JP2017509363A - System and method for preventing erroneous site surgery - Google Patents

Abstract

The container holds at least one surgical instrument, has a locking mechanism, and has a signature label that prevents access to the surgical instrument until the correct surgical site is identified. To use the container, confirm the correct surgical site, sign the label, remove the label from the container, place the label in the medical record, unlock the container, remove the surgical tool, and start the surgery , Where the surgical team is forced to pause to confirm the correct surgical site before starting the surgery. Preferably, the container top is removed and placed between the surgeon and the surgeon to define a “neutral zone” where the hands to prevent stabs by sharps are not crossed. The container also preferably has a compartment for storing syringes filled with used sharps and / or local anesthesia, and the top is replaced after surgery for safe disposal of sharps. It may be closed tightly. [Selection] Figure 20

Description

  The present invention relates generally to surgical devices and methods, and more particularly to surgical devices and methods for preventing erroneous site surgery.

  In the United States, avoidable patient injuries, or the unacceptable rate of so-called medical errors, has attracted much attention in recent years. Estimating the number of annual medical errors in the United States is difficult to confirm, but a recent publication, Dr. Lucian Leape, “To Err is Human” has an avoidable mortality rate of 48 years per year. It is suggested to be between 6,000 and 96,000 patients.

  According to the definition of the Association of Medical Institutions (JCAHO), wrong site surgery includes wrong left and right sides or parts of the body, wrong treatment, and wrong patient surgery.

(Incidence of wrong site surgery)
Between January 1995 and March 2001, JCAHO investigated voluntary reports of 1,152 “Sentinel Events”. Wrong site surgeries were 114 cases (9.9%) and included procedures in neurosurgery, urology, orthopedics, and vascular surgery. Despite the positive attitude of JCAHO's sentinel event policy, underreporting by medical institutions probably affects these statistics. Only 66% of the 1,152 total events were “self-reported” by the institutions involved; the rest came from patient complaints and media stories. Compared to the 114 cases that JCAHO received from the United States over a period three times longer than that, the New York State Department of Health used the mandatory reporting system for the period from April 1, 1998 to March 31, 2000. Received 46 false site surgical reports. This suggests that spontaneous incident reports can underestimate the true incidence of false site surgery more than 20 times.

  The American Medical Insurance Association (PIAA) investigated claims data from 22 medical malpractice carriers representing 110,000 physicians between 1985 and 1995. There were 331 wrong site surgeries. The complete PIAA database documents nearly 1000 terminated medical malpractice claims, including erroneous site surgery. However, this number also probably underestimates the incidence of erroneous site surgery. Most false site surgeries involve relatively minor procedures (arthroscopy rather than limb amputations or major neurosurgical procedures), so sequelae may be minimal and unclaimed There is. As a result, false site surgical rate estimates derived from litigation data, as well as estimates based on incident reports, probably underestimate the true rate of this problem.

(Factors identified as contributing to wrong site surgery)
Several factors have been identified that can contribute to an increased risk of erroneous site surgery. These risk factors include the following:
More than one surgeon participated in the procedure because multiple procedures were envisaged or the patient's care was transferred to another surgeon;
• Multiple treatments on the same patient during a single trip to the operating room, especially if multiple treatments are performed on the left and right different sides of the same patient;
Abnormal temporal pressure associated with unusual start time, or pressure to speed up preoperative procedures; and body that may alter the normal process for instrument setup and patient positioning Abnormal patient characteristics such as physical malformations and excessive obesity.

The root cause identified by the hospital was mostly related to the procedures used for communication, patient preoperative evaluation, and surgical site validation. Communication issues fall into two main categories:
Failure to engage the patient (or family, if appropriate) in the process of identifying the correct surgical site, either during the informed consent process or by the physical act of marking the intended surgical site And • Surgical teams by excluding certain members of the surgical team (eg, surgical surgeons) from participating in the surgical site validation process, or by relying solely on the surgeon to determine the correct surgical site Incomplete or inaccurate communication between members of

The integrity of the patient's preoperative assessment was a frequent contributor, often through failure to review medical records and imaging studies in the period immediately before surgery. The procedure for validating the correct surgical site was found to be often defective due to the following factors:
・ There is no formal procedure;
・ There is no final check in the operating room;
Lack of verbal communication in the verification procedure;
• Not all relevant information sources available in the operating room;
There is no checklist to ensure that all relevant sources have been checked;
• Some members of the surgical team were excluded from the verification process and felt that they were not allowed to point out possible mistakes; and I left it up.

(Measures by the Japan Association of Medical Institutions (JCAHO) to reduce surgery at the wrong site)
JCAHO proposes the following feasible strategies to reduce the risk of erroneous site surgery:
• Engage patients in the marking process to clearly mark the surgical site and increase the reliability of the marking process;
・ Requires verbal confirmation of the correct surgical site in the operating room by each member of the surgical team;
A validation checklist that includes all documents that refer to the intended surgical procedure and surgical site, including medical records, X-ray and other imaging studies, and direct observation of the surgical site marked on the patient by the surgical team To develop;
・ Surgeon's involvement in obtaining informed consent;
• Ensure through ongoing monitoring that verification procedures are in place for high-risk actions; and • “Time-out” just before the action begins.
(Source: Federation of Medical Institutions (JCAHO) Sentinel Event Alert, 6th edition, August 28, 1998)

  Unfortunately, this seemingly most preventable problem still occurs, despite the implementation of measures to prevent wrong patients, wrong sites, and left and right side surgery. (The above statistics do not cover the number of times a transplant or device was to be placed as part of the procedure and when the surgeon was ready to use them, they were not available. In these examples, the surgeon either changes the plan or waits while the surgical team attempts to locate the appropriate implant or equipment that is sometimes present in another hospital. The false assumption of medical professional incontinence contributed to this problem, coupled with the fact that tissue medicine focuses on individual medical errors rather than systematic approaches.

  In an attempt to improve patient safety, a JCAHO accredited institution is required to comply with “universal protocol to prevent wrong site, wrong procedure, wrong person's operation”, effective July 1, 2004 Is done. As part of the universal protocol, a “pause” or “timeout” is required. This serves as a final confirmation of the following items prior to the incision: (1) correct patient; (2) correct treatment, site and left and right sides; and, where applicable, (3) graft tissue or device availability. This agrees that all members of the surgery team pause to review the surgery and that the correct treatment is being performed on the correct patient, at the correct surgical site, and on the right and left sides, This is the expected time.

  In theory, this ensures that any errors that have been made can be detected before incision. In practice, however, “timeouts” are rarely done; and even when done, there is no unified or organizational aspect. The universal protocol does not specify the specific time at which the pause occurs, and the protocol about what should happen during the pause, i.e. what information should be communicated by whom to whom Not specified.

