JP6709479B1 - Medical device management system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a technology which enables reuse of a disposable medical device and optimizes user inventory, maker inventory and physical distribution according to the usage situation of a patient. A dialysis patient 99 regularly purchases a reusable dialysis indwelling needle set 80x in order to perform artificial dialysis at home, and they are delivered regularly. The management server 10 instructs the factory 90 to manufacture and ship the medical device 80 based on the contract details and usage history with the dialysis patient 99. In the RFID 81, product information, manufacturing information, information such as a destination user (dialysis patient 99) is written at the time of manufacturing and shipping. When performing artificial dialysis, the information written in the RFID 81x, 81d of the indwelling needle set 80x for dialysis is read by the user side reader/writer 85 connected to the medical device 86, and the number of times of use of the indwelling needle set 80x for dialysis is determined. It is checked whether it is within the upper limit. [Selection diagram] Figure 2

Description

The present invention relates to a medical device management system and a dialysis indwelling needle, for example, a medical device such as a syringe, a dialysis indwelling needle, and a dialyzer that is used for a patient and is discarded after each use or after a certain number of uses. The present invention relates to a medical device management system for continuously delivering medical products to predetermined users (patients, medical institutions, etc.) and a dialysis indwelling needle managed by the medical device management system.

In recent years, changes in the medical environment and medical needs are increasing, and as the diversification of medical services has been exclaimed, it is also important to respond to society and the environment. For example, in response to social demands, medical devices that have previously been assumed to be disposers are now actively used for reuse. As a technique for coping with such a situation, there is a technique for cleaning and reusing a medical device (see, for example, Patent Document 1). Patent Document 1 discloses a technique of simultaneously cleaning and sterilizing a cleaning object such as a contact lens in a single cleaning tank.

In addition, as a technology for managing medical equipment, an IC chip (also called an RF tag or RFID) is attached to the medical equipment to enhance traceability, use an appropriate type for surgery, etc., and manage after use. There is also a technology that makes it possible to thoroughly implement (see Patent Document 2, for example). Patent Document 2 discloses a technique in which an IC chip is attached to a medical device (medical device) used for surgery, the number of tools before and after surgery is managed, and misplacement in a patient's body is prevented.

Further, there is also a technique of attaching an RFID to a package and performing physical distribution management with a medical institution as a delivery destination (for example, refer to Patent Document 3).

JP, 7-265394, A JP, 2019-5008, A JP, 2018-116482, A

By the way, in recent years, patient-oriented services have also been emphasized, and there is an increasing demand for using medical equipment suitable for each patient. For example, dialysis patients need to receive continuous maintenance dialysis therapy (hereinafter simply referred to as “dialysis”), but indwelling needles and dialysers for dialysis may be compatible depending on the product, and thus self-dialysis It is desirable to use the one suitable for the physical condition. That is, when performing dialysis, it is desirable that medical equipment suitable for oneself is always prepared. In addition, if disposable medical devices that have been disposed of after each use can be reused a certain number of times, the medical devices that are continuously used can be suppressed, the overall medical cost can be suppressed, and the burden on the individual can also be suppressed. ..

The technique disclosed in Patent Document 1 is an effective technique as a technique for cleaning medical equipment, but is not supported in terms of how to manage each patient, and another technique is required. Was there.

The technique disclosed in Patent Document 2 is efficient in terms of management of medical devices, but basically it is a technique of appropriately performing distribution and storage, so that a patient is associated with a medical device. No consideration was given to the point, and another technique was needed.

The technique disclosed in Patent Document 3 can more continuously monitor the environment in which the luggage is placed during the transportation process. However, as in Patent Document 2, in relation to associating the patient with the medical device, No consideration was given and another technique was needed.

The present invention has been made in view of the above circumstances, and an object thereof is to provide a technique for delivering disposable medical devices in a timely manner without waste in accordance with the usage conditions of patients.

