System and method for managing surgical instrument during surgical procedures

Abstract

To provide a system and a method for managing one or a plurality of surgical instruments.SOLUTION: A surgical instrument can include a surgical sponge 10 including an identification element, and the management can include counting or position specification, or both of them. The identification element can be made into an RFID tag. The RFID tag stores unique identification information related to the surgical sponge. A system and a method for detecting the RFID tag can include changing a power level of an RFID interrogator for improving the accuracy for scanning the RFID tag or a plurality of tags. A plurality of surgical instruments with the RFID tag (namely, surgical sponges) can be packaged or bundled through a strap 38, or in a container.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Provisional Patent Application No. 62 / 894,300, filed on August 30, 2019. No. 6,313,635, filed on Dec. 13, 2003, the entire contents of which are incorporated herein by reference. do.

[0002] The present disclosure relates generally to systems and methods for detection and identification of surgical objects, and more particularly to Specifically, it concerns tracking and management of RFID tagged sponges. [Background technology]

[0003] Before and after a surgical procedure, keep track of the tools and surgical instruments used during the procedure to It is important to ensure proper sterilization and disposal of tools and equipment. Tools and instruments must be placed accurately to prevent them from being inadvertently lost or left behind inside the patient. It is also important to count. Surgical sponges are used to trap blood and It is an example of a surgical instrument that may be constructed of absorbent material to absorb other bodily fluids. HCPs have reported cases that are usually associated with surgical sponges being inadvertently left inside a patient. Considering the risk of infection, strict measures are in place to keep track of the location of all sponges used during surgery. Follow the steps below.

[0004] Traditionally, HCPs relied on counting surgical sponges by hand; This requires handling and exposure to dirty sponges and is prone to human error. To reduce the possibility of retained surgical sponges associated with inaccurate manual counting methods, Surgical sponges can be labeled with radiopaque markers, barcodes, or RFID or LC-compatible labels. Patients are tagged with radio transponders such as answer transponders. To reduce or eliminate the risks associated with surgical instruments being left behind in the patient, There is a need to provide an efficient and accurate count of sponges for use. Summary of the Invention

[0005] Manage the inventory of surgical instruments used during surgical procedures to A method is provided to ensure proper accounting of surgical instruments after a surgical procedure. The surgical instruments may be implants, towels, suture needles, clips, stems, etc. The sponge may be a surgical instrument, a puller, or other surgical instrument. This method provides an inventory of surgical sponges. The inventory includes a first sponge type, the first sponge being a first surgical sponge. The first surgical sponge includes a first RFID tag. The D-tag is a first unique identification associated with the first surgical sponge. a first power level associated with the first sponge type; The first package content information stores the complete content of the first package. It supports.

[0006] This method operates the RFID reader at a default power level and a first unique identifier, a first power level parameter stored in the first RFID tag; and receiving the first package content information. A first power level different from the default power level, corresponding to a power level parameter of 1. reconfiguring the RFID reader to operate at a first power level; Operating the FID reader at a first power level and receiving a first set of responses. and

[0007] The method further comprises: comparing a first response set with a first package content to determine an error condition. and comparing the surgical procedure to the database if a no-error condition is determined. and identifying the first package content information as having been tallied in the package record. The method involves reconfiguring the RFID reader to operate at a default power level. Includes step.

[0008] The method includes the steps of placing a first surgical sponge within a body for a surgical procedure; removing a first surgical sponge from the body; operating an RFID reader; and detecting the RFID. The ID reader reads the first RFID tag and updates the database record of the surgical procedure. and counting out the first surgical sponge by The method includes identifying counted and decounted states based on database records. The method includes displaying the status of an inventory of a particular surgical sponge.

[0009] In this method, the first package may further include a plurality of surgical sponges, each of which may include a The sponges include a unique identifier associated with each surgical sponge in the first package; Each RFID tag includes an associated RFID tag that stores the first power level parameter. The first package contents information identifies all other surgical sponges in the first package. The information may include information to distinguish

[0010] In this manner, the inventory of surgical sponges is divided into a second surgical sponge of a second sponge type. and a second package containing a third surgical sponge of a second sponge type. The second sponge type may be different from the first sponge type. The three surgical sponges are respectively equipped with the second and third RFID tags, the second surgical sponge a second RFID tag storing a second unique identifier associated with the sponge; a third RFID tag storing a third unique identifier associated with the second and third RF The ID tag includes second package content information and a second power supply associated with the second sponge type. The second package content information also stores the level parameter. Corresponds to the content.

[0011] This method also reconfigures the RFID reader to operate at a default power level. After that, run the RFID reader at the default power level and run the RFID reader for the first time. a second power level parameter, and a third unique identifier, The second power level parameter may be different from the first power level parameter. and second package content information. The method then comprises configuring the device to operate at a second power level. and receiving a second response set. These methods may include detecting a second and a third unique identifier in the second response set. Identify the second and third surgical sponges as counted in the database record if The method includes the steps of: comparing the second response set to second package content information. and determining an error condition.

[0012] The method also includes triggering an alert if an error condition is determined. Alert triggers can include sounding an alarm, displaying a warning, initiating a haptic response, and more. In this method, the first result set may include any of these combinations. If there is a mismatch with the package content information, an error condition is determined.

[0013] The method also involves placing an RFID reader adjacent to the sterile field where the surgical procedure will take place. and identifying the first surgical sponge as counted and then placing the first package. and removing the first surgical sponge from the storage container.

[0014] The method includes the steps of receiving a first set of responses and receiving a second set of responses. The steps include: exposing the first package and the second package to an RFID reader, The first distance may include disposing the first pad at a first distance and a second distance from the first pad. The first preferred reading range of the cage, and the second distance is the second preferred reading range of the second package. a read range, and the first power level parameter and the second power level parameter are , the first distance and the second distance are selected to be within the same read range. The read range can be between about 12 inches and about 36 inches.

[0015] Manage the inventory of surgical sponges used during surgical procedures and ensure that surgical sponges are used after surgical procedures. An alternative method of ensuring proper removal of the sponge is also provided. This method involves using a surgical sponge. providing an inventory of sponges, the inventory including a first surgical sponge of a first sponge type; A first package including a sponge is included, the first surgical sponge being tagged with a first RFID tag. The first RFID tag includes a first unique identifier associated with the first surgical sponge. Remember.

[0016] The method operates an RFID reader to read RFID tags on surgical sponge inventory. and reading, in response to the operation of the RFID reader, the stored position in the RFID tag. and receiving a response signal including the desired identifier. a measure of the power level of a response signal from a first RFID tag when read by a determining a first received signal strength indicator (RSSI) based on the first RSS; I is a first predetermined identifier associated with a first sponge type represented by a first unique identifier. If threshold is met, the first surgical sponge is counted in the database record of the surgical procedure and identifying the identified object as the object.

[0017] The method includes the steps of placing a first surgical sponge within a body for a surgical procedure; removing a first surgical sponge from the body; and detecting a first RFID tag with an RFID reader. The step of reading the tag and identifying the first surgical spot as being de-counted in the database. and identifying a range of the number of users. The method includes counting and analyzing the number of users based on the database records. and displaying the status of the inventory of surgical sponges identifying the de-counted status. .

[0018] In this method, the inventory of surgical sponges is divided into a second surgical sponge of a second sponge type. and a second package containing the second surgical sponge, the second package containing the second RFID tag. The second RFID tag stores a second unique identifier associated with the second surgical sponge. The method also includes determining a second RSSI from a second RFID tag; The RSSI of 2 is associated with a second sponge type indicated by a second unique identifier. If a second predetermined threshold is met, the second surgical procedure is recorded as having been counted in the database. and identifying the sponge.

[0019] In this method, the first package may contain a single sponge per package, and the second The package may include multiple sponges per package. The first RSSI is The RSSI of the

[0020] The method includes the steps of placing a first package at a first distance from an RFID reader. The first distance may be a first preferred read range of the first package. The method includes the step of placing a second package at a second distance from the RFID reader. The second distance may be a second preferred read range of the second package. The first and second predetermined thresholds are set so that the first and second distances are the same for all readings. The read range can be selected to be within a range of about 12 inches to about 36 inches. The range may be between 0.01 and 0.1.

[0021] Manage the inventory of surgical sponges used during surgical procedures and ensure that surgical sponges are used after surgical procedures. A further alternative method for ensuring proper removal of the sponge is provided. This method comprises the steps of: providing an inventory of sponges for use in the method, the inventory including a first sponge type and a second sponge type; A first package including a surgical sponge may be included. The first surgical sponge may include a first The first RFID tag is associated with a first surgical sponge. a first unique identifier, a first package content information, and a first sponge type associated with the first unique identifier, The first package content information stores a first assigned power level for the first Corresponds to the complete contents of the package.

[0022] The method includes operating the RFID reader at a first power level for a first limited period of time to manually and reading RFID tags of an inventory of surgical sponges and, during a first limited time period, collecting a first response set; evaluating the first response set to determine whether the first response set is All surgical supplies in the first package are included if they match the first package content information. determining a complete first package such that the message is in a first response set; The method further includes determining whether the first power level is equal to the first assigned power level. A step of determining whether a complete first package is determined and a first power If the level matches the first assigned power level, the surgical procedure database and identifying the first surgical sponge as having been counted in the record. , reconfiguring the RFID reader to operate at a second power level for a second limited period of time. The second power level is different from the first power level.

[0023] The method includes disposing at least one of the collected surgical sponges in a body for a surgical procedure. and removing the collected surgical sponge from the body. D. Operate the reader and read the first RFID tag with the RFID reader. and aggregating the first surgical sponge by using the first surgical sponge. Provide counts and decounts of surgical sponges by sponge type and The method includes a step of displaying the status of the sponge inventory.

[0024] In this method, the inventory of surgical sponges is divided into a second surgical sponge and a third surgical sponge. and a second package containing a sponge, the second and third surgical sponges being The second sponge includes a second RFID tag. The tag includes a second unique identifier associated with the second surgical sponge, second package content information , and a second assigned power level associated with the second sponge type. The third sponge includes a third RFID tag. The third RFID tag identifies a third surgical sponge. a third unique identifier associated with the sponsi, second package content information, and a second sponsi and storing a second assigned power level associated with the second package type. The information corresponds to the complete contents of the second package.

[0025] The method also includes a step of operating the RFID reader at a power level for a second limited period of time. collecting a second response set during a second limited time period; If the second response set matches the second package content information, A complete first set was performed so that all surgical sponges in the package were present in the second response set. 2. Determine the package of the second power level that matches the second assigned power level. determining whether a complete second package is determined and a second power level is determined; A database record of the surgical procedure is generated when the power level of the surgical instrument matches the second assigned power level. and identifying the second and third surgical sponges as having been counted in the obtain.

[0026] Manage the inventory of surgical sponges used during the surgical procedure and replace them after the surgical procedure. A system for ensuring proper removal of the sponge is also provided. The inventory includes a first surgical sponge of a first sponge type. The first package includes a first surgical sponge. The first surgical sponge is labeled with a first RFID tag. The first RFID tag includes a first unique identification associated with the first surgical sponge. a first power level associated with the first sponge type; The first package content information stores the complete content of the first package. The system also responds to RFID read operations by automatically adjusting the power level parameters. configured to operate at one of a plurality of power levels in response to receiving the meter Includes a capable RFID reader.

[0027] The system includes a surgical sponge inventory that identifies counted and uncounted quantities. The RFID reader includes a database configured to store data representative of a status of the warehouse. The RFID reader is configured to operate at a default power level. a first unique identifier, a first power level parameter, and a first package content information; The RFID reader is configured to receive the first power level parameter. The meter operates at a first power level that is different from the default power level, corresponding to the first The RFID reader can be reconfigured to operate at a first power level. receiving a first response set at a power level and determining if a first unique identifier is present in the first response set; If so, identify the first surgical sponge as having been counted in the database record of the surgical procedure. The first response set is compared to the first package content information to determine an error condition. The system also identifies counted and uncounted quantities of surgical sponges. A display device for displaying the status of the inventory.

