CN1799491A - Filth for evaluating washing performance of medical instrument and soiling method for evaluating washing performance - Google Patents
Filth for evaluating washing performance of medical instrument and soiling method for evaluating washing performance Download PDFInfo
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- CN1799491A CN1799491A CN 200510137835 CN200510137835A CN1799491A CN 1799491 A CN1799491 A CN 1799491A CN 200510137835 CN200510137835 CN 200510137835 CN 200510137835 A CN200510137835 A CN 200510137835A CN 1799491 A CN1799491 A CN 1799491A
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Abstract
The invention provides a filth for evaluating the washing performance of a medical instrument which is a simulated body fluid occurring in a human body cavity to be used in evaluating the washing performance of a medicinal instrument and can achieve a favorable reproducibility in the evaluation of the washing performance. The method includes a filth injecting step for injecting the filth 5 into the pipe 1 of the medical appliance and a filth layer forming step for forming a filth layer in the pipe through air feed or inspiration in the filth injecting step. An air passage for passing through the filth is formed by air feed or inspiration to the pipe 1 to cause the filth coated evenly in the pipe 1.
Description
Technical field
The method and the cleaning evaluation that the present invention relates to adopt dirt to pollute medical apparatus and instruments use dirt, described method to be used to estimate the cleaning treatment efficient of medical apparatus and instruments, and described dirt uses when reusable medical apparatus and instruments being carried out the cleaning evaluation.
Background technology
In recent years, endoscope owing to can insert in the body cavity checks internal organs and treats and frequently used.Must carry out cleaning and sterilizing after endoscope uses and handle in checking or treating, make it always remain on clean state.
To carry out the cleaning evaluation of medical apparatus and instruments for the various medical apparatus and instruments that comprise endoscope.That is, after cleaning and sterilizing was handled, residual to whether also having dirt on this apparatus, perhaps the residual quantity of dirt was estimated, and estimates cleaning from aspects such as positions for the medical apparatus and instruments that has dirt to adhere to.Confirmation method to medical apparatus and instruments cleaning and sterilizing treatment effect is for example proposing in the 6th, 428, No. 746 communiques of U.S.'s patent of invention.
On the other hand, endoscope need carry out the medical apparatus and instruments that cleaning and sterilizing is handled, wherein be provided with pipeline, for example, be used for inserting the various pliers of metacheirisis affected part forceps channel, be used to aspirate the suction channel that water and suction endoscope insertion part front end observation window rinse water etc. are sent in affected part send water to form in body cavity the place ahead.
When the medical apparatus and instruments that is provided with these pipelines is carried out the cleaning evaluation, there is multiple dirt to be suitable for.When the dirt that injects the medical apparatus and instruments pipeline being selected in order to carry out the cleaning evaluation, pay the utmost attention to the feature of dirt, for example, regardless of viscosity etc., dirt adheres on inner surface of pipeline, or has a certain amount of dirt to remain in character such in the pipeline by top-priority.
On the other hand,, all can produce the fluid retention of dirt in the pipeline clearly in case allowed the dirt of high viscosity attached to after in the medical apparatus and instruments that pipeline is arranged.
When the medical apparatus and instruments that pipeline is arranged was carried out the cleaning evaluation, the viscosity height of used dirt was to cause the reason that the fluid retention of dirt takes place in the pipeline of medical apparatus and instruments.In case the fluid retention of dirt takes place in the pipeline, then because atmosphere draught-free in the pipeline, thereby can't promote the drying of dirt.In addition, as to dry by force in the pipeline of the fluid retention that has dirt, hardening after the dirt drying might blocking pipe.And owing in the pipeline dirt is arranged, the pollution condition instability is difficult to cleaning is correctly estimated.
For example, when the viscosity of dirt causes in the pipeline fluid retention, use high viscosity to clean to estimate pollute endoscope channel with dirt after, even through suitable drying time, also can't promote the drying of pipeline.In addition,, then block pipeline after the fluid retention thing drying, be difficult to make the pollutional condition in the pipeline to keep stable if excessively prolong drying time.If then there is the problem that can't correctly estimate cleaning in the pollutional condition instability.
As mentioned above, for prevent to be used to diagnose or treat after medical apparatus and instruments the infection accident takes place when reusing, the cleaning treatment of various medical apparatus and instruments after use that is used for medical field is particularly important.Therefore, begun various rinsers are developed and made its practicability, this rinser be used for medical apparatus and instruments is carried out cleaning treatment.
On the other hand, when medical apparatus and instruments is made in exploitation, when for example using rinser that medical apparatus and instruments is carried out cleaning treatment, must be according to coming the cleaning of medical apparatus and instruments is estimated attached to the dirt on the medical apparatus and instruments.For the cleaning of medical apparatus and instruments, use rinser that medical apparatus and instruments is actually used in human body after accompanying dirt clean, aspects such as residual position of dirt and residual quantity are estimated from the medical apparatus and instruments afterwards.
Therefore, the cleaning evaluation of medical apparatus and instruments can only be carried out under given conditions, and it is long to estimate the required time, can't estimate fast.And also there is same problem when cleaning with hands.
For sanitary earthenware and enamelwork, open 2000-352101 communique and the special dirt that has proposed to be used for sanitary earthenware and the evaluation of enamelwork cleaning in the 2001-104192 communique of opening the spy.Open the spy and to have proposed a kind of simulation dirt in the 2000-352101 communique, residual dirt adheres to situation and heeltap situation when being used to estimate flushing and being attached to the dirt of sanitary earthenware, and this simulation dirt has added stain in the main component fatty acid of formation slop.In addition, open the spy and to have proposed a kind of simulation dirt in the 2001-104192 communique, be used to estimate the residual situation of adhering to of washing dirt when being attached to the enamelwork dirt, this simulation dirt is formed by fatty acid, and this fatty acid is the hands stain on incrustation scale, backstairs or the plate face such as bath or the most composition of oil stain.