(1) A medical device management system according to the present invention includes a reader/writer that reads and writes information from an IC tag attached to a disposable medical device that is discarded after a single use or a plurality of uses.
A database that records information about the medical device and information about patients using the medical device;
A usage management unit that manages usage of the medical device based on the information of the IC tag;
Equipped with
The medical device is an artificial dialysis medical device or a medical device that is inserted into a blood vessel during a surgical operation .
Medical devices (hereinafter, also referred to as "disposal type medical devices") that are discarded after single use or after multiple uses include medical syringes (injection needles, syringes, indwelling needles for dialysis, etc.), There are dialysers, catheters, infusion tubes, etc. These medical devices are used for patients, and when exposed to body fluids, they are washed or reused after each use or discarded after a certain number of uses. For example, a dialysis patient performs dialysis three times a week, and the indwelling needle and dialyzer for dialysis are optimally selected in consideration of the shunt state and compatibility. In the medical device management system, the usage status of such a medical device is associated with a patient by an IC tag (also referred to as “RFID”) and managed so that a desired medical device can always be used for each patient. More specifically, the usage history is written in the IC tag by a reader/writer each time it is used. For example, the lead writer is provided in the dialysis machine, and the patient (or medical staff) causes the lead writer to read each time the medical device (here, indwelling needle for dialysis) is used. Based on the reading results, the dialysis machine determines whether it is used properly (whether the patient is correct, is an appropriate medical device, has an appropriate number of times of use, etc.), and if it is in an appropriate state , Update usage history. If the use is inappropriate, the user terminal (mobile phone, tablet, smart watch, etc.) or dialysis machine is warned to that effect and the use is discontinued. Since the usage history is updated, the stock status can be grasped, and the dialysis patient can place an order as needed or the system can automatically place an order. The usage history may include the dialysis time (start/end time) in addition to the number of times. Further, when the reader/writer is connected to the user terminal or is integrally configured, the position information may be included in the usage history because the position information can be acquired by the GPS function.

(2) The medical device is an indwelling needle for dialysis,
The lead writer may be attached to the cleaning device for the indwelling dialysis needle, and the history of cleaning the indwelling dialysis needle by the cleaning tool may be reflected in the database.
The indwelling needle for dialysis is composed of a sheath (or cannula) and a puncture needle (or inner needle), and may be all or a part of those components, but a component unit managed by an IC tag is applicable. .. That is, with respect to those that are cleaned and reused, IC tags are attached to each and the cleaning history is recorded and managed in the system side (that is, the database).

(3) The reader/writer may reflect the cleaning history by the cleaning device on the IC tag.
When the recording capacity of the IC tag is sufficient to store the cleaning history, by recording it on the IC tag, reuse can be managed by the device on the patient side (cleaning device here) without referring to the system side. Become.

(4) The medical device is a dialysis indwelling needle,
The lead writer is attached to a dialysis machine that performs dialysis using the medical device,
The lead writer acquires the information of the IC tag when performing the dialysis, and reflects the usage history of the medical device in the database.
When the same indwelling needle for dialysis is reused, the needle tip becomes dull as it is used and becomes unsuitable for use. Therefore, the number of times of use is managed by the information of the IC tag. The upper limit of the number of uses depends on the material and shape of the indwelling needle for dialysis.

The dialysis device may permit dialysis when the usage history of the indwelling needle for dialysis is within a range suitable for reuse.
If the usage history, that is, the number of times of use exceeds the upper limit, do not allow dialysis using the dialysis indwelling needle and use a different dialysis indwelling needle, and the patient (or the medical staff in charge) To that effect. Further, the remaining usable number of times may be displayed on the dialysis machine or the user terminal.

(6) The dialysis device may not permit dialysis when it is determined from the usage history of the dialysis indwelling needle that the dialysis device has not been washed since the last use.
If it has not been washed after the previous use, it is judged that the hygiene condition is not suitable for reuse, dialysis using the dialysis indwelling needle is not permitted, and the patient is advised to use another dialysis indwelling needle. (Or the medical staff in charge) to that effect.

(7) A supply management unit that manages the supply (generally, manufacturing, inventory, and physical distribution) of the medical device based on the information of the IC tag may be provided. That is, when the user's stock of medical devices used by a certain patient becomes low, a predetermined number of the medical devices are shipped in time for the next use.

(8) You may have a user management part which manages the said patient or the medical institution which the said patient uses, and the subscription contract regarding the said medical device.
By knowing the shipping destination (substantially the same as or near the place of use) and the planned number of times of use per week in the subscription contract (subscription contract), the system predicts when the patient is out of stock based on the number of times of use. And, it is possible to automatically optimize distribution to a large number of location areas in the area, and to build optimum distribution (production factory, distribution route, distribution means, etc.).

(9) The present invention provides an indwelling needle for dialysis with an IC tag,
An indwelling needle for dialysis,
An IC tag attached to the indwelling needle for dialysis,
The IC tag records a history of use of the indwelling needle for dialysis by a patient,
The usage history is notified to the medical device management system that manages shipping to the patient.
That is, the information of the IC tag is referred to by the medical device management system of (1) to (8) described above.

According to the present invention, disposable medical devices, such as medical injectors and dialysers, can be managed by IC tags, and can be delivered in a timely and lean manner according to the usage status of the patient.