  Thus, it can be seen that there is a need for improved surgical procedures and devices to prevent or at least reduce false site surgery. It is primarily directed to satisfy these and other needs that the present invention is directed to.

Association of Medical Institutions (JCAHO) Sentinel Event Alert, 6th edition, August 28, 1998

  Generally speaking, the present invention imposes a pause just before surgery begins, and performs a pre-operative assessment to identify the exact site of surgery that the surgical team will perform during the pause. Thus, a system and method for preventing erroneous site surgery is provided. By imposing a pre-operative assessment, the surgical team has a last chance to catch any avoidable mistakes that could otherwise lead to erroneous site surgery.

  In a first embodiment of the invention, the system includes a container that holds one or more surgical instruments, a locking mechanism for securely closing the container, and a peel that prevents or at least obstructs access to the locking mechanism. Includes a confirmation label. The surgeon cannot easily open the container to obtain the surgical tool until the correct surgical site is confirmed and the label is removed. Surgical tools include one or more scalpels or other blades, syringes loaded with local anesthetics, needles, scopes, and / or other surgical tools necessary to initiate surgery. The label includes, for example, a checklist for confirming surgery related information and one or more locations for signature.

  In one aspect of the invention, the locking mechanism includes a locking member that fits through two openings in the container that align when the container is closed. Preferably, the container has a bottom and a top that slides away from the bottom, with one lock opening passing through the top and the other lock opening of an internal partition defining a compartment for the surgical instrument. Formed inside.

  In another aspect of the invention, the bottom of the container has one or more dedicated compartments for the surgical needle. In use, the bottom may be placed next to one member of the surgical team to store the surgical needle after it has been used in surgery. Thereafter, at the end of the surgery, the container may be closed and all surgical sharps may be safely disposed of at once.

In yet another aspect of the invention, the top of the container may be removed from the bottom and placed between the surgeon and one member of the surgical team to define a neutral zone where the hands do not cross. If the neutral zone is clearly defined, the incidence of punctures when handing surgical sharps back and forth is reduced.

In another aspect of the invention, the container may be adapted to be tracked and / or monitored, for example using a data collection and / or display device, system or technique fixed to at least a portion of the container.

In another aspect of the invention, the container can be adapted to provide a surgical team with a quick and easy visualization mechanism to indicate the correct site on which surgery is to be performed, ie, the left or right side.

  In use, the system forces the surgical team to pause before starting surgery after the patient is draped and the surgeon and surgical technician wear a sterile gown together, at which time all surgical team members Suspend to ensure that they have the right patient, the right surgery is performed on the right site and the left and right sides, and all necessary surgical instruments or implants are physically available . Once the information is confirmed, this may require the surgeon to review medical records and imaging studies; the surgeon removes the double tip pen from the top of the container and signs the label on the container Use the ink side. The label is then peeled off and placed in the medical record, and the surgeon now has access to a lock to open the container and remove the surgical tool.

  The pen's surgical marking pen side can be used to mark an incision. The top of the container is then turned upside down and functions as a surgical neutral zone, which allows sharp instruments to be exchanged between surgeons and surgical technicians without actually passing the sharp instruments from hand to hand. Define possible "neutral zones" where hands do not cross. The container may also have a pre-loaded local anesthetic with needle and syringe to further facilitate the start of surgery. In addition, the compartment within the container has a region with a printed numbered foam pad for counting and storage of suture needles and other sharps, and at the end of the operation, the container is counted. It can be safely reclosed with all sharps in the container and safely discarded as a unit.

  In a second exemplary embodiment, the bottom of the container has four compartments including one short syringe compartment. In a third exemplary embodiment, labels are affixed to the top and bottom of the container to lock the container closed, so that the label doubles as a lock. In a fourth embodiment, the locking member is provided by a coupling member that is attached through an aligned opening formed by two external tabs on the container, and a label covers the locking member.

In a fifth embodiment, the locking member is provided by a wrapping material surrounding the container and the label is removably applied to the wrapping material or to a pull tab for opening the wrapping material. And in yet another embodiment, the container does not include the locking mechanism or includes the locking mechanism, but the label does not cover the locking mechanism, but the label is prominently arranged and difficult to notice. This hinders access to opening the container, which urges the surgical team to pause to perform a pre-operative assessment to confirm the correct site of surgery.

  A method of preventing erroneous site surgery includes providing a container having a label attached to the container so that the surgical tool can be held and peeled off to verify information related to the surgery. Performing a pre-operative evaluation using the label to confirm the correct surgical site; removing the label from the container; opening the container and removing the surgical tool; Using the method. Thus, a pre-operative evaluation to confirm that the correct surgical site has been identified is performed prior to making an incision and starting surgery. Preferably, the container comprises a locking mechanism that securely closes the container, and the label is arranged to prevent access to the locking mechanism so that the label must be removed to open the container.

  In one aspect of the method of the present invention, the container has a top that is removed to open the container. The method further includes placing the top of the removed container between the surgeon and one of the members of the surgical team to define a neutral zone where the hands do not collide; and creating a stab at each other And exchanging surgical sharps between the surgeon and one member of the surgical team. The exchange is performed by a procedure in which the surgeon places surgical sharps on top of the container and a member of the surgical team picks them up and vice versa.

In another aspect of the method, the container includes a bottom having at least one compartment for holding a surgical tool and one or more additional compartments for a surgical needle, and one of the members of the surgical team. Placing the bottom of the container removed next to the person. The method further includes storing the used surgical needle in a dedicated compartment at the bottom of the container after the surgical needle has been used in a surgical procedure. The method further includes the step of returning the top of the container to close the container at the end of the surgery; and safely discarding the container with the used sharps in it.

  The specific techniques and structures used by the present invention to remedy the shortcomings of conventional devices and to achieve the advantages described herein are described in the detailed description of the exemplary embodiments of the invention and the accompanying drawings and It will be apparent from the claims.