As above-mentioned spy open the 2000-352101 communique and special open propose in the 2001-104192 communique like that, the simulation dirt in order to the cleaning of evaluation sanitary earthenware and enamelwork has been proposed.But do not propose reusable medical apparatus and instruments such as endoscope are estimated the simulation dirt of usefulness, for example have simulation dirt with akin composition of human body fluid and viscosity.Therefore, need to occur a kind of medical apparatus and instruments and clean the evaluation dirt, it can carry out the cleaning evaluation to medical apparatus and instruments rapidly in short time, and can estimate repeatedly under the same conditions.
In addition,, consider from the viewpoint of infection management in recent years, must clean after in medical procedure, using, carry out disinfection then or sterilize for the reusable various medical apparatus and instruments that comprise endoscope.The method of the cleaning of medical apparatus and instruments, sterilization, sterilization has a variety of.For utilizing the whole bag of tricks to clean the cleaning of back medical apparatus and instruments, be to estimate by the pollutant residual quantity of cleaning on the medical apparatus and instruments of back.Therefore, with dirt, it is recyclable and to have the composition that can confirm to clean the Restzustand of back in medical apparatus and instruments be very important to clean the back for the evaluation of medical apparatus and instruments cleaning.
As the spy open proposed in the 2000-352101 communique cleaning evaluation with the simulation dirt.The Restzustand and the heeltap situation of dirt are estimated after the spy opens the simulation dirt that proposes in the 2000-352101 communique to be used for flushing is attached to dirt on the sanitary earthenware.
In addition, for example proposing to be used for the simulation dirt that the medical apparatus and instruments cleaning is estimated in the 6th, 447, No. 990 communiques of U.S.'s patent of invention.When estimating the cleaning of medical apparatus and instruments, use with various food usually to be the compound simulation dirt that gets of main body.
The spy opens the simulation dirt that proposes in the 2000-352101 communique and is based on that purpose that the cleaning of sanitary earthenware is estimated constitutes.For reusable medical apparatus and instruments and sanitary earthenware, because in the using method of simulation dirt, the dirt difficulty that comes off is cleaned load, and aspect difference such as cleaning method applicatory when cleaning, so above-mentioned simulation dirt is not suitable for the cleaning of evaluation medical apparatus and instruments.
In addition, the simulation dirt that proposes in the 6th, 447, No. 990 communiques of U.S.'s patent of invention is the cleaning that is used to estimate reusable medical apparatus and instruments.Although be attached to the human body biological component of medical apparatus and instruments and the concentration of this composition during the formation of this simulation dirt is conceived to use, the difficulty that dirt comes off when not considering cleaning is cleaned load.
That is, according to the difference of human body in the diagnosis and treatment, difference and the shape of medical apparatus and instruments and the difference of structure at dirt residual position in medical apparatus and instruments, the biological component that is attached to medical apparatus and instruments is that the composition of dirt is also different.Therefore, must simulate the composition or the simulation of dirt and clean load condition (being the different dirt attachment states at dirt different remaining positions on medical apparatus and instruments), estimate with various cleaning methods and rinser.
Same with the simulation dirt that proposes in the 6th, 447, No. 990 communiques of U.S.'s patent of invention, the factor that the simulation dirt that compound various food form does not consider to clean the load aspect.And food is the big article of parameter, so the difference of weather, the place of production and maker, the performance of the simulation dirt of producing has nothing in common with each other, and is having any problem aspect the repeatability of estimating.
Summary of the invention
Therefore, in view of above situation, the purpose of this invention is to provide the cleaning evaluation pollution method of medical apparatus and instruments, when having eliminated the cleaning of estimating the medical apparatus and instruments pipeline, this method inserts the fluid retention state of the dirt in the pipeline, stable pollutional condition can be formed, cleaning can be correctly estimated.
In addition, the purpose of this invention is to provide a kind of medical apparatus and instruments cleaning evaluation dirt, when the cleaning of medical apparatus and instruments is estimated, body fluid in its simulation human body body cavity, and its repeatability to the cleaning evaluation is good.
Moreover, the purpose of this invention is to provide a kind of medical apparatus and instruments and clean the evaluation dirt, it is the dirt that the cleaning of the reusable medical apparatus and instruments that comprises endoscope is estimated, can be enough the simulation dirt reproduce and the identical pollutional condition of clinical condition after medical apparatus and instruments is actually used in human body, and have repeatability, this repeatability has been considered the different cleaning maneuver of corresponding different pollutional condition selections.
Medical apparatus and instruments of the present invention cleans to estimate and is characterised in that with pollution method it possesses following steps: the dirt implantation step that injects dirt in the pipeline of medical apparatus and instruments; Supply gas in the pipeline that has injected dirt in above-mentioned dirt implantation step or air-breathing, the pollution layer that makes the pipeline inner face form pollution layer forms step.
In addition, the cleaning evaluation of medical apparatus and instruments of the present invention is characterised in that with dirt it contains the simulation dirt, and described simulation dirt only is modulated into by reagent, and constitutes with composition and the concentration of having simulated human consumption liquid.
Have again, the cleaning evaluation of medical apparatus and instruments of the present invention is characterised in that with dirt, described simulation dirt is in harmonious proportion by the commercial reagent and forms, and described commercial reagent is solution and adheres to commercial reagent with material, and described solution contains when the medical apparatus and instruments cleaning is estimated the material as index; Described adhering to material is added in the described solution, is used for making above-mentioned solution to estimate the position attached to the cleaning of above-mentioned medical apparatus and instruments.
Description of drawings
[Fig. 1] is the key diagram of the 1st kind of method of dirt implantation step in explanation the 1st embodiment.
[Fig. 2] is the key diagram of the 2nd kind of method of dirt implantation step in explanation the 1st embodiment.
[Fig. 3] is the key diagram that crud layer forms the 1st kind of method of step in explanation the 1st embodiment.
[Fig. 4] is the key diagram that crud layer forms the 2nd kind of method of step in explanation the 1st embodiment.
[Fig. 5] is the key diagram that crud layer forms the 3rd kind of method of step in explanation the 1st embodiment.
[Fig. 6 a] is the figure of the dirt state in the pipeline that the dirt implantation step causes in explanation the 1st embodiment.
[Fig. 6 b] is that crud layer forms the profile of step at the pollution layer of pipeline inner face formation in explanation the 1st embodiment.
