JP2005152451A - Check device for confirming sterilization - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To simply and surely confirm the sterilization effect in a tube by freely adjusting the length of a tube corresponding to a tube of a medical device to be sterilized, and obtaining the sterilization effect substantially similar to that of the tube. <P>SOLUTION: This check device 1 for confirming the sterilization includes a tube corresponding part 2 having the constitution corresponding to the tube of an endoscope to be sterilized, wherein a coating part (an indicator composition for confirming sterilization) 3 for confirming the sterilization effect in sterilization treatment is applied to the whole or part of an inner wall 2b of the tube corresponding part 2, and the tube corresponding part 2 can be freely cut into a desired length. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  In the present invention, a medical device requiring sterilization treatment is housed in a sterilizer, and high-temperature high-pressure steam sterilization (hereinafter referred to as autoclave sterilization) or ethylene oxide gas sterilization (Ethylene Oxide Gas sterilization, hereinafter referred to as EOG sterilization). In particular, the present invention relates to a sterilization confirmation test apparatus for confirming the sterilization effect corresponding to an endoscope.

Conventionally, medical devices used for inspection and treatment purposes have been cleaned and disinfected to prevent infectious diseases, and in the case of medical endoscopes in particular, the used endoscope must be sterilized and sterilized. Become indispensable.
Recently, when performing disinfection sterilization, autoclave sterilization (high-temperature high-pressure steam sterilization) or EOG sterilization that can be used immediately after sterilization without any complicated work and is advantageous in terms of running cost is also used for endoscope equipment. It is becoming mainstream as a sterilization method.

In such a sterilization process such as autoclave sterilization and EOG sterilization, an operation for confirming whether or not the sterilization effect by the sterilization process is sufficiently obtained is usually performed.
As a conventional method for confirming the sterilization effect, when a medical device is sterilized by autoclave sterilization or EOG sterilization, for example, a tape-like chemical indicator (Chemical Indicator: CI) is attached to the medical device (sterilization device). Alternatively, there is a method of confirming the sterilization effect by placing a sheet-like chemical indicator or biological indicator (BI) between the articles to be sterilized.
Such an indicator for confirming sterilization indicates that the medical device has been exposed to a temperature and gas capable of being sterilized for a certain period of time. Generally, a temperature is applied to a tape-like (or sheet-like) surface. Ink that reacts with gas is printed.

As described above, conventionally, when confirming the sterilization effect, a sterilization confirmation indicator attached directly to a medical device to be sterilized or a sterilization confirmation indicator enclosed in a sealed package (such as a sterilization pack) is used. By confirming the color change, the sterilization effect was confirmed.
However, although the sterilization effect on the surface of the medical device is guaranteed by the method for confirming the sterilization effect, it is difficult to sufficiently confirm the sterilization up to the thin duct of the medical device such as an endoscope. Met.
Therefore, conventionally, in view of such problems, for the purpose of confirming the sterilization effect in a thin duct, for example, as shown in JP-A-2002-355297, cotton to which a sterilization indicator composition is attached is used. An indicator for sterilization confirmation has been proposed in which a state-like material is inserted into a thin conduit so that sterilization in the conduit can be confirmed.
JP 2002-355297 A

However, in the conventional example of the above-mentioned Japanese Patent Application Laid-Open No. 2002-355297, a plurality of sterilization indicators corresponding to each medical device are required for medical devices such as endoscopes having a variety of pipes. For this reason, it becomes necessary to select an appropriate sterilization indicator for each length and diameter corresponding to the conduit of the medical device, which is very troublesome. Further, since it is necessary to prepare various sterilization indicators, the cost becomes expensive.
Furthermore, inserting a sterilization confirmation indicator directly into a medical device for confirming the sterilization effect opens a sterilization pack containing a medical device that needs to maintain a sterilized state after sterilization, and the medical device Since the sterilization effect cannot be confirmed without taking out the sterilization confirmation indicator inserted in the conduit of the device, there is a disadvantage that the sterility of the medical device cannot be confirmed until just before use.