FIG. 1 is a perspective view of a container for surgical sharps according to a first exemplary embodiment of the present invention, showing the container in a closed and locked position. FIG. 2 is a left side view of the container of FIG. FIG. 3 is a top view of the container of FIG. 1 showing the label on the container, including a confirmation / signature label covering the locking member so that the container is not unlocked and opened until the label is removed. Show. FIG. 4 is a perspective view of the container of FIG. 1 unlocked and in the open position. FIG. 5 is a cross-sectional view of the container of FIG. 1 taken along line 5-5, showing the locking member being removed from the aligned locking openings to unlock the container. 6 is a perspective view of the lock member of FIG. FIG. 7 is a plan view of the handling instruction label of FIG. FIG. 8 is a plan view of the confirmation / signature label of FIG. FIG. 9 is a plan view of a label covering the surgical pen of FIG. FIG. 2 is a top view of the container of FIG. 1 ready for use, used in surgery to hold a syringe loaded with a local anesthetic and a surgical blade, and empty space for used sutures and syringe needles. Indicates the section. It is a perspective view in use of the container bottom part of FIG. 10, and shows a mode that the used surgical suture and syringe needle are stored in those exclusive divisions. FIG. 11 is a schematic view of the container shown in FIG. 10 in use, showing the container bottom holding surgical sharps and the container top inverted and defining a neutral zone between the surgeon and surgical technician. FIG. 13 is an exploded perspective view of a container for surgical sharps according to a second exemplary embodiment. FIG. 14 is a plan view of the bottom of the container of FIG. FIG. 15 is a perspective view of a container for surgical sharps in a closed and locked position, according to a third exemplary embodiment. FIG. 16 is a perspective detail view of a container for surgical sharps according to a fourth exemplary embodiment, showing the label being peeled away to expose the lock. FIG. 17 is a side view of a container for surgical sharps according to a fifth exemplary embodiment, showing a label located on a sterile inner packaging wrapped with an outer packaging. FIG. 18 is a plan detail view of the container of FIG. 17 showing the sterile inner packaging opener strip and pull tab. FIG. 6 is a perspective view of a container for a surgical instrument in a closed position, according to another embodiment of the invention. FIG. 6 is a perspective view of a container for a surgical instrument, showing an outer container, according to another embodiment. FIG. 20 is a top view of the container of FIG. 19. FIG. 6 is a perspective view of a container for a surgical instrument according to another embodiment of the present invention, showing the container with an RFID transponder. FIG. 5 is a perspective view of a container for a surgical instrument according to another embodiment of the present invention, showing the container having a data storage device. FIG. 23A is a perspective view of a container for a surgical instrument according to another embodiment of the present invention, showing the container with a central control unit. FIG. 23B is a schematic diagram of the components of an illustrative embodiment of a central control unit. FIG. 6 is a perspective view of a container for a surgical instrument according to another embodiment of the present invention, illustrating one example of a surgical site visual indicator. FIG. 5 is a perspective view of a container for a surgical instrument according to another embodiment of the present invention, illustrating another example of a surgical site visual indicator. FIG. 26 is a perspective view of one embodiment of a lock pin member including a data collection and / or display device. FIG. 27 is a top view of one embodiment of a lock pin member including an alternative embodiment of a data collection and / or display device. FIG. 28 is a perspective view of one embodiment of a lock pin member including a data collection and / or display device and a flash drive. FIGS. 29A and 29B are a flow diagram illustrating an exemplary embodiment of a method for preventing mistakes that make mistakes during surgery in accordance with the present invention. 1 is a schematic view of a surgical system using a surgical container according to the present invention. FIG. 6 is a perspective view of a container for a surgical instrument according to another embodiment of the present invention. FIG. 32 is another perspective view of the container shown in FIG. 31. FIG. 32 is a top view of the container shown in FIG. 31. FIG. 32 is a bottom view of the container shown in FIG. 31. It is a side view of the container shown in FIG. FIG. 32 is another side view of the container shown in FIG. 31. FIG. 32 is a front view of the container shown in FIG. 31. FIG. 32 is a rear view of the container shown in FIG. 31.

  Referring to the drawings, the present invention includes a surgical system and a method of using the surgical system to impose a preoperative assessment to prevent erroneous site surgery. The system includes a container that holds one or more surgical tools required for surgery, a locking mechanism for securely closing the container in a closed position, and a position that prevents or at least obstructs access to the locking mechanism. Contains certain confirmation and / or signature labels. In this way, the surgical team is forced to pause and deal with the label in order to access the surgical tools necessary to initiate the surgery.

  Reference is made to FIGS. 1-11 illustrating a surgical system 10 according to a first exemplary embodiment of the present invention. FIGS. 1-4 show the surgical container 12, locking mechanism 14, and verification and signature label 16 of the surgical system 10. The container 12 has a bottom 18 and a top 20, which can be placed in the closed position of FIG. 1 and the open position of FIG. In the illustrated embodiment, the top 20 and bottom 18 slide relative to each other to open and close the container 12. For example, the container 12 may have an edge and groove structure 22 so that the top 20 can slide away from the bottom 18. In addition, the container may include a detent or other structure for snapping the top 20 and bottom 18 so that it cannot freely open and slide when it is unlocked.

  In an alternative embodiment, the container has a hinge for pivotal opening movement, preferably with a hinge that allows the top to be separated from the bottom. The size of the container 12 is selected primarily based on the intended contents and may be customized for different types of surgery and / or surgeons. In general, however, the container 12 is not too large to get in the way or too small to be overlooked. In a typical commercial embodiment, the container 12 is about 1-2 inches high, about 4-6 inches wide, and about 8-10 inches long. The container 12 is also preferably approximately rectangular with a corrugated top end to facilitate gripping and is preferably made of a plastic material, although other materials may be used as appropriate. it can.

  Preferably, the bottom surface of the bottom 18 and the top surface of the top 20 are provided with gripping properties so that they do not slip on a substantially horizontal surface on which they are placed. For example, the gripping properties are attached to the bottom surface of the bottom 18 and the layer 13 of friction material, such as rubber or soft plastic, that is fitted or applied to the top surface (or part thereof) of the top 20. A pad 15 with an adhesive made of a friction material such as rubber or soft plastic may be included. In this way, the top 20 that is inverted from the bottom 18 is held in place during use, as will be described in detail below.

  With further reference to FIGS. 5 and 6, the locking mechanism 14 firmly secures the container 12 in the closed position. The locking mechanism 14 preferably includes a single locking member that is received in lock engagement with the top and bottom of the container through two aligned locking openings. For example, in the illustrated embodiment, when the container 12 is in the closed position, the locking member 24 slides linearly into the first locking opening 26 on the top 20 and the second locking opening 28 on the bottom 18. The locking member 24 preferably has a locking pin 32 housed in the aligned openings 26 and 28 and a knob 34 for ease of gripping by hand. The top 20 has a recess 36 that is configured to at least partially accommodate the knob 34 to provide a low profile, in which the first locking opening 26 is disposed. The second locking opening 28 is preferably formed within one or more partition walls 38 that define a compartment in the bottom 18 so that the opening is not obstructed and another to define the opening. Does not require an upright structure. The locking member 24 can be made of plastic, metal, or other material. It will be appreciated that other types of locking mechanisms may be used to accomplish the objectives described herein.

  Still referring to FIGS. 7-9, the confirmation and signature label 16 can be peeled off and the locking member so that the locking member 24 cannot be accessed to unlock the container 12 until the label is peeled off. 24 is covered. In the exemplary commercial embodiment shown in FIG. 8, the confirmation and signature label 16 has a front surface that can be written on, including a checklist that a surgical technician fills in, and a surgical team member. It has a place to sign after confirming that the information entered in the checklist is correct. For example, the checklist should preferably be correct for the patient name, surgical procedure type / name, left and right of the incision (left, right, or midline), and right and left of the pathology (left, right, or midline). Provide confirmation and confirmation that appropriate equipment and any surgical implants are present and counted.

