System and method for preventing wrong-site surgeries

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.

TECHNICAL FIELD

The present invention relates generally to surgical devices and procedures and, in particular, to surgical devices and procedures for preventing wrong-site surgeries.

BACKGROUND OF THE INVENTION

A great deal of attention has recently been given to the unacceptable rate of avoidable patient injuries, or so-called medical mistakes, in the United States. Estimates of the number of medical mistakes per year in the United States is difficult to ascertain, but a recent publication,To Err is Human, by Dr. Lucian Leape, suggests that the avoidable death rate for medical mistakes are between 48,000 and 96,000 patients per year.

As defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), wrong-site surgery includes wrong side or site of the body, wrong procedure, and wrong-patient surgeries.

Prevalence of Wrong-Site Surgery

From January 1995 to March 2001, JCAHO reviewed voluntary reports of 1,152 “sentinel events.” Wrong-site surgery accounted for 114 cases (9.9%) and included procedures in neurosurgery, urology, orthopedics, and vascular surgery. Despite the high profile of JCAHO's Sentinel Event Policy, under-reporting by healthcare organizations likely affects these statistics. Only 66% of the 1,152 total events were “self-reported” by the institutions involved; the balance coming from patient complaints or media stories. Using a mandatory reporting system, the New York State Department of Health received 46 reports of wrong-site surgery from Apr. 1, 1998 through Mar. 31, 2000, compared with 114 cases JCAHO received nationally over a period 3 times longer. This suggests that voluntary incident reporting may grossly underestimate the true incidence of wrong-site surgery by a factor of 20 or more.

The Physician's Insurance Association of America (PIAA) reviewed the claims data from 22 malpractice carriers representing 110,000 physicians from 1985 to 1995. There were 331 cases of wrong-site surgery. The complete PIAA database documents almost 1,000 closed malpractice claims involving wrong-site surgery. However, this figure also likely underestimates the prevalence of wrong-site surgery. Since most wrong-site surgeries involve relatively minor procedures (arthroscopy, rather than limb amputations or major neurosurgical procedures), sequelae are minimal and may not result in a claim. Consequently, estimates of the incidence of wrong-site surgery derived from litigation data likely underestimate the true prevalence of this problem, as do estimates based on incident reports.

Factors Identified as Contributing to Wrong-Site Surgery

Several factors have been identified that may contribute to an increased risk of wrong-site surgery. These risk factors include:More than one surgeon involved in the case, either because multiple procedures were contemplated or because the care of the patient was transferred to another surgeon;Multiple procedures were conducted on the same patient during a single trip to the operating room, especially when the procedures were on different sides of the patient;Unusual time pressures related to an unusual start time or pressure to speed up the preoperative procedures; andUnusual patient characteristics such as physical deformity or massive obesity that might alter the usual process for equipment set-up or positioning of the patient.

The root causes identified by hospitals were most often related to communication, preoperative assessment of the patient, and the procedures used to verify the operative site. Communication issues fall into two major categories:Failure to engage the patient (or family, when 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; andIncomplete or inaccurate communication among members of the surgical team, often through exclusion of certain members of the team (e.g., surgical technicians) from participation in the site verification process, or through reliance solely on the surgeon for determining the correct operative site.

The completeness of the preoperative assessment of the patient was a frequent contributing factor, often through failure to review the medical record or imaging studies in the immediate preoperative period. The procedures for verifying the correct operative site were found to be flawed in many cases due to:No formal procedure;No final check in the operating room;The absence of any oral communication in the verification procedure;All relevant information sources not available in the operating room;No checklist to ensure all relevant information sources were checked;Some members of the surgical team were excluded from the verification process and felt they were not permitted to point out a possible error; andTotal reliance on the surgeon for verifying the surgical site.

JCAHO Strategies for Reducing Wrong-Site Surgery

The Joint Commission offers the following possible strategies for reducing the risk of wrong-site surgery:Clearly mark the operative site and involve the patient in the marking process to enhance the reliability of the process;Require an oral verification of the correct site in the operating room by each member of the surgical team;Develop a verification checklist that includes all documents referencing the intended operative procedure and site, including the medical record, X-rays and other imaging studies and their direct observation of the marked operative site on the patient;Personal involvement of the surgeon in obtaining informed consent;Ensure through ongoing monitoring that verification procedures are followed for high-risk procedures; and

“Time out” immediately before starting the procedure. (Source: Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert, issue six, Aug. 28, 1998.)

Despite the implementation of strategies to prevent wrong patient, wrong site, wrong side surgery, regrettably this seemingly most preventable of complications still occurs. (The aforementioned statistics do not address the number of times in which implants or instrumentation is going to be placed as a part of the procedure, and are not available when the surgeon is ready for them. In these instances, the surgeon must either change plans, or wait while the surgical team attempts to locate the appropriate implants or instrumentation, sometimes located at another hospital.) The fraudulent assumption of a medical professional's infallibility, coupled with organized medicine's focus on the individual's medical mistakes rather than a systems approach have contributed to this problem. In an attempt to improve patient safety, “[e]ffective Jul. 1, 2004, compliance with the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery will be required of all Joint Commission accredited organizations.” As a part of the universal protocol, a “pause” or “time out” is required. This serves as a final verification of: (1) the correct patient; (2) the correct procedure, site and side; and as applicable, (3) the availability of implants or instrumentation, prior to making incision. This is a time when all members of the surgical team are supposed to pause to review the case, and agree that the correct procedure is being done on the correct patient, at the correct site, and on the correct side. In theory, this would ensure that any errors that had been made could be detected prior to incision. In reality, the “time out” seldom occurs; and when it does, not in any uniform or regular manner. The universal protocol does not specify a particular time for the pause to occur, and it does not specify a protocol as to what should happen during the pause, that is to say, what information should be communicated by whom, and to whom.

