Management system and management method

A management system for electrocardiograph measurement wear tracks usage history and quality status to ensure efficient and accurate reuse determination, addressing damage and hygiene concerns in lending systems.

JP2026073952APending Publication Date: 2026-05-01TORAY INDUSTRIES INC
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
TORAY INDUSTRIES INC
Filing Date
2025-10-01
Publication Date
2026-05-01

AI Technical Summary

Technical Problem

Existing systems for lending electrocardiograph measurement wear to multiple patients face issues with damage, dirt, and hygiene concerns, leading to increased operator workload and potential reuse determination errors.

Method used

A management system that includes a data storage unit, reading unit, and control unit to track the usage history and quality status of medical devices using identification information, enabling centralized management and determination of device reusability.

Benefits of technology

Facilitates efficient and accurate assessment of medical device reusability, reducing workload and minimizing errors in device lending decisions.

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Abstract

This invention provides a management system and management method that can easily determine whether or not a medical device can be used. [Solution] The management system of the present disclosure includes: a data storage unit that stores data relating to at least one of the usage history and quality status of one or more medical devices in association with the identification information of one or more medical devices; a reading unit that reads the identification information of a candidate medical device from among the one or more medical devices that is a candidate for use; and a control unit that reads the data related to the read identification information from the data storage unit and determines whether or not the candidate medical device can be used based on the read data.
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Description

Technical Field

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[0003]

[0001] The present disclosure relates to a management system and a management method for medical devices.

Background Art

[0002] Techniques have been developed for having a patient wear dedicated measurement ware attached with an electrocardiograph for a specified period to measure electrocardiogram data while at home (for example, Patent Document 1). In an electrocardiogram examination consignment service, the measurement ware and the electrocardiograph are lent from a delivery management center that has received a request from a medical institution. The patient installs the electrocardiograph on the measurement ware, and the patient continuously wears the measurement ware with the electrocardiograph installed thereon at all times for the specified period. When the examination period ends, the measurement ware and the electrocardiograph are returned from the patient to the delivery management center. The measurement ware returned to the delivery management center is laundered, disinfected, etc., and then lent to other patients again.

[0003] During the process of repeatedly lending the measurement ware to multiple patients, damage, dirt, etc. of the measurement ware may occur. In addition, there are also patients who have a psychological resistance on the hygiene aspect to using measurement ware that has been used by others. Therefore, when newly lending the measurement ware from the delivery management center to the patient, it is necessary for the operator at the delivery management center to check each time whether there are any problems with damage, dirt, and cleanliness of the measurement ware as a lending candidate, and to determine whether the measurement ware is reusable. Such work leads to an increase in the workload of the operator, and there are problems that can improve the risk of a decrease in work efficiency and a mistake in determining whether reuse is possible.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] This disclosure aims to provide a management system and management method that can easily determine whether or not a medical device can be used. [Means for solving the problem]

[0006] The management system of this disclosure includes: a data storage unit that stores data relating to at least one of the usage history and quality status of one or more medical devices in association with the identification information of one or more medical devices; a reading unit that reads the identification information of a candidate medical device from among the one or more medical devices that is a candidate for use; and a control unit that reads the data related to the read identification information from the data storage unit and determines whether or not the candidate medical device can be used based on the read data. [Effects of the Invention]

[0007] The present invention provides a management system and management method that can easily determine whether or not a medical device can be used. [Brief explanation of the drawing]

[0008] [Figure 1] This diagram illustrates the sequence of steps involved in an electrocardiogram examination according to this embodiment. [Figure 2] This figure shows the measuring device according to this embodiment. [Figure 3] This diagram shows the reverse side of the front panel of the measuring garment. [Figure 4] This is a diagram showing the back of the measuring garment. [Figure 5] This figure shows an example of a measurement garment with the electrocardiograph removed. [Figure 6] This figure shows the configuration of the management system for the measurement software according to this embodiment. [Figure 7] This diagram shows an example of a record stored in the data storage unit of the management device. [Figure 8] This diagram shows a method for measuring the resistance between electrodes of a measuring device. [Figure 9]This flowchart shows the procedure from washing and disinfecting the measurement garment to estimating the number of viable bacteria. [Figure 10] This diagram shows the method for disinfecting measuring wear. [Figure 11] This flowchart shows the procedure for calculating the soiling score of the garment being measured. [Figure 12] This diagram shows how to capture digital images of measuring wear. [Figure 13] This figure shows an example where a portion of the measurement wear is used as the imaging area. [Figure 14] This is a flowchart showing the procedure for calculating the dimensional score of measuring wear. [Figure 15] This diagram shows how to capture digital images of measuring wear. [Figure 16] This diagram shows another method for measuring the dimensional score of measuring wear. [Figure 17] This is a flowchart explaining the process for registering measurement wear. [Figure 18] This is a flowchart explaining the process for returning measurement wear. [Figure 19] This is a flowchart explaining the process for lending out measurement wear. [Figure 20] This figure shows the hardware configuration of the management device according to this embodiment. [Modes for carrying out the invention]

[0009] [Electrocardiogram (ECG) test] FIG. 1 is a diagram for explaining a series of processes of an electrocardiogram examination according to the present embodiment. An electrocardiogram examination of a patient 104 as a subject is ordered from a medical institution 101 to a data center 102 (S1), and an order receipt notice is transmitted from the data center 102 to a distribution management center 103 (S2). In the distribution management center 103 that has received the order receipt notice, measurement wear suitable for the size of the patient 104 is selected as a lending candidate. An operator of the distribution management center 103 determines whether the measurement wear of the lending candidate can be lent using a management system 100 that centrally manages data of a plurality of measurement wears (S4). More specifically, it is determined whether the measurement wear of the lending candidate can be used or reused (hereinafter unified as reuse). When it is determined that it can be reused, it is determined that lending is possible, and when it is determined that it cannot be reused, it is determined that lending is not possible. When it is determined by the management system 100 that lending is possible, the measurement wear and the electrocardiograph are lent to the patient 104 (S4). For example, a set including the measurement wear, the electrocardiograph, and an instruction manual is delivered to the home of the patient 104 by express delivery or mail. The set may be delivered by a drone.

[0010] The patient 104 continues to wear the measurement wear for a specified period, for example, about one to two weeks. When the examination period ends, the measurement wear and the electrocardiograph are returned from the patient 104 to the distribution management center 103 (S5). For example, a set including the used measurement wear and the electrocardiograph is delivered to the distribution management center 103 by mail or express delivery. The set may be delivered by a drone. The measurement wear returned to the distribution management center 103 is inspected for damage, dirt, etc. after being washed, disinfected, etc., and the data of the measurement wear in the management system 100 is updated (S6). The electrocardiogram data recorded on the electrocardiograph is transmitted from the distribution management center 103 to the data center 102 (S7), and an analysis request is transmitted from the data center 102 to an analysis center 105 (S8). In the analysis center 105, analysis of the electrocardiogram data of the patient is performed. The analysis result is transmitted from the analysis center 105 to the data center 102 (S9) and transferred from the data center 102 to the medical institution 101 (S10).

