System and method for managing surgical items during surgical procedure

Abstract

A system and method of managing one or more surgical articles, where the surgical articles may include a surgical sponge having an identification element, and where the management may include counting, positioning, or both. The identification element may be an RFID tag. The RFID tag stores unique identification information related to the surgical sponge. Systems and methods for detecting RFID tags may include changing the power level of an RFID interrogator to improve the accuracy of scanning RFID tags. A plurality of surgical articles (i.e., surgical sponges) with RFID tags may be packaged or bundled by a strip or packaged or bundled within a container.

Description

[0001] This application is a divisional application of the invention patent application filed on August 28, 2020, with application number 202080060474.9 and invention title "System and method for managing surgical items during surgery". Cross-references to related applications

[0002] This application claims priority and all benefits to U.S. Provisional Patent Application No. 62 / 894,300, filed August 30, 2019, the entire contents of which are incorporated herein by reference. Background Technology

[0003] This disclosure generally relates to systems and methods for detecting and identifying surgical subjects, and more specifically to tracking and managing sponges tagged with RFID.

[0004] Before and after a surgical procedure, it is important to track the tools and surgical items used to ensure proper sterilization and disposal. Accurate counting of tools and items is also crucial to ensure no items are accidentally lost or retained in the patient's body. Surgical sponges are one example of surgical items, typically made of absorbent material used to absorb blood and other bodily fluids in and around the incision site. Given the risks associated with surgical sponges being accidentally retained in the patient's body, healthcare professionals (HCPs) generally follow rigorous procedures to explain the contents of each sponge used during surgery.

[0005] In the past, HCP relied on manually counting surgical sponges. However, manual counting requires handling and exposure to contaminated sponges and is prone to human error. To reduce the possibility of retained surgical sponges associated with inaccurate manual counting methods, surgical sponges have been tagged with radiopaque markings, barcodes, or wireless transceivers (such as RFID or LC transceivers). Therefore, effective and accurate surgical sponge counting is needed to reduce or eliminate the risks associated with surgical items remaining in the patient's body. Summary of the Invention

[0006] A method is provided for managing an inventory of surgical sponges used during a surgical procedure to ensure proper reporting of the surgical sponges after the procedure. Surgical articles may be surgical sponges. Surgical articles may be implants, towels, suture needles, clips, surgical staples, or other surgical instruments. The method includes providing an inventory of surgical sponges. The inventory includes a first package containing a first surgical sponge of a first sponge type, wherein the first surgical sponge includes a first RFID tag. The first RFID tag stores a first unique identifier associated with the first surgical sponge, first package contents information, and a first power level parameter associated with the first sponge type. The first package contents information corresponds to the entire contents of the first package.

[0007] The method includes operating an RFID reader at a default power level and receiving a first unique identifier, a first power level parameter stored in a first RFID tag, and first package contents information at the RFID reader. The method also includes reconfiguring the RFID reader to operate at a first power level, which differs from the default power level and corresponds to the received first power level parameter; operating the RFID reader at the first power level; and receiving a first response set at the first power level.

[0008] The method includes comparing a first response set with first package contents information to determine an error state; when no error state is determined, identifying the first package contents information as included in the database record of the procedure. The method also includes reconfiguring the RFID reader to operate at a default power level.

[0009] The method includes positioning a first surgical sponge inside the body for a surgical procedure; removing the first surgical sponge from the body; and operating an RFID reader to count the first surgical sponge by reading a first RFID tag using the RFID reader and updating a database record of the surgical procedure. The method also includes displaying the status of the surgical sponge inventory based on the database record and identifying the counting status.

[0010] In this method, the first package may further contain multiple surgical sponges, each including an associated RFID tag storing a unique identifier and a first power level parameter associated with each surgical sponge in the first package. The first package contents information on each RFID tag may include information for identifying all other surgical sponges in the first package.

[0011] In this method, the surgical sponge inventory may include a second package containing a second surgical sponge of a second sponge type and a third surgical sponge of a second sponge type. The second sponge type may differ from the first sponge type. The second and third surgical sponges each include a second and a third RFID tag, respectively. The second RFID tag stores a second unique identifier associated with the second surgical sponge, and the third RFID tag stores a third unique identifier associated with the third surgical sponge. The second and third RFID tags also store second package contents information and a second power level parameter associated with the second sponge type, wherein the second package contents information corresponds to the entire contents of the second package.

[0012] The method may further include, after reconfiguring the RFID reader to operate at a default power level, operating the RFID reader at the default power level, and receiving at the RFID reader one of a second and a third unique identifier, a second power level parameter, wherein the second power level parameter differs from the first power level parameter, and second package contents information. The method may then include reconfiguring the RFID reader to operate at the second power level and receiving a second response set. The method includes, when both the second and third unique identifiers are present in the second response set, identifying the second and third surgical sponges as counted in a database record. The method may include comparing the second response set with the second package contents information to determine an error state.

[0013] The method may also include triggering an alarm upon determining an error state. Triggering an alarm may include issuing an audible alarm, displaying a warning, activating a tactile response, or a combination thereof. In this method, an error state is determined when a first result set does not match the first package content information.

[0014] The method may also include positioning an RFID reader near a sterile area where the surgical procedure is performed; and removing the first surgical sponge from the first package after the first surgical sponge has been identified as being included.

[0015] In this method, the steps of receiving a first response set and receiving a second response set may respectively include positioning a first package and a second package at a first distance and a second distance from the RFID reader, wherein the first distance is a first preferred reading range of the first package and the second distance is a second preferred reading range of the second package, and wherein a first power level parameter and a second power level parameter are selected such that the first distance and the second distance are within the same read range. The preferred read range may be between approximately 12 inches and approximately 36 inches.

[0016] An alternative method is also provided for managing a stock of surgical sponges used during surgery to ensure proper removal of the sponges after the procedure. The method includes providing a stock of surgical sponges. The stock includes a first package containing a first surgical sponge of a first sponge type, wherein the first surgical sponge includes a first RFID tag. The first RFID tag stores a first unique identifier associated with the first surgical sponge.

[0017] The method includes operating an RFID reader to read RFID tags of a surgical sponge inventory; and receiving a response signal including a unique identifier stored in the RFID tag in response to operating the RFID reader. The method includes determining a first Received Signal Strength Indicator (RSSI) as a measure of the power level of the response signal from the first RFID tag when read by the RFID reader; and identifying the first surgical sponge as counted in a database record of the surgical procedure when the first RSSI meets a first predetermined threshold associated with a first sponge type indicated by a first unique identifier.

[0018] The method includes positioning a first surgical sponge inside the body for a surgical procedure; removing the first surgical sponge from the body; reading a first RFID tag with an RFID reader; and identifying the first surgical sponge as dispensed in a database. The method also includes displaying the status of the surgical sponge inventory based on database records and identifying the dispensed / dispensed status.

[0019] In this method, the surgical sponge inventory may include a second package containing a second surgical sponge of a second sponge type. The second surgical sponge includes a second RFID tag storing a second unique identifier associated with the second surgical sponge. The method may further include determining a second RSSI from the second RFID tag; and identifying the second surgical sponge as counted in a database when the second RSSI meets a second predetermined threshold associated with the second sponge type indicated by the second unique identifier.

[0020] In this method, the first package may contain a single sponge per package, and the second package may contain multiple sponges per package. The first RSSI may be higher than the second RSSI.

[0021] The method may include positioning a first package at a first distance from an RFID reader. The first distance may be a first preferred reading range for the first package. The method may also include positioning a second package at a second distance from an RFID reader. The second distance may be a second preferred reading range for the second package. A first predetermined threshold and a second predetermined threshold may be selected such that the first distance and the second distance are within the same reading range. This reading range may be between approximately 12 inches and approximately 36 inches.

[0022] An alternative method is provided for managing the inventory of surgical sponges used during surgery to ensure proper removal of the sponges after the procedure. This method includes providing an inventory of surgical sponges. The inventory may include a first package containing a first surgical sponge of a first sponge type. The first surgical sponge includes a first RFID tag. The first RFID tag stores a first unique identifier associated with the first surgical sponge, first package contents information, and a first allocation power level associated with the first sponge type. The first package contents information corresponds to the entire contents of the first package.

[0023] The method includes operating an RFID reader at a first power level for a first finite time period to read RFID tags for a surgical sponge inventory; collecting a first response set within the first finite time period; evaluating the first response set to determine a complete first package when the first response set matches first package contents information, indicating that all surgical sponges within the first package are present in the first response set. The method also includes determining whether the first power level matches a first allocated power level; and identifying the first surgical sponge as counted in a database record of the surgical procedure when a complete first package is determined and the first power level matches the first allocated power level. The method further includes reconfiguring the RFID reader to operate at a second power level for a second finite time period. The second power level differs from the first power level.

[0024] The method includes positioning at least one of the surgical sponges to be counted inside the body for a surgical procedure; removing the counted surgical sponge from the body; and operating an RFID reader to count a first surgical sponge by reading a first RFID tag using the RFID reader. The method also includes displaying the status of the surgical sponge inventory, providing the quantity of surgical sponges counted and decounted for each type of surgical sponge.

[0025] In this method, the inventory of surgical sponges also includes a second package containing a second surgical sponge and a third surgical sponge, the second and third surgical sponges being of the second sponge type. The second sponge includes a second RFID tag, which stores a second unique identifier associated with the second surgical sponge, second package contents information, and a second allocation power level associated with the second sponge type. The third sponge includes a third RFID tag. The third RFID tag stores a third unique identifier associated with the third surgical sponge, second package contents information, and a second allocation power level associated with the second sponge type. The second package contents information corresponds to the entire contents of the second package.

