JP2006271461A - Method of manufacturing medical instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a sterilized medical instrument with an IC tag (RFID). <P>SOLUTION: The method of manufacturing the medical instrument is characterized by a process of attaching the IC tag to a syringe, a first sterilization process for sterilizing the syringe with the IC tag, a process for aseptically filling the syringe with a medicament, a process for wrapping the syringe in a pack, a process for sterilizing the syringe wrapped in the pack with high pressure steam or ethylene oxide gas as a second sterilization process under a prescribed condition, and a process for writing information in the IC tag. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

The present invention relates to a method for manufacturing a medical device provided with an IC tag (RFID), and more particularly to a manufacturing method including a sterilization step in the final step of the medical device. Here, the medical device is a sterilizable disposable medical device or a reusable medical device.

Conventionally, medical instruments equipped with barcodes have been widely used as identification means for storing various types of information. In manufacturing Mäger, these are sterilized by high-pressure steam sterilization, ethylene oxide gas (EOG) sterilization, γ-ray sterilization, electronic Wire sterilization is applied.

By the way, the barcode has a limit in the amount of information for storing the identification information. On the other hand, an IC tag (RFID) currently stores a virtually infinite amount of information (about 32 digits) and is useful for preventing medical errors. However, the IC tag does not function normally due to sterilization. There is a problem that an IC tag cannot be provided in a medical instrument that requires sterilization. In order to solve this problem, an RFID that can be sterilized by high-pressure steam by providing a heat-resistant protective material having a heat-resistant temperature of 160 ° C. and a maximum of 10 hours has been proposed (Patent Document 1: Japanese Patent Application Laid-Open No. 2003-111172).
JP 2003-111772 A

However, although the above publication relates to a surgical instrument management system and discloses a heat-resistant temperature and a heat-resistant time, there is no disclosure about pressure conditions for high-pressure steam sterilization. In addition, no mention is made of ethylene oxide gas (EOG) sterilization. Further, there is no mention of sterilizing a storage container (syringe or the like) equipped with an IC tag in a state where a medicine is stored.

The present invention has been made in view of the above problems, and an object of the present invention is to provide a novel method for manufacturing a medical instrument provided with an IC tag (RFID).

In order to achieve the above object, a method for producing a medical device of the present invention includes a step of providing an IC tag in a syringe, a first sterilization step of sterilizing a syringe provided with an IC tag, The step of filling the medicine, the step of surrounding the syringe in the pack, the step of performing high-pressure steam sterilization or ethylene oxide gas sterilization as the second sterilization under a predetermined condition in the state surrounded by the pack, and information on the IC tag And a step of writing. Further, the high-pressure steam sterilization is performed at a predetermined temperature (° C.) and a predetermined pressure (Pa) for a predetermined time (minute). In addition, ethylene oxide gas sterilization is characterized in that it is performed for a predetermined time (minutes) at a predetermined temperature (° C.) and a predetermined pressure (Pa). A first sterilization step of sterilizing the syringe provided with the IC tag, a step of aseptically filling the syringe with a medicine, a step of surrounding the syringe in a pack, and a predetermined condition in a state surrounded by the pack The second sterilization comprises a step of performing high-pressure steam sterilization or ethylene oxide gas sterilization.

Moreover, the manufacturing method of the syringe filled with the chemical | medical agent of this invention is a manufacturing method of the medical device provided with the IC tag, Comprising: The process of providing an IC tag in a medical device, The process of surrounding a medical device in a pack And a step of performing high-pressure steam sterilization or ethylene oxide gas sterilization under a predetermined condition in a state surrounded by a pack, and a step of writing information on the IC tag. A method of manufacturing a medical device including an IC tag in which information is written in advance, the step of providing the IC tag in the medical device, the step of surrounding the medical device in a pack, and the state of being surrounded by the pack The method comprises a step of performing high-pressure steam sterilization or ethylene oxide gas sterilization under predetermined conditions, and a step of writing information in an IC tag. Further, the high-pressure steam sterilization is performed at a predetermined temperature (° C.) and a predetermined pressure (Pa) for a predetermined time (minute). The ethylene oxide gas sterilization is performed at a predetermined temperature (° C.) and a predetermined pressure (Pa) for a predetermined time (minutes). The medical instrument is a medical needle, syringe, catheter, blood sampling instrument. , An infusion set, and / or an infusion tube.