Accordingly, it can be seen that a need exists for improvements to surgical procedures and devices to prevent or at least reduce wrong-site surgeries. It is to the provision of meeting these and other needs that the present invention is primarily directed.

SUMMARY OF THE INVENTION

Generally described, the present invention provides a system and method for preventing wrong-site surgeries by imposing a pause just before the surgery starts, during which time the surgical team conducts a pre-operative assessment to confirm that correct site of the surgery about to be performed. By imposing the pre-operative assessment, the surgical team gets one last chance to catch any avoidable mistake that would otherwise lead to a wrong-site surgery.

In a first example embodiment of the present invention, the system includes a container that holds one or more surgical implements, a lock mechanism for securing the container closed, and a removable confirmation label that blocks or at least impedes access to the lock mechanism. The surgeon cannot readily open the container to get the surgical implements until the correct surgical site has been confirmed and the label has been removed. The surgical implements include one or more scalpels or other blades, a syringe loaded with a local anesthetic, a needle, a scope, and/or other surgical implements needed at the outset of the surgery. The label includes, for example, a checklist for confirming surgery-related information and one or more fields for signatures.

In one aspect of the invention, the lock mechanism includes a lock member that fits through two openings in the container that align when the container is closed. Preferably, the container includes a bottom and a top that slides off the bottom, with one lock opening being through the top, and the other lock opening formed into an internal divider wall that also defines compartments for the surgical implements.

In another aspect of the invention, the container bottom has one or more dedicated compartments for surgical needles. In use, the bottom may be positioned beside a surgical team member for storing surgical needles after they have been used in the surgery. Then, at the conclusion of the surgery, the container may be closed and the surgical sharps all safely disposed of at once.

In yet another aspect of the invention, the container top can be removed from the bottom and positioned between the surgeon and a surgical team member to define a neutral zone where hands do not meet. With the neutral zone clearly defined, the incidence of stickings when passing the surgical sharps back and forth is reduced.

In another aspect of the invention, the container can be adapted to be tracked and/or monitored using, for example, a data capture and/or display device, system or technology secured to at least one portion of said container.

In another aspect of the invention, the container can be adapted to provide a quick and easy visualization mechanism to relate to the surgical team the correct site, i.e. left side or right side, the surgical procedure should occur.

In use, the system forces a surgery team to pause prior to initiating the surgery, after the patient is draped and the surgeon and surgical technician are both sterilely gowned, when all members of the surgical team pause to make sure that they have the correct patient, the correct operation is being performed, on the correct site and side, and all necessary surgical instrumentation or implants are physically available. Once that information is confirmed, which might require the surgeon to review the medical record or the imaging studies; the surgeon removes a dual-tipped pen from the top of the container and uses the ink side to sign the label on the box. The label is then removed and placed in the medical record, and the surgeon now has access to the lock to open the container and remove the surgical implement(s). The surgical marking pen side of the pen can be used to mark the incision. The container top is then turned upside down and serves as the surgical neutral zone, which defines a hands-free “neutral zone” where sharp instruments can be traded between the surgeon and surgical technician without the actual passing of sharp instruments from hand to hand. In addition, the container may also have pre-loaded local anesthetic with a needle and syringe, to further expedite the starting of the operation. Furthermore, compartments in the container will have foam padded areas, with printed numbers, for the counting and storage of suture needles, as well as other sharps, and at the end of the surgical case the container can be reclosed securely, with all the sharps in the container accounted for, and safely disposed of as one unit.

In a second example embodiment, the container bottom has four compartments with a shorter syringe compartment. In a third example embodiment, the label is attached to the top and bottom of the container to lock it closed, so that the label doubles as the lock. In a fourth example embodiment, the lock member is provided by a tie member that fits through aligned openings formed by two external tabs on the container, and the label covers the lock member. In a fifth example embodiment, the lock member is provided by a wrapper that encloses the container, and the label is removably attached to the wrapper or to a pull tab for opening the wrapper. And, in still other embodiments, the container does not include a lock mechanism, or it does include a lock mechanism and the label does not cover it, but the label impedes access to opening the container by being prominently positioned so that it is hard not to notice it, which prompts a pause for the surgical team to conduct the pre-operative assessment to confirm the correct site of the surgery.

The method of preventing wrong-site surgery comprises the steps of providing a container that holds a surgical implement and has a label for confirming surgery-related information, with the label 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 surgical implement; and using the surgical implement at the outset of the surgery. In this way, the pre-operative assessment confirming that the correct surgical site has been identified is done before making an incision and starting the surgery. Preferably, the container is provided with 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.

In one aspect of the method, the container includes a top that is removed to open the container. The method further includes the steps of 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. The exchanging is done by the surgeon placing the surgical sharps into the container top and the surgical team member then picking them up, and vice versa.