[Fig. 7] is the key diagram that the 1st kind of method of the dirt implantation step that injects dirt in the 2nd embodiment in endoscope channel is described.
[Fig. 8] is the key diagram that the 2nd kind of method of the dirt implantation step that injects dirt in the 2nd embodiment in endoscope channel is described.
[Fig. 9] is the key diagram that the 3rd kind of method of the dirt implantation step that injects dirt in the 2nd embodiment in endoscope channel is described.
[Figure 10] is the key diagram that the 4th kind of method of the dirt implantation step that injects dirt in the 2nd embodiment in endoscope channel is described.
[Figure 11] is the key diagram that the crud layer of endoscope channel in explanation the 2nd embodiment forms the 1st kind of method of step.
[Figure 12] is the key diagram that the crud layer of endoscope channel in explanation the 2nd embodiment forms the 2nd kind of method of step.
[Figure 13] is the key diagram that the crud layer of endoscope channel in explanation the 2nd embodiment forms the 3rd kind of method in the step.
The specific embodiment
It is following that cleaning evaluation to the medical apparatus and instruments in the embodiments of the present invention is elaborated with pollution method with reference to accompanying drawing.
The 1st embodiment
Below with Fig. 1 to Fig. 6 the medical apparatus and instruments in the 1st kind of embodiment clean is estimated and to be described with pollution method.
Fig. 1 is the key diagram of the 1st kind of method of explanation dirt implantation step.Fig. 2 is the key diagram of the 2nd kind of method of explanation dirt implantation step.Fig. 3 is the key diagram that the explanation crud layer forms the 1st kind of method of step.Fig. 4 is the key diagram that the explanation crud layer forms the 2nd kind of method of step.Fig. 5 is the key diagram that the explanation crud layer forms the 3rd kind of method of step.Fig. 6 a is the key diagram of dirt state in the pipeline that causes of explanation dirt implantation step.Fig. 6 b is that the explanation crud layer forms the profile of step at the pollution layer of pipeline inner face formation.
The cleaning evaluation of medical apparatus and instruments comprises with pollution method: inject the dirt implantation step of dirt in pipeline, reach the pollution layer that makes the pipeline inner face form even crud layer under the situation of not having the fluid retention that injects dirt in pipeline and form step.
Utilize Fig. 1 that the cleaning evaluation of medical apparatus and instruments the 1st kind of method with dirt implantation step in the pollution method described.In addition, for dirt, will be elaborated below.
The pipeline 1 of medical apparatus and instruments has the peristome 1a (below, claim a 1a of end opening portion) of an end and the peristome 1b of the other end (below, claim other end peristome 1b) basically.In addition, also have except that the 1a of both ends open portion, 1b, the medical apparatus and instruments of peristome 2 is arranged at pipeline 1 intermediate formation.Peristome 2 is set is in order to insert other medical apparatus and instruments, or be used for being connected with the attaching device of medical apparatus and instruments to the inside of pipeline 1.
When pipeline 1 has peristome 2, before injecting dirt, peristome 2 is sealed with thromboembolism 3.Miscellaneous part beyond the also available thromboembolism 3 such as button etc. can seal the parts of peristome 2 sealings to peristome 2.
After peristome 2 sealings with pipeline 1, the syringe 4 that dirt 5 is housed is positioned on a 1a of end opening portion of pipeline 1.Syringe 4 with an end opening portion 1a place that is positioned on pipeline 1 slowly pushes dirt 5 in the pipeline 1.The dirt 5 that injects from syringe 4 is injected into and is filled in the pipeline 1, injects this dirt 5 till dirt 5a flows out from the peristome 1b of the other end.Flow out from the other end peristome 1b of pipeline 1 in case confirm the dirt 5 that injects from syringe 4, syringe 4 stops to inject dirt 5.
Below, with Fig. 2 the cleaning evaluation of medical apparatus and instruments the 2nd kind of method with the dirt implantation step in the pollution method described.In addition, the part identical with Fig. 1 used identical symbol, do not elaborate at this.
In the 2nd kind of method of dirt implantation step, pipe (tube) 7b is positioned on a 1a of end opening portion of pipeline 1, and this pipe 7b and the 1st glass tubing 8a join, and the 1st glass tubing 8a is arranged on the waste rexeptacle 8 that fills dirt 5.The front end of the 1st glass tubing 8a is immersed in the dirt 5 in the waste rexeptacle 8.Waste rexeptacle 8 is provided with the 2nd glass tubing 8b, and (tube) 7a links to each other with air feeder 6 by pipe.The 2nd glass tubing 8b is not immersed in the dirt in the waste rexeptacle 8, and supplying gas of air feeder 6 is admitted to waste rexeptacle 8 inside.
Promptly supply gas after the 2nd glass tubing 8b is admitted in the waste rexeptacle 8 the inner air voltage rise height of waste rexeptacle 8 from air feeder 6.Inner air voltage rise height causes dirt 5 to be injected in the pipeline 1 through the 1st glass tubing 8a and pipe 7b.After confirming that air feeder 6 and waste rexeptacle 8 inject filling dirt 5 in pipeline 1, stop air feeder 6 work, stop injecting dirt.
Adopt any one method in dirt implantation step the 1st, the 2nd kind of method, after dirt 5 was injected in the pipeline 1, shown in Fig. 6 a, the inner face of pipeline 1 was all by dirt 5 fillings.
Then, with Fig. 3 medical apparatus and instruments being cleaned the 1st kind of method of estimating with pollution layer formation step in the pollution method describes.The part identical with Fig. 1 used identical symbol, do not elaborate at this.
The 1a of end opening portion at the pipeline 1 of having been filled by dirt 5 installs aeriferous syringe 13.The syringe 13 of a 1a of end opening portion that is contained in pipeline 1 is with 1 inside, air injection tube road of syringe 13 inside.The air that injects from syringe 13 will be filled in the peristome 1b that pipeline 1 interior dirt is pushed the other end to.After the air that injects from syringe 13 is released the dirt in the pipeline 15, the path that the formation air runs through in the dirt in the pipeline 1 between a 1a of end opening portion and the other end peristome 1b.Be about to air and be injected in the dirt 5 that is filled in the pipeline, form the sound of path until hearing air to run through dirt, can form uniform pollution layer at pipeline 1 inner face dirt 5 like this, and fluid retention can not take place.
