Abstract:
The present invention relates to a kit and method for the storage and transportation of medical equipment, in particular endoscopes. A method of storing medical equipment, using a kit comprising a bag made from a flexible plastics material, a first closure device for securing the bag closed and a second closure device for securing the bag closed, comprises: a) placing an item of medical equipment in a first, clean state within the bag; b) securing the bag closed with the first closure device; c) removing the first closure device; d) removing the medical equipment from the bag for use; e) placing said used medical equipment, in a second, dirty state, in the bag; and f) securing the bag closed with the second closure device, such that the bag is sealed to retain moisture within the bag.

Description:
BACKGROUND 
       [0001]    a. Field of the Invention 
         [0002]    The present invention relates to a kit for the storage and transportation of medical equipment. In particular, the present invention relates to a single-use storage device for endoscopes. 
         [0003]    b. Related Art 
         [0004]    Flexible medical endoscopes are used for the internal examination of various parts of the human or animal body. They are produced in diameters ranging from 0.02 to 0.6 inches (0.5 to 15 mm) and with lengths of 12 to 120 inches (300 to 3000 mm). The majority of endoscopes have internal channels, down which air, water or accessories may be directed so as to facilitate examinations, or to carry out surgical procedures. 
         [0005]    Due to the invasive nature of many of the procedures for which flexible medical endoscopes are used, it is necessary that the endoscopes and all the detachable parts and components such as the valves are thoroughly cleaned and disinfected prior to and after each use. It is desirable if the room in which the cleaning and disinfection are carried out is in close proximity to the operating theatre or procedure room; however, this is often not the situation and as a result, endoscopes are frequently carried over reasonably long distances both prior to and after being used on a patient. 
         [0006]    At least in the United Kingdom and France, the recent BSE (Bovine Spongiform Encephalopathy) crisis has led to heightened concerns that the human form, Creutzfeldt-Jakob Disease (CJD), may be transmitted by contaminated endoscopes or their detachable parts. Moreover, the recent re-emergence of tuberculosis also presents a threat of airborne contamination in areas where endoscopes are being used and transported. 
         [0007]    Several national and international clinical guidelines regarding the use, storage and cleaning of endoscopes have recently been published. These include:
   National Endoscopy Programme Decontamination Standards for Flexible Endoscopes, updated March 2009, L. Thomson et al.   Multisociety Guideline on Reprocessing Flexible GI Endoscopes, 2011, Bret T. Petersen et al.   ESGE ESGENA guideline, Cleaning and disinfection in gastrointestinal endoscopy, update 2008, U. Beilenhoff et al.   Department of health Choice Framework for local Policy and Procedures 01-06—Decontamination of flexible endoscopes: Operational management manual 13536: 1.0: England.   
 
         [0012]    Many of the current methods of carrying endoscopes are unsatisfactory for a number of reasons including:
       limited protection of the endoscope against accidental damage or contamination;   limited protection for users against contamination and possible infection from a used endoscope; and   limited protection for clean endoscopes against cross-contamination from used endoscopes or other potentially contaminated surfaces.       
 
         [0016]    Furthermore, to reduce the possibility of cross-contamination and to allow accurate records to be kept regarding how and when the endoscope has been used, it is necessary to keep full traceability records. 
         [0017]    It is an object of the present invention, therefore, to provide an improved means and method of storing and transporting medical equipment such as endoscopes. 
       SUMMARY OF THE INVENTION 
       [0018]    According to the invention there is provided a method of storing medical equipment using a kit comprising a bag made from a flexible plastics material, a first closure device for securing the bag closed and a second closure device for securing the bag closed, the method comprising: 
         [0000]    a) placing an item of medical equipment in a first, clean state within the bag;
 
b) securing the bag closed with the first closure device;
 
c) removing the first closure device;
 
d) removing the medical equipment from the bag for use;
 
e) placing said used medical equipment, in a second, dirty state, in the bag; and
 
f) securing the bag closed with the second closure device, such that the bag is sealed to retain moisture within the bag.
 
