to a medical procedure on the left side (medical patient facing outwards) with the second color  110  identifying a neutral site on the right side of the garment  100 , the color scheme being divided down the midline (M) of the garment  100 . 
         [0041]    The bed covering  115  bears the same color scheme as the garment  100  with the first color  120  and visual indicia  130  on the left side (if the medical patient were laying in supine position on bed covering  115 ) and the second color  125  on the right side of the bed covering  115 . The bed covering  115  being divided into the two colors down the midline (M′). 
         [0042]    Referring now to  FIG. 2B , the garment  100  has a first color  105  identifying a medical procedure site on one side of the medical patient&#39;s body and the second color  110  identifying a neutral site on the other side of the garment. When the medical patient, in this case, is positioned in a prone position, the first color  105  of the garment  100  will overlay the first color  120  of the bed covering  115 . The second color  110  of the garment  100  will overlay the second color  125  of the bed covering  115 . 
         [0043]    Further, the visual indicia  130  verifies the correct side on which the medical procedure is going to be performed by indicating “yes.” Thus, the position necessitated by the medical procedure should always have the first color  105  and the second color  110  of the trim  111  of the garment  100  aligned and matching the same color of the bed covering  115 . This ensures that the correct body position and correct body side will be subjected to a medical procedure. 
         [0044]    The principles exemplified in  FIGS. 1A-2B  are clearly illustrated in  FIG. 3 . Referring now to  FIG. 3 , there is a medical patient  150  positioned on a bed  140 . The medical patient  150  has a garment  100  as described above in  FIGS. 1A-2B . The garment  100  has a trim  111  with a first color  105  and a second color  110 . The first color  105  identifies the side of the medical patient&#39;s body that is subject to a medical procedure, whereas the second color  110  identifies the side of the body that is a neutral site. 
         [0045]    The medical patient  150  is laying in a supine position over a bed covering or bedding  115  in accordance with an embodiment of the present invention. The bed covering  115  has a first color  120  and a second color  125 . The first color  120  of the bed covering  115  matches the first color  105  of the garment  100 . The second color  125  of the bed covering  115  matches the second color  110  of the garment  100 . Thus, it is clear that the medical patient  150  is subject to a medical procedure to occur on the left side of their body. This is reinforced by the visual indicia  130  present on the bed covering  115 . The “yes” marking verifies that this is the correct side. If the medical patient  150  is having a hand operation, given both the color scheme of the garment  100  and the bed covering  115  the staff can be assured the hand operation is to occur on the left hand rather than the right hand. 
         [0046]    Referring to  FIG. 4 , there is a flowchart illustrating a method  200  of verifying that the correct garment  100  and bed covering  115 , as shown in  FIG. 3 , is used to correctly identify a site of a medical procedure to take place on a medical patient&#39;s body. 
         [0047]    Generally speaking, a medical patient, when arriving at a medical facility such as a hospital or surgical center, the medical patient must first check in. This verifies the medical patient is at the facility and the facility can begin the prepping phase. Typically a nurse or practitioner will come out after some time and greet the patient and take them to begin the pre-procedure prepping process. 
         [0048]    In a step  205 , the nurse or practitioner identifies (verifies) the side of the medical patient&#39;s body for the medical procedure to take place. The nurse or practitioner may ask the patient which side of the body is the medical procedure to be performed and compare the medical patient&#39;s response with their medical records. 
         [0049]    In a step  210 , the correct garment and bedding combination is selected. The nurse or practitioner may provide the medical patient with a variety of prepackaged garment and bedding combinations asking the medical patient to select the correct garment/bedding combination. 
         [0050]    There may be numerous combinations of garments/bedding but exemplary combinations should be right side medical procedure, left side medical procedure, right side prone medical procedure, and left side prone medical procedure or any combination thereof. The nurse or practitioner may also have to inform the medical patient whether they will be placed in a supine or prone position. The medical patient should then select a garment/bedding combination package and verify with the nurse or practitioner the correct combination has been selected. 
         [0051]    In step  215 , the medical patient puts on the garment and the nurse or practitioner places the bedding on the bed. Further, the placement of the garment and the bedding may be performed wholly or in part by either the medical patient or nurse or practitioner. 
         [0052]    In a step  220 , once the patient has the garment on, both the medical patient and the nurse or practitioner verify the garment is on in the correct orientation and the correct garment has been selected. The nurse or practitioner can then verify and sign off on the verification of the proper garment selection. The medical patient can then do the same. The nurse or practitioner can then have the patient lie down in the correct position on the bed. 
         [0053]    The nurse or practitioner can observe, as well as the medical patient, whether the color scheme of the garment and the bedding align with one another. It should be visually apparent that the colors on each side of the midline of the garment and the bedding align and match one another. If this is not the case, the method  200  should be restarted to ensure accuracy. Once the medical procedure is to begin, the staff will still perform any and all other protocol including “time out” procedures to further ensure the medical patient&#39;s identity, the medical procedure to be performed, and the nature of the medical procedure. 
         [0054]    Although this invention has been described with a certain degree of particularity, it is to be understood that the present disclosure has been made only by way of illustration and that numerous changes in the details of construction and arrangement of parts may be resorted to without departing from the spirit and the scope of the invention.