In another aspect of the method, the container includes a bottom with at least one compartment that holds the surgical implement and with one or more additional compartments for surgical needles, and positioning the removed container bottom beside a surgical team member. The method further includes the steps of, after the surgical needles have been used in the surgery, storing the used surgical needles in the dedicated compartments in the container bottom. In addition, the method includes replacing the top on the container to close the container at the conclusion of the surgery; and disposing of the container with the used sharps safely inside.

The specific techniques and structures employed by the invention to improve over the drawbacks of the prior devices and accomplish the advantages described herein will become apparent from the following detailed description of the example embodiments of the invention and the appended drawings and claims.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

Referring to the drawing figures, the present invention includes a surgical system and a method of using the surgical system to impose a pre-operative assessment to prevent wrong-site surgeries. The system includes a container that holds one or more surgical implements needed for the surgery, a lock mechanism that secures the container in a closed position, and a confirmation and/or signature label in a position that prevents or at least impedes access to the lock. In this way, the surgical team is forced to pause to deal with the label in order to access the surgical implements needed to start the surgery.

Referring toFIGS. 1-11, where is illustrated a surgical system10according to a first example embodiment of the present invention.FIGS. 1-4show the surgical container12, the lock mechanism14, and the confirmation and signature label16of the surgical system10. The container12has a bottom18and a top20that can be positioned in the closed position ofFIG. 1or the opened position ofFIG. 4. In the depicted embodiment, the top20and the bottom18slide relative to each other to open and close the container12. For example, the container12may include a lip-and-groove arrangement22to permit the top20to be slid off of the bottom18. In addition, the container12may include detents or other structures for snapping closed the top20and bottom18so that the container cannot freely slide open when it is unlocked. In alternative embodiments, the container has a hinge for a pivotal opening motion, preferably with the hinge permitting the top to be separated from the bottom. The size of the container12is selected based primarily on the intended contents and may be customized for different types of surgeries and/or different surgeons. In general, though, the container12is not too large to be obtrusive or too small to escape notice. In a typical commercial embodiment, the container12is about 1-2 inches high, about 4-6 inches wide, and about 8-10 inches long. In addition, the container12is preferably generally rectangular with scalloped top edges for ease of gripping, and is preferably made of a plastic material, though other materials may be suitably employed.

Preferably, the bottom surface of the bottom18and the top surface of the top20are provided with gripping features so that they will not slip on a substantially horizontal surface they are resting upon. For example, the gripping features may include a layer13of frictional material such as rubber or soft plastic inlayed or applied onto the top surface (or a portion thereof) of the top20, and an adhesive-backed pad15of frictional material such as rubber or soft plastic attached to the bottom surface of the bottom18. In this way, the bottom18and the inverted top20are held in place during use, as described in detail below.

Referring additionally toFIGS. 5 and 6, the lock mechanism14secures the container12in the closed position. The lock mechanism14preferably includes a lock member that is received in locking engagement through two aligned lock openings in the top and bottom of the container. For example, in the depicted embodiment the lock member24linearly slides into a first lock opening26in the top20and a second lock opening28in the bottom18when the container12is in the closed position. The lock member24preferably includes a lock pin32that is received in the aligned openings26and28and a tab34for ease of grasping by hand. The top20may have a recess36configured to at least partially receive the tab34to provide a low profile, with the first lock opening26positioned within the recess. The second lock opening28is preferably formed into one or more divider walls38that define compartments in the bottom18, so that the opening is out of the way and so a separate upstanding structure is not required for defining the opening. The lock member24can be made of a plastic, metal, or other material. It will be understood that other types of lock mechanisms may be used to accomplish the herein-described purposes.

Referring additionally toFIGS. 7-9, the confirmation and signature label16is removable and covers the lock member24so it cannot be accessed to unlock the container12until the label is removed. In a typical commercial embodiment shown inFIG. 8, the confirmation and signature label16has a front side that can be written upon and that includes a checklist to be filled out by the surgical technician, and fields where surgical team members sign after confirming that the information entered in the checklist is correct. For example, the checklist preferably provides for confirming the correctness of the patient name, the type/name of the surgical procedure, the laterality of the incision (left, right, or midline), and the laterality of the pathology (left, right, or midline), and for confirming that the proper instrumentation and any surgical implants are present and accounted for. It will be understood that the confirmation and signature label16may be customized for the same or other surgical uses, and thus is not limited to the specific representation depicted herein. Thus, in alternative embodiments, the checklist may call for the same surgery-related information of the depicted embodiment, only some of this information, or additional information. Preferably, the confirmation and signature label16is adhesive-backed and has a pull tab so that it can be easily removed from the container12and, if desired, placed in the medical record (the patient's record/chart/file) after it has been signed and removed.

In addition, the container12preferably has instructions for use prominently displayed on it. For example, in the depicted embodiment the instructions are marked on an adhesive-backed label40that is applied to the container top20. Alternatively, the instructions may be printed or otherwise marked directly on the container12or elsewhere, or they may be omitted.

Referring additionally toFIG. 10, the container12preferably has an adhesive-backed label42applied to the container top20to cover and hold a pen44within a recess46formed in the container top20. The pen44preferably has two marking tips48and50at opposing ends. A writing tip48is similar to a conventional ink pen for filling in and signing the confirmation and signature label16. And a surgical tip50is similar to a conventional surgical pen with indelible ink for pre-operatively marking the surgical site on the patient's body, and optionally for the signature of the surgeon. In alternative embodiments, the pen44may be removably attached to the container12by hook-and-loop fasteners or other conventional attachment structures; the pen44may be a conventional one-tipped ink or surgical pen, or it may be omitted. In addition, a small measuring ruler may be included in the recess46or provided (e.g., etched, printed, or otherwise applied) on the container, for example, at location52(FIG. 4).

