JPH09642A - Code mark provided medical tool for implantation and management system therefor - Google Patents

Abstract

PURPOSE: To enable the confirmation of necessary data by providing an implantation type medical appliance with identification code markings which are referred to the relevant data stored at a different location. CONSTITUTION: A manufacturer 3 provides an implantation type cardiac pacemaker 1 with necessary data using 2-dimensional symbol data codes 2, inputs into a host computer of a data center 7 the information carried by the 2-dimensional symbol data codes 2 and other information separately stored in a computer. A channeler 4 who has bought the cardiac pacemaker 1 reads the 2-dimensional symbol data codes 2 for the estabishment of the identification of the pacemaker 1 and inputs into the host computer of the data center 7 some specified information relevant to the identity of the pacemaker 1. At a medical organization 5, the 2-dimensional symbol data codes 2 are read from the pacemaker 1 for the establishment of its identification and some specified information corresponding to its identity is inputted into the host computer of the data center 7.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a management system for medical devices that are directly implanted in the body and used by attaching an identification code mark to each individual, and manufacturing or distributing each individual. By recording the necessary information at each stage, it is possible to easily track the individual from the user (patient) side as well as from the manufacturer or the administration side as needed. is there.

[0002]

2. Description of the Related Art In recent years, medical devices which are implanted in the body and are directly related to life support have been widely used. For example, there are implantable cardiac pacemakers and artificial heart valves, which are manufactured using advanced electronic technology and technology.

Since such a thing is directly related to life support, if a manufacturing defect is discovered or a failure occurs after the start of use, it is necessary to take immediate action, especially for the user ( It is necessary to take appropriate measures for patients) as soon as possible.

That is, when a manufacturer discovers a defect at the manufacturing stage, the information needs to be promptly transmitted to the medical field and the user (patient). In addition, when a failure occurs in a medical device of a user (patient), the details of the failure are fed back from the medical field to the manufacturer or the administration, and appropriate for patients using the same type of medical device. Attention should be paid to take action.

However, in the past, individual medical devices have not been integrated and managed from the manufacturing process to the use. Therefore, when a defect is found in a certain medical device, the medical device is used. The information was not immediately communicated to the patient.

Further, when a failure is found in a medical device used by a patient, it is considered that the same kind of medical device is used because no identification mark is attached to the medical device. The appropriate information was not communicated to other patients and necessary measures were not taken.

[0007]

That is, since these medical devices are finally implanted and used in the patient's body, they are used in the unpacked state as the usage pattern of the product. It will be. Therefore, the information written on the packaging is no longer present.

[0008] In general, information on a product, such as a manufacturer name, a manufacturing number, or a lot number, is written on the package of the product, and the product can be identified by these information. In addition, for general products, it is possible to attach a label containing such information to the product itself, which is widely used.

[0009] However, in the case of a medical device to be used by implanting it in the body, implanting a medical device with a label attached thereto has a problem in ensuring safety and is insufficient in terms of durability. Moreover, if all necessary information is written on the label, the label becomes large and cannot be attached to a small medical device.

On the other hand, there is a method of engraving a product number or the like instead of attaching a label, but it is difficult for a manufacturer to manage the product number for a long period of time, and it is difficult to replace an agent with an imported product. The location of care becomes unclear, and it is impossible to identify the medical device only by the product number and it is impossible to extract necessary information.

[0011]

[Means for Solving the Problems] That is, instead of attaching a label in which necessary information is written to the medical device itself,
By marking the medical device itself with a code mark that can identify it, and by including the minimum necessary information in this code mark and recording other information separately, this marking and recording will be performed. It is possible to confirm necessary and sufficient information by referring to it.

In addition, the necessary information is manufactured, distributed,
If it is recorded at each stage of medical treatment, necessary information can be surely retrieved by reading and referring to this code mark when the medical device is taken out of the patient's body even after being implanted in the patient. Become. Then, it becomes possible to feed back necessary information to relevant parts.

Since this marking is a medical device to be implanted in the patient's body, from the viewpoint of safety and durability,
It should be non-toxic, not obscured by aging, and have excellent corrosion resistance. In addition, it is desirable that the code mark be as small as possible so that it can be displayed on a small medical device.

Therefore, the medical device for implanting a body with a code mark according to the present invention is a medical device for implanting a body in which a code mark for identifying the individual is marked (claim 1).

Further, in the management system for medical devices for internal implantation according to the present invention, the medical device for internal implantation marked with an individual identification code mark is manufactured, distributed, and manufactured in various stages from medical production to use. Then, the marked individual identification code mark is read to identify the individual, the necessary information is recorded at each stage for each individual (Claim 2), and the information at each stage is integrated into a computer. (Claim 3).

Alternatively, in addition to the computer unification of the above information, after implanting a medical device for implanting a body with a code mark into a patient, depending on the situation, the medical device for implanting the body can be taken out of the body or left with the code mark. By reading, the medical device for implanting in the body can be identified (Claim 4), and manufacturing, distribution, medical care, government, and other countries are required through a computer that centralizes the state of the identified medical device for implanting in the body. Feedback is given to the place where it seems to be (claim 5).

[0017]

[Function] A code mark is marked on a medical device for implantation in the body. As the code mark to be used, for example,
A bar code format generally used conventionally can be used. When a code mark for optical reading is used, a two-dimensional symbol data code (see, for example, US Pat. No. 4,939,534) can be used to write a necessary and sufficient amount of information in a very small area. When using this two-dimensional symbol data code, it is desirable to engrave the symbol by laser processing in order to enhance the durability of the symbol.

At the time of manufacture, the manufacturer marks a code mark unique to each medical device. The code mark includes the product name, manufacturer, model number, manufacturing lot number, etc. of the marked product, and these information can be read directly by reading the code mark. Alternatively, the code mark only identifies the medical device, and the necessary information is recorded by inputting it into a computer etc. separately so that the corresponding information can be retrieved from the computer by reading and inputting the code mark. You may leave it.

Then, a medical device marked with such a unique code mark is required for each individual medical device identified by the code mark at the subsequent distribution stage (including importers and retail stores) or in the medical field. To record information. For example, when the code mark is read by a reading device and the identified item is in the distribution stage, the purchaser and the date of sale are input to the computer and the patient name, hospital name, etc. are input to the computer and recorded. I'll do it. Then, by reading and inputting the code mark, the corresponding information can be retrieved from the computer.

Further, by centralizing the records of manufacturing, distribution, medical treatment, etc. in the host computer, necessary information can be confirmed from various places when necessary, and necessary information can be transmitted to various places. You will be able to.

After implantation in the patient,
The necessary information can be taken out by taking out the medical device from the patient's body, or by reading this code mark by an appropriate method without identifying the medical device and identifying the medical device in use, and referring to the computer. And
When a failure or the like is found, necessary information can be fed back to the relevant organization, and this information can be transmitted to other medical institutions or the like.

[0022]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of a medical device for implanting with a code mark according to the present invention and a management system for a medical device for implanting in a body according to the present invention will be described with reference to the drawings.

FIG. 1 shows an implantable cardiac pacemaker 1 marked with a two-dimensional symbol data code 2 as an example of a medical device for implanting a body with a code mark.

The information recorded in the two-dimensional symbol data code 2 includes a product name, a manufacturer, a standard number (model number), a production lot number, a unique ID number, a component and material of a tool, a production date, a permission year. Record the date, warranty period, etc. as information. Alternatively, only the unique ID number necessary for identifying the product may be recorded as the two-dimensional symbol data code 2, and other information may be recorded in the computer.

As a medical device for implantation in the body, an implantable cardiac pacemaker and a lead wire, an implantable defibrillator and its lead wire, an artificial heart valve and an artificial heart valve annulus, an artificial blood vessel (as a device directly related to the maintenance of life). Those used for thoracic aorta, etc.). There are also implants and bolts and nuts that are not directly related to life support.

Next, the management system of the medical device for implantation in the body will be explained based on the system conceptual diagram of FIG. In the figure, 3 is a manufacturer, 4 is a distributor, 5 is a medical institution, 6 is a patient, and 7 is an information center having a host computer. When the manufacturer 3 is overseas, the distributor 4 includes an importer. The distributor 4 includes both wholesalers and retailers. The information center 7 may be a public institution or a trade association.

First, as described above, the manufacturer marks necessary information on the implantable cardiac pacemaker 1 with the two-dimensional symbol data code 2.
In addition, other necessary information, which is not described in the two-dimensional symbol data code 2, is separately input to the computer. Then, the information of the two-dimensional symbol data code 2 and the information input to the computer are input to the host computer of the information center 7.

Next, the distributor 4 who purchased this cardiac pacemaker 1 reads the two-dimensional symbol data code 2 of the cardiac pacemaker 1, identifies this individual, and records the specific information corresponding to this. As the information, for example, the date of purchase, the date of sale, the purchase destination, the sale destination, etc. are recorded. As a recording method, it is desirable to input the result of reading the two-dimensional symbol data code 2 into the computer at the same time as the reading result, but it is also possible to enter it in a recording ledger or the like. Also, the information input to this computer is input to the host computer of the information center 7.

Then, in the medical institution 5, the two-dimensional symbol data code 2 of the cardiac pacemaker 1 is read, the individual is identified, and the specific information corresponding thereto is recorded. As the information, for example, patient attributes (patient name, date of birth, address, contact information, etc.), hospital institution information (hospital name, medical department, attending doctor, contact information, etc.), date of implementation, etc. are recorded. As a recording method, it is desirable to input the result of reading the two-dimensional symbol data code 2 into the computer at the same time as the reading result, but it is also possible to enter it in a recording ledger or the like. Also, the information input to this computer is input to the host computer of the information center 7.

By recording the necessary information at each stage in this manner, the information that is unique to the individual can be searched for the host computer of the information center 7 so that the organization that needs the information can easily and quickly. Also, you will be able to get accurate information. Further, the information center 7 can quickly transmit necessary information to necessary related organizations.

In particular, after implantation in a patient, the medical instrument can be directly identified by reading the code mark marked on the medical instrument implanted in the body, and there is no room for error in the information result. Then, by feeding back the information to the information center 7, the necessary information can be transmitted to the manufacturer and patients using the same kind.

On the other hand, when a manufacturer of a medical device notices a product defect and recalls the product, the final user (patient) of the medical device having the defect can be detected without omission, and those persons can be detected. Necessary measures will be taken promptly.

[0033]

As described above, according to the medical device for implanting a body with a code mark according to the present invention, the medical device for implanting a body is marked with a code mark for identifying the individual. The individual can be identified only by reading the code mark of itself, and the read contents are correct.
In addition, by using the two-dimensional symbol data code, it is possible to write necessary information even for a small medical device.

Further, according to the management system of the medical device for internal implantation according to the present invention, the medical device for internal implantation marked with the individual identification code mark is manufactured, manufactured, distributed, and used for manufacturing products such as medical products. At each stage, the marked individual identification code mark was read to identify that individual, the information required at each stage was recorded for each individual, and the information at each of these stages was integrated into a computer. Therefore, by recording the necessary information at each stage corresponding to one identification code mark, it is possible to record all the information peculiar to that individual, and refer to the computer for these information. Can be more easily confirmed and transmitted to others

Further, in addition to the computer unification of the above information, after the implantable medical device with a code mark is implanted in a patient, the code mark is taken out of the body or left embedded in the body depending on the situation. By reading the, it becomes possible to identify the medical device for internal implantation, through a computer that centralizes the state of the identified medical device for internal implantation,
Since feedback is provided to places where manufacturing, distribution, medical care, government, and other countries are considered necessary, medical devices implanted in patients can be reliably identified, and patients using such medical devices can also be identified. However, necessary information will be promptly and accurately transmitted, and defect information, failure information, etc. will be surely contacted to necessary organizations and necessary measures will be taken.

[Brief description of drawings]

FIG. 1 is a plan view showing a cardiac pacemaker marked with a two-dimensional symbol data code as an example of a medical device for implanting a code mark according to the present invention.

FIG. 2 is a conceptual block diagram showing a management system of a medical device for implanting according to the present invention.

[Explanation of symbols]

 1 Cardiac Pacemaker 2 2D Symbol Data Code 3 Manufacturer 4 Distributor 5 Medical Institution 6 Patient 7 Information Center

Claims (5)

[Claims] 1. A medical device for implanting a body with a code mark, wherein a code mark for identifying the individual is marked on the device for implanting a body. 2. A medical device for implantation in a body, which is marked with a code mark for individual identification, is read at each stage of manufacturing, distribution, medical treatment, and the like from the production of products to the use, and the read code mark for individual identification is read. A management system for medical devices for implantation in a body, which is characterized by identifying an individual and recording necessary information at each stage for each individual. 3. A medical device for implantation in a body, which is marked with an individual identification code mark, is read at each stage of manufacturing, distribution, medical treatment, and the like from the production of a product to its use, and the individual identification code mark is read. Identify the individual,
A management system for medical devices for implantation in a body, wherein necessary information is recorded at each stage for each individual and information at each stage is unified in a computer. 4. A medical device for implantation in a body, which is marked with a code mark for individual identification, is read by reading the code mark for individual identification marked at each stage from manufacturing, distribution, medical product production to use. Identify the individual,
Record the necessary information at each stage for each individual, centralize the information at these stages in a computer, and after implanting the medical device for implanting with a code mark in the patient, implant it according to the situation A management system for an implantable medical device, wherein the implantable medical device can be identified by reading the code mark while the medical device is taken out of the body or embedded in the body. 5. A medical device for implanting in a body, which is marked with an individual identification code mark, is read at each stage of manufacturing, distribution, medical treatment, and other steps from the production to the use of the marked individual identification code mark. Identify the individual,
Record the necessary information at each stage for each individual, centralize the information at these stages in a computer, and after implanting the medical device for implanting with a code mark in the patient, implant it according to the situation By reading the code mark while the medical device is taken out of the body or embedded in the body, the medical device for implantation in the body can be identified, and the state of the identified medical device for implantation in the body is integrated through a computer to manufacture, A management system for implantable medical devices characterized by providing feedback to places deemed necessary such as distribution, medical care, government, and other countries.