  It will be appreciated that the verification and signature label 16 may be customized for the same or other surgical applications and is therefore not limited to the specific expressions presented herein. Thus, in alternative embodiments, the checklist may require the same surgical related information as the illustrated embodiment, only some of this information, or additional information. Preferably, the confirmation and signature label 16 has an adhesive on the back and has a pull tab so that it can be easily removed from the container 12 and, if desired, after being signed and peeled off It may be placed in a medical record (patient medical history / medical record / file).

  The container 12 also preferably has instructions for use displayed prominently on the container. For example, in the illustrated embodiment, instructions for use are shown on an adhesive label 40 affixed to the top 20 of the container. Alternatively, instructions for use may be printed or marked directly on the container 12 or elsewhere, or omitted.

  Still referring to FIG. 10, the container 12 preferably has an adhesive applied to the top 20 of the container to cover and hold the pen 44 in a recess 46 formed in the top 20 of the container. It has a label 42. The pen 44 preferably has marking ends 48, 50 at both ends. The writing end 48 is similar to a conventional ink pen for writing and signing on the confirmation and signature label 16. The surgical end 50 is then similar to a conventional surgical pen with indelible ink for marking the surgical site on the patient's body prior to surgery, and possibly for the surgeon's signature. In an alternative embodiment, the pen 44 may be removably attached to the container 12 by a hook-and-loop fastener or other conventional attachment structure; the pen 44 may be a conventional ink pen or surgical pen at the end. It may be omitted. A small measurement ruler may also be included in the recess 46 or provided (eg, etched, printed, or affixed) on the container, for example at location 52 (FIG. 4).

  The bottom 18 of the container 12 preferably has several compartments (collectively referred to as compartments 54) defined by an internal partition wall 38. The size, shape and configuration of the compartment 54 may be selected for the surgical instrument desired to be retained in the container 12 and so customized depending on the surgery and surgeon. In the illustrated embodiment, the container 12 includes a first compartment 54a preloaded with a syringe 56 containing a local anesthetic such as lidocaine, and one or more surgical blades such as # 10 and # 15 scalpels. 58 has a second compartment 54b preloaded. It will be appreciated that the container 12 may include both a syringe 56 and a blade 58, only one of them, and / or other surgical instruments such as a surgical needle packet. In alternative embodiments, the compartment may include other types of blades, blade handles, disposable scalpels, syringes containing other local anesthetics, arthroscopic probes, and / or other necessary to initiate the surgery. Surgical tools, sized, shaped and configured. Further, the second section 54b for the blade 58 may have a foam lining sheet.

Still referring to FIG. 11, the illustrated container 12 is sized, shaped and configured to store used syringe needles 60 and suture needles 62 after use in surgery. And a fourth section 54d. The compartments 54c and 54d are preferably lined with adhesive sheets 64 and 66, which have numbered spaces that hold the used needles in place and facilitate the counting of used needles. For example, the attachment sheets 64 and 66 can be made from foam and / or magnetic material.
The first section 54a can also be used for many purposes, such as holding an unused suture package 68 so that it can be easily accessed as needed during surgery. Therefore, it can be seen that the bottom of the container in FIG. 10 shows a state just opened, and the bottom of the container in FIG. 11 shows a state during use during surgery.

  A method of using the system 10 to prevent erroneous site surgery will be described. The container 12 is provided in the closed, locked position of FIGS. 1-3 and is preloaded with one or more surgical tools necessary to begin the surgery. The confirmation and signature label 16 prevents access to the locking member 24 so that the surgical team must address the label before the container 12 can be unlocked and opened to begin the operation. This effectively enforces a pause or “time-out” before surgery begins, thereby facilitating preoperative evaluation. At this point, the surgeon initiating the operation fills in the checklist on label 16. For example, when using the confirmation and signature label 16 of FIG. 8, the surgeon will have the correct patient present, the correct type / name of the surgical procedure, the right and left of the incision (right, left, or midline), pathological Check for correct left and right (left, right, or midline) and presence of appropriate equipment and / or required surgical implants.

  The attending surgeon will then review all the information that has been verified and entered on the signature label 16 by the surgical technician and he / she will review him / her to indicate that the information has been reviewed and confirmed that the information is correct. Sign her name. Thereafter, the surgeon (or surgical surgeon) removes the confirmation and signature label 16 from the container 12, removes the locking member 24 (or activates a locking mechanism to unlock the container), and removes the container 12. Open (see FIG. 4) to access the surgical tool in the container. The stripped confirmation and signature label 16 can be placed in the medical record to document that a “timeout” and confirmation has been made. At this point, the start time of the operation is recorded and it is considered that the operation has started.

  Individual hospital operating room policies preferably require that the operating / attending surgeon himself open the container and / or sign his / her name before making an incision. In this way, the system 10 operates on every operation to ensure that the correct operation is performed on the correct side, on the correct patient, and that all necessary surgical instruments or implants are available. Force the team to pause at the same time (ie, just before the incision). A container for a surgical instrument and a verification and / or signature label arranged to prevent or prevent opening the container to force a pause immediately prior to surgery, but herein It will be appreciated that other surgical systems not specifically described in may be used with the present system to achieve the functionality described herein. Also, the system 10 is possible, but not intended, to replace the current surgical antecedents (ie, all of JHACO's advice / recommendations) to prevent erroneous site surgery. It should be noted that it is designed to complement existing strategies by forcing a pause immediately before, giving it a last chance to prevent false site surgery.

  The uniqueness of the system 10 provides additional safety features. One of these safety features relates to the “neutral zone”, which is generally considered to be the area between surgeons and surgical technicians, where the surgeon's hand and the surgeon's hand are It is assumed that you will never meet. In practice, however, this is a rough, undefined range, which is a range of surgeons and technicians who are embraced, slightly turned to one side and / or their weight during the course of surgery. Shifting can enlarge, reduce, and shift. Because of this, and to concentrate on the patient and the surgical procedure, surgeons and technicians occasionally create stabs when handing sharp instruments back and forth.

Still referring to FIG. 12, after the container 12 has been opened to begin surgery, the top 20 of the container is flipped so that when the surgeon 70 and surgeon 72 are heading towards the operating table 74, It may be placed on a cart or other horizontal surface between. As described above, the top surface of the top 20 of the container and the bottom surface of the bottom 18 of the container are preferably provided with gripping performance so that they do not slip and move during the operation. In this position, the top 20 of the container defines a well-defined, laterally neutral zone 76 that is not allowed to touch. When the surgeon 72 finishes using the sharp instrument, he can simply place it in the neutral zone, i.e., the top 20 of the inverted container. The surgeon 70 can similarly add or remove a sharp instrument from the top of the inverted container. By having a well-defined neutral zone 76 for the surgeon 72 and the surgeon 70 to never actually deliver sharp instruments to each other and instead to deliver sharps indirectly to each other, The occurrence rate can be reduced.