         [0019]    Preferably the first and second closure devices are single use and the step of removing the first closure device comprises breaking the first closure device. 
         [0020]    In preferred embodiments of the invention the first closure device comprises a distinguishing means and an identification means, and the second closure device comprises a distinguishing means and an identification means, the distinguishing means of the first and second closure devices being different. The identification means is used to identify and trace the item of medical equipment and, as such, the method preferably further comprises associating the identification means of the first and second closure devices with the item of medical equipment to enable identification of said medical equipment when it is sealed within the bag. 
         [0021]    In some embodiments the kit further comprises a sheet of absorbent material, and the method preferably comprises placing the sheet of absorbent material into the bag before placing the item of medical equipment in the bag. The absorbent material can, therefore, absorb any liquid on the surface of the piece of medical equipment. Typically the sheet of absorbent material will be placed into the bag before the item of used medical equipment is placed in the bag 
         [0022]    Preferably the closure devices are cable ties. In embodiments in which the closure devices are cable ties and the cable ties each include a tab portion, the step of removing the first closure device preferably comprises pulling the tab portion so as to break the cable tie. This enables the closure device to be removed from the bag without needing to cut the closure device. 
         [0023]    Typically the item of medical equipment is an endoscope. 
         [0024]    Also according to the present invention there is provided a kit for the storage of medical equipment, the kit comprising:
       a bag made from a flexible plastics material;   a first closure device for securing the bag closed, the closure device being single use and the closure device having a distinguishing means and an identification means; and   a second closure device for securing the bag closed, the closure device being single use and the closure device having a distinguishing means and an identification means,   wherein, the distinguishing means of the first and second closure devices are different.       
 
         [0029]    Typically a single piece of medical equipment or a piece of medical equipment together with its accessories will be stored and transported within the bag. The closure devices are used to seal the bag closed and the distinguishing means are used to indicate whether the contents of the bag are clean or dirty. The distinguishing means may comprise lettering on a part of each of the first and second closure devices. 
         [0030]    Preferably the identification means of the first and second closure devices are interrelated. More preferably, and in order to uniquely identify the piece of medical equipment stored within the bag, the identification means of the first and second closure devices are identical to enable traceability of the medical equipment during use. 
         [0031]    For ease of use and cost effectiveness the first and second closure devices are preferably cable ties. However, to prevent the need to cut the cable ties to remove them from the bag, the cable ties preferably each include a tab portion, the tab portion being arranged such that, in use, a force applied to the tab portion breaks the cable tie. 
         [0032]    It is advantageous if the bag has a rectangular base to allow the medical equipment to be more easily placed within the bag while the bag is supported on an appropriate surface. Additionally, the kit may further comprise a sheet of absorbent material, which can be laid in the base of the bag prior to the medical equipment. 
         [0033]    In preferred embodiments, all of part of the kit is sterilised before use. 
         [0034]    The invention also provides an assembly comprising:
       a bag made from a flexible plastics material;   first and second closure devices for securing the bag closed, the closure devices each being single use and the closure devices each having a distinguishing means and an identification means, the distinguishing means of the first and second closure devices being different; and   a piece of medical equipment contained within the bag;   wherein, one of the first and second closure devices is secured around the bag to seal the bag closed.       
 
         [0039]    The assembly is primarily designed for applications in which the piece of medical equipment comprises an endoscope; however, the piece of medical equipment may be any suitable medical equipment they may be contained within the bag. 
         [0040]    Preferably the identification means of the first and second closure devices are interrelated. More preferably, and in order to uniquely identify the piece of medical equipment stored within the bag, the identification means of the first and second closure devices are identical to enable traceability of the medical equipment during use. The distinguishing means are typically used to indicate whether the contents of the bag are clean or dirty, and the distinguishing means preferably comprises lettering on a part of each of the first and second closure devices. 
         [0041]    For ease of use the first and second closure devices are preferably cable ties. However, to prevent the need to cut the cable ties to remove them from the bag, the cable ties preferably each include a tab portion, the tab portion being arranged such that, in use, a force applied to the tab portion breaks the cable tie. 
         [0042]    It is advantageous if the bag has a rectangular base. Additionally the assembly may further comprise a sheet of absorbent material positioned in the bag for absorbing moisture from the piece of medical equipment. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0043]    The invention will now be further described, by way of example only, and with reference to the accompanying drawings, in which: 
           [0044]      FIG. 1  shows a storage kit for medical equipment according to an embodiment of the present invention; the kit being in use with an endoscope and a first closure device placed within a storage bag; 
           [0045]      FIG. 2  shows the storage bag of  FIG. 1  secured closed with a second closure device; 
           [0046]      FIG. 3  shows a pair of closure devices according to an embodiment of the present invention; and 
           [0047]      FIG. 4  shows a part of the two closure devices of  FIG. 3 , with the closure devices separated for use. 
       
    
    
     DETAILED DESCRIPTION 
       [0048]    The kit  10  and method of the present invention is designed to provide an easy and cost effective storage means for enclosing and transporting medical equipment, such as endoscopes. 
         [0049]    The kit  10  comprises a storage bag  12  that is made from a flexible plastics material. The material of the bag  12  preferably has sufficient barrier properties so as to be able to retain moisture within the bag  12  when the bag is closed. The plastics material is preferably food-grade plastic. Additionally, the bag  12  is resistant to cleaning and sterilisation fluids to which it may be exposed during cleaning and processing of the medical equipment. In this example, the plastics material is transparent so that the contents of the bag  12  can be seen at all times; however, in other embodiments the bag  12  may be printed with graphics or text, which may include warning symbols and/or instructions for use. 
         [0050]    The bag  12  has a rectangular or square base  14 , facilitating placement of the bag  12  on a supporting surface and facilitating the placement of medical equipment, for example an endoscope  16 , into the bottom of the bag  12 . In this example, the bag base  14  has dimensions of about 100 cm×50 cm; however, in other embodiments the bag  12  may be of any suitable size. 
         [0051]    The kit  10  further includes two closure devices  18 ,  20 , which are each single use. The closure devices  18 ,  20  are used to seal the bag  12  closed and permit the identification of the medical equipment held within the bag  12 . 
         [0052]    In this example, the closure devices  18 ,  20  are cable ties  18 ,  20  having a head portion  22 ,  22 ′ and a tail portion  24 ,  24 ′. The tail portion  24 ,  24 ′ includes engagement means  26  which, in use, engage with corresponding engagement means  28  in the head portion  22 ,  22 ′. The engagement means  26 ,  28  are arranged such that the tail portion  24 ,  24 ′ can be engaged with the head portion  22 ,  22 ′ so as to form a closed loop in the cable tie  18 ,  20 , but the tail portion  24 ,  24 ′ cannot be disengaged from the head portion  22 ,  22 ′ without permanently disabling or breaking the cable tie  18 ,  20 , as described further below. In this way, the engagement means  26 ,  28  forms a one-way locking means and the closure devices  18 ,  20  are single use. 
         [0053]    In this embodiment, the engagement means  26  of the tail portion  24 ,  24 ′ is in the form of a series of protrusions or barbs and the engagement means  28  of the head portion  22 ,  22 ′ is in the form of a slot including a detent feature. The protrusions on the tail portion  24 ,  24 ′ are shaped such that they can be pushed through the slot in a first direction but cannot be withdrawn from the slot in an opposing direction, due to the engagement of the protrusions with the detent. 
         [0054]      FIGS. 3 and 4  illustrate one embodiment of a closure device  18 ,  20  having a ‘break to open’ feature. Each cable tie  18 ,  20  includes a tab portion  30  that is located between the head portion  22 ,  22 ′ and the tail portion  24 ,  24 ′ of the cable tie  18 ,  20 . The tab portion  30  includes a grip portion  32  suitable for gripping between a thumb and finger of a user of the kit  10 . The tab portion  30  further includes a line of weakness  34  in the form of a thinner section of plastics material that spans the width of the cable tie  18 ,  20 . The tab portion  30  is designed such that, as a user pulls the grip portion  32 , the cable tie  18 ,  20  tears along the line of weakness  34  thereby breaking the cable tie  18 ,  20  such that the cable tie  18 ,  20  cannot be used again. In some embodiments the line of weakness  34  may be provided by a line of perforations. 
         [0055]    Each of the cable ties  18 ,  20  also includes distinguishing means  36  to enable the cable ties  18 ,  20  to be distinguished from each other. In some embodiments the distinguishing means  36  are in the form of colours, with one of the cable ties  18  being red and the other cable tie  20  being green. In other embodiments, the distinguishing means  36  may additionally or alternatively include symbols, lettering or numbers to enable the two cable ties  18 ,  20 , or other closure devices, to be distinguished. For example, the head portion  22 ′ of one of the cable ties  20  may include the word CLEAN and the head portion  22  of the other cable tie  18  may include the word DIRTY. This is illustrated in the embodiment shown in  FIGS. 3 and 4 . 
