Systems and methods for implementing assistive techniques to facilitate surgical procedures

Abstract

A surgical management system and method provides a safer, more accurate, intuitive, and efficient surgical workflow. The system may include a display interface and a primary display. The display interface can accept a manual count-in and count-out of surgical items, and a data reader can facilitate an electronic count-in and count-out of surgical items. If the manual count does not match the electronic count, a visual indication is provided on the primary display. The manual and electronic counts can be applied to multiple parts of the surgery and various types of surgical items. The system can prevent use of the data reader until pre-operative procedures are satisfied. The system can facilitate real-time updates of fire risk assessments, starting surgical drape timers, and identifying surgical instrumentation required as indicated for revision surgery.

Description

[Technical Field]

[0001] The present invention relates to systems and methods for performing assistive techniques to facilitate surgical procedures.

[0002] [CROSS-REFERENCE TO RELATED APPLICATIONS] This patent application claims priority to and the full benefit of U.S. Provisional Patent Application No. 63 / 424,557, filed November 11, 2022, the entire contents of which are incorporated herein by reference. [Background technology]

[0003] Before and during surgical procedures, it is essential that clinical staff accurately perform all surgical procedures (e.g., verifying patient identity and performing item counts). In particular, clinical staff must ensure an accurate inventory of surgical sponges that are "counted in" for use in the surgical field and those that are "counted out" before the end of the surgical procedure, thereby ensuring that surgical sponges are not inadvertently left behind inside the patient. Surgical procedures are often performed manually, with output recorded on whiteboards located in the operating room. For example, clinical staff sometimes count surgical sponges manually, which is prone to human error. They also sometimes write manual counts on whiteboards, which is prone to illegibility. More recently, surgical sponges have been tagged with radiopaque markers, bar codes, and / or wireless transponders, such as radio frequency identification (RFID) tags, facilitating wireless electronic counting of surgical sponges using a data reader. One exemplary method for accomplishing this is disclosed in commonly owned U.S. Patent Application Publication No. 2022 / 0246288, published August 4, 2022, the entire contents of which are incorporated herein by reference. While such assistive technology addresses certain shortcomings of manual counting, it is desirable to further incorporate the technology into various surgical procedures. Summary of the Invention

[0004] The present disclosure is directed to a surgical management system and method that provides a safer, more accurate, intuitive, and efficient surgical workflow. While many examples are disclosed in the context of surgical sponge counting, these can be extended to other instruments and aspects. The system may aggregate relevant information on a primary display to enable surgical personnel to quickly determine performed or pending safety checks (e.g., pre-operative and / or intra-operative procedures), reconcile manual and electronic counts of surgical sponges, maintain an updated fire risk assessment, and the like. The system may include a display interface that accepts user input. The display interface may be separate from the primary display. Alternatively, the display interface and the primary display may be integrated.

[0005] In many cases, the system may disable certain functions until required pre-operative or intra-operative procedures are satisfied. In the context of item counting, the system intuitively allows for tracking of counts based on item type (e.g., sponges, needles, etc.), the party responsible for the count, the sub-procedure performed, etc. Finally, aggregation of information (including information previously recorded manually) also allows for data refinement and reporting by management.

[0006] Thus, according to a first aspect of the present disclosure, a method for facilitating a surgical procedure with a surgical management system is disclosed. A first user input may be received at a display interface. The first user input may be a manual count-in of surgical items being counted into the surgical procedure. For example, a medical staff member may input that one, five, or more sponges are being counted into the surgical procedure. The manual count may be displayed on the display or updated as needed. A data reader may detect identification tags associated with the surgical items being counted into the surgical procedure. One or more processors receive identification information from the one or more identification tags. The one or more processors identify an electronic count-in of the surgical items based on the identification information. The electronic count-in may be displayed on a primary display or updated as needed. A visual indication may be provided if the manual count of surgical items does not match the electronic count-in of the surgical items. The visual indication may be highlighting of the row, field, or tile in which the count is displayed. Optionally, an auditory indication may be provided.

[0007] It may be appropriate to count out surgical objects as needed or at the end of a surgical procedure. The display interface may accept a second user input regarding the manual count-out of one or more of the surgical objects being counted out of the surgical procedure. These surgical objects were previously counted into the surgical procedure. The one or more processors may update the manual count of the surgical objects based on the manual count-in and manual count-out, and this updated manual count (updated manual count) is displayed on the primary display. For example, a user may count in five surgical sponges and then manually count out three. This "5" may remain displayed on the primary display, but may be erased and then a "2" may be displayed in the row associated with the same sponge type. This configuration indicates that five surgical sponges of that sponge type were previously counted in, three surgical sponges were counted out, and two remain counted in. In other words, each manual count-in and manual count-out entry prior to the updated entry provided in the display interface may remain displayed on the primary display. Each successive count instance may be marked as a past entry by the use of a cross-out (or other indicia, such as color coding).

[0008] The one or more processors receive identification information from one or more of the surgical items to be counted out from the surgical procedure based on wireless detection by the data reader of an identification tag. The one or more processors determine an electronic countout of the surgical items based on the identification information of the one or more items to be counted out. The primary display may display a manual count, an electronic count-in, and an electronic count-out. A visual indication may be displayed if the manual count does not match the electronic countout of the surgical items.

[0009] In certain embodiments, the one or more processors may determine the electronic count of items remaining as count-in as the difference between the electronic count-in and the electronic count-out. The electronic count of items remaining as count-in may be displayed, and a visual indication may be provided if the manual count does not match the electronic count of items remaining as count-in.

[0010] In certain embodiments, the methods disclosed herein may be used to allow for different staff members to administer the count, for example, during a shift change (i.e., "handoff"). A first manual count may be entered by a first medical staff member. At the handoff, the system indicates that a second staff member is taking over the count. An identification input indicating a staffing change may be accepted on the display interface or via the data reader. For example, the second staff member may scan their badge with the optical scanner of the data reader or may use the RFID functionality of the data reader. The second staff member may then count in or count out the surgical items. For example, the second staff member may enter a second manual count in the display interface of additional surgical items being counted in for the surgical procedure. The one or more processors may update the manual count of the surgical items based on the first manual count in and the second manual count in. The updated manual count may be displayed, including displaying a first manual count-in and a second manual count-in. The first manual count-in and the second manual count-in may be displayed as having been entered by different staff members. For example, the numbers of sponges being counted in may be different colors, shapes, or other indicators.

[0011] In certain embodiments, the system may be utilized to associate multiple counts each with a different phase or portion of the procedure (also referred to herein as a "sub-procedure"). For example, based on information discovered during a first portion of the surgical procedure, an emergency (emerging) need may arise for which a separate sponge count may be indicated or required. Additionally or alternatively, a second surgeon may take over responsibility for the procedure and may desire a separate sponge count. One exemplary method includes associating a manual count with the first portion of the surgical procedure on a display interface. An indicator associated with the second portion of the surgical procedure may be generated. This may include generating a tile, tab, or list. With the indicator associated with the second portion of the surgical procedure selected, subsequent surgical items being manually or electronically counted in or out are displayed in association with the second portion. When the indicator associated with the second portion of the surgical procedure is selected, the count associated with the first portion may be invisible, or vice versa. Thus, a user may selectively switch between display screens to view and modify the counts associated with each portion of the procedure.

[0012] According to a second aspect of the present disclosure, a method for facilitating a surgical procedure with a surgery management system includes preventing item counting prior to confirmation and / or satisfaction of a pre-operative or intra-operative procedure. In one variation, one or more processors prevent counting surgical items into the surgical procedure based on unconfirmed (unauthenticated) surgical information. A primary display displays a plurality of grouped content tiles, at least one of which is visually de-emphasized (e.g., "grayed out"). Stored surgical information, including patient information (stored patient information) and / or clinical information (stored clinical information), is received from a database. This information may be displayed on the primary display. Before or after this, additional patient information is received based on wireless detection by a data reader of a patient tag associated with the patient. This may include optical scanning of a patient-worn barcode by the data reader. The one or more processors may determine that the procedure information is in a verified state (authenticated state) based on the patient information matching the stored patient information, and then highlight (e.g., "brighten") the grouped content tile. Further, if the procedure information is in a verified state, the one or more processors may enable the data reader to initiate counting-in of surgical items into the surgical procedure. If the patient information does not match the stored patient information, a warning may be provided.