[0026] The method may further include operating the RFID reader at the power level for a second finite time period; collecting a second response set during the second finite time period; evaluating the second response set to determine that the second package is complete when the second response set matches the second package contents information such that all surgical sponges in the second package are present in the second response set, and determining whether the second power level matches the second allocated power level; and identifying the second surgical sponge and the third surgical sponge as included in the database record of the surgical procedure when the complete second package is determined and the second power level matches the second allocated power level.

[0027] A system is also provided for managing a surgical sponge inventory used during surgery to ensure proper removal of the surgical sponges after the procedure. The system includes a surgical sponge inventory. The inventory includes a first package containing a first surgical sponge of a first sponge type. The first surgical sponge includes a first RFID tag. The first RFID tag stores a first unique identifier associated with the first surgical sponge, first package contents information, and a first power level parameter associated with the first sponge type. The first package contents information corresponds to the entire contents of the first package. The system also includes an RFID reader, which is configurable to receive the power level parameter in response to an RFID reading operation at one of a plurality of power levels.

[0028] The system includes a database configured to store data representing the status of surgical sponge inventory, identifying counted and de-counted quantities. An RFID reader is configured to operate at a default power level. The RFID reader is configured to receive a first unique identifier, a first power level parameter, and first package contents information. The RFID reader can be reconfigured to operate at a first power level, different from the default power level, corresponding to the received first power level parameter; and to operate at the first power level. The RFID reader receives a first response set at the first power level, and when the first unique identifier is present in the first response set, identifies the first surgical sponge as counted in the database record of the surgical procedure, and compares the first response set with the first package contents information to determine an error status. The system also includes a display device to display the status of the surgical sponge inventory, identifying counted and de-counted quantities.

[0029] In this system, the inventory of surgical sponges may include a second package containing a second surgical sponge and a third surgical sponge. The second and third surgical sponges are of a second sponge type. The second sponge includes a second RFID tag. The second RFID tag stores a second unique identifier associated with the second surgical sponge, second package contents information, and a second allocation power level associated with the second sponge type. The third sponge includes a third RFID tag. The third RFID tag stores a third unique identifier associated with the third surgical sponge, second package contents information, and a second allocation power level associated with the second sponge type. The second package contents information corresponds to the entire contents of the second package.

[0030] The RFID reader is further configured to operate at a default power level; receiving a second unique identifier, a second power level parameter, and first package contents information. The RFID reader is reconfigured to operate at a second power level, different from the first power level, corresponding to the received second power level parameter; and operates at the second power level. The RFID reader receives a second response set at the second power level; and when the second and third unique identifiers are present in the second response set, identifies the second and third surgical sponges as included in the database record of the surgical procedure; and compares the second response set with the second package contents information to determine an error state.

[0031] RFID readers can also trigger alarms when an error is detected. Alarms can include any of the following: alerts, warnings, tactile responses, or combinations thereof. An error is determined when the first result set does not match the information of the first package contents.

[0032] An alternative system is provided for managing the inventory of surgical sponges used during surgical procedures to ensure proper removal of the sponges after the procedure. The system includes an inventory of sterile surgical sponges. The inventory includes a first package containing a first surgical sponge of a first sponge type, wherein the first surgical sponge includes a first RFID tag. The first RFID tag stores a first unique identifier associated with the first surgical sponge, first package contents information, and a first power level parameter associated with the first sponge type. The first package contents information corresponds to the entire contents of the first package. The surgical sponge inventory includes a second package containing a second surgical sponge and a third surgical sponge. The second and third surgical sponges are of the second sponge type. The second sponge includes a second RFID tag. The second RFID tag stores a second unique identifier associated with the second surgical sponge, second package contents information, and a second power level associated with the second sponge type. The third sponge includes a third RFID tag. The third RFID tag stores a third unique identifier associated with the third surgical sponge, second package contents information, and a second power level associated with the second sponge type.

[0033] The system includes an RFID reader, which is configurable to receive a power level parameter in response to an RFID reading operation at one of a plurality of power levels. The system also includes a database configured to store data representing the status of the surgical sponge inventory, identifying counted and discontinued quantities.

[0034] The RFID reader is configured to read RFID tags at multiple power levels. The RFID reader is configured to count the first package at the first power level when the RFID reader operates at a first power level associated with a first sponge type and determines that the first package is intact. The RFID reader is also configured to count the second package at a second power level, different from the first power level, when the RFID reader operates at a second power level and determines that the second package is intact, wherein the second power level is associated with a second sponge type different from the first sponge type.

[0035] A first power level is associated with a first sponge type such that, based on a first packaging configuration of the first sponge type, the preferred reading distance for the first sponge type is between 12 inches and 36 inches from the RFID reader; and a second power level is associated with a second sponge type such that, based on a second packaging configuration of the second sponge type, the preferred reading distance for the second sponge type is between 12 inches and 36 inches from the RFID reader. Attached Figure Description

[0036] Referring now to the accompanying drawings, schematic illustrations are shown in detail. Although the drawings are schematic, they are not necessarily drawn to scale, and certain features may be exaggerated to better illustrate and explain the innovative aspects of the illustrative examples. Furthermore, the exemplary descriptions herein are not intended to be exhaustive or otherwise limit or constrained to the precise forms and configurations shown in the drawings and disclosed in the detailed embodiments described below.

[0037] The advantages of this disclosure will be readily apparent, as they can be better understood by referring to the following detailed description when considered in conjunction with the accompanying drawings, wherein: Figure 1 The surgical instrument is illustrated as a surgical sponge; Figure 2 An exemplary system for managing surgical supplies inventory is illustrated, showing first and second item packages within the reading range of an RFID reader and surgical supplies inventory at a distance from the RFID reader; Figure 3 This illustrates an identification scheme that can store information on RFID tags. Figure 4 This illustrates the first method of managing surgical supplies during surgery; Figure 5 This illustrates a second method for managing surgical supplies during surgery; Figure 6 This illustrates a third method for managing surgical supplies during surgery. Detailed Implementation

[0038] This disclosure relates to systems and methods for managing the inventory of surgical items during surgery to ensure that surgical items are properly removed from the patient after the surgical procedure and thus prevent surgical items from undesirably remaining in the patient's body.

[0039] Figure 1 This illustration depicts a surgical article, surgical sponge 10, having one or more tags for counting or detecting the surgical article before, during, or after a surgical procedure. Specifically, as described in detail below, Figure 1 The surgical article illustrated may include a surgical sponge 10, which further includes a label 20. However, although not shown in the figure, other alternatives to the surgical article 10 have been considered, including laparotomy pads, gauze, implants, towels, suture needles, clips, staples, or surgical instruments. Another example of a surgical article may include a surgical instrument containing a label 20, such as a scalpel or forceps.

[0040] Tag 20 may include counting elements, detection elements, or any combination thereof, and may be incorporated within a handle, between layers of surgical article 10, or between other portions. As described in detail below, each surgical article 10 may include one or more tags 20, and each tag 20 may include various combinations of counting elements or detection elements. For example, one of these tags 20 may include an RFID element (RFID tag). However, additionally or alternatively, consistent with the disclosure herein, each tag 20 may include any number of counting elements and any number of detection elements.

[0041] The label 20 can be configured to include unique identification information for each surgical item 10. The unique identification information may include a unique serial number or other identifier assigned only to the corresponding item 10. The unique identification information may also convey the type, size, weight, manufacturing date, expiration date, quantity, unique identifier of each item packaged together, or other information used for counting or detecting the items 10, similar items 10 within the corresponding package.

[0042] Tag 20 can convey the unique identification information by emitting an electromagnetic signal or wave corresponding to the unique identification information. Additionally, each surgical item 10 may include a second tag (not shown) with a unique identifier or other information, which may be in a form that can be scanned by an optical scanning device or in a human-readable form that can be manually entered into a user interface of a scanning device, computer, or other system. Multiple tags on surgical items may differ from one another, but all may include the same unique identification information associated with the specific surgical item to which the tag is affixed. Tag 20 may allow the HCP to identify the quantity of surgical items 10 present or to determine the location of surgical items 10 within the patient's body, within the operating room, or both. Alternatively, tag 20 may be detectable within the operating room but not within the patient's body.

[0043] The label 20 can be incorporated within the handle, between layers of the surgical article 10, or between other parts. For example, the label 20 can be adhered to or encapsulated within layers of the surgical article 10, embedded within the handle, or attached to other parts of the article 10. Each label 20 can be rigid to increase its lifespan. In other examples, the label 20 can be flexible to allow the surgical article 10 and the label to be folded or shaped in a more preferred manner for use inside the patient's body. Furthermore, the label 20 can be encapsulated in a waterproof and sterilizable biocompatible plastic coating, bag, or shell 26. The shell 26 can be attached to the surgical article 10 by sutures, adhesives, or similar types of fasteners.

[0044] The counting or detection element of tag 20 can be configured to cooperate with at least one detector interrogation antenna (detection antenna) of the reader as a scanning device, such as a handheld device operable by HCP. Alternatively, the detector interrogation antenna can be incorporated into a surgical instrument tray, surgical cart, or container. However, it is conceivable that any suitable antenna (including antennas integrated within optical scanning devices) can be configured to detect the detection element included in tag 20. The antenna may also include circuitry, coils, or loops configured to define an antenna plane, wherein signals that can be carried on, or can be understood as electromagnetic fields, can be transmitted outward from the antenna plane, received by tag 20, and then tag 20 provides a response signal that can be projected back to the antenna. A scanning device or scanning apparatus with an antenna is described in U.S. Patent No. 8,181,860, filed September 13, 2007, the disclosure of which is incorporated herein by reference.

