Abstract:
A disposable anesthesia conduit cover kit that includes a dispenser and pre-measured, or cut to length tubing segments with fasteners to secure each end of the tubing segment. The dispenser may be wall mounted or lay flat and alternative dispenser configurations are provided. The tubing segments protect the anesthesia conduit cover from blood or body fluids to protect patients and healthcare workers from infectious and pathogenic microorganisms and to assist with the compliance of both state and federal regulations.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not applicable. 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       REFERENCE TO MICROFICHE APPENDIX 
       [0003]    Not applicable. 
       FIELD OF THE INVENTION 
       [0004]    This invention relates to the prevention of the growth and/or spread of bloodborne pathogens and in particular involves a kit for preventing the spread of bloodborne pathogens from forced air warming unit accordion-type hoses. 
       BACKGROUND OF THE INVENTION 
       [0005]    Much research has been conducted into the subject of blood-borne contamination and the transmission of infectious diseases in the surgical environment. Many guidelines have been formulated by multiple agencies and organizations. The available scientific evidence reflects that these dictums are ineffective and impractical. Pathogenic microorganisms have been cultured from various sources in the operating room before and after disinfection. Anesthesia equipment has been cited as reservoirs for bacterial colonization. Some investigators have proposed the necessity of anesthesia equipment design changes that will increase the ease and effectiveness of adequate disinfection. Single use anesthesia devices are one potential solution. 
         [0006]    The rate of new infections that patients acquire while hospitalized in the United States is staggering; it is suggested that 10% of hospital inpatients will be victims of nosocomial infection (as cited in Loftus et al., 2008), with the rate in Canada perhaps slightly higher. There is strong evidence suggesting that the incidence and associated risk are only increasing, with an annual mortality conservatively estimated at many tens of thousands of patients. See AANA Journal, June 2009, Vol. 77, No. 3, page 230. 
         [0007]    The prevention of the transmission of blood-borne pathogens (Human Immunodeficiency Virus and Hepatitis B) in the workplace was the impetus for the United States Department of Labor&#39;s Occupational Safety &amp; Health Administration (“OSHA”) Regulations for Bloodborne pathogens (1991). As the risk for blood and body fluid exposure for healthcare workers is extraordinary, safety and exposure prevention in the healthcare setting is imperative. These concerns were the foundation for recommendations on hospital infection control and decontamination procedures from various regulatory agencies. However, concerns over the increasing prevalence of antibiotic resistant microorganisms such as methicillin resistant staphylococcus aureus (“MRSA”) (Boyce, Potter-Bynoe, Chenevert, and King, 1997; Loftus et al. 2008), the inability of current infection control policies to eradicate hospital acquired infections (“HAI”), and the skyrocketing costs of HAI; have fueled debate on the adequacy of current recommendations, stimulated scientific investigation, and forced an emphasis on best practices (Williams, 2008). The Joint Commission on the Accreditation of Hospitals (“JCAHO”), the principal accrediting body for healthcare institutions, announced that infection prevention is among its highest priorities for 2009 (Soule, n.d.). Additionally, The Centers for Medicare and Medicaid Services (“CMS”), as a result of the Federal Government&#39;s Deficit Reduction Act of 2005, announced that they would no longer reimburse for many HAIs (CMS Fact Sheet, 2008), an action which has major implications for the economic viability of an already troubled healthcare system. 
         [0008]    In The Cost of Nosocomial Infections (Press Ganey Associates, n.d.) report that hospital acquired infections add a mean cost of $13,973 to each hospital stay. Within the surgical arena, much has been achieved with the intent to maintain sterility of surgical instruments and the surgical field, and thereby protect the patient from potential pathogens and disease transmission. The 1996 National Nosocomial Infections Surveillance Report found that surgical site infections (“SSI”) still account for 17% of the total HAIs (as cited in Mauermann and Nemergut, 2006), and with SSI caused by MRSA the cost is $135,367. Engemann et al. (2003) describe the actual number of SSIs occurring each year in the United States as 500,000, and they estimate for those caused by MRSA the additional losses can approximate $92,363 (as cited by Nelson, Bivens, Shinn, Wanzer, and Kasper, 2009). 