[0011] [Measurement Wear] FIG. 2 is a view showing the measurement wear 1 according to the present embodiment, and shows a state in which the measurement wear 1 is worn on the torso. FIG. 3 is a view showing the back surface (the surface in contact with the skin) of the front body part of the measurement wear 1. FIG. 4 is a view showing the back of the measurement wear 1.

[0012] As shown in FIG. 2(A), the main body of the measurement wear 1 includes a front body part 31 and a back body part 32 (see FIG. 4). The front body part 31 and the back body part 32 are connected by two shoulder belts 33, and both sides of the side abdomen are separated. Loop tapes 36 with size adjustment scales printed thereon are sewn at both ends of the body part of the front body part 31. Each scale part has a loop structure. Torso belts 37 are sewn on both sides of the body part of the back body part 32. Hooks 37A are attached to the front body part side tips of each torso belt 37, and are configured to be hooked on the loop of an arbitrary scale in the loop tape 36. More specifically, by inserting the tip part of the hook 37A from the lower side of the loop, the hook is fixed at the position of the number of the loop. In the example of the figure, the tips of both torso belts 37 are fixed at the position of the number "7" respectively, and as shown in FIG. 2(B), the hooks 37A of both torso belts 37 are hooked on the loops of the number "7" respectively. By fixing the hooks 37A on both sides to the loops in this way, the front body part 31 and the back body part 32 are connected on both sides of the side abdomen. In this example, the torso belts 37 are separated into two (see FIG. 4), but these torso belts may be integrated so as to be connected to each other on the back side of the measurement wear 1.

[0013] A electrocardiograph 10 (measuring instrument) is detachably attached to the center of the body part of the front body part 31. A plurality of connector parts (electrodes) are provided on the part of the front body part 31 facing the back surface side of the electrocardiograph 10, and the electrocardiograph 10 is fixed to the front body part 31 by aligning and pressing the back surface of the electrocardiograph 10 against these connector parts.

[0014] Figure 5 shows an example of the measurement wear 1 with the electrocardiograph 10 removed. Four connector parts 25, 26, 27, and 28 are provided between the loop tapes 36 at the lower part of the front body 31, which are fitted to the back surface of the electrocardiograph 10.

[0015] As shown in Figure 3, washable dry electrodes 20, 21, and 22 that come into contact with the patient's (subject's) skin are attached to the back of the torso of the front garment 31 to which the electrocardiograph 10 is attached. Each of the electrodes 20, 21, and 22 is connected to at least one of the above-mentioned multiple connector parts 25 to 28 via lead wires (wiring) not shown. One of the connector parts 25 to 28 may be a connector part that is not connected to any of the electrodes 20 to 22, but assists in connecting to the electrocardiograph 10. When washing the measurement garment 1, the electrocardiograph 10 is removed from the measurement garment 1. On the other hand, the electrodes 20, 21, and 22 are made of a washable material, for example, Hitoe®, and can be washed while attached to the measurement garment 1.

[0016] The arrangement of electrodes 20, 21, and 22 conforms to CC5, one of the lead methods for Holter electrocardiograms. When the measurement wear 1 is worn, the electrocardiograph 10 and electrodes 20, 21, and 22 are positioned around the patient's underbust. Electrode 20 is the positive electrode, electrode 21 is the negative electrode, and electrode 22 is the ground electrode. As described above, electrodes 20, 21, and 22 are connected to the connector part of the electrocardiograph 10 by lead wires, and these are covered by an electrically insulating material 23.

[0017] The electrocardiograph 10 is equipped with a rechargeable battery and, when fully charged, can measure electrocardiogram data (measurement data) for a period of one to two weeks or longer. The electrocardiograph 10 includes a storage unit capable of storing all electrocardiogram data measured over a period of one to two weeks or longer. The electrocardiograph 10 includes a communication unit capable of communicating with an information processing device such as a computer via wired or wireless connection. The communication unit has the function of communicating with the information processing device via wired or wireless connection and transmitting the electrocardiogram data stored in the storage unit to the information processing device.

[0018] As shown in Figure 4, a two-dimensional code 50 (identification mark) is printed on the torso of the back panel 32 of the measuring wear 1. An example of a two-dimensional code is the QR code (registered trademark), but it is not limited to this. The identification information read from the two-dimensional code 50 includes an identification code (e.g., an identification number) that can uniquely identify the measuring wear 1, and the manufacturing date of the measuring wear 1. As mentioned above, the waist belts 37 may be integrated so as to be connected to each other on the back side of the measuring wear 1, in which case the two-dimensional code 50 may be printed on the surface of the integrated waist belts.

[0019] [Management System] Figure 6 shows the configuration of the measurement wear management system 100 according to this embodiment. The management system 100 includes a two-dimensional code reader 110 (reading unit) that reads the two-dimensional code 50 printed on the measurement wear 1, a management device 120 that centrally manages data from multiple measurement wears 1, and an operating device 130 (operating device) used by workers at the distribution management center 103 when operating the management device 120. The two-dimensional code reader 110 reads the two-dimensional code 50 of the measurement wear 1 and acquires the identification information of the measurement wear 1. The specific configuration of the two-dimensional code reader 110 is not particularly limited, but for example, the two-dimensional code reading function installed in a regular smartphone may be used.

[0020] The management device 120 comprises a receiving unit 121, a data storage unit 122, a control unit 123, and a data communication unit 124. The control unit 123 has the function of a determination unit that determines whether the measurement wear 1 can be used or reused (whether it can be lent out). The receiving unit 121 communicates with the 2D code reader 110 by wire or wireless and receives the identification information of the measurement wear 1 acquired by the 2D code reader 110. The identification information received by the receiving unit 121 is transferred to the control unit 123. The data storage unit 122 stores data for one or more measurement wear 1s. Specifically, one record is created for each measurement wear, and each record contains the identification information, expiration date information, usage history information, and quality status information of the measurement wear 1. In other words, the data storage unit 122 records the expiration date information, usage history information, and quality status information in association with the identification information of one or more measurement wears.

[0021] When a new (unused) measuring wear 1 is registered, the control unit 123 creates a new record corresponding to the identification code contained in the identification information read from the two-dimensional code 50 of the measuring wear 1 and adds it to the data storage unit 122. When the measuring wear 1 is returned from the patient to the delivery management center 103, the control unit 123 uses the identification code contained in the identification information read from the two-dimensional code 50 of the returned measuring wear 1 as a key to read the record of the measuring wear 1 stored in the data storage unit 122 and updates the field values ​​of the record. When the measuring wear 1 is newly loaned from the delivery management center 103 to a patient, the control unit 123 uses the identification code contained in the identification information read from the two-dimensional code 50 of the candidate measuring wear 1 as a key to read the record of the measuring wear 1 stored in the data storage unit 122 and determines whether the measuring wear 1 can be reused based on the field values ​​of the record.