[0045] Many manufacturers can purchase a wide variety of tags from the market. Some tags can be configured to provide a large amount of user-accessible memory, sometimes in the form of read-only memory or write-once memory. An exemplary tag is an RFID tag 20 that can be detected by an RFID antenna. However, it is contemplated that surgical articles 10 may include any suitable tag that can be detected by any corresponding detection antenna. The applicant has described surgical articles 10 and methods of managing surgical articles including various tags in PCT application No. PCT / US2016 / 057077, filed October 14, 2016, the disclosure of which is incorporated herein by reference.

[0046] Surgical articles may include a surgical sponge 10, which includes an absorbent material body 11. The absorbent material body 11 of the surgical sponge 10 may include a top surface 12 and an opposite bottom surface 14. The surgical sponge 10 may also include a lead, handle, or cord 16. The lead 16 may include radiopaque marking material configured to appear in medical scans. For example, the lead may include radiopaque marking material configured to appear in MRI images to allow identification of surgical sponge 10 accidentally retained in the patient's body.

[0047] For HCP, it may be important to track the surgical sponge 10 before, during, and after the procedure to ensure that it is not accidentally retained or left inside the patient. Therefore, as described above, the RFID tag 20 can be used to identify the location and quantity of sponges used during the procedure. The RFID tag 20 can be attached to the top surface of the absorbent material body 11, near the edge or corner of the surgical sponge 10. Although not shown in the figure, it is conceivable that the RFID tag 20 can be incorporated into the handle, between layers of absorbent material, or between other parts of the surgical sponge 10 in various ways. For example, the RFID tag 20 can be adhered to or embedded within the handle or attached to other parts of the surgical sponge 10.

[0048] The detection element of RFID tag 20 can be used with a multiplex detection system. RFID tag 20 may include a capacitor and an antenna (not shown), the antenna receiving power from the reader's detection antenna (RFID antenna) to charge the capacitor of RFID tag 20. This capacitor becomes the power source for operating the RFID tag 20 when it is not powered. RFID tag 20 may have an integrated circuit including reading functionality, carrier frequency modulation functionality, and a read-only memory portion with burned-in code. The integrated circuit of the detection element and the corresponding antenna are encapsulated in a blood-, water-, or saline-water resistant enclosure. Therefore, RFID tag 20 can withstand repeated sterilization and be attached to other surgical items, such as metal instruments, that are repeatedly sterilized and reused. Depending on the carrier frequency and the type of RFID tag 20, RFID tag 20 can vary significantly in terms of cost, size, and resistance to interventional tissue shielding.

[0049] One feature of RFID-based technology is that the RFID tag 20 serves the dual purpose of detecting the location of the surgical sponge 10, in addition to counting or identifying it. Therefore, some RFID tags 20 can function as both a detection element and a counting element. The RFID tag, in conjunction with the reader's detection antenna, both detects the location of the surgical sponge 10 and provides data for determining the unique identification information of the surgical sponge 10. The RFID tag 20 can operate in the MHz range and above. Exemplary frequencies may include approximately 13.35 to 14.15 MHz (high frequency), the range from 850 to 950 MHz (ultra-high frequency), or the microwave frequency range (i.e., 2.45 to 2.55 GHz). The increased bandwidth provided by these RFID tags 20 increases the likelihood of detecting and locating the corresponding surgical sponge 10 within the interrogation area and within a short time.

[0050] Turn now Figure 2 A system for detecting, identifying, and managing an inventory of surgical objects during surgery is disclosed. The scanning device can be configured to maintain a record of surgical items 10 used during the procedure, stored in onboard memory, or to work with a server. The scanning device includes an RFID interrogator that communicates with the onboard memory. The RFID interrogator includes physical components and operating software for generating and receiving radio frequency signals. The physical components of the interrogator include a radio controller, comprising a transmitter, a signal receiver, or a transceiver for generating signals.

[0051] Records of surgical items created and maintained by this system can be stored in the onboard memory of the scanning device, or the records can be communicated to a server for storage. The scanning device can have a wired or wireless connection to the server. In some alternatives, one or more devices can be positioned to communicate between the scanning device and the server. In one example, a scanning device in the operating room can communicate with a computer located in that operating room, which in turn communicates with other medical devices and tools in the operating room. The computer can communicate information to a router that acts as a gateway to the network. The server is also connected to the network, so the scanning device communicates with the server through multiple layers of devices.

[0052] At the end of the surgical procedure, these records can be transferred to a server and matched with patient records (such as electronic medical records) to update them and provide an indication of when and which specific surgical items were used for each patient.

[0053] exist Figure 2 Examples of various containers for packaging or bundling two or more surgical sponges 10 are shown. One or more strips 38 can be used to bundle or package two or more surgical sponges 10 together. The strips 38 can be configured to bundle the two or more surgical sponges 10 to maintain a defined relationship between the RFID tags 20 of adjacent surgical sponges 10 in the bundle 30. For example, multiple surgical sponges 10 can be stacked vertically and packaged together by strips or strips 38. The strips 38 can be configured to bundle 2, 3, 5, 10, 20 or more surgical sponges 10 together. Alternatively, one or two or more surgical sponges 10 can be packaged or bundled within a bag or container 50. The container 50 can be configured similarly to the strips, wherein the container 50 is configured to maintain a defined relationship between the RFID tags 20 of adjacent surgical sponges 10 in the container 50. The container 50 may include poly-Tyvek. ® Bag with poly-Tyvek ® A rigid base for the cover, or a similar containing device. Any number of surgical sponges 10 or surgical instruments may be packaged or bundled within strips 38 or container 50.

[0054] As described above, bundling or packaging surgical sponges 10 presents challenges for scanning the RFID tags 20 of individual surgical sponges 10 included in the bundle 30. A potential challenge when attempting to scan the RFID tags 20 of packaged surgical sponges 10 is the increased likelihood of interference between RFID tags 20, which could lead to inaccurate counting of surgical sponges 10 or a shortened detection range. Providing sufficient detection range is important for surgical instruments and items because they need to be kept sterile, and RFID readers may not be sterile or available in sterile areas. If the reading range is insufficient, the HCP will need to spend additional time and incur additional costs to sterilely cover the scanner before each surgery. On the other hand, simply increasing the scanner power output to overcome the challenges of densely packaged surgical items with RFID tags may result in undesirable inclusion of surgical sponges transported or stored nearby (including in adjacent operating rooms or other storage locations). Accidentally including surgical items not intended for active surgical procedures can lead to wasted time for the HCP and extended surgical procedures, while also requiring the effort of explaining surgical items never intended for use in the surgery.

[0055] A system 100 for managing surgical supplies during surgery. Figure 2 As shown in the diagram. System 100 includes hardware and software for communicating with surgical items tagged with RFID tags, creating and maintaining database records for managing the inventory of surgical items, including type numbers, types, and unique identifiers for surgical items that can be used in specific surgical procedures. System 100 provides an interface to the HCP to input information into the database and access that information and other information in the database before, during, and after the surgical procedure.

[0056] System 100 includes a system computer 101 that communicates with a display 102. The display 102 may be an integrated display, such as a tablet computer that also includes a touchscreen 104, or other input hardware (not shown). Alternatively, the display 102 may simply be a monitor with input functionality provided by the system computer 101 and other hardware communicating with the display 102. Other input hardware (not shown) may include a microphone for voice command control, or a camera or other sensors for providing gesture control. Additional alternative input hardware may include a trackball, touchpad, keyboard, mouse, etc.

[0057] The monitor 102 can be supported on the base 106. The base 106 can be mounted on a column, such as... Figure 2As shown. In other alternatives, the base 106 can be a mobile trolley or a fixed unit. The base 106 can be a mechanical support for the display 102, which is an integrated display including a power supply, with all computing and input functions within the display itself, such as a tablet computer. Alternatively, the base 106 can support functions not integrated into the display 102. For example, the base 106 can include a system computer 101 and a rechargeable battery that powers the system 100 (including the display 102). The base 106 can accommodate a central processing unit, memory devices, data storage devices, and other hardware of the system computer 101.

[0058] The base 106 can also support an RFID reader 108 that communicates with the system computer 101. The RFID reader 108 can be integrated into the base 106 or can be removable and operated remotely from the base 106. The base 106 can provide a docking station for removable mobile RFID readers (e.g., handheld RFID readers 108). When docked in the base 106, the RFID reader can rely on its own external power source and can communicate with the system computer 101 using a wired docking connection.

[0059] The RFID reader may include an RFID transceiver capable of communicating between the RFID reader 108 and an RFID tag (e.g., tag 20 of the surgical sponge 10). The RFID reader 108 may include its own power supply, data processing, and internal memory or data storage device. The RFID reader 108 may be configurable to operate at different power levels supplied to the RFID transceiver to vary the effective output of radio power from the antenna.

[0060] System 100 may include or communicate with an external computing device 110. This may include additional memory or data storage. Device 110 may provide wireless connectivity to other systems, such as a router or modem, to communicate with remote resources, such as a hospital network or an internet server. In other alternatives, network connectivity is integrated into system computer 101 without requiring external device 110.

[0061] System 100 can be installed in a surgical environment such as a hospital operating room. System 100 can be adapted to be covered for positioning in a sterile area. Alternatively, system 100 can be positioned adjacent to, but outside of, the sterile area to avoid the need for sterile covering. In another alternative, base 106 can be positioned outside the sterile area, but mobile RFID reader 108 can be detached from base 106 and enter the sterile area via appropriate sterile covering or other sterilization preservation measures that may be known in the art.

