EP1126013B2 - Cleaning composition for medical devices - Google Patents

Abstract

A liquid cleaning agent for surgical instruments contains a non-ionic tenside and an amino-acid and/or an amino-acid derivative. The non-ionic tenside is selected from the group of alkylethoxylates whose alkyl groups have a saturated or unsaturated, straight or branched chained alkyl group with 10 to 18 pref. 12 to 14 carbon atoms. The fluid system contains amino-acid carboxylic acid and/or glutaminic acid. The non-ionic tenside contains isotri-decanolethoxylate and/or lipid alcohol polyglycol-ether.

Description

The present invention relates to the use of liquid detergents containing surfactants, corrosion inhibitors and other additives that enhance cleaning for cleaning medical instruments, in particular for cleaning flexible endoscopes by removing X-ray contrast agents.

Endoscopes are tubular or tubular instruments used to examine body cavities and hollow organs. They are equipped with an optical system consisting of lens and eyepiece, a lighting device and usually rinsing and suction devices and channels for introducing special instruments. Flexible endoscopes (which are also referred to as fiber endoscopes) are equipped with a fiber optic light guide, which consists of a tightly packed bundle of hair-thin and therefore highly flexible individual fibers. Due to the flexibility of the glass fibers, light and image can be transmitted via virtually any bend. In addition to the fiber bundles and the Bowden cables for the movement of the tip channels for flushing and air and a generally larger biopsy and at the same time suction duct are housed.

The endoscopy alone, for example, for the removal of tissue samples, but also in combination with other methods, such. As the ultrasound (endoscopic ultrasonography) or X-ray diagnostics are performed. For example, X-ray contrast images of the gallbladder and the bile ducts and of the pancreatic duct system are commonly used. This is -. B. in the context of an endoscopic retrograde cholangiography (ERC) or an endoscopic retrograde cholangiopancreatography (ERCP) - introduced an X-ray contrast agent under X-ray control in the duct system to be examined.

X-ray contrast agents are agents for improving the radiographic representation of body spaces, hollow organs and vessels. They absorb X-rays either weaker (negative X-ray contrast agents) or stronger (positive X-ray contrast agents) than the surrounding body tissue. The radiopaque (i.e., radiopaque) positive X-ray contrast agents contain predominantly high atomic number elements (such as iodine and barium) because their X-ray absorptivity is greater. For cholangiography, organic iodine derivatives derived from pyridines or aromatic carboxylic acids are typically used. Examples of these are iodoxamic acid [3,3 '- (4,7,10,13-tetraoxahexadecanedioyldiamino) -bis (2,4,6-triiodobenzoic acid)] and [3,3' - (3,6,9-trioxaundecanedioyldiamino)] bis (2,4,6-trüodbenzoesäure)].

Endoscopies mostly take place in microbially colonized areas of the body. The number of endoscopic examinations of the upper and lower gastrointestinal tract and the tracheobronchial system, often associated with invasive procedures, is very high. A transmission of pathogens by contaminated endoscopy itself and by endoscopic accessories has been proven many times.

From the prior art, the problems in the cleaning and disinfection of catheters and endoscopes are known. Thus, A. Beck ( "Wiederaufbereitung - Investigations on the reuse of catheters, guidewires and angio-endoscopes", Schnitzor-Verlag GmbH, Konstanz, 1993, 110-114) describes the difficulties with regard to sufficient cleaning of such medical instruments due to deposited blood components and encrusted contrast agent.

In particular, infections with a long incubation period are very difficult and usually impossible to detect in practice. Furthermore, it must be expected that even patients whose illness is dumb or unrecognized come into contact with endoscopes. Of particular importance in this context are infections with microorganisms whose transmission takes place through the blood and mucous membranes, such. As tuberculosis, hepatitis, HIV infections, salmonellosis, Yersinia infections, dysentery and the like.

A requirement for endoscopy should therefore be full compliance with all necessary preventive measures for infection prevention. However, the cleaning and disinfection of fiber endoscopes has long been a stepchild of technological development. For example, there are problems with residual water and corresponding bacterial incorrect colonization, moreover, endoscopes are difficult to dry.

In the prior art, e.g. a variety of cleaning and disinfecting agents based on glucoprotamine for cleaning medical instruments described.

So describe B. Meyer and C. Kluin ("Efficacy of glucoprotamin containing disinfectant against different species of atypical mycobacteria" in: Journal of Hospital Infection (1999), 42: 151-154 ) a disinfectant containing glucoprotamine and nonionic surfactants having a mycobactericidal activity. This as well as in the patent application WO 97/28829 A1 described cleaning and disinfecting agents based on alkylpropylenediamine, glucoprotamine and surfactants, should be suitable for cleaning endoscopes. In the patent application WO 97/28829 A1 For the procedure for cleaning and disinfecting medical instruments, it is stated that this is carried out at a temperature of 55 ° C - 65 ° C.