[0022] The data communication unit 124 communicates with the operating device 130 via wired or wireless connection, receives information input by the worker via the operating device 130 and transfers it to the control unit 123, and also transmits information output from the control unit 123 to the operating device 130. The specific configuration of the management device 120 is not particularly limited, but for example, the functions of the management device 120 may be realized by running the management application according to this embodiment on a normal computer device. The specific configuration of the operating device 130 is not particularly limited, but for example, a normal smartphone may be used. In Figure 6, the 2D code reader 110 and the operating device 130 are shown as separate devices, but the operating device 130 may be equipped with the functions of the 2D code reader 110 so that the two can be integrated into a single device.

[0023] Figure 7 shows an example of a record stored in the data storage unit 122. As described above, one record is created for each measuring wear, and each record includes identification information, expiration information, usage history information, and quality status information for the measuring wear 1. The identification information includes fields for the identification code and the date of manufacture. The expiration information includes a field for the expiration date. The usage history information includes fields for the cumulative number of uses and cumulative usage time, as an example of information regarding the usage history of the measuring wear. The quality status information includes fields for the resistance value between electrodes, viable bacteria count, dirt score, and dimensional score, as an example of information regarding the quality status of the measuring wear. Data including at least one selected from the date of manufacture, expiration date, cumulative number of uses, cumulative usage time, resistance value between electrodes, viable bacteria count, dirt score, and dimensional score is an example of data used to determine whether the measuring wear can be reused. The details of these fields will be explained in order below.

[0024] (0. Identification code) The identification code is a code that uniquely identifies the measurement wearer 1. The identification information read from the 2D code 50 of the measurement wearer 1 includes the identification code of the measurement wearer 1, which is written to the field. In the example in Figure 7, the identification code of the measurement wearer 1 is 10001.

[0025] (1.Date of manufacture) The manufacturing date is the manufacturing date of the measuring wear 1. The identification information read from the 2D code 50 of the measuring wear 1 includes the manufacturing date of the measuring wear 1, and this is written to the field. In the example in Figure 7, the manufacturing date of the measuring wear 1 is October 10, 2023. In this embodiment, the identification information of the measuring wear is defined by a pair of identification codes and manufacturing dates, but the identification information of the measuring wear may also be defined by the identification code alone.

[0026] (2. Expiration date) The expiration date is the expiration date of Measurement Wear 1, which is the expiration date of medical devices as stipulated by the Medical Care Act of Japan, and in this example, it is set to 3 years after manufacture. The identification information read from the 2D code 50 of Measurement Wear 1 includes the manufacturing date of Measurement Wear 1, and adding 3 years to this date gives the expiration date of Measurement Wear 1. In the example in Figure 7, the expiration date of Measurement Wear 1 is October 10, 2026.

[0027] (3. Cumulative number of uses) The cumulative usage count is the cumulative number of times the measurement wear 1 has been used. When the measurement wear 1 is returned from the patient to the delivery management center 103, 1 is added to the cumulative usage count. In this embodiment, as an example, it is assumed that between the time the measurement wear 1 is lent to a patient and the time it is returned, it is washed 10 times in a household washing machine using tap water below 40 degrees Celsius and household detergent, and then hung to dry 10 times. Based on this assumption, the upper limit threshold for the cumulative usage count, which will be described later, is set. In the example in Figure 7, the cumulative usage count of the measurement wear 1 is 5 times.

[0028] (4. Cumulative usage time) The cumulative usage time is the cumulative usage time of the measurement wear 1. The electrocardiogram data recorded by the electrocardiograph 10 includes the total acquisition time of that electrocardiogram data. The total acquisition time is the sum of the time that the electrocardiograph 10 was actually operating to acquire electrocardiogram data. When the measurement wear 1 is returned from the patient to the delivery management center 103, the total acquisition time of the electrocardiogram data recorded by the electrocardiograph 10 is added to the cumulative usage time. For example, if the electrocardiogram examination period is two weeks, the total acquisition time of the electrocardiogram data will be approximately 336 hours. In the example in Figure 7, the cumulative usage time of the measurement wear 1 is 1680 hours.

[0029] (5. Resistance between electrodes) The resistance between electrodes is the resistance between the electrodes attached to the measuring wear 1, and is ideally 0Ω. More specifically, the resistance between electrodes is the resistance of the lead wires between electrodes 20-22 and the connector portion to which electrodes 20-22 are connected. In this embodiment, in order to measure the resistance in a state close to that in which a patient is actually wearing the garment, as shown in Figure 8, the fabric portion around the electrodes is fixed with jigs 140A and 140B, and the resistance between electrodes is measured while a worker applies tensile force from various directions to the fabric in the unfixed areas. Alternatively, the resistance between electrodes may be measured with the measuring wear 1 attached to a torso. The measured value may be an average or a maximum value. In the example in Figure 7, the resistance between electrodes of the measuring wear 1 is 10Ω. The measurement may also be performed using a machine that performs the actions of fixing the fabric portion around the electrodes, applying tensile force from various directions to the fabric in the unfixed areas, and measuring the measured value between electrodes as a series of actions.

[0030] (6. Viable Bacteria Count) The number of viable bacteria is the number of viable bacteria per unit surface area attached to the measurement garment 1 after disinfection. Figure 9 is a flowchart showing the procedure from washing and disinfecting the measurement garment 1 to estimating the number of viable bacteria according to this embodiment. A machine that performs the series of operations shown in Figure 9 may be used, or some of the steps may be performed by an operator. First, the measurement garment 1 is washed in a commercial washing machine using water at 40 degrees Celsius or lower and commercial detergent (S901). Next, as shown in Figure 10, a fabric sample 141 made of the same material as the fabric of the measurement garment 1 is sealed in a sterilization bag 142 (S902). The dimensions of the fabric sample 141 are not particularly limited, but for example, they are about 10 cm x 20 cm. The water temperature and detergent type can be any suitable temperature and type.

[0031] The measuring garment 1 and the fabric sample 141 sealed in the sterilization bag 142 are disinfected in a disinfection device (sterilization device) 149 in accordance with one of the disinfection methods for hospital linens stipulated in the "Regarding the Outsourcing of Services for Hospitals, Clinics, etc." of the Medical Care Act of Japan (S903). In this embodiment, as an example, a disinfection method using ethylene oxide gas (EOG) is used. Experiments conducted by the inventors of this disclosure have shown that the disinfection method using EOG is suitable for disinfecting the measuring garment 1 without impairing the conductivity of the electrodes attached to the measuring garment 1 and without changing the dimensions of the garment. In this disinfection method, the measuring garment 1 and the fabric sample 141 sealed in the sterilization bag 142 are disinfected under vacuum with a mixture of EOG and an inert gas for 1 hour at atmospheric pressure or 90 minutes under a pressure of 1 kg / cm3.