[0062] System 100 may be equipped with an inventory 112 of surgical supplies tagged with RFID tags that will be managed during the surgical procedure. Figure 2 In this system, the inventory of surgical supplies is displayed as a mobile cabinet or trolley with drawers 114, which contain supplies of various types of RFID-tagged surgical supplies (such as surgical sponges 10). As mentioned above, surgical sponges 10 can be packaged or bundled in various quantities. RFID-tagged surgical sponges 10 come in various shapes, ranging from as small as 2 inches by 2 inches to as large as 8 inches by 108 inches. There are also variations in the number of layers constituting a single surgical sponge 10. For example, some surgical sponges 10 may have as few as 4 layers or as many as 32 layers. Most commonly, surgical sponges 10 are packaged one to ten in a single package.

[0063] Each surgical item, such as surgical sponge 10, is tagged with an RFID tag, such as tag 20, which contains data for uniquely identifying the individual item and providing additional information related to managing the inventory of surgical items. Now refer to Figure 3 An exemplary identification scheme 120 that may be stored in RFID tag 20 is shown. Various tag and data encoding schemes are currently available, and the description of identification scheme 120 is not intended to be limiting. Typically, RFID tags are manufactured with a tag identifier (TID) 122 assigned by the manufacturer of the RFID integrated circuit (IC). This TID 122 is typically stored in a write-once storage location, also known as a read-only memory location on the IC. In addition to the TID 122 provided by the tag manufacturer, other information relating to associating the tag IC with a specific surgical item (e.g., surgical sponge 10) may also be provided.

[0064] Identification scheme 120 may include a portion 124 specifically for identifying the type of tagged surgical items (i.e., sponge type ID). In one alternative, the sponge type ID 124, as described above, is a value that can be used by system computer 101 in conjunction with a lookup table to retrieve other descriptive information associated with that sponge type, such as the quantity of sponges of that type, the name displayed on the user interface, and a specified power level at which the RFID reader operates when counting sponges of that type. The lookup table may be stored locally on system computer 101, for example, in a data storage device of integrated display 102, in a data storage device provided within dock 106, in a data storage device of external computer device 110, or remotely from system computer 101, for example, at a hospital network or Internet server location. In other alternatives, the sponge type ID 124 may be encoded to directly provide certain information without needing to be associated with a lookup table value. For example, the sponge type ID 124 may directly correspond to a specified RFID reader power level associated with a particular sponge type. In either case, the sponge type ID 124 may correspond to a power level parameter associated with that sponge type stored on the RFID tag. The power level parameter may be directly encoded as a power level value in dBm, or it may otherwise provide data corresponding to power, current, voltage, or other settings so that the reader can directly or indirectly control or modulate the power output from the reader's antenna. Alternatively, the sponge type ID 124 may be associated with or encoded with the following: an RSSI threshold associated with that sponge type and a minimum read strength for including the surgical item in the surgical procedure, as described in more detail below.

[0065] Identification scheme 120 may include information for identifying sponge packaging, the number of sponges in the packaging, and the location of a particular sponge within that number. For example, the identification scheme may include a unique packaging ID 126 and a sponge number 128. Each sponge in each package may be assigned a unique identifier shared by all members of the single package. The unique packaging ID 126 may also be encoded such that certain values ​​within the unique packaging ID are used to identify or designate the package as a specific type of surgical article. The unique packaging ID 126 may also be encoded such that certain values ​​identify the number of sponges in the package. For each sponge 10 in a package, the sponge number 128 distinguishes it from the other sponges in the package. For example, in a package containing 10 sponges, there is a sponge with sponge number 128 1, a sponge with sponge number 128 2, and so on, up to sponge number 128 10. The unique packaging ID 126 and sponge number 128 together may represent packaging content information stored on a label.

[0066] Identification scheme 120 may include a read-only copy 130 of the TID in rewritable memory as a security measure to ensure that the data being written has been uniquely assigned and is not copied from a previous tag. The TID copy 130, alone or in combination with other data stored on the tag, can be used as a unique identifier to uniquely identify the sponge bearing that tag. As a further possible security measure in identification scheme 120, or as a way to ensure that the data has not been corrupted, is a checksum 134. All or part of the data contained in the identification scheme on tag 120 can be used as input to a mathematical algorithm for generating the checksum value. The specific mathematical algorithm may be proprietary to the sponge manufacturer to ensure that its tag uniquely identifies sponges produced only by the first party or by an authorized party. A simple example of such an algorithm could be summing the values ​​in all other data fields of identification scheme 120, dividing the sum by a given constant, and using the remainder as the checksum value. Without knowing the specific constant used in the algorithm, unauthorized products may be detected by system computer 101 as a step in the verification of the authenticity of the tag data during the accounting process.

[0067] The identification scheme 120 may include provisions for writing labels during the counting or counting process. For example, Figure 3 The identification scheme 120 includes a count bit 132, which is a flag triggered after the sponge has been counted. This triggering can be accomplished, for example, by sending a command from an RFID reader operating in count mode at the end of the surgical procedure when the sponge has been counted, instructing the tag to change the value of this data field. This value can be particularly useful in emergency situations where a sponge with an RFID tag has been used on a patient but the normal counting process has not been completed. The count bit 132 is a value triggered during the procedure and can be used by the system computer 101 to properly manage the inventory of surgical supplies during the surgical procedure.

[0068] During the surgical procedure, system 100 manages the inventory of surgical items based on information stored on RFID tags (e.g., surgical sponge 10 and RFID tag 20) on the surgical items. System 100 may include a database of records storing information necessary for managing the inventory of surgical items, specifically identifying the entry and exit status of surgical items associated with a particular surgical procedure. In particular, system 100 may be configured to enter a surgical item at the start of the surgical procedure by scanning it with RFID reader 108 and to exit it at the end of the surgical procedure. To overcome the challenges of variable package quantities and different types of surgical items that may be used during the surgical procedure (e.g., sponge sizes in one package differ from sponge sizes in another), RFID reader 108 may be configured to operate with dynamic power levels based on power level parameters stored on the tags or retrieved from a lookup table based on data stored on the tags.

[0069] More specifically, system 100 may initially operate RFID reader 108 at a default power level. This default power level may represent an intermediate value within the full capability range of RFID reader 108. Alternatively, the default power level may be a high or low extreme, depending on the desired initial set of reads. For example, in environments very close to the storage location, such as where base 106 is mounted to an extension of storage cabinet 112, it may be necessary to set the default power level to a low extreme of the RFID reader 108's capability. In this way, system 100 will not face an overly diffused set of reads. Alternatively, it may be desirable to set the default power level to a high extreme of the RFID reader 108's capability, where system 100 is positioned at a greater distance from the storage location and the sterile area where the surgical procedure will be performed. Another consideration may be the amount of ambient electromagnetic noise in the environment that could interfere with consistent communication between RFID tag 20 and RFID reader 108.

[0070] System 100 can evaluate the strength of a response signal received from a specific tag and assign an indicator reflecting the strength of the received response. In other words, system 100 reports the power level of the tag's backscattered response signal in relation to the power level of the RFID reader's initial transmitted signal. The response signal strength indicator, or RSSI, can be used to evaluate the quality of a specific tag's response within the RFID reader's reading area.

[0071] When the RFID reader 108 operates at the default power level, the system 100 receives response output signals from the RFID tags 20 within the effective range of the RFID reader 108. In one configuration, these signals include the aforementioned unique identifier, the aforementioned power level parameters, and packaging contents information of the surgical items affixed to the RFID tags 20. The system 100 can select a first such response and reconfigure the RFID reader 108 to operate at the power level parameters of the first such response, which differ from the default power level. Once reconfigured, the system 100 operates the RFID reader 108 at the first power level to receive a first set of responses at the first power level. Within the first set of responses, there are unique identifiers, packaging contents information, and power level parameters for all RFID tags 20 that responded to the RFID reader 108 operating at the first power level. By comparing the first set of responses with the packaging contents information in the first response selected in response to operating the RFID reader at the default power level, the system 100 can determine whether a complete first package exists to be registered for the surgical procedure; otherwise, an error state is determined. This sequence of steps can be repeated until all desired surgical items have been counted for a particular surgical procedure.

[0072] In an alternative, for a given RFID reader power, system 100 can be configured to count only those tagged items that provide a response signal that is sufficiently strong relative to the RSSI associated with the sponge type. For example, operating an RFID reader at a specific power level might generate a large number of responses representing items stored nearby. The minimum RSSI required to count surgical items helps ensure that only those surgical items specifically provided for the RFID reader to count and actually usable for the surgical procedure are counted, without unintentionally including other nearby items.

[0073] Checking the integrity of the packaging during registration can be important to avoid confusion for HCP and to ensure the correct and intended quantity and type of sponges are provided for the surgical procedure. System 100 verifies the presence of all intended surgical items when comparing the first response set with the first package contents information. For example, when selecting a first response and reconfiguring to an associated first power level parameter, System 100 is configured to determine an error state if fewer than all package contents are present when queried with a power level parameter specified for a particular sponge type. The power level parameter is specifically set for a particular sponge type based on the packaging configuration—such as the number of sponges in the package and the size and thickness of materials that may interfere with effective communication of radio signals. Specifically, the power level parameter for the sponge type is selected to maintain a preferred reading distance greater than a first distance D1 and less than a second distance D2 between the RFID reader 108 and the package of surgical items presented for counting. In the first example, the interval defined between the first distance D1 and the second distance D2 constitutes the preferred reading range for surgical articles at a distance from the reader to maintain their sterility, minimizing the impact of any quantity of sponges stored near system 100, taking into account differences in packaging or manipulation by HCP. In one example, the first preferred distance D1, measured from the RFID reader, is approximately 12 inches and the second preferred distance D2 is 36 inches.

[0074] It should be understood that the reading range of RFID reader 108 begins at zero distance and extends away from RFID reader 108. RFID tags placed close to RFID reader 108 respond to inquiries at this distance and can therefore be read by RFID reader 108. Differences in packaging density (i.e., how many items are in the package), potential interference from item materials, and how the items or packaging are held by HCP are all factors that can affect the quality of the response signal and thus the reliability of the reading. However, placing surgical items close to an RFID reader may compromise the sterility of the surgical items. Therefore, it is preferable to establish a preferred reading range far enough from the RFID reader to maintain the sterility of the product, but not so far that only surgical items stored nearby will sense a response.

[0075] These measurements are illustrative only and are not intended to be limiting. In other examples, other distances are envisioned for the first and second distances to maintain the sterility of surgical items and minimize the impact on other environmental conditions. For example, the stock of stored sponges is set at a distance D3 that is greater than the maximum preferred read distance D2, and is therefore intended to be outside the effective reading range of RFID reader 108 during the calculation process.

[0076] Below is an example table showing the type of sponge (e.g., given in square size and number of layers where applicable), the quantity of that type of sponge in a single package, and the associated power level parameters (corresponding to the effective power output at the antenna of RFID reader 108).

[0077] As detailed in the table, the power level associated with different packages ranges from 10 dBm to 25 dBm. The power unit dBm (or expressed as dBmw) is a unit of level used to indicate the power ratio expressed in decibels (dB) relative to one milliwatt (mW). The number of packages can range from 1 to 10 sponges within a single package, but other quantities are contemplated within the scope of this disclosure. Assuming all other factors remain constant, the more sponges in a package, the higher the associated power level parameter for the associated sponge type. Packages with only 1 sponge have a lower power level parameter. In addition to considering the number of sponges in a package, the size of the sponges in the package can also affect the package's power level. For example, the table above lists several packages with a quantity of 1 sponge per package, but those with more material (i.e., larger size) of sponge are generally associated with lower power levels. In this way, System 100 effectively manages the inventory of surgical supplies during surgery, preventing surgical supplies stored nearby from being accidentally counted.

[0078] It should also be noted that the list above provides illustrative examples of packaging types by the main dimensions of the sponges in the packaging and the quantity of that type of sponge in a single package. This table is not intended to be restrictive, and this disclosure also covers surgical articles of other sizes, quantities, or types.

[0079] The power level associated with a specific packaging type can be determined empirically. For example, to determine the power level for a particular packaging type and quantity, a sample package of that type and quantity can be scanned at various power levels under diverse environmental conditions (i.e., with different quantities and locations of items relatively close to the scanner). The result sets across different conditions can be evaluated, providing the set with the highest confidence in reading all items in the package, while minimizing the impact of environmental noise on successful package reading. Further, other methods for determining the preferred power level can be envisioned.

[0080] In relation to managing the inventory of surgical supplies, system 100 includes a display 102 to communicate the inventory status of surgical supplies to the HCP. Specifically, system 100 may display information identifying the types and quantities of surgical supplies that have been counted, as well as the quantity of surgical supplies that have been counted after being removed from the surgical procedure.

[0081] System 100 can also be configured to warn HCP when an error is identified, for example, when the RFID reader is configured to operate at a power level corresponding to the type of sponge in the package, the result set shows fewer sponges than the total number of sponges in the package. System 100 can display information about the error on display 102, such as identifying the type of sponge provided, the quantity counted as present, the expected quantity in the package, and the difference between the two. Alternatively or supplementarily, system 100 can make the alarm display accompanied by an audible alarm, such as a visual warning with a flashing light. If the reader 108 is not docked with the base 106, system 100 can also activate a tactile response, for example, within the mobile RFID reader 108. The tactile response may include vibration pulses or pulse patterns.

[0082] In an alternative, bundle 30 may include a main label 32, which may include unique identification information. For example, the main label 32 may include the number of surgical sponges 10 contained in bundle 30, and unique identification information for each sponge 10 contained in bundle 30. In addition to the unique identification of the sponges within bundle 30, the main label 32 may include a unique identifier for the packaging.

[0083] The main tag 32 can be configured to identify which side of the bundle 30 or package / object should be scanned based on the location of the RFID tag 20. For example, the main tag 32 or package 38 may include an indicator 40 to facilitate this placement / orientation, such as an arrow pointing to the side of the bundle 30 that should be scanned for optimal accuracy. Alternatively, the indicator 40 can be placed on the side of the bundle that should be positioned closest to the scanner. The indicator 40 can be placed on one or more sides of the sponge bundle 30. The indicator 40 can be placed on any side / face of the bundle.

[0084] Container 50 is configured to contain a single sponge, multiple sponges, a bundle 30, or multiple bundles 30 and may include a similar master label 52 configured to identify the contents of container 50. For example, the container master label 52 may identify the contents of container 50, such as the number of sponges or bundles 30 contained in container 50, and any additional equipment or medical devices contained in container 50. Container 50 configured to contain surgical sponge bundles 30 may include similar indicators configured to identify optimal scan orientation / position / movement, as described above with respect to indicator 40. Master labels 32, 52 may be provided in association with bundles 30 or container 50 and may provide human-readable or machine-readable information, such as RFID tags, barcodes, QR codes, etc. Master labels 32, 52 may provide additional information or the same information provided on item labels (e.g., RFID tag 20). Master labels 32, 52 may be used to perform additional verification prior to the use of the item during surgery.

[0085] A first method 400 for managing an inventory of surgical items used during surgery is illustrated. Surgical items may be surgical sponges 10, as described above. Implementing the described method 400 helps HCP ensure the proper removal of surgical items after the surgical procedure. The method includes a first step 402 of providing an inventory of surgical items (e.g., surgical sponges). The inventory may be stored in a container, such as... Figure 2 The mobile cabinet 112 shown is included in the inventory. The inventory includes packaging of surgical items. In the first example, the inventory includes at least a first package containing at least a first surgical sponge of a first sponge type. The first surgical sponge includes a first RFID tag storing a first unique identifier associated with the sponge, first package contents information, and a first power level parameter associated with the first sponge type. The first package contents information corresponds to the entire contents of the first package. The use of the terms "first" or "second" refers only to independent repetitions of method steps and is not intended to limit or require that "first" be different from "second," unless specifically indicated.

[0086] As described above, the package may include more than one item, for example, a quantity of 2, 3, 5, 10, 20 or more within a single package. The unique identifier may be a single memory data field of an identification scheme stored on an RFID tag, or it may be an entry combining multiple data fields to form a single unique identifier. Package contents information includes the information necessary to identify the unique package and its contents (e.g., quantity). In one example, the package contents information is associated with a unique package ID 126 of identification scheme 120 and may include a sponge type ID 124 to retrieve the total package quantity, and a sponge number 128, which identifies the location of a specific sponge within the package out of the total quantity.

[0087] The method includes a second step 404 of operating the RFID reader at a default power level. Operating the RFID reader involves activating the transmission of radio energy to elicit a response from RFID tags within the reader's range. To initiate this step, the HCP can provide input to the RFID reader directly or via some other connected hardware. The default power level represents the reader's power level setting and is not necessarily associated with a specific sponge type. For example, the default power level could represent an intermediate range of the RFID reader's capabilities. Alternatively, the default power level could represent an intermediate range of power level parameters associated with different sponge types that the RFID reader is suited to read. In one example, the default power level parameter could be 15 dBm. In other alternatives, depending on the specific environment in which the RFID reader operates or other considerations as described above, the default power level can be selected as one of the maximum or minimum limits of the RFID reader's capability range.

[0088] The method includes step 406: receiving one or more responses at the RFID reader indicating that the RFID reader is operating at a default power level. This step may include the HCP specifically presenting the packaging of surgical items with RFID tags to the RFID reader, or vice versa, positioning them such that the RFID reader is within its effective reading range. Preferred reading ranges may be between 12 inches and 36 inches. The response to step 404 may include one or more tag data. For example, in an environment with multiple RFID tags, the RFID reader may employ anti-collision features or read, collect, and process data from multiple tags in a single reading operation. This anti-collision feature is described, for example, in the industry standard ISO / IEC 15693-3:2009 – Anti-collision and Transmission Protocols. The RFID reader communicates with or is combined with a computer processing device to perform the operations of this method. Information may be stored in a database on the memory of another computer processing device within the RFID reader, or may be distributed among multiple computer processing devices. Description of any processing or computation steps may be performed by the RFID reader or another device communicating with the RFID reader.

[0089] In the received response data, the data from the first tag is used to continue the steps of method 400. The data from the first tag includes a first unique identifier, a first power level parameter stored in the first RFID tag, and first package contents information for the first tag. The data from which method 400 continues from this step 406 could originally be the first complete data received within the response time. Alternatively, the response to step 406 could prioritize the use of certain types of sponges over others, or other criteria could be used to specify or select specific sponges for sequential execution of the steps of method 400. In one example, the response data received at the default power level can be evaluated to determine if multiple sponges from a single package exist in the response set. If a minimum percentage of sponges from a single package exists in the response data, a first tag for continuing the steps of method 400 can be selected from the package that has at least the minimum percentage present in the response set. The minimum percentage could be approximately 25% to approximately 50% of the sponges in a complete package. The minimum percentage could be at least 30% of the sponges in a complete package.