It is a figure explaining an outline of delivery management of a medical device for dialysis to a dialysis patient by a medical device management system concerning this embodiment. It is a figure explaining an outline of delivery management of a medical device for dialysis to a dialysis patient by a medical device management system concerning this embodiment. It is a figure which shows the single type indwelling needle for dialysis which is an example of the medical device managed by the medical device management system which concerns on this embodiment. It is a figure which shows the example of the dialysis which used the single type indwelling needle for dialysis which concerns on this embodiment. It is a figure which shows another example of the indwelling needle for dialysis with RFID based on this embodiment. It is a block diagram showing a schematic structure of a medical device management system concerning this embodiment. It is a figure which shows the example of the user information (patient information) recorded on user DB based on this embodiment. It is a figure which shows the example of the medical device information recorded on medical device DB based on this embodiment. It is a flowchart of the delivery processing example of the indwelling needle for dialysis which concerns on this embodiment. It is a flowchart which shows the example of a process of reading/writing the use history by RFID of the indwelling needle for dialysis which concerns on this embodiment. It is a flowchart which shows the process example of reading/writing of the washing|cleaning history by RFID of the indwelling needle for dialysis which concerns on this embodiment.

Next, a mode for carrying out the present invention (hereinafter, simply referred to as “embodiment”) will be specifically described with reference to the drawings. First, an outline of this embodiment will be described with reference to FIGS. 1 and 2 show the outline of delivery management of a medical device 80 for dialysis to a dialysis patient 99 by the medical device management system 1 according to this embodiment. In the medical device management system 1, the concept of IoT (Internet of Things) is introduced to the delivery management of the medical device 80 to manage the medical device 80 around the world. Specifically, the dialysis patient 99 enters into a subscription contract for the medical device 80. When concluding a subscription contract, the dialysis patient 99 or the medical institution accesses a predetermined WEB site as described later, and (or under the advice of the medical institution) himself or herself, the desired medical treatment of the desired manufacturer. The device 80 (hereinafter, indwelling needle set 80x for dialysis and dialyzer 80d) is designated. A traceable RFID 81 is attached to the medical device 80 to monitor the usage status of the medical device 80 of the dialysis patient 99, optimize the product inventory, user inventory, and physical distribution of the medical device 80 to eliminate waste. Realize a new type of subscription system that delivers what is said to be as needed and when it is needed. As a result, it is possible to suppress the procurement cost of the medical device 80 in the medical institution as well as the medical cost of the dialysis patient 99 and reduce the manufacturing cost of the manufacturer of the medical device 80. In the present embodiment, among the medical devices used for artificial dialysis, a disposable medical device will be described as a “medical device”, and a medical device of the apparatus will be described as a “medical device”.

The dialysis patient 99 performs dialysis (maintenance hemodialysis therapy) at his/her dialysis facility (hospital) three times a week. A dialysis device 86a is installed as a medical device 86 for artificial dialysis at a place where dialysis is performed (that is, a home or a dialysis facility). The dialysis patient 99 makes regular purchases (subscription contracts) of the indwelling needle set 80x for dialysis and the dialyzer 80d as medical instruments 80 used for dialysis, and these are factory 90 (or warehouse 91) of each manufacturer. Delivered regularly from. The dialysis indwelling needle set 80x is expected to be reused a plurality of times (for example, 5 times) by washing after use. The dialyzer 80d is discarded after each use. The dialysis patient 99 can select the most suitable medical device 80 (dialysis indwelling needle set 80x or dialyzer 80d), and for example, the dialyzer 80d can be a natural membrane type or a synthetic membrane type (further made of polysulfone or polymethylmethacrylate). (Manufactured), the manufacturer can be designated, and the number of needle gauges of the indwelling dialysis needle set 80x can be designated. In recent years, the development of downsizing of the dialysis device 86a has progressed, and a portable small dialysis device has been proposed. Such a compact dialysis machine is suitable as a home dialysis machine, and even for a dialysis patient 99, which has been difficult to introduce in the past from the viewpoint of installation space, apparatus cost, etc., the dialysis machine 86a is installed at home, It becomes more familiar to perform dialysis without going to a dialysis facility. In such a situation, the dialysis patient 99 and the dialysis facility (that is, the medical staff) are regularly delivered to the dialysis patient 99 by delivering the dialysis indwelling needle set 80x and the dialyzer 80d under the subscription contract. ) Can significantly reduce the burden of arranging them.

Here, the medical device management system 1 performs contract management with the dialysis patient 99, manufacturing and delivery management of the medical device 80, and management of use of the medical device 80 by the dialysis patient 99. Specifically, an RFID 81 is attached to the medical device 80, and the RFID 81 is read/written and the management server 10 manages supply (manufacturing/stocking/shipping) and use.

That is, the management server 10 instructs the factory 90 to manufacture and ship the medical device 80 based on the contract content (ordering) with the dialysis patient 99. The factory 90 reports the fact that the medical device 80 with the RFID 81 is manufactured/shipped to the management server 10. The RFID 81 has product information, manufacturing information, a destination user (dialysis patient 99), etc. at the time of manufacturing/shipping. Information is written. When the delivery to the dialysis patient 99 is completed, the information is reflected in the management server 10 by the notification from the delivery company or the received dialysis patient 99.

When the dialysis patient 99 performs dialysis, the user side reader/writer 85 connected to the medical device 86 writes in the RFID 81 (81x, 81d) of the medical device 80 (here, the indwelling needle set 80x and dialyzer 80d for dialysis). It is checked whether or not the dialysis patient 99 has a contract, and it is ready for use (dialysis indwelling needle set 80x is within the upper limit of reuse or dialyzer 80d is new). Is checked.

The check result (that is, use data) is notified to the management server 10 from the user terminal 70 to which the medical device 86 (user-side reader/writer 85) is connected. If it can be used, artificial dialysis is performed by the dialysis device 86a. At this time, the usage history is written in the RFID 81. The read/write control function for the RFID 81 may be installed in the medical device 80 (dialysis device 86a or cleaning device 86b) or the user terminal 70.

In addition, the medical device 86 and the user terminal 70 display the check result and notify the dialysis patient 99 whether or not the use is appropriate. In the case of improper use, a warning is given and the operation is interrupted, and the use of the proper medical device 80 is urged. If the user terminal 70 is a smartphone or a tablet terminal, an application for managing the operation of the medical device 86 and the use history/washing history is introduced, and the user side reader/writer 85 is connected to read/write the RFID 81. May be In this case, the location information acquired by the GPS function of the smartphone or the tablet terminal is associated with the usage history and the like and notified to the management server 10. If the management server 10 is used at a position other than the registered position, the management server 10 can determine that there is a possibility of unauthorized use and confirm with the dialysis patient 99 or the like.

After the artificial dialysis is completed, the reusable dialysis indwelling needle set 80x is washed by the washing device 86b. The user side reader/writer 85 is also attached to the cleaning device 86b, the cleaning history is written in the RFID 81x of the indwelling needle set 80x for dialysis, and the user terminal 70 notifies the management server 10 of that fact.

The management server 10 grasps the user inventory of the dialysis patient 99 based on the usage history and the cleaning history of the medical device 80 remaining in the home (or the dialysis facility) of the dialysis patient 99, and when the user inventory decreases to a predetermined number, Issue manufacturing/shipping instructions to the factory 90.

A specific example of the dialysis indwelling needle set 80x will be described with reference to FIGS. 3 and 4. FIG. 3 is a diagram showing a dialysis indwelling needle set 80 which is a single type dialysis indwelling needle. FIG. 4 is a diagram showing an example of dialysis using the indwelling needle set 80x for dialysis. This dialysis indwelling needle set 80x corresponds to the single needle type (single puncture) indwelling needle previously filed by the applicant of the present application in Japanese Patent Application No. 2019-5804, and will be briefly described.

The dialysis indwelling needle set 80x is composed of three members: a puncture needle 80a, a sheath 80b, and an inner cylinder 80c. In the indwelling needle set 80x for dialysis, the puncture needle 80a, the sheath 80b, and the inner cylinder 80c are attached with RFIDs 81a, 81b, 81c, respectively.

As shown in FIG. 4, when the puncture needle 80a is inserted and integrated from the opening on the left side of the sheath 80b in the figure, the distal end portion of the puncture needle 80a protrudes from the open end of the sheath 80b on the right side in the figure for a predetermined length. In this state, the puncture needle 80a and the sheath 80b are punctured into the blood vessel of the dialysis patient 99 (S1). Subsequently, the puncture needle 80a is pulled out (S2), and instead, the inner cylinder 80c is inserted into the sheath 80b to be integrated (S3). At this time, the tip of the inner cylinder 80c extends a predetermined length (for example, 3 to 5 cm) from the tip of the sheath 80b. Blood purified by the dialysis device 86a (dialyzer 80d) is returned from the tip of the inner cylinder 80c. A space for blood removal is formed between the inner cylinder 80c and the sheath 80b, and the blood removed at the tip of the sheath 80b is sent to the dialyzer 80d. In this way, single-needle type artificial dialysis is performed (S4), and after the dialysis is completed, the dialyzer 80d is discarded and the dialysis indwelling needle set 80x is washed and reused a predetermined number of times.

By adopting such a single needle type indwelling needle set 80x for dialysis, the dialysis patient 99 can be punctured from two locations to one location, and the physical burden can be suppressed. Further, in the recent insurance medical care system, there is a problem that the procurement cost does not decrease at the dialysis facility (hospital), contrary to the downward trend in the insurance points of the medical device 80 (dialysis indwelling needle set 80x). However, also from this viewpoint, the cost can be reduced, and further, by adopting the reuse described later, the procurement cost of the medical device 80 can be surely suppressed.

FIG. 5 shows another example of the dialysis indwelling needles 80e, 80f, 80b to which the RFID 81 is attached.
The indwelling needle 80e for dialysis shown in FIG. 5A shows a state in which the puncture needle 80ea and the sheath 80eb are separated (upper) and a state in which they are integrated (lower). An RFID 81f is attached to the sheath 80eb. The RFID may be attached to the puncture needle 80ea. The indwelling needle 80f for dialysis shown in FIG. 5(b) shows a state in which the puncture needle and the sheath are integrated, and the RFID 81f is attached to the wing portion 80fb extending laterally from the indwelling needle body 80fa (here, the sheath). Has been. In the indwelling needle 80g for dialysis shown in FIG. 5C, the RFID 81g is attached to the branch portion of the Y-shaped clamping 81ga. Generally, these have a structure that they are discarded once, but they can be reused by changing the material and shape of the needle.

FIG. 6 is a block diagram showing a schematic configuration of the medical device management system 1.
The medical device management system 1 includes a management server 10, a user terminal 70, and a medical device 86, and is connected on the network 2.

The medical device 86 has the dialysis device 86a and the washing device 86b used for artificial dialysis of the dialysis patient 99, as described above. A user side reader/writer 85 for reading/writing the RFID 81 attached to the medical device 80 is connected to the medical device 86. The medical device 86 is connected to the management server 10 via the network 2 directly or via the user terminal 70.

The user terminal 70 is, for example, a personal terminal 71 of a dialysis patient 99 or a medical institution terminal 72 of a dialysis facility. When the dialysis patient 99 lives overseas and exports the medical device 86 from Japan, a predetermined agent (agent) may intervene. In such a case, an agent used by the agent as the user terminal 70. A terminal 75 is included. The dialysis patient 99 and the medical institution can make a contract on the WEB using their respective user terminals 70, and can confirm/change the contract contents. In addition, the delivery status of the medical device 80 can be confirmed.

The management server 10 includes an overall device 11, a user management device 20, a medical device management device 30, a physical distribution management device 40, a user DB 51, a medical device DB 52, and a server side reader/writer 55.

The overall device 11 comprehensively manages the management server 10 and controls communication with external devices (here, the user terminal 70 and the medical device 80) via the network 2.

The user management device 20 acquires/updates the content of the subscription contract and manages a user who is a delivery destination of the medical device 80, such as a dialysis patient 99, a dialysis facility, or an agent. That is, the user management device 20 manages contracts of dialysis patients 99 and the like, manages/updates patient information (also referred to as user information and user data), manages/updates user inventory and usage history of the medical device 80 for each dialysis patient 99. I do. The user management device 20 provides a WEB site for concluding, renewing, and confirming a contract with a medical institution or a dialysis patient 99, and the dialysis patient 99 or the like accesses the WEB site to access the contract conditions ( Register the specifications of the indwelling indwelling needle set 80x and dialyzer 80d, the delivery cycle, settlement conditions, etc.) of the subscription target and patient information. The patient information and contract conditions are recorded/updated in the user DB 51. Specific examples of patient information and the like will be described later with reference to FIG. 7.

The medical device management apparatus 30 manages the manufacture of the medical device 80 and the use in the dialysis patient 99. Information of the medical device 80 (also referred to as medical device information or medical device data) is recorded/updated in the medical device DB 52. Also, the dialysis patient 99 registers and manages the medical device 86 (for example, the dialysis device 86a and the cleaning device 86b) when the medical device 80 is used. A specific example of the medical device data will be described later with reference to FIG.

The physical distribution management device 40 manages the manufacturer and supply (manufacturing/shipping/delivery) of the medical device 80. The physical distribution management device 40 also has a function of performing a customs clearance process on the network when the medical device 80 is exported overseas. That is, regarding the delivery of the medical device 80 to the dialysis patient 99 overseas, the customs clearance processing is completed on the network at the stage of shipping from the factory 90 (or the warehouse 91). To this end, NACCS (Nippon Automated Cargo and Port Consolidated System), which is a system for online processing of procedures for customs and other related administrative agencies and related private businesses for ships and aircraft entering and leaving Japan and for import and export By introducing a computerized business system that has an API for linking, an automatic command execution function, and a schedule execution function for routine processing into the management server 10 and digitizing it, not only export procedures but also customs procedures at destinations are simplified. To be done. Also, at this time, by attaching the information written in the RFID 81 to the document relating to the customs clearance procedure, even if the actual item confirmation work occurs due to a sampling inspection or the like, a predetermined reader can confirm and collate the read baggage, which is a wasteful work. It can control the customs clearance smoothly.

The server-side reader/writer 55 is installed in the factory 90 (warehouse 91) or the like, writes predetermined medical device information and patient information in the RFID 81 of the medical device 80 to be shipped, and records the information in the user DB 51 and the medical device DB 52. ..

FIG. 7 is a diagram showing an example of the patient information D10 recorded in the user DB 51. The user information D10 includes basic user information D11, contract information D12, and history information D13.

As the user basic information D11, an ID, a name, an authentication means, an address, a telephone, an electronic mail address, a payment means, and a delivery destination are recorded. Here, the ID is “01234abc”, the name of the dialysis patient 99 is “XXXXX”, the authentication means is the password “XXXXXXX”, the address is “Naha City, Okinawa Prefecture, Japan”, and the telephone number is "098-866-xxxx", e-mail address is "abcd1234xxx@xxx.xx.jp", delivery address is "Naha City, Okinawa Prefecture 〇○ (home)", payment method is bank settlement "○〇Bank account number xxx- yyy...”.

As the contract information D12, what kind of medical device 80 is regularly purchased is recorded. Here, the "reuse type A dialysis performed three times a week" type is selected as the dialysis set. In this reuse type A, a single indwelling needle set (TYPE: A123, manufacturer: A company) and a dialyzer (TYPE: D001, manufacturer: D company) are contracted. The reuse type A single indwelling needle set corresponds to the dialysis indwelling needle set 80x (puncture needle 80a, sheath 80b, inner cylinder 80c) shown in FIGS. 3 and 4. The contract information D12 may also include the delivery timing (delivery day), the number of users in stock, and the like.

In the history information D13, regarding the medical device 80 shipped to the dialysis patient 99, the status at the factory 90 (warehouse 91), the distribution status, and the user status after the delivery to the dialysis patient 99, which is the user, are individually indicated. The medical device 80 is recorded. Here, for example, the puncture needle 80a with the management number "A12345-01-1", the sheath 80b with the management number "A12345-02-1", and the management number "A12345-" that constitute the reused indwelling needle set 80x for dialysis. Regarding the inner cylinder 80c of "03-1", factory status "shipping 3/30", physical distribution status "4/2 delivery", user status use date and time "5/1 18:30-22:30, 5/3 18: 45-22:45, 5/5 20:00-24:00" and the cleaning date and time "5/1 22:45-, 5/3 23:00-, 5/6 00:15-". The expiration date (date) is recorded under the control number, and it is managed so that it cannot be used beyond this expiration date. The puncture needle 80a with the management number "A12345-01-1" has an expiration date of "2019/06/30", and the dialysis indwelling needle set 80x of the medical device 86 is "2019/07" by sensing the RFID 81. It is controlled so that it cannot be used after "/01".

FIG. 8 is a diagram showing an example of medical device information recorded in the medical device DB 52. The management number, expiration date, factory status, distribution status, contract patient user ID, and user status are recorded in the medical device DB 52 for each type of product. Here, the indwelling needle set 80x for dialysis is shown. The medical device 80 (inner needle 80a) of A12346-01-1 has the factory status “4/1 shipment”, the physical distribution status “4/3 delivery”, and the user ID “9321uvw”. The user status is the date and time of use "4/15 13:30-17:30, 4/17 14:45-18:45, 4/19 14:00-18:00, 4/22 14:15-18. :15, 4/24 14:00-18:00", and the cleaning date/time is "4/15, 4/17, 4/19, 4/22". In this case, 5 days are recorded as the status of the usage day. Here, assuming that the upper limit of use of the indwelling needle set 80x for dialysis is 5 times, from this record, the management number. It can be seen that the medical device 80 (inner needle 80a) of A12346-01-1 has been discarded because it exceeded the upper limit of use.

FIG. 9 is a flowchart of a delivery processing example of the indwelling needle set 80x for dialysis. The user management device 20 refers to the user DB 51 and checks the usage status of the medical device 80 by the dialysis patient 99 who is the user once/day (S11). The user management device 20 determines whether it is the timing to manufacture the medical device 80 based on the usage status (S12), and if it is the manufacturing timing (Yes in S12), manufacture of the medical device 80 corresponding to the manufacturing timing. Processing is performed (S13).

After the manufacturing process (S13) or when it is not the manufacturing timing (No in S12), the user management device 20 determines whether it is the delivery timing (S14). If it is the delivery timing (Yes in S14), the corresponding medical device 80 is delivered to the destination of the contracted dialysis patient 99 (S15). After the delivery, the physical distribution status is checked, and when the dialysis patient 99 is notified of the delivery, the delivery completion processing is performed and the delivery status is set (S16).