  According to the method for manufacturing a medical device of the present invention, information stored in an IC tag (RFID) is not defective, and much more information than a barcode (type of medical device, manufacturer name, filling Can be stored in the hospital where it is used, and it can be used with the user (nurse), attending physician, patient, ward, etc., and can be easily confirmed by accessing the host computer in the hospital. This makes it easier to manage medical devices and medicines, leading to prevention of medical errors.

  Hereinafter, the present invention will be described based on examples.

<Example 1>
A syringe filled with a medicine will be described as an example of a medical instrument. Hereinafter, a preferred embodiment of the present invention will be described based on the drawings. As shown in the sectional view of FIG. 1, the pre-filled syringe 1 includes an outer cylinder 2, a cap 3, a gasket 4, and a pusher 11. A nozzle 6 is provided on one end side 5 (left side in the illustrated example) of the outer cylinder 2, and an open end 8 is formed on the other end side 7 (right side in the illustrated example) of the outer cylinder 2. The prefilled syringe 1 has the outer tube 2 filled with the chemical 9 from the open end 8, the nozzle 6 on one end side 5 of the outer tube 2 is sealed with the cap 3, and the open end 8 is a gasket. 4 is provided.

The outer cylinder 2 is made of a plastic such as a thermoplastic resin (sometimes made of glass). The IC tag (RFID) 10 is provided by embedding, pasting, or the like at any appropriate position on either or both of the outer cylinder 2 and the flange portion 11a of the pusher 11. The outer cylinder 2 is formed of a transparent or translucent material, preferably a material having low oxygen permeability and water vapor permeability. Examples of the material for forming the outer cylinder 2 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyester and cyclic polyolefin can be used, and among them, resins such as polypropylene and cyclic polyolefin are preferable because they are easy to mold and have heat resistance. As a material of the gasket 4, a known material conventionally used for a gasket for a syringe can be used. Examples thereof include rubber, elastomer, polyolefin resin, fluorine resin, and polyester resin. As the rubber, for example, natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber are preferable, and vulcanized rubber is particularly preferable. As the elastomer, for example, a polyvinyl chloride elastomer, a polyolefin elastomer, a styrene elastomer, a polyester elastomer, a polyamide elastomer, a polyurethane elastomer, and a mixture thereof are preferable. Among the above rubbers and elastomers, styrene-butadiene rubber, butyl rubber, and styrene elastomers are particularly preferable because they have suitable hardness and elastic properties and can be sterilized by high-pressure steam. Further, as the polyolefin resin, for example, polypropylene, poly (4-methylpentene-1) and cyclic polyolefin are preferable, and as the fluorine resin, for example, polytetrafluoroethylene, tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer Polymers, tetrafluoroethylene / hexafluoropropylene copolymers are preferred, and polyester resins are preferably, for example, polyethylene phthalate, polyethylene naphthalate, and amorphous arylate, which have a glass transition point of 110 ° C. or higher, or a melting point. It is the material which has. Among the above polyolefin resins, fluorine resins, and polyester resins, polypropylene, poly (4-methylpentene-1), cyclic polyolefin, and polyethylene naphthalate are less likely to absorb and absorb drugs and can be sterilized under high pressure steam. It is preferable because of its excellent thermoformability.

The IC tag (RFID) 10 includes a syringe manufacturer name, a syringe outer diameter, a friction coefficient between the outer cylinder 2 and the gasket 4, drug data relating to a drug (drug identification data such as drug name and drug identification data, drug identification code, etc. Drug identification data such as drug identification data, standard drug code, standard drug number (serial number, etc.), upper limit / limit value of injection speed, etc.), production lot number, sterilization condition (first sterilization condition / 2) Sterilization conditions, etc.) areas where hospitals (users) store non-rewritable data, arbitrary numbers, codes, physicians in charge, physician codes in charge, patient names, patient codes, etc. Is provided with an area for recording rewritable data. Reading information (data) stored in these IC tags includes an electromagnetic coupling (electromagnetic induction) method, a microwave (radio wave) method, and an optical method for reading information on the IC tag. A coupling (electromagnetic induction) method is used, and a frequency of 13.56 MHz (readable range: 0 to 70 cm) or 125 KHz (readable range: 0 to 100 cm) is used.