The bottom18of the container12preferably includes a number of internal compartments (collectively referred to as the compartments54) defined by the internal divider walls38. The size, shape, and configuration of the compartments54are selected for the surgical implements desired to be held in the container12, and as such may be customized depending on the surgery and the surgeon. In the depicted embodiment, the container12has a first compartment54athat is pre-loaded with a syringe56containing a local anesthetic such as lidocaine, and a second compartment54bthat is pre-loaded with one or more surgical blades58, such as Number 10 and 15 scalpels. It will be understood that the container12may be provided with both the syringe56and the blades58, with only one of these, and/or with other surgical implements such as packets of surgical needles. In alternative embodiments, the compartments are sized, shaped, and configured for including other types of blades, handles for the blades, disposable single-unit scalpels, a syringe with another local anesthetic, arthroscopic probes, and/or other surgical implements needed to start the case. In addition, the second compartment54bfor the blades58may have a sheet of foam lining.

Referring additionally toFIG. 11, the depicted container12has a third compartment54cand a fourth compartment54dthat are sized, shaped, and configured for storing used syringe and suture needles60and62after they have been used in the surgery. The compartments54cand54dare preferably each lined with an attachment sheet64and66that holds the used needles in place and that has numbered spaces for ease in counting the used needles. For example, the attachment sheet64and66may be made of a foam and/or magnetic material. In addition, the first compartment54acan be used for miscellaneous purposes such as holding unused suture packages68so they are readily accessible as needed during the surgery. Thus, it will be noted that the container bottom18ofFIG. 10is shown just opened and ready for use, and the container bottom18ofFIG. 11is shown in the midst of use during the surgery.

A method of using the system10to prevent wrong-site surgeries will now be described. The container12is provided in the closed, locked position ofFIGS. 1-3, preloaded with one or more surgical implements needed to start the surgery. The confirmation and signature label16prevents accessing the lock member24, so the surgical team must deal with the label before it can unlock and open the container12to start the surgery. This effectively forces a pause or “time out” before the surgery can commence, thereby prompting the pre-operative assessment. At this time, the surgical technician who is starting the case fills out the checklist on the label16. For example, when using the confirmation and signature label16ofFIG. 8, the surgical technician checks for the correct patient being present, the correct type/name of the surgical procedure, the correct laterality of the incision (left, right, or midline), the correct laterality of the pathology (left, right, or midline), and the presence of the proper instrumentation and/or needed surgical implants. The attending surgeon then confirms all the information written on the confirmation and signature label16by the surgical technician and signs his name to indicate that he/she has personally reviewed and confirmed the information to be correct. Then the surgeon (or the technician) removes the confirmation and signature label16from the container12, removes the lock member24(or otherwise actuates the lock mechanism to unlock the container), and opens the container12(seeFIG. 4) to access the surgical implements in the container. The removed confirmation and signature label16can be placed in the medical record to document that the “time out” and confirmation was performed. At this point, the surgery start time is recorded, and surgery is considered started.

The individual hospital's operating room policy preferably requires the operating/attending surgeon to open the box him/herself, and/or to sign his/her name prior to making incision. In this way, the system10forces the surgical team to pause at the same time in every case (namely, just prior to incision), to ensure that the correct surgery is being done, on the correct side, to the correct patient, and that all needed surgical instrumentation or implants are available. It will be understood that other surgical systems that include a container for surgical implements and a confirmation and/or signature label that is positioned to block or impede opening of the container to force a pause just before the start of a surgery, but not specifically described herein, may be used with the system to accomplish the functionality described herein. It should also be noted that the system10is not meant to replace current pre-operative measures to prevent wrong-site surgery (Le., all of JHACO's advice/recommendations), though it could, but rather it is designed to supplement those measures by providing a last chance to prevent wrong-site surgery by forcing the pause just before the incision.

The uniqueness of the system10provides additional safety features. One of these safety features relates to the “neutral zone,” which is generally considered to be the area between the surgeon and the surgical technician, where the surgeon's hands and the surgical technician's hands are supposed to never meet. But in practice, this is a general and undefined area, and it can expand, shrink, and shift as the surgeon and technician lean over, turn slightly to one side, and/or shift their weight during the course of the surgery. Because of this, and because of the focus on the patient and the surgical procedure, occasionally the surgeon and technician stick each other when passing sharp instruments back and forth.

Referring additionally toFIG. 12, after the container has been opened to start the surgery, the container top20may be inverted and placed on a cart or other horizontal surface between the surgical technician70and the surgeon72as they face the operating table74. As described above, the top surface of the container top20and the bottom surface of the container bottom18preferably have gripping features so that they do not slip and move during the surgery. In this position, the container top20defines a clearly demarcated, lateral neutral zone76where hands are not allowed to meet. When the surgeon72is done with a sharp instrument, he can simply place it in the neutral zone, that is, in the upside-down container top20. The surgical technician70can likewise add or remove sharp instruments to or from the inverted container top. By the surgeon72and the surgical technician70never actually handing each other sharp instruments, but instead having a clearly defined neutral zone76for indirectly passing sharps to each other, the incidence of needle sticks can be reduced.