Then, with Fig. 4 medical apparatus and instruments being cleaned the 2nd kind of method of estimating with pollution layer formation step in the pollution method describes.The part identical with Fig. 1 used identical symbol, do not elaborate at this.
Pipe (tube) 10 is positioned on a 1a of end opening portion of the pipeline 1 that is filled with dirt 5, and this pipe 10 connects the 1st glass tubing 12a, and the 1st glass tubing 12a is arranged on the returnable 12 that reclaims dirt 5 usefulness.The leading section of the 1st glass tubing 12a is set at the dirt 5 that immersion is recovered in the returnable 12.Returnable 12 is provided with the 2nd glass tubing 12b, and the 2nd glass tubing 12b links to each other with suction machine 9 by pipe (tube) 11.The front end of the 2nd glass tubing 8b is set at does not have to immerse the position that is recycled to the dirt 5 in the returnable 12, and the air in 9 pairs of returnable of suction machine 12 aspirates.
Promptly by the suction of suction machine 9, the air of returnable 12 is aspirated by the 2nd glass tubing 12b, thereby the air-pressure drop of returnable 12 inside is low.Because the inner air pressure drop is low, the dirt 5 that is filled in the pipeline 1 is passed through the 1st glass tubing 12a and pipe 10 suctions, thereby is recycled in the returnable 12.After dirt 5 in the pipeline 1 is sucked machine 9 suctions, form the path of dirt 5 in the pipeline 1 that runs through between a 1a of end opening portion and other end peristome 1b.The dirt 5 that promptly is filled in the pipeline 1 is sucked the path that the back forms perforation, thereby the inner face of pipeline 1 forms the pollution layer of dirt 5.
Further with Fig. 5 medical apparatus and instruments being cleaned the 3rd kind of method of estimating with pollution layer formation step in the pollution method describes.The part identical with Fig. 1 used identical symbol, do not elaborate at this.
At a 1a of end opening portion of the pipeline 1 that is filled with dirt 5 pipe (tube) 15 from air feeder 14 has been installed.The pipe 15 of the end opening portion 1a of air feeder 14 by being installed in pipeline 1 is supplied gas to the inside of pipeline 1.Release to other end peristome 1b from the dirt that supplying gas of air feeder 14 will be filled in the pipeline 1, at one end form the path that connects in the dirt 5 in the pipeline between peristome 1a and the other end peristome 1b 1.Promptly supply gas and form the perforation path, form the pollution layer of dirt 5 at the inner face of pipeline 1 with this by the dirt in being filled in pipeline 15.
Any one method in the 1st～3 kind of method of use pollution layer formation step as shown in Figure 6, forms the air flue 18 that connects in the dirt 5 of pipeline 1.Thus, dirt 5 spreads out at the inner face of pipeline 1, forms the even pollution layer of no liquid retention.
Form step by above-mentioned dirt implantation step and pollution layer, to other end peristome 1b, the air flue 18 of inner face forms pollution layers with the dirt 5 that spreads out at the pipeline inner face, has obtained drying through this pollution layer of reasonable time from a 1a of end opening portion of pipeline 1.The dry available constant temperature and humidity machine of pollution layer carries out.In addition, the dirt 5 that is used for polluting pipeline 1 both can use the also available existing dirt of sticking material.
The 2nd embodiment
Below utilize Fig. 7～Figure 13 that the cleaning evaluation with medical apparatus and instruments is described with the 2nd embodiment that pollution method is used for endoscope channel.
Fig. 7 is the key diagram of explanation to the 1st kind of method of the dirt implantation step of endoscope channel injection dirt.Fig. 8 is the key diagram of explanation to the 2nd kind of method of the dirt implantation step of endoscope channel injection dirt.Fig. 9 is the key diagram of explanation to the 3rd kind of method of the dirt implantation step of endoscope channel injection dirt.Figure 10 is the key diagram of explanation to the 4th kind of method of the dirt implantation step of endoscope channel injection dirt.Figure 11 is the key diagram that the pollution layer of explanation endoscope channel forms the 1st kind of method of step.Figure 12 is the key diagram that the pollution layer of explanation endoscope channel forms the 2nd kind of method of step.Figure 13 is the key diagram that the pollution layer of explanation endoscope channel forms the 3rd kind of method of step.
At first, the endoscope channel in the 2nd embodiment 20 is described.Formed endoscope channel 20 from the 20a of open rearward end portion of the interface side of endoscope, through operating portion and insertion section, is communicated to the front end opening 20b of insertion section front end always.Operating portion is provided with cylinder (cylinder) portion 21 and forceps channel 22 that is communicated with endoscope channel 20.Trunk portion 21 places are provided with action button 23, for example carry out forwards sending the operation of water from the front end opening 20b of endoscope channel 20, and carry out the operation of aspirating from the front end opening 20b of endoscope channel 20 by the suction pump that is arranged on the 20a of open rearward end portion by the conveying pump that is installed in the 20a of open rearward end portion.In addition, forceps channel 22 is for various inspections or treatment are inserted endoscope channel 20 and the peristome of setting with pliers.
Being pliers inserts endoscope channels 20 from forceps channel 22, outstanding from front end opening 20b by making this pliers, can carry out live body to affected part and take and treat.Use pliers to carry out that live body is taked and when treating, as will wash affected part the time, the operator can send water from front end opening 20b by action button 23.
Utilize Fig. 7 that the 1st kind of method injecting the dirt implantation step of dirt in endoscope channel 20 is described.Before injecting dirt, utilize action button 23 or encapsulant with trunk portion 21 sealings.24 sealings of forceps channel 22 usefulness pliers bolts.