An injection needle (not shown) can be attached to the nozzle 6 provided on one end side 5 of the outer cylinder 2. For this reason, on the outer surface of the nozzle 6, for example, a screw groove (not shown) for mounting the injection needle may be formed. The cap 3 and the gasket 4 are made of an appropriate elastic material such as rubber or elastic plastic. For example, a ring-shaped groove or the like may be formed on the peripheral surface of the gasket 4 in order to improve the sealing performance after sealing and sterilizing the chemical solution 9 filled in the outer cylinder 2. .

Next, the pre-filled syringe 1 in this embodiment is made by the manufacturing method described below.

As shown in the flowchart of FIG. 2, first, the IC tag 10 is provided on the outer cylinder 2 and / or the pusher 5 constituting the syringe 1 (step S1). Thereafter, for example, cleaning is performed by receiving a high-speed water jet, and contaminants including a pyrogen adhering to the inner and outer surfaces of the outer cylinder 2 are removed (preferably performed in an aseptic chamber). Thereafter, the substrate is wetted by any one of a method of immersing in distilled water, a method of exposing to steam, or a method of sterilizing with steam while immersed in distilled water. In order to sterilize the outer cylinder 2 with steam, a Koch sterilizer, an autoclave, or the like is preferably used. In the case of an autoclave, it is sterilized under predetermined conditions, for example, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜2.8 kgf / cm ² . Moreover, it is sterilized (first sterilization) with a predetermined condition, for example, 100 to 135 ° C. for 1 to 60 minutes and a pressure of about 1.5 kgf / cm ² with EOG (ethylene oxide gas) (step S2).

The cap 3 constituting the syringe 1 is preferably separately sterilized in distilled water and then steam sterilized (first sterilization) (step S2). For steam sterilization of the cap 3, a Koch sterilizer, an autoclave, or the like is preferably used. The gasket 4 constituting the syringe 1 is preferably sterilized by steam (first sterilization) after being immersed in distilled water (step S2). For steam sterilization (first sterilization) of the pusher 5 provided with the gasket 4, a Koch sterilization pot, an autoclave, or the like is preferably used. In the case of an autoclave, it is sterilized under predetermined conditions, for example, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜2.8 kgf / cm ² . In the case of EOG (ethylene oxide gas) sterilization, sterilization is performed under predetermined conditions, for example, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜1.5 kgf / cm ² .

When the process is simplified, the surface of the gasket 4 is wetted by any one of a method of immersing in distilled water, a method of exposing to steam, or a method of sterilizing with steam while immersed in distilled water. Put into a state. In order to sterilize the gasket 4 with steam (first sterilization), a Koch sterilization pot, an autoclave, or the like is preferably used. In the case of an autoclave, it is sterilized under predetermined conditions, for example, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜2.8 kgf / cm ² . In the case of EOG (ethylene oxide gas) sterilization, sterilization is performed under predetermined conditions, for example, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜1.5 kgf / cm ² .

And the nozzle 6 currently formed in the one end side 5 of the outer cylinder 2 is sealed with the cap 3 under aseptic conditions, such as the inside of a clean bench. After the inside of the outer cylinder 2 is filled with the chemical 9 from the open end 8 on the other end side 7 of the outer cylinder 2 (step S3), the gasket 4 is usually removed from the open end 8 of the outer cylinder 2 under the reduced pressure. The open end 8 of the outer cylinder 2 is sealed (step S4).

The prefilled syringe 1 thus filled and sealed with the chemical solution 9 is surrounded by an individual packaging pack (step S5), and then subjected to high pressure steam sterilization, ethylene oxide gas sterilization, etc. as second sterilization under predetermined conditions. (Step S5).

Sterilization of the prefilled syringe 1 in this step can also be steam sterilization using a Koch sterilization pot, an autoclave, or the like. The conditions for steam sterilization vary depending on the size of the outer cylinder 2, the shape of the cap 3 and the gasket 4, etc., for example, predetermined conditions, 100 to 135 ° C., 1 to 60 minutes, and the pressure is about 2.8 kgf / cm. Sterilized with ² . In addition, in order to prevent the gasket 4 from coming off due to the internal pressure of the chemical liquid 9 that has become high during steam sterilization, and when the outer cylinder 2 is made of plastic, the outer cylinder 2 is not deformed by the internal pressure of the chemical liquid 9. It is necessary to appropriately increase the internal pressure of the sterilization chamber. In the case of EOG (ethylene oxide gas) sterilization, sterilization is performed under predetermined conditions, for example, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜1.5 kgf / cm ² .