  The container bottom 18 can also be placed on a cart or other horizontal surface next to the surgeon 70 (eg, opposite the container top 20), or at other locations convenient for the surgeon. For the surgeon 70, because the container bottom 18 is accessible, he / she can use all of the conventional sharps boxes or needle holders or counters in a manner that normally uses them, as shown in FIG. The container bottom can be used during the surgery to store used sharps (eg, scalpel, needle). Container 12 or at least its top 20 may be red to minimize the possibility of needle sticks, similar to conventional sharps boxes. Alternatively, other colors such as purple or opaque may be used.

Furthermore, at the end of the surgery, all sharps used during the surgery can be placed in the container 12 and the container can be closed and safely discarded. A detent or other snap structure on the container 12 keeps the container closed. Additionally, the locking mechanism 14 may include a detent or other snap structure so that the locking member can be reinserted to securely close the container. In this way, all of the surgical sharps used during surgery can be safely discarded as a single unit.

  Referring to FIGS. 13 and 14, a surgical system 110 according to a second embodiment of the present invention is shown. Similar to the system 10 of the first embodiment, the system 110 is housed in a container 112 having a bottom 118 and a top 120, an alignable first opening 126 (not shown), and a second opening 128. A locking mechanism having a locking member 124 and a number of dividing walls 138 forming a compartment 154 for the surgical tool. However, in this embodiment, compartment 154b extends across the entire container bottom 118, and compartments 154a, 154c, and 154d each have the same length. Also, the foam insert sheets 64 and 66 for compartments are configured for different arrangements of compartments.

Referring to FIG. 15, a surgical system 210 according to a third embodiment of the present invention is shown. The system 210 has a container 212 having a bottom 218 and a top 220 and a verification and signature label 216, similar to the embodiment described above. However, in this embodiment, the label 216 extends across the bottom 218 and top 220 of the container 212 to keep the container closed. Thus, label 216 also functions as a locking mechanism and thus does not include a separate locking mechanism. In use, after label 216 is filled, signed, and peeled from container 212, the container can be opened to begin surgery without additional removal of another locking member.

Referring to FIG. 16, a surgical system 310 according to a fourth embodiment of the present invention is shown. The system 310 includes a locking mechanism 314 having a container 312 having a bottom 318 and a top 320, and a locking member 324 received in two alignable openings 326, 328, similar to the first embodiment. However, in this embodiment, the locking member is a plastic tie band or twisted string, and the alignable locking openings 326 and 328 are defined in a knob extending from the outside of the container. The system 310 may also include a spare string 324 for relocking the container 312 after use for safe disposal of the container. In an alternative embodiment, the locking mechanism is provided by a conventional slide lock or snap lock mechanism similar to a commercially available surgical sharp box.

With reference to FIGS. 17 and 18, a surgical system 410 according to a fifth exemplary embodiment of the present invention is shown. The system 410 is similar to the second exemplary embodiment and has a container 412 for a surgical instrument and a verification and / or signature label 416 that is used and peeled off just prior to initiating surgery. However, in this embodiment, the locking mechanism is provided as a packaging material 414 having a label 416 thereon. The packaging material 414 is preferably made of a transparent plastic material and is formed therein with a perimeter opening strip 415a, similar to the packaging material, opener strip, and red pull tab on a conventional compact disc case. A pull tab 415b. Label 416 is preferably positioned over packaging material 414 across pull tab 415 so that pull tab 415b is pulled and opening strip 415a is pulled to partially open the packaging material when peeling the label. The The label 416 wraps around or around most of the circumference of the container 412 so that in order to remove the packaging material 414, the label must first be peeled off, which is preoperatively. Encourage a pause for evaluation.

In the embodiments described herein, all of these components are sterilized so that the surgeon can sign the label on the operating table just prior to beginning the procedure. In order to maintain the packaging material in a sterile condition, an outer packaging material 478, preferably peelable, is provided to surround the sterile components, as shown in FIGS.

In other exemplary embodiments, the system comprises a container for a surgical instrument and a confirmation and / or signature label affixed to the container so that it can be peeled, but the locking mechanism for the container is Has a locking mechanism that is not or not covered by a label. Instead, the label is placed directly or indirectly on the container to simply prevent it from opening; that is, the label is in a prominent position so that it is not easily overlooked, and the label is Encourage the surgical team to perform a pre-assessment. Such an embodiment is provided by a first exemplary embodiment modified to have no locking mechanism and a fourth exemplary embodiment modified such that the label is only at the top of the container.

In yet another alternative embodiment, the system has a container with a surgical scalpel (or other surgical tool) in it and has another way to force a pause without filling out the label. For example, the system can include a locking mechanism for the container that itself forces a pause. The lock may be a small combination lock, which is known only to the operating room nurse. Physicians and surgical technicians confirm that they have the correct patient and correct surgery, communicate that information to the operating room nurse, who then verifies the information and then locks the combination. Give the doctor and surgical technician a code to unlock.

19A-25, an alternative embodiment of a surgical system according to the present invention will be described. The surgical system 500 has many similarities to the embodiments described above. Surgical system 500 preferably includes a container 512 that is adapted to be trackable and / or capable of electronically communicating with other components of system 500. The ability to be tracked and / or electronically communicate with other components of the system 500 allows the surgical user to continuously monitor and verify that the scheduled surgical procedure for a patient is correct. Thereby extending the prevention of erroneous site surgery to multiple patient-healthcare interactions.

The container 512 has a top 514 and a bottom 516 that are tightly closed together, thereby providing one internal compartment. The inner compartment is designed to hold a surgical instrument as described in FIG. 4, FIG. 10 or FIG. The internal compartment is designed to hold preloaded surgical instruments that are specific to each surgical procedure. As part of system 500, it has one or more labels similar to those previously described, such as label 16 described and illustrated in FIG. At least the label for the surgeon or other surgical team member should be filled with information about the surgical site, that is, the information on the surgical site to perform a preoperative evaluation to confirm the correct surgical site. Must be allowed to do.

The container 512 has a locking mechanism, shown as a pin member 518, which slidably engages the top 514 and / or is disposed within the top 514, as shown in FIGS. The size and shape are determined such that at least a portion of the member 518 is firmly secured in an opening located in the bottom 516. Another mechanism for locking the container 512 may include a conventional slide lock or snap lock mechanism similar to a commercially available surgical sharp box or other previously described mechanism. Whatever mechanism locks the container 512, the label must cover the locking mechanism and / or prevent unlocking of the locking mechanism before peeling the label. To assist the user in signing the label, the top 514 of the container 512 may have a recessed holding area 520 that is sized and shaped to hold a writing instrument such as the pen 522. In order to hold the pen 522 in the recessed holding area 520, the writing instrument locking member, which is depicted herein as two parallel spaced finger-like extensions 524 and 526, is held in Secured to the bottom surface 527 of region 520. The finger-like extensions 524 and 526 have some elasticity so that when the pen 522 is inserted between the two finger-like extensions 524 and 526, both of them are separated. When the pen 522 is fully inserted, the finger-like extensions 524 and 526 snap back to the original position to secure the pen 522 in place.