         [0056]    Furthermore, each of the cable ties  18 ,  20  includes associated or interrelated identification means (not shown). This identification means allows identification and traceability of the medical equipment held within the bag  12 . The identification means may comprise a unique serial number, a barcode or other suitable means to identify the specific piece of medical equipment. The identification means on each of the two cable ties  18 ,  20  may be identical, or the identification means may be interrelated, for example including consecutive or related serial numbers (e.g. 123456A and 123456B). The use of interrelated identification means permits the piece of medical equipment to be identified and the state of the equipment to be determined, e.g. clean or dirty. The cable ties  18 ,  20  may, optionally, include means for identifying or recording a time at which the medical equipment is placed into the bag  12 . 
         [0057]    The ability to uniquely identify the medical equipment held within the bag  12  and to determine the state of the equipment is particularly important for endoscopes, as it is a requirement to record each step of the cleaning and decontamination cycle of the endoscope. 
         [0058]    In this example, before use, the two closure devices  18 ,  20  are joined together so as to form a unique pair. The two closure devices  18 ,  20  are preferably joined along only a part of their length, such that the closure devices  18 ,  20  are easily separated.  FIG. 3  shows two such closure devices  18 ,  20  in the form of cable ties  18 ,  20 , as previously described. In this example the head portions  22 ,  22 ′ of the cable ties  18 ,  20  are joined along their length by a weakened and thinner section  38  of plastics material. This weakened joint  38  between the two cable ties  18 ,  20  may be easily broken by hand by a user of the kit  10  so that the two cable ties  18 ,  20  are separated for use. In other embodiments, the weakened joint may be formed by a line of perforations between the two cable ties  18 ,  20 . The advantage of the two closure devices  18 ,  20  being joined in this way before use is that they remain as a unique pair. This enables suitable identification means, as described above, to be pre-applied to the closure devices. In other embodiments the two closure devices  18 ,  20  may be provided separately before use. 
         [0059]    The use of the kit  10  will now be described in relation to the storage and transportation of an endoscope  16 . 
         [0060]    The kit  10  is designed to initially be used to store a cleaned endoscope  16  ready for use. The storage bag  12  is opened such that the endoscope  16  may be placed inside without coming into contact with the outside surface of the bag  12 . In a preferred embodiment, the base  14  of the bag  12  is placed within a suitably sized tray  40  and the sides of the bag  12  are folded or rolled down so that they cover the sides of the tray  40 . The endoscope  16  is then laid within the bag  12  in the base of the tray  40 . This is illustrated in  FIG. 1 . Optionally, a sheet or pad of absorbent material may be placed within the bag  12  prior to the endoscope  16 . This absorbent layer acts to absorb any moisture from the endoscope  16  and also provides a layer of protection while the endoscope  16  is stored within the bag  12 . 
         [0061]    The pair of closure devices  18 ,  20  is separated, and a first one  18  of the two closure devices  18 ,  20  is placed within the bag  12  together with the clean endoscope  16 . The closure device  18  placed inside the bag  18  is the one used to indicate that the endoscope  16  is used and dirty and, therefore, in this example is the red coloured cable tie  18 . 
         [0062]    The sides of the bag  12  are then brought together and the bag  12  is sealed closed with the second closure device  20 . This closure device  20  indicates that the endoscope  16  within the bag  12  is clean and, in this example, is the green coloured cable tie  20 . The sealed bag  12  is illustrated in  FIG. 2 . 
         [0063]    The endoscope  16  may then be transported fully enclosed within the bag  12  to wherever it is needed. If desired, the bag  12  may be carried within the tray  40 . In a further embodiment of the invention, an outer bag or pouch (not shown) is provided. This outer pouch includes handles and is sized to receive the storage bag  12  within it. The outer pouch enables the storage bag  12  to be carried easily and also provides additional support and protection which may be desirable, in particular, for larger or heavier pieces of medical equipment. 