Another glucoprotamin- and surfactant-containing agent for instrument disinfection and cleaning is described in a brochure from Henkel on the product "Sekusept®Plus", published in October 1992.

In addition to glucoprotamine-based cleaning and disinfecting agents, the state of the art for cleaning articles from medical facilities, such as medical instruments, knows those based on other active ingredients. In the patent application WO 91/13965 A1 for instance, a cleaning and disinfecting agent containing glutamic acid derivatives, quaternary ammonium compounds and surfactants is disclosed.

Therefore, in advance of an endoscopic examination, not only the transmission of microorganisms derived from patients must be prevented, but also a special attention should be paid to pathogens from rinsing water or stagnant water.

The prior art knows liquid cleaning agents for cleaning of flexible endoscopes, which contain surfactants in addition to essentially organic solvents, acids or alkalis, and sometimes also enzymes. However, the compounds mentioned have some disadvantages:

Although solvents, acids and alkalis are in principle suitable for their effectiveness for cleaning, but have the disadvantage that they are too aggressive for the sensitive material and can damage the endoscope accordingly.

The handling of enzyme-containing cleaners is problematic for safety reasons, since these are classified as sensitizing substances and accordingly harmful to health, which is why z. B. Skin contact should be avoided.

The prior art liquid cleaners are relatively effective at removing blood and secretion residues as well as at the separation of fat and other hydrocarbonaceous compounds. However, they are not suitable for completely removing residues of X-ray contrast agents.

Even the smallest amounts of remaining X-ray contrast media include bacteria in the endoscope channels, which can then no longer be completely eliminated with the usual disinfectants. With regular use of flexible endoscopes in practice builds up over time on the inside of the channels an increasing film of the X-ray contrast agent and other residues, which may result in that the microbiological result is no longer satisfactory, even after the disinfection subsequent to the cleaning.

For the patients, this means an increased risk of infection and therefore represents a significant threat. To protect against infection then remains only the possibility of repair, which is both expensive and expensive.

The object of the invention is therefore to develop a liquid cleaning agent for the removal of X-ray contrast agents, which does not have the disadvantages of the prior art, which thus shows a good cleaning performance at the same time high material compatibility and also for the removal of X-ray contrast agents, such. As organic, aromatic iodine derivatives, in particular from flexible endoscopes.

• ■ mindestens ein nichtionisches Tensid und
• ■ Pyrrolidoncarbonsäure

enthalten, zur Reinigung empfindlicher medizinischer Instrumente, flexibler Endoskope und empfindlicher medizinischer Oberflächen durch Entfernung von Röntgenkontrastmitteln.It has now surprisingly been found that all these objects are achieved by the use of liquid detergents, which

• ■ at least one nonionic surfactant and
• ■ pyrrolidonecarboxylic acid

For cleaning delicate medical instruments, flexible endoscopes and delicate medical surfaces by removing X-ray contrast agents.

It was particularly surprising that the cleaning agents used according to the invention clean better and more gently than the preparations of the prior art and that the microbiological problem of the prior art could be substantially reduced by this improved cleaning in the tested flexible endoscopes.

Surprisingly, by the inventive use of cleaning agents also dried on sparingly soluble aromatic halogen compounds such. B. X-ray contrast agent residues, completely detach from the surfaces. Due to the use of the cleaning agent according to the invention, flexible endoscopes are still microbiologically immaculate even after months of constant use in practice. This significantly increases patient safety and extends the life of these high quality medical devices.

For example, it has been demonstrated that the use of the cleaning agent according to the invention, especially in duoendoscopes over which X-ray contrast agents are preferably administered, has a significantly better cleaning performance than the cleaners of the prior art. This greatly improved the microbiological status of duoendoscopes (after subsequent disinfection).

According to the invention, the nonionic surfactant or surfactants are selected from the group of alkylethoxylates whose alkyl group is a saturated or unsaturated, straight or branched chain alkyl group having 10 to 18, preferably 12 to 14 carbon atoms, preferably 2 to 15, in particular 5 to 9, per molecule , especially containing 7 ethylene oxide units. Very particular preference is given to isotridecanol ethoxylate and / or fatty alcohol polyglycol ethers.

