Abstract:
An apparatus for safely and conveniently placing and retrieving biological indicators and/or computerized data tracers from deep within loads of Regulated Medical/Infectious Waste comprises a rod with a cavity for holding the biological indicators and/or computerized data tracers. Preferably, the rod is tapered to a point on one end, has a handle on the opposite end, and has a cover to enclose the cavity. Additionally, it is preferred that the rod is fitted with a movable sealing ring of soft material for sealing the area where the rod penetrates the waste load.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to an apparatus and method for improving the safety, convenience and accuracy of the testing of autoclaves required by regulations for the treatment of Regulated Medical/Infectious Waste. 
     2. Description of the Prior Art 
     Most regulating authorities require the periodic testing of autoclaves used for the treatment of Regulated Medical/Infectious Waste. The testing is to ensure that proper treatment, residence time, temperature and spore kill are taking place. Conventionally, the testing of an autoclave used for the treatment of Regulated Medical/Infectious Waste is widely preformed by placing biological indicators on top of a cart/bin of waste, subjecting the cart/bin of waste (which has the biological indicators placed on top thereof) to a treatment (e.g., exposure to steam, or exposure to steam and vacuum such as in U.S. Pat. Nos. 7,815,851 and 6,867,393, both of which are incorporated herein by reference) in the autoclave, and then analyzing the biological indicators to determine if the waste has been properly treated. Because this practice readily exposes the biological indicators positioned on top of the waste to steam during the autoclave treatment, the biological indicators typically reflect that the autoclave treatment of the waste was successful (e.g., a “No Growth” test result). However, while this conventional testing method is safe and convenient, it is often lacking in accuracy in that it may provide a test result that is not reflective of the effectiveness of the treatment within (as opposed to on top of) the waste. 
     SUMMARY OF THE INVENTION 
     It is an object of this invention to provide a safe and convenient means for placing deep within a load of Regulated Medical/Infectious Waste and subsequently retrieving therefrom biological indicators and computerized data tracers. 
     Another object of this invention is to provide a means to facilitate accurately testing the efficacy of autoclaves used for the treatment or Regulated Medical/Infectious Waste. 
     These and other objects are provided by our invention which is set out below. 
     In a preferred embodiment of our invention, our inventive autoclave test probe comprises a rod with a handle on one end to facilitate handling of the probe especially during use of the probe (e.g., insertion of the probe into a load of waste and removal of the probe from a load of waste), a tapered point on the opposite end to permit the probe to easily puncture through boxes and bags within the waste load, a cavity formed in the rod for holding one or more biological indicators and/or a computerized data tracer, an opening or bore formed in the rod forming an entrance to the cavity, a cover movably mounted on the rod for opening and closing the entrance to the cavity, and a movable sealing ring of softer material for sealing the area where the probe enters the waste load. 
     In this preferred embodiment, the cover for the cavity is tubular in shape and is movably mounted on the rod. In this preferred embodiment, at least one pin or the like (e.g., dowel, set screw) is positioned on the rod for engaging at least one slot or detent formed in the cover for maintaining the cover on the rod. Preferably, the cover is rotationally or longitudinally held in the closed position, covering the cavity, with a spring-loaded detent pin which engages a detent on the inside of the tubular cover. The cover has an opening formed therein which is of sufficient size to allow a biological indicator and/or computerized data tracer to be inserted through the opening into the cavity when the cover is in an open position (that is, when the cover is positioned on the rod such that the opening in the cover is aligned with the entrance to the cavity). Preferably, holes are formed in the cover, and bores are formed in the rod extending between the cavity and the exterior of the rod, the holes in the cover being aligned with the bores in the rod when the cover is in a closed position (that is, when the cover is positioned on the rod to close the entrance to the cavity) to create passageways between the cavity and the exterior of the probe to allow air, vapors, or steam to pass into and through the cavity. 