[0028] In the system, the inventory of surgical sponges is divided into a second surgical sponge and a third surgical sponge. The second and third surgical sponges may include a second package containing a surgical sponge. The second sponge contains a second RFID tag. The FID tag is a second unique identifier associated with the second surgical sponge, the second package and a second assigned power level associated with the second sponge type. The third sponge includes a third RFID tag. The third RFID tag a third unique identifier associated with the third surgical sponge; second package content information; and and a second assigned power level associated with the second sponge type. The package content information corresponds to the complete contents of the second package.

[0029] The RFID reader operates at a default power level and records a second unique identifier, The power level parameter and the first package content information are further configured to receive the power level parameter and the first package content information. The RFID reader adjusts the first power level in response to the received second power level parameter. and reconfiguring the power supply to operate at a second power level different from the power level. The RFID reader receives a second response configured at a second power level and and a third unique identifier is present in the second response set, the second and third surgical sponges. The second response set is identified as having been collected in the database record of the surgical procedure, and the second response set is It is compared with package content information to determine error conditions.

[0030] If an error condition is determined, the RFID reader may trigger further alerts. Alerts can be alarms, warnings, haptic responses, or any combination of these. The error condition may include one in which the first result set does not match the first package content information. If not, it is determined.

[0031] Manage the inventory of surgical sponges used during the surgical procedure and replace them after the surgical procedure. An alternative system is provided to ensure proper removal of the sponge. This system includes: Contains an inventory of sterile surgical sponges. The inventory consists of the first surgical sponge of the first sponge type. The first package includes a surgical sponge, the first surgical sponge having a first RFID tag. The first RFID tag includes 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. The first package content information is stored in the first package. The inventory of surgical sponges includes secondary and tertiary surgical sponges. The second and third surgical sponges are included in the second package. The second sponge contains a second RFID tag. The D-tag is a second unique identifier associated with the second surgical sponge, the second package contents and storing a second assigned power level associated with the second sponge type. The third sponge includes a third RFID tag. a third unique identifier associated with the three surgical sponges, second package content information, and A second assigned power level associated with the second sponge type is stored.

[0032] The system receives the power level parameters in response to an RFID read operation. In response, an RFID reader that can be configured to operate at one of multiple power levels. The system is also configured to store data representative of the status of an inventory of surgical sponges. Contains a database configured to identify counted and uncounted quantities .

[0033] The RFID reader is configured to read RFID tags at multiple power levels. The RFID reader detects a first electrical signal associated with the first sponge type. and when it determines that the first package is complete, it closes the first package. The RFID reader is configured to count at a first power level. D The reader operates at a second power level different from the first power level, and the second power level relates to a second sponge type that is different from the first sponge type and is packaged in a second and counting a second package at a second power level when the second power level is determined to be complete. It is composed of:

[0034] The first power level is associated with the first sponge type, so that the first sponge type The preferred read range is based on a first packaging configuration of a first sponge type. , between 12 inches and 36 inches from the RFID reader. The second power level is As this relates to the sponge type, the preferred read range for the second sponge type is also , based on a second packaging configuration of a second sponge type, from an RFID reader It ranges from 12 inches to 36 inches.

[0035] Referring now to the drawings, an exemplary embodiment is shown in detail. The drawings represent schematic diagrams. However, the drawings are not necessarily to scale and are intended to better illustrate and explain the innovative aspects of the illustrative examples. Certain features may be exaggerated for clarity. The exemplary figures are to be construed to conform to the precise configurations and arrangements shown in the drawings and disclosed in the following detailed description. It is not intended to be exhaustive or to be restrictive or limiting.

[0036] The advantages of the present disclosure may be best understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: It will be easily understood that the same will be better understood by . [Brief description of the drawings]

[0037] [Figure 1] 1 shows a surgical instrument as a surgical sponge. [Diagram 2] 1 illustrates an exemplary system for managing a surgical instrument inventory showing first and second instrument packages within reading range of an RFID reader and a surgical instrument inventory remote from the RFID reader. [Diagram 3] 1 illustrates an identification scheme for information that can be stored on an RFID tag. [Figure 4] 1 illustrates a first method for managing surgical instruments during a surgical procedure. [Diagram 5] 1 illustrates a second method for managing surgical instruments during a surgical procedure. [Figure 6] 1 illustrates a third method for managing surgical instruments during a surgical procedure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] The present disclosure provides a method for managing an inventory of surgical instruments during a surgical procedure and removing the surgical instruments from a patient after the surgical procedure. to ensure proper removal of surgical instruments, thereby preventing undesirable loss of surgical instruments within the patient. The present invention relates to a system and method for preventing left-behind processing.

[0039] Figure 1 shows the surgical instruments before, during, or after a surgical procedure. One such method has one or more tags for counting or detecting The surgical instrument shown in FIG. 1 is a surgical sponge 10. As will be described in detail below, the present invention includes a surgical sponge 10 that further includes a tag 20. However, Although not shown in the figures, other alternatives for the surgical instrument 10 include abdominal pads, gauze, Implants, towels, sutures, clips, staples, or surgical tools Another example of a surgical instrument may include a tag. The surgical instruments may include surgical tools such as a scalpel or forceps including 20.

[0040] The tag 20 may include an aggregation element, a detection element, or any combination thereof. , may be incorporated into the handle, between layers, or in other portions of the surgical instrument 10. As will be described in detail below, each surgical instrument 10 may include one or more tags 20. , each tag 20 can include various combinations of aggregation or sensing elements. For example, one of these tags 20 may include an RFID element (an RFID tag). However, each tag 20 may additionally or alternatively include any number of It may include a summing element and any number of sensing elements.

[0041] The tag 20 may be configured to contain a unique identification for each surgical instrument 10 . The unique identification information may be a serial number or The unique identification information may include other identifiers such as type, size, weight, date of manufacture, expiration date, etc. , the number of similar devices 10 in the corresponding package, the uniqueness of the devices packaged together 10. The device 10 may further convey an identification of the device 10 or other information used to count or detect the device 10. It is possible.

[0042] The tag 20 is read by transmitting an electromagnetic signal or wave corresponding to a unique identification. Each surgical instrument 10 may further include a unique identifier. or capable of being scanned by an optical scanning device, or a scanning device, computer Humans can manually enter the information into a computer or other system's user interface. A second tag (not shown) may be included that has other information in a readable form. Multiple tags may differ from one another but relate to the particular surgical instrument to which they are affixed. The tags 20 contain the same unique identification information associated with each surgical instrument 10. or for use in surgery inside the patient, in the operating room, or both inside the patient and in the operating room In another alternative, the tag 20 may be located in the operating room. detectable, but not detectable in the patient's body.

[0043] The tag 20 may be incorporated into the handle, between layers, or in other portions of the surgical instrument 10. For example, the tag 20 may be adhered or encapsulated within a layer of the surgical instrument 10. , embedded in the handle, or attached to other portions of the instrument 10. The tag 20 may be rigid to extend its useful life. How can the surgical instrument 10 and tag be folded in a more favorable manner for use inside a patient? In addition, the tag 20 may be water resistant or flexible to allow it to be molded. Permeable, sterilizable, biocompatible plastic coating, pouch, or housing2 The housing 26 may be encapsulated within the tubing 22. The housing 26 may be secured by stitching, adhesive, or a similar method. The device can be coupled to the surgical instrument 10 via a fastener of any of the above types.

[0044] The counting or sensing element of the tag 20 may be a handheld device or other device operable by the HCP. As any scanning device, the reader includes at least one detector interrogator antenna. It works in conjunction with the interrogating antenna. Alternatively, the detector interrogator antenna may be attached to a surgical instrument tray, a surgical cart, or the like. However, it may be integrated into the optical scanning device. Any suitable antenna, including one integrated with a sensor, may be used to detect the sensing element included in tag 20. It is contemplated that the antenna may be configured to define an antenna plane. and further includes a circuit, coil, or loop that is carried by or understood as an electromagnetic field. A signal that can be interpreted is transmitted outward from the plane of the antenna and received by the tag 20, It then provides a response signal that can be projected back onto the antenna. U.S. Patent No. 8,181,860, filed on September 13, describes a scanning device equipped with an antenna. No. 6,399,623, the disclosure of which is incorporated herein by reference.

[0045] A wide variety of tags are commercially available from several manufacturers. Some are accessible to users in the form of read-only or write-once memory. One exemplary tag can be configured to provide a large amount of memory that can be used for storing RFID tags. However, the surgical instrument 10 may be any suitable RFID tag 20 that can be detected by a tamper-evident RFID tag. It is contemplated that the tag may include any suitable tag that is detectable by any corresponding detection antenna. Applicant filed PCT Application No. PCT / US2 on October 14, 2016. In No. 016 / 057077, a surgical instrument including 10 surgical instruments and various tags Methods for managing such conditions are described herein, the disclosure of which is incorporated herein by reference.

[0046] The surgical instrument may include a surgical sponge 10 including a body 11 of absorbent material. The absorbent material body 11 of the syringe 10 may include an upper surface 12 and an opposing lower surface 14. The sponge 10 may further include a lead, handle, or string 16 . The lead 16 may include a radiopaque marker material configured to show up in a medical scan. For example, the lead may enable identification of a surgical sponge 10 that has been inadvertently left behind within a patient. The present invention relates to a method for treating a vascular endothelial cell comprising the steps of: obtain.

[0047] The HCP tracks surgical sponges10 before, during, and after the surgical procedure to Ensuring that sponge 10 is not inadvertently left behind or abandoned within the patient Therefore, as described above, the RFID tag 20 can be used to The location and number of sponges used can be identified. The sponge 10 may be bonded to the top surface of the absorbent material body 11 adjacent an edge or corner of the sponge 10. Although not shown, the RFID tag 20 may be placed within the handle, between layers of absorbent material, or within the surgical instrument. It is contemplated that the adhesive layer 14 may be incorporated in any manner within other portions of the cosmetic sponge 10. For example, The RFID tag 20 may be attached or embedded in the handle or on the surgical sponge 10. It can be bonded to other moieties.

[0048] The sensing elements of the RFID tag 20 may be used in conjunction with a multiplexed sensing system. 20 may include a capacitor and an antenna (not shown), which may be used to The RFID tag 20 receives power from the detection antenna (RFID antenna) and This capacitor serves as a power source for the operation of the unpowered RFID tag 20. The RFID tag 20 has a reading function, a carrier frequency modulation function, and a burned-in code. The integrated circuit may include a read-only memory portion having a read-only memory code. The integrated circuit and corresponding antenna are housed in an enclosure that is resistant to blood, water, or saline. Therefore, the RFID tag 20 can withstand repeated sterilization. It can be attached to other surgical instruments, such as metal instruments, which can be sterilized and reused multiple times. Depending on the carrier frequency and the type of RFID tag 20, Tags20 vary widely in cost, size, and resistance to shielding by intervening tissue. There is a possibility that.

[0049] One feature offered by RFID-based technology is that the RFID tag 20 can In addition to counting or identifying the sponges 10, the location of the surgical sponges 10 is detected. Therefore, a particular RFID tag 20 has a dual purpose of detecting RFID tags can function as both detection and counting elements. In conjunction with the antenna, the position of the surgical sponge 10 is detected and a unique identifier for the surgical sponge 10 is obtained. The RFID tag 20 operates in the MHz range and above. Exemplary frequencies are approximately 13.35 to 14.15 MHz (high frequency); in the 850 to 950 MHz range (ultra-high frequency), or in the microwave frequency range (i.e. These RFID tags 20 can include The additional bandwidth provided by the IR-1000 is used to detect the corresponding surgical sponge 10 within the interrogation zone in a short period of time. It can increase the probability of detection and discovery.

[0050] Turning now to FIG. 2, a surgical object is placed on the surgical A system for detecting, identifying, and managing inventory of CTs is disclosed. The device stores, in its on-board memory or in conjunction with a server, the surgical instruments used in the procedure. The scanning device may be configured to maintain a record of the number of reads and writes in communication with the on-board memory. The RFID interrogator includes a device that generates and receives radio frequency signals. It contains the physical components and operating software required to interrogate. Among the physical components are radio controllers that include signal generating transmitters, signal receivers, or transceivers. controller is included.

[0051] The surgical instrument records created and maintained by the system are stored in on-board memory. The records are stored on the scanning device or the records are communicated to a server for storage. The scanning device has a wired or wireless connection to the server. In one example, there are one or more devices placed in communication between the device and the server. The scanning devices in the operating room further communicate with other medical devices and tools in the operating room. The computer can communicate with a computer located in the operating room. The server also communicates the information to a router that acts as a gateway to the network. , the scanning device communicates with the server through multiple device layers.

[0052] At the end of the surgical procedure, the records are sent to a server and matched with patient records, such as electronic medical records. and update the same, providing an indication of how many times which particular surgical instruments were used on each patient. It is possible.

[0053] FIG. 2 shows a device for packaging or bundling two or more surgical sponges 10. Various examples of containers are shown. and bundling or packaging two or more surgical sponges 10 together. The strap 38 can be used to bundle two or more surgical sponges 10 together, and to separate adjacent ones of the bundle 30. and configured to maintain a defined relationship between the RFID tags of the surgical sponges. For example, multiple surgical sponges 10 may be stacked on top of each other and secured together with straps or The straps 38 may be packaged together as 2, 3, 5, 1 The sponge may be configured to bundle together 0, 20, or more surgical sponges 10. Alternatively, one or more surgical sponges 10 may be placed in a pouch or container 50. The container 50 can be packaged or bundled in a The container 50 may be configured to receive RFID tags of adjacent surgical sponges 10 within the container 50. The container 50 is configured to maintain a defined relationship between the tags 20. (Tyvek) pouch, rigid bag with poly Tyvek cover The surgical sponges 10 may include any number of surgical sponges 10, Alternatively, the surgical instruments may be packaged by straps 38 or in a container 50. or bundled.

[0054] Bundling or packaging the surgical sponges 10 as described above results in bundles 30 This creates a challenge for scanning the RFID tags 20 of the individual surgical sponges 10 contained in the When packaged, the RFID tag 20 of the surgical sponge 10 may When attempting to scan, one potential challenge is the high possibility of interference between RFID tags 20. This may result in inaccurate counting of the surgical sponges10 and a shorter detection distance. The sterility of surgical tools and instruments must be maintained, and RFI D Readers may not be sterile or available within a sterile field. Providing sufficient detection distance is important for surgical tools and instruments. If the distance is insufficient, the HCP must provide additional time to sterile drape the scanner before each procedure. On the other hand, it is necessary to spend time and incur additional costs. Simply increasing scanner power to overcome the challenge of RFID-tagged surgical instruments If the equipment is not delivered, it may be necessary to transport or store surgical supplies nearby, including adjacent operating rooms or other storage areas. Undesirable accumulation of ranges may occur. Attempts have been made to calculate surgical instruments, but they are not intended for active use in surgical procedures. Accidental collection of missing surgical instruments wastes HCP time and extends surgical procedure times. It may be a possible cause.

[0055] A system 100 for managing surgical instruments during a surgical procedure is illustrated in FIG. The system 100 communicates with the RFID tagged surgical instruments and maintains an inventory of the surgical instruments. Hardware and software to create and maintain database records that you manage the type number of those surgical instruments adapted for use in a particular surgical procedure; The system 100 includes identifying the type, and a unique identification number. Enter information into the database and view that information in the database before, during, and after the surgical procedure. and provides an interface for accessing other information.

[0056] The system 100 includes a system computer 101 in communication with a display 102. The display 102 may be coupled to a touch screen 104, or other input hardware (not shown). Alternatively, the display may be an integrated display such as a tablet computer that further includes a display (not including the display). Alternatively, the display 102 may simply be a computer system 101 and a display. A monitor with input capabilities provided by other hardware that communicates with the Other input hardware (not shown) includes a microphone for voice command control. or a video camera or other sensor to provide gesture control. Alternative input hardware includes trackballs, touchpads, keyboards, and mice. etc.

[0057] The display 102 may be supported on a base 106. As shown in FIG. The base 106 may be mounted on a pole. In another alternative, the base 106 may be mounted on a mobile cart. The base 106 may be a display unit such as a tablet computer. The Play itself has an integrated display that includes all power, computing and input capabilities Alternatively, the base 106 may be a mechanical support for the display 102. It may support functions not integrated within the Spray 102. For example, the Base 10 6 supplies power to the system computer 101 and the display 102. The base 106 may include a rechargeable battery for powering the system 100. Central Processing Unit, Memory Device, Data Storage Device, System Computer Other hardware for the 101 can be accommodated.

[0058] The base 106 also includes an RFID reader 108 in communication with the system computer 101. The RFID reader 108 may be integrated into the base 106 or may be The handheld device 102 may be attached or detached and may be operated remotely from the base 106. The base 106 may be attached or detached from the handheld device 102. Dock for removable mobile RFID readers such as the Dot RFID Reader 108 When docked in the base 106, the RFID reader can , which may rely on its own external power source and may communicate with the system computer 101 You can use the wired dock connection for that.

[0059] The RFID reader is a RFID reader 108 and an RFID tag (surgical sponge 10 The RFID tag 20 may include an RFID transceiver that enables communication between the RFID tag 20 and the The RFID reader 108 has its own power supply, data processing, and a memory or data storage device. The 08 can be configured to operate with various levels of power provided to the RFID transceiver. The antenna can be adjusted to change the effective output of wireless energy.

[0060] The system 100 may include an external computing device 110 or The computer may communicate with the computing device 110, which may include additional memory or data storage. The device 110 may include a hospital network or an internet server. Wireless connections to other systems, such as routers or modems, to communicate with remote resources In another alternative, the network connection may provide a is integrated into the system computer 101 without the need for a

[0061] The system 100 may be provided in a surgical environment, such as an operating room in a hospital. The device can be adapted to be draped for placement in a sterile field. Alternatively, the system 100 may be located adjacent to but outside of the sterile field and may be used to sterilize the sterile field. The need for a drape can be avoided. In a further alternative, the base 106 can be covered with a sterile flap. The mobile RFID reader 108 may be located outside the field, but the mobile RFID reader 108 may be located within the base 06 and covered with appropriate sterile draping or other disinfectant as known in the art. A sterile field can be entered using a sterile maintenance means.

[0062] The system 100 is configured to monitor and record RFID tagged hands that are to be managed during a surgical procedure. In FIG. 2, the surgical tool inventory may include a surgical sponge 10. 1 drawer containing a supply of RFID-tagged surgical instruments of several different types, such as 14. As shown above, the handheld device 10 is a mobile cabinet or cart with a The surgical sponge 10 may be packaged or bundled in various quantities. D-tagged Surgical Sponges 10 range from a minimum of 2" x 2" to a maximum of 8" x 108" The number of layers that make up a single surgical sponge 10 can vary from 100 to 200 mm. There is also variation in thickness. For example, some surgical sponges have a minimum of 4 plies (pl y) or up to 32 plies. Most commonly, the surgical sponge 10 is a single Up to 10 units from the package will be packaged within the package.

[0063] Each surgical instrument, e.g., surgical sponge 10, may be labeled with a unique identifier for each individual item. provides data to manage the inventory of surgical instruments, as well as other relevant information to manage the inventory of surgical instruments The tag is tagged with an RFID tag, e.g., tag 20, which contains data relating to the 1, an exemplary identification scheme 120 that may be stored on an RFID tag 20 is illustrated. A variety of tag and data encoding schemes are currently available, including identification schemes 120. The description is not intended to be limiting. Generally, an RFID tag is an RFID integrated circuit ( Manufactured with a tag identification (TID) 122 assigned by the IC manufacturer This TID122 is typically stored in a write-once memory location and is read-only on the IC. Also called a read-only memory location. TID12 provided by the tag manufacturer In addition to 2, other information may be associated with the tag IC to a particular surgical instrument, such as a surgical sponge 10. The present invention may be provided in connection with attaching the

[0064] The identification scheme 120 identifies the type of surgical instrument that is being tagged, i.e., sponge. A portion 124 may be included dedicated to identifying the type ID. The type ID 124, as shown above, indicates the number of sponges of that sponge type, the user input, The name displayed on the interface, and the RFID reader when counting sponges of that type. Further specifications related to sponge types, such as the power levels at which they are specified to operate, are available. The system computer 101 then stores the information in combination with a lookup table to retrieve the information. The lookup table is a value that can be used based on the data of the integrated display 102. data storage, data storage provided to the base 106, external computer device Local to the system computer 101, such as data storage at 110, System computers 101 such as hospital networks and Internet server locations In another alternative, the sponge type ID 124 may be stored remotely from It may be coded to provide specific information directly, without requiring correlation with a table value. For example, sponge type ID 124 represents a specified R associated with a particular type of sponge. Directly corresponds to FID reader power level. In either case, sponge type ID12 4 corresponds to the power level parameters stored in the RFID tag related to the sponge type The power level parameter may either directly encode the power level value in dBm or may be expressed as power, Control or vary the current, voltage, or direct or indirect power output from the reader's antenna. Alternatively, the data may be provided to correspond to other settings of the reader to be checked. The sponge type ID 124 indicates the sponge type and and RSS related to minimum read strength for counting surgical instruments in surgical procedures It may be correlated or coded to the I threshold.

[0065] The identification scheme 120 may include information about the package of sponges, the number of sponges in the package, and and information to help identify where a particular sponge is within that quantity. For example, the identification scheme may include a unique package ID 126 and a sponge number 128. Each package of sponge is made up of all the components common to a single package. A unique package ID 126 may be assigned to each package. A specific value in the package ID identifies the package as being for a particular type of surgical instrument. The unique package ID 126 may be encoded to help identify or specify the package. Also, a specific value may be coded to identify the quantity of sponge in the package. For every 10 sponges in the cage, sponge number 128 is different from the other sponges in the package. For example, a package of 10 sponges contains sponge number 128. one sponge with sponge number 1, one sponge with sponge number 2, and so on until sponge number 128. There are up to 10 sponges. The unique package ID 126 and sponge number 128 are In addition, the tag can represent package content information stored on the tag.

[0066] The identification scheme 120 ensures that the data written is uniquely assigned and copied from the previous tag. As a security measure to ensure that the data in the rewritable memory is not The TID copy 130 may include a read-only copy 130 of the TID. This can be combined with other data stored on the tag to uniquely identify the sponge to which the tag is attached. This can serve as a unique identifier to identify the user. As a countermeasure or a way to ensure that data is not corrupted, an identification scheme 120 is a checksum 134. All or part of it may be used as input to a mathematical algorithm to generate a checksum value. A specific mathematical algorithm determines whether the tag is a sponge manufactured by a first party, or or other licensed party. Such algorithms may be proprietary to sponge manufacturers. A simple example of a scheme would be to sum up all the values ​​of the other data fields in the identification scheme 120, The solution is to divide that sum by a given constant and use the remainder as the checksum value. Unauthorized products that do not know the specific constants used in the algorithm may be unable to determine whether the tag data is authentic. As a step in the counting process, the system computer 101 It is detected.

[0067] The identification scheme 120 defines rules for writing to tags during the counting or decounting process. For example, the identification scheme 120 of FIG. 3 may include a switch after the sponges are decounted. The tabulation exclude bit 132 is a flag that can be toggled. When counted at the end of a surgical procedure from an RFID reader operating in exclusion mode by sending a command to the tag to change the value of this data field. This value can be achieved by using a RFID tagged sponge that has completed the normal counting procedure. This may be particularly advantageous in emergency situations where the data is used on a patient without the need for a program. This is a value that can be switched during the process, which is important for properly managing the inventory of surgical instruments during a surgical procedure. may be used by the system computer 101 in

[0068] The system 100 includes a RFID tag 20 and a surgical sponge 10. Based on the information stored in the FID tags, the inventory of surgical instruments during a surgical procedure is managed. The system 100 determines the counting and de-counting status of surgical instruments associated with a particular surgical procedure. A database of records that specifically identifies and stores information necessary to manage the inventory of surgical instruments. In particular, the system 100 scans the instrument with an RFID reader 108. The surgical instruments are counted at the beginning of the surgical procedure and counted at the end of the procedure. It may be configured to count-out the surgical instruments upon completion. Various package quantities and types of surgical instruments that may be used in a procedure (e.g. To overcome the challenge of different sizes of sponges in one package compared to another, To this end, the RFID reader 108 reads the data stored on the tag or A dynamic power level based on a power level parameter retrieved from a lookup table based on the The device may be configured to operate with a bell.