Furthermore, the container bottom18may be placed on a cart or other horizontal surface beside the surgical technician70(e.g., on the opposite side of the container top20) or elsewhere in a position that is convenient for the technician. With the container bottom18accessible to the technician70, he/she can use the container bottom during the surgical case to store all the used sharps (e.g., scalpels, needles), as shown inFIG. 11, similarly to how the technician would normally use a conventional sharps box or needle holder or counter. The container12or at least its top20may be red in color, similar to a conventional sharps box, to help minimize the likelihood of needle sticks. Alternatively, another color such as purple or opaque may be used.

Moreover, at the end of the case, all the sharps used during the surgery can be put in the container12, and the container can be closed and safely disposed of. The detents or other snapping structures of the container12hold the container closed. In addition, the lock mechanism14may be provided with detents or other snapping structures so that the lock member can be reinserted to secure the container12closed. This way, all of the surgical sharps used during the case can be safely disposed of as a single unit.

Turning now toFIGS. 13 and 14, there is illustrated a surgical system110according to a second example embodiment of the present invention. Similarly to the system10of the first example embodiment, the system110includes a container112with a bottom118and a top120, a lock mechanism having a lock member124that is received in alignable first opening126(not shown) and second opening128, and a number of divider walls138forming compartments154for the surgical implements. In this embodiment, however, compartment154bextends all the way across the container bottom118, and compartments154a,154c, and154deach have the same length. In addition, the foam sheet inserts64and66for the compartments are configured for the different arrangement of the compartments.

Turning now toFIG. 15, there is illustrated a surgical system210according to a third example embodiment of the present invention. The system210is similar to that of the above-described embodiments, having a container212with a bottom218and a top220and a confirmation and signature label216. In this embodiment, however, the label216is positioned extending across the bottom218and top220of the container212to hold it closed. In this way, the label216also functions as the lock mechanism, so a separate lock mechanism is not included. In use, after the label216is filled out, signed, and removed from the container212, the container can be opened to start the case without additionally having to remove a separate lock member.

Turning now toFIG. 16, there is illustrated a surgical system310according to a fourth example embodiment of the present invention. The system310is similar to that of the first embodiment, having a container312with a bottom318and a top320, and a lock mechanism314with a lock member324received in two alignable lock openings326and328. In this embodiment, however, the lock member is a plastic tie wrap or a twisty tie, and the alignable lock openings326and328are defined in tabs extending from the exterior of the container. In addition, the system310may include a spare tie324for relocking the container312after use for safe disposal. In an alternative embodiment, the lock mechanism is provided by a conventional slide-lock or snap-lock mechanism similar to that of commercially available surgical sharps boxes.

Turning now toFIGS. 17 and 18, there is illustrated a surgical system410according to a fifth example embodiment of the present invention. The system410is similar to that of the second embodiment, having a container412for surgical implements and a confirmation and/or signature label416for use and removal just prior to starting the surgery. In this embodiment, however, the lock mechanism is provided as a wrapper414with the label416on it. The wrapper414is preferably made of a clear plastic material and has a circumferential opener strip415awith a pull tab415bformed into it, similar to the wrapper, opener strip, and red pull tab on some conventional compact disc cases. The label416is preferably positioned on the wrapper414over the pull tab415so that when the label is peeled off, the pull tab415bis pulled and the opener strip415ais pulled to partially open the wrapper. The label416can be sized and shaped so that it wraps all the way, or most of the way, around the container412, so that in order to remove the wrapper414, the label must first be removed, thereby prompting the pause for the pre-operative assessment.

In the embodiments described herein, all of these components are sterilized so that the surgeon can sign the label at the operating table immediately prior to starting the surgery. To maintain the wrapper in sterile condition, a removable outer wrapper478is preferably provided that encloses the sterile components, as shown inFIGS. 17 and 18.

In other example embodiments, the system is provided with a container for surgical implements and a confirmation and/or signature label removably attached to the container, but without a lock mechanism for the container or with a lock mechanism that is not covered by the label. Instead, the label is positioned directly or indirectly on the container to merely impede opening the container; that is, the label is in a prominent position so that it is not easily overlooked and it thereby prompts the surgical team to conduct the pre-operative assessment. Such embodiments are provided by the first example embodiment modified without the lock mechanism, and the fourth example embodiment modified with the label on the container top only.

In still other alternative embodiments, the system includes a container with a scalpel (or other surgical implement) in it, with another way of forcing a pause without filling out a label. For example, the system can include a lock mechanism for the container that by itself forces the pause. The lock can be a small combination lock, with a combination that only the circulating nurse knows. The doctor and scrub tech confirm that they have the right patient and the right operation, and relay that information to the circulating nurse, who then confirms the information and gives them the code to open up the combination lock.

Referring toFIGS. 19A-25, an alternative embodiment of a surgical system in accordance with the present invention is described. The surgical system500has many similarities to that of the above-described embodiments. The surgical system500contains a container512which is preferably adapted to be trackable and/or can electronically communicate with other components of the system500. The ability to be trackable and/or electronically communicate with other components of the system500allows the users of the surgical procedure the ability to continuously monitor and check that the scheduled surgical procedures for a patient is correct, thereby extending the prevention of wrong site surgeries to multiple patient-medical representatives interactions.