[0032] After disinfection with EOG, the fabric sample 141 is removed from the sterilization bag 142, and the number of viable bacteria per unit surface area attached to the disinfected fabric sample 141 is measured (S904). The method for measuring the number of viable bacteria attached to the fabric sample 141 is not particularly limited, but for example, the number of viable bacteria per unit surface area can be measured by washing the fabric sample 141 with physiological saline, fluorescently staining the viable bacteria in the wash solution, and counting them under a microscope. From the number of viable bacteria per unit surface area of ​​the fabric sample 141, the number of viable bacteria per unit surface area attached to the disinfected measurement garment 1 is estimated (S905). In the example in Figure 7, the number of viable bacteria attached to the disinfected measurement garment 1 is 147 cells / cm2. Note that washing with physiological saline may damage the fabric of the measurement garment 1, but in this embodiment, washing with physiological saline is performed on the fabric sample 141 instead of the measurement garment 1, so the fabric of the measurement garment 1 is not damaged. Figure 9 shows an example of the procedure, and the washing procedure (S901) may be performed after the viable bacterial count estimation procedure (S905).

[0033] (7. Dirt Score) The soiling score is a numerical representation of the degree of soiling on the fabric of garment 1, using the brightness of a digital image. Specifically, when comparing a digital image of a new garment with a digital image of a garment with soiling, the average brightness of the digital image of the soiled garment is lower than the average brightness of the digital image of the new garment. This property is used to calculate the soiling score of garment 1 based on the brightness of the digital image of garment 1.

[0034] Figure 11 is a flowchart illustrating the procedure for calculating the soiling score of the measuring wear 1 according to this embodiment. A system that performs the series of operations shown in Figure 11 may be used, or some of the steps may be performed by an operator. First, a digital image of the measuring wear 1 is taken (S1101). More specifically, as shown in Figure 12, a digital image 145 including the measuring wear 1 and a color sample 143 of a predetermined brightness is taken. The equipment used to take the digital image is not particularly limited, but for example, the camera function of a regular smartphone may be used. The color sample 143 includes, for example, multiple color samples. In the example shown in the figure, multiple bar-shaped color samples are arranged in the left-right direction.

[0035] Next, to eliminate the effects of variations in the shooting environment, the brightness of the digital image 145 of the measurement wear 1 is corrected (S1102). Specifically, a digital image including a new measurement wear and a color sample (the same color sample 143 is used) is taken. The brightness of the digital image 145 to be corrected is corrected so that the brightness of the color sample included in this digital image matches the brightness of the color sample 143 included in the digital image 145 to be corrected. Note that the digital image including the new measurement wear and color sample can be taken in advance before photographing the measurement wear to be corrected, or it can be taken after or simultaneously with photographing the measurement wear to be corrected.

[0036] Finally, the average brightness of the corrected digital image of measurement garment 1 is calculated, and this becomes the dirt score of measurement garment 1 (S1103). Typically, the dirt score of a used measurement garment is lower than that of a new measurement garment. For example, the dirt score of a new measurement garment is 255, while the dirt score of a used measurement garment is 208. Furthermore, the dirt score of a measurement garment with more dirt attached to the fabric will be even lower. In the example in Figure 7, the dirt score of measurement garment 1 is 204.

[0037] The area of ​​the digital image used to calculate the soiling score is not limited to the entire garment 1, but may be a partial area. For example, if soiling is noticeable, only a portion of the front panel 31 (such as the right shoulder, left chest, or hem) may be photographed. Alternatively, a portion of the back panel 32 (such as the center of the back or waist) or a portion of the waist belt 37 (such as the area around the hook 37A, which is frequently operated by the user) may be targeted. In this case, it is sufficient that the photographed area can be identified as roughly corresponding to the same area on a new garment 1 and a used garment 1; it is not necessary to photograph the exact same area. Even if the position or range of the photographed area differs slightly, it is possible to compare it with the corresponding area on a new garment by performing correction using the color sample 143. When photographing a partial area of ​​the garment 1, multiple parts of the new garment may be photographed in advance along with the color sample, and correction may be performed using the digital image of the part that matches the actually photographed part. In this process, the same body part can be divided into multiple regions, and correction can be performed using the digital image corresponding to the region closest to the area being evaluated that was actually captured.

[0038] Figure 13 shows an example of photographing a portion of the garment 1 as the shooting area 148. A portion of the front body 31 is selected as the shooting area 148, and the stain 147 is included in this shooting area 148. A color sample 143 is placed within the shooting area 148, and a digital image 149 is captured. In this way, by arbitrarily setting the shooting area instead of limiting it to the entire garment, the effect of localized stains can be appropriately quantified, and the stain condition of the garment 1 can be evaluated more flexibly and appropriately. In other words, if the stain on the garment 1 is localized, if the entire garment is used as the shooting area, the brightness of areas other than the stained area will become dominant due to the averaging of brightness, and the stain score tends to be a large value. However, by narrowing the shooting area, the stain condition can be evaluated more appropriately. On the other hand, if the stain is distributed over a wide area, the stain condition of the entire garment 1 can be appropriately evaluated by photographing the entire garment 1 as described above.

[0039] Furthermore, the shooting area is not limited to the entire garment 1, the front panel 31, the back panel 32, or the waist belt 37; it may also be possible to define an area of ​​5cm x 5cm or 1cm x 1cm at any location and take a photograph. In this case, the shooting area may span multiple parts. As the area of ​​dirt increases relative to the shadow area, the brightness of the digital image tends to decrease, so by arbitrarily defining the shooting area for the dirt to be evaluated, an appropriate evaluation becomes possible.

[0040] The shooting area may be defined by the worker observing the measurement garment 1 and targeting the area that they deem to be noticeably dirty. While it may be difficult for a worker to accurately determine whether the dirt directly affects the continued use of the measurement garment 1 through visual inspection, quantifying and standardizing the dirt score allows for a more appropriate and objective judgment. On the other hand, the shooting area may not be determined by the worker's own judgment, but rather one or more predetermined parts or areas may be uniformly set as the shooting area regardless of whether they are dirty or not. If multiple parts or areas are photographed, the dirt score may be calculated based, for example, on the minimum or average of the average brightness calculated for each of the multiple parts or areas. By defining the shooting area in advance, the decision on whether to continue using the garment can be made based on objective and consistent criteria, without relying on human subjectivity.

[0041] Measurement garment 1 may come in various color variations, and in this case as well, the soiling score can be appropriately calculated by using a digital image of a new measurement garment of the same color as the measurement garment being evaluated.