[0069] More specifically, the system 100 initially operates the RFID reader at a default power level. This default power level is used to operate the RFID reader. 108 full operating capability. Alternatively, the default power level may be , which may be a high or low extreme value depending on the first set of read results of interest. For example, The base 106 is attached to an extension of the inventory cabinet 112. In environments where the RFID reader 108 is in close proximity to other devices, the default power level It may be desirable to set the low extremes of the capacity. In this manner, the system 100 , you won't be overwhelmed by an overly extensive result set. Alternatively, you can use the default power It may be desirable to set the level at the high extreme of the RFID reader 108's operating capabilities. In this case, the system 100 is connected to an inventory storage location and a sterile filter where a surgical procedure is to be performed. Another consideration is the distance between the RFID tag 20 and the RFID reader. Ambient electromagnetic noise in the environment that may interfere with consistent communication between the It can be a quantity.

[0070] The system 100 evaluates the strength of the response signal received from a particular tag and In other words, System 1 can assign indicators that reflect the strength of the answer. 00 is the backscatter response of the tag in relation to the power level of the RFID reader's initial transmission signal. Report the power level of the signal. Response Signal Strength Indicator or RSSI is used to The quality of the response of a particular tag within the reading zone of the FID reader can be assessed.

[0071] When operating the RFID reader 108 at the default power level, the system 100 , receiving a response output signal from the RFID tag 20 within the effective range of the RFID reader 108. In one configuration, contained within these signals is the The unique identifier of the surgical instrument, power level parameters, and package contents information The system 100 selects such a first response and uses a different power level than the default power level. Reconfiguring the RFID reader 108 to operate with different first response power level parameters. Once reconfigured, the system 100 can configure the RFID reader 108 to Operate at a first power level and receive a first response set at the first power level. Within the response set are all the response signals that respond to operation of the RFID reader 108 at the first power level. The unique identifier, package content information, and power level parameters of every RFID tag 20 are recorded. The first set of responses is generated for the RFID reader at the default power level. by comparing the package content information from the first response selected in response to the operation; The system 100 is a complete first-class package for checking into a surgical procedure. This sequence of steps determines whether to restart the system or to detect an error condition. This may be repeated until all desired surgical instruments for a particular surgical procedure have been tabulated. do.

[0072] In one alternative, for a particular RFID reader power, the system 100 These tags provide a sufficiently strong response signal compared to the RSSI associated with the tag type. For example, the RFID reader can be set to a specific power level to count only the devices. When operated in a , a number of responses can be generated that represent instruments stored nearby. By requiring a minimum RSSI for counting ingredients, RFID readers are given special Only those surgical instruments presented will be collected and made available for actual surgical procedures. Also, other nearby fixtures are not unintentionally included.

[0073] Check package integrity during the check-in process to avoid confusion for HCPs Ensure that the appropriate and anticipated quantity and type of sponges are present for the surgical procedure. It is important to ensure that the system 100 stores the first response set in a first package. By comparing with the available information, it is possible to verify that all expected surgical instruments are actually present. For example, the first response is selected and the associated first power level parameter is recalculated. When configured, the system 100 uses the power level parameters specified for that sponge type. If less than all packaged contents are present when asked in the The power level parameter may be, for example, The number of sponges in the package, the size of the material that may prevent the wireless signal from transmitting effectively and thickness, which are specifically tailored to specific sponge types depending on the packaging configuration. Specifically, the power level parameters of the sponge type are The distance between the package of surgical instruments presented for collection and the first distance D1 selected to maintain a preferred read distance greater than and less than the second distance D2. In the first example, the space defined between the first distance D1 and the second distance D2 is Establish a preferred read range for surgical instruments away from the scanner, maintain sterility, or Any products stored near the system 100 that are due to packaging or handling by HCPs Minimize the impact of the amount of sponge that is removed. In one example, , the first preferred distance D1 is about 12 inches, and the second preferred distance D2 is about 36 inches. It is.

[0074] The reading range of the RFID reader 108 is zero distance from the RFID reader 108. It should be understood that the RFID reader 108 starts with an RFID The tag responds to a query at that distance and can therefore be read by the RFID reader 108. Different packaging densities, i.e. the number of devices in a package, and the material of the devices, Potential interference and how the equipment or packaging is held by the HCP , all of which can affect the quality of the response signal and therefore the reliability of the reading. However, placing surgical instruments right next to the RFID reader This may compromise the sterility of the surgical instruments. Establish a favorable read range far enough away from the RFID reader to maintain Preferably, the distance is close enough to the surgical instrument to trigger a response, but not so far away that it would simply elicit a response from the surgical instruments stored nearby. stomach.

[0075] These measurements are merely illustrative and are not intended to be limiting. The first step is to maintain the sterility of surgical instruments and minimize their impact on other environmental conditions. and other distances for the second distance are contemplated. The repository is located at a distance D3 that is greater than the maximum priority read distance D2, and therefore the counting process The RFID tag 104 is intended to be outside the effective read range of the RFID reader 108 in the device.

[0076] Sponge type (e.g. indicated by square dimensions and number of pieces, if applicable), single The number of sponges of that type in the package and the number of RFID readers An exemplary table of associated power level parameters corresponding to the effective power output of the tenna is shown below. vinegar.

[0077] [Table 1]

[0078] The range of power levels associated with the different packages is 10d The power unit dBm (or dB m w) is Used to indicate a power ratio expressed in decibels (dB) relative to 1 milliwatt (mW). The package quantity range is one square meter in a single package. The number of sponges may range from 10 to 100, although other quantities are contemplated within the scope of this disclosure. Assuming everything else is constant, the more sponge in the package, the greater the associated The associated power level parameter of the sponge type will be higher. The power level parameters are lower in the package. The size of the sponge in the package is In addition to considering the number of sponges in the package, the power level of the package also has an impact. For example, in the table above, several quantities per package are given. However, these sponges, which contain more material and therefore are larger in size, typically require lower power levels. In this manner, the system 100 effectively manages the inventory of surgical instruments during a surgical procedure. to avoid inadvertent counting of surgical instruments stored nearby.

[0079] The above table shows the primary dimensions of the sponge in the package and the corresponding sizes in a single package. It is also noted that illustrative examples of package types by quantity of sponge of each type are provided. This table is not intended to be limiting and does not include other sizes, quantities, or types. Surgical instruments of the type described herein are also contemplated by the present disclosure.

[0080] The power level associated with a particular package type can be determined empirically. For example, to determine the power level for a particular package type and quantity, One example package for this is a lab that uses a factorial design of experiments to test different environmental conditions (i.e., scanner The number and location of equipment stored relatively close to each other may vary, and the equipment may be operated at various power levels. It can evaluate result sets across a range of conditions to successfully read the package contents. The signal that reads all the instruments in the package is generated while minimizing the effect of environmental noise during the reading. The most reliable set of results can be evaluated. Other methods for determining the preferred power level are also available. It is further contemplated that such a method may be employed.

[0081] In connection with managing the inventory of surgical instruments, the system 100 may include a system for monitoring the status of the inventory of surgical instruments. The system 100 includes a display 102 for communicating the tally to the CP. The type and quantity of surgical instruments used and when the instruments were removed from the surgical procedure Information identifying the quantity of surgical instruments that were subsequently decounted may be displayed.

[0082] The system 100 also detects power level parameters corresponding to the device type from the RFID reader. When configured to operate with the meter, the total quantity of sponges in the package Alerts HCP to error condition determinations, such as when low quantities appear in a result set The system 100 may be configured to determine the type of sponge presented, what is present, and the number of items that have been collected and tallied, the number expected in the package, and identifying any discrepancies between the two. Information regarding the error can be displayed on the display 102. The system 100 Alternatively, or in addition, this alert indication may be provided by an audible alarm, a visual alert such as a flashing light, or the like. The system 100 may also include, for example, a method for transmitting a read signal from the reader 108 to the base 106. When the mobile RFID reader 108 is undocked from the The tactile response may include a vibration pulse or pattern of pulses.

[0083] Alternatively, the bundle 30 may include a master tag 32 that contains unique identifying information. For example, , the master tag 32 includes the number of surgical sponges 10 contained in the bundle 30, as well as 0. The master tag 32 may include a unique identification for each sponge 10 contained in the bundle 30. In addition to the unique identification number of the sponge in the package, The unique identification number may include a unique identification number for the device.

[0084] The master tag 32 determines which bundle 30 or which bundle 30 is to be scanned based on the location of the RFID tag 20. The Master Tag 32 or the marker may be configured to identify the side of the package / object. The package 38 may be marked with various symbols, such as an arrow pointing to the side of the bundle 30 that should be scanned for optimal accuracy. It may include indicators 40 to facilitate such placement / orientation. The indicator 40 can be placed on the side of the stack that is to be placed closest to the scanner. The indicators 40 may be located on one or more sides of the stack of sponges 30. The indicator 40 can be placed on any side / face of the bundle.

[0085] Configured to hold an individual sponge, a plurality of sponges, a bundle 30 or a plurality of bundles 30 The container 50 includes a similar master tag 52 configured to identify the contents of the container 50. For example, the container master tag 52 may include a number or bundle of sponges contained in the container 50. The contents of the container 50, such as the number of 30, as well as any additional equipment or medical devices contained in the container 50. The container 50 configured to hold a stack of surgical sponges 30 may be indicative of 40. As described above with respect to the camera 40, the camera 40 is configured to identify the optimal scanning direction / position / motion. The master tag 32, 52 may be attached to the bundle 30 or container 5. 0 and human-readable or machine-readable information provided in connection with the User's personal information, such as RFID tags; The master tag 32, 52 may provide a bar code, a QR code, etc. Provide additional or identical information to that provided on an instrument tag, such as an FID tag 20. The master tag 32, 52 allows for additional testing prior to the use of the instrument in a surgical procedure. This is useful for carrying out the testimony.

[0086] A first method 400 for managing an inventory of surgical instruments used during a surgical procedure is shown. The surgical instrument may be a surgical sponge 10, as described above. Implementing 00 will ensure HCPs properly retrieve surgical instruments after a surgical procedure. This method is the first to provide an inventory of surgical instruments such as surgical sponges. Step 402. The inventory is stored in a container, such as the mobile cabinet 112 shown in FIG. The inventory includes packages of surgical instruments. In the above, the inventory includes at least a first surgical sponge of a first sponge type. The first surgical sponge also includes a first package. The first surgical sponge includes a first unique identifier associated with the sponge. a first power associated with the identifier, the first package content information, and the first sponge type; The first package content information includes a first RFID tag that stores the level parameter. Corresponds to the complete contents of the first package. Use of the designation "first" or "second" The use of simply refers to an individual iteration of the aggregation methodology steps, unless otherwise noted. , is not intended to limit or require that the "first" be different from the "second."

[0087] As mentioned above, packages can be 2, 3, 5, 10, 20 or more in a single package. The unique identifier may include multiple devices, such as an amount of the device, an identification scheme stored in the RFID tag, and a It can be a single memory data field of the same system, or it can combine entries from multiple data fields. Together these may constitute a single unique identifier. The package contents information may include a unique package and includes such information necessary to identify the contents of the package (e.g. quantity). In one example, the package content information may be a unique package ID 126 of the identification scheme 120. Related to sponge type ID124 to get the complete package quantity and specific A sponge number 128 that identifies the position in the package that the sponge occupies within the complete quantity; may include.

[0088] This method operates the RFID reader at a default power level in the second step. 404. The step of operating the RFID reader includes: This refers to activating the emission of radio energy to elicit a response from an RFID tag. To initiate a step, the HCP must either directly or through other connected hardware components The default power level may be different for each particular slot. Indicates the power level setting of the reader that is not related to the type of pongee. For example, the default The power level may represent the mid-range of the RFID reader's operating capabilities. The power levels of the tags vary depending on the type of tag that the RFID reader is adapted to read. The power level parameter may represent a mid-range associated with the power type. The power level parameter can be 15 dBm. Another alternative is to use the default power level. The force level may vary depending on the particular environment in which the RFID reader is operating, or other considerations mentioned above. can be chosen to be one of the maximum or minimum extremes of the RFID reader's possible range. .