     Further, the cavity preferably is sized to accept the type of biological indicator selected by the user. The cavity also may be sized to permit the inclusion of a mechanical or electronic measuring or recording device (e.g., a computerized data tracer) that measures and/or measures and records the autoclave treatment conditions applied within the waste load during the autoclave treatment. 
     Preferably, additional bores that preferably are smaller than the bores formed in the rod that allow air, vapors, steam to enter and pass through the cavity are formed in the rod and extend from the cavity to the exterior of the probe, preferably between the end of the cavity that is closer to the end of the probe having the tapered point and the exterior of the probe between where the cavity is located and the end of the probe having the tapered point, to allow condensate which might accumulate in the cavity to drain from the cavity. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a view in side elevation of a preferred autoclave test probe constructed in accordance with the invention. 
         FIG. 2  is the side elevational view of the preferred autoclave test probe shown in  FIG. 1 , except without the cavity cover for the probe being installed on the probe. 
         FIG. 3  is a view in side elevation of the preferred autoclave test probe (except without the cavity cover for the probe being installed on the probe) shown in  FIG. 2 , after the probe has been rotated 90 degrees so that the portion of the dowel or setscrew  6  that extends from the rod  1  now points to the top of the drawing sheet. 
         FIG. 3   a  is an enlarged partial view taken in cross-section of the portion of the autoclave test probe contained in the circle  3   a  shown in  FIG. 3 . 
         FIG. 4  is a view is side elevation of the cavity cover shown in  FIG. 1 . 
         FIG. 5  is a view in side elevation of the preferred autoclave test probe shown in  FIG. 1 , after the cover  27  has been rotated to a closed position to close the entrance  31  to the cavity or chamber  21  (which is shown in the fathom). 
         FIG. 6  is a perspective view of the autoclave test probe shown in  FIG. 1 . 
         FIG. 7  is an enlarged view of the first end portion of the autoclave test probe highlighting optional condensate drainage bores formed in the rod extending between the cavity and the exterior of the probe to permit condensate that might accumulate in the cavity to drain from the cavity. 
         FIG. 8  is an enlarged view of the first end portion of the autoclave test probe with its cover  27  in an open position showing positioned in the cavity or chamber  21  of the probe a biological indicator  23  and a device  25  for measuring and/or measuring and recording autoclave treatment conditions during an autoclave treatment. 
     
    
    
     DETAILED DESCRIPTION 
     Turning to the drawings, there is shown our inventive apparatus or autoclave test probe  11  for testing autoclaves used for the treatment of Regulated Medical/Infectious Waste. In this preferred embodiment of the invention shown in the drawings, the apparatus  11  has a rod  13  having a first end portion  13 , a second end portion  15 , and a middle portion  17  located between the first and second end portions  13  and  15 . 
     The rod  13  has a cavity or chamber  21  formed therein, preferably in the first end portion of the rod  13 , for holding one or more biological indicators  23  (e.g., ampoules, spore strips, etc.) and/or a device  25  (e.g., a computerized data tracer) that measures and/or measures and records the autoclave treatment conditions (e.g., temperature, pressure, and/or humidity) applied within the waste load during treatment in an autoclave. 
     The apparatus  11  also has means for maintaining the one or more biological indicators  23  and/or the device  25  in the cavity or chamber  21  when desired. Examples of such means include doors mounted on the rod  13  for closing off the cavity or chamber  21  when desired, a cage for holding the one or more biological indicators  23  and/or the device  25  wherein the cage may be removably press-fit into the cavity  21 , or a cover (such as a cover  27  which is described below). 