[0013] In another variation, the method includes, by one or more processors, preventing counting-in of a surgical object into a surgical procedure based on surgical information in an unconfirmed state. A pre-operative procedure is displayed on the primary display, the pre-operative procedure including a series of actions to be performed before the start of an invasive phase of the surgical procedure. For example, one of the series of actions includes verifying surgical personnel. Stored surgical information, including patient information and clinical information, is received from a database. The primary display displays the patient information and clinical information. The display interface accepts inputs configured to satisfy each of the series of actions of the pre-operative procedure. The primary display may change an indicator corresponding to each of the series of actions when it is determined that each of the inputs has been performed to satisfy the respective series of actions. Once all of the series of actions of the pre-operative procedure have been satisfied, the surgical information is considered to be in a confirmed state. The one or more processors enable the data reader to initiate counting-in of a surgical object into a surgical procedure based on the surgical information being in a confirmed state.

[0014] According to a third aspect of the present disclosure, there is provided a method for facilitating a surgical procedure by assessing a fire risk. The method includes receiving stored surgical information from a database. One or more processors may identify an initial fire risk assessment based on the surgical information. Additionally or alternatively, a user may provide input to a display interface regarding surgical characteristics of the surgical procedure. The surgical characteristics may include the use of an alcohol-based solution, the surgical site being above the xiphoid process, the patient receiving supplemental oxygen, and / or the use of an instrument that may be an ignition source. The one or more processors receive identification information from a surgical instrument used during the surgical procedure based on wireless detection by a data reader of an identification tag. The one or more processors identify an updated fire risk assessment based on the initial fire risk assessment and the fire risk associated with the surgical instrument. For example, the updated fire risk assessment may be higher if the surgical instrument is an electrocautery instrument, a laser source, or a fiber optic light source. The updated fire risk assessment may be displayed on a primary display, and a visual indicator or warning may be provided, if desired, if the updated fire risk assessment exceeds a predetermined threshold. The method may include displaying on the primary display a remediation checklist if the updated fire risk assessment exceeds a predetermined threshold, and preventing visualization of other aspects on the primary display until the remediation checklist is satisfied.

[0015] According to a fourth aspect of the present disclosure, a method for facilitating a surgical procedure with a surgical management system may include preventing premature draping after use of an alcohol-based product, potentially increasing the risk of a fire. The method includes receiving, in one or more processors, an indication of use of an alcohol-based product to prepare a surgical site. This step may include detecting an identification tag from packaging associated with the alcohol-based product with a data reader. Additionally or alternatively, an image may be captured by a camera. The image may include the surgical site and a medical staff member. Using machine vision that utilizes artificial intelligence, the image may be analyzed to predict that the medical staff member is applying the product to the surgical site in a manner consistent with a method for using the alcohol-based product. Based on the indication, the one or more processors may start a drape timer with a predetermined value, which may be displayed on a primary display.

[0016] According to a fifth aspect of the present disclosure, a method for facilitating a surgical procedure via a surgical management system may include providing intraoperative guidance for instrumentation required based on a revised surgical procedure. The revised surgical procedure may be required based on an aspect of the originally planned surgery. As an example, a liver biopsy may be required based on a lesion detected during an appendectomy. Because certain instrumentation may be common to both the originally planned surgery and the revised surgical procedure, the method may display on a primary display the instruments required to satisfy the required instrumentation given the current instrumentation. The method may include receiving a list of current instrumentation being used during the surgical procedure. A user may provide user input to the display interface indicating an indication of the revised surgical procedure. One or more processors access a database to identify the required instrumentation list for the revised surgical procedure. The current instrumentation list is compared to the required instrumentation list. The primary display displays the required instruments to avoid duplication. In certain embodiments, the required instruments may be automatically requested through a hospital inventory system. If at least one of the required instruments is unavailable, an alternative instrument may be displayed, which may be based on hospital inventory, surgeon preference, and / or surgeon reference material from similar surgical procedures. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a perspective view of a surgical management system. [Figure 2] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 3] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 4] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 5] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 6A] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 6B] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 7] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 8] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 9] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 10] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 11] FIG. 1 illustrates a display screen and possibly a display interface of a primary display of a surgery management system. [Figure 12] 1A-1C illustrate exemplary surgical articles for use with the methods of the present disclosure. [Figure 13] 1 is a flowchart of a method for verifying information or completing a procedure prior to the start of a surgical procedure. [Figure 14] 1 is a flow chart of a method for reconciling manual and electronic counts of surgical objects, particularly surgical sponges. [Figure 15] 1 is a flowchart of a method relating to fire risk assessment. [Figure 16] 1 is a flowchart of a method for determining whether required prerequisite steps have been performed to allow a surgical process to proceed. [Figure 17] FIG. 1 is a schematic diagram of the electronic components of a surgical management system. [Figure 18] 10 is a flow chart illustrating a method for initiating a sub-procedure during a main surgical procedure and maintaining a count of separate sponges during the sub-procedure. DETAILED DESCRIPTION OF THE INVENTION

[0018] FIG. 1 illustrates a surgical sponge management system 10 comprising a stand 12, a dispenser assembly 14, and an electronics subsystem 16. The stand 12 supports the dispenser assembly 14, which is configured to house and ergonomically dispense a sponge sorter and surgical drapings. The electronics subsystem 16 comprises a module base 18, a display interface 20, and a data reader 22. The display interface 20 may be removably coupled to the module base 18. The display interface 20 may be a tablet that displays a graphical user interface (GUI). The tablet may include a processor 24 or may provide wireless connectivity to remote resources, such as a hospital network or Internet server, for remote processing. The module base 18 may include a cradle configured to removably couple to the data reader 22. The illustrated embodiment shows the cradle recess sized to receive and support the data reader 22, configured to be used as a handheld device or while supported in the cradle, with seamless transitions between these configurations. A primary display 21, such as a monitor separate from the tablet, may be located elsewhere in the operating room. The illustrated surgical sponge management system 10 may be exemplary, and other similar embodiments may be described for counting other surgical items whose quantities may be dispensed during a surgical procedure.

[0019] The data reader 22 may be an RFID scanner configured to detect an RFID tag 120 associated with the sponge 26, 110 (see FIG. 12 ). The RFID scanner comprises physical components and operating software for generating interrogation signals and receiving responses to the interrogation signals. The physical components may include a signal generating transmitter and a signal receiver or transceiver, such as those disclosed in commonly owned International Publication Nos. WO 2021 / 041795, published March 4, 2021, and WO 2021 / 097197, published May 20, 2021, the entire contents of each of which are incorporated herein by reference. Exemplary tags are disclosed in commonly owned U.S. Patent No. 8,181,860, published October 2, 2008, and WO 2017 / 112051, published June 29, 2017, the entire contents of each of which are incorporated herein by reference. As used herein, a surgical sponge 26 may be any absorbent article, including, but not limited to, a laparotomy pad, gauze, towel, chux, etc. Additionally, as an alternative to a surgical sponge, it is understood that aspects of the present disclosure may be modified for use with non-absorbent surgical articles, including implants, clips, staples, or surgical instruments. For example, commonly owned U.S. Patent Application Publication No. 2019 / 0000589, published January 3, 2019, which is incorporated herein by reference, discloses embodiments in which scannable and human-readable elements are exposed on forceps and suture needles.

[0020] A surgical procedure (and corresponding surgical procedure) may include multiple phases (e.g., pre-operative check-in, sign-in, time-out, and sign-out). During these phases, the surgical procedure may indicate one or more steps such as patient ID (identity verification), surgical site verification, item counting, etc. The presently disclosed system 10 facilitates progression through the surgical procedures and phases in an efficient, intuitive, and error-proof manner. Among other features described below, the system 10 may require technology-assisted confirmation of manually performed steps, provide "lockouts" or triggers for their absence, and provide visual indicators of successful or unsuccessful completion of various steps of the surgical procedure.

[0021] 2-4 illustrate an exemplary GUI for the primary display 21 for performing method steps for verifying patient identity. It will be appreciated that, alternatively or additionally, the display output may be provided on a tablet. The GUI may be configured with tiles of various sizes and shapes suitable for intuitive conveyance of information. Of particular interest is the patient identification tile 28, which presents patient identification information, including name, date of birth, allergies, etc. Additionally, the patient identification tile 28 may include indicia 30a, 30b associated with the patient identification. The processor 24 is configured to receive data indicative of a first patient identification input. The first patient identification input may be manually provided to the display interface 20. For example, clinical staff may search for the patient by name and / or date and time of surgical procedure. The processor 24 may be configured to communicate with the hospital system's electronic medical record (EMR) to access and download data. Once a patient is selected, the identification information may be inserted into the patient identification tile 28.

