Methods and systems for holding surgical instrument count sheets

Abstract

The disclosure includes systems and methods for hospital based sterilization of surgical instruments. An exemplary system includes a wrapped sterilization tray or container defining at least one opening to permit a sterilant to pass therethrough and least one surgical instrument disposed in the sterilization tray. The system still further includes a count sheet holder disposed on the sterilization wrap or container. The count sheet holder defines a compartment for receiving a count sheet and means for attaching the count sheet holder to the sterilization container or wrapped tray.

1 . A system for hospital based sterilization of surgical instruments, comprising:
 a) a sterilization tray defining at least one opening to permit a sterilant to pass therethrough and a plurality of sides, wherein the bottom and plurality of sides cooperate to define a compartment for receiving surgical instruments to be sterilized;   b) at least one surgical instrument disposed in the sterilization tray;   c) a sterilization wrap wrapped around the sterilization tray, the sterilization wrap being made from a breathable material adapted and configured to permit sterilant to pass through the wrap and through the tray;   d) a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization tray; and   e) a pouch-shaped count sheet holder disposed on the sterilization wrap, the count sheet holder including:
 i) a first sheet of material; 
 ii) a second sheet of material disposed on and attached to the first sheet of material proximate the perimeter of the first and second sheets to define an elongate opening proximate a peripheral edge of the first sheet of material of the count sheet holder, wherein the opening is in communication with a generally rectangular compartment defined between the first and second sheets of material for receiving the count sheet; and 
 iii) a fastener for attaching the count sheet holder to the sterilization wrap. 
   
     
     
         2 . The system of  claim 1 , wherein the fastener is applied to an outwardly disposed face of the first sheet of material. 
     
     
         3 . The system of  claim 2 , wherein a peripheral edge of the second sheet of material extends beyond the peripheral edge of the first sheet of material to form an overhang, such that the elongate opening proximate the peripheral edge of the first sheet of material of the count sheet holder is located behind the second sheet of material. 
     
     
         4 . The system of  claim 3 , wherein the overhang includes adhesive disposed on an inner face of the overhang such that the adhesive causes the overhang adhere to the sterilization wrap when pressed against the wrap after the count sheet is inserted in the count sheet holder, thereby preventing access to the count sheet. 
     
     
         5 . The system of  claim 4 , wherein the count sheet holder further includes a removable tamper evident strip that, when removed, provides access to the count sheet and visual indication that the count sheet holder has been compromised. 
     
     
         6 . The system of  claim 2 , wherein the fastener includes pressure sensitive adhesive applied to the outwardly disposed face of the first sheet of material and the count sheet holder further includes a removable protective layer of material disposed on top of the pressure sensitive adhesive. 
     
     
         7 . The system of  claim 1 , wherein the perimeter of each of the first and second sheets defines four peripheral sides, and further wherein the first layer and second layer of material are joined about their periphery at three of the four sides. 
     
     
         8 . The system of  claim 1 , wherein the first sheet of material is at least partially transparent to permit the contents of the generally rectangular compartment to be viewed from outside the count sheet holder when the count sheet holder is mounted on the sterilization wrap. 
     
     
         9 . The system of  claim 3 , wherein the count sheet holder includes indicia thereon to inform a user of the count sheet holder that the count sheet is not to be considered to be sterile so as to avoid contamination of the sterile field of an operating room. 
     
     
         10 . The system of  claim 1 , wherein a peripheral edge of the second sheet of material extends beyond the peripheral edge of the first sheet of material to form a foldable flap adapted and configured to be folded over the elongate opening, and further wherein the fastener is applied to an outwardly disposed face of the second sheet of material. 
     
     
         11 . The system of  claim 1 , wherein the count sheet holder further includes a zipper closure disposed proximate the elongate opening for facilitating closure of the count sheet holder. 
     
     
         12 . A method of sterilizing surgical instruments in a hospital sterilization department, comprising:
 a) providing a sterilization tray defining at least one hole therethrough to permit a sterilant to pass therethrough and a plurality of sides, wherein the bottom and plurality of sides cooperate to define a compartment for receiving surgical instruments to be sterilized;   b) disposing at least one surgical instrument in the sterilization tray;   c) wrapping a sterilization wrap around the sterilization tray, the sterilization wrap being made from a breathable material adapted and configured to permit sterilant to pass through the wrap and through the tray;   d) providing a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization tray;   e) disposing a pouch-shaped count sheet holder on the sterilization wrap, the count sheet holder including:
 i) a first sheet of material; 
 ii) a second sheet of material disposed on and attached to the first sheet of material proximate the perimeter of the first and second sheets to define an elongate opening proximate a peripheral edge of the first sheet of material of the count sheet holder, wherein the opening is in communication with a generally rectangular compartment defined between the first and second sheets of material for receiving the count sheet; and 
 iii) a fastener for attaching the count sheet holder to the sterilization wrap; 
   f) disposing the count sheet in the count sheet holder to form a sterilization package;   g) sterilizing the sterilization package until the at least one surgical instrument is sterilized.   
     