     In the preferred embodiment of the invention shown in the drawings, the cavity or chamber  21  is formed by a slot  29  that extends completely through the rod  13 , which creates at one end of the slot  29  an entrance  31  to the cavity or chamber  21 , the entrance  31  being of sufficient size to permit at least one biological indicator  23  and/or device  25  to be inserted through the entrance  31  to be placed inside the cavity or chamber  21 . In the preferred embodiment shown in the drawings, the means for maintaining the one or more biological indicators  23  and/or the device  25  in the cavity or chamber  21  when desired is a cover  27 . The cover  27 , which is movably mounted on the rod  13 , forms the back wall of the cavity or chamber  21  and allows for the entrance  31  to the cavity or chamber  21  to be opened and closed, as desired. Alternatively, the cavity or chamber  21  may be formed by a slot that extends only partially into the rod  13  such that the back wall of the cavity or chamber  21  is formed by the portion of the rod  13  at the end of the slot. 
     Regarding cover  27 , the apparatus  11  is provided with means for maintaining the cover  27  on the rod  13 . One preferred example of such means is where pins are provided on the rod  13  and slots are provided on the cover  27 , as shown in the drawings, to maintain the cover  27  on the rod  13  and facilitate rotation of the cover  27  back and forth between an open position and a closed position on the rod  13 . Specifically, in the preferred embodiment of the invention shown in the drawings, the cover  27  is rotatably mounted on the rod  13  preferably using a pin  33  or the like (e.g., a pin or dowel or set screw) press-fit into one end of a bore  35  extending through the rod  13  that engages a slot  37  formed in the cover  27 , and a spring-loaded detent pin  39  or the like positioned in and extending from the other end of the bore  35  that engages a groove formed on the inside surface of the cover  27 , the groove having a detent formed at one end of the groove to receive the ball of the detent pin  39  when the cover  27  is positioned in a closed position over the entrance  31  of the cavity or chamber  21 . Another example of such means for maintaining the cover  27  on the rod  13  is where a pair of snap rings or similar retainer mechanism is mounted on the rod  13  with one of the pair positioned at one end of the cover  27  and the other of the pair positioned at the other end of the cover  27  to engage and hold the cover  27  on the rod  13 . 
     In the preferred embodiment shown in the drawings, the cover  27  is provided with an opening  41  formed therein which is of sufficient size to allow at least one biological indicator  23  and/or a device  25  to be inserted through it to permit the at least one biological indicator  23  and/or a device  25  to be inserted into the cavity or chamber  21  through its entrance  31  when the cover  27  has been rotated into an open position placing the opening  41  of the cover  27  into alignment with the entrance  31  of the cavity or chamber  21 . 
     After at least one biological indicator  23  and/or a device  25  have been placed in the cavity or chamber  21 , the cover  27  may be rotated into a closed position where the opening  41  of the cover  27  is no longer in alignment with the entrance  31  of the cavity or chamber  21  to secure or maintain the at least one biological indicator  23  and/or the device  25  in the cavity or chamber  21 . 
     Preferably, holes  43  are formed in the cover  27 , and bores  45  are formed in the rod  13  extending between the cavity  21  and the exterior of the rod  13 , and the placement of the holes  43  and the bores  45  is such that the holes  43  in the cover  27  are aligned with the bores  45  in the rod  13  when the cover  27  is in a closed position (that is, when the cover  27  is positioned on the rod  13  to close the entrance  31  to the cavity  21 ) to create passageways between the cavity  21  and the exterior of the apparatus  11  to allow air, vapors, or steam to pass into and through the cavity  21 . 
     Preferably, the autoclave test probe  11  has a handle  47  formed in or mounted on the second end portion  17  of the rod  13  to facilitate handling of the probe  11  especially during use of the probe  11  (e.g., insertion of the probe  11  into a load of waste and removal of the probe  11  from a load of waste). Further, preferably, the probe  11  has a tapered point  49  formed on the end of the first end portion  15  of the rod  13  to permit the probe  11  to easily puncture through boxes and bags within the waste load. 
     Preferably, the apparatus  11  is provided with a sealing ring  51  slidably mounted on the rod  13  for sealing the load of waste where the rod  13  penetrates the load of waste when the apparatus  11  is in use. 