After the second sterilization step, data is written to the IC tag 10. The information written here is data that cannot be rewritten by the hospital (user), such as the name of the syringe manufacturer, the outer diameter of the syringe, the coefficient of friction between the outer cylinder 2 and the gasket 4, and the drug data relating to the drug (drug name, drug identification) Drug identification data such as data, drug identification data such as drug identification code, drug identification data such as standard drug code, standard drug number (serial number, etc., upper limit / limit value of injection rate), etc., manufacturing The lot number, sterilization conditions (first sterilization conditions / second sterilization conditions), and the like are included.

In the present embodiment, the manufacturing process of the pre-filled syringe provided with the IC tag has been described. However, the same manufacturing process is possible for the infusion solution-containing bag provided with the IC tag. Note that there was no abnormality in the data information stored in the IC tag after the second sterilization, and it was confirmed that sterilization was performed reliably. In addition, the step of providing the syringe with an IC tag in which information is written in advance may be the first step, and information may not be written into the IC tag after sterilization.

<Example 2>
A syringe that is not filled with a medicine will be described as an example of a medical instrument. Hereinafter, a preferred embodiment of the present invention will be described based on the drawings. The configuration is substantially the same as that of the first embodiment shown in the cross-sectional view of FIG. 1 except that there is no cap 3 that is not filled with the chemical solution 9 and that seals the nozzle 6. The syringe 1 includes an outer cylinder 2, a gasket 4, and a pusher 5. A nozzle 6 is provided on one end side 5 (left side in the illustrated example) of the outer cylinder 2, and an open end 8 is formed on the other end side 7 (right side in the illustrated example) of the outer cylinder 2.

The outer cylinder 2 is made of a plastic such as a thermoplastic resin (sometimes made of glass). The IC tag (RFID) 10 is provided by embedding, pasting, or the like at any appropriate position on either or both of the outer cylinder 2 and the flange portion 5a of the pusher 5.

The IC tag (RFID) 10 includes a syringe manufacturer name, a syringe outer diameter, a friction coefficient between the outer cylinder 2 and the gasket 4, drug data relating to a drug (drug identification data such as drug name and drug identification data, drug identification code, etc. Drug identification data such as drug identification data, standard drug code, standard drug number (serial number, etc.), upper limit / limit value of injection speed, etc.), production lot number, sterilization condition (first sterilization condition / 2) Sterilization conditions, etc.) areas where hospitals (users) store non-rewritable data, arbitrary numbers, codes, physicians in charge, physician codes in charge, patient names, patient codes, etc. Is provided with an area for recording rewritable data.

An injection needle (not shown) can be attached to the nozzle 6 provided on one end side 5 of the outer cylinder 2. For this reason, on the outer surface of the nozzle 6, for example, a screw groove (not shown) for mounting the injection needle may be formed. The gasket 4 is made of a suitable elastic material such as rubber or elastic plastic. For example, a ring-shaped groove may be formed on the peripheral surface of the gasket 4.

Next, the syringe 1 in this embodiment is made by the manufacturing method described below.

As shown in the flowchart of FIG. 3, first, the IC tag 10 is provided on the outer cylinder 2 and / or the pusher 5 constituting the syringe 1 (step S11). Thereafter, for example, cleaning is performed by receiving a high-speed water jet (step S12), and contaminants including exothermic substances adhering to the inner and outer surfaces of the outer cylinder 2 and exothermic substances adhering to the surface of the gasket 4 are removed (preferably Performed in a sterile room).

Then, under aseptic conditions such as in a clean bench, the gasket 4 is usually inserted into the outer cylinder 2 from the open end 8 of the outer cylinder 2 under reduced pressure, and the open end 8 of the outer cylinder 2 is sealed. (Step S14).

The syringe 1 in which the gasket 4 is thus inserted is surrounded by an individual packaging pack (step S15), and then subjected to high-pressure steam sterilization, ethylene oxide gas sterilization, etc. as sterilization under predetermined conditions (step S16).