[0089] This method runs the RFID reader at the default power level. The method includes receiving 406 a response or responses to the request for the execution of the process. The step involves an HCP placing a package of RFID-tagged surgical instruments into an RFID reader. or vice versa, the RFID reader physically presents the The preferred read range is: , may be between 12 inches and 36 inches. The response to step 404 may be one or more For example, in an environment where multiple RFID tags are present, The reader uses anti-collision features or reads data from multiple tags in one read operation. For example, such anti-collision mechanisms can be used to read, collect and process the data. The functionality is based on the industry standard ISO / IEC15693-3:2009-Anti-collision and The RFID reader is configured to transmit the control signal in order to perform the operations of the method. Communicates with or incorporates a computer processing device The information is stored in the memory of the RFID reader, in the memory of a separate computer processing device, may be held in a centralized database or distributed across multiple computing devices. Any description of processing or computational steps may be provided by the RFID reader, or The method may be performed by another device in communication with the

[0090] The received response data includes data from the first tag, and the method continues with steps 400. The first tag data is used to identify a first unique identifier, a first power level parameter stored in said first tag and a first package content information of said first tag; The data for continuing the method 400 from step 406 may include receiving the response time. Alternatively, the response of step 406 may be a response of some type Prioritize the use of sponges over other types of sponges or use other criteria You can specify or select a particular sponge to step through the steps of method 400. In one example, the response data received at the default power level is evaluated to generate a single packet. It can be determined whether multiple sponges from a cage are present in the response set. A minimum percentage of sponges from a single package is present in the response data If so, the first tag for continuing the steps of method 400 is at least one tag in the response set. The minimum percentage is selected from packages in which the minimum percentage exists. The percentage may be between about 25% and about 50% of the sponge. The minimum percentage is the percentage of the sponge in the complete package. The range may be at least 30%.

[0091] Based on the first RFID tag data, the method 400 identifies a sponge type that corresponds to the first sponge type. reconfiguring the RFID reader to operate according to a first power level parameter set by the Step 408 includes a step 410 of operating the RFID reader at a first power level. This action constitutes a second interrogation by the RFID reader, but at the default power level. The first power level is a different power level than the default power level. It can be high or low, which can lead to more or fewer responsive tags. If the first power level is higher than the default power level, e.g. Sponge types with multiple sponges packed more densely in one package are stronger. More powerful queries overcome interference caused by the proximity of multiple tags, making the system more responsive. A tag with high response can be found. The first power level is lower than the default power level. In some cases, such as when a single sponge type is packaged in one package, The read range drops to closer ranges, resulting in fewer responding tags. 400 includes receiving 412 a first response set to a first power level.

[0092] During step 412 of receiving the first response set at the first power level, the system: may be configured to selectively look for a single sponge type corresponding to the first sponge type. A response to a question at a first power level that is not consistent with a first sponge type is a first They can be automatically excluded from the response set, reducing the amount of data to be processed.

[0093] Next, the method 400 determines whether an error condition exists by detecting a power level different from the default power level. a first set of responses in response to operation of the RFID reader at a first power level; The first response set includes a step 414 of comparing the package contents information to the first response set. The uniqueness of all tags present within the effective reading range of an RFID reader at a power level of The RFID reader is run at the default level and the first package Based on the response to step 404 receiving the content information, a first response set (RFID link A comparison can be made between the response when the reader is operated at a first power level and the response when the reader is operated at a second power level.

[0094] If the package is complete, i.e., there are no errors, the first response set is , suitably including identification numbers of all sponges indicated by the first package content information The first package content information is information about multiple sponges in a single package. In this case, it governs the use of surgical instruments during the surgical procedure and the use of the instruments in the patient after the surgical procedure. Minimize HCP error or confusion in avoiding unwanted left-behind of surgical instruments It is important to verify that all expected equipment is actually present in order to If so, the complete package of surgical instruments is counted in the surgical procedure in step 416 and the instruments are , can be placed in an appropriate staging area at the HCP's fingertips during the surgical procedure. The steps above starting with step 404 operate the RFID reader under default power. will continue to hold the 4th Branch until the desired inventory of surgical instruments is collected and available for surgical procedures. 17. When the RFID performs the steps described, the package Various types of sponges may exist together, with different quantities and associated power levels. The different power levels associated with the different package types are R Approximately 12 inches to approximately 36 inches between the FID reader and the surgical sponge package Maintain a favorable read range.

[0095] Comparing the first response set to the first package content information determines whether the package is complete. If this determination is made in step 418, the HCP may indicate that the package is not This step can be performed in a variety of ways. For example, RFID A visual alert can be presented to the HCP on a display that is in communication with the reader. Visual alerts include the type of sponge presented, the number and ID of tags responding, It will display specific information about the error, such as the number expected in the cage and identifying the discrepancy between the two. Alternatively, or in addition, the HCP may be shown using a display or an RFID reader. The user may be alerted to an error decision by a solid light or other visual alert, such as a flashing light. HCPs can be notified of errors, for example with an audible alarm or tactile response in the RFID reader. The tactile response may include a vibration pulse or pattern of pulses.

[0096] When alerted to an error condition, the HCP must correct the error, if possible, or Discard the incomplete package of sponge and move on to other packages offered in your inventory. Continue along branch 419 and operate the RFID scanner at its default power level. The process begins with the inventory of desired surgical instruments being compiled and made available for surgical procedures. The steps of method 400 may be repeated until

[0097] Once the desired inventory of surgical instruments has been collected, the HCP may then schedule the surgical procedure as step 420. Once the surgical procedure is complete, the surgical instruments are removed from the patient in step 422. Following removal from the patient, the RFID reader may be The surgical instruments are de-counted by re-reading them using a scanner. Alternatively, de-counting surgical instruments may involve optical scanning of the labels provided on the surgical instruments. You can review the data or manually enter information to designate surgical instruments as exempt. and

[0098] During the de-counting step 424, the RFID reader operates at a default power level. Alternatively, RFID readers can be used to measure and record data that has been counted for processing and is not yet decounted. The power level parameter of the sponge type may be different from that of the sponge type. The sponge types are tabulated and the sponge types have different associated power level parameters. When used in a sponge, the RFID reader operates at different power levels associated with different sponge types. RFI can be operated by cycling through the RFIs and executing interrogation operations in sequence. D The reader receives a response set and is not associated with a power level for a particular interrogation cycle. Respond to power levels for a particular interrogation cycle while excluding responses of other types of sponges. Only responses from sponges of the same type can be registered.

[0099] The method 400 also includes a step 426 of displaying the status of the surgical instrument inventory. Although illustrated at the end of the method shown, this step is performed continuously throughout the method. It is contemplated that the RFID reader may be able to respond to interrogations steps 406, 412. The sponge type is shown, and the number of counted and decounted external tissues is shown as the surgical procedure progresses. Maintain a current tally of surgical instruments. For example, to show the status of instrument inventory, View specific counts of counted and excluded surgical instruments by surgical instrument type. This indication of inventory status may include a direct inventory of surgical instruments present for a surgical procedure. Provides direct and instantaneous calculations, reducing the burden on HCPs to track and tally surgical instrument usage Minimize and ensure that no surgical instruments are left behind on the patient following the surgical procedure.

[0100] A second method 500 for managing an inventory of surgical instruments used during a surgical procedure is shown in FIG. The surgical instrument may be a surgical sponge 10, as described above. Implementing method 500 may assist an HCP in properly removing surgical instruments following a surgical procedure. Any feature of any of the methods and systems described herein helps to ensure The features / steps may be used with other methods and systems described throughout. I want you to understand that.

[0101] The method 500 includes a first step 50 of providing an inventory of surgical instruments, such as surgical sponges. 2. The inventory may be stored in a container such as the mobile cabinet 112 shown in FIG. The inventory includes packages of surgical instruments. In the first example, the inventory is At least a first package including at least a first surgical sponge of a first sponge type. The first surgical sponge includes a first unique identifier associated with the sponge, a first package content information for the first sponge type and a first power level parameter associated with the first sponge type. The first package content information includes a first RFID tag that stores the first package content information. The use of the designation "primary" or "secondary" corresponds to the complete content of the page. refers only to a separate iteration of the method steps, and unless otherwise noted, "first" refers to It is not intended to limit or require anything different from "Second."

[0102] As mentioned above, packages can be 2, 3, 5, 10, 20 or more in a single package. The unique identifier may include multiple devices, such as an amount of the device, an identification scheme stored in the RFID tag, and a It can be a single memory data field of the same system, or it can combine entries from multiple data fields. Together these may constitute a single unique identifier. The package contents information may include a unique package and information necessary to identify the contents of the package (such as quantity). , the package content information is associated with a unique package ID 126 of the identification scheme 120; Please refer to sponge type ID 124 to get the complete package quantity and if the specific sponge is and a sponge number 128 identifying the location in the package that it occupies within the complete quantity. can be done.

[0103] The method 500 includes a step 504 of operating an RFID reader and and receiving 506 the tag information in response to the actuation. To get started, HCPs can use RFID tags directly or through other connected hardware components. This step allows the HCP to provide input to the RFID tagged surgical instrument. Specifically presenting the package to an RFID reader, or vice versa Position the package so that the reader is within the effective reading range of the RFID reader. The preferred read range may be between 12 inches and 36 inches. A response to the tag 504 may include one or more tag data. In an environment where D tags are present, RFID readers must use anti-collision functions or It is possible to read, collect and process data from multiple tags in a single read operation. For example: For example, such anti-collision features are covered by the industry standard ISO / IEC15693-3: 2009 - Anti-collision and transmission protocols described in RFID readers The method includes the steps of: The information is then sent to the RFID reader, another computer processing device, and The information is stored in a database stored in the memory of the computer's Any processing or computational steps described may be distributed across the RFID reader. This may be performed by the RFID reader itself, or by another device in communication with the RFID reader.

[0104] The received response data of the first tag continues the steps of method 500. and the data of the first tag is a first unique identifier sufficient to identify the sponge type. The information identifying the sponge type includes a unique identifier and information. The associated RSSI aggregation threshold for the group may be included or used to obtain it. The data for continuing the method 500 from step 506 is the first data received within the response time. Alternatively, the response of step 506 may be a complete list of some type of sponge. Prioritize the use of sponges over other types of sponges, or use other criteria to select specific sponges. A range may be specified or selected to step through the steps of method 500 in sequence.

[0105] Based on the first RFID tag data, the method 500 calculates an RS of the first RFID tag response. Step 508 of determining the RSSI and associating the determined RSSI with a sponge type. The RFID reader includes a step 510 of comparing the RSSI with the tag information including a threshold RSSI. Determine the RSSI of the first RFID tag response or process the first RFID tag response to obtain the RSSI. A separate computing device, such as a system computer, to determine the SSI. The RSSI may be used to communicate information related to the first RFID tag response. The power of the response signal is determined as a measure of the power of the input signal.

[0106] The RSSI determined for a particular tag is equal to or greater than the RSSI threshold associated with the sponge type. If so, the associated sponge is selected for use with the surgical procedure in step 512. The devices are counted in the RSSI threshold for the associated surgical instrument type. It is intended that a tag response not exceeding 100% does not indicate an error that the HCP must be alerted to. Rather, a low RSSI may indicate, for example, that a device is stored nearby but is not functioning properly during a surgical procedure. It may simply represent the tag response as environmental noise from surgical instruments not intended for use. As shown along branch 513, a step 504 of operating the reader, tag information A step 506 of receiving information, a step 508 of determining an RSSI value, and a comparison step The process 510 continues until the desired inventory of surgical instruments is checked into the surgical procedure. Repeated.

[0107] The method 500 includes displaying 520 the status of the device inventory. Although illustrated at the end of this section, this step is performed continuously throughout the method. It is contemplated that the type of sponge will respond to the RFID reader question step 506. However, as the surgical procedure progresses, the current count of counted and decounted surgical instruments is updated. For example, displaying the status of an instrument inventory can be done by type of surgical instrument present. In addition, the system may display specific counts of counted and decounted surgical instruments. This display of inventory status provides a direct and immediate accounting of surgical instruments present for a surgical procedure. provide surgical instruments, minimize the burden on HCPs in tracking and counting the use of surgical instruments, and Ensures that no surgical instruments are left behind on the patient after the procedure.