Advantageously, the total amount of nonionic surfactants (one or more compounds) is selected from the range of 1.0 to 20.0 wt .-%, preferably from 10.0 to 15.0 wt .-%, each based on the total weight of preparations.

eingesetzt.According to the invention, the pyrrolidonecarboxylic acid (pyroglutamic acid), which is characterized by the following structural formula:

used.

Advantageously, the total amount of the amino acid is selected from the range of 0.1 to 10.0 wt .-%, preferably from 0.5 to 2.0 wt .-%, each based on the total weight of the preparations.

In a particularly advantageous embodiment, the cleaning agents used according to the invention can be further Amphoteric surfactants included. Amphoteric surfactants are surfactants that possess both acidic and basic hydrophilic groups and thus behave acidic or basic depending on the condition. For the purposes of the present invention, for example, amphoteric surfactants based on aliphatic polyamines having carboxy, sulfo or phosphono side chains, for example R-NH- (CH ₂ ) _n -COOH, are advantageous.

According to the invention are preferred z. As amphoteric surfactants whose alkyl group is a saturated or unsaturated, straight or branched chain alkyl group having 10 to 18, preferably 12 to 14 carbon atoms.

Also particularly advantageous are amphoteric surfactants from the group of amphopropionates, such as. Cocobetainamido amphopropionate, which is characterized by the following structure:

Advantageously, the total amount of amphoteric surfactants (one or more compounds) is selected from the range of 1.0 to 10.0 wt .-%, preferably from 2.0 to 5.0 wt .-%, each based on the total weight of the preparations ,

The detergents used according to the invention can be in the form of liquid concentrates and packaged, for example, in dosing bags, so that a use solution can be prepared fresh in each case. It is particularly advantageous if the pH of the concentrate is between 5 and 9. The liquid concentrates are preferably diluted with water to a use solution. Preference is given to the use of working solutions containing 0.5 to 5 wt .-% of cleaning agent according to the invention. The use solution preferably has a pH between 6 and 8 in order to achieve optimal protection of the sensitive material.

• ■ nichtionische Tenside: zwischen 0,005 und 1 Gew.-%
• ■ Aminosäure: zwischen 0,0005 und 0,5 Gew.-%
• ■ Amphotenside: zwischen 0,005 und 0,5 Gew.-%

It is advantageous to carry out the dilution in such a way that the content of the individual substances in the working solution is as follows:

• ■ nonionic surfactants: between 0.005 and 1% by weight
• ■ Amino acid: between 0.0005 and 0.5 wt .-%
• Amphoteric surfactants: between 0.005 and 0.5% by weight

The cleaning agents used according to the invention can also advantageously contain conventional corrosion inhibitors, such as, for example, benzotriazole, in particular if they can come into contact with metallic surfaces, in particular with non-refined steels or materials of non-ferrous metal alloys, when used. It is preferred to choose the content of one or more corrosion inhibitors between 0.1 and 5 wt .-%, based on the total weight of the formulation.

In addition, the cleaning agents used according to the invention may advantageously additionally contain complexing agents and / or pH regulators in order to reduce the negative influence of fluctuating water hardness or to ensure that the pH of the cleaning agent is within a range which does not damage the sensitive material.

In addition to the abovementioned components, the cleaning agents used according to the invention for such preparations may contain customary preservatives, dyes, fragrances and / or other customary auxiliaries. These contribute in the majority of cases not to the cleaning effect, but serve the storage and aesthetic purposes. However, it is also possible to use those components which develop a (preservative, nourishing effect and at the same time provide for a particular color and / or a pleasant fragrance.

The amounts of such carriers and perfume to be used in each case can easily be determined by the skilled person by simple trial and error, depending on the nature of the particular product.

The following examples serve to describe the invention, of course, without intending to limit the invention to these examples. All amounts, proportions and percentages are, unless otherwise stated, on the weight and the total amount or on the total weight of the preparations based.

Examples: Example 1:

5% pyrrolidone 5% isotridecanol 5% Fettalkoholpolyglykolether 3% Cocobetainamido amphopropionate 1 % corrosion protection 10% glycol 1 % pH regulator rest water

It is set to a pH of 8.

Example 2:

7.5% pyrrolidone 5% isotridecanol 5% Fettalkoholpolyglykolether 1 % corrosion protection 10% alcohols 1 % pH regulator 3% complexing rest water

It is set to a pH of 8.

Example 3:

1 % pyrrolidone 6% isotridecanol 6% Fettalkoholpolyglykolether 2.25% Cocobetainamido amphopropionate 1 % corrosion protection 10% glycol 2% pH regulator 3% complexing rest water

It is set to a pH of 8.

An application test was carried out with a liquid detergent according to example formulation 3. For this purpose, 129 duoendoscopes were cleaