DE102011050765A1 - Method for determining degree of pollution of narrow-lumen medical device e.g. flexible endoscope, involves introducing clean swab into transparent test vessel using holder for predetermined time - Google Patents

Abstract

The method involves inserting or removing a clean swab (102) of a wire (100) into a cavity (104) of a medical device (106). The clean swab is introduced into a transparent test vessel using a holder fixed at an end of the wire for detection of adenosine triphosphate (ATP) or adenosine monophosphate (AMP). The clean swab is left in the test container for predetermined time. The test container is introduced into the measuring device for luminescence measurement. An independent claim is included for a device for determining degree of pollution of narrow-lumen medical device.

Description

Field of the invention

The invention relates to the field of hygiene, in particular to the verification of the cleaning of small-sized medical devices (i.e., with narrow cavities), in particular the cleaning of flexible endoscopes.

• a) der Erkennung, Verhütung, Überwachung, Behandlung oder Linderung von Krankheiten,
• b) der Erkennung, Überwachung, Behandlung, Linderung oder Kompensierung von Verletzungen oder Behinderungen,
• c) der Untersuchung, der Ersetzung oder der Veränderung des anatomischen Aufbaus oder eines physiologischen Vorgangs oder
• d) der Empfängnisregelung zu dienen bestimmt sind und deren bestimmungsgemäße Hauptwirkung im oder am menschlichen Körper weder durch pharmakologisch oder immunologisch wirkende Mittel noch durch Metabolismus erreicht wird, deren Wirkungsweise aber durch solche Mittel unterstützt werden kann.“

A medical device is a product within the meaning of § 3 no. 1 of the German Medical Devices Act. There it says:
"Medical devices are all instruments, apparatus, devices, software, substances and preparations made of substances or other articles used individually or interlinked, including software specifically intended for diagnostic or therapeutic use by the manufacturer and used by the manufacturer for the proper functioning of the medical device Manufacturer for use for humans by means of their functions for the purpose

• (a) the detection, prevention, monitoring, treatment or alleviation of diseases;
• b) the detection, monitoring, treatment, alleviation or compensation of injury or disability,
• (c) the examination, replacement or alteration of the anatomical structure or a physiological process; or
• (d) they are intended to serve the purposes of conception and that their principal intended effect in or on the human body is not achieved by pharmacological or immunological means or metabolism, but the mode of action of which may be assisted by such means. "

Due to their design, the cleaning of English-language medical devices places special demands on the reprocessing process, since in particular the cleaning success within a narrow cavity can usually not be checked by visual inspection. Flexible endoscopes pose even more stringent requirements because their ducts are crafted by hand, so each flexible endoscope is a one-off piece and therefore requires an individual preparation process.

Furthermore, the characteristics of the contamination depend, inter alia, on the patient, the type of application of the endoscope on the patient (intervention), the duration of intervention and the duration between application and treatment.

Therefore, cleaning that is sufficiently effective according to hygienic aspects is typically possible only by a combination of manual and mechanical cleaning methods.

As a result, although the cleaning performance of a machine cleaning process can be determined or validated, this cleaning performance can not ensure the cleaning success in all cases.

This has the consequence that after each cleaning process, the cleaning success must be determined separately. This is not feasible by visual inspection in Englumigen medical products.

State of the art

In the food industry, it is sometimes necessary to measure bacterial contaminants routinely during the production process. For this purpose, the detection of ATP (adenosine triphosphate, which occurs only in living organisms) by means of a luciferin-luciferase reaction has proven to be a useful method. This is z. In the publication [ Hawronsky, J.-M. and Holah, J .: "ATP: a universal hygiene monitor"; Trends in Food Science & Technology, Volume 8, 1997, Issue 3, Pages 79-84 ], the contents of which are hereby incorporated by reference into this specification.

A useful method, this proof in Englumigen medical devices such. However, to use flexible endoscopes, but is not yet known.

task

The object of the invention is to specify a method and a device which make it possible to check the degree of soiling of an English-language medical device or the cleaning success of such a medical device.

solution

This object is achieved by the inventions having the features of the independent claims. Advantageous developments of the inventions are characterized in the subclaims. The wording of all claims is hereby incorporated by reference into the content of this specification. The inventions also include all reasonable and in particular all mentioned combinations of independent and / or dependent claims.

In the following, individual process steps are described in more detail. The steps do not necessarily have to be performed in the order given, and the method to be described may also have other steps not mentioned.

A method is proposed for determining the degree of soiling of a narrow-gauge medical device-in particular a flexible endoscope-in which the medical device has at least one cavity, with the following steps:
A wire, which has a swab at one end, is introduced with the swab ahead into the at least one cavity of the medical device and removed again. As a result, the swab absorbs any remaining contamination of the cavity of the medical device after an inadequate preparation, at least partially or with relatively high probability.

The swab can be made for example of a small sponge or foam. It should preferably be sterile and / or clean.

The term of sterility is in the DIN EN 556-1 Are defined. This definition is hereby incorporated by reference into a part of the description.

As clean, in the context of the description of the swab, a condition is considered in which the swab shows only a very small AMP (adenosine monophosphate) reaction when measured directly in a test container without application in a cavity. It is sufficient for the solution of the problem if the swab has such a reproducible state that he always has an equal AMP concentration on its surface.

It is favorable in the proposed method, the wire with the swab to the stop, d. H. over the full length of the cavity of the medical device to introduce into this and then remove again.

The end of the wire where the swab is located is then fixed to a holder.

To ensure that there is no contamination of the swab by z. B. not enough disinfected hands o. Ä. Comes, the fixation of the wire is done without touching the swab or the adjacent end region of the wire by the user.

The swab is then inserted with the help of the holder in a test container containing the substances required for the detection of ATP and / or AMP. As a result, the swab gets in contact with these substances.

The swab is then left in the test container for a predetermined time to allow the necessary chemical and biochemical reactions for ATP and AMP detection, respectively, to proceed through the luciferin-luciferase reaction.

The test container is then introduced into a measuring device for luminescence measurement.

The determined ATP and / or AMP content indicates the contamination of the swab with living microorganisms and / or dead residues and thus allows a conclusion on the degree of contamination of the medical device.

The proposed method is very sensitive. It is also able to detect small amounts of living microorganisms or non-living pollution. This makes it possible for the first time to check the cleaning success of narrow-gauge medical devices.

The known sensitive methods for checking the degree of contamination of Englumigen medical devices are relatively complex in their handling. The known methods are either selective (eg they can only detect blood or protein residues) or place special demands on the analyst's skills in the field of reprocessing medical devices (medical practices, central sterile supply departments, endoscope departments , etc.) are not always given. For example, you must work with rinsing solutions; These must be passed through the narrow cavity, then collected and fed to the chemical or microbiological analysis. The chemical analysis makes special demands because various reagents have to be dosed in defined volumes. The microbiological analysis, however, delivers results only with several days delay.

The proposed method, however, is characterized both by the simplicity of handling and by the speed.

By using a swab at the end of a long wire, it is possible to take a smear even on long lumens. The use of an ATP and / or AMP detection system ensures that the test result is immediately available.

The inclusion of the swab in a holder avoids that the swab is contaminated during sampling by the user or the environment. This leads to reliable results. It also further increases the sensitivity of the detection.

The proposed method reduces the pollution degree of essentially only a few simple steps.

In an advantageous development of the method, the wire is shortened after the fixation of the end by breaking at a designated edge on the length of the holder. This allows to completely insert the test container with the holder and the potentially contaminated swab (sample) to be examined into the measuring instrument and close it tightly, which improves the procedure and the accuracy of the measurement.

Furthermore, to solve the problem, a device for determining the degree of contamination of a lumen-shaped medical device is proposed, wherein the medical device has at least one cavity. Among other things, the device has a wire which is at least as long as the cavity of the medical device to be tested. The wire has at its one end a swab, which is typically made of foam and whose diameter is adapted to the diameter of a cavity to be tested of the medical device.

It is advantageous if the swab is sterile and / or clean, ie free of ATP and / or AMP.

It also includes a holder for receiving and fixing that end of the wire, which has the swab. Another component of this device is a test container. The holder is designed such that the swab can be introduced by means of the holder in the test container.

The wire should advantageously consist of a flexible material as possible, but whose modulus of elasticity is at least so great that it is possible to introduce the wire with a pressure force of 10 N in the medical device without it kinks or breaks off. This makes it possible to introduce the wire into the medical device in such a way that the wire follows the course of the cavity of the medical device. Preferably, this material is a plastic.

The holder advantageously has a channel which extends over its entire length and which makes it possible to pass the wire through the holder. Furthermore, at its upper end remote from the swab, the holder has at least one sharp edge on which the protruding part of the wire can be broken off after the end of the wire carrying the swab has been fixed. As a result, the fixed part of the wire is shortened to the length of the holder, whereby the test container with the sample to be examined fits completely into the measuring device.

Preferably, the test container in a chamber contains the substances required for ATP and / or AMP detection and is also designed to be transparent and suitable for a suitable measuring device into which the test container can be introduced for performing a measurement. It is favorable if the substances present in the test container are a luciferin luciferase kit which, in combination with ATP and / or AMP, carries out a bioluminescence reaction which can be measured by the measuring device.

Furthermore, the device may also comprise a measuring device for luminescence measurement. In the meter, it may be advantageous z. For example, the model "Lumitester PD-20" of the manufacturer Kikkoman act, for which also suitable test containers are commercially available.

Further details and features will become apparent from the following description of preferred embodiments in conjunction with the subclaims. In this case, the respective features can be implemented on their own or in combination with one another. The possibilities to solve the problem are not limited to the embodiments. For example, area information always includes all - not mentioned - intermediate values and all imaginable subintervals.

The embodiments are shown schematically in the figures. The same reference numerals in the individual figures designate the same or functionally identical or with respect to their functions corresponding elements. In detail shows:

1 an illustration of step a) the determination of the degree of contamination of an endoscope according to the inventive method;

2 an overview of a preferred embodiment of the holder;

3 a view of the swab facing end of this preferred embodiment of the holder;

4 a view of the swab facing away from the end of this preferred embodiment of the holder; and

5 a schematic cross section through the arrangement in the meter in an advantageous embodiment of the invention during a luminometric measurement (step e)).

1 schematically illustrates the first step of the method according to the invention: a flexible wire 100 who at one end has one sterile swabs 102 has, with the swab ahead in the cavity 104 an endoscope 106 introduced. The swab touches 102 on the walls of the cavity 104 along. He can thereby absorb any impurities present there. After the swab 102 using the wire 100 as far as possible in the cavity 104 of the endoscope 106 is introduced, it is removed again.

The end of the wire 100 which the swab 102 has, is then attached to a holder 200 fixed. In 2 Figure 3 is an overall view of that preferred embodiment of the holder 200 shown, which is designed for the test container for the measuring device "Kikkoman Lumitester PD-20". A feather 202 This ensures that the holder 200 in the test container 502 (S. 5 ) does not slip. At one end of the holder 200 there is a recording device 204 for the swab 102 while the other end of the holder 200 designed so that it connects to the end of the test container 502 a smooth finish 206 forms.

3 shows the same preferred embodiment of the holder 200 from the swab 102 facing out. This end is characterized by the receiving and fixing device 204 for the swab 102 which, in this embodiment, consists of three arms between which the swab 102 is clamped. For this purpose the wire becomes 100 with the end without swab ahead in the channel 300 extending through the entire length of the holder 200 pulls, threaded, pushed through and pulled out at the other end of the holder until the swab 102 is fixed.

That from the swab 102 opposite end of the same preferred embodiment of the holder 200 is in 4 shown. At this end of the channel 300 through which the wire 100 is guided, there are two sharp edges 400 at which the after fixation of the swab 102 protruding part of the wire 100 can be canceled. This will ensure that the wire completes 206 of the owner 200 or the test container is not surmounted, so that the test container with the holder 200 completely fits into the meter and its lid can close tightly.

The following will be on 5 Referenced. If the wire 100 with the swab 102 firmly in the holder 200 is fixed, the holder with the swab in the test container 502 introduced to then perform the luminometric measurement can. The test container 502 contains a luciferin luciferase kit 506 in one through a membrane 504 closed chamber. When inserting the holder 200 in the test container 502 the holder pierces the membrane 504 so that the swab possibly contaminated with ATP and / or AMP 102 in contact with the luciferin luciferase kit 506 comes.

Then the test container 502 into the meter 500 used and this closed.

The arrangement with a luminometric measurement in the measuring device 500 is in 5 shown schematically in cross section. The on the holder 200 fixed swabs 102 is in the test container 502 , In the luciferin luciferase kit 506 In the case of contamination, a bioluminescent reaction takes place which contains a photodetector 508 in the meter 500 is detected. The type of holder 200 and test container 502 is chosen according to the advantageous developments of the invention so that the lid 510 of the measuring device 500 tightly closes, which prevents light from outside falsifying the measurement.

Since the luciferin-luciferase reaction in the presence of ATP and / or AMP requires a certain amount of time until sufficient bioluminescence can be observed, the actual measurement of the measuring device does not start until after a predetermined time of a few seconds. From the strength of luminescence, the meter can 500 close to the amount of existing ATP or AMP.

A measure of this amount is provided by the meter 500 displayed. From this level may be due to the degree of contamination of the endoscope 106 getting closed.

LIST OF REFERENCE NUMBERS

100

 wire

102

 swab

104

 cavity

106

 endoscope

200

 holder

202

 feather

204

 Fixation for swabs

206

 graduation

300

 Channel for wire

400

 sharp edge

500

 gauge

502

 test container

504

 membrane

506

 Luciferin-luciferase kit

508

 photodetector

510

 Cover of the measuring device

quoted literature

quoted non-patent literature

• DIN EN 556-1
• Hawronsky, J.-M. and Holah, J .: "ATP: a universal hygiene monitor"; Trends in Food Science & Technology, Volume 8, 1997, Issue 3, Pages 79-84; doi: 10.1016 / S0924-2244 (97) 01009-1

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited non-patent literature

• Hawronsky, J.-M. and Holah, J .: "ATP: a universal hygiene monitor"; Trends in Food Science & Technology, Volume 8, 1997, Issue 3, Pages 79-84 [0008]
• DIN EN 556-1 [0015]

Claims (7)

Method for determining the degree of soiling of a narrow-gauge medical device, wherein the medical device ( 106 ) at least one cavity ( 104 ), comprising the following steps: a) a wire ( 100 ), which at its one end has a swab ( 102 ) is, with the swab ahead in the at least one cavity ( 104 ) of the medical device ( 106 ) introduced and removed again; b) the end of the wire ( 100 ), which the swab ( 102 ), is attached to a holder ( 200 ), b1) fixing the wire ( 100 ) without touching the swab ( 102 ) or the adjacent end region of the wire ( 100 ) by the user; c) the swab ( 102 ) with the help of the holder ( 200 ) in a test container ( 502 ), which contain the substances required for the detection of ATP (adenosine triphosphate) and / or AMP (adenosine monophosphate) ( 506 ), whereby the swab ( 102 ) comes in contact with the substances; d) the swab ( 102 ) is left in the test container for a predetermined time; and e) the test container ( 502 ) is transferred to a measuring device ( 500 ) for luminescence measurement. Method according to one of the preceding claims, characterized in that the wire ( 100 ) after fixation of the end in step b) by breaking off at an edge ( 400 ) to the length of the holder ( 200 ) is shortened. Device for determining the degree of contamination of a narrow-gauge medical device, wherein the medical device ( 106 ) at least one cavity ( 104 ), comprising the following components: a) a wire ( 100 ), a1) where the wire ( 100 ) at its one end a swab ( 102 ) whose diameter corresponds to the diameter of a cavity to be tested ( 104 ) of the medical device is adapted; a2) where the length of the wire ( 100 ) at least the length of the cavity to be tested ( 104 ) corresponds to the medical device; b) a holder ( 200 ) for receiving and fixing that end of the wire ( 100 ), which the swab ( 102 ) having; c) a test container ( 502 ); d) the holder ( 200 ) is formed such that the swab ( 102 ) with the help of the holder ( 200 ) into the test container ( 502 ) can be introduced. Device according to the preceding claim, characterized in that the wire ( 100 ) consists of a flexible material having a modulus of elasticity, which allows the wire ( 100 ) with a pressure force of 10 N into the cavity ( 104 ) of the medical device ( 106 ) without kinking or breaking the wire. Device according to one of the preceding device claims, characterized in that a) that the holder ( 200 ) over a channel ( 300 ), which extends over the entire length of the holder ( 200 ) and at least the diameter of the wire ( 100 ) Has; and b) that the holder ( 200 ) at his from the swab ( 102 ) opposite end over at least one sharp edge ( 400 ), on which the protruding part of the wire ( 100 ) can be canceled. Device according to one of the preceding device claims, characterized in that a) that the test container ( 502 ) is transparent; b) that the test container ( 502 ) the substances required for the detection of ATP and / or AMP ( 506 ) contains; and c) that the test container ( 502 ) suitable for a suitable measuring device ( 500 ) into which it can be introduced for performing a measurement. Device according to one of the preceding device claims, characterized by a measuring device ( 500 ) for luminescence measurement.

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