After trunk portion 21 and forceps channel 22 are sealed, be positioned on the 20a of open rearward end portion of endoscope channel 20 with managing 25 syringes 26 that dirt 5 will be housed.The syringe 26 that is positioned on the 20a of open rearward end portion of endoscope channel 20 slowly injects dirt 5 inside of endoscope channel 20.By the dirt 5 that syringe 26 injects, be injected into and be filled in the endoscope channel 20, till dirt flows out from front end opening 20b.Flow out from the front end opening 20b of endoscope channel 20 in case confirm the dirt that injects by syringe 26, then stop to inject dirts 5 with syringe 26.
Utilize the 2nd kind of method injecting the dirt implantation step of dirt in Fig. 8 subtend endoscope channel to describe.The part identical with Fig. 7 used identical symbol, do not elaborate at this.
In the 2nd kind of method of dirt implantation step, the forceps channel 22 of endoscope channel 20 is sealed, and the syringe 28 that dirt 5 is housed is installed on the trunk portion 21 by managing 27.The syringe 28 that is positioned on the trunk portion 21 injects dirt 5 to endoscope channel 20.The dirt 5 that injects with syringe 26 is injected into and is filled in the endoscope channel 20, till being injected into dirt and flowing out from front end opening 20b and the 20a of open rearward end portion.The dirt 5 that affirmation is injected by syringe 26 stops to inject dirts 5 with syringe 26 after flowing out from the front end opening 20b of endoscope channel 20 and the 20a of open rearward end portion.
Utilize the 3rd kind of method injecting the dirt implantation step of dirt in Fig. 9 subtend endoscope channel to describe.The part identical with Fig. 7 used identical symbol, do not elaborate at this.
In the 3rd kind of method of dirt implantation step, the trunk portion 21 of endoscope channel 20 is sealed with forceps channel 22, and suction machine 29 is positioned on the 20a of open rearward end portion by managing 30.The front end opening 20b of endoscope channel 20 is immersed in the dirt 5 in the waste rexeptacle 31.By the suction action of suction machine 29, the dirt 5 in the front end opening 20b of the endoscope channel 20 suction waste rexeptacle 31.The dirt of confirming to be sucked 5 stops suction action after the 20a of the open rearward end portion outflow of endoscope channel 20.
Utilize the 4th kind of method injecting the dirt implantation step of dirt in Figure 10 subtend endoscope channel to describe.The part identical with Fig. 7 used identical symbol, do not elaborate at this.
In the 4th kind of method of dirt implantation step, the trunk portion 21 of endoscope channel 20 is sealed with forceps channel 22, and pipe 33 is positioned on the 20a of open rearward end portion, and this pipe 33 is connected with the 1st glass tubing 34a of the waste rexeptacle 34 that dirt 5 is housed.The front end of the 1st glass tubing 34a is immersed in the dirt 5 in the waste rexeptacle 34.Waste rexeptacle 34 is provided with the 2nd glass tubing 34b, and the 2nd glass tubing 34b joins with air feeder 32 by managing 35.The front end of the 2nd glass tubing 34b is configured in the position that does not contact dirt 5 in the waste rexeptacle 34.Air feeder 32 work, after supplying gas in waste rexeptacle 34 inside, the air of waste rexeptacle 34 presses liter.Thereby dirt 5 from the 1st glass tubing 34a through manage 33 and the 20a of open rearward end portion be injected in the endoscope channel 20.After confirming that injection endoscope channel 20 interior dirts 5 flow out from front end opening 20b, action stops to supply gas.
Use any one method in above-mentioned the 1st～4 kind of method, dirt 5 injections are fills up in the endoscope channel 20.
Then, utilize Figure 11 that the 1st kind of method of the pollution layer formation step of endoscope channel in the 2nd embodiment described.The part identical with Fig. 7 used same-sign, no longer elaborates.
Below, utilize Figure 12 that the 2nd kind of method that the endoscope channel pollution layer forms step described.The part identical with Fig. 7 used same-sign, no longer elaborates.
Utilize Figure 13 that the 3rd kind of method that endoscope channel pollution layer in the 2nd kind of embodiment forms step described.The part identical with Fig. 7 used same-sign, no longer elaborates.
Use above-mentioned pollution layer to form in the step any one method in the 1st～3 kind of method, make in the endoscope channel 20 and form air flue in the dirts 5.Thus, dirt 5 is spread the inner face that is coated in endoscope channel 1, forms the even pollution layer of no liquid retention.
Form on the basis of step at above-mentioned dirt implantation step and pollution layer, inner face from the 20a of open rearward end portion of endoscope channel 20 to front end opening 20b forms air flue, dirt 5 is coated in the inner face of endoscope channel 20 by the shop, this state is through suitable drying time, is used for the cleaning evaluation after making its drying.And drying can be used constant temperature and humidity machine.In addition, be used for polluting endoscope channel 20 interior dirts 5 and both can have used the also available existing dirt of sticking material.
Then, utilize table 1 and table 2 that the pollution method of the embodiment that carries out with the inventor and the comparative test result of pollution method in the past are described, the pipeline internal protein of wherein having measured the medical apparatus and instruments that comprises endoscope is quantitative.Wherein, use BSA (bovine serum albumin) as dirt, the mensuration system is used Micro BCA method (protein determination kit).In addition, in above-mentioned dirt implantation step, in a single day dirt is injected into and is filled in the pipeline, and pollution layer forms in the step by suction or supplies gas and dirt unnecessary in the pipeline is released the operation that forms air flue and pollution layer abbreviates the ventilation operation as.I.e. table 1 expression be in the past pollution method, do not contain the ventilation operation; What table 2 was represented is the used pollution method of present embodiment, contains the ventilation operation.