[0022] The processor 24 is configured to display a first indicator 30a indicating a first patient identification input. FIG. 2 shows a check mark adjacent to a calendar icon, indicating to clinical staff that the presented information has been obtained by providing the patient's name, surgical date and time, etc. However, because assistive technology has not yet been utilized to confirm the patient's identity, this method may include "locking" or making other portions of the primary display 21 inaccessible. In other words, selectable or viewable features of the primary display 21 may be grayed out so that, even if selected, the corresponding action is not performed. A second indicator 30b indicating a second patient identification input may be color-coded or presented differently from the first indicator 30a to alert clinical staff that a second patient identification input has not been provided to the system 10. As shown in FIG. 2, the second indicator 30b is presented as a negative sign juxtaposed with the check mark of the first indicator 30a. Additionally, while somewhat grayed out, other tiles representing the phases of the surgical procedure (i.e., check-in, sign-in, time-out, and sign-out) may be color-coded to correspond to the color coding of the second indicator 30b, thereby informing clinical staff of the reason for the "lockout."

[0023] The method includes accepting a second patient identification input. The second patient identification input may be provided using assistive technology. The data reader 22 may be configured to detect a tag that stores patient information. In one example, the patient may be wearing a wristband that includes an optical tag (e.g., a barcode or quick response code), and the data reader 22 may include an optical sensor configured to detect the optical tag. A prompt may be provided on the primary display 21 instructing the clinical staff to remove the data reader 22 from the cradle and scan the optical tag on the wristband.

[0024] The processor 24 is configured to compare the second patient identification input with the first patient identification input. A mismatch of the second patient identification input with the first patient identification input may indicate that clinical staff manually entered incorrect identification information. FIG. 3 illustrates such an instance, visually highlighting the mismatch by updating the second indicator 30b. The patient identification tile 28 is shown as an exclamation point, while the remainder of the primary display 21 remains grayed out or inaccessible. In certain embodiments, a warning 33 may be displayed on the display interface 20 indicating that the second patient identification input does not match the first patient identification input. A selectable option may be provided to override the mismatch, which is stored and transmitted to the EMR and associated with the surgical report.

[0025] If the second patient identification input matches the first patient identification input, the processor 24 may be configured to indicate successful patient identification by changing the second indicator 30b. FIG. 4 shows the second indicator 30b as a check mark matching the check mark of the first indicator 30a. The system 10 may also provide audible feedback, such as a tone or noise, to indicate successful patient identification. The processor 24 may also be configured to enable visualization of more or other portions of the primary display 21. FIG. 4 shows tiles 32, 34, 36, and 38 illuminated, other than the patient identification tile 28. Additionally, information has been inserted into the procedure identification tile 32 and the staff identification tile 34. The procedure checklist tile 36 has been updated to indicate completion of the sign-in phase. Below the sign-in phase, the first and second patient identification inputs are listed, respectively. If the processor 24 determines that the patient identification has been confirmed by the assistive technology, other software or hardware functions may be enabled.

[0026] FIG. 5 illustrates another embodiment of a surgery checklist tile 36 in which method steps for procedure confirmation are performed (also referred to herein as "time-out"). These steps may include a scan-in by a clinical staff leader, introductions by the clinical staff, and confirmation of the surgical procedure and surgical site. The method may include processor 24 receiving a first participant input indicating a team leader scan. The clinical staff team leader may wear a badge including an optical tag that can be scanned by data reader 22. The method may include processor 24 receiving a second participant input indicating a staff introduction. For the staff introduction, as well as for the input corresponding to the surgical procedure and surgical site identification, display interface 20 may include a microphone (not shown) configured to detect audio within the operating room. Using voice recognition, artificial intelligence, or other means, processor 24 may process the audio to determine whether staff have been introduced and whether the surgical procedure and surgical site have been confirmed. Clinical staff may be trained to speak these items aloud. Processor 24 may compare the audible input to the input received from the patient EMR (after patient ID has been verified).

[0027] The surgical checklist tile 36 may insert or list standard practices or hospital procedures associated with or prescribed for a given surgical procedure. In one example, four categories of checklists may be provided: a first category including a pre-operative check-in process, a second category including a sign-in process, a third category including a time-out process, and a fourth category including a sign-out process. In one embodiment, the pre-operative check-in process may include the patient or patient's representative affirmatively verifying ID, surgery and surgical site, consent, and optional site marking. Additionally, a medical professional may verify medical history and physical information, pre-anesthesia assessment, nursing assessment, diagnostic and radiology results, blood products, and the presence or history of special equipment, devices, or implants. The pre-operative check-in may also include verification of beta-blocker administration, indication for venous thromboembolism prophylaxis, and measurement of normothermia.

[0028] In one embodiment, the check-in process may include repeated verification of ID, planned procedure, surgical site, and consent. The check-in process may also include verification of patient allergy information, pulse oximeter information, assessment of risk of difficult airway or aspiration, risk of blood loss (e.g., greater than 500 milliliters), number of blood units currently available, verification of anesthesia safety checklist completion, and verification that team members have discussed the treatment plan and addressed any concerns.

[0029] In one embodiment, a time-out process may be performed before a medical procedure is performed, i.e., before the skin is incised. A designated team member may cease all activities during the time-out process. The time-out process may include the team member introducing themselves to the patient and reiterating ID, the procedure to be performed, the surgical site, and consent. The time-out process may further include verifying that the site is marked and visible, verifying a fire risk assessment, verifying that relevant images are properly labeled and displayed, and verifying equipment status and any concerns regarding the equipment. The surgeon may state any critical or atypical steps expected during the procedure, the case duration, and the expected blood loss. The anesthesia professional may verify the administration of prophylactic antibiotics within one hour prior to the incision and may verify any additional concerns. The scrub personnel and circulating registered nurse may verify that sterility indicators are valid and may verify any additional concerns. A medical professional, such as a registered nurse, may certify completion of the time-out process.

[0030] In one embodiment, the sign-out process may be completed before the patient leaves the operating room. A medical professional, such as a registered nurse, may verify completion of sponge, blade, and instrument counts, ensure that samples taken are identified and labeled, and identify any equipment concerns that need to be addressed. The medical professional may further discuss wound classification and record major concerns of all team members, including concerns regarding patient recovery and management. The sign-out process may further include debriefing from team members, including a discussion of team performance, major events, and any permanent changes to preference cards.

[0031] The counting process described herein may be disabled if the checklist process detailed in the Surgery Checklist tile 36 is not successfully completed. Figure 6A schematically illustrates a failed checklist process described in the Surgery Checklist tile 36, depicting an incomplete sign-in step due to failure to enter one or more values. As a result, the display interface 20 provides a message instructing the medical professional to complete any incomplete sign-in checklist to proceed with enabling the counting functionality disclosed herein.

[0032] Once the required checklist detailed in the surgical checklist tile 36 is completed, the surgical phase of the surgical procedure may begin. Surgical sponges 26 and / or other items (needles, blades, etc.) may be counted into the surgical procedure. In particular, the processor 24 may be configured to identify sponges 26 as being counted in or counted out based on detection of RFID tags by the data reader 22. Referring now to FIG. 6B, the display interface 20 provides an updated list identifying the types and quantities of sponges 26 counted in and the types and quantities of sponges 26 counted out. On the primary display 21, the item count tile 38 is configured to juxtapose manual counting with electronic counting (i.e., counting assisted by assistive technology). The processor 24 is configured to receive a first item count input. The first item count input may be associated with a manual count and may be entered by entering each instance in which one or more of the plurality of surgical sponges 26 are counted out of the surgical procedure. FIG. 5 illustrates each instance of the first item count entry, with the current count highlighted to indicate the progress of the countout. The item count tile 38 also includes an electronic count, which may be the same data displayed on the display interface 20, but reformatted. In the illustrated example, the electronic count matches the manual count. A check mark or other indicator may be provided to further emphasize this. In instances where the electronic count does not match the manual count, visual or audible feedback may be provided. The visual indicator may be a warning-style highlight, prompt, or the like, as shown. Thus, where manual and electronic counts are performed separately, the presently disclosed system 10 synergistically utilizes the two to provide an additional check during a surgical procedure.

[0033] 7 and 8 illustrate system 10 for use with a cautery device, where display interface 20 cooperates with primary display 21 to indicate that the cautery device is being used and the level and / or duration of use. Processor 24 may receive a cautery input, for example, on display interface 20, indicating that clinical staff is activating the cautery device (not shown). Processor 24 may be configured to provide a corresponding output on primary display 21. For example, surgical checklist tile 36 in FIG. 7 shows an indicator containing a negative sign for "smoke clearance," indicating that smoke clearance associated with the cautery device is unused and / or disabled. Clinical staff activates the cautery device at a plus-one power level, after which FIG. 8 updates surgical checklist tile 36 and item count tile 38. The indicator in surgical checklist tile 36 changes to a check mark, indicating that smoke clearance, which may be associated with the cautery device, is being used. Item count tile 38 lists the cautery device and power level. 7 and 8 show the patient identification tile 28 and the surgical checklist tile 36 (except for the smoke clearance option) as grayed out to draw the user's attention to the smoke clearance option. Alternatively, the patient identification tile 28 and the surgical checklist tile 36 could be brightened (see FIGS. 6A and 6B).