FIG. 10 is a flowchart showing a processing example of reading/writing the usage history by the RFID 81x of the indwelling needle set 80x for dialysis. When the dialysis patient 99 uses the indwelling needle set 80x for dialysis, the dialysis device 86a reads the RFID 81x of the indwelling needle set 80x for dialysis with the connected user-side reader/writer 85 (S21), the number of times of use and use. The deadline is checked (S22). At this time, user verification may be performed to determine whether or not the user is an appropriate user.

If it is within the expiration date and the number of times of use is within the predetermined limit (Yes in S23), the dialysis device 86a writes the usage history in the RFID 81x with the user side reader/writer 85 (S24), and the management server 10 via the network 2. (S25). In the management server 10, the usage history is reflected in the user DB 51.

When the expiration date or the number of times of use exceeds the limit (No in S23), the dialysis device 86a warns that effect and uses another dialysis indwelling needle set 80x (S26). At this time, as a general rule, the dialysis indwelling needle set 80x that received the warning cannot be used. Further, even when it can be determined from the usage history and the cleaning history that the cleaning device 86b has not performed cleaning after the previous use, a warning may be issued to use another dialysis indwelling needle set 80x.

FIG. 11 is a flowchart showing a processing example of reading/writing the cleaning history by the RFID 81x of the indwelling needle set 80x for dialysis.

The dialysis patient 99 cleans the dialysis indwelling needle set 80x used after the artificial dialysis with the cleaning device 86b. When the dialysis indwelling needle set 80x is set on the cleaning device 86b, the cleaning device 86b reads the RFID 81x of the dialysis indwelling needle set 80x (S31) and checks the number of times of use (S32). If it is within the use upper limit (No in S33), the cleaning device 86b performs the cleaning process (S34), writes the cleaning history in the RFID 81x (S35), and notifies the management server 10 (S36). When it exceeds the upper limit of use (Yes in S33), a warning lamp or a display display notifies the user to discard the dialysis indwelling needle set 80x (S37). When a plurality of dialysis indwelling needle sets 80x are simultaneously washed with the same cleaning device 86b in a dialysis facility or the like, it may be notified which dialysis indwelling needle set 80x is to be discarded.

As described above, in the medical device management system 1 according to the present embodiment, the concept of IoT (Internet of Things) is introduced in the delivery management of the medical device 80, and the RFID 81 having traceability is attached to the medical device 80 to provide medical treatment for the dialysis patient 99. According to the usage status of the device 80, the product inventory, user inventory, and physical distribution of the medical device 80 are predicted and optimized, waste is eliminated, and what is needed is delivered as much as needed and when needed. As a result, the following advantages can be obtained for the dialysis patient 99, medical institutions, and medical device manufacturers.
(1) Merits of dialysis patient 99 The dialysis patient 99 manages his/her own dialysis indwelling needle set 80x to be reused by himself, so that the medical device management system 1 can ensure safety even with a reuse needle. Specifically, since the usage history and the cleaning history can be properly grasped by the medical device 80 with the RFID 81, the medical device 80 which has been conventionally assumed to be disposable can be reused. In particular, in the conventional reuse, there is a concern that an infection may occur due to reuse of the medical device 80 used by another person, but the dialysis patient 99 does not reuse the medical device 80 of another person and use the medical device 80 of another person. Therefore, such concerns have been dispelled. In addition, it is possible to conclude a contract that ensures delivery and never use fake needles. Further, by using the optimum indwelling needle set 80x for dialysis, deterioration of the shunt of the dialysis patient 99 can be suppressed and the number of blood vessel repairs can be reduced. This can significantly reduce the physical burden on the dialysis patient 99 and can avoid the cost of health insurance due to the repair.
(2) Merits of medical device manufacturers In the past, medical device manufacturers, in principle, do not participate in the next order once they have delivered. In the meantime, in practice, medical institutions do not always use medical instruments that have an expiration date before the expiration date. In some cases, it expires and is discarded. The system will be able to manage up to the point where the medical device manufacturer disposes it without using it. In other words, (a) the system knows what the expiration date is approaching, prompts the medical institution to respond to it, and suppress waste. It becomes easy to control not to discard according to the number of delivered items and the usage situation of the customer, which allows the production side to control the production amount. As a result, raw material procurement costs and factory operating costs can be suppressed. (B) Planned production will be performed at the factory because a subscription contract can be made with patients and medical institutions. In the medical industry, due to its characteristics (that is, from the viewpoint of patient needs, ordering/stocking at medical institutions, ordering/manufacturing from manufacturers, etc.), products such as contact lenses and supplements that are commoditized are available. Other than that, it has been considered unfamiliar with medical device 80 subscription contracts in the medical industry. In particular, a subscription contract in which a patient (here, a dialysis patient 99) is involved in a medical action (medical process), in other words, a contract for a medical device 80 for use in a medical action is not assumed. However, from the usage status (including the number of times) of the medical device 80 (for example, the above-mentioned dialysis indwelling needle set 80x) to which the subscription contract is applied, and the status management of the medical device 80 from the usage status and the cleaning status (the dialysis indwelling device with the RFID 81 is used). The medical device management system 1 manages three points, that is, the state of the needle tip of the needle set 80x) and the contract status, so that management after production and shipping can be grasped as a whole from the contract content. As a result, in the factory 90, it is possible to greatly improve efficiency and reduce costs, including production amount adjustment and planning in production, raw material procurement cost and planning, inventory management, and personnel cost in production. In addition, a detailed annual production schedule can be planned, leading to stable operation of the factory. In addition, as the number of contractors increases, the number of shipments will increase quantitatively, and the plant operation plan will significantly improve profits. That is, the scheduled precision of quantitative production is increased by the subscription contract of the medical device 80, and the number of times of use of the dialysis patient 99 is counted by using the management server 10, whereby the final production/inventory adjustment and the like can be made precise. ..
(3) Benefits of medical institutions Procurement costs can be reduced by subscription contracts and reuse. When the medical fee system for public health insurance is applied, the conditions for requesting medical fee may be constrained and the amount that can be charged may be suppressed, which may cause an increase in cost and an appropriate profit cannot be obtained. There were cases. However, by controlling the amount of procurement and simplifying the procurement method, it not only reduces the cost of the product itself but also the human rights cost for managing it. In addition, it is possible to reduce waste of items that have been discarded due to excess inventory or expiration date.

