Abstract:
A cycle counter for sterilization cycles for a disposable instrument features a plurality of tabs. With each sterilization after the initial use, a tab is removed by medical personnel. The instrument is disposed of after the final use with no tabs left.

Description:
BACKGROUND OF THE INVENTION  
     FIELD OF THE INVENTON  
       [0001]     The field of the invention is sterilization cycle counting for a disposable medical instrument.  
         [0002]     This system enables a user to track the number of uses of a reusable medical device. This system incorporates sterilization indicator tabs that are added to a portion of the plastic hub of reusable arthroscopic shavers and burrs. The invention was created to develop a method that could be used by the operating room staff which would indicate how many times a reusable shaver blade has been cycled. Without such a system, the operating room personnel have no way of knowing how many times the device has been cycled; i.e. used and sterilized.  
         [0003]     A typical cycle of use for a reusable blade or burr would be as follows: 
        1) Product is delivered, sealed and sterilized, to the hospital.     2) Product is used for surgery.     3) The shaver is cleaned at the hospital site using common cleaning techniques.     4) The device is then autoclaved (or otherwise sterilized) along with other reusable devices.     5) The device is delivered acseptically back to the surgical suite.        
 
         [0009]     With conventional arthroscopic/endoscopic shavers there is no visual indicator of how many times the device has been through this cycle. It has been reported that some devices have been used well beyond the recommended useful life. One such device is described by its manufacturer to be qualified for a given number of uses, for example, seven. The effectiveness of the device beyond this point is not recommended and the manufacturer advises that the device be disposed of after the recommended number of cycles.  
       SUMMARY OF THE INVENTION  
       [0010]     A cycle counter for sterilization cycles for a disposable instrument features a plurality of tabs. With each sterilization, after the initial use, a tab is removed by medical personnel. The instrument is disposed of after the final use with no tabs left.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  is an exploded side elevational view of a prior art shaver blade.  
         [0012]      FIG. 2  is an end view of a component of the shaver blade of  FIG. 1 , modified in accordance with the principles of this invention.  
         [0013]      FIG. 3  shows a cross-section of  FIG. 2  taken along the line A-A.  
         [0014]      FIG. 4  is an enlarged view of a portion of  FIG. 3 . 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0015]     As shown in  FIG. 1 , a prior art shaver blade  10  comprises an inner member  18  rotatably situated within an outer member  19 . The outer member has a molded hub  19   a  at its proximal end to facilitate its attachment to a handpiece (not shown). Inner member  18  has a conventional spring retainer  12  which is press fit adjacent a ring tang  13   b  to facilitate the retention of the shaver blade within the handpiece in a manner enabling rotation of the inner member. Retainer  13  is situated adjacent a hub  13   a  of the inner member. In the prior art device the proximal rim  13  of retainer  12  is smooth and circular. In the preferred embodiment of the invention, the hubs  13   a  and  19   a  as well as components  12  and  13   b  are molded from suitable polymeric material and rim  13  is modified to form new rim  16  having tabs  14 . The sterilization indicator tabs  14  provide a simple, visual, inexpensive method of indicating how many times the shaver blade has been cycled. If the number of recommended uses is seven, six small, removable sterilization indicator tabs  14  are molded into the distal rim  16  of plastic spring retainer component  12  formed. These tabs are easily removable and, if they are removed by the user one at a time after each sterilization, they become visual indicators for the operating room personnel of how many times the device has been cycled. These tabs are an integral feature of the device and their removal does not adversely affect the performance of the device in any way.  
         [0016]     It will be understood that the tabs may be attached to or integrally formed with other portions of the hubs of the inner or outer members. For example, the tabs could be formed as extensions from the proximal or distal ends of hubs  13   a  or  19   a.    
         [0017]     The new processing cycle would be as follows: 
        1) Product is delivered, sealed and sterilized, to the hospital, with 6 sterilization indicator tabs.     2) Product is used for surgery.     3) The shaver is cleaned at the hospital site using common cleaning techniques.     4) One of the sterilization indicator tabs is removed from the device using a common surgical tool such as a forceps.     5) The device is then autoclaved along with other reusable devices.     6) The shaver is delivered acseptically back to the surgical suite for reuse.     7) The cycle is repeated until all tabs have been removed after which the device is disposed of.        
 
         [0025]     It will be understood that any number of tabs may be molded into rim  16 , depending upon how many uses one desires to track.  
         [0026]     It will be understood by those skilled in the art that numerous improvements and modifications may be made to the preferred embodiment of the invention disclosed herein without departing from the spirit and scope thereof.