[0090] Based on the first RFID tag data, method 400 includes step 408 of reconfiguring the RFID reader to operate according to a first power level parameter corresponding to the first sponge type; and step 410 of operating the RFID reader at the first power level. This operation constitutes a second interrogation of the RFID reader, but at a power level different from the default power level. The first power level may be higher or lower than the default power level, and this may return more or fewer responding tags. When the first power level is higher than the default power level, for example for a sponge type where multiple sponges are densely packed in a single package, more responding tags may be found because the higher power interrogation overcomes the interference caused by the close proximity of multiple tags. When the first power level is lower than the default power level, for example for a sponge type packaged in a single package, fewer responding tags may be found because the effective reading range is reduced to a closer range. Therefore, method 400 includes step 412 of receiving a first set of responses at the first power level.

[0091] During step 412, when receiving the first set of responses at the first power level, the system can be configured to selectively search for a single sponge type corresponding to the first sponge type. Any response to an inquiry at the first power level that does not match the first sponge type can be automatically excluded from the first set of responses to reduce the amount of data to be processed.

[0092] Next, method 400 includes step 414, in response to operating the RFID reader at a first power level different from the default power level, comparing a first response set with first package contents information to determine an error state. The first response set contains unique identifiers of all tags within the effective reading range of the RFID reader at the first power level. Based on the response to step 404, which involves operating the RFID reader at the default level and receiving the first package contents information, the first response set (responses when operating the RFID reader at the first power level) can be compared.

[0093] If the packaging is intact—i.e., there are no errors—the first response set will correctly contain the identification of all sponges indicated by the first package contents information. In the case where the first package contents information contains multiple sponges in a single package, this is an important verification that all desired items are present, minimizing errors or clutter in the HCP's management of surgical item usage during the procedure and in avoiding undesirable retention of surgical items in the patient's body after the procedure. In this case, at step 416, the surgical items in the intact package can be counted into the surgical procedure, and these items can be placed in a suitable waiting area for the HCP's use during the procedure. The steps described above, beginning at step 404 with the RFID reader operating at default power, can be repeated along branch 417 until the desired stock of surgical items has been counted and made available for the surgical procedure. Different types of sponges, different package quantities, and different associated power levels may be encountered when the RFID performs the described steps. The different power levels associated with different package types maintain a preferred reading range of approximately 12 inches to approximately 36 inches between the RFID reader and the package of surgical sponges, regardless of the sponge type.

[0094] Comparing the first response set with the first package contents information may indicate that the package is not complete. After making this determination at step 418, the HCP can receive an alarm for the error. This step can be performed in several ways. For example, a visual alarm can be displayed to the HCP on a display communicating with an RFID reader. The visual alarm can display specific information about the error, such as identifying the type of sponge provided, the number and identity of the response tags, the expected quantity in the package, and the difference between the two. Alternatively or additionally, the HCP can receive an alarm for the error determination via other visual alarms, such as an illuminated or flashing light on the display or the RFID reader. The HCP can also receive an alarm for the error in the form of an audible alarm or a tactile response (e.g., within the RFID reader). A tactile response may include vibration pulses or pulse patterns.

[0095] Upon receiving an error alert, the HCP may, if possible, correct the error or discard the incomplete sponge packaging and turn to other packaging available in the inventory, continuing along branch 419 and repeating the steps of method 400; starting with the RFID scanner operating at the default power level and continuing until the desired inventory of surgical items has been counted and is available for the surgical procedure.

[0096] Once the desired inventory of surgical items has been counted, the HCP can proceed with the surgical procedure, as in step 420. After the surgical procedure is completed, the surgical items are removed from the patient in step 422. After removal from the patient, the surgical items are counted, for example, at step 424, by reading the surgical items again using an RFID reader. Alternatively, counting surgical items may include optically scanning a tag provided on the surgical item, or manually entering information to designate the surgical item as counted.

[0097] During step 424, the RFID reader may operate at a default power level. Alternatively, the RFID reader may operate at a power level corresponding to the power level parameters of the sponge types included in the process but not yet calculated. When multiple sponge types are included, and each sponge type has different associated power level parameters, the RFID reader may operate by performing sequential interrogation operations while cycling through different power levels associated with different sponge types. The RFID reader may receive a set of responses and record only those responses from sponge types corresponding to the power level of a particular interrogation cycle, while excluding any responses from other sponge types not associated with the power level of said particular interrogation cycle.

[0098] Method 400 also includes step 426, which displays the status of the surgical supplies inventory. Although illustrated in... Figure 4 The method is presented at the end, but this step is expected to be performed continuously throughout the method, indicating the type of sponge in response to RFID reader inquiries in steps 406 and 412, and maintaining the current count of surgical items being added to and de-counted as the surgical procedure progresses. For example, displaying the status of the item inventory could include showing the exact count of surgical items being added to and de-counted for each type of surgical item present. This display of inventory status provides a direct and intuitive statistic of the surgical items present during the surgical procedure, minimizing the burden on HCP in tracking and counting the use of surgical items and ensuring that no surgical items remain in the patient's body after the surgical procedure.

[0099] exist Figure 5This document illustrates a second method 500 for managing the inventory of surgical items used during surgery. Surgical items may be surgical sponges 10, as described above. Implementing the described method 500 helps HCP ensure the proper removal of surgical items after the surgical procedure. It should be understood that any feature / step of any method and system described herein can be used in conjunction with other methods and systems described throughout.

[0100] Method 500 includes a first step 502 of providing an inventory of surgical items (e.g., surgical sponges). The inventory can be stored in containers, such as... Figure 2 The mobile cabinet 112 shown is included in the inventory. The inventory includes packaging of surgical items. In the first example, the inventory includes at least a first package containing at least a first surgical sponge of a first sponge type. The first surgical sponge includes a first RFID tag storing a first unique identifier associated with the sponge, first package contents information, and a first power level parameter associated with the first sponge type. The first package contents information corresponds to the entire contents of the first package. The use of the terms "first" or "second" refers only to independent repetitions of method steps and is not intended to limit or require that "first" be different from "second," unless specifically indicated.

[0101] As described above, the package may include more than one item, for example, a quantity of 2, 3, 5, 10, 20 or more within a single package. The unique identifier may be a single memory data field of an identification scheme stored on an RFID tag, or it may be an entry combining multiple data fields to form a single unique identifier. Package contents information includes the information necessary to identify the unique package and its contents (e.g., quantity). In one example, the package contents information is associated with a unique package ID 126 of identification scheme 120 and may include a sponge type ID 124 for retrieving the total package quantity, and a sponge number 128 that identifies the location of a specific sponge within the package out of the total quantity.

[0102] Method 500 includes step 504 of operating an RFID reader and step 506 of receiving tag information in response to operating the RFID reader. To initiate this step, the HCP can provide input to the RFID reader directly or via other connected hardware. This step may include the HCP specifically presenting a package of RFID-tagged surgical items to the RFID reader, or vice versa, positioning them so that the RFID reader is within its effective reading range. Preferred reading ranges may be between 12 inches and 36 inches. The response to step 504 may include one or more tag data. For example, in an environment with multiple RFID tags, the RFID reader may employ anti-collision features or read, collect, and process data from multiple tags in a single reading operation. Such anti-collision features are described, for example, in the industry standard ISO / IEC 15693-3:2009 – Anti-collision and Transmission Protocols. The RFID reader is in communication with or in conjunction with a computer processing device to perform these operations of the method. Information may be stored in a database on the memory of the RFID reader, another computer processing device, or may be distributed among multiple computer processing devices. Any processing or calculation steps can be described by the RFID reader or another device communicating with the RFID reader.

[0103] In the received response data, the data of the first tag is used to continue the steps of method 500. The data of the first tag includes a first unique identifier and information sufficient to identify the sponge type. The information identifying the sponge type may include or be used to retrieve the RSSI inclusion threshold associated with a specific sponge type. The data from which method 500 continues from this step 506 may be the first complete data received within the response time. Alternatively, the response of step 506 may prioritize the use of certain types of sponges over others, or other criteria may be used to specify or select specific sponges for sequential execution of the steps of method 500.

[0104] Based on the first RFID tag data, method 500 includes a step 508 of determining the RSSI of the first RFID tag response, and a step 510 of comparing the determined RSSI with tag information (including an RSSI threshold associated with the sponge type). The RFID reader may determine the RSSI of the first RFID tag response, or it may transmit information related to the first RFID tag response to another computing device, such as a system computer, to process the first RFID tag response and determine the RSSI. The RSSI is determined as a measure of the power of the response signal relative to the power of the interrogation signal that caused the response.

[0105] If the determined RSSI for a particular label is equal to or higher than the RSSI threshold associated with that sponge type, the associated sponge is counted in the surgical procedure for its use at step 512. It is anticipated that a label response that does not meet or exceed the associated RSSI threshold for the associated surgical item type will not siginate an error that must alert the HCP. Instead, a low RSSI can simply be siginated as ambient noise, such as ambient noise from surgical items stored nearby that are not intended for use in the surgical procedure. The steps of operating reader 504, receiving label information 506, determining 508, and comparing 510 RSSI values ​​can continue and be repeated until the desired stocked surgical items have been verified for use in the surgical procedure, as shown along branch 513.