         [0009]    Hall (1994) reports that the ability of the inanimate surgical environment to transmit infectious diseases or pathogenic microorganisms; has not been the focus of much research. Kramer, Scwebke, and Kampf (2006, p. 2334) discuss “inanimate surfaces as a frequent source of outbreaks for nosocomial infections”. Mangum, Horan, Pearson, Silver, and Jarvis (1999, p. 247), report that, “environmental surfaces in the operating room are rarely implicated as sources of pathogens important in the development of SSIs”. Despite these disagreements, Williams (2008, p. 274) proposes that the goal of all perioperative practices should be to prevent environmental contamination and breaching the chain of infection. She notes that “without a clean environment, other infection control measures such as hand hygiene and decontamination procedures may be undermined”. Current recommendations are consistent in their mandate that contaminated surfaces be cleansed with an appropriate disinfectant, only whenever visible soiling with blood or body fluids is recognized (OSHA, 1991, section 1910.1030[d][4][ii]) (CDC, 1999). OSHA offers more stringent stipulations on disinfection in this same section with “Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning”. 
         [0010]    However, Rowley and Dingwall (2007), citing multiple scientific studies, note the inability of current decontamination and sterilization procedures to remove all microbial and proteinaceous materials from surgical and anesthetic equipment. Multiple scientific studies have confirmed bacterial contamination and colonization of the surgical environment, pre and post disinfection (Hall, 1994; Nelson, Bivens, Sbinn, Wanzer, &amp; Kasper, 2006). Madar, Novakova, &amp; Baska (2005) found that inanimate objects tested for microbial growth, cultured bacteria (including MRSA) off of 92% of tested stethoscopes. The researchers also found pathogens on blood pressure cuffs, esmarch bandages, and refrigerator door handles. Boyce et al. (1997) discovered that out of 38 patients with MRSA infection or colonization, 27% of environmental surfaces in the patient rooms tested positive for MRSA. 
         [0011]    When the results were controlled for body site of infection or colonization, 85% with a wound or urine infection had positive colonization of environmental surfaces in their rooms. Most notable of those surfaces were patient gowns, linens, overbed tables, and blood pressure cuffs. The concern of cross contamination is compounded by the ability of pathogens to survive for weeks or even months on inanimate surfaces (Kramer et al.). 
         [0012]    Considerable evidence has also been acquired to implicate anesthesia equipment as reservoirs of bacterial colonization and blood contamination (Hall, 1994; Masylak et al, 2002; Simmons, 2000). Also noted as included in this area are the anesthesia machine, the supply cart(s), the surgical bed, and specialized equipment such as infusion pumps, warming devices, intravenous (IV) line poles, phones. See AANA Journal, June 2009, Vol. 77, No. 3, page 231. 
         [0013]    However, to date, there are no national guidelines for recommendations regarding the decontamination of anesthesia equipment (King &amp; Cooke, 2001). The American Society of Anesthesiologists (“ASA”) and the American Association of Nurse Anesthetists (“AANA”) address the issue in their respective publications ( Recommendations for Infection Control for the Practice of Anesthesiology,  2 nd  Edition) from the former and (The AANA Infection Control Guide, 2009) from the latter. Though similar, the recommendations from these professional anesthesia organizations differ in some respects. Confounding the lack of universal recommendations, Perry and Monaghan (2001) discuss problems with the design of anesthesia equipment that create difficulties with contaminant identification and disinfection. This research has led to the advent of disposable products for the anesthesia provider i.e. laryngoscope blades, oral airways, LMAs, and so forth. King and Cooke (2001) propose the idea of single-use anesthesia equipment to safeguard patients and staff against blood-borne diseases, while at the same time, installing a realistic method of achieving infection control mandates without hindering operating suite turnover time. 
         [0014]    Despite mandates and recommendations for policies on disinfection of the operating room environment, the feasibility of this task is only surpassed by the non-compliance resulting from its impracticality (Boyce et al., 2007). Additionally, the redesign of equipment and the development of methods to protect equipment from blood contamination (which can serve as agars for microbial growth), achieve satisfactory levels of disinfection, and satisfy governmental and accrediting organization dictums is conspicuously absent. 
         [0015]    No application currently exists to protect the accordion-type hoses of forced air warming units from such contamination, or to provide a practical method of disinfection for the hoses that do become soiled. Forced air warming units and the accordion-type hoses used therewith have become an integral part of anesthesia care. Arizant Medical, the manufacturer of the prototype forced air warming unit, claims that between introduction in 1987 through 1999, their device had been utilized in excess of 20 million times. With 26,000,000 anesthetics performed annually in the United States, and forced air warmers now used in the majority of these operations, the potential for contamination occurrences is staggering. 