         [0064]    In order to remove the endoscope  16  from the bag  12 , a user must break the cable tie  20  around the bag  12 . Because the break in the cable tie  20  is permanent, the cable tie  20  cannot be reused and must be disposed of. This reduces the likelihood of cross-contamination of the endoscope  16  through opening and re-closing of the bag  12  prior to use. 
         [0065]    After it has been used, the endoscope  16  is placed back inside the bag  12 . The first closure device  18  is then sealed around the bag  12 . This closure device  18  indicates that the endoscope  16  is used and dirty. The endoscope  16 , enclosed within the bag  12 , may then be transported to suitable cleaning facilities. 
         [0066]    When sealing the bag  12  closed, the closure device  18 ,  20  should be secured as tightly as possible around the bag  12 . This minimises any likelihood of contamination because the endoscope  16  is fully enclosed within the bag  12 . Additionally, when a used endoscope  16  is contained within the bag  12  it is preferable if the bag  12  is sealed sufficiently so that the endoscope  16  is kept moist. The moisture that is retained within the bag  12  facilitates the subsequent cleaning of the endoscope  16 . 
         [0067]    As before, the cable tie  18  must be broken to remove it from the bag  12  to enable the subsequent cleaning and disinfection of the endoscope  16 . Once the endoscope  16  has been cleaned, a new kit  10  is used to store the endoscope  16  ready for use. 
         [0068]    In some situations it may be unnecessary or undesirable to place an absorbent pad or sheet of absorbent material within the bag  12  when the endoscope  16  is clean. As such, a sheet of absorbent material may only be positioned within the bag before a dirty endoscope  16  is placed in the bag  12 . 
         [0069]    It will also be appreciated that in some situations it is preferable not to place the first closure device  18  in the bag  12  with the clean endoscope  16  to minimise any possibility of contamination. In these cases, the first closure device  18  may be retained with the bag  12  either by being placed in the tray  40  or in the outer pouch, if provided. 
         [0070]    Although in the preceding embodiments the closure devices  18 ,  20  have comprised cable ties, the closure devices may be of any suitable type and may include, for example, a cable lock, single use padlock or an elasticated band. 
         [0071]    In some embodiments it may be desirable if the kit includes a third closure device (not shown). This third closure device also includes distinguishing means, to enable the closure device to be distinguished from the first and second closure devices  18 ,  20 , and identification means at least similar to those of the first and second closure devices  18 ,  20 . In particular, the identification means of the third closure device may be related to or identical to the identification means of the first and second closure devices. The set of three closure devices may be used to distinguish whether the endoscope, or other piece of medical equipment, within the bag is used and dirty, clean and wet, or clean and dry. The three closure devices may be coloured red, blue and green for example. 
         [0072]    The present invention has been developed particularly for use with endoscopes and hence is described herein with particular reference to that use, it will be appreciated, however, that the present invention may also be used for the safe storage and transportation of other medical equipment. 
         [0073]    Providing interrelated identification means on each of the closure devices means that the medical equipment, in this case the endoscope, may be traced easily throughout its use, allowing the required records to be efficiently maintained within a hospital or other healthcare facility. It will be appreciated that in some cases it is not necessary to provide interrelated or identical identification means on each of the closure devices because, for example, the actual identification means (e.g. serial number) can simply be recorded at each stage in the process in relation to that specific piece of medical equipment. 
         [0074]    The kit and method of the present invention, therefore, overcomes many of the problems associated with the current storage and transportation of medical equipment. In particular, the present invention provides: 
         [0000]    i) a bag for enclosing the medical equipment to prevent contamination of the equipment when in a clean state and to prevent contamination of external surfaces when the equipment is in a dirty state,
 
ii) single use closure devices to prevent unnecessary and unauthorised opening of the bag, and
 
iii) means to uniquely identify the medical equipment held within the storage bag for traceability.