  Accordingly, the present invention has been made in view of the above problems, and can be freely adjusted so as to have a duct length corresponding to the duct of a medical device to be sterilized, and is substantially the same as the sterilization effect of this duct. An object of the present invention is to provide a test apparatus for sterilization confirmation capable of easily and surely confirming the sterilization effect in a pipe line by adopting a configuration capable of obtaining the sterilization effect.

  In order to achieve the above object, the sterilization confirmation test apparatus according to the first aspect of the present invention has a pipe-corresponding portion having a configuration corresponding to a pipe line of a medical device, and an inner wall of the pipe-corresponding part. The sterilization confirmation indicator composition for confirming the sterilization effect when sterilizing the whole or at least a part is applied, and the length corresponding to the pipe line can be freely cut. To do.

  The test apparatus for sterilization confirmation according to the first aspect of the present invention is the test apparatus for sterilization confirmation according to the first aspect, wherein the pipe-corresponding part is equivalent to the pipe line so as to cover the outside of the pipe line-corresponding part. The heat insulating material which has the characteristic to reduce the thermal conductivity with respect to a part is provided.

  The test apparatus for sterilization confirmation of the present invention can be freely adjusted so as to have a pipe length corresponding to the pipe line of a medical device to be sterilized, and obtains a sterilization effect substantially similar to the sterilization effect of this pipe line. By adopting such a configuration, there is an advantage that the sterilization effect in the pipeline can be confirmed easily and reliably.

  Embodiments of the present invention will be described below with reference to the drawings.

  1 and 2 show a first embodiment of the test apparatus for sterilization confirmation according to the present invention, FIG. 1 is a perspective view showing a schematic configuration of the test apparatus for sterilization confirmation, and FIG. 2 shows the test apparatus for sterilization confirmation of FIG. It is sectional drawing. Note that the test apparatus for sterilization confirmation of the present embodiment is an embodiment in the case of being configured for an endoscope having a pipeline as a medical device to be sterilized. It is not limited to mirrors.

  As shown in FIG. 1, the test apparatus 1 for sterilization confirmation of the present embodiment has a shape (diameter) and material (for example, a fluororesin) substantially the same as the conduit of an insertion portion of an endoscope (not shown) to be sterilized. It has a pipeline-corresponding portion 2 configured.

As shown in FIG. 2, the pipe-corresponding part 2 has a pipe-line part 2a corresponding to the pipe-line of the insertion part, and the sterilization confirmation indicator composition is provided on the inner wall 2b of the pipe-line part 2a. The coating part 3 is applied.
The coating portion 3 is a coating of the inner wall 2b of the pipe portion 2a with ink or the like that reacts with temperature or gas generally used for indicators for sterilization confirmation (chemical indicators, biological indicators, etc.). By this, it is formed.

  The coating portion 3 is required to be connected from the distal end portion to the base end portion in the longitudinal direction of the inner wall 2b of the pipe line portion 2a, but the circumference of the inner wall 2b of the pipe line portion 2a. In the direction, it may be formed so as not to be provided on the entire inner wall but to be disposed on a part of at least the inner wall 2b.

Further, the pipe-corresponding portion 2 is formed in accordance with the plurality of types of endoscopes so as to correspond to a plurality of types of endoscopes (not shown) having different diameters to be sterilized. It has become.
Further, the pipe equivalent portion 2 is formed of a material substantially the same as that of an actual endoscope, and can be freely cut according to the length of the endoscope to be sterilized.

Next, the operation of the test apparatus for sterilization confirmation of this embodiment will be described with reference to FIGS.
Now, when a predetermined endoscope is sterilized, sterilization confirmation is performed using the sterilization confirmation test apparatus 1 of the present embodiment. In this case, the operator prepares a test apparatus 1 for sterilization confirmation having a pipe-corresponding portion 2 substantially the same as the pipe diameter of an endoscope (not shown) to be sterilized. Then, the operator cuts the pipe-corresponding portion 2 using a cutting means (not shown) according to the pipe length of the endoscope.