[0108] A particular package of surgical instruments is presented by the HCP for counting, e.g. Update the display step to include package quantity and type as aggregated. If the system does not approve the package, the HCP must not bring the package closer to the RFID reader. or by placing the package in the center in front of the reader. The HCP may attempt to adjust the position of the package by rotating the package to read the RFID tag. Adjusting the orientation relative to the reader or moving and rotating the package relative to the RFID reader In some cases, it may be necessary to determine the exact number of packages that can be counted by a combination of the following: The RSSI specified may not reach the threshold RSSI associated with the device type. If the HCP is strong enough in the counting phase, the device can be discarded as defective. Failure to achieve a response signal will result in the device being unable to provide a response signal during the de-counting phase. and confusion for HCPs trying to manage and calculate instrument inventory at the end of a surgical procedure. There is a possibility of a connection.

[0109] Once the desired inventory of surgical instruments has been collected, the HCP may then schedule the surgical procedure as step 514. Once the surgical procedure is complete, the surgical instruments are removed from the patient in step 516. Following removal from the patient, the RFID reader may be The surgical instruments are de-counted by re-reading them using a scanner. Alternatively, de-counting surgical instruments may involve optical scanning of the labels provided on the surgical instruments. You can review the data or manually enter information to designate surgical instruments as exempt. and

[0110] During the count-out step 518, a response to the interrogation signal is received to determine whether the sponge was previously used for treatment. When the RFID reader is configured to run at a default power level, Alternatively, the RFID reader can de-count messages that are counted for treatment. The power levels of successive interrogation cycles are adjusted according to the power level parameters associated with the PON type. In a further alternative, the RFID reader may operate by changing the The variable power level technique described above in step 424 is combined with the evaluation of the RSSI of a particular sponge. Combined, these steps ensure that the correct sponges are decounted. The sponge is presented within range of the RFID reader to achieve the required RSSI during scanning. This allows sponges remaining in the surgical field to be removed without inadvertently being counted out.

[0111] Consistent with the above discussion, the method 500 may be used to measure and / or measure the amount of blood collected during, for example, a surgical procedure. Displaying the status of the instrument inventory 520, including providing an identification number for the instrument that has been removed. include.

[0112] A further method 600 for managing an inventory of surgical sponges used during a surgical procedure is shown in FIG. As with methods 400, 500 above, the surgical instrument may be manually inserted as described above. The present invention relates to a surgical sponge 10, and the method includes the steps of: Again, the method 400 described above may be useful in assisting the HCP in ensuring Like 500, method 600 includes a first method of providing an inventory of surgical instruments, such as surgical sponges. The inventory includes a step 602 of storing the items in a container such as the mobile cabinet 112 illustrated in FIG. The inventory includes packages of surgical instruments. In an example, the inventory includes at least a first surgical sponge of a first sponge type. The first surgical sponge also includes a first package. The first surgical sponge includes a first unique identifier associated with the sponge. a first package content information and a first electrical code associated with the first sponge type; The first package content information includes a first RFID tag that stores the force level parameter. , corresponds to the complete contents of the first package. The use only refers to individual iterations of the aggregation methodology steps and unless otherwise stated. is not intended to limit or require that "first" be different from "second" .

[0113] As mentioned above, packages can be 2, 3, 5, 10, 20 or more in a single package. The unique identifier may include multiple devices, such as an amount of the device, an identification scheme stored in the RFID tag, and a It can be a single memory data field of the same system, or it can combine entries from multiple data fields. Together these may constitute a single unique identifier. The package contents information may include a unique package and information necessary to identify the contents of the package (such as quantity). , the package content information is associated with a unique package ID 126 of the identification scheme 120; Please refer to sponge type ID 124 to get the complete package quantity and if the specific sponge is and a sponge number 128 that identifies the location in the package that it occupies within the complete quantity. .

[0114] The method 600 includes a step 604 of operating an RFID reader. and receiving 606 the tag information in response to operating 604. Operate the reader 604 by running the RFID reader for a first period at an initial power level. During this step 604, the RFID reader is operated for a first limited period. A first response set is collected during the period of time that the first response set is based on the initial power level. The test is evaluated to determine if a complete first package is present in the answer set. That is, based on the collected tag responses and the package content information of the tag responses, All devices in the package are RFID readers operating at an initial power level for a first period of time. The complete package is then used to determine whether it is present in the response set as a response to the request. Upon determining that the message is in the response set, the method 600 optionally performs a complete patch analysis. The cage is then powered to the associated RFID reader at step 604 to match the initial power level of the RFID reader. The step of evaluating whether the power level of the device is within the specified power level.

[0115] A complete package is present and the associated power level of the complete package matches the initial power level. Once it is determined that the type with the force level is the instrument in the complete package, step 6 The complete package is found, but the instrument is an early electrical device. The power level of the device may not be the same as that of the device that has an associated power level that matches the power level of the device. In that case, the instrument does not count as a surgical procedure.

[0116] The fixtures are counted after the first operation of the RFID reader at the initial power level for the first period. Then, the RFID reader may select an increment (increment) from the initial power level in step 612. The method can be reconfigured to operate at incremental power levels. Start with a low power level RFID reader and increment to a high power level, or The RFID can start at a high power level and increment to a low power level. At Bell, background tag responses from nearby stored equipment are detected by the RFID reader. At lower power levels, tags are more likely to be received by the Do not pack the RFID reader in a tightly packed package as this can cause interference or attenuation of the RFID reader interrogator signal. Therefore, fewer tag responses may be received from the surgical instruments that are Cycle a range of power levels within the operating capabilities of the RFID reader to detect RFID tagged instruments. It is beneficial to ensure that the appropriate set is counted for the surgical procedure.

[0117] RFID readers at increasing power levels, receiving response sets, and tallying packages The operating steps are determined to be complete and match the power levels of the cyclic operation. If the desired RFID tagged fixture inventory is of a type having an associated power level that The desired inventory of surgical instruments may continue along branch 613 until the desired inventory of surgical instruments is tallied for placement. Once counted as a surgical procedure, the HCP may proceed with the surgical procedure as step 614. Once the surgical procedure is completed, the surgical instruments are removed from the patient in step 616. Following removal from the patient, for example, in step 618, using an RFID reader The surgical instruments are de-counted by reading them again. At step 618, the RFID reader may operate at a default power level. Alternatively, the tally-out step 618 may be performed in the same manner as the tally-out step 424 or Alternatively, the surgical instruments may be excluded from the count. The method includes optically scanning the labels provided on the surgical instruments or counting and de-counting the surgical instruments. This may include manually entering information to designate the device as an external device. The method 600 may, for example, include recording identification numbers of instruments that are counted and decounted throughout a surgical procedure. including displaying the status of equipment inventory, including providing

[0118] In one embodiment, in step 402, an inventory of sponges is provided, such as inventory 112. An RFID reader, such as an RFID reader 108, is provided and may be connected to the touch screen 104 or is input to the RFID reader 108, and the RFID reader 108 is switched to operate in the tally mode. The RFID reader 108 is connected to the system computer 101 or the RFID reader. - Initially operates at a default power level value of 15 dBm stored in one of the 108 The RFID reader 108 may be configured to perform an interrogation cycle, such as at step 404. The first response to the question from the portion of the inventory that was presented to the RFID reader for counting. The system 100 receives the set. In one of the suppliers 108, for example in step 406, the sponsors in a single package The first response set is evaluated to identify at least 30% of the messages. -108 is 2 18" x 18" wrap sponges in the same unique package ID 12 6.

[0119] The RFID reader 108 may, for example, in step 408, read an 18" x 18" lap sponge. Reconfigure to operate at 14 dBm, which is the power level parameter associated with the type. The power level parameters are stored in the system computer 101 or the RFID reader 108. Retrieved from a stored lookup table or database. RFID Reader 108 performs an interrogation cycle at 14 dBm, for example, in step 410. The reader 108 receives the second response set, for example, at step 412. The pack contains five 18” x 126 packs with the same unique pack ID representing the complete package. 18” lap sponge. Optionally, the system The data from the second response set that did not correspond to the 8" x 18" lap sponge type could be excluded. The system 100 may determine the complete package, for example, in step 414, and may then Pack of 5 18" x 18" Lap Sponges for Use in Surgical Procedures with Tip 416 The RFID reader 108 is reconfigured to operate at a default power level. For example, in step 417, the remaining stock of inventory 112 is counted until all the required instruments are tallied. The RFID reader 108 continues to take inventory of the part. At the default power level, of the ten 2” x 2” gauge sponges in the package Detects at least three of the following, reconfigures it to operate at 25 dBm, and sets the power level to 25 dBm: The bell detects 10 of the 10 sponges in the package and detects 10 2” x 2” sponges. Count the packages of gauze sponges. When the remaining inventory 112 is counted, e.g. At step 420, a procedure is performed using the collected instruments.

[0120] After the surgical procedure is completed, the counted instruments are decounted, resulting in step 424. No instruments are left unintentionally inside the patient after procedures such as RFID readers. The input 108 can be provided to the touch screen 104 or the RFID reader 108. The RFID reader 108 can be switched to operate in the non-counting mode by The 18" x 18" lap sponge and 2" x 2" gauze sponge were then While searching for each, continuous interrogation was performed at 14 dBm and 25 dBm with 300 ms intervals. Successive questions are repeated until all sponges of one type are removed from the count. Successive interrogation cycles then determine the power levels associated with the aggregated sponge types. Optionally, the system 100 may generate a response for each spot identified in the response set. The RSSI associated with each sponge was evaluated to determine the minimum response strength that existed before the sponge was counted out. You can verify that it exists.

[0121] Some explanations have been given in the above disclosure. However, the explanations given in this specification It is not intended to be exhaustive or to limit use to any particular format. The terminology used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings, and the present disclosure may be modified in various ways without departing from the spirit and scope of the present invention. The present invention can be implemented in other ways than as described above.

Claims

1. Administering surgical sponges used during a surgical procedure and cleaning the surgical sponges after said surgical procedure 1. A method for ensuring proper removal of sponge comprising the steps of: Providing a supply of surgical sponges, said supply comprising a first sponge a first package including a first surgical sponge of a type, said first surgical sponge The surgical sponge includes a first RFID tag, the first RFID tag being associated with the first surgical sponge. a first unique identifier associated with the package, first package content information, and a storing a first power level parameter associated with a package type; the information corresponds to a complete content of the first package; operating the RFID reader at a default power level; The RFID reader reads the first unique identifier, the first unique identifier stored in the RFID tag. receiving the first power level parameter and the first package content information; and the default power level corresponding to the received first power level parameter; reconfiguring the RFID reader to operate at a different first power level. and, operating the RFID reader at the first power level; receiving a first response set at the first power level; Comparing the first response set to the first package content information to determine an error condition. and If a no-error condition is determined, the database record of the surgical procedure is counted. identifying the first package content information as a reconfiguring the RFID reader to operate at the default power level. Top and placing the first surgical sponge within a body for a surgical procedure; removing the first surgical sponge from the body; Operate the RFID reader and read the first RFID tag with the RFID reader. and updating the database record of the surgical procedure. excluding surgical sponges; and a surgical sponge that identifies counting and de-counting status based on said database records. displaying the status of said supply; A method comprising:

2. The first package further comprises a plurality of surgical sponges, each surgical sponge comprising: a unique identifier associated with each surgical sponge in the first package; and an associated RFID tag for storing the device parameters; The first package content information of each RFID tag includes information about other items in the first package.

10. The method of claim 1, wherein information identifying all surgical sponges is included.

3. The supply of surgical sponges may include a second surgical sponge of a second sponge type and a second package containing a third surgical sponge of the second sponge type; The second sponge type is different from the first sponge type, The second surgical sponge and the third surgical sponge each have a second RFID a second RFID tag and a third RFID tag, the second RFID tag being associated with the second surgical site; a second unique identifier associated with the Pongee, the third RFID tag storing the third unique identifier; storing a third unique identifier associated with the surgical sponge; A third RFID tag stores second package content information and information about the second sponge type. and storing an associated second power level parameter, said second package content information being The method according to claim 1 or 2, which corresponds to the complete contents of the second package. Law.