[0106] Method 500 includes step 520, which displays the status of the item inventory. (Although illustrated in...) Figure 5 The method is presented at the end, but this step is envisioned to be performed continuously throughout the method, indicating the type of sponge in response to an RFID reader inquiry in step 506, and maintaining the current count of surgical items being added and removed as the surgical procedure progresses. For example, displaying the status of the item inventory could include showing the exact count of surgical items added and removed for each type of surgical item present. This display of inventory status provides a direct and intuitive statistic of the surgical items present during the procedure, minimizing the burden on the HCP in tracking and counting the use of surgical items and ensuring that no surgical items remain in the patient's body after the procedure.

[0107] If the HCP provides a packaged surgical item for counting but it is not recognized by the system—for example, by adding the package quantity and type through an update display step—the HCP may attempt to adjust the package's positioning relative to the RFID reader by moving the package closer to it or centering it in front of the reader. The HCP may also attempt to count the package by rotating it to adjust its orientation relative to the RFID reader, or by a combination of moving and rotating the package relative to the RFID reader. In some cases, the RSSI of a particular item may never reach the threshold RSSI associated with that item type. In such cases, the HCP may discard the item as a defective item. Failure to obtain a sufficiently strong response signal during the counting phase may indicate that the item will not provide a response signal during the counting phase, potentially leading to confusion for the HCP when attempting to manage and interpret item inventory at the end of the surgical procedure.

[0108] Once the desired surgical supplies have been counted in the inventory, the HCP can proceed with the surgical procedure, as in step 514. After the surgical procedure, the surgical supplies are removed from the patient in step 516. After removal from the patient, the surgical supplies are counted, for example, by reading them again using an RFID reader in step 518. Alternatively, counting the surgical supplies may include optically scanning a tag provided on the surgical supplies or manually entering information to designate the surgical supplies as counted.

[0109] During the counting step 518, when a response to an interrogation signal is received and the sponge has previously been counted in the process, the RFID reader can operate at the default power level and count the sponge. Alternatively, the RFID reader can operate by changing the power level of the continuous interrogation cycle according to a power level parameter associated with the type of sponge being counted in the process. In another alternative, the RFID reader can combine the variable power level technique described in step 424 above with an assessment of the RSSI of a specific sponge to ensure that the correct sponge is counted. To achieve the necessary RSSI during the counting process, the sponge can be presented within the range of the RFID reader so that sponge remaining in the surgical area is not unintentionally counted.

[0110] Consistent with the above description, method 500 includes displaying the status of the item inventory 520, for example, including providing identification of items that are counted and debited throughout the procedure.

[0111] exist Figure 6 The diagram illustrates another method 600 for managing the inventory of surgical sponges used during surgery. Similar to methods 400 and 500 described above, the surgical item can be surgical sponge 10, as mentioned above, and this method helps the HCP ensure the proper removal of the surgical sponge after the surgical procedure. Again, as in methods 400 and 500 described above, method 600 includes a first step 602 of providing an inventory of surgical items (e.g., surgical sponges). The inventory can be stored in containers, such as… Figure 2 The mobile cabinet 112 shown is included in the inventory. The inventory includes packaging of surgical items. In the first example, the inventory includes at least a first package containing at least a first surgical sponge of a first sponge type. The first surgical sponge includes a first RFID tag storing a first unique identifier associated with the sponge, first package contents information, and a first power level parameter associated with the first sponge type. The first package contents information corresponds to all contents of the first package. The use of the terms "first" or "second" refers only to independent repetitions of method steps and is not intended to limit or require that "first" be different from "second," unless specifically indicated.

[0112] As described above, the package may include more than one item, for example, a quantity of 2, 3, 5, 10, 20 or more within a single package. The unique identifier may be a single memory data field of an identification scheme stored on an RFID tag, or it may be an entry combining multiple data fields to form a single unique identifier. Package contents information includes the information necessary to identify the unique package and its contents (e.g., quantity). In one example, the package contents information is associated with a unique package ID 126 of identification scheme 120 and may include a sponge type ID 124 to retrieve the total package quantity, and a sponge number 128, which identifies the location of a specific sponge within the package out of the total quantity.

[0113] Method 600 includes a step 604 of operating an RFID reader and a step 606 of receiving tag information in response to operating the RFID reader 604. Step 604 of operating the RFID reader includes operating the RFID reader at an initial power level for a first time period. During this step 604, the RFID reader collects a first set of responses within the first limited time period. Based on the initial power level, the first set of responses is evaluated to determine whether a complete first package exists in the set of responses—that is, whether each item in the complete package is present in the set of responses as the RFID reader operates at the initial power level for the first time period, based on the collected tag responses and the package contents information of the tag responses. Upon determining that a complete package exists in the set of responses, method 600 optionally includes a step of evaluating whether the complete package belongs to a type having a relevant power level that matches the initial power level of the RFID reader in step 604.

[0114] If it is determined that an intact package exists and that the intact package is of a type with an associated power level matching the initial power level, in step 610, the items in the intact package are included in the surgical procedure. It is possible that an intact package is found but the items are not of a type with an associated power level matching the initial power level; in such cases, these items are not included in the surgical procedure.

[0115] Once items have been counted after the RFID reader has been operating at its initial power level for a first period of time, in step 612, the RFID reader can be reconfigured to operate at an increased power level, different from the initial power level. This method can start with the RFID reader at a low power level and gradually increase to a higher power level, or alternatively, start with the RFID reader at a higher power level and progressively decrease to a lower power level. At higher power levels, the RFID reader is more likely to receive background tag responses from nearby stored items. At lower power levels, fewer tag responses may be received from densely packed surgical items because tags that are very close together can cause interference or attenuation of the RFID reader's interrogator signal. Therefore, it is beneficial to cycle through the entire power level range within the RFID reader's capability range to ensure that the correct groups of RFID-tagged items are counted in the surgical procedure.

[0116] The steps of operating the RFID reader at an increasing power level, receiving response sets, and counting packages (when they are determined to be complete and of a type with an associated power level matching the power level of cyclic operation) can continue along branch 613 until the desired inventory of RFID-tagged items is counted in the process. Once the desired inventory of surgical items has been counted in the surgical procedure, the HCP can proceed with the surgical procedure as in step 614. After the surgical procedure is completed, the surgical items are removed from the patient in step 616. After removal from the patient, the surgical items are counted in step 618, for example, by reading the surgical items again using the RFID reader. In the counting step 618, the RFID reader can operate at the default power level. Alternatively, the counting step 618 can be similar to counting steps 424 or 518, both as described above. Alternatively, counting surgical items can include optically scanning the tags provided on the surgical items or manually entering information to designate the surgical items as counted. Consistent with the above description, method 600 includes displaying the status of the item inventory, for example, including providing identification of items counted and deducted throughout the surgical procedure.

[0117] In one execution example, at step 402, a sponge inventory, such as inventory 112, is provided. An RFID reader, such as RFID reader 108, is provided and triggered to operate in counting mode by providing input at touchscreen 104 or RFID reader 108. RFID reader 108 is configured to initially operate at a default power level of 15 dBm, which is stored in one of system computer 101 or RFID reader 108. RFID reader 108 performs an interrogation loop, such as at step 404, and receives a first set of interrogation responses from a portion of the inventory provided to the RFID reader for counting. System 100 in system computer 101 or RFID reader 108 evaluates the first set of responses to identify at least 30% of the sponges in a single package, such as at step 406. RFID reader 108 determines that two 18"x18" overlapping sponges with the same unique package ID 126 are present in the first set of responses.

[0118] RFID reader 108 is reconfigured to operate at 14 dBm, for example, in step 408, which is the power level parameter associated with the 18" x 18" lap sponge type. This power level parameter is retrieved from a lookup table or database stored in system computer 101 or RFID reader 108. RFID reader 108 performs an interrogation loop at 14 dBm, for example, in step 410. RFID reader 108 receives a second set of responses, for example, in step 412. The second set of responses includes response data from five 18" x 18" lap sponges that have the same unique package ID 126, representing a complete package. Optionally, the system can exclude any data in the second set of responses that does not correspond to the 18" x 18" lap sponge type. System 100 determines the complete package, for example, in step 414, and includes the five 18" x 18" lap sponges for use during surgery, for example, in step 416. RFID reader 108 is reconfigured to operate at the default power level and continues counting the remaining stock 112 until all necessary items have been counted, for example, in step 417. RFID reader 108 follows the same sequence, detecting at least three of the ten 2"x2" gauge sponges in the package at the default power level, reconfiguring to operate at 25 dBm, and detecting ten sponges in the package at 25 dBm power level to count the ten 2"x2" gauze sponges. Once the remaining stock 112 has been counted, an operation is performed with the counted items, for example, in step 420.

[0119] After the surgical procedure is completed, the items are counted to ensure that no items are accidentally left in the patient's body after the surgery, as in step 424. The RFID reader 108 is triggered to operate in counting mode by providing input at touchscreen 104 or the RFID reader 108. The RFID reader 108 performs a continuous interrogation cycle at 300 ms intervals, at 14 dBm and 25 dBm, while searching for counted 18"x18" overlapping sponges and 2"x2" gauze sponges, respectively. Continuous interrogation continues until all types of sponges have been counted, after which continuous interrogation cycles occur only at the power level associated with the type of sponge counted. Optionally, the system 100 can evaluate the RSSI associated with each sponge identified in the response set to ensure a minimum response strength exists before that sponge is counted.

[0120] Several descriptions have been discussed in the foregoing disclosure. However, the discussion here is not intended to be exhaustive or restrictive of any particular form. The terminology used is intended to be descriptive rather than restrictive. Based on the foregoing teachings, many modifications and variations are possible, and this disclosure can be practiced in ways different from the specific descriptions.