  Thereafter, the operator puts the cut sterilization confirmation test apparatus 1 and the endoscope to be sterilized into the chamber of the steam pressure sterilizer, and performs a normal sterilization process, for example, high-temperature high-pressure steam sterilization (autoclave sterilization). To do. In this case, when the sterilization check test apparatus 1 and the endoscope are stored in a sterilization storage case or a sterilization pack, the sterilization check test apparatus 1 is connected to the endoscope. The test apparatus 1 for sterilization confirmation is accommodated so that it may become the same conditions. For example, when sterilization is performed by storing an endoscope in a sterilization storage case, the sterilization confirmation test apparatus 1 is also stored in the sterilization storage case, and this sterilization storage case is stored in a sterilization pack. The sterilization process is performed in the chamber.

  After the completion of sterilization, the operator takes out the sterilization confirmation test apparatus 1 from the vapor pressure sterilization apparatus and observes the color change of the coating portion 3 of the removed sterilization confirmation test apparatus 1. In this case, since the coating part 3 is exposed in the cross section of the pipe line equivalent part 2, it can be easily confirmed. And if the color of this coating part 3 changes completely, this test device 1 for sterilization confirmation is fully sterilized, it has the same pipe line structure as this test device 1 for sterilization confirmation, and the said vapor | steam is simultaneous. It can be confirmed that the endoscope placed in the chamber of the autoclave is also sufficiently sterilized.

  In this embodiment, the sterilization method is not limited to high-temperature and high-pressure steam sterilization (autoclave sterilization), and gas sterilization such as EOG gas sterilization and other methods may be performed as necessary. In this case, the coating part 3 of the test apparatus 1 for sterilization confirmation needs to be formed using ink that reacts according to the sterilization method.

Therefore, according to the present embodiment, as described above, the length of the medical device (endoscope) to be sterilized can be freely adjusted so as to correspond to the length of the conduit, and the sterilization effect of the conduit By adopting a configuration capable of obtaining substantially the same sterilization effect, confirmation of the sterilization effect in the pipeline can be easily and reliably performed.
Further, after the sterilization is completed, the sterilization effect of the endoscope can be confirmed by simply taking out the sterilization confirmation test apparatus 1 and observing it, so that the sterilization can be confirmed in a short time. Since the sterilization effect can be confirmed without opening the sterilization pack containing the sterilization and removing the sterilization confirmation indicator inserted in the endoscope's conduit, the sterility of the endoscope is maintained until just before use. It is also possible. Thereby, the safety | security of the endoscope as a medical device can be improved, and relief and trust can be provided with respect to a doctor and a patient.
Furthermore, since the test apparatus for sterilization confirmation of the present embodiment can be implemented with a simple configuration, it greatly contributes to cost reduction.

  3 and 4 show a second embodiment of the test apparatus for sterilization confirmation according to the present invention, FIG. 3 is a perspective view showing a schematic configuration of the test apparatus for sterilization confirmation, and FIG. Sectional drawing in the longitudinal direction of a test apparatus, FIG.4 (B) is the sectional view on the AA line of FIG. 4 (A). 3 and 5, the same components as those in the test apparatus 1 for sterilization confirmation of the first embodiment are denoted by the same reference numerals, description thereof is omitted, and only different portions are described.

  The sterilization check test apparatus of the present embodiment is improved so as to have a configuration corresponding to an actual endoscope as compared with the sterilization check test apparatus 1 of the first embodiment.

  As shown in FIG. 3, the test apparatus 1A for sterilization confirmation of the present embodiment is made of a material substantially the same as a part (for example, a pipe line itself) covered with a snake tube such as an insertion portion of an endoscope (not shown) to be sterilized. For example, it has a pipe-corresponding portion 2A made of a fluororesin.

4A and 4B, the pipe equivalent part 2A is provided so as to cover the pipe equivalent part 2 of the first embodiment and the entire pipe equivalent part 2. The heat insulating material 4 is provided.
The heat insulating material 4 is made of, for example, a polyester resin, a polyurethane resin, or the like, and is made of a material that is substantially the same as a snake tube of an endoscope to be sterilized, and has a thermal conductivity with respect to the pipe-corresponding portion 2. It has the property of reducing. Further, as shown in FIG. 3, the heat insulating material 4 is formed in a rectangular parallelepiped shape and incorporates the pipe line equivalent portion 2 therein.

As shown in FIG. 3, the pipe-corresponding portion 2A of this embodiment is formed in a predetermined length and wound up, and cuts only the length necessary for sterilization confirmation. It can be used.
Other configurations are the same as those of the first embodiment.

In addition, although the said heat insulating material 4 was formed in the rectangular parallelepiped shape, it is not limited to this, You may comprise circular shape similarly to the snake tube etc. of an endoscope. In addition, it is desirable that the heat insulating material 4 and the pipe line portion 2 a built in the heat insulating material 4 are configured using a transparent or translucent member. In this case, the heat insulating material 4 is built in from the outside of the heat insulating material 4. It is possible to observe the coated part 3.
Further, in this embodiment, the pipe-corresponding portion 2A is configured to cover the heat insulating material 4 on the pipe-corresponding portion 2 of the first embodiment, but is not limited to this, for example, simply A communication port that communicates from the distal end portion to the proximal end portion and that corresponds to a pipe line may be provided inside the heat insulating material 4, and the coating portion 3 may be applied to the inner wall of the communication port.

Next, the operation of the test apparatus for sterilization confirmation of the present embodiment will be described with reference to FIGS.
Now, when a predetermined endoscope is sterilized, sterilization confirmation is performed using the sterilization confirmation test apparatus 1 of the present embodiment. In this case, the operator prepares the sterilization confirmation test apparatus 1A having the pipe-corresponding portions 2 and 2A substantially the same as the pipe diameter of the endoscope (not shown) to be sterilized. Then, similarly to the first embodiment, the operator cuts the pipe-corresponding portion 2A using cutting means (not shown) according to the pipe length of the endoscope.

  Thereafter, the worker puts the cut sterilization confirmation test apparatus 1A and the endoscope to be sterilized into the chamber of the steam pressure sterilizer, and performs a normal sterilization process, for example, high-temperature and high-pressure steam sterilization (autoclave sterilization). To do. In this case, when the sterilization check test apparatus 1A and the endoscope are stored in a sterilization storage case or a sterilization pack, the sterilization check test apparatus 1A is connected to the endoscope. The test apparatus 1A for sterilization confirmation is accommodated so as to satisfy the same conditions. For example, when sterilization is performed by storing an endoscope in a sterilization storage case, the sterilization confirmation test apparatus 1 is also stored in the sterilization storage case, and this sterilization storage case is stored in a sterilization pack. The sterilization process is performed in the chamber.

After the completion of sterilization, the operator takes out the sterilization confirmation test apparatus 1A from the vapor pressure sterilization apparatus and observes the color change of the coating portion 3 of the removed sterilization confirmation test apparatus 1.
In this case, since the coating part 3 is exposed in the cross section of the pipe line equivalent part 2, it can be easily confirmed. And if the color of this coating part 3 changes completely, this test device 1 for sterilization confirmation is fully sterilized, it has the same pipe line structure as this test device 1 for sterilization confirmation, and the said vapor | steam is simultaneous. It can be confirmed that the endoscope placed in the chamber of the autoclave is also sufficiently sterilized.

  Further, when the heat insulating material 4 and the pipe portion 2a built in the heat insulating material 4 are configured using a transparent or translucent member, the heat insulating material 4 is built in from the outer periphery of the heat insulating material 4. It becomes possible to observe the color change in the coating part 3.

  In the present embodiment, the sterilization method is not limited to high-temperature and high-pressure steam sterilization (autoclave sterilization) as in the first embodiment, and gas sterilization such as EOG gas sterilization or other methods may be performed as necessary. You may carry out. In this case, the coating part 3 of the test apparatus 1 for sterilization confirmation needs to be formed using ink that reacts according to the sterilization method.

  Therefore, according to the present embodiment, the configuration similar to the structure of the endoscope to be sterilized as compared with the first embodiment makes it possible to perform the sterilization effect in the duct more accurately. Other effects are the same as those of the first embodiment.