[0042] (8. Dimensional score) The dimensional score is a numerical representation of the degree of stretching of the fabric of the measurement garment 1. In detail, like ordinary clothing, the fabric of the measurement garment shrinks slightly with each wash, and may also stretch depending on how the patient wears and handles it. In the measurement garment 1 of the electrocardiograph 10, the underbust measurement is particularly important, and in this embodiment, the underbust measurement of the measurement garment 1 is measured and this is used as the dimensional score of the measurement garment 1.

[0043] Figure 14 is a flowchart illustrating the procedure for calculating the dimensional score of the measuring wear 1 according to this embodiment. A system may be used to perform the series of steps shown in Figure 14, or some of the steps may be performed by an operator. First, a digital image of the measuring wear 1 is taken (S1301). In detail, as shown in Figure 15, a digital image 146 including the measuring wear 1 and a predetermined size sample 144 is taken. The equipment used to take the digital image is not particularly limited, but for example, the camera function of a typical smartphone may be used.

[0044] Next, in order to eliminate the effects of variations in the shooting environment, the size of the digital image 146 including the measurement wear 1 is corrected (S1302). Specifically, a digital image including a new measurement wear and a size sample (the same as size sample 144) is taken in advance. The size of the digital image 146 including the measurement wear 1 is corrected so that the size of the size sample 144 included in this digital image matches the size of the size sample 144 included in the digital image including the measurement wear 1 to be measured.

[0045] Next, the underbust dimensions (number of pixels) of the measurement garment 1 in the corrected digital image 146 are measured (S1303), and this is converted to dimensions in real space (cm) (S1304). Finally, the difference between the underbust dimensions (cm) of the measurement garment 1 being measured and the underbust dimensions (cm) of a new measurement garment becomes the dimension score of the measurement garment 1 (S1305). In the example in Figure 7, the dimension score of the measurement garment 1 is +0.5cm.

[0046] Alternatively, instead of following steps S1301 to S1305 above, the worker may directly measure the underbust measurement (cm) of the measuring garment 1. Furthermore, the step of converting to dimensions in real space in step S1304 may be omitted, and the dimension score may be calculated based on the dimensions (number of pixels) in the digital image measured in step S1303.

[0047] Alternatively, instead of measuring the underbust measurement, the dimensions of mark 147 (a logo in this example) printed on the measuring garment 1 may be measured, as shown in Figure 16, and this may be used as the dimension score for the measuring garment 1. In the example in Figure 16, an example is shown in which the dimension score is calculated by measuring the width 148 of mark 147. Mark 147 may be printed at any location on the measuring garment 1. Thus, the dimension score may be calculated based on the difference between the dimensions of a predetermined mark provided on the measuring garment 1 and the dimensions of a predetermined mark provided on an unused measuring garment.

[0048] [Processing during registration of measuring wear] Next, the process by which the management device 120 according to this embodiment adds a record of the new measurement wear 1 to the data storage unit 122 will be explained with reference to the flowchart in Figure 17. The process in the flowchart in Figure 17 is executed when registering the data of a new measurement wear 1 with the management device 120.

[0049] In step S1601, the worker at the distribution management center 103 has the two-dimensional code 50 printed on the measuring wear 1 read by the two-dimensional code reader 110. The two-dimensional code reader 110 reads the two-dimensional code 50 on the measuring wear 1 and obtains the identification information of the measuring wear 1.

[0050] In step S1602, the receiving unit 121 of the management device 120 communicates with the 2D code reader 110 by wire or wireless connection and receives the identification information of the measurement wear 1. The receiving unit 121 then transfers the identification information of the measurement wear 1 to the control unit 123.

[0051] In step S1603, the control unit 123 creates a new record corresponding to the identification code included in the identification information transferred in step S1602, and adds the record to the data storage unit 122. Specifically, the control unit 123 creates a new record and writes the identification code and manufacturing date included in the transferred identification information to the identification code and manufacturing date fields of the record, respectively. The control unit 123 adds the new record to the data storage unit 122.

[0052] In step S1604, the control unit 123 sets the field value for the expiration date of the record created in step S1603. Specifically, the control unit 123 adds 3 years to the manufacturing date included in the identification information transferred in step S1602 and sets this as the field value for the expiration date. Note that 3 years is just an example, and other values ​​may be used.

[0053] In steps S1605 and S1606, the control unit 123 initializes the cumulative usage count and cumulative usage time field values ​​of the record created in step S1603 to 0 and 0 hours, respectively.

[0054] In steps S1607 to S1610, the control unit 123 initializes the field values ​​of the resistance value between electrodes, the number of viable bacteria, the contamination score, and the dimensional score of the record created in step S1603 to an arbitrary value, for example, NULL.

[0055] As a result of the above process, when a new measuring wear 1 is registered, a record of the measuring wear 1 is added to the data storage unit 122 of the management device 120. Note that the order in which the initialization processes in steps S1604 to S1610 above are executed can be changed at will.

[0056] [Processing upon return of measurement wear] Next, the process by which the management device 120 according to this embodiment updates the data of the measurement wearer 1 recorded in the data storage unit 122 will be explained with reference to the flowchart in Figure 18. The process in the flowchart of Figure 18 is executed when the measurement wearer 1, which had been lent to a patient, is returned to the delivery management center 103.

[0057] In step S1701, the worker at the distribution management center 103 has the two-dimensional code 50 printed on the measuring wear 1 read by the two-dimensional code reader 110. The two-dimensional code reader 110 reads the two-dimensional code 50 on the measuring wear 1 and obtains the identification information of the measuring wear 1.

[0058] In step S1702, the receiving unit 121 of the management device 120 communicates with the 2D code reader 110 by wire or wireless means and receives the identification information of the measurement wear 1. The receiving unit 121 then transfers the identification information of the measurement wear 1 to the control unit 123.

[0059] In step S1703, the control unit 123 searches for records stored in the data storage unit 122 using the identification code included in the identification information transferred in step S1702 as a key, and reads the record corresponding to the identification code. The read record contains the data of the measuring wear 1 whose 2D code 50 was read in step S1701.

[0060] In step S1704, the control unit 123 updates the cumulative usage time of the measuring wear 1. Specifically, the control unit 123 adds 1 to the field value of the cumulative usage count of the record read in step S1703.

[0061] In step S1705, the control unit 123 updates the cumulative usage time of the measurement wear 1. Specifically, the worker operates the operating device 130 to input the total acquisition time of the electrocardiogram data recorded in the electrocardiograph 10. The data communication unit 124 communicates with the operating device 130 via wired or wireless connection, receives the total acquisition time of the electrocardiogram data, and transfers it to the control unit 123. For example, if the electrocardiogram examination period is two weeks, the total acquisition time of the electrocardiogram data is approximately 336 hours. The control unit 123 adds the total acquisition time transferred from the data communication unit 124 to the field value of the cumulative usage time of the record read in step S1703.

[0062] In step S1706, the control unit 123 updates the resistance value between the electrodes of the measuring wear 1. Specifically, for example, an operator measures the resistance value between the electrodes of the measuring wear 1 according to the procedure in Figure 8 described above, and operates the operating device 130 to input the measured resistance value. The data communication unit 124 communicates with the operating device 130 by wire or wireless connection, receives the resistance value between the electrodes, and transfers it to the control unit 123. The control unit 123 writes the resistance value between the electrodes transferred from the data communication unit 124 to the field of the resistance value between electrodes in the record read in step S1703.

[0063] In step S1707, the control unit 123 updates the number of viable bacteria on the measurement garment 1. Specifically, for example, an employee measures the number of viable bacteria per unit surface area after washing and disinfecting the measurement garment 1 according to the procedure in Figure 9 described above, and operates the operating device 130 to input the measured number of viable bacteria. The data communication unit 124 communicates with the operating device 130 by wire or wireless connection, receives the number of viable bacteria, and transfers it to the control unit 123. The control unit 123 writes the number of viable bacteria transferred from the data communication unit 124 to the number of viable bacteria field of the record read in step S1703.

[0064] In step S1708, the control unit 123 updates the dirt score of the measuring wear 1. Specifically, for example, an operator calculates the dirt score of the measuring wear 1 by following the procedure in Figure 11 described above, and operates the operating device 130 to input the calculated dirt score. The data communication unit 124 communicates with the operating device 130 by wire or wireless connection, receives the dirt score, and transfers it to the control unit 123. The control unit 123 writes the dirt score transferred from the data communication unit 124 to the dirt score field of the record read in step S1703.

[0065] In step S1709, the control unit 123 updates the dimensional score of the measuring wear 1. Specifically, for example, an operator calculates the dimensional score of the measuring wear 1 by following the procedure in Figure 14 described above, and operates the operating device 130 to input the calculated dimensional score. The data communication unit 124 communicates with the operating device 130 by wire or wireless connection, receives the dimensional score, and transfers it to the control unit 123. The control unit 123 writes the dimensional score transferred from the data communication unit 124 to the dimensional score field of the record read in step S1703.

[0066] As a result of the above process, when the measurement wearer 1 that was lent to the patient is returned to the distribution management center 103, the data of the measurement wearer 1 recorded in the data storage unit 122 of the management device 120 will be updated. Note that the order in which the update processes in steps S1704 to S1709 above are executed can be changed at will.

[0067] [Processing when renting out measuring wear] Next, the process by which the management device 120 according to this embodiment determines whether the measurement wear 1 can be reused will be explained with reference to the flowchart in Figure 19. The process in the flowchart in Figure 19 is a process according to the management method according to this embodiment, and is executed when a new measurement wear is lent to a patient from the distribution management center 103 in order to determine whether the candidate measurement wear 1 can be reused.

[0068] In step S1801, the worker at the distribution management center 103 has the 2D code 50 printed on the loan candidate (candidate for use) measuring wear 1 read by the 2D code reader 110. The 2D code reader 110 reads the 2D code 50 on the measuring wear 1 and obtains the identification information of the measuring wear 1.

[0069] In step S1802, the receiving unit 121 of the management device 120 communicates with the 2D code reader 110 by wire or wireless connection and receives identification information of the measurement wear 1 that is a candidate for loan. The receiving unit 121 then transfers the identification information of the measurement wear 1 that is a candidate for loan to the control unit 123.

[0070] In step S1803, the control unit 123 searches for records stored in the data storage unit 122 using the identification code included in the identification information transferred from the receiving unit 121 in step S1802 as a key, and reads the record corresponding to the identification code. The read record contains the data of the measurement wear 1 of the loan candidate 1 whose 2D code 50 was read in step S1801.

[0071] In step S1804, the control unit 123 determines whether the measurement wear 1 can be reused based on its expiration date. Specifically, the control unit 123 refers to the expiration date field value of the record read in step S1803 and determines whether the current date is within the expiration period. If the current date is within the expiration period (S1804=YES), the control unit 123 proceeds to the subsequent step S1805. On the other hand, if the current date is within the expiration period (S1804=NO), the control unit 123 determines that the measurement wear 1 cannot be reused and sends a message to that effect to the operation device 130 via the data communication unit 124 (S1812). When the message that the measurement wear 1 cannot be reused is displayed on the display of the operation device 130, the worker selects another measurement wear as the new candidate for loan in place of the current candidate for loan, and returns to step S1801.

[0072] Instead of a worker selecting loan candidates, a computer (such as the operating device 130 or management device 120) may perform the selection automatically. In this case, the computer may select loan candidates based on arbitrary criteria, such as prioritizing those with the oldest expiration dates or those with smaller identification code values. The computer may also display the selected candidates to the worker on a screen.

[0073] In step S1805, the control unit 123 determines whether the measurement wear 1 can be reused based on the cumulative number of uses of the measurement wear 1 that is a candidate for loan. Specifically, the control unit 123 refers to the field value of the cumulative number of uses in the record read in step S1803 and determines whether this value exceeds a predetermined upper threshold, for example, 10 times. If the cumulative number of uses does not exceed the predetermined upper threshold (S1805=YES), the control unit 123 proceeds to the subsequent step S1806. On the other hand, if the cumulative number of uses exceeds the predetermined upper threshold (S1805=NO), the control unit 123 determines that the measurement wear 1 cannot be reused and sends a message to that effect to the operation device 130 via the data communication unit 124 (S1812). When the message that the measurement wear 1 cannot be reused is displayed on the display unit of the operation device 130, the worker selects another measurement wear as the new loan candidate in place of the current measurement wear 1 and returns to step S1801.

[0074] In step S1806, the control unit 123 determines whether the measurement wear 1 can be reused based on its cumulative usage time. Specifically, the control unit 123 refers to the cumulative usage time field value of the record read in step S1803 and determines whether this value exceeds a predetermined upper threshold, for example, 24 hours × 14 days × 10 times = 3360 hours. If the cumulative usage time does not exceed the predetermined upper threshold (S1806 = YES), the control unit 123 proceeds to the subsequent step S1807. On the other hand, if the cumulative usage time exceeds the predetermined upper threshold (S1806 = NO), the control unit 123 determines that the measurement wear 1 cannot be reused and sends a message to that effect to the operation device 130 via the data communication unit 124 (S1812). When the display of the operating device 130 shows a message indicating that the device is not reusable, the worker selects another piece of measuring wear as the new candidate for loan, replacing the current candidate for loan, measuring wear 1, and returns to step S1801.

[0075] In step S1807, the control unit 123 determines whether the measurement wear 1 can be reused based on the resistance value between the electrodes of the candidate measurement wear 1. Specifically, the control unit 123 refers to the field value of the resistance value between electrodes in the record read in step S1803 and determines whether this value exceeds a predetermined upper threshold, for example, 1000Ω. If the resistance value between electrodes does not exceed the predetermined upper threshold (S1807=YES), the control unit 123 proceeds to the subsequent step S1808. On the other hand, if the resistance value between electrodes exceeds the predetermined upper threshold (S1807=NO), the control unit 123 determines that the measurement wear 1 cannot be reused and sends a message to that effect to the operation device 130 via the data communication unit 124 (S1812). When the message that the measurement wear 1 cannot be reused is displayed on the display unit of the operation device 130, the worker selects another measurement wear as the new candidate for loan in place of the current candidate measurement wear 1 and returns to step S1801.