Table 1
| μ g/ suction channel | Log (logarithm is represented) | |
| There is not the ventilation operation | 157725 | 5.20 |
| 309900 | 5.49 | |
| 653474 | 5.82 | |
| 688275 | 5.84 |
Table 2
| μ g/ suction channel | Log (logarithm is represented) | |
| The ventilation operation is arranged | 246825 | 5.39 |
| 214275 | 5.33 | |
| 222150 | 5.35 | |
| 219600 | 5.34 |
During the medical apparatus and instruments cleaning was estimated, index was a bacterium sometimes, index is for example Organic substances etc. of other materials sometimes.In addition, how the cleaning evaluation is estimated with the reduction of index number before and after cleaning, and index is represented with the Log logarithm.As shown in Table 1 and Table 2, the method that contains the operation of ventilating is compared with the method for not having the ventilation operation, and the former is improved at the stability of index protein determination value.And the error of Log logarithm value is in the scope of allowing among the resulting result of the pollution method in the above-mentioned embodiment.Therefore, when the cleaning of medical apparatus and instruments is estimated, when imagination can be estimated with the proteic absolute value of index, must pass through the stability that ventilation operation assurance is polluted.In a word, the pollution method in the above-mentioned embodiment is the effective ways that cleaning is estimated that carry out to medical apparatus and instruments.
Below for two examples medical apparatus and instruments in the above-mentioned the 1st and the 2nd embodiment being cleaned the particular content of estimating with dirt is elaborated.Below the medical apparatus and instruments of explanation cleans to estimate with dirt and is used for inserting body cavity when these medical apparatus and instruments use to estimating as reusable medical apparatus and instruments cleanings such as endoscopies, is used for the diagnosis and the treatment of internal organs in the body cavity.Such as, when the endoscope in the medical apparatus and instruments inserts body cavity, contacted a lot of Digestive systems.
Digestive system is made of various compositions.In the constituent of Digestive system, bile and serum composition are the highest as the contained concentration of main component.And bile and serum mainly are made of protein and lipid.
On the other hand, for the protein and the lipid that constitute bile and serum, these two kinds of article of selling with the reagent form are arranged, promptly simulate dirt so the reagent of protein and lipid can be adjusted into the simulation Digestive system that bile is identical with serum-concentration in concentration and the Digestive system.That is, after the position is estimated in the cleaning of polluting medical apparatus and instruments with the simulation dirt of simulation Digestive system, medical apparatus and instruments identical state in the time of can reappearing with clinical use.
Therefore, the protein of selling on the market by allotment generates all experimental results of simulating dirt with the reagent of lipid and shows, mix 0.1g/dl～8.0g/dl serum albumin and 1.0g/dl～4.0g/dl glycoprotein as protein, and make and wherein contain 0.5g/dl～7.0g/dl phospholipid as lipid, can synthesize the simulation dirt thus.
Specifically, experiment according to the inventor, with the 7.5g/dl serum albumin as serum albumin, with 4.0g/dl mucin (gastric mucin for example, ホ グ system チ Application) mixes as phospholipid as glycoprotein and with 5.0g/dl lecithin, can generate the simulation dirt, this simulation dirt has and the protein of the main component that constitutes Digestive system bile and serum and the protein and the lipid of lipid same concentrations.That is, serum albumin, mucin and lecithin that the market is sold mix according to specified weight or ratio respectively, can generate the concentration of being made up of protein and lipid and be similar to the bile of human consumption liquid and the simulation dirt of serum.
On the other hand, when the cleaning that carries out medical apparatus and instruments was estimated, elder generation estimated the position with the cleaning that dirt pollutes medical apparatus and instruments, then with after rinser cleaning or the hand washing totally, cleaned the dirt recovery of estimating the position with remaining in medical apparatus and instruments, estimated thus.The method that reclaims residual dirt has supercritical ultrasonics technology for example, wipe method and the perfusion method that carries out with recovery liquid etc.As the evaluation of cleaning, but the cleaning of perusal medical apparatus and instruments estimate the position and observe, but also perusal is estimated the residual dirt that reclaims at the position and is estimated from cleaning.Moreover the residual dirt that the position is estimated in recyclable cleaning carries out quantitative analysis and makes evaluation.
As the quantitative analysis assessment method, can utilize with the quantitative method of protein, for example Kjeldahl method (Kjeldahl method, Kjeldahl), Lowry method (phenol reagent process) and BCA method etc. as index.In addition, also can make to have bacterium in the dirt, carry out quantitative analysis as index with bacterium.
With protein component in the dirt is in the index quantitative method of being carried out, the BCA method is after the medical apparatus and instruments after being polluted by dirt is cleaned, the recovery liquid that use contains surfactant carries out quantitative assay to reclaiming the dirt protein that contains in the liquid after reclaiming and remaining in medical apparatus and instruments and clean the dirt of estimating the position.And surfactant concentrations preferably is no more than the upper limit of concentration of setting in the BCA method.
Can the not get dirty influence of properties and dirt recovery method of BCA method is correctly to quantification of protein.
In addition, also available Micro BCA method replaces the BCA method.Micro BCA method is the sample after remaining in dirt on the medical apparatus and instruments of use after cleaning and reclaiming to be placed on to reclaim in the liquid dilute, make its concentration reach the interior as 0.5 μ g/ml～20.0 μ g/ml of protein determination scope of Micro BCA method, from reclaim liquid, take out the diluted residual dirt sample of 1ml, after wherein adding the reaction reagent that 1ml mixes up in advance, it was reacted 1 hour in 60 ℃ environment.After reacted sample is cooled to room temperature, with the light measurement absorbance of 562nm.The measurement result of this absorbance is made into standard curve in addition, therefrom calculates Protein content.In addition, the protein determination scope of Micro BCA method for example is 0.5 μ g/ml～20.0 μ g/ml, so as cleaning metewand, be suitable for those most and require by cleaning the cleaning evaluation of the application medical apparatus and instruments that significantly reduces dirt.
When measuring the protein content that cleans residual dirt on the medical apparatus and instruments of back with this BCA method or Micro BCA method, the estimator constitutes concentration is the highest in the human consumption liquid composition the composition-bile and the concentration of serum by simulation, the simulation dirt that use is generated by reagent is so can carry out the cleaning evaluation under near the condition of clinical state.
In addition, be cleaned the medical apparatus and instruments that evaluation is polluted with dirt, because can carry out quantitatively, so available concrete numerical value is estimated cleaning with BCA method or Micro BCA method protein to residual dirt for above-mentioned.
Moreover above-mentioned cleaning evaluation can generate with the reagent of selling on the market with dirt, so the favorable reproducibility of the concentration of dirt and character when the cleaning of doing medical apparatus and instruments is estimated, can be carried out quantitative assessment under identical conditions.