The present invention has been described above based on the embodiment. It should be understood by those skilled in the art that this embodiment is an exemplification, that various modifications can be made to the combination of the respective constituent elements, and that such modifications are within the scope of the present invention. For example, the usage history and the cleaning history are written in the RFID 81 (81x) of the medical device 80 (dialysis indwelling needle set 80x), but are recorded in the user terminal 70 or the management server 10 and are not written in the RFID 81 of the medical device 80. You may do it. In addition, as the medical device 80, a needle (for example, a Huber needle) which is a kind of central venous catheter and is used for the treatment of puncturing a subcutaneously implantable port (CV port) and supplying a drug (anticancer drug or the like) is also applied. it can. Since the Huber needle can be inserted and punctured by a dialysis patient 99 and his/her family under the guidance of a doctor, by applying the subscription contract as described above and managing the number of times of use with the RFID 81, the medical device 80 (here In this way, it is possible to reduce the trouble of arranging Huber needles, and to maintain good hygiene and reduce the risk of infectious diseases.

1 Medical Device Management System 2 Network 10 Management Server 20 User Management Device 30 Medical Device Management Device 40 Physical Distribution Management Device (Supply Management Unit)
70 user terminal 71 personal terminal 72 medical institution terminal 75 agent terminal 80 medical device 80a puncture needle 80b sheath 80c inner cylinder 80d dialyzer 80e, 80f, 80g dialysis indwelling needle 80x dialysis indwelling needle set 81, 81a to 81g, 81x RFID (IC tag)
85 User side reader/writer 86 Medical device 86a Dialysis device 86b Cleaning device 90 Factory 91 Warehouse

Claims (7)

A reader/writer that reads and writes information from the IC tag attached to the indwelling needle for dialysis ,
A database for recording patient information using the information and the indwelling needle the dialysis of the dialysis indwelling needle,
A use management unit that manages the use of the indwelling needle for dialysis based on the information of the IC tag,
Equipped with
The medical device management system , wherein the lead writer is attached to the dialysis indwelling needle cleaning device, and the cleaning history of the dialysis indwelling needle by the cleaning device is reflected in the database . The said lead writer is attached to the washing|cleaning apparatus of the said dialysis indwelling needle, and the washing|cleaning history of the said dialysis indwelling needle by the said washing|cleaning apparatus is reflected on the said IC tag, The claim 1 characterized by the above-mentioned. Medical management system. The lead/writer is attached to a dialysis device that performs dialysis using the dialysis indwelling needle, acquires information on the IC tag when performing the dialysis, and records the usage history of the dialysis indwelling needle. The medical device management system according to claim 1, which is reflected in a database . The medical device management system according to claim 3 , wherein the dialysis device permits dialysis when the usage history of the indwelling needle for dialysis is within a range suitable for reuse . The medical device management according to claim 4 , wherein the dialysis device does not permit dialysis when it is determined from the usage history and the cleaning history of the indwelling needle for dialysis that it has not been cleaned since the last use. system. The medical device management system according to claim 1 , further comprising a supply management unit that manages the supply of the indwelling needle for dialysis based on the information of the IC tag . The medical device management system according to claim 6 , further comprising a user management unit that manages the patient or a medical institution used by the patient and a subscription contract regarding the indwelling needle for dialysis .

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