[0034] As previously mentioned, the processor 24 may communicate with an EMR to access and review patient data, etc. It is contemplated that all of the aspects and data described herein may be collected and transmitted to an EMR (e.g., the cloud) through means known to those skilled in the art. Additionally, the methods described herein may be used to aggregate data across various patients, operating rooms, hospitals, clinical staff, etc., to provide a comprehensive analysis of surgical procedure suitability and best practices. FIG. 9 shows one representation of such an administrator display 23, listing various metrics via a dashboard. Each of multiple tiles is selectable to "drill down" into the underlying data supporting the metrics, for example, by viewing each surgical procedure where an anomaly occurred.

[0035] FIG. 10 illustrates how system 10 simultaneously maintains separate counts for a first procedure and a second procedure. In one embodiment, the second procedure may be a sub-procedure of the first procedure. For example, a sub-procedure may be planned, with the surgeon intending to track one portion of the surgical procedure separately from the second portion. A sub-procedure may be emergency (emerging) or unplanned, where an event or new information during the first or main procedure necessitates the performance of an unplanned sub-procedure. The illustrated primary display 21 displays selectable outputs 42A, 42B for either Procedure 1 or Procedure 2. Box 43 is illustrated to indicate that Procedure 2 is the current selection. Additionally, an information box 44 providing information regarding sponge and surgical item usage and counts associated with Procedure 2 displays a banner 45 identifying the current selection of Procedure 2. A medical professional may provide an input to system 10 to switch primary display 21 to display current information regarding Procedure 1. Primary display 21 may be further configured to simultaneously display an overall count including information related to both Procedure 1 and Procedure 2.

[0036] FIG. 11 illustrates how system 10 is configured to provide fire risk information to a viewer on primary display 21. The primary display is configured to display patient-related information, completed checklists, and accessible copies of signed consent forms. Primary display 21 is further configured to display fire risk information in the form of a fire risk checklist, as identified by banner 51. A list 52 of information related to fire risks associated with the current procedure is displayed. List 52 may include a description of the procedure type being performed, the fire risks associated with the selected procedure type, and risk factors associated with the selected procedure type. In one embodiment, system 10 may access a remote server device to access fire risk information for the selected procedure type. In another embodiment, a medical professional may register tools, surgical supplies, anticipated procedure details, etc., from a selectable list prior to the start of the procedure. In the illustrated example, an alcohol prep process is described as part of the procedure. The alcohol prep process includes a mandatory timer that allows an exemplary 60-second period for the alcohol to evaporate, during which potential inflammatory effects must not be initiated. Illustrated line item 53 reminds the viewer that the alcohol preparation process requires the activation of a timer, and a timer activation button 54 is provided that, when pressed or selected, prompts the display of a visible timer and an alarm or warning after the timer has run out. Other line items are contemplated, such as a warning panel that, if acknowledged, enables use of the described cauterization device and alerts the viewer to the potential fire risks associated with use of the device before power is applied to the device. The information on the illustrated primary display 21 is exemplary; other lists, caution warnings, and precautionary measures may be implemented to prevent foreseeable fire risks.

[0037] As previously mentioned, one exemplary embodiment of a surgical management system is in the context of managing and counting surgical sponges. FIG. 12 illustrates a surgical article 110 that is a surgical sponge having a tag 120 disposed between opposite surfaces 112, 114 of a body of absorbent material 111. Alternative surgical articles for use with the methods disclosed herein include laparotomy pads, gauze, implants, towels, sutures, clips, staples, or surgical instruments such as scalpels or forceps. The tag 120 may be an RFID tag and may be configured to communicate unique identification information by transmitting an electromagnetic signal or electromagnetic wave to a data reader 22, or alternatively, the tag may be optically readable by an optical detector. The unique identification information may include a unique serial number or other identifier and / or type, size, weight, date of manufacture, expiration date, etc.

[0038] Referring now to FIG. 13, an exemplary method 200 for facilitating a surgical procedure is illustrated. While the method 200 is described herein for use with the procedure management system 10 of FIG. 1, it may also be utilized with other systems. The method 200 begins in step 202 with an unidentified procedure (e.g., procedure information). In step 204, stored procedure information, including patient and clinical information, may be received from a database (not shown). The procedure information may be displayed on the primary display 21. A pre-checklist is also executed (step 206) prior to the start of the surgical procedure to verify the procedure information. Prior to the completion of the pre-checklist, the processor 24 may prevent the unidentified procedure information from counting surgical items 110 toward the surgical procedure. The pre-checklist may include various steps, such as verifying the patient's identity, the procedure to be performed, and the medical personnel's identity. The pre-checklist may also include the completion of other pre-operative procedures, including a series of actions to be performed before the start of the invasive phase of the surgical procedure. Based on the satisfaction of the pre-checklist, processor 24 determines that the surgical information is in a verified (authenticated) state, after which processor 24 allows the surgical item 110 to be counted into the surgical procedure.

[0039] In certain embodiments, primary display 21 may display multiple grouped content tiles, at least one of which is visually de-emphasized. Patient information is received based on wireless detection by data reader 22 of a patient tag associated with the patient. Processor 24 determines that the surgical information is in a verified state based on the confirmed patient information matching the stored patient information. As described above, the presentation of the de-emphasized grouped content tiles may be altered on primary display 21 based on the confirmed state of the surgical information. Conversely, if the confirmed patient information does not match the stored patient information, a warning may be provided on the primary display and / or display interface (step 208), and the system may prevent subsequent system functions from operating and provide assistance for addressing the discrepancy.

[0040] If, in step 206, it is determined that the pre-checklist items have been satisfied, method 200 may proceed to optional step 210, where a count timeout may be imposed. This timeout (interruption) may involve measures to reinforce the counting process by medical professionals present during the surgical procedure. For example, a professional signed into the procedure may be required to acknowledge compliance with the counting process by entering an identification number or by scanning a badge into data reader 22. Such a timeout may be indicated in a variety of applications to enhance compliance and effectively remind the professional of required steps in the process. In step 212, the surgical procedure may begin. In step 214, sponges are counted in and out according to the methods described herein. Throughout the surgical procedure, the count in and count out may be displayed on display interface 20 and / or primary display 21 (see FIG. 6B). In step 222, method 200 ends.

[0041] FIG. 14 is a flow chart illustrating an exemplary method 300 for counting sponges using manual and electronic counting steps. Method 300 is described herein for use with the surgical sponge management system 10 of FIG. 1, but may also be used with other similar surgical counting systems. Method 300 begins at step 302. Count-related input is received by a medical worker at step 304. The count-related input may be one of a manual count-in (step 308), an electronic count-in (step 310), a manual count-out (step 312), and an electronic count-out (step 312). The manual count-in and count-out may be user inputs to an appropriate screen of display interface 20. For example, display interface 20 may be in a count-in mode or a count-out mode, and the user may select a value corresponding to the number of sponges counted in or counted out, respectively. The electronic count-in and count-out may be performed using data reader 24, as described above.

[0042] Referring simultaneously to FIG. 6B, the electronic count-in and count-out are updated and displayed (steps 316, 318). In particular, a tally of both the manual and electronic count-in sponges is displayed. As can be seen from the item count tile 38 in FIG. 6B, the "count" (i.e., manual count) is displayed adjacent to the "auxiliary count" (i.e., electronic count). Furthermore, the manual count is shown as incrementally updated with each instance in which a sponge is counted in or out during surgery. For example, FIG. 6B shows three or four instances in which a 4×4 sponge was counted in, reflected by a crossed-out number and an increasing value, and one instance in which a group of 4×4 sponges was counted out, reflected by a crossed-out number and a decreasing value. Because the highest number in the manual count is the same as the number identified as counted in by the electronic count, it can be inferred that the count-in was accurate. For illustrative purposes, a similar situation is presented with 4×8 sponges.

[0043] In step 320, it is determined whether a discrepancy exists between the number of sponges counted in manually and the number of sponges counted in electronically. According to the manual count of Figure 6B, one sponge remains counted in per type. However, according to the adjacent count, all sponges are identified as having been counted out. If in step 320 it is determined that a discrepancy exists between the number of sponges counted in manually and the number of sponges counted in electronically, a warning is provided (step 322).

[0044] Regardless of whether there is a discrepancy, the method includes displaying a sponge count that includes a tally of both the manually counted-out sponges and the electronically counted-out sponges (step 328). The method 300 continues until the surgical procedure is identified as complete (step 330), for example, by an input into the display interface 20. After the surgical procedure, a report (e.g., accurate sponge count or confirmed sponge count) may be generated for use at the administrator's workstation 23.