  To enable monitoring and / or tracking, a tracking and / or monitoring mechanism is disposed on or together with the container 512, which may include, for example, a data collection and / or display device or system or other digital information option, Is preferably shown as a bar code (optical machine readable representation of data) 528, which is a unified product code (UPC). The UPC can be programmed with patient identification information similar to the aforementioned labels, including the patient's name or other identification means, the type of surgery, the surgical site, and the physician name. Therefore, when a doctor or a member of a medical support team scans the barcode 528 with a barcode reader or scanner, they can see the information. Alternatively, the container may use a two-dimensional bar code, such as a quick response code (QR code®) adapted to be read by an imaging device such as a camera.

Referring to FIG. 21, the container 512 is shown with another embodiment using a tracking and / or monitoring mechanism, shown herein as, for example, a radio frequency identification (RFID) transponder 530. RFID transponder 530 generally includes a chip for storage and / or processing, an antenna for transmitting and receiving information, and an inlay for supporting the chip and antenna. Although any RFID transponder known to those skilled in the art can be used, RFID transponder 530 is an active tag with a battery that runs the microchip circuit, or a microchip circuit that induces the antenna of the tag to induct. A passive tag that does not have a battery and uses an RFID reader designed to transmit electromagnetic waves to supply power. RFID transponder 530 can be a read-only tag with pre-written data on it, a write-once tag that allows the user to write data to the tag only once, or the user can write new data to the transponder as needed. It can be a full read / write tag that can be written.

  The inlay may be a base film that can support and hold the chip and the antenna. Alternatively, the inlay can be a label or tag with a self-adhesive coating to ensure that the RFID chip and antenna are attached to the surface. The inlay may be embedded in a plastic casting or cast in a polyurethane resin coating.

22-25 show an example of a container 512 having additional functions. FIG. 22 shows a container 512 having an additional recessed storage area 532 adapted to store a data storage device, shown here as flash drive 534. The flash drive 534 preferably includes patient related information that can be transported to the operating room anywhere the container 512 moves, i.e., from the location of the initial preoperative discussion. 23A and 23B show a container 512 that has been converted to a “smart” container. The top 514 is adapted to include a central control unit 536 that includes, for example, a processor 538, a memory 540, an image processor 542, a GPS function 544, and a Bluetooth® wireless function 546. Central control unit 536 is powered by battery 550 and is electrically connected to a display unit 552 such as LED screen 554, see FIG. 23A. Data input devices such as buttons 558 and a keyboard (not shown) may be included to allow the user to input data. The container 512 may also include a connection point shown herein as a USB port 560 to allow data transfer from the central control unit 536 to a flash drive or via a cable to a computer system. .

  24 and 25 are diagrams showing the high-speed identification characteristics of the container 512. FIG. As part of the overall surgical system 500, the container is equipped with a visual indicator to alert the surgical team which side of the patient (left or right), sometimes referred to as “left and right”, the surgical procedure will be performed. Designed to provide easy and fast visualization to use. As shown in FIG. 24, the container 512 is colored code of some red shades, all or at least partially displayed herein with pink / rose hash marks to show the right surgical procedure. A top 514, a bottom 516, and a lock pin 518. The locking mechanism is preferably colored as well. FIG. 25 shows a dashed hatch reference, container 512 and lock pin 518, which has a surgical indicator on the left and is illustrated as a purple base color, preferably lavender. Alternative visual indicators may include symbols, characters, words or phrases. In either embodiment, the surgeon or surgical team member can simply assure that the location or left and right of the surgical site is aligned with the color of the container 512.

  FIGS. 26-28 illustrate a pin member 518 that is adapted to include additional features that enhance tracking capabilities and / or allow electronic communication with other components of the system 500. As shown in FIG. 26, the knob 560 includes a bar code 528 secured to the side 562. FIG. 27 is a top view of the pin member 518 and shows the RFID transponder 530 secured to the top surface 564. FIG. 28 shows a pin member 518 having a recessed knob receiving area 566 that is sized and shaped to receive a data storage device such as a flash drive 534.

The container 512 may include the entire period including hospitalization / pre-operative period, pre-operative treatment day in the pre-operative waiting area, and the actual operating room, depending on the ability to be tracked and / or communicated with other components of the surgical system. It can be used in multiple time periods during a surgical procedure. The system, apparatus and method according to the present invention, with reference to FIGS. 29A and 29B, provide multiple protection steps at multiple points in time when the patient passes through the surgical environment, thereby enabling the wrong patient, wrong site, Designed to prevent false left and right side surgery. As used herein, the terms “surgical environment” or “surgical procedure” refer to his / her medical team, including but not limited to office personnel, nurses, medical technicians, surgeons, and the like. Define any period of interaction with a medical team associate. The duration of interaction includes before and during hospitalization, including before, during and after surgery.

(Pre-surgery reservation)
Guaranteeing prevention of erroneous site surgery begins in the first step of the surgical procedure. At the time of surgery appointment, an error begins and the error persists throughout the entire period of the actual surgical procedure. Referring to step 610, the system and method of the present invention begins when a surgeon's office schedules surgery with a patient. At the time the surgery is scheduled by the hospital, the patient's name and information is associated with a single container, preferably a traceable container such as container 512.

The container 512 may be given a unique container identification number similar to the vehicle identification number (VIN) used for automobiles. A container identification number (CIN) is established at the time of manufacture and persists with a particular container. This number is unique to the container, the number is not reused and never applies to different containers. The unique identification number can be integrally formed in the container, or it can be attached to the container as part of a separate label or as part of a QR® / scan code. When a unique number is assigned to a container and / or is further associated with a particular patient, the container and patient information associated therewith is serialized. This allows the container to be tracked and analyzed as it moves through the medical system.

  If it is determined that the patient has incorrect information, i.e. if the patient should have undergone the right surgery, but the container is coded for the left surgery, the container is destroyed and the The reason for destruction is electronically attached to the unique number. This means that the hospital or manufacturer examines all containers manufactured or scheduled for one medical procedure to determine how many containers were actually used in such a surgical procedure. to enable. For containers that are not being used, the reasons for failure to use in medical procedures, potential errors (incorrect / inaccurate manual entry), incorrect site operations / medical accidents that should never occur It can be reviewed and provides insight into when, where, and why a surgical error occurred. Such regular review of data gives hospitals the ability to identify areas that need improvement.