     The cavity or chamber  21  preferably is positioned in the first end portion  15  of the rod  13  near the tapered point  49 . Preferably, the cavity is sized to hold the type of biological indicator  23  and/or the type of device  25  selected by the user of the apparatus  11 . In the preferred embodiment of the invention shown in the drawings, the cavity  21  has a first portion  53  for holding at least one biological indicator  23 , a second portion  55  for holding a device  25  for measuring and/or measuring and recording autoclave treatment conditions during the autoclave treatment, and a third portion  57  connecting the first portion  53  of the cavity  21  to the second portion  55  of the cavity  21  that permits a sensor  59  from the device  25  for measuring and/or measuring and recording autoclave treatment conditions during an autoclave treatment when such device  25  is held in the second portion  55  of the cavity  21  to extend into the first chamber  53  but otherwise substantially blocks such a device  25  from entering the first portion  53  of the chamber  21  from the second portion  55  of the cavity  21  via the third portion  57  of the cavity, thereby avoiding damage to a biological indicator  23  by being hit by a main portion of the device  25  when the apparatus  11  is in use. 
     As only shown in  FIG. 7  for purposes of clarity, preferably, additional bores or condensate drainage holes  61  that preferably are smaller than the bores  45  formed in the rod  13  that allow air, vapors, steam to enter and pass through the cavity  21  are formed in the rod  13  and extend from the cavity  21  to the exterior of the probe or apparatus  11 , preferably between the end of the cavity  21  that is closer to the end of the probe or apparatus  11  having the tapered point  49  and the exterior of the probe or apparatus  11  between where the cavity  21  is located and the end of the probe or apparatus  11  having the tapered point  49 , to allow condensate which might accumulate in the cavity  21  to drain from the cavity  21 . 
     Preferably, the rod  13 , cover  27 , and handle  47  are made from a polymeric material, such as amorphous thermoplastic polyetherimide (PEI), such as that sold under the mark Ultem 1000, and the sealing ring  51  is made from a soft material such as a silicone rubber. 
     In use, the apparatus  11  may be used in the testing of autoclaves used for the treatment of Regulated Medical/Infectious Waste in accordance with our inventive method of placing deep within the load of Regulated Medical/Infectious Waste and subsequently retrieving therefrom at least one biological indicator  23  and/or a device  25  for measuring and/or measuring and recording autoclave treatment conditions during an autoclave treatment to determine efficacy of the autoclave treatment. In accordance with the method, at least one biological indicator  23  and/or a device  25  for measuring and/or measuring and recording conditions during an autoclave treatment is placed into the cavity  21  of the apparatus  11 , and then the at least one biological indicator  23  and/or the device  25  for measuring and/or measuring and recording conditions during an autoclave treatment is secured or maintained (e.g., by closing (e.g., rotating the cover  27  to a closed position) the cover  27 ) in the cavity  21  of the apparatus  11 . Then, the apparatus  11  is inserted into the load of waste so that the cavity or chamber  21  holding the at least one biological indicator  23  and/or the device  25  is positioned deep within the load of waste, and, when the apparatus  11  is provided with a sealing ring  51 , so that the sealing ring  51  seals the load of waste where the rod  13  penetrates the load of waste. After the portion of the apparatus  11  having the cavity or chamber  21  containing at least one biological indicator  23  and/or a device  25  has been inserted deeply into the load of waste, the load of waste (with the apparatus  11  being inserted therein) is subjected to an autoclave treatment. After the autoclave treatment, the apparatus  11  is removed from the load of waste, and the at least one biological indicator  23  and/or the device  25  for measuring and/or measuring and recording autoclave treatment conditions during an autoclave treatment is removed from the cavity  21  of the apparatus  11  for use in determining efficacy of the autoclave treatment by, for example, testing (e.g., by incubating) the biological indicator(s)  23  that have been removed from the cavity  21  after being subjected to the autoclave treatment with the load of waste to determine whether a test organism has been destroyed, and/or analyzing the autoclave treatment conditions measured by the device  25 .