[0045] As mentioned above, many surgical procedures utilize electrocautery. Furthermore, surgical procedures often require the use of alcohol for sterilization and oxygen for sedated patients. The combination of electrocautery, alcohol, and oxygen poses a fire risk by providing the necessary heat, fuel, and oxygen, respectively, for a fire. It is known to assess the risk of fire in certain surgical procedures. For example, certain types of surgical procedures, such as those located above the xiphoid process, may pose an increased risk of fire. The surgical management system 10 of the present disclosure facilitates an intuitive and semi-automated process of assessing fire risk. Referring to FIG. 15 , method 400 begins at step 402. At step 404, data related to the planned surgical procedure is accessed. This data may include information regarding surgical aids (e.g., tools, instruments, materials, fluids, etc.) listed for use in the surgical procedure. This data may include fire risk factors for various surgical aids. This data may include rules, such as requiring a waiting period after rubbing alcohol is administered to a patient. At step 406, the medical professional may register surgical aids, tools, instruments, surgical items, etc. to be used in the procedure, for example, by scanning the device or object with the data reader 22 or by exposing a barcode or other visual code to a camera device operated by the system 10. At step 408, the processor 24 may determine an aggregate fire risk based on the provided data regarding the surgical procedure to be performed and the surgical aids scanned by the medical professional. At step 412, the processor 24 may determine whether the aggregate fire risk exceeds a threshold. If the aggregate fire risk does not exceed the threshold, the method 400 proceeds to step 418. If the aggregate fire risk exceeds the threshold, the method 400 proceeds to step 412, where a fire risk hazard warning is displayed and mitigation details are provided to the medical professional. At step 414, the system 10 may monitor the execution of the fire risk mitigation details. At step 416, a determination may be made whether the fire risk has been sufficiently mitigated.If the fire risk is mitigated, method 400 proceeds to step 418. If the fire risk is not mitigated, method 400 returns to step 412. At step 418, a message may be displayed indicating that the fire risk has been mitigated, and the remaining steps of the surgical procedure, such as the sponge counting method described herein, may be enabled. At step 420, method 400 ends. Method 400 is provided as an exemplary method for incorporating a fire risk assessment into a surgical parts counting method such as those disclosed herein. Many additional or alternative method steps are possible, and the present disclosure is not intended to be limited to the examples provided herein.

[0046] With concurrent reference to Figure 11, the method 400 of Figure 15 may be utilized to provide a detailed fire risk checklist on the primary display 21. Details of the procedure to be performed and the potential fire risks associated therewith may be displayed on the primary display 21, and the medical professional may be provided with a series or list of precautions that may be selected or configured to significantly reduce the risk of flammable materials being exposed to potential ignition sources during the procedure.

[0047] FIG. 16 is a flowchart illustrating an exemplary method 500 for determining whether prerequisite steps have been performed to allow a surgical process to proceed. While the method 500 is described herein for use with the surgical sponge management system 10 of FIG. 1, it may also be used with other similar surgical counting systems. The method 500 begins at step 502. At step 504, data related to the surgical procedure to be performed is accessed. This data may include a list of surgical items that may be used in the procedure. This data may include materials or procedures to be applied. In one embodiment, a surgical drape may be required for use in the procedure. At step 506, the processor 24 may determine (identify) from the data one or more prerequisite steps required to begin the procedure or to begin a sub-procedure or portion of the procedure. At step 508, a prompt describing the prerequisite steps may be displayed. In the case of using a surgical drape, the prompt may instruct the medical professional to deploy (apply, place) the surgical drape at a specified time. At step 510, performance of the required step may be determined by monitoring sensors, cameras, user input, etc. In instances where deployment of a surgical drape is required, system 10 may monitor a camera device, and a medical professional may remove support tape from the adhesive on the surgical drape to expose a barcode that is only visible after removal of the support tape, indicating to system 10 through the camera device that the surgical drape has been deployed. At step 512, a determination is made as to whether the required step has been performed. If the required step has been performed, method 500 proceeds to step 516. If the required step has not been performed, method 500 proceeds to step 514, where an error message is displayed providing information regarding the required step that was determined not to have been performed, and method 500 returns to step 508. At step 516, a message is displayed confirming performance of the required step, and further steps of the surgical procedure, such as a sponge counting procedure, may be enabled.At step 518, method 500 ends. Method 500 is provided as an exemplary method for monitoring the occurrence of a required step in a surgical procedure and conditionally enabling a subsequent portion of the surgical procedure based on a determination of the occurrence of the required step. Many additional or alternative method steps are possible, and this disclosure is not intended to be limited to the examples set forth herein.

[0048] FIG. 17 schematically illustrates a system 10 configured to operate a surgical item counting method during a surgical procedure. The illustrated system 10 includes a processor 24. The processor 24 may include random access memory (RAM) and durable memory useful for storing programmable code or programmed instructions. The illustrated system 10 further includes a display interface 20, which may comprise a computer tablet useful for a medical professional to input information, such as a manual count-in-sponge entry; a data reader 22; a camera 28 useful for capturing images, such as barcode information; a sensor, such as a smoke detection sensor, useful for determining the presence or absence of smoke; and a primary display 21 (which may be an output device or a touchscreen device configured as an input / output device). The camera 28 may be a stand-alone device, such as mounted on the stand 12 of FIG. 1. In another embodiment, the camera 28 may be an embedded camera integrated into the display interface 20, which may be embodied, for example, as a commercially available tablet device.

[0049] FIG. 18 is a flow chart illustrating a method 800 for initiating a sub-procedure during a main surgical procedure and maintaining a separate sponge count during the sub-procedure. Method 800 is described herein for use with the surgical sponge management system 10 of FIG. 1, but may also be utilized with other similar procedure counting systems. Method 800 begins at step 802. At step 804, a surgical procedure is identified as the main procedure to be performed. At least one sponge or group of sponges is identified as a Type 1 sponge for use in or during the main procedure. At step 806, the surgical procedure progresses, and a medical professional deploys (uses, places) surgical sponges as needed by the surgeon. At step 808, a count-in and count-out of surgical sponges is maintained (continued) according to the type of sponge being deployed, according to the methods disclosed herein. At step 810, a determination is made whether a sub-procedure, such as a procedure to treat an unanticipated condition detected in a patient, has been initiated by the surgeon during the surgical procedure. If a sub-procedure has begun, the method 800 proceeds to step 812, where the sponge type of the sponges designated for use in the sub-procedure is set to type 2. The method 800 then proceeds to step 814.

[0050] Method 800 is provided as an exemplary method for performing unplanned sub-procedures in a surgical procedure while maintaining separate sponge counts by type between the main procedure and the sub-procedure. Many additional or alternative method steps are possible, and the present disclosure is not intended to be limited to the examples set forth herein.

[0051] With concurrent reference to Figure 10, the method 800 of Figure 18 may be utilized to provide details of simultaneously tracked procedures on the primary display 21. Details of each identified procedure or sub-procedure to be performed may be displayed on the primary display 21. The medical professional may be provided with a clear depiction (such as a diagram) of the currently active procedure and provided with procedure-specific details.

[0052] Reference is now made to the following exemplary clauses, which constitute certain inventive aspects of the present disclosure.

[0053] Clause 1. A method of facilitating a surgical procedure with a procedure management system including a radio frequency (RFID) reader, a processor, a user interface, and a primary display separate from the user interface: accepting a manual count-in of a first quantity of a plurality of surgical sponges of a first sponge type being counted into the surgical procedure through a first user input to the user interface; displaying the manual count-in of the first quantity of the plurality of surgical sponges on the primary display; receiving sponge identification information from each of one or more of the plurality of surgical sponges being counted into the surgical procedure based on wireless detection by the RFID reader of an RFID tag, the sponge identification information indicating that each of the one or more of the plurality of surgical sponges counted into the surgical procedure is a first sponge type. receiving, identifying the surgical sponges as being the first sponge type or the second sponge type; determining, by one or more processors, for each of one or more of the plurality of surgical sponges counted into the surgical procedure, whether the surgical sponge associated with an RFID tag is the first sponge type or the second sponge type; generating an electronic count-in of a second quantity of the plurality of surgical sponges of the first type based on detection of the RFID tag by the RFID reader; displaying on the primary display the electronic count-in of the second quantity of the first type of surgical sponges; and providing on the primary display a first visual indication if the electronic count-in of the plurality of surgical sponges of the first sponge type does not match the manual count-in of the first quantity of the plurality of surgical sponges.