The container512has a top514and a bottom516secured together to provide an interior compartment. The interior compartment is designed to hold surgical instruments, such as described inFIG. 4,10, or11. The interior compartment is designed to hold pre-loaded surgical instruments specific for each surgical procedure. As part of the system500, one or more labels, similar to the labels as described previously, for example label16described and illustrated inFIG. 8. The label must allow at least the surgeon, or other surgical team members, to fill in the surgical-site information within an input field of the label, i.e. the surgical-site information to conduct a pre-surgery assessment confirming the correct surgical site.

The container512has a locking mechanism, illustrated herein as a pin member518sized and shaped to slidably engage and/or be positioned within the top514where at least a portion of the pin member518is secured within an opening positioned within the bottom516, as described inFIG. 4-6. Alternative mechanisms for locking the container512may include conventional slide-lock or snap-lock mechanism similar to that of commercially available surgical sharps boxes or other previously described mechanisms. Whatever mechanism locks the container512, the label must cover and/or prevent the locking mechanism from opening prior to the removal of the label. To aid the user in signing the label, the top514of the container512may contain a recessed holding area520sized and shaped to hold a writing utensil, such as a pen522. To retain the pen522within the recessed holding area520, a writing utensil locking member, illustrated herein as two parallel and spaced apart finger-like extensions524and526, are secured to the bottom surface527of the recessed holding area520. The finger-like extensions524and526have some elasticity so that when the pen522is inserted between the two finger-like extensions524and526, both move apart. Once the pen522is fully inserted within, the finger-like extensions524and526snap back to their original position, securing the pen522in place.

To allow for monitoring and/or tracking, positioned on or with the container512is a tracking and/or monitoring mechanism using, for example, a data capture and/or display device or system or other digital information options, illustrated herein as a bar code (an optical machine-readable representation of data)528preferably a Universal Product Code (UPC). The UPC can be programmed with various patient identifying information similar to that of the labels described previously, including the patient name or other identification means, type of surgery, site of surgery, and physician name. As such, when a physician or medical support team member scans the bar code528with a bar code reader or scanner, they will be able to view the information. Alternatively, the container may use a two dimensional bar code, such as a Quick Response Code (QR code), which is adapted to be read by an imaging device, such as a camera.

Referring toFIG. 21, the container512is shown using an alternative embodiment of a tracking and/or monitoring mechanism using, for example, a data capture and/or display device or system, illustrated herein as a radio-frequency identification (RFID) transponder530. The RFID transponder530generally comprises a chip for storage and/or processing, an antenna for transmitting and receiving information, and an inlay for supporting the chip and antenna. While any RFID transponder known to one of skill in the art may be used, the RFID transponder530may be an active tag having a battery which runs the microchip circuitry, or a passive tag without a battery and using a RFID reader which is designed to send electromagnetic waves to induce the tag's antenna to power the microchip circuitry. The transponder530may be a read-only tag which contains data pre-written thereon, a write-once tag which allows the user to write data to the tag one time, or a full read and write tag which enables the user to write new data to the transponder as needed.

The inlay may be a substrate film which can support and hold the chip and antenna. Alternatively, the inlay can be a label or tag having self adhesion coating to ensure that the RFID chip and antenna adhere to a surface. The inlay may be embedded in plastic castings or casted in polyurethane resin coatings.

FIGS. 22-25illustrate examples of the container512having additional features.FIG. 22shows the container512having an additional recessed storage area532adapted to store a data storage device, illustrated herein as a flash drive534. The flash drive534preferably contains information relating to the patient that can be transported wherever the container512travels, i.e. from the initial pre-op discussion to the surgical room.FIGS. 23A and 23Billustrates a container512converted to a “smart” container. The top514is adapted to include a central control unit536including, for example, a processor538, memory540, graphic processing unit542, GPS functioning544, and Bluetooth wireless capability546. The central control unit536can be powered by a battery550and electrically connected to a display unit552, such as an LED screen554, seeFIG. 23A. Data input devices, such as buttons558or a keyboard (not shown), may be included to allow the user to input data. The container512may also contain a connection point, illustrated herein as a USB port560to allow for transfer of data from the central control unit536to a flash drive or a computer system via cables.

FIGS. 24 and 25illustrate rapid identification features of the container512. As part of the overall surgical system500, the containers are designed to provide easy and rapid visualization using a visual indicator to alert the surgical team as to which side (left or right), sometimes referred to as “laterality”, of the patient a surgical procedure is to take place. As shown inFIG. 24, the container512includes all or at least a portion of the top514, the bottom516, and the locking pin518having a color coding of some shade of red, illustrated herein as pink/rose color hash markings, to indicate a right side surgical procedure. The locking mechanism is preferably colored as well.FIG. 25illustrates the container512, and locking pin518, having a left side surgical procedure indicator, illustrated as a purple based color, see broken line hatchings, preferably a lavender color. Alternative visual indicators may include symbols, letters, words or phases. In any embodiment, the surgeon or surgical team member can easily ensure that the position of the surgical site or laterality aligns with the color of the container512.

FIGS. 26-28illustrate the pin member518adapted to contain additional features that enhance the tracking and/or can electronic communication with other components of the system500. As illustrated inFIG. 26, the tab560contains a bar code528secured to the side surface562.FIG. 27illustrates a top view of the pin member518showing an RFID transponder530secured to the top surface564.FIG. 28illustrates the pin member518having a tab recessed receiving area566sized and shaped to receive a data storage device such as flash drive534.