  In the present embodiment, the sterilization confirmation test device 1A itself is wound up, pulled out by the length to be used, and cut by a cutting means (not shown). A holding tool that holds 1 in a pullable manner may be provided. In this case, if the holder is provided with cutting means to cut the sterilization confirmation test apparatus 1A drawn out by a predetermined length, the operator's preparation process can be greatly shortened.

  The present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the spirit of the invention.

[Appendix]
(1) For confirming the sterilization effect when the whole or at least a part of the inner wall of the pipe-corresponding part has a pipe-corresponding part having a configuration corresponding to the pipe of the medical device. A test apparatus for sterilization confirmation characterized in that the sterilization confirmation indicator composition is applied and the length of the pipe line corresponding portion can be freely cut.

  (2) The test apparatus for sterilization confirmation according to appendix (1), wherein the medical device is an endoscope, and the duct-corresponding portion has substantially the same diameter as the duct of the endoscope.

  (3) The sterilization confirmation test composition according to appendix (1), wherein the sterilization confirmation indicator composition is an ink member having a characteristic of reacting with a temperature or a gas used in the sterilization confirmation indicator. .

  (4) The pipe line equivalent part is provided with a heat insulating material having a characteristic of reducing thermal conductivity with respect to the pipe line equivalent part so as to cover the outside of the pipe line equivalent part. The test apparatus for sterilization confirmation as described in 1).

  (5) The test apparatus for sterilization confirmation according to appendix (4), wherein the heat insulating material is formed in a rectangular parallelepiped shape, and a base end portion is wound and stored.

  (6) The holding means for holding the wound heat insulating material so as to be drawable is provided, and the holding means is provided with a cutting means for cutting the heat insulating material drawn by a predetermined length. Test apparatus for sterilization confirmation according to appendix (5).

  (7) The test apparatus for sterilization confirmation according to appendix (4), wherein the heat insulating member is configured using a transparent member or a translucent member.

  (8) The sterilization treatment is high-temperature high-pressure steam sterilization or ethylene oxide gas sterilization, and the indicator composition for sterilization confirmation is capable of reacting according to this sterilization treatment. The test apparatus for sterilization confirmation according to any one of appendix (8).

  The test apparatus for sterilization confirmation of the present invention can be freely adjusted so as to have a pipe length corresponding to the pipe line of a medical device to be sterilized, and obtains a sterilization effect substantially similar to the sterilization effect of this pipe line. Because it is possible to confirm the sterilization effect in the pipeline easily and reliably, a plurality of endoscopic examinations using an endoscope are performed, and the internal structure used in the first examination is used. This is especially effective when the endoscope is reprocessed and used repeatedly on the same day.

The perspective view which shows 1st Example of the test apparatus for sterilization confirmation of this invention, and shows schematic structure of the test apparatus for sterilization confirmation. Sectional drawing of the test apparatus for sterilization confirmation of FIG. The perspective view which shows 2nd Example of the test apparatus for sterilization confirmation of this invention, and shows schematic structure of the test apparatus for sterilization confirmation. Sectional drawing of the test apparatus for sterilization confirmation of FIG.

Explanation of symbols

1, 1A ... sterilization test device,
2, 2A ... pipeline equivalent part,
2a ... pipe section,
2b ... inner wall,
3 ... coating part (indicator composition for sterilization confirmation),
4 ... Insulating material.
Attorney Susumu Ito

Claims (2)

  For sterilization confirmation for confirming the sterilization effect when sterilizing the entire inner wall or at least a part of the inner wall of the pipe-corresponding part having a configuration corresponding to the pipe line of the medical device A test apparatus for sterilization confirmation, characterized in that the indicator composition is applied and the length of the pipe line corresponding portion can be cut freely. The heat insulating material which has the characteristic to which the said pipe line equivalent part reduces the thermal conductivity with respect to the said pipe line equivalent part is provided so that the outer side of this pipe line equivalent part may be covered. Test equipment for sterilization confirmation.

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