Referring to step 614, if the patient is undergoing a surgical procedure that requires the surgeon to perform a specific left and right side procedure, the color coded as described in FIGS. 24 and 25. A container 512 is associated with the patient. For surgical procedures that do not require left and right, the container 512 will be achromatic, such as gray.

  An alternative embodiment of the medical system 500 may include the use of a non-sterile outer box 521, as shown in FIG. 19B, which has an upper portion 523 that can be secured to the lower portion 525 and contains a container 512. To do. Preferably, the outer box includes a tracking and / or electronic communication mechanism such as a barcode or RFID tag. Outer box 521 may also be color coded to match the color of container 512. In this way, the container 512 can be transported to various locations and / or handled by the surgical team on the way to the operating room without concern for contamination. In addition to color coding or color matching, various patient-related information, such as patient name, medical history, surgical procedure, left and right sides of surgery, and associated color codes, can be found on identification and tag labels such as bar scans. Coded.

Referring to step 618, at the time of the surgical procedure, the container 512 is delivered to the patient in the preoperative waiting area. With reference to step 620, at this point, many opportunities are available to confirm that the patient will receive the correct surgical procedure at the correct surgical site. When the surgeon visits the patient, discusses the surgery, and perhaps marks the surgical site, the surgeon 622A and the patient 622B will confirm the surgical site. Additional surgical team members may also perform a surgical procedure check. For example, the preparation room nurse 622C and the operating room nurse 622D can confirm that the patient information is correct by matching the patient information and the scan bar information. Thus, surgeon 622A, preparation room nurse 622C, and operating room nurse 62D may scan a barcode using a barcode reader.

  If the information matches, the patient continues the medical procedure process. As part of the system 500, when a barcode scan is performed, the information may be displayed with a matching color background so that medical professionals can easily and quickly visually confirm left and right. Good (ie, the surgical procedure for the right side is displayed in at least a rosy color that matches the rosy color of the container 512). The determination or confirmation of the surgical procedure and / or location at this point can prevent errors made by the surgeon's office or hospital schedule manager when scheduling an operation. Also, all members of the surgical team are aware of which procedure is being performed on the correct patient and on which side of the procedure the procedure will occur. Referring to step 624, if the surgeon or member of the surgical team determines that the operation is not scheduled correctly, a new container 512 with the correct information is ordered and brought to the pre-operative waiting area.

  Referring to step 626, if it is determined that the patient information is correct, he / she is transferred to the operating room. At this point, the patient is checked in. Referring to step 628, patient information may be verified at check-in and checked against the barcode information in container 512. Referring to step 630, the operating room nurse enters this information into the electronic health record. This information must match the information already in the electronic health record. Referring to steps 632 and 634, if any information is in error, the electronic health record can be suspended or “frozen” so that any individual accessing the health record The patient will know that they should not undergo any surgical procedure.

Referring to step 636, container 512 is presented to the surgeon when it is determined that the information is relevant, ie, it is the right patient, it is the right surgery, and the right surgery site. . If the container 512 is in the outer box, the surgeon simply removes the outer box and opens the container 512. Referring to step 638, in each case, once the patient is ready and draped, a formal and final timeout is performed by a member of the surgical team. Referring to step 640, the surgeon fills in a label placed on the locking mechanism of container 512, such as label 16, or scans barcode 530, and with reference to step 642, removes the label. Remove. The system 500 can be adapted to allow the surgeon to perform an electronic signature, which can then be transferred to the patient's chart. If the container 512 includes a flash drive or other storage device, the surgeon or nurse can use such a device to match patient information in the electronic medical record. If any information does not match, a freeze may occur and warn those involved in the surgery to stop further procedures. Referring to step 644, he / she can now open the container 512 to gain access to the surgical instrument in the container and begin surgery.

Referring to FIG. 30, the present invention is shown linked to a smart operating room. For example, the container 512 disposed in the surgical operating room 700 may include a container control panel such as the control panel 554. An information reader such as an RFID reader 702 is disposed in the surgical operating room 700 for reading the RFID tag 530. The container control board 554 is preferably electronically connected to a hospital or central control unit 704 with one or more central computers 705 outside the operating room 700 via wired or wireless technology. The control unit may be a manned station that functions like a flight control tower. Alternatively or in addition, the container control board 554 may be in electronic communication with an operating room control unit 706 located in the operating room having at least one computer 707. An individual on duty to the central control unit 704 may give the surgeon in the operating room 700 permission to proceed to the operation of opening the container 512 based on information received from the container, for example, using a radio frequency device. . Based on the received information, the container may be opened remotely using an electronic lock 710 on the container 512. Preferably, the lock is electrically coupled or in communication with the hospital controller 704 and / or operating room control unit 706.

Additional features of the system may include a container 512 and / or a surgical instrument having LEDs attached to allow tracking by an optical or camera-guided navigation system. In addition to the features described above, it is understood that the container 512 includes or is adapted to include one or more of the features described above as part of the system or as a feature of an embodiment of the container. .

In addition to providing a timeout, the medical system 500 allows for tracking errors from pre-operative hospitalization to the actual surgical procedure. This provides the hospital with valuable data regarding where errors or potential errors may have occurred.

Thus, the present invention provides many advantages. In particular, the system and method of the present invention is sufficient and consistent with final confirmation of the correct patient, procedure, and surgical site and, where applicable, final confirmation of the graft or instrument immediately prior to the incision. I guarantee that. The marking of the surgical site, the need to use and remove a confirmation checklist before accessing the surgical blade needed to start the surgery, and the resulting openness between the patient, surgeon, and surgical team Communication, all of which contribute to reducing medical errors in the wrong site. The surgical container provided by the present invention also provides a needle box for disposing of sharps at the end of surgery, and stabs from surgeons and surgeons who pass sharp instruments such as scalpels and needles to each other. Or it can be used as a neutral zone during surgery to reduce the incidence of lacerations. Furthermore, the use of the present invention can be extended to other areas of the hospital where incisions may be made, such as interventional imaging rooms, intensive care units, or emergency rooms.

With reference to FIGS. 31-38, another embodiment of a container 810 is shown. Container 810 has a top 814 and a bottom 816 that are closed together tightly to provide one interior compartment. The inner compartment is designed to hold a surgical instrument as described in FIG. The internal compartment is designed to hold pre-loaded surgical instruments specific to each surgical procedure. One or more labels similar to those shown previously, such as the label 16 described and shown in FIG. 8, can be secured to the container 810. The label fills at least the surgeon, or other surgical team member, with surgical site information, i.e., surgical site information to perform a pre-operative assessment to confirm the correct surgical site, within the label entry location. It is necessary to allow that.