With the ability to track and/or communicate with other components of the surgical system, the container512can be used in multiple time periods within the entire surgical procedure, including pre-hospitalization/surgical period, the day of pre-surgical procedure in the pre-op holding area, and the actual operating room. The systems, devices and methods in accordance with the present invention are designed to prevent wrong patient, wrong site, wrong side surgery by providing multiple steps of protection at multiple time points when the patient is passing through the surgical procedure environment, seeFIGS. 29A and 29B. As described herein, the use of the term “surgical procedure environment” or “surgical procedure” defines any period when the patient is interacting with his/her medical team or medical team associates including but not limited to office personnel, nurses, medical technicians, surgeons. The time period of interaction includes pre-hospitalization and hospitalization, including pre, post and during a surgical operation.

Ensuring the prevention of wrong site surgeries begins as early as the initial steps of the surgical procedure. At the time of surgical booking, errors can be initiated and perpetuated all the way through the actual surgical procedure. The system and methods of the present invention start when the surgeon's office schedules the surgery with the patient, see step610. At the time the surgery is scheduled by the hospital, the patient's name and information are associated with a container, preferably a trackable one such as container512.

The container512may be provided with a unique container identification number, similar to a vehicle identification number (VIN) used for automobiles. The container identification number (CIN) may be established at the time of manufacture and remains with a particular container. This number is unique to the container in that the number is never reused and never applied to different containers. The unique identification numbers can be integrally formed into the container or may be attached to the container as part of a separate label, or part of the QR/Scan codes. Once the unique number is assigned to a container and/or is then further correlated or associated to a particular patient, the container as well as the patient information coupled to it is serialized. This allows for the container to be tracked and analyzed as it moves through the medical system. In cases in which a patient has been determined to have wrong information, i.e. the patient should have a right side surgery, but the box is coded for a left side surgery, the container is destroyed and the reason(s) for its destruction is electronically attached to the unique number. This allows for hospitals or manufactures to review all containers manufactured or scheduled for a medical procedure to determine how many were actually used in such surgical procedures. For those containers not used, reasons as to why containers failed to be used in a medical procedure, potential errors (incorrect/inaccurate manual inputs), or wrong site surgeries/never events can be reviewed, providing insight as to when, where, and why surgical mistakes were made. Periodical reviews of such data allows hospitals an ability tom identify areas that need improvement.

If the patient is undergoing a surgical procedure which requires the surgeon to perform a procedure on a particular side, a color coded container512, such as those described inFIGS. 24 and 25, is associated with the patient, see614. For surgical procedures that do not require laterality, the container512will be a neutral color, such as gray.

Alternative embodiments of the medical system500may include the use of a non-sterile outer box521, seeFIG. 19Bhaving an upper portion523securable to a lower portion525which houses the container512. Preferably, the outer box contains tracking and/or electronic communications mechanisms, such as a bar code or RFID tag. The outer box521may also be color coded to match the color of the container512. In this manner, the container512can be transported to various locations and/or handled by the surgical team while on route to the operating room without concerns of contamination. In addition to color coding or matching, various patient related information, such as for example the patient's name, history, surgical procedure, side of surgery, associated color coding is encoded to an identifying label or tag label, such as a bar scan.

At the time of the surgical procedure, the container512is delivered to the patient at the pre-operation holding area, see618. At this point, numerous opportunities are available to confirm that the patient will undergo the correct surgical procedure at the correct site, see620. When the surgeon visits with the patient to discuss the surgery, and possibly mark the site of surgery, the surgeon622A and the patient622B and will confirm the site of surgery. Additional surgical team members may also perform surgical procedure checks. For example, the prep nurse622C, and the operating room nurses622D, may confirm the patient's information is correct by matching the patient information to the information of the scan bar. As such, the surgeon622A, prep nurse622C, and the operating room nurses62D may scan the bar code using a bar code reader.

If the information matches, the patient continues with the medical procedure process. As part of the system500, when a scan of the bar code is performed, the information may be displayed (i.e. surgical procedure for right side would be displayed with at least a rose color that matches the rose color of the container512) with a matching color background so that the medical professionals can easily, quickly visually confirm laterality. Determining or confirming surgical procedures and/or location at this point prevents any mistakes made at the surgeons' office or by the hospital scheduler when scheduling the procedure. In addition, all members of the surgical team are aware of what procedure needs to be performed on the correct patient, and on what side the procedure is to occur. If the surgeon or surgical team member determines the surgery was not scheduled correctly, a new container512with the correct information will be ordered and brought back to the pre-operation holding area, see624.

Once the patient information has been determined to be correct, he/she will be transferred to the operating room. At this point, the patient will be checked in, see626. At check in, patient information is verified and may be checked against the bar code information of the container512, see628. The operating nurse will put in the information in the electronic health record, see630. This information must match the information already in the electronic health records. If any information is incorrect, the electronic health record can be put on hold, or on “freeze” so that any individual accessing the record would know that the patient must not undergo any surgical procedures, see632and634.