[0076] In step S1808, the control unit 123 determines whether the measurement wear 1 can be reused based on the number of viable bacteria in the measurement wear 1 that is a candidate for loan. Specifically, the control unit 123 refers to the field value of the number of viable bacteria in the record read in step S1803 and determines whether this value exceeds a predetermined upper threshold, for example, 120 bacteria / cm2. If the number of viable bacteria does not exceed the predetermined upper threshold (S1808=YES), the control unit 123 proceeds to the subsequent step S1809. On the other hand, if the number of viable bacteria exceeds the predetermined upper threshold (S1808=NO), the control unit 123 determines that the measurement wear 1 cannot be reused and sends a message to that effect to the operation device 130 via the data communication unit 124 (S1812). When the message that the measurement wear 1 cannot be reused is displayed on the display unit of the operation device 130, the worker selects another measurement wear as the new loan candidate in place of the current loan candidate measurement wear 1 and returns to step S1801.

[0077] In step S1809, the control unit 123 determines whether the measurement wear 1 can be reused based on its soiling score. Specifically, the control unit 123 refers to the field value of the soiling score in the record read in step S1803 and determines whether this value is below a predetermined lower threshold, for example, 200. If the soiling score is not below the predetermined lower threshold (S1809=YES), the control unit 123 proceeds to the subsequent step S1810. On the other hand, if the soiling score is below the predetermined lower threshold (S1809=NO), the control unit 123 determines that the measurement wear 1 cannot be reused and sends a message to that effect to the operation device 130 via the data communication unit 124 (S1812). When the display of the operating device 130 shows a message indicating that the device is not reusable, the worker selects another piece of measuring wear as the new candidate for loan, replacing the current candidate for loan, measuring wear 1, and returns to step S1801.

[0078] In step S1810, the control unit 123 determines whether the measurement wear 1 can be reused based on its dimensional score. Specifically, the control unit 123 refers to the field value of the dimensional score in the record read in step S1803 and determines whether this value is within a predetermined range, for example, within ±1 cm. If the dimensional score is within the predetermined range (S1810=YES), the control unit 123 proceeds to the subsequent step S1811. On the other hand, if the dimensional score is outside the predetermined range (S1810=NO), the control unit 123 determines that the measurement wear 1 cannot be reused and sends a message to that effect to the operation device 130 via the data communication unit 124 (S1812). When the message that the measurement wear 1 cannot be reused is displayed on the display unit of the operation device 130, the worker selects another measurement wear as the new candidate for loan in place of the current candidate for loan, measurement wear 1, and returns to step S1801.

[0079] In step S1811, the control unit 123 sends a reusable message to the operating device 130 via the data communication unit 124. When the reusable message is displayed on the display of the operating device 130, the worker decides to lend the currently available measurement wear 1 to the patient.

[0080] The message indicating that the device is unusable, sent in step S1812 according to the determination results in steps S1804 to S1810, may include information indicating the result of the determination process that formed the basis for the determination that the device is unusable (the reason or basis for the determination that it is unusable). For example, if it is determined in step S1807 that the resistance value between the electrodes exceeds a predetermined upper limit threshold, the message indicating that the resistance value exceeds the predetermined upper limit threshold and at least one of the measured resistance value may be included in the message indicating that the device is unusable.

[0081] By executing the above processes, when a new measurement device is loaned to a patient from the distribution management center 103, it is possible to automatically determine whether the candidate measurement device 1 can be reused. Note that the order in which the determination processes in steps S1804 to S1810 above are executed can be changed at will. In addition, the conditions to be considered when determining whether the device can be reused can be arbitrarily selected, and only the corresponding determination processes can be executed. Furthermore, the thresholds and ranges used in each determination process can be changed at will.

[0082] (Another example of operation 1) The determination processes in steps S1804 to S1810 may all be performed, and based on these determination processes, a decision may be made as to whether the measuring wear can be reused. If it is determined that the conditions are not met in at least one of the determination processes in steps S1804 to S1810, it is decided that the wear cannot be reused, and if it is determined that all of the conditions are met, it is decided that the wear can be reused. The message sent when it is determined that the wear cannot be reused may include information indicating the result of at least one of the determination processes that was determined not to meet the conditions.

[0083] (Another example of operation 2) The process for lending out measuring wear shown in Figure 19 can be performed continuously by computer processing from reading the 2D code in step S1801 to determining whether it can be reused in step S1811 or step S1812. However, during or between steps, the worker may additionally determine whether the measuring wear is unsuitable for reuse through visual inspection. In that case, the worker interrupts the work, selects another measuring wear as the new candidate for lending instead of the current candidate measuring wear 1, and returns to step S1801. When the worker determines that the wear is unsuitable for reuse through visual inspection, it is when the candidate for lending has obvious dirt or damage and is deemed unsuitable for lending. More specifically, this includes, but is not limited to, cases where the 2D code 50 cannot be read, the waist belt 37 is frayed, the markings on the loop tape 36 are difficult to see, or the hook 37A is broken or damaged.

[0084] As described above, the measurement wear management system 100 according to this embodiment comprises a measurement wear 1 (medical device) on which a two-dimensional code 50 (identification mark) is printed, a two-dimensional code reader 110 (reading unit) that reads the two-dimensional code 50 and acquires identification information of the measurement wear 1, and a management device 120 that manages the measurement wear 1 based on the identification information. The management device 120 includes a receiving unit 121 that receives identification information from the two-dimensional code reader 110, a data storage unit 122 (storage unit) that stores data of the measurement wear 1 including the identification information, and a control unit 123 that determines whether the measurement wear 1 can be reused based on the data of the measurement wear 1. The data of the measurement wear 1 includes the expiration date of the measurement wear 1, the cumulative number of uses, the cumulative usage time, the resistance value between electrodes, the number of viable bacteria, the soiling score, and the dimensional score, and the control unit 123 determines whether the measurement wear 1 can be reused based on at least one of these selected values.

[0085] Due to the features described above, the measurement wear management system 100 according to this embodiment can automatically determine whether the measurement wear 1 can be reused. In this embodiment, an example of applying the technology of this disclosure to a measurement wear management system has been described, but the technology of this disclosure can be applied not only to measurement wear but also to management systems for any medical device that is repeatedly lent to patients and reused.

[0086] [Hardware configuration] Figure 20 shows the hardware configuration of the management device 120 according to this embodiment. 120 is composed of a computer device 600. The computer device 600 includes a CPU 601, an input interface 602, a display device 603, a communication device 604, a main memory 605, and an external memory device 606. In Figure 20, these devices are interconnected by a bus 607, but they may be interconnected via a wireless network or the internet.