Claims

1. A method of managing surgical sponges used during a surgical procedure to ensure proper removal of the surgical sponges after the surgical procedure, the method comprising: providing a supply of surgical sponges, the supply including a first package containing a first surgical sponge of a first sponge type, wherein the first surgical sponge includes a first RFID tag storing a first unique identifier associated with the first surgical sponge, first package content information, and a first power level parameter associated with the first sponge type, wherein the first package content information corresponds to an entirety of the first package; operating an RFID reader at a default power level; at the RFID reader, receiving the first unique identifier, the first power level parameter stored in the first RFID tag, and the first package content information; reconfiguring the RFID reader to operate at the first power level, the first power level different from the default power level, corresponding to the received first power level parameter; operating the RFID reader at the first power level; receiving a first set of responses at the first power level; comparing the first set of responses to the first package content information to determine an error status; upon determining no error status, identifying the first package content information as accounted for in a database record of the surgical procedure; displaying a status of the supply of surgical sponges, identifying an accounted for status, according to the database record.

2. The method of claim 1, wherein, the first package contains a plurality of surgical sponges, each of the surgical sponges including an associated RFID tag storing a unique identifier associated with the surgical sponge, the first power level parameter, and the first package content information, and wherein the first package content information on each RFID tag includes information for identifying all other surgical sponges in the first package.

3. The method of claim 1, wherein, the supply of surgical sponges includes a second package containing a second surgical sponge of a second sponge type and a third surgical sponge of the second sponge type, the second sponge type different from the first sponge type, wherein the second and third surgical sponges include second and third RFID tags, respectively, the second RFID tag storing a second unique identifier associated with the second surgical sponge, the third RFID tag storing a third unique identifier associated with the third surgical sponge, the second and third RFID tags each further storing second package content information, and a second power level parameter associated with the second sponge type, wherein the second package content information corresponds to an entirety of the second package.

4. The method of claim 3, further comprising: reconfiguring the RFID reader to operate at the default power level; operating the RFID reader at the default power level; at the RFID reader, receiving one of the second and third unique identifiers, the second power level parameter, the second power level parameter different from the first power level parameter, and the second package content information; reconfiguring the RFID reader to operate at a second power level different from a default power level, the second power level corresponding to the received second power level parameter; receiving a second set of responses; identifying the second surgical sponge and a third surgical sponge as accounted for in the database record when the second unique identifier and a third unique identifier are present in the second set of responses; and comparing the second set of responses to the second package content information to determine an error state.

5. The method of any one of claims 1-4, further comprising: triggering an alarm upon determining the error state.

6. The method of claim 5, wherein, triggering the alarm includes any of sounding an audible alarm, displaying a warning, activating a haptic response, or a combination thereof.

7. The method of any one of claims 1-4, wherein, comparing the first set of responses to the first package content information to determine an error state includes: determining that the first set of responses matches the first package content information; and determining a no error state in response to determining that the first set of responses matches the first package content information.

8. The method of any of claims 1-4, further comprising positioning the RFID reader near a sterile field where the surgical procedure is performed; and removing the first surgical sponge from the first package after identifying the first surgical sponge as accounted for.

9. The method of claim 4, wherein, the steps of receiving the first set of responses and receiving the second set of responses include positioning the first package and the second package at a first distance and a second distance from the RFID reader, wherein the first distance is a first read range of the first package, the second distance is a second read range of the second package, and wherein the first power level parameter and the second power level parameter are selected such that the first distance and the second distance are within a same preferred read-in distance range of the RFID reader.

10. The method of claim 9, wherein, the same preferred read-in distance range of the RFID reader is between about 12 inches and about 36 inches.

11. A system for managing surgical sponges used in a surgical procedure to ensure that the surgical sponges are properly removed after the surgical procedure, the system comprising: a sterile supply of surgical sponges, the supply comprising: a first package containing a first surgical sponge of a first sponge type, wherein the first surgical sponge includes a first RFID tag storing a first unique identifier associated with the first surgical sponge, first package content information, and a first power level associated with the first sponge type, wherein the first package content information corresponds to an entirety of the contents of the first package; and a second package containing a second surgical sponge of a second sponge type, wherein the second sponge includes a second RFID tag storing a second unique identifier associated with the second surgical sponge, second package content information, and a second power level associated with the second sponge type; an RFID reader configurable to operate at one of a plurality of power levels in response to receiving a power level parameter in response to an RFID read operation; and a database configured to store data representing a state of the supply of surgical sponges, identifying an accounted for quantity and a removed quantity; wherein the RFID reader is configured to: read the RFID tags at the plurality of power levels; the first package is counted in when the RFID reader operates at a first power level associated with the first sponge type and determines that the first package is intact; and the second package is counted in when the RFID reader operates at a second power level different from the first power level and determines that the second package is intact, wherein the second power level is associated with a second sponge type different from the first sponge type; wherein the first power level is associated with the first sponge type such that, based on a first package configuration of the first sponge type, a preferred read distance of the first sponge type is between 12 inches and 36 inches from the RFID reader, and wherein the second power level is associated with the second sponge type such that, based on a second package configuration of the second sponge type, a preferred read distance of the second sponge type is between 12 inches and 36 inches from the RFID reader.

12. A method of managing surgical sponges used during a surgical procedure to ensure proper removal of the surgical sponges after the surgical procedure, the method comprising: providing a supply of surgical sponges, the supply including a first package of surgical sponges comprising a first sponge type, wherein the first surgical sponges include first RFID tags that store first unique identifiers associated with the first surgical sponges; operating an RFID reader to read the RFID tags of the supply of surgical sponges; in response to operating the RFID reader, receiving a response signal including the first unique identifiers stored in the first RFID tags; determining a first predetermined threshold associated with the first sponge type based on the first unique identifiers; determining a first received signal strength indicator (RSSI) as a measure of a power level of the response signal from the first RFID tags read by the RFID reader; identifying the first surgical sponges as counted in in a database record of the surgical procedure when the first RSSI satisfies the first predetermined threshold associated with the first sponge type; positioning the first surgical sponges in a body for the surgical procedure; removing the first surgical sponges from the body; reading the first RFID tags with the RFID reader and identifying the first surgical sponges as counted out in the database record; and based on the database record, displaying a status of the supply of surgical sponges identifying counted in, counted out status.

13. The method of claim 12, wherein, the supply of surgical sponges further includes a second package of surgical sponges comprising a second sponge type, the second surgical sponges including second RFID tags that store second unique identifiers associated with the second surgical sponges; the method further comprising determining a second predetermined threshold associated with the second sponge type based on the second unique identifiers; determining a second RSSI from the second RFID tags; identifying the second surgical sponges as counted in in the database record when the second RSSI satisfies the second predetermined threshold associated with the second sponge type.

14. The method of claim 13, wherein, the first packages each contain a single sponge, and the second packages each contain a plurality of sponges, and wherein the first RSSI is higher than the second RSSI.

15. The method of claim 13 or 14, further comprising positioning the first package at a first distance from an RFID reader, wherein the first distance is a first read distance for the first package; positioning the second package at a second distance from the RFID reader, wherein the second distance is a second read distance for the second package; and wherein, The first and second predetermined thresholds are selected such that the first and second distances are within a same preferred read-in distance range of the RFID reader.

16. The method of claim 15, wherein, The same preferred read-in distance range of the RFID reader is between about 12 inches and about 36 inches.

17. A method of managing surgical items used during a surgical procedure to ensure proper removal of the surgical items after the surgical procedure, the method comprising: providing a supply of surgical items, the supply including a first package containing a first surgical item of a first item type, wherein the first surgical item includes a first RFID tag storing a first unique identifier associated with the first surgical item; operating an RFID reader to read the RFID tags of the supply of items; in response to operating the RFID reader, receiving a response signal including the first unique identifier stored in the first RFID tag; determining a first predetermined threshold associated with the first item type based on the first unique identifier; determining a first received signal strength indicator (RSSI) as a measure of a power level of the response signal from the first RFID tag read by the RFID reader; identifying the first surgical item as in-count in a database record of the surgical procedure when the first RSSI satisfies the first predetermined threshold associated with the first item type; positioning the first surgical item in a body for the surgical procedure; removing the first surgical item from the body; reading the first RFID tag with the RFID reader and identifying the first surgical item as out-count in the database record; and based on the database record, displaying a status of the supply of surgical items identifying in-count and out-count status.

18. A system for managing surgical sponges used during a surgical procedure to ensure proper removal of the surgical sponges after the surgical procedure, the system comprising: a sterile supply of surgical sponges, the supply including: a first package containing a first surgical sponge of a first sponge type, wherein the first package includes a master RFID tag storing a first unique identifier associated with the first surgical sponge, first package content information, and a first assigned power level associated with the first sponge type, wherein the first package content information corresponds to an entirety of the contents of the first package; and an RFID reader configurable to operate at one of a plurality of power levels in response to receiving a power level parameter in response to an RFID read operation; and a database configured to store data representing a status of the supply of surgical sponges identifying an in-count quantity and an out-count quantity; wherein the RFID reader is configured to: operate at a default power level; receive the first unique identifier, the first power level parameter, and the first package content information; reconfigure to operate at a first power level corresponding to the received first power level parameter, the first power level being different than the default power level; operate at the first power level; receive a first set of responses at the first power level; identify the first surgical sponge as in-count in a database record of the surgical procedure when the first unique identifier is present in the first set of responses; and The first set of responses is compared to the first packaging content information to determine an error state.

19. The system of claim 18, wherein, The primary label is configured to identify a side of the package that is to be scanned.

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