Once a determination has been made the information matches, i.e. it is the correct patient, it is the correct surgery and correct surgical site, container512is presented to the surgeon, see636. If the container512is placed in an outer box, the surgeon simply removes the outer box and opens container512. In either case, once the patient is prepped and draped, a formal and final timeout is performed by the members of the surgical team, see638. The surgeon fills in the label, see640, either a label such as 16 or scans the bar code530, placed over the locking mechanism of container512and pulls it off, see642. The system500can be adapted to allow the surgeon to perform electronic signatures, which can then be transferred to the patient's chart. If the container512contains a flash drive or other memory storage device, the surgeon or nurses could use such device to match the patient information in the electronic health record. If any information does not match, a freeze could ensue, warning those involved with the surgery to stop any further proceedings. He/she can now open the container512to gain access to the surgical equipment therein and begin surgery, see644.

Referring toFIG. 30, the present invention is shown linked to a smart surgery room. For example, the container512located in a surgical room700may contain a container control panel such as control panel554. Within the surgical room700, an information reader, such as a RFID reader702is located to read the RFID tag530. The container control panel554is preferably electronically connected, via wired or wireless technology, to a hospital or central control unit704having one or central computers705outside the surgical room700. The control unit could be a manned station functioning similar to a flight control tower. Alternatively, or in addition to, the container control panel554may be in electronic communication with a surgical room control unit706having at least one computer707located within the room. Individuals manning the control unit704may provide the surgeon within the surgical room700clearance to proceed with opening the container512based on the information received from the container, using, for example, a radiofrequency device. Based on the information received, the container may be opened remotely using an electronic lock710on the container512. Preferably, the lock would be electrically coupled or in communication with the hospital control unit704and/or the surgical room control unit706.

Additional features of the system may include container512and/or the surgical equipment having LEDs attached thereto to allow for tracking by optical or camera guided navigation systems. In addition to the above described features, it is understood that the container512may include or be adapted to include one or more features described previously, whether as part of a system or as a feature of a container embodiment.

In addition to providing a timeout, the medical system500allows for tracking of errors from pre-hospitalization to the actual surgical procedure. This provides a hospital valuable data as to where errors or possible errors may have occurred.

Accordingly, the present invention provides a number of advantages. In particular, the system and method of the invention insure a final confirmation of the correct patient, procedure, site, and as applicable, implants or instrumentation, is performed thoroughly and consistently, immediately prior to allowing incision to be made. The marking of the surgical site, the required use and removal of the confirmation checklist before accessing the surgical blades needed to start the surgery, and the resulting open communication between the patient, the surgeon, and the operating team, all contribute to reducing wrong-site medical errors. In addition, the surgical container provided by the invention can be used as a needle box for sharps disposal at the end of the case, and as a neutral zone during the case to decrease the incidence of needle sticks or lacerations from the surgeon and the surgical technician handing each other sharp instruments such as scalpels or needles. Furthermore, use of the invention can actually be extended to other areas of the hospital where an incision might be made, such as in the interventional radiology suite, the intensive care unit, or the emergency room.

Referring toFIGS. 31-38, an alternative embodiment of a container810is shown. The container810has a top814and a bottom816secured together to provide an interior compartment. The interior compartment is designed to hold surgical instruments, such as described inFIG. 4,10, or11. The interior compartment is designed to hold pre-loaded surgical instruments specific for each surgical procedure. One or more labels, similar to the labels as described previously, for example label16described and illustrated inFIG. 8, can be secured to the container810. The label must allow at least the surgeon, or other surgical team members, to fill in the surgical-site information within an input field of the label, i.e. the surgical-site information to conduct a pre-surgery assessment confirming the correct surgical site.

The container812has a locking mechanism, illustrated herein as a pin member818, similar to pin518, sized and shaped to slidably engage and/or be positioned within the top514where at least a portion of the pin member818is secured within an opening positioned within the bottom516, as described inFIGS. 4-6. A ring819is secured to or integrally formed to the pin member818, acting as a mechanism for grabbing and pulling the pin member818out. Alternative mechanisms for locking the container812may include conventional slide-lock or snap-lock mechanism similar to that of commercially available surgical sharps boxes or other previously described mechanisms. Whatever mechanism locks the container812, the label must cover and/or prevent the locking mechanism from opening prior to the removal of the label.

To aid the user in signing the label, the top814of the container812may contain a recessed holding area820sized and shaped to hold a writing utensil, such as a pen822. To retain the pen822within the recessed holding area820, a writing utensil locking member, illustrated herein as two parallel and spaced apart finger-like extensions824and826, are secured to the bottom surface827of the recessed holding area820. The finger-like extensions824and826have some elasticity so that when the pen822is inserted between the two finger-like extensions824and826, both move apart. Once the pen822is fully inserted within, the finger-like extensions824and826snap back to their original position, securing the pen822in place. A plurality of vents,828, are used to allow for release substances, such as heat/steam when the device is sterilized. Adjacent to the recessed area820, is a second or extended recessed area830which contains a securing mechanism, illustrated herein as a compression member832which may be used as a compression point for surgical equipment, such as surgical blades stored thereunder.

In addition to the above described features, it is understood that the container810may include or be adapted to include one or more features described previously, whether as part of a system or as a feature of a container embodiment including but not limited to monitoring and/or tracking or color coding features.

It is to be understood that this invention is not limited to the specific devices, methods, conditions, or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only. Thus, the terminology is intended to be broadly construed and is not intended to be limiting of the claimed invention. For example, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, the term “or” means “and/or,” and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. In addition, any methods described herein are not intended to be limited to the sequence of steps described but can be carried out in other sequences, unless expressly stated otherwise herein.

While the invention has been described with reference to an example embodiment, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.