[0087] The CPU (Central Processing Unit) 601 executes a computer program on the main memory 605. The computer program is a program that implements each of the above-described functional configurations of the management device 120. The computer program may not be a single program, but rather a combination of multiple programs or scripts. Each functional configuration is realized by the CPU 601 executing the computer program.

[0088] The input interface 602 is a circuit for inputting operation signals from input devices such as keyboards, mice, and touch panels to the management device 120.

[0089] The display device 603 displays data output from the management device 120. The display device 603 is, for example, an LCD (liquid crystal display), an organic electroluminescent display, a CRT (cathode ray tube), or a PDP (plasma display), but is not limited to these. Data output from the computer device 600 can be displayed on the display device 603.

[0090] The communication device 604 is a circuit for the management device 120 to communicate with an external device wirelessly or via a wired connection. Data can be input from an external device via the communication device 604. The data input from the external device can be stored in the main memory 605 or the external memory 606. The communication device 604 corresponds to the receiving unit 121 and the data communication unit 124 of the management device 120 according to this embodiment.

[0091] The main memory 605 stores computer programs, data necessary for the execution of computer programs, and data generated by the execution of computer programs. Computer programs are deployed and executed on the main memory 605. The main memory 605 is, for example, RAM, DRAM, or SRAM, but is not limited to these. The data storage unit 122 of the management device 120 according to this embodiment may be built on the main memory 605.

[0092] The external storage device 606 stores computer programs, data necessary for the execution of computer programs, and data generated by the execution of computer programs. These computer programs and data are read into the main memory 605 when the computer programs are executed. The external storage device 606 is, for example, a hard disk, optical disk, flash memory, and magnetic tape, but is not limited to these. The data storage unit 122 of the management device 120 according to this embodiment may be built on the external storage device 606.

[0093] The computer program may be pre-installed on the computer device 600, or it may be stored on a storage medium such as a CD-ROM. Furthermore, the computer program may be uploaded to the internet.

[0094] Furthermore, the management device 120 according to this embodiment may be configured as a single computer device 600, or as a system consisting of multiple interconnected computer devices 600.

[0095] While several embodiments have been described, these embodiments are presented as examples and are not intended to limit the scope of the embodiments. These embodiments can be implemented in various other forms, and various omissions, substitutions, modifications, and combinations are possible without departing from the spirit of the embodiments. These embodiments and their variations are included in the scope and spirit of this disclosure, as well as in the claims and their equivalents. [Explanation of Symbols]

[0096] 1...Measurement wear (medical device), 10...Electrocardiograph, 20...Electrode, 21...Electrode, 22...Electrode, 25...Connector part (electrode), 26...Connector part (electrode), 27...Connector part (electrode), 28...Connector part (electrode), 31...Front body, 32...Back body, 33...Shoulder belt, 36...Loop tape, 37...Waist belt, 50...2D code (identification mark), 101...Medical institution, 102...Data center, 103...Distribution management center, 104...Patient, 105...Analysis center, 10 0...Management system, 110...2D code reader (reading unit), 120...Management device, 121...Receiver, 122...Data storage unit (storage unit), 123...Control unit, 124...Data communication unit, 130...Operating device, 140A...Jig, 140B...Jig, 141...Fabric sample (sample), 142...Sterilization bag, 143...Color sample, 144...Size sample, 145...Mechanical image, 146...Mechanical image, 147...Stain, 148...Shooting area, 149...Mechanical image

Claims

1. A data storage unit that stores data relating to at least one of the usage history and quality status of one or more medical devices, associated with the identification information of one or more medical devices, A reading unit reads identification information of a candidate medical device from among the one or more medical devices mentioned above, A control unit reads the data related to the read identification information from the data storage unit and determines whether or not the candidate medical device can be used based on the read data, A management system equipped with [specific features / features].

2. The read-out data includes at least one suitability judgment data selected from the following: the expiration date of the medical device to be used, which is set based on the manufacturing date of the medical device to be used; the cumulative number of uses of the medical device to be used; the cumulative usage time of the medical device to be used; the measured resistance between multiple electrodes of the medical device to be used; and a contamination score calculated based on the brightness of a digital image taken of the entire or at least partial area of ​​the medical device to be used. The control unit determines whether or not the medical device to be used can be used based on the data for determining whether or not it can be used, according to claim 1.

3. The aforementioned candidate medical device is a measuring garment worn by the patient, and the measuring garment is equipped with an electrocardiograph and the aforementioned multiple electrodes. The management system according to claim 2, wherein the resistance between the electrodes is measured while applying a tensile force to another part of the measuring wear, with the electrode portion of the measuring wear fixed.

4. The aforementioned candidate medical device is a measuring garment worn by the patient. The data read out includes the measured number of viable bacteria attached to the garment after washing and disinfection. The control unit determines whether or not the measuring wear can be used based on the measured number of viable bacteria, according to the management system according to claim 1 or 2.

5. The management system according to claim 4, wherein the number of viable bacteria attached to the measuring wear is estimated from the measured number of viable bacteria attached to a sample that is disinfected together with the measuring wear.

6. The aforementioned candidate medical device is a measuring garment worn by the patient. The aforementioned quality status includes a dimensional score calculated based on the difference between the dimensions of the measuring garment and the dimensions of an unused measuring garment. The control unit determines whether or not the measuring wear can be used based on the dimensional score. The management system according to claim 1 or 2.

7. The medical device to be used is provided with an identification mark, and the reading unit reads the identification information from the identification mark. The management system according to claim 1 or 2.

8. The management system according to claim 1 or 2, wherein the one or more medical devices are measuring wear worn by a patient, and an electrocardiograph is attached to the measuring wear.

9. The aforementioned candidate medical devices are candidates for the measurement wear to be lent to the subject. The control unit determines whether or not to lend out the candidate measuring wear. If the control unit determines that the candidate measurement wear can be lent out, the candidate measurement wear will be made available for loan to the subject. If the control unit determines that the candidate measuring wear is unavailable for loan, the reading unit reads the identification information of a measuring wear candidate other than the candidate measuring wear, and the control unit determines whether or not the other candidate measuring wear is available for loan, the management system according to claim 8.

10. The reading unit reads the identification information from the returned measuring wear after the measuring wear lent to the subject has been returned by the subject. The control unit updates the data related to the identification information in the data storage unit based on the usage history and quality status of the returned measuring wear. The management system according to claim 9.

11. From one or more medical devices that are candidates for use, read the identification information of the candidate medical device. Data related to the identification information read from the data storage unit, which stores data relating to at least one of the usage history and quality status of the one or more medical devices, is read from the data storage unit that stores data relating to the identification information of the one or more medical devices. Based on the data read out, the feasibility of using the candidate medical device is determined. Management method.

Citation Information

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