4. after reconfiguring the RFID reader to operate at the default power level; operating the RFID reader at the default power level; one of the second unique identifier and the third unique identifier, the first power level the second power level parameter different from the second package parameter, receiving content information; The R is configured to operate at the second power level different from the default power level. reconfiguring the FID reader; receiving a second response set; the second unique identifier and the third unique identifier are present in the second response set. If so, the second surgical sponge and the third hand are recorded as having been counted in the database record. identifying a surgical sponge; Comparing the second response set to the second package content information to determine an error condition. Steps to The method of claim 3 further comprising:

5. triggering an alert if the error condition is determined. The method according to any one of claims 1 to 4.

6. The step of triggering the alert may include sounding an alarm, displaying a warning, or and any one of the following combinations: initiating a conscious response; 5. The method according to claim 5.

7. If the first response set does not match the first package content information, the error The method according to claim 1 , wherein a - state is determined.

8. Positioning the RFID reader adjacent to a sterile field where the surgical procedure will be performed. Steps and After identifying the first surgical sponge as counted, removing the first surgical sponge from the first package. removing the first surgical sponge; The method of claim 1 , further comprising:

9. The step of receiving the first response set and the step of receiving the second response set The steps respectively include: positioning the device at a first distance and a second distance from the ID reader; The first distance is a first read range of the first package, and the second distance is a second read range of the second package, The first power level parameter and the second power level parameter are and the second distance are selected to be within the same read distance range. Item 5. The method according to item 4.

10. 10. The method of claim 9, wherein the read distance range is between about 12 inches and about 36 inches. Method of posting.

11. Administering surgical sponges used during a surgical procedure and cleaning the surgical sponges after said surgical procedure 1. A method for ensuring proper removal of sponge comprising the steps of: Providing a supply of surgical sponges, said supply comprising a first sponge a first package including a first surgical sponge of a type, said first surgical sponge The first RFI stores a first unique identifier associated with the first surgical sponge. including a D tag; Operate an RFID reader to read the RFID tag of the supply of surgical sponges. The steps to take, In response to operation of the RFID reader, the unique identification stored in the RFID tag is read. receiving a reply signal including the identifier; from the first RFID tag when read by the RFID reader. determining a first received signal strength indicator (RSSI) as a measure of the power level of the response signal; and The first RSSI meets a first predetermined threshold associated with the first sponge type. the first surgical sponge is counted in the database record of the surgical procedure if and identifying the placing the first surgical sponge within a body for a surgical procedure; removing the first surgical sponge from the body; The first RFID tag is read by the RFID reader and counted in the database. identifying the first surgical sponge as having been excluded; and a surgical sponge that identifies counting and de-counting status based on said database records. displaying the status of said supply; A method comprising:

12. The supply of surgical sponges includes a second surgical sponge of a second sponge type. The second package further includes a second surgical sponge. a second RFID tag storing an associated second unique identifier; determining a second RSSI from the second RFID tag; The second RSSI meets a second predetermined threshold associated with the second sponge type. identifying the second surgical sponge as having been counted in the database if Steps to be taken The method of claim 11 further comprising:

13. The first package contains a single sponge per package, and the second package The package contains multiple sponges per package. The method of claim 12 , wherein the first RSSI is higher than the second RSSI.

14. placing the first package at a first distance from the RFID reader. whereby the first distance is a first reading distance of the first package. and, placing the second package a second distance from the RFID reader. wherein the second distance is a second reading distance of the second package. and Further comprising: The first and second predetermined thresholds are determined based on the first and second distances.

14. The method according to claim 12 or 13, wherein the distances are selected to be within the same read distance range. The method according to any one of claims 1 to 5.

15. 15. The method of claim 14, wherein the read distance ranges from about 12 inches to about 36 inches. The method described.

16. Manage surgical sponges used during a surgical procedure and re-use the surgical sponges after said surgical procedure.

1. A method for ensuring proper removal of a syringe comprising: Providing a supply of surgical sponges, said supply comprising a first sponge a first package including a first surgical sponge of a type, said first surgical sponge The surgical sponge includes a first RFID tag, the first RFID tag being associated with the first surgical sponge. a first unique identifier associated with the package, first package content information, and a a first assigned power level associated with said first package type; the content information corresponds to a complete content of the first package; Operate the RFID reader at a first power level for a first limited time period to identify the surgical sponsor. reading an RFID tag of said supply of goods; collecting a first response set during the first limited time period; The first response set is evaluated to determine whether the first response set is consistent with the first package content. If the information matches, all of the surgical sponges in the first package are determining a complete first package as present in the answer set, said first power level being determining whether the first assigned power level is met; The complete first package is determined, and the first power level is determined based on the first allocation. If the power level matches the power level specified in the database record for that surgical procedure, the surgical procedure is considered to have been counted in the database record for that surgical procedure. identifying the first surgical sponge by to operate at a second power level different from the first power level for a second limited period of time. reconfiguring the RFID reader as follows: placing at least one of the tabulated surgical sponges within a body for a surgical procedure; and removing the counted surgical sponge from the body; Operate the RFID reader and read the first RFID tag with the RFID reader. excluding the first surgical sponge by reading the first surgical sponge; Provides the number of counted and decounted surgical sponges by type of surgical sponge. indicating a status of said supply of surgical sponges; A method comprising:

17. The supply of surgical sponges includes a second surgical sponge and a third surgical sponge. and a second package including said second surgical sponge and said third surgical sponge. The second type is sponge type. The second sponge includes a second RFID tag, the second RFID tag being a second unique identifier associated with the second surgical sponge; and storing a second assigned power level associated with the second sponge type; The third sponge includes a third RFID tag, and the third RFID tag is a third unique identifier associated with the surgical sponge; a second package content information; and storing a second assigned power level associated with the second sponge type; the second package content information corresponds to a complete content of the second package; operating the RFID reader at said power level for a second limited period of time; collecting a second response set during the second limited time period; The second response set is evaluated to determine whether the second response set is consistent with the second package contents. If the information matches, all of the surgical sponges in the second package meet the second response criteria. determining a complete second package as present in the answer set, said second power level being determining whether the second assigned power level is met; The complete second package is determined and the second power level is determined based on the second allocation. a power level that matches the power level recorded in the database of the surgical procedure. identifying the second surgical sponge and the third surgical sponge as 20. The method of claim 16, further comprising:

18. Administering surgical sponges used during a surgical procedure and cleaning the surgical sponges after said surgical procedure A system for ensuring proper dispensing of sponge, comprising: A supply of surgical sponges, said supply comprising a first surgical sponge of a first sponge type. a first package including a surgical sponge, the first surgical sponge comprising a first RFI a first RFID tag associated with the first surgical sponge; A unique identifier, first package content information, and a first sponge type associated with the unique identifier, A first power level parameter is stored, and the first package content information is The supplies correspond to the complete contents of the package, In response to receiving the power level parameter in response to the RFID read operation, an RFID reader configurable to operate at one of several power levels; The status of said supply of surgical sponges identifying counted and decounted quantities. a database configured to store data representative of the state of the Including, The RFID reader includes: Operate at a default power level; and The first unique identifier, the first power level parameter, and the first package. receiving cage contents information; the default power level corresponding to the received first power level parameter; reconfiguring the power supply to operate at a first power level different from operating at the first power level; receiving a first response set at the first power level; If the first unique identifier is present in the first response set, identifying the sponge as having been accounted for in a database record of said surgical procedure; Comparing the first response set to the first package content information to determine an error condition. The system is configured to:

19. Counting said supply of surgical sponges, identifying counted and uncounted quantities.

20. The system of claim 18, further comprising a display device configured to display the calculated value. Hmm.

20. The supply of surgical sponges includes a second surgical sponge and a third surgical sponge. a second package including the second surgical sponge and the third surgical sponge The second type is sponge type. The second sponge includes a second RFID tag, the second RFID tag being a second unique identifier associated with the second surgical sponge; and storing a second power level parameter associated with the second sponge type; The third sponge includes a third RFID tag, the third RFID tag being a third unique identifier associated with the third surgical sponge; and storing a second assigned power level associated with the second sponge type; the second package content information corresponds to a complete content of the second package; The RFID reader includes: operating at said default power level; The second unique identifier, the second power level parameter, and the second package. receiving cage contents information; a second power level parameter corresponding to the received second power level parameter, different from the first power level; and reconfiguring the first power level to operate at the second power level. operating at the second power level; and receiving a second response set to the second power level; The second unique identifier and the third unique identifier are present in the second response set. the second surgical sponge and the third surgical sponge are then Identifying the database record as having been counted; and The second response set is compared to the second package content information to determine an error condition.

20. The method according to claim 18 or 19, further configured to: The system is as follows:

21. The RFID reader triggers an alert if the error condition is determined. The system of claim 20 further configured to:

22. The alert may be any of an alarm, a warning, a tactile response, and combinations thereof.

22. The system of claim 21 including one.

23. If the first response set does not match the first package content information, the error 23. The system according to any one of claims 18 to 22, wherein a -state is determined.

24. Administering surgical sponges used during a surgical procedure and cleaning the surgical sponges after said surgical procedure A system for ensuring proper dispensing of sponge, comprising: A supply of sterile surgical sponges, said supply comprising a first sponge type and a first A first package including a surgical sponge, the first surgical sponge having a first R a first RFID tag associated with the first surgical sponge, a first unique identifier, first package content information, and a first sponge type; and storing a first power level parameter for the first package content information. The complete package includes: The supply of surgical sponges includes a second surgical sponge and a third surgical sponge. a second package including said second surgical sponge and said third surgical sponge; The sponge is a second sponge type, the second sponge including a second RFID tag, The second RFID tag includes a second unique identifier associated with the second surgical sponge. a second package content information, and a second assignment associated with the second sponge type; the third sponge includes a third RFID tag; and the third sponge stores a power level that has been measured. The RFID tag includes a third unique identifier associated with the third surgical sponge, a second unique identifier associated with the third surgical sponge, and package content information, and a second assigned address associated with said second sponge type. A supply that stores the power level; In response to receiving the power level parameter in response to the RFID read operation, an RFID reader configurable to operate at one of several power levels; The status of said supply of surgical sponges identifying counted and decounted quantities. a database configured to store data representative of the state of the Including, The RFID reader includes: Reading an RFID tag at multiple power levels; The RFID reader detects the first power level associated with the first sponge type. and when it determines that the first package is complete, aggregating at a first power level; The RFID reader is configured to read the first sponge type at a different power level than the first sponge type. a second power level associated with a second sponge type different from the first sponge type, if it is determined that the package is complete, then collect a second package at the second power level. and calculating the number of times ... The first power level is applied to the first sponge type in a first packaging configuration. Based on this, the preferred reading distance of the first sponge type is The first sponge type is between 12 inches and 36 inches from the front. The second power level is based on a second packaging configuration of the second sponge type. The preferred reading distance of the second sponge type is 12 mm from the RFID reader. The system associated with the second sponge type is between 36 inches and 40 inches. Hmm.

25. Manage surgical instruments used during a surgical procedure and monitor the availability of surgical instruments after said surgical procedure. A method for ensuring proper removal comprising: Providing a supply of surgical instruments, the supply being of a first instrument type. a first package including a first surgical instrument, the first surgical instrument comprising a first RF a first RFID tag associated with the first surgical instrument, a first package content information and a first device type associated with the first device type; a power level parameter stored in said first package; The steps and operating the RFID reader at a default power level; The RFID reader reads the first unique identifier, the first unique identifier stored in the RFID tag. receiving the first power level parameter and the first package content information; and the default power level corresponding to the received first power level parameter; reconfiguring the RFID reader to operate at a different first power level. and, operating the RFID reader at the first power level; receiving a first response set at the first power level; Comparing the first response set to the first package content information to determine an error condition. and If a no-error condition is determined, the database record of the surgical procedure is counted. identifying the first package content information as a reconfiguring the RFID reader to operate at the default power level. Top and positioning the first surgical instrument within the body for a surgical procedure; removing the first surgical instrument from the body; Operate the RFID reader and read the first RFID tag with the RFID reader. and updating the database record of the surgical procedure. removing surgical instruments from the collection; and identifying counted and de-counted conditions based on said database records. displaying the status of said supply; Includes, a method.