The container 812 has a locking mechanism, similar to the pin member 518 described in FIGS. 4-6, shown in this drawing as the pin member 818, which slidably engages the top 514. , And / or is sized and shaped to be disposed within the top 514 such that at least a portion of the pin member 518 is secured within an opening located in the bottom 516. The ring 819 is fixed to the pin member 818 or formed integrally with the pin member, and functions as a mechanism for grasping and pulling out the pin member 818. Another mechanism for locking the container 812 may include a conventional slide lock or snap lock mechanism, similar to a commercially available surgical sharp box or other previously described mechanism. Whatever mechanism locks the container 812, the label must cover the locking mechanism and / or prevent the locking mechanism from being released prior to removal of the label.

To assist the user in signing the label, the top 814 of the container 812 may have a recessed holding area 820 that is sized and shaped to hold a writing instrument such as a pen 822. In order to hold the pen 822 in the recessed holding area 820, the writing instrument locking member, which is depicted herein as two parallel separated finger-like extensions 824 and 826, is held recessed. Secured to the bottom surface 827 of region 820. Finger-like extensions 824 and 826 have some resilience so that when pen 822 is inserted between two finger-like extensions 824 and 826, they both leave. When the pen 822 is fully inserted, the finger-like extensions 824 and 826 snap back to the original position to secure the pen 822 in place. A plurality of vents 828 are used to allow release of materials such as heat / steam when the device is sterilized. Adjacent to the recessed retention region 820 is a second or expanded recessed region 830 that includes a locking mechanism, shown herein as a compression member 832, which is stored underneath. It can be used as a consolidation point for surgical instruments such as surgical blades.

In addition to the features described above, the container 810 may include one or more of the features described above, including but not limited to monitoring and / or tracking or color coding functions as part of the system or as a feature of the container embodiment. It will be appreciated that may be adapted to have

The present invention is not limited to the specific apparatus, methods, conditions, or parameters described and / or shown herein, and the terminology used herein is by way of example only for certain embodiments. It should be understood that this is for the purpose of explaining. Accordingly, the terms are intended to be interpreted broadly and are not intended to limit the claimed invention. For example, in the specification including the appended claims, the singular forms “a”, “an”, and “the” include the plural, the term “or” means “and / or”, and the specific value. A reference to includes at least its specific value unless the context clearly indicates otherwise. In addition, any method described in this specification is not limited to the order of the steps described unless explicitly stated otherwise in this specification, and may be performed in any other order. .

Although the invention has been described with reference to one exemplary embodiment, various modifications, additions and deletions are within the scope of the invention as defined by the following claims. Those skilled in the art will appreciate.

Claims (14)

It is a system for preventing mistakes that make mistakes in surgical sites in surgical procedures,
A top having a first locking portion adapted to engage with a second locking portion; and a bottom having the second locking portion adapted to engage with the first locking portion; A container having;
One or more surgical tools disposed in one or more compartments;
A locking mechanism that securely closes the container in the closed position;
A peelable label having a checklist for confirming surgery related information and one or more signature areas;
The label is disposed within the container to prevent or obstruct access to at least a portion of the locking mechanism without first removing the label; and secured to at least a portion of the container A data collection and / or display device;
A system for preventing mistakes that make mistakes in the surgical site in a surgical procedure.   The system according to claim 1, wherein the data collection device is a bar code.   The system for preventing errors and mistakes in a surgical site according to claim 1, wherein the data collection device is a radio frequency identification (RFID) transponder.   The top has a first locking opening sized and shaped to receive a locking pin, and the bottom has a second locking opening sized and shaped to receive a locking member. The bottom is adapted to slide into engagement with the top so that the top and the bottom can move between a closed position and an open position, each being located within the top or within the bottom 2. The method according to claim 1, wherein when the lock opening is in the closed position, an overlap direction is formed to accommodate the lock member. system.   The locking mechanism for securely closing the container in the closed position has a locking pin having at least a portion for linearly engaging the top and the bottom when the container is in the closed position; The system for preventing the mistake which made a mistake in the surgery site in the surgical treatment of Claim 3 characterized by these.   The system for preventing mistakes in a surgical procedure according to claim 1, wherein the container is adapted to provide a visual indication for indicating the surgical site.   The system according to claim 1, wherein the visual indication is a color code.   The system according to claim 1, wherein the top and bottom have one or more compartments for holding surgical instruments. A method for preventing an error in a surgical operation in a surgical operation,
Identifying an individual in need of a surgical procedure;
Encoding the personal information into a data collection and / or display device;
A top having a first locking portion adapted to engage with a second locking portion; and a bottom having the second locking portion adapted to engage with the first locking portion; A container having;
One or more surgical tools disposed in one or more compartments;
A locking mechanism that securely closes the container in the closed position;
A peelable label having a checklist for confirming surgery related information and one or more signature areas;
The label is disposed within the container to prevent or obstruct access to at least a portion of the locking mechanism without first removing the label; and secured to at least a portion of the container A data collection and / or display device;
Associating with the individual in need of a surgical procedure;
Using the data collection and / or display device secured to at least a portion of the container to verify patient information when the individual in need of a surgical procedure participates in a medical environment; ;
A method for preventing mistakes that make mistakes in the surgical site during a surgical procedure.   Further comprising associating a visual display device with the container, the visual display device providing a visual confirmation to the user regarding the surgical site of the individual on which the surgical procedure is to be performed. The method for preventing the mistake of operating site mistakes in the surgical treatment of Claim 9.   11. The visual display device of claim 10, wherein the visual display device is a color code, wherein the color indicates a treatment for the left or right anatomical portion of the individual in need of a surgical procedure. A method for preventing mistakes in the surgical site during a surgical procedure.   The surgical procedure of claim 9, wherein the step of associating the container with the patient in need of a surgical procedure occurs when the patient is scheduled for a surgical procedure. To prevent mistakes in the surgical site. 10. A method for preventing mistakes in the surgical site of the surgical procedure according to claim 9, wherein the container is obtained at a surgical site;
Verifying the correct surgical site and entering the surgical site information in the surgical site information input area of the label to perform a pre-operative assessment to confirm the correct surgical site;
Removing the label from the container and storing the label as a medical record for the preparation of subsequent evidence that a pre-operative evaluation to confirm the correct surgical site was actually performed;
Opening the container and removing the at least one surgical instrument and using the at least one surgical instrument at the start of surgery;
Have
Here, a pre-operative assessment to confirm the correct surgical site is performed in a timely manner before opening the container, removing at least one surgical instrument, and starting surgery with the at least one surgical instrument;
Timely execution of the pre-operative assessment is facilitated by the label being placed to prevent or at least prevent opening of the container, and the initial position, input area, and removal of the label are Effectively accomplishing the dual purpose of firstly encouraging the promotion of the pre-operative evaluation and secondly producing documentation that the pre-operative evaluation was actually performed,
A method for preventing mistakes and mistakes in the surgical site in a surgical procedure.   14. The method according to claim 13, wherein the step of verifying the correct surgical site comprises obtaining data from the data collection and / or display device. Way for.

Images