     
         13 . The method of  claim 12 , wherein the count sheet holder is disposed after the sterilization step. 
     
     
         14 . The method of  claim 12 , wherein the count sheet holder is reused in a subsequent sterilization operation. 
     
     
         15 . A system for hospital based sterilization of surgical instruments, comprising:
 a) a sterilization container having a bottom portion and a top portion, at least one of the bottom portion and the top portion defining at least one hole therethrough to permit a sterilant to pass therethrough, wherein the bottom portion and top portion cooperate to define an interior compartment for receiving surgical instruments to be sterilized;   b) at least one surgical instrument disposed in the sterilization container;   c) a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization container; and   d) a count sheet holder disposed on the sterilization container, the count sheet holder including:
 i) a cover portion; 
 ii) a body portion; 
 iii) a hinge attaching the cover portion to the body portion, wherein the body portion and cover portion cooperate to define a compartment for containing a count sheet when the cover is closed; and 
 iv) a fastener for fastening the count sheet holder to the sterilization container. 
   
     
     
         16 . The system of  claim 15 , wherein the count sheet holder further includes at least one outwardly extending tab on at least one of the cover portion and body portion to facilitate opening or closure of the count sheet holder. 
     
     
         17 . The system of  claim 16 , wherein the count sheet holder further includes at least one vent to permit air or other gas to be evacuated from the compartment. 
     
     
         18 . The system of  claim 16 , wherein the count sheet holder includes an interlocking bead along two parallel sides of the count sheet holder. 
     
     
         19 . The system of  claim 15 , wherein the sterilization container includes at least one handle or latch and wherein the fastener of the count sheet holder includes a strap extending from the count sheet holder for attaching to the handle or latch of the sterilization container. 
     
     
         20 . The system of  claim 19 , wherein the strap includes a tip located at a distal end of the strap having at least one barb for engaging an opening defined in the strap. 
     
     
         21 . The system of  claim 20 , wherein the opening is cross-shaped. 
     
     
         22 . The system of  claim 15 , wherein the count sheet holder includes a snap closure to maintain the count sheet holder in a closed condition. 
     
     
         23 . The system of  claim 15 , wherein the count sheet holder is at least partially transparent to permit the contents of the count sheet holder to be viewed from outside the count sheet holder when the count sheet holder is mounted on the sterilization container. 
     
     
         24 . A method for sterilizing surgical instruments in a hospital, comprising:
 a) providing a sterilization container having a bottom portion and a top portion, at least one of the bottom portion and the top portion defining at least one opening to permit a sterilant to pass therethrough, wherein the bottom portion and top portion cooperate to define an interior compartment for receiving surgical instruments to be sterilized;   b) disposing at least one surgical instrument in the sterilization container;   c) providing a count sheet including a listing describing the at least one surgical instrument disposed in the sterilization container;   d) disposing a count sheet holder on the outside of the sterilization container, the count sheet holder having a body portion defining a compartment for containing a count sheet;   e) disposing the count sheet in the count sheet holder to form a sterilization package;   f) sterilizing the sterilization package until the at least one surgical instrument is sterilized.   
     
     
         25 . The method of  claim 24 , wherein the count sheet holder further includes:
 a) a cover portion; and   b) a fastener for fastening the count sheet holder to the sterilization container.   
     
     
         26 . The method of  claim 24 , wherein:
 a) the sterilization container includes at least one handle;   b) the fastener of the count sheet holder includes a strap extending from the count sheet holder for attaching to the handle of the sterilization container; and   c) the disposing step includes directing the strap of the fastener of the count sheet holder around the handle of the sterilization container to attach the count sheet holder to the sterilization container.   
     
     
         27 . The method of  claim 24 , wherein the body of the count sheet holder includes an elongate tube closed on a first end and open on the second end, and the count sheet holder further includes:
 i) a cover portion adapted and configured to attach to the second end of the body portion; and   ii) a fastener a for fastening the count sheet holder to the sterilization container.   
     
     
         28 . The method of  claim 25 , wherein the count sheet holder further includes a hinge attaching the cover portion to the body portion, wherein the body portion and cover portion cooperate to define the compartment for containing a count sheet when the cover is closed. 
     
     
         29 . The method of  claim 24 , wherein disposing the count sheet in the count sheet holder includes rolling the count sheet holder into a cylindrical shape prior to inserting the count sheet into the body portion of the count sheet holder. 
     
     
         30 . The method of  claim 29 , wherein disposing a count sheet holder on the outside of the sterilization container includes attaching the count sheet holder to the container using a strap.