Sterilization of the syringe 1 in this step can be steam sterilization using a Koch sterilization pot, an autoclave, or the like. The conditions for steam sterilization vary depending on the size of the outer cylinder 2 and the shape of the gasket 4, but for example, sterilization is performed under predetermined conditions, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜2.8 kgf / cm ² . Is done. In the case of EOG (ethylene oxide gas) sterilization, sterilization is performed under predetermined conditions, for example, 100 to 135 ° C., 1 to 60 minutes, and the pressure is ˜1.5 kgf / cm ² .

After the sterilization process, data is written to the IC tag 10. The information written here is data that cannot be rewritten by the hospital (user), such as the name of the syringe manufacturer, the outer diameter of the syringe, the coefficient of friction between the outer cylinder 2 and the gasket 4, and the drug data relating to the drug (drug name, drug identification) Drug identification data such as data, drug identification data such as drug identification code, drug identification data such as standard drug code, standard drug number (serial number, etc., upper limit / limit value of injection rate), etc., manufacturing The lot number, sterilization conditions (first sterilization conditions / second sterilization conditions), and the like are included. Note that there was no abnormality in the data information stored in the IC tag after the second sterilization, and it was confirmed that sterilization was performed reliably.

In the present embodiment, the manufacturing process of the syringe provided with the IC tag has been described, but the same manufacturing is also performed for disposable medical instruments such as a medical needle, a catheter, a blood collection device, an infusion set, and an infusion tube provided with the IC tag. A process is possible. In addition, as a first step, a process of providing an IC tag on which information has been written in advance in a medical instrument may be performed so that information is not written to the IC tag after sterilization.

It is a figure which shows the cross section of the Example of this invention. It is a flowchart which shows the manufacturing process of the Example of this invention. It is a flowchart which shows the manufacturing process of the other Example of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Syringe, 2 ... Outer cylinder, 3 ... Cap, 4 ... Gasket, 10 ... IC tag

Claims (9)

Providing an IC tag on the syringe;
A first sterilization step of sterilizing the syringe provided with the IC tag;
Aseptically filling the syringe with the drug;
Surrounding the syringe in a pack;
Performing high-pressure steam sterilization or ethylene oxide gas sterilization as second sterilization under predetermined conditions in a state surrounded by the pack;
Writing information into the IC tag;
The manufacturing method of the medical instrument characterized by comprising. Providing a syringe with an IC tag pre-written with information;
A first sterilization step of sterilizing the syringe provided with the IC tag;
Aseptically filling the syringe with the drug;
Surrounding the syringe in a pack;
Performing high-pressure steam sterilization or ethylene oxide gas sterilization as second sterilization under predetermined conditions in a state surrounded by the pack;
The manufacturing method of the medical instrument characterized by comprising.   3. The method for producing a syringe filled with a medicine according to claim 1, wherein the autoclaving is performed at a predetermined temperature (° C.) and a predetermined pressure (Pa) for a predetermined time (minute). The method for producing a syringe filled with a medicine according to claim 1 or 2, wherein the ethylene oxide gas sterilization is performed at a predetermined temperature (° C) and a predetermined pressure (Pa) for a predetermined time (minute). A method of manufacturing a medical device provided with an IC tag,
Providing the IC tag on a medical instrument;
Surrounding the medical device in a pack;
A step of performing high-pressure steam sterilization or ethylene oxide gas sterilization under predetermined conditions in a state surrounded by the pack;
Writing information into the IC tag;
The manufacturing method of the medical instrument characterized by comprising. A method of manufacturing a medical device having an IC tag in which information is written in advance,
Providing the IC tag on a medical instrument;
Surrounding the medical device in a pack;
A step of performing high-pressure steam sterilization or ethylene oxide gas sterilization under predetermined conditions in a state surrounded by the pack;
Writing information into the IC tag;
The manufacturing method of the medical instrument characterized by comprising.   The method for producing a medical device according to claim 5 or 6, wherein the autoclaving is performed at a predetermined temperature (° C) and a predetermined pressure (Pa) for a predetermined time (minute).   The method for producing a medical device according to claim 6, wherein the ethylene oxide gas sterilization is performed at a predetermined temperature (° C.) and a predetermined pressure (Pa) for a predetermined time (minute). The medical device according to any one of claims 5 to 8, wherein the medical device is at least one of a medical needle, a syringe, a catheter, a blood collection device, an infusion set, and an infusion tube. .

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