         [0016]    Because of the design of its accordion-type hose, the forced air warming unit is prone to problems with contaminant identification and proper disinfecting. The accordion-type hose is constructed with ridges and troughs, which allow the hose to bend and flex, and to some extent, stretch. The ridges and troughs form an irregular surface area along the length of the hose. The irregular surface area is extremely difficult, if not impossible to clean and/or disinfect properly. Buildup and contamination is especially prone to occur in the difficult to access troughs of the hose. 
         [0017]    Moreover, surgical and anesthesia staff, under pressure to expedite operating room turnovers (Masylak et al., 2002), are unlikely to achieve a satisfactory level of disinfection. At a current cost of approximately $75, replacement after each case is not a cost effective or practical alternative. Therefore, the need for a practical and affordable solution is quite evident. 
       BRIEF SUMMARY OF THE INVENTION 
       [0018]    The inventive surgical and anesthesia conduit cover kit was devised to protect one of the most utilized and difficult to clean anesthetic devices; from contamination with blood or body fluids, and thereby eliminate it as a potential vector for the transmission of pathogens. 
         [0019]    The inventive surgical and anesthesia conduit cover kit is a disposable barrier kit developed to protect the forced air warmer&#39;s hose from environmental contamination. In so doing, the inventive kit reduces costs incurred from unnecessary hose replacement, as well as man-hours lost on timely and imperfect disinfecting routines. More importantly, without the possibility of contamination by blood and body fluids, the equipment cannot serve as a potential reservoir for infectious and pathogenic microorganisms and potentially eliminates the danger to patients and to healthcare workers. 
         [0020]    The inventive surgical and anesthesia conduit cover kit for infection control in the operating room environment comprises a tubing member sized to fit over a forced air warming unit accordion-type hose. The tubing member is sufficiently long to substantially cover the length of the accordion-type hose. A dispenser is provided to contain and dispense the tubing member. The dispenser includes fasteners for securing the tubing member to the accordion-type hose. The dispenser can be removably wall mounted or may be placed on a flat surface. 
         [0021]    The tubing member can be provided in individual segments, sized according to the length of the accordion-type hose to be covered. The segments may be divided by cutting or with pre-fabricated perforations. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]      FIG. 1  is a perspective view of the inventive anesthesia conduit cover kit; 
           [0023]      FIG. 2  is a perspective view showing the conduit cover as used on an accordion-type hose on a forced air warming unit with a patient; 
           [0024]      FIG. 3  is a perspective view showing the conduit cover as used on an accordion-type hose; 
           [0025]      FIG. 4  is a perspective view of a polymer snap type gripping fastener; 
           [0026]      FIG. 4A  is a perspective view of an open-ended polymer fastener; 
           [0027]      FIG. 5  is a perspective view of a polymer ratcheting gripping fastener; 
           [0028]      FIG. 6  is a perspective view of an alternative polymer snap type gripping fastener; 
           [0029]      FIG. 7  is a perspective view of a hook and loop type strap fastener; 
           [0030]      FIG. 8  is a perspective view of a zip tie; 
           [0031]      FIG. 9  is a perspective view of a wall-mounted, flat frame dispenser; 
           [0032]      FIG. 10  is a perspective view of a dispenser having a wire frame and separator; 
           [0033]      FIG. 11  is a perspective view of a molded dispenser including a fastener container; 
           [0034]      FIG. 12  is a perspective view of a low profile molded dispenser; 
           [0035]      FIG. 13  is a perspective view of a dispenser having a serrated cutting edge and a fastener container; and 
           [0036]      FIG. 14  is a perspective view of a dispenser having a slotted top and a fastener container. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0037]    An embodiment of the inventive surgical and anesthesia conduit kit is shown in  FIG. 1 . A dispenser D contains a tubing member T, which is pulled from the dispenser opening  32 . The tubing member T is typically separated into individual tubing segments  10 . Each tubing segment  10  has a leading edge  14  and a trailing edge  16 . A perforation  20  is positioned between the leading edge  14  and the trailing edge  16  that allows each tubing segment  10  to be individually separated. A cover  30  is provided which covers the dispenser opening  32  to maintain the tubing member T in a sanitary condition prior to extracting individual tubing segments  10  from the dispenser D. 