Below other the dirt that is different from that above-mentioned cleaning evaluation constitutes with dirt is described in detail for example.
As mentioned above, the cleaning evaluation of medical apparatus and instruments is after the medical apparatus and instruments that polluted by dirt in to medical procedure cleans, the evaluation of being undertaken by the residual quantity of dirt on the medical apparatus and instruments.The evaluation methodology of estimating medical apparatus and instruments cleaning back dirt Restzustand has perusal to remain in dirt or other observational techniques that medical apparatus and instruments cleans the evaluation position.Perhaps, adopt some ways of recycling, after estimating the position dirt is reclaimed from the cleaning of medical apparatus and instruments, observe dirt after the recovery by naked eyes or other view modes, or carry out quantitative analysis etc.
As the view mode beyond the perusal, in order to detect residual dirt, for example available protein dyes in conjunction with pigment etc.Then available bacterium or protein carry out check and analysis as index during quantitative analysis.Detecting the method for bacterium counts method, detects method of protein such as Lowry method and BCA method etc. as cultivating back mensuration bacterium.
When cleaning is estimated, preferably in the perusal evaluation, can numerically estimate cleaning by volumetric analysis.In addition, in the medical apparatus and instruments, endoscope is owing to inserting in the body cavity, so endoscope contacts, adheres to a lot of Digestive systems in body cavity.
Below the medical apparatus and instruments of explanation cleans to estimate and uses dirt, be the index material when estimating by cleaning and add therein adhere to the simulation dirt that constitutes with material, described index material for example contains the solution of bacterium or contains the proteinic solution of Digestive system main component; Adding described adhering to material is medical apparatus and instruments to be cleaned the tack of estimating the position in order to guarantee to contain bacterium or protein solution containing.This simulation dirt is to use commercially available reagent to constitute, and for example makes protein with serum albumin etc., adheres to material with works such as glycoproteins etc.Glycoprotein can be used hyaluronate.
Promptly, in the detection method of quantitative analysis, measure bacterium and count the solution that detects as index in the bacterium that detects as index in the method or Lowry method and the BCA method by cultivating the back based on protein, and in order to make solution attached on the medical apparatus and instruments and the reagent of selling on the simulation dirt available markets of forming with material that adheres to that adds in solution synthesizes.Hereinafter for the cleaning method of estimating medical apparatus and instruments respectively, and rinser etc. clean maneuver, use material for adhering to, change addition (concentration) and the material that adheres to material during evaluation, to change medical apparatus and instruments is cleaned the adhesive force of estimating the position, promptly change the cleaning load of the difficulty that comes off of the dirt that adheres to.
Below use above-mentioned simulation dirt that the cleaning evaluation methodology of medical apparatus and instruments is described.Make above-mentioned simulation dirt estimate the position, place certain hour attached to cleaning with the reusable medical apparatus and instruments headed by the endoscope or the experiment sample of simulated medical instrument etc.For there being the simulation dirt to adhere to and placed the medical apparatus and instruments behind the certain hour, clean by the cleaning method that will estimate cleaning, for example the hand washing method of patient's hand washing or the cleaning maneuver of utilizing various rinsers to clean etc.To the medical apparatus and instruments after cleaning, adopt above perusal to medical apparatus and instruments residual simulation dirt estimate, estimate cleaning according to the amount of the residual dirt after cleaning simultaneously, for example after reclaiming residual simulation dirt with after the standard solution dilution, adopt Lowry method, BCA method, the protein as analysis indexes is carried out volumetric analysis.
When carrying out this cleaning evaluation, the appraiser changes adhering to amount of substance (concentration) or material of adding in the simulation dirt, to change the adhesive force of dirt to medical apparatus and instruments.That is since when the human body different parts carried out diagnoses and treatment attached to the dirt attachment state difference of waste concentration difference on the medical apparatus and instruments and medical apparatus and instruments different parts, be necessary to select suitable cleaning maneuver according to dirt that adheres to and attachment area.In order to select to cleaning maneuver, use is adhered to amount of substance (concentration) and the different simulation dirt of material, can reappear clinical situation or more serious pollutional condition, select should cleaning the cleaning evaluation of load, and can select the most appropriate cleaning maneuver.
Above-mentioned as cleaning evaluation with adhering to the glycoprotein of using material with the hyaluronate conduct in the simulation dirt of dirt, as hyaluronate, can use hyaluronate sodium.Determine that this adheres to when using material, used cleaning maneuver, the factors such as operation when reaching evaluation are determined when the glycoprotein concentration of the biological component that the preferred combination medical apparatus and instruments may adhere to when reality is used in treatment, medical apparatus and instruments cleaning.Consider to learn by inventor's experiment on these the basis, adhere to concentration with material preferably smaller or equal to 10mg/ml.Especially when estimating the difference of cleaning maneuver, it is suitable adhering to the material concentration height.And when diameter is than the cleaning in tubule road in estimating flexible endoscope, must make concentration the most suitable, to guarantee simulating dirt attached to carrying out the position that cleaning is estimated.
As mentioned above because can generate the simulation dirt with the reagent of selling on the market, so can carry out favorable repeatability the cleaning evaluation, and can select the cleaning maneuver.
By above-mentioned implementation method, can provide a kind of medical apparatus and instruments to clean evaluation and use pollution method, when the pipeline cleaning of medical apparatus and instruments is estimated, can remove the fluid retention that inserts dirt in the pipeline, form stable pollutional condition, cleaning is correctly estimated.
In addition, can provide a kind of medical apparatus and instruments to clean evaluation and use dirt, when the medical apparatus and instruments cleaning is estimated, body fluid in the simulation human body body cavity, and the repeatability that cleaning is estimated is good.
Moreover, can provide a kind of medical apparatus and instruments to clean the evaluation dirt, it is a dirt of estimating the cleaning of the reusable medical apparatus and instruments that comprises endoscope, can be enough the simulation dirt reproduce and the identical pollutional condition of clinical condition after medical apparatus and instruments is actually used in human body, and have repeatability, this repeatability has been considered the different cleaning maneuver of corresponding different pollutional condition selections.