[0054] Clause 2. Accepting a manual countout of a third quantity of the plurality of surgical sponges of the first sponge type being counted out of the surgical procedure through a second user input to the user interface; displaying the manual countout of the third quantity of the plurality of surgical sponges on the primary display; receiving sponge identification information from each of one or more of the plurality of surgical sponges counted out of the surgical procedure based on wireless detection by the RFID reader of an RFID tag, the sponge identification information identifying each of the one or more surgical sponges counted out of the surgical procedure as being of the first sponge type or the second sponge type; receiving by the one or more processors. 10. The method of claim 1, further comprising: determining, for each of one or more of the plurality of surgical sponges counted into the surgical procedure, whether the surgical sponge associated with the RFID tag is a first sponge type or a second sponge type; generating an electronic countout of a fourth quantity of the plurality of surgical sponges of the first type based on detection of the RFID tag by the RFID reader; displaying on the primary display the electronic countout of the fourth quantity of the plurality of surgical sponges of the first type; and providing on the primary display a second visual indication if the electronic countout of the fourth quantity of the plurality of surgical sponges does not match the manual countout of a third quantity of the plurality of surgical sponges.

[0055] Clause 3. The method of clause 2, further comprising providing a third visual display indicating how many of the plurality of surgical sponges of the first type remain counted-in based on at least one of a manual count-in and an electronic count-in, and further based on at least one of a manual count-out and an electronic count-out.

[0056] Clause 4. The method of clause 2, further comprising providing a third visual display indicating how many of the plurality of surgical sponges of the first type remain counted-in based on the manual count-in, the electronic count-in, the manual count-out, and the electronic count-out.

[0057] Clause 5. The method of clause 2, wherein the first visual indication and the second visual indication are configured to indicate a potential error in counting the plurality of surgical sponges.

[0058] Clause 6. The method of clause 2, further comprising: accepting a manual count-in of a fifth quantity of a plurality of surgical sponges of a second sponge type being counted into the surgical procedure through a third user input to the user interface; displaying the manual count-in of the fifth quantity of the plurality of surgical sponges on the primary display; generating an electronic count-in of a sixth quantity of a plurality of surgical sponges of the second type based on detection of an RFID tag by the RFID reader; displaying the electronic count-in of the sixth quantity of the plurality of surgical sponges of the second type on the primary display; and providing a third visual indication on the primary display if the electronic count-in of the sixth quantity of the plurality of surgical sponges does not match the manual count-in of the fifth quantity of the plurality of surgical sponges.

[0059] Clause 7. The method of clause 6, further comprising: accepting a manual countout of a seventh quantity of the plurality of surgical sponges of the second sponge type being counted out from the surgical procedure through a fourth user input to the user interface; displaying the manual countout of the seventh quantity of the plurality of surgical sponges on the primary display; generating an electronic countout of an eighth quantity of the plurality of surgical sponges of the second type based on detection of the RFID tag by the RFID reader; displaying the electronic countout of the eighth quantity of the plurality of surgical sponges on the primary display; and providing a fourth visual indication on the primary display if the electronic countout of the eighth quantity of the plurality of surgical sponges does not match the manual countout of the seventh quantity of the plurality of surgical sponges.

[0060] Clause 8. The method of clause 7, further comprising providing a fifth visual indication indicating how many of the plurality of surgical sponges remain counted in based on the manual count-in of the first quantity, the manual count-in of the fifth quantity, the electronic count-in of the second quantity, the electronic count-in of the sixth quantity, the manual count-out of the third quantity, the manual count-out of the seventh quantity, the electronic count-out of the fourth quantity, and the electronic count-out of the eighth quantity.

[0061] Clause 9. The method of clause 7, wherein the first visual indication, the second visual indication, the third visual indication, and the fourth visual indication are configured to indicate a potential error in counting the plurality of surgical sponges.

[0062] Clause 10. The method of clause 7, wherein the portion of the plurality of sponges of the first type is a portion of the plurality of sponges manually counted in by a first medical user, and the portion of the plurality of sponges of the second type is a portion of the plurality of sponges manually counted in by a second medical user.

[0063] Clause 11. The method of clause 7, wherein the first type of sponge portion is a portion of a plurality of sponges that has been manually counted in by one or more medical workers of a first work shift that ends prior to the start of a second work shift, and the second type of sponge portion is a portion of a plurality of sponges that has been manually counted in by one or more medical workers of a second work shift.

[0064] Clause 12. The method of clause 7, wherein the first type of sponge portions are portions of a plurality of sponges that are manually counted in at (during) a first part of the surgical procedure, and the second type of sponge portions are portions of a plurality of sponges that are manually counted in at (during) a second part of the surgical procedure.

[0065] Clause 13. The method of clause 12, wherein the first part of the surgical procedure comprises a primary part of the surgical procedure and the second part of the surgical procedure comprises an ancillary part of the surgical procedure.

[0066] Clause 14. The method of clause 12, wherein the first portion of the surgery comprises a planned portion of the surgery (planned portion) and the second portion of the surgery comprises an emergency portion of the surgery (emerging portion) necessitated by new information discovered in the planned portion.

[0067] Clause 15. The method of clause 12, wherein the first portion of the surgical procedure includes a portion associated with a first surgeon and the second portion of the surgical procedure includes a portion associated with a second surgeon.

[0068] Clause 16. The method of clause 12, wherein the first part of the surgery includes a part of the surgery that addresses an isolated area of ​​the patient (the area that is isolated), and the second part of the surgery includes a part of the surgery that addresses an area of ​​the patient outside the isolated area.

[0069] Clause 17. The method of clause 1, wherein the first visual indication is configured to signal a potential error in counting the plurality of surgical sponges.

[0070] Clause 18. The method of clause 1, further comprising: accepting a manual count-in of a third quantity of a plurality of surgical sponges of a second sponge type being counted into the surgical procedure through a second user input to the user interface; displaying the manual count-in of the third quantity of the plurality of surgical sponges on the primary display; generating an electronic count-in of a fourth quantity of a plurality of surgical sponges of the second type based on detection of an RFID tag by the RFID reader; displaying the electronic count-in of the fourth quantity of the plurality of surgical sponges of the second type on the primary display; and providing a second visual indication on the primary display if the electronic count-in of the fourth quantity of the plurality of surgical sponges does not match the manual count-in of the third quantity of the plurality of surgical sponges.

[0071] Clause 19. The method of clause 1, further comprising: temporarily disabling manual count-in and receipt of RFID tag sponge identification information prior to utilizing a plurality of surgical sponges; monitoring for successful entry of a first type of patient identification confirmation; monitoring for successful entry of a second type of patient identification confirmation; and selectively enabling acceptance of manual count-in and receipt of RFID tag sponge identification information upon (during or after) monitoring for successful entry of the first type of patient identification confirmation and monitoring for successful entry of the second type of patient identification confirmation.

[0072] Clause 20. The method of clause 1, further comprising: temporarily disabling manual count-in and receipt of RFID tag sponge identification information prior to use of a plurality of surgical sponges; monitoring for successful entry of some form of patient identification confirmation; monitoring for successful entry of confirmation of the intended procedure (scheduled procedure); and selectively enabling acceptance of manual count-in and receipt of RFID tag sponge identification information upon (during or after) monitoring for successful entry of some form of patient identification confirmation and monitoring for successful entry of confirmation of the intended procedure.

[0073] Clause 21. The method of clause 1, further comprising: temporarily disabling manual count-in and RFID tag sponge identification information receipt prior to utilizing a plurality of surgical sponges; monitoring for successful entry of left and right surgical site confirmation; and selectively enabling acceptance of manual count-in and RFID tag sponge identification information receipt upon (during or after) monitoring for successful entry of left and right surgical site confirmation.

[0074] Clause 22. The method of clause 1, further comprising implementing a surgical timeout configured to highlight counting of multiple surgical sponges.

[0075] Clause 23. The method of clause 1, further comprising: monitoring a sensor to provide details of the surgical procedure; and selectively enabling portions of the surgical procedure based on details from the sensor.

[0076] Clause 24. The method of clause 23, wherein monitoring a sensor to provide details includes monitoring a camera device to capture images of the surgical procedure.

[0077] Clause 25. The method of clause 24, wherein monitoring a camera device that captures images of the surgical procedure includes monitoring exposure of a QR code (registered trademark) configured to be visible upon use of the surgical equipment.

[0078] Clause 26. The method of clause 24, wherein monitoring a camera device that captures images of the surgical procedure includes monitoring the deployment (use, placement) of a flammable material, the method further including assessing a fire risk due to the deployment of the flammable material, and wherein selectively enabling a portion of the surgical procedure includes providing a second visual indication on the primary display indicating a fire hazard if the fire risk exceeds a threshold.