         [0038]    The tubing member T is generally constructed of an anti-static polymer and is typically pink in color. In order to cover the diameter of the accordion-type hose  34 , the tubing member T is typically approximately 5-7 inches in diameter and the wall of the tubing member T is typically approximately 2-6 mils thick. 
         [0039]    The length of the tubing segment  10  corresponds to the length of the accordion-type hose  34 , which is used with a forced air warming unit F, as best seen in  FIG. 2 . The dispenser D can be left on a horizontal flat surface, such as a table or it may be wall mounted. In  FIG. 1 , hook and loop mounting pads  22  are shown. The hook and loop mounting pads  22  allow an empty dispenser D to be removed from the matching half of the hook and loop mounting pads  22  and a full, replacement dispenser D can be mounted on the wall on the same matching half of the hook and loop mounting pads  22 . 
         [0040]    In  FIG. 1  elastic fasteners  12  are shown on each end of the tubing segment  10 . The elastic fasteners may be integral with our externally applied to the tubing segment  10 . The elastic fasteners  12  secure the leading edge  14  and the trailing edge  16  to the accordion-type hose  34 , as best seen in  FIG. 3 . Alternative fasteners may be used to secure the leading edge  14  and trailing edge  16  of the tubing segment  10 . For example, in  FIG. 4  a polymer snap type gripping fastener  40  is shown. The snap type gripping fastener  40  is non-adjustable and includes a tab  40   a  that engages a slot  40   b  to secure the fastener  40  to the tubing segment  10 . 
         [0041]    In  FIG. 3 , a detail of the accordion-type hose  34  is shown which shows the ridges  35   a  and troughs  35   b.  The ridges  35   a  and troughs  35   b  create irregular surfaces along the length of the accordion-type hose  34 , which is very difficult or impossible to clean and/or disinfect properly. 
         [0042]    In  FIG. 4A  an open-ended polymer fastener is shown that includes a resilient partial-circular band  42  having ends  42   a.  The ends  42   a  slip around the leading edge  14  and the trailing edge  16  of the tubing segment  10  to maintain a tight seal and to secure the tubing segment  10  to the accordion-type hose  34 . When the open-ended fastener is removed, the ends  42   a  return to their original shape, which allows the open-ended fasteners to be reused. A handle  43  is attached to the partial-circular band  42 , which allows easy application of the ends  42   a  onto the tubing segment  10  at the desired locations. Also included on the handle  43  is a gripping surface  43   a  to further simplify and enhance the ability of the user to grip the fastener handle  43 . The partial-circular band  42  may also be made of flexible or resilient, non-polymer materials as desired. 
         [0043]    In  FIG. 5  a polymer ratcheting gripping fastener  44  is shown. Tab  44   a  includes serrated ridges  45   a.  Tab  44   a  engages slot  44   b.  Slot  44   b  includes serrated ridges  45   b,  which are engaged by the serrated ridges  45   a  on tab  44   a.  The ratcheting gripping fastener  44  can be adjusted to a limited extent by partially or fully engaging tab  44   a  with slot  44   b.    
         [0044]    In  FIG. 6  an alternative polymer snap type gripping fastener  46  is shown. Tab  46   a  includes a resilient locking member  47 . Tab  46   a  engages slot  46   b  and locking member  47  engages the interior of slot  46   b  to secure the fastener  46 . 
         [0045]    In  FIG. 7  a hook and loop type strap fastener  50  is shown. Hooks  50   a  are on one side of the fastener  50  while loops  50   b  are on the other side of the fastener  50 . When fastener  50  is wrapped around a tubing segment  10 , the hooks  50   a  on one side of the fastener  50  engage the loops  50   b  on the other side of the fastener. 
         [0046]    In  FIG. 8  a zip tie fastener  52  is shown. The leading end  52   a  is inserted into slot  52   b.  Ridges  53   a  along the length of fastener  52  are retained in the slot  52   b  by a resilient clamping member  53   b.    
         [0047]    The anesthesia conduit kit may include any of the fasteners shown in  FIGS. 1 ,  4 - 8  or an alternative desired fastener may also be used. 