Claims (16)
1, medical apparatus and instruments cleans to estimate and uses pollution method, it is characterized in that, it comprise in the pipeline of medical apparatus and instruments the dirt implantation step that injects dirt, and in the pipeline that has injected dirt by above-mentioned steps by supplying gas or the air-breathing pollution layer that makes the pipeline inner face form pollution layer forms step.
2, medical apparatus and instruments as claimed in claim 1 cleans to estimate and uses pollution method, it is characterized in that, in the described dirt implantation step, from an end of the pipeline of described medical apparatus and instruments dirt is injected, and above-mentioned pipeline is filled, and dirt is flowed out from the other end.
3, medical apparatus and instruments as claimed in claim 1 cleans to estimate and uses pollution method, it is characterized in that, have the sealing step in the described dirt implantation step, before injecting dirt, the opening of sealing except the dirt flow export of the dirt inlet of pipeline one end of described medical apparatus and instruments and the other end.
4, medical apparatus and instruments as claimed in claim 1 cleans to estimate and uses pollution method, it is characterized in that described pollution layer forms in the step, by in described pipeline, supplying gas or air-breathing, form the air flue that connects dirt in the pipeline, make dirt form conforming layer at above-mentioned pipeline inner face.
5, medical apparatus and instruments cleans to estimate and uses dirt, it is characterized in that, it contains the simulation dirt that is only formed by the reagent modulation, and constitutes with composition and the concentration of having simulated human consumption liquid.
6, medical apparatus and instruments as claimed in claim 5 cleans to estimate and uses dirt, it is characterized in that, described simulation dirt is simulated the composition and the concentration of main composition bile and serum in the described human consumption liquid.
7, medical apparatus and instruments as claimed in claim 6 cleans to estimate and uses dirt, it is characterized in that described simulation dirt uses the reagent of protein and lipid, and described protein and lipid are protein and the lipids that constitutes described bile and serum.
8, medical apparatus and instruments as claimed in claim 7 cleans to estimate and uses dirt, it is characterized in that in the described simulation dirt, what described protein was used is the reagent of serum albumin and glycoprotein, and what described lipid was used is phospholipid reagent.
9, medical apparatus and instruments as claimed in claim 8 cleans to estimate and uses dirt, it is characterized in that, described simulation dirt be adjusted to contain 0.1g/dl～8.0g/dl serum albumin and 1.0g/dl～4.0g/dl glycoprotein as protein and 0.5g/dl～7.0g/dl phospholipid as lipid.
10, medical apparatus and instruments as claimed in claim 9 cleans to estimate and uses dirt, it is characterized in that in the described simulation dirt, described serum albumin uses sero-abluminous reagent, and described glycoprotein uses mucinous reagent, and described phospholipid uses the reagent of lecithin.
11, medical apparatus and instruments as claimed in claim 10 cleans to estimate and uses dirt, it is characterized in that, for described simulation dirt, use the 7.5g/dl serum albumin to modulate as phospholipid as glycoprotein and use 5.0g/dl lecithin as serum albumin, use 4.0g/dl mucin.
12, medical apparatus and instruments cleans to estimate and uses dirt, it is characterized in that, contain the simulation dirt that forms by commercially available reagent modulation, described commercial reagent is the solution and the commercial reagent of using material of adhering to that is added in the described solution that contains as the material of medical apparatus and instruments cleaning evaluation index, and described adhering to material is used for making above-mentioned solution to estimate the position attached to the cleaning of medical apparatus and instruments.
13, clean evaluation as claim item 12 described medical apparatus and instruments and use dirt, it is characterized in that the material as the cleaning evaluation index that contains in the described solution is protein such as bacterium, serum albumin.
14, clean evaluation as claim item 12 described medical apparatus and instruments and use dirt, it is characterized in that described adhering to having used glycoprotein in the material.
15, clean evaluation as claim item 14 described medical apparatus and instruments and use dirt, it is characterized in that the described glycoprotein that adheres to material contains hyaluronate or hyaluronate sodium.
16, clean to estimate as the described medical apparatus and instruments of claim item 15 and use dirt, it is characterized in that, to adhere to the hyaluronate of the glycoprotein of material or the concentration of hyaluronate sodium be smaller or equal to 10mg/ml as described.
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| JP2004-378014 | 2004-12-27 | ||
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US9351797B2 (en) | 2012-10-08 | 2016-05-31 | 3M Innovative Properties Company | Wash monitor and method of use |
| US9575022B2 (en) | 2012-10-08 | 2017-02-21 | 3M Innovative Properties Company | Electronic indicator for monitoring efficacy of a cleaning cycle |
| CN107589117A (en) * | 2017-08-22 | 2018-01-16 | 贵州省畜牧兽医研究所 | A kind of quick microscopy diagnostic kit of swine eperythrozoonosis and preparation method thereof |
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| DE19602673A1 (en) * | 1996-01-25 | 1997-08-07 | Pereg Gmbh | Synthetic test soiling |
| US6428746B1 (en) * | 1997-09-18 | 2002-08-06 | Custom Ultrasonics Inc. | Method for determining the efficacy of a decontamination procedure |
| US6447990B1 (en) * | 1998-08-10 | 2002-09-10 | University Of Manitoba | Artificial test soil |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US9351797B2 (en) | 2012-10-08 | 2016-05-31 | 3M Innovative Properties Company | Wash monitor and method of use |
| US9575022B2 (en) | 2012-10-08 | 2017-02-21 | 3M Innovative Properties Company | Electronic indicator for monitoring efficacy of a cleaning cycle |
| US10563245B2 (en) | 2012-10-08 | 2020-02-18 | 3M Innovative Properties Company | Wash monitor and method of use |
| US11434518B2 (en) | 2012-10-08 | 2022-09-06 | 3M Innovative Properties Company | Wash monitor and method of use |
| CN107589117A (en) * | 2017-08-22 | 2018-01-16 | 贵州省畜牧兽医研究所 | A kind of quick microscopy diagnostic kit of swine eperythrozoonosis and preparation method thereof |
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