[0079] Clause 27. The method of clause 26, further comprising: identifying a time-dependent (time-sensitive) fire risk; and starting a timer based on the time-dependent fire risk.

[0080] Clause 28. The method of clause 23, wherein monitoring a sensor to provide details includes monitoring the operation of a surgical tool utilized in the surgical procedure.

[0081] Clause 29. The method of clause 28, wherein monitoring the operation of the surgical tool includes assessing the fire risk from the surgical tool in light of surgical storage parameters.

[0082] Clause 30. The method of clause 1, further comprising providing a selectable user input that causes the primary display to display an assessment of how many of the plurality of surgical sponges are currently counted in.

[0083] Clause 31. The method of clause 1, further comprising displaying a color-coded overview of a plurality of surgical sponges using a first color and a second color, the first color being utilized to provide details regarding a first portion of a plurality of sponges of a first type and the second color being utilized to provide details regarding a second portion of a plurality of sponges of a second type.

[0084] Clause 32. A method of facilitating a surgical procedure with a procedure management system including a radio frequency (RFID) reader, a processor, a user interface, and a primary display separate from the user interface, comprising: utilizing a plurality of surgical sponges during a surgical procedure, the plurality of surgical sponges including a first portion of a plurality of surgical sponges of a first type being counted in by a first medical user working a first shift occurring at a relatively early time, and a second portion of a plurality of surgical sponges of a second type being counted in by a second medical user working a second shift occurring at a relatively later time; accepting, through a first user input to the user interface, a manual count-in of a first quantity of the plurality of surgical sponges of the first sponge type being counted in to the surgical procedure; displaying, on the primary display, the manual count-in of the first quantity of the plurality of surgical sponges; receiving sponge identification information from each of one or more of the plurality of surgical sponges counted in to the surgical procedure based on wireless detection by the RFID reader of an RFID tag, wherein the sponge identification information is displayed externally. receiving, identifying each of one or more of the plurality of surgical sponges counted into the surgical procedure as being a first sponge type or a second sponge type; determining, by one or more processors, for each of one or more of the plurality of surgical sponges counted into the surgical procedure, whether the surgical sponge associated with an RFID tag is the first sponge type or the second sponge type; generating an electronic count-in of a second quantity of the plurality of surgical sponges of the first type based on detection of the RFID tag by the RFID reader; displaying on the primary display the electronic count-in of the second quantity of the first type of surgical sponges; providing on the primary display a first visual indication when the electronic count-in of the plurality of surgical sponges of the first sponge type does not match the manual count-in of the first quantity of the plurality of surgical sponges; and accepting, through a second user input to the user interface, a manual count-in of a third quantity of the plurality of surgical sponges of the second sponge type being counted into the surgical procedure;a displaying, on the primary display, a manual count-in of a third quantity of the plurality of surgical sponges; generating an electronic count-in of a fourth quantity of the plurality of surgical sponges of a second type based on detection of RFID tags by an RFID reader; displaying, on the primary display, the electronic count-in of the fourth quantity of the plurality of surgical sponges of the second type; providing, on the primary display, a third visual indication if the electronic count-in of a sixth quantity of the plurality of surgical sponges does not match the manual count-out of a fifth quantity of the plurality of surgical sponges; and displaying, on the primary display, details of a first portion of the plurality of sponges and details of a second portion of the plurality of sponges different (distinct) from the details of the first portion of the plurality of sponges;

[0085] Clause 33. The method of clause 32, wherein displaying the details of the second portions of the plurality of sponges differently includes displaying the details of the first portions in a first color and displaying the details of the second portions in a second color.

[0086] Clause 34. The method of clause 32, wherein displaying details of second portions of the plurality of sponges differently includes displaying details of the first portions on a first portion of the primary display and displaying details of the second portions on a second portion of the primary display distal (away) from the first portion of the primary display.

[0087] Clause 35. A method of facilitating a surgical procedure with a procedure management system including a radio frequency (RFID) reader, a processor, a user interface, and a primary display separate from the user interface, comprising: utilizing a plurality of surgical sponges during the surgical procedure, the plurality of surgical sponges including a first portion of a plurality of surgical sponges of a first type being counted in during a first sub-operation of the surgical procedure and a second portion of a plurality of surgical sponges of a second type being counted in during a second sub-operation of the surgical procedure; accepting, through a first user input to the user interface, a manual count-in of a first quantity of the plurality of surgical sponges of the first sponge type being counted in to the surgical procedure; displaying, on the primary display, the manual count-in of the first quantity of the plurality of surgical sponges; receiving sponge identification information from each of one or more of the plurality of surgical sponges counted in to the surgical procedure based on wireless detection by the RFID reader of an RFID tag, the sponge identification information indicating that each of the one or more of the plurality of surgical sponges counted in to the surgical procedure is a first sponge. receiving, identifying the surgical sponges as being the first sponge type or the second sponge type; determining by one or more processors, for each of one or more of the plurality of surgical sponges counted into the surgical procedure, whether the surgical sponge associated with the RFID tag is the first sponge type or the second sponge type; generating an electronic count-in of a second quantity of the plurality of surgical sponges of the first type based on detection of the RFID tag by the RFID reader; displaying on the primary display the electronic count-in of the second quantity of the first type of surgical sponges; providing on the primary display a first visual indication if the electronic count-in of the plurality of surgical sponges of the first sponge type does not match the manual count-in of the first quantity of the plurality of surgical sponges; accepting through a second user input to the user interface a manual count-in of a third quantity of the plurality of surgical sponges of the second sponge type being counted into the surgical procedure; and displaying on the primary display the manual count-in of the third quantity of the plurality of surgical sponges;a method comprising: generating an electronic count-in of a fourth quantity of a plurality of surgical sponges of a second type based on detection of the RFID tags by an RFID reader; displaying on a primary display the electronic count-in of the fourth quantity of the plurality of surgical sponges of the second type; providing on the primary display a third visual indication if the electronic count-in of a sixth quantity of the plurality of surgical sponges does not match the manual count-out of a fifth quantity of the plurality of surgical sponges; displaying on the primary display details of a first portion of the plurality of sponges and details of a second portion of the plurality of sponges different from the details of the first portion of the plurality of sponges;

[0088] Clause 36. The method of clause 35, wherein displaying the details of the second portions of the plurality of sponges differently includes displaying the details of the first portions in a first color and displaying the details of the second portions in a second color.

[0089] Clause 37. The method of clause 35, wherein displaying details of second portions of the plurality of sponges differently includes displaying details of the first portions on a first portion of the primary display and displaying details of the second portions on a second portion of the primary display distal from the first portion of the primary display.

[0090] The above disclosure is not intended to be exhaustive or to limit the invention to any particular form. The terminology used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings, and the invention may be practiced otherwise than as specifically described.

Claims

1. 1. A method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, comprising: accepting a manual count-in of surgical items being counted into the surgical procedure through a first user input to the display interface; displaying, on the primary display, a manual count of the surgical object based on the manual count-in; receiving, at the one or more processors, identification information from one or more of the surgical objects counted into the surgical procedure based on wireless detection by the data reader of an identification tag; determining, by the one or more processors, an electronic count-in of the surgical object based on the identification information; displaying the manual count-in and the electronic count-in on the primary display; providing a visual indication on the primary display when the manual count of the surgical objects does not match the electronic count-in of the surgical objects; A method comprising:

2. accepting, via a second user input to the display interface, a manual countout of one or more of the surgical objects being counted out of the surgical procedure, the one or more surgical objects having been previously counted in to the surgical procedure; and updating, by the one or more processors, the manual count of the surgical object based on the manual count-in and the manual count-out; displaying the updated manual count on the primary display; and receiving the identification information from one or more of the surgical objects counted out from the surgical procedure based on wireless detection by the data reader of the identification tag; determining, by the one or more processors, an electronic countout of the surgical objects based on the identification information of one or more of the surgical objects being counted out; displaying the manual count, the electronic count-in, and the electronic count-out on the primary display; providing a visual indication on the primary display when the manual count of the surgical objects does not match the electronic count out of the surgical objects; The method of claim 1 further comprising:

3. determining, by the one or more processors, an electronic count of the items remaining as count-in as a difference between the electronic count-in and the electronic count-out; displaying the electronic count of remaining items as a count-in on the primary display; providing a visual indication on the primary display when the manual count of the surgical items does not match the electronic count of items remaining to be counted in; The method of claim 2 further comprising:

4. 4. The method of claim 1, wherein each entry of the manual count-in and manual count-out preceding an update entry remains displayed on the main display and remains indicated as an old entry, and optionally the old entry is canceled.