26. The first package further includes a plurality of surgical instruments, each of the surgical instruments including the first a unique identifier associated with each surgical instrument in the package; and an associated RFID tag storing the first package content of each RFID tag. The information includes information for identifying all other surgical instruments in the first package.

26. The method of claim 25,

27. The supply of surgical instruments includes a second surgical instrument of a second instrument type and a second package including a third surgical instrument of an instrument type, said second instrument type comprising: Unlike the first device type, The second surgical instrument and the third surgical instrument each have a second RFID tag and and a third RFID tag, the second RFID tag being associated with the second surgical instrument. a third RFID tag storing a second unique identifier associated with the third surgical instrument; storing an associated third unique identifier and identifying the second and third RFID tags; The message includes second package content information and a second power level associated with the second appliance type. The second package content information also stores a complete parameter of the second package.

27. The method according to any one of claims 25 to 26, wherein the method corresponds to the entire content.

28. after reconfiguring the RFID reader to operate at the default power level; operating the RFID reader at the default power level; one of the second unique identifier and the third unique identifier, the first power level the second power level parameter different from the second package parameter, receiving content information; The R is configured to operate at the second power level different from the default power level. reconfiguring the FID reader; receiving a second response set; the second unique identifier and the third unique identifier are present in the second response set. the second surgical instrument and the third surgical instrument are counted in the database record. identifying the instrument; Comparing the second response set to the second package content information to determine an error condition. Steps to 28. The method of claim 27, further comprising:

29. triggering an alert if the error condition is determined.

29. The method of any one of claims 25 to 28.

30. The step of triggering the alert may include sounding an alarm, displaying a warning, or and any one of the following combinations: initiating a conscious response; 29. The method according to claim 29.

31. If the first response set does not match the first package content information, the error 31. The method according to any one of claims 28 to 30, wherein a state is determined.

32. Positioning the RFID reader adjacent to a sterile field where the surgical procedure will be performed. Steps and After the first surgical instrument is identified as having been counted, the first surgical instrument is Step 1: Take out the product from the package 32. The method of any one of claims 25 to 31, further comprising:

33. The step of receiving the first response set and the step of receiving the second response set The steps respectively connect the first package and the second package to the RFID reader. a first distance and a second distance from the reader; The first distance is a first read range of the first package, and the second distance is a second read range of the second package, The first power level parameter and the second power level parameter are and the second distance are selected to be within the same read distance range.

33. The method according to any one of items 28 to 32.

34. 34. The method of claim 33, wherein the read distance range is between about 12 inches and about 36 inches. The method described.

35. Manage surgical instruments used during a surgical procedure and monitor the availability of surgical instruments after said surgical procedure. A method for ensuring proper removal comprising: Providing a supply of surgical instruments, the supply being of a first instrument type. a first package including a first surgical instrument, the first surgical instrument being a first RFID tag storing a first unique identifier associated with the surgical instrument; P and Operate an RFID reader to read the RFID tag on the supply of surgical instruments. Steps and In response to operation of the RFID reader, receiving a response signal including a unique identifier of the from the first RFID tag when read by the RFID reader. determining a first received signal strength indicator (RSSI) as a measure of the power level of the response signal; and If the first RSSI meets a first predetermined threshold associated with the first device type. if so, identifying the first surgical instrument as having been counted in a database record of the surgical procedure. and positioning the first surgical instrument within the body for the surgical procedure; removing the first surgical instrument from the body; reading the first RFID tag with the RFID reader and identifying the first RFID tag in the database record; identifying the first surgical instrument as being de-counted; and identifying counted and de-counted conditions based on said database records. displaying the status of said supply; A method comprising:

36. The supply of surgical instruments includes a second package containing a second surgical instrument of a second instrument type. a second surgical instrument associated with the second surgical instrument; a second RFID tag storing a unique identifier; determining a second RSSI from the second RFID tag; If the second RSSI meets a second predetermined threshold associated with the second device type. a sequence for identifying the second surgical instrument as having been counted in the database record; Tep and 36. The method of claim 35, further comprising:

37. The first package includes a single device per package, and the second package includes Each package contains multiple instruments, 37. The method of claim 36, wherein the first RSSI is higher than the second RSSI.

38. placing the first package at a first distance from the RFID reader. whereby the first distance is a first reading distance of the first package. and, placing the second package a second distance from the RFID reader. wherein the second distance is a second reading distance of the second package. and Further comprising: The first and second predetermined thresholds are determined based on the first and second distances.

38. Any of claims 36 to 37, wherein the distances are selected to be within the same read distance range. The method according to any one of claims 1 to 5.

39. 39. The method of claim 38, wherein the read distance range is between about 12 inches and about 36 inches. The method described.

40. Manage surgical instruments used during a surgical procedure and monitor the availability of surgical instruments after said surgical procedure. A method for ensuring proper removal comprising: Providing a supply of surgical instruments, the supply being of a first instrument type. a first package including a first surgical instrument, the first surgical instrument comprising a first RF a first RFID tag associated with the first surgical instrument, a first package content information and a first device type associated with the first device type; The first package content information stores an assigned power level of the first package. Steps, corresponding to the complete contents of the cage, Operate the RFID reader at a first power level for a first limited time period to identify the surgical instrument. reading an RFID tag of said supply; collecting a first response set during the first limited time period; The first response set is evaluated to determine whether the first response set is consistent with the first package content. If the information matches, all of the surgical instruments in the first response set are determining a complete first package to be present in said first power level; determining whether a first assigned power level is met; The complete first package is determined, and the first power level is determined based on the first allocation. If the power level matches the power level specified in the database record for that surgical procedure, the surgical procedure is considered to have been counted in the database record for that surgical procedure. identifying the first surgical instrument; to operate at a second power level different from the first power level for a second limited period of time. reconfiguring the RFID reader as follows: placing at least one of the collected surgical instruments within the body for the surgical procedure; and removing the counted surgical instruments from the body; Operate the RFID reader and read the first RFID tag with the RFID reader. excluding the first surgical instrument by reading the first surgical instrument; Provides counts and decounts of surgical instruments by type of surgical instrument and displaying the status of said supplies of the device; A method comprising:

41. The supply of surgical instruments includes a second package including a second surgical instrument and a third surgical instrument. The package further includes the second surgical instrument and the third surgical instrument are of a second instrument type; The second device includes a second RFID tag, the second RFID tag being a second unique identifier associated with the surgical instrument, second package content information, and storing a second assigned power level associated with the appliance type; The third device includes a third RFID tag, the third RFID tag being a third unique identifier associated with the surgical instrument, second package content information, and storing a second assigned power level associated with the second appliance type; the second package content information corresponds to a complete content of the second package; operating the RFID reader at said power level for a second limited period of time; collecting a second response set during the second limited time period; The second response set is evaluated to determine whether the second response set is consistent with the second package contents. If the information matches, all of the surgical instruments in the second package are read by the second response sensor. determining a complete second package to be present in said set, said second power level being determining whether a second assigned power level is met; The complete second package is determined and the second power level is determined based on the second allocation. a power level that matches the power level recorded in the database of the surgical procedure. identifying the second surgical instrument and the third surgical instrument as 41. The method of claim 40, comprising:

42. Manage surgical instruments used during a surgical procedure and monitor the availability of surgical instruments after said surgical procedure. A system to ensure proper removal, comprising: A supply of surgical instruments, the supply including a first surgical instrument of a first instrument type. a first package including a first surgical instrument, the first surgical instrument including a first RFID tag; The first RFID tag includes a first unique identifier associated with the first surgical instrument, a first package content information and a first power level parameter associated with the first appliance type; and storing the first package content information for the complete content of the first package. corresponding supplies, In response to receiving the power level parameter in response to the RFID read operation, an RFID reader configurable to operate at one of several power levels; a status of said supply of surgical instruments identifying counted and decounted quantities; a database configured to store data representing Including, The RFID reader includes: Operate at a default power level; and The first unique identifier, the first power level parameter, and the first package. receiving cage contents information; the default power level corresponding to the received first power level parameter; reconfiguring the power supply to operate at a first power level different from operating at the first power level; receiving a first response set at the first power level; If the first unique identifier is present in the first response set, identifying the instrument as having been accounted for in a database record of said surgical procedure; The first response set is compared to the first package content information to determine an error condition. and determining whether or not a particular

43. A calculated value of said supply of surgical instruments identifying counted and uncounted quantities.

43. The system of claim 42, further comprising a display device configured to display:

44. The supply of surgical instruments includes a second package including a second surgical instrument and a third surgical instrument. Package included. the second surgical instrument and the third surgical instrument are of a second instrument type; The second device includes a second RFID tag, the second RFID tag being a second unique identifier associated with the surgical instrument, second package content information, and storing a second power level parameter associated with the second appliance type; The third device includes a third RFID tag, the third RFID tag being a third unique identifier associated with the surgical instrument, second package content information, and storing a second assigned power level associated with the second appliance type; the second package content information corresponds to a complete content of the second package; The RFID reader includes: operating at said default power level; The second unique identifier, the second power level parameter, and the second package. receiving cage contents information; a second power level parameter corresponding to the received second power level parameter, different from the first power level; and reconfiguring the first power level to operate at the second power level. operating at the second power level; and receiving a second response set to the second power level; The second unique identifier and the third unique identifier are present in the second response set. the second surgical instrument and the third surgical instrument are then inserted into the database of the surgical procedure. Identify the data in the source record as having been counted; The second response set is compared to the second package content information to determine an error condition.

44. The system of claim 43, further configured to:

45. The RFID reader triggers an alert if the error condition is determined.

45. The system of claim 44, further configured to:

46. The alert may be any of an alarm, a warning, a tactile response, and combinations thereof.

46. ​​The system of claim 45, comprising one.

47. The error condition occurs when the first response set does not match the first package content information.

47. The system of claim 43, wherein the determination is made if

48. Manage surgical instruments used during a surgical procedure and monitor the availability of surgical instruments after said surgical procedure. A system to ensure proper removal, comprising: A supply of sterile surgical instruments, the supply comprising a first surgical instrument of a first instrument type. a first package including a surgical instrument, the first package including a first RFID tag; The first RFID tag includes a first unique identifier associated with the first surgical instrument. a first package content information and a first power level parameter associated with the first appliance type; and storing a meter, the first package content information being a complete content of the first package. Corresponding to, The supply of surgical instruments includes a second package including a second surgical instrument and a third surgical instrument. and wherein the second surgical instrument and the third surgical instrument are of a second instrument type. the second device includes a second RFID tag, the second RFID tag being a second unique identifier associated with the second surgical instrument, second package content information, and storing a second assigned power level associated with a second appliance type; and a third RFID tag, the third RFID tag being associated with the third surgical instrument. a third unique identifier associated with the second device type, second package content information, and a supply that stores an associated second allocated power level; In response to receiving the power level parameter in response to the RFID read operation, an RFID reader configurable to operate at one of several power levels; a status of said supply of surgical instruments identifying counted and decounted quantities; a database configured to store data representing Including, The RFID reader includes: Reading an RFID tag at multiple power levels; The RFID reader operates at a first power level associated with the first device type. and when it is determined that the first package is complete, the first package is transferred to the first and aggregating at the power level of The RFID reader is different from the first power level and is a first device type. and a second power level associated with the second appliance type different from the second appliance type. if the cage is determined to be complete, collect the second package at the second power level. and calculating the number of times ... The first power level is based on a first packaging configuration of the first device type. and a preferred reading distance of the first device type is 12 inches from the RFID reader. and the second power is associated with the first appliance type such that the power is between 36 inches and 18 inches. The level is based on a second packaging configuration of the second device type. The preferred reading distance of the tool type is 12 inches to 36 inches from the RFID reader. and associated with the second instrument type such that the second instrument type is between.

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