System and method for preventing wrong-site surgeries

• US 20060096877A1
• Filed: 11/09/2005
• Published: 05/11/2006
• Est. Priority Date: 11/09/2004
• Status: Active Grant

• Current Assignee: StartBox, LLC
• Original Assignee: StartBox, LLC
• Inventors: Khajavi, Kaveh, Griffin, James D.
• Granted Patent: US 8,616,215 B2
• Time in Patent Office: Days
• US Class Current: 206/363
• CPC Class Codes: A61B 2050/0059 parallel to the lid plane
• CPC Class Codes: A61B 2050/008 Pegs inserted, e.g. forced, into openings
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 50/3001 for sharps
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 50/362 for sharps

Abstract

A container holds at least one surgical implement, has a lock mechanism, and has a signature label that impedes access to the surgical implement until the correct surgical site is confirmed. A method of using the container includes the steps of confirming the correct surgical site, signing the label and removing it from the container, placing the label in the medical record, unlocking the container, removing the implement, and beginning the surgery, wherein the surgical team is forced to pause to confirm the correct surgical site before starting the surgery. Preferably, the container top may be removed and placed between the surgeon and surgical technician to define a no-hands “neutral zone” to avoid being stuck by the sharps. Also, the container preferably includes compartments for storing used sharps and/or a local anesthetic-loaded syringe, and the top may be replaced and secured for safely disposing of the sharps after the surgery.

Claims

1. A system for preventing a wrong-site error during a surgical procedure, comprising:

a container movable between a closed position and an open position, the container defining one or more internal compartments;

one or more surgical implements positioned within the one or more compartments, wherein the surgical implements are needed when beginning the surgical procedure;

a lock mechanism that secures the container in the closed position; and

a removable label including a checklist for confirming surgery-related information and one or more fields for signatures, wherein the label is positioned covering access to the lock mechanism so that in order to open the container, the label must first be removed.

2. The system of claim 1, wherein the one or more surgical implements comprise a syringe loaded with a local anesthetic, at least one surgical blade, or both.

3. The system of claim 1, wherein the one or more compartments include dedicated compartments for storing surgical needles after they have been used in the surgical procedure.

4. The system of claim 1, wherein lock mechanism includes a lock member and two alignable openings in the container for receiving the lock member with the container in the closed position.

5. The system of claim 4, wherein the container includes a top and a bottom that slidably move relative to each other between the closed and opened positions, the top defines a first one of the lock openings, the bottom has one or more internal divider walls that define the one or more compartments, and the divider walls define a second one of the lock openings.

6. The system of claim 4, wherein lock member comprises a tie member.

7. The system of claim 1, further comprising a pen with a first writing ink tip for writing on the label and a second surgical indelible ink tip for preoperatively marking a surgical location on a patient'"'"'s body, wherein the pen is removably attached to the container.

8. The system of claim 1, wherein container has a bottom and a top that is removable from the bottom in the open position so that the bottom may be positioned and used for storing used surgical implements and the top may be positioned between a surgeon and a surgical team member and used to define a neutral zone where hands do not meet.

9. The system of claim 8, wherein top and the bottom have frictional features so that the bottom does not slip and the top, when inverted, does not slip, when placed on generally horizontal surfaces.

10. A system for preventing wrong-site surgery, comprising:

a container having a bottom and a top that is movable between a closed position and an open position, the bottom defining one or more internal compartments;

one or more surgical implements positioned within the one or more compartments;

a removable label for confirming surgery-related information, wherein the label is positioned on the container to prevent or at least impede opening the container unless the label is first filled out and removed.

11. The system of claim 10, wherein the one or more surgical implements comprise a syringe loaded with a local anesthetic, at least one surgical blade, another surgical implement needed when beginning a surgical procedure, or a combination thereof.

12. The system of claim 10, wherein the one or more compartments include dedicated compartments for storing surgical needles after use.

13. The system of claim 10, further comprising a lock mechanism that secures the container in the closed position, wherein the lock mechanism is positioned so that label prevents or at least impedes accessing the lock mechanism to open the container unless the label is first removed.

14. The system of claim 10, wherein the label is removably attached to at least a portion of the top and at least a portion of the bottom to lock the container in the closed position.

15. The system of claim 10, further comprising a wrapper enclosing the container to lock it in the closed position, wherein the label is removably attached to the wrapper.

16. The system of claim 15, wherein the wrapper includes a circumferential opener strip and a pull tab, and the label is positioned over the pull tab.

17. A method of preventing wrong-site surgery, comprising:

providing a container holding at least one surgical implement, and a label for confirming surgery-related information, wherein the label is removably attached to the container;

using the label to conduct a pre-operative assessment confirming a correct surgical site;

removing the label from the container;

opening the container and removing the at least one surgical implement; and

using the at least one surgical implement at the outset of the surgery, wherein the pre-operative assessment confirming the correct surgical site is done before starting the surgery.

18. The method of claim 17, wherein the container has a lock mechanism securing it closed and the label is positioned blocking access to the lock mechanism so that the label must be removed to open the container.

19. The method of claim 17, wherein the container includes a top that is removed to open the container, and further comprising:

positioning the removed container top between a surgeon and a surgical team member to define a neutral zone where hands do not meet; and

exchanging surgical sharps between the surgeon and the surgical team member without sticking each other, wherein the surgeon places selected ones of the surgical sharps within the container top for the surgical team member to then pick up, and vice versa.

20. The method of claim 17, wherein the container includes a bottom with at least one compartment that holds the at least one surgical implement and with one or more dedicated compartments for surgical needles, and further comprising:

positioning the removed container bottom beside a surgical team member; and

after the surgical needles have been used in the surgery, storing the used surgical needles in the dedicated compartments in the container bottom.

21. The method of claim 19, wherein the container includes a bottom with at least one compartment that holds the at least one surgical implement and with one or more dedicated compartments for surgical needles, and further comprising:

positioning the removed container bottom beside a surgical team member;

after the surgical needles have been used in the surgery, storing the used surgical needles in the dedicated compartments in the container bottom; and

replacing the top on the container to close the container; and

disposing of the container with the used sharps safely inside.

22. The method of claim 17, wherein the step of using the label to conduct a pre-operative assessment confirming a correct surgical site comprises:

filling out a checklist of surgery-related information; and

signing in a signature field.