5. the manual count-in is entered by a first medical staff member; The method comprises: accepting an identifying input on the display interface or via the data reader indicating a staffing change; accepting a second manual count-in of additional surgical items being counted into the surgical procedure through a third user input into the display interface by a second medical staff member; updating, by the one or more processors, the manual count of the surgical object based on the manual count-in and the second manual count-in; displaying the updated manual count-in, including the manual count-in and the second manual count-in, on the primary display; Further comprising: The method of any one of claims 1 to 4, wherein the manual count-in and the second manual count-in are displayed in a manner that identifies them as having been entered by different medical staff members.

6. The method of claim 5 , wherein the identification as having been entered by different medical staff members comprises text of different colors.

7. The method of claim 5 , wherein the identification input is an optical bar code associated with each of the first and second medical staff members.

8. Associating the manual count with a first portion of the surgical procedure on the display interface; generating, on the display interface, an indicia associated with a second portion of the surgical procedure; accepting, via another input on the display interface, another manual count-in of surgical items being counted into the second portion of the surgical procedure; displaying on the primary display another manual count of the surgical items on a display screen separate from the display screen associated with the manual count associated with the first portion of the surgical procedure; The method of any one of claims 1 to 6, further comprising:

9. The method of claim 8 , further comprising receiving a toggle input to selectively switch between item counts associated with the first portion of the surgical procedure and the second portion of the surgical procedure.

10. 10. The method of claim 8 or claim 9, wherein the second portion of the surgery is based on an emergency portion of the surgery necessitated by information discovered in the first portion.

11. The method of any one of claims 8 to 10, wherein the first portion of the surgical procedure is associated with a first surgeon and the second portion of the surgical procedure is associated with a second surgeon.

12. preventing the data reader from counting in surgical objects into the surgical procedure prior to the start of a surgical phase of the surgical procedure; receiving inputs on the display interface configured to satisfy a pre-operative procedure; enabling, by the one or more processors, the data reader to count-in the surgical object into the surgical procedure based on satisfaction of the pre-operative procedure; The method of any one of claims 1 to 11, further comprising:

13. 13. The method of claim 12, wherein the pre-operative procedure is selected from the group consisting of patient information verification, surgical information verification, and fire risk assessment.

14. displaying, on the primary display, a plurality of grouped content tiles, at least one of the grouped content tiles being visually de-emphasized; modifying, on the primary display, the presentation of the de-enhanced grouped content tiles based on satisfaction of the pre-operative procedure; 14. The method of claim 12 or claim 13, further comprising:

15. 15. The method of any one of claims 1 to 14, wherein the surgical object is one of a surgical sponge and a surgical instrument, and optionally the data reader is a radio frequency identification (RFID) reader and the identification tag is an RFID tag.

16. 1. A method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, comprising: preventing, by the one or more processors, counting into the surgical procedure surgical items based on unconfirmed procedure information; displaying, on the primary display, a plurality of grouped content tiles, at least one of the grouped content tiles being visually de-emphasized; receiving stored surgical information from a database, the stored surgical information including stored patient information and stored clinical information; displaying the stored patient information on the primary display; receiving patient information based on wireless detection by the data reader of a patient tag associated with the patient; determining, by the one or more processors, that the surgical information is in a verified state based on the patient information matching the stored patient information; modifying, on the primary display, the presentation of the de-highlighted grouped content tile based on the confirmed status of the surgical information; enabling, by the one or more processors, counting in the surgical item into the surgical procedure based on the procedure information being in the confirmed state; A method comprising:

17. 17. The method of claim 16, further comprising providing a warning on the primary display and / or on the display interface if the patient information does not match the stored patient information.

18. 18. The method of claim 16 or claim 17, wherein receiving the patient information comprises utilizing optical scanning of a patient-worn barcode by the data reader.

19. The method of any one of claims 16 to 18, wherein receiving the patient information includes confirmation by the patient prior to the start of the surgical procedure.

20. 1. A method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, comprising: preventing, by the one or more processors, counting into the surgical procedure surgical items based on unconfirmed procedure information; displaying on the primary display a pre-operative procedure comprising a series of actions to be performed before the start of an invasive phase of the surgical procedure; receiving stored surgical information, including patient information and clinical information, from a database; displaying the patient information and the clinical information on the primary display; receiving, on the display interface, inputs configured to satisfy each of the series of actions of the pre-operative procedure; modifying an indicia on the primary display corresponding to each of the series of actions when the one or more processors determine that each of the inputs has been performed to satisfy each of the series of actions; determining, by the one or more processors, that the surgical information is in a confirmed state based on all of the series of actions of the pre-operative procedure being satisfied; enabling, by the one or more processors, counting in the surgical item into the surgical procedure based on the procedure information being in the confirmed state; A method comprising:

21. 21. The method of claim 20, wherein the pre-operative procedures are displayed in a grouped content tile that is visually de-emphasized with the unconfirmed surgical information.

22. one of the series of actions includes identifying a surgical participant; The method comprises: receiving participant information based on wireless detection by the data reader of a participant tag associated with the surgical participant; determining, by the one or more processors, whether the participant information matches the clinical information of the stored surgical information; 22. The method of claim 21 further comprising:

23. 1. A method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, comprising: receiving stored surgical information from a database; determining, by the one or more processors, an initial fire risk assessment based on the surgical information; and receiving, in the one or more processors, identification information from a surgical instrument used during the surgical procedure based on wireless detection by the data reader of an identification tag; determining, by the one or more processors, an updated fire risk assessment based on the initial fire risk assessment and a fire risk associated with the surgical instrument; displaying the updated fire risk assessment on the primary display; and A method comprising:

24. accepting, via user input on the display interface, procedure characteristics of the surgical procedure; further updating, by the one or more processors, the updated fire risk assessment; and displaying the updated fire risk assessment on the primary display; and 24. The method of claim 23, further comprising:

25. 25. The method of claim 24, wherein the surgical characteristics are selected from the group consisting of: (i) using an alcohol-based solution; (ii) the surgical site being above the xiphoid process; (iii) the patient receiving supplemental oxygen; and (iv) using additional equipment that could be an ignition source.

26. The method of any one of claims 23 to 25, wherein the surgical tool is selected from the group consisting of an electrocautery device, a laser source, and a fiber optic light source.

27. 27. The method of any one of claims 23 to 26, further comprising visually highlighting or displaying a sign associated with the updated fire risk assessment when the updated fire risk assessment exceeds a predetermined threshold.

28. 28. The method of claim 27, wherein the indicia is a confirmation display screen, the method further comprising: preventing visualization of other aspects on the primary display until a confirming input is received on the confirmation display screen.

29. displaying on the primary display a remediation checklist if the updated fire risk assessment exceeds a predetermined threshold; blocking visualization of other aspects on the primary display until the improvement checklist is satisfied; and The method of any one of claims 23 to 28, further comprising:

30. 1. A method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a camera, a display interface, and a primary display separate from the display interface, comprising: receiving, at the one or more processors, an indication of use of an alcohol-based product to prepare a surgical site; initiating a drape timer of a predetermined value based on the indication of use of the alcohol-based product; displaying the drape timer on the primary display; Including, The method, wherein the step of receiving the indication includes at least one of (i) detecting, by the data reader, an identification tag from packaging associated with the alcohol-based product, and (ii) analyzing an image captured by the camera and including the surgical site and a medical staff member.

31. 31. The method of claim 30, further comprising receiving, from a database, a drape policy associated with the medical equipment, and wherein the predetermined value is based on the drape policy.

32. 1. A method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a camera, a display interface, and a primary display separate from the display interface, comprising: receiving, at the one or more processors, a list of current instrumentation being used during the surgical procedure; accepting revision surgical instructions via user input to the display interface; accessing, by the one or more processors, a database to identify an instrumentation list for the revision surgery; comparing the current instrumentation list with the required instrumentation list; displaying on the primary display the instruments necessary to satisfy the required instrumentation given the current instrumentation; A method comprising:

33. 33. The method of claim 32, further comprising automatically requesting the required equipment through a hospital inventory system.

34. 34. The method of claim 32 or claim 33, wherein at least one of the required instruments is unavailable, the method further comprising displaying, on the primary display, an alternative instrument, optionally based on at least one of hospital inventory, surgeon preference, and surgeon's archived documentation from similar surgical procedures.

35. 1. A surgical management system, comprising: A display interface; A data reader; an optional primary display; one or more processors comprising a memory for storing instructions; Equipped with The instructions are configured to be executed by the processor to perform a method according to any one of claims 1 to 34.

36. A non-transitory computer-readable medium storing instructions, comprising: A non-transitory computer-readable medium, the instructions being configured to, when executed by one or more processors, perform the method of any one of claims 1 to 34.

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