         [0048]    Although a box type dispenser D is shown in  FIG. 1 , alternative dispensers D are shown in  FIGS. 9-14 .  FIG. 9  shows a wall-mounted dispenser that includes a rear frame  62  that is mounted to a wall surface with screws  62   a  or other fasteners. The tubing member T is on a rod  60 , which is held by a loop  60   a.  Loop  60   a  is attached to the rear frame  62  to secure the tubing member T. Although not shown, the tubing member T may be divided into tubing segments  10 , as shown in  FIG. 1  with perforations  20 , or the tubing member T may be continuous in length. A continuous length tubing member T can be cut to the desired length to fit on an accordion-type hose  34  or may also be used to cover any desired elongate member for which sanitary coverage is desired. 
         [0049]    In  FIG. 10  an alternative dispenser D is shown constructed of a wire frame  76 . The wire frame  76  may be attached to a wall surface at the holes  72   a  or may be positioned on a flat surface, such as a table or other horizontal work surface. The tubing member T is on a tube  70 , which is rotatable on rod  70   a.  The separator  74  is formed from a bend in the wire frame  76 . The separator  74  allows the tubing member T to be separated easily at each perforation  20 . 
         [0050]    In  FIG. 11  an alternative dispenser D is shown constructed of a molded body  80 , which attaches to a wall mount frame  82  with pins  82   a  and  82   b.  A vertical slot  84   a  intersects a pair of upwardly angled slots  84   b,    84   c.  A pointed edge  84   d  is formed at the intersection of the vertical slot  84   a  and the upwardly angled slot  84   c.  A pointed edge  84   e  is also formed at the intersection of vertical slot  84   a  and upwardly angled slot  84   b.  Each upwardly angled slot  84   b,    84   c  is angled upwardly from a horizontal plane approximately 2-20 degrees. Each pointed edge  84   d,    84   e  serve to separate the tubing member T into individual tubing segments  10 . The tubing segments may be defined by perforations  20 . Although two pointed edges  84   d,    84   e  are provided, a single pointed edge,  84   d  or  84   e  could be used to separate the tubing member T into individual tubing segments  10 . Two pointed edges  84   d,    84   e  advantageously allow for separation of the tubing member T in either direction relative to the body  80 . The tubing member T is on a spool  85 , which is free to rotate within the body  80 . Also molded into body  80  is a recessed container  86  to hold fasteners  52 . Although fasteners  52  are shown, any desired fastener may be stored in container  86 . 
         [0051]    In  FIG. 12  an alternative dispenser D is shown constructed of a molded body  90 . Tubing member T is removed from opening  94  in the top of body  90 . Opening  92  allows for an inspection of the contents of the body  90  to determine if it needs to be refilled. The tubing member T may include perforations  20  (not shown) or may be of continuous length. If tubing member T is of continuous length, it can be cut to fit the desired length to fit the accordion-type hose or any other elongate member. Fasteners  52  or other fastener types may be included in a separate container or they may be attached to the body  90 . 
         [0052]    In  FIG. 13  a dispenser D is shown comprising a box  100  having a sharpened edge  104  that is used to cut the tubing member T to the desired length. Cover  102  provided sanitation protection to keep the sharpened edge  104  and tubing member T covered. A container  105  on the inside of cover  102  provides ready access to fasteners  52  or any fasteners that are stored in the container  105 . 
         [0053]      FIG. 14  shows a dispenser having a box container  110 , which includes a slot  112 . The tubing member T is fed out of slot  112 . Individual tubing segments  10  are shown overlapping between the trailing edge  16  of the leading segment  10  and the leading edge  14  of the following segment  10   a,  whereby the trailing edge  16  of each tubing segment  10  pulls the leading edge  14  of the next tubing segment  10   a.  A container  105  on the inside of cover  102  provides ready access to fasteners  52  or any fasteners that are stored in the container  105 . 
         [0054]    While several embodiments and elements of the invention have been shown and described, it should be understood that other variations and elements will be apparent to those skilled in the art. Also, although the invention is directed to use with accordion-type hoses on forced air warming units, it is contemplated that the invention may also be used on other elongate members such as cardiac monitoring leads and the like. Therefore, it will be understood that the embodiments and elements shown in the drawings and described herein are merely for illustrative purposes, and are not intended to limit the scope of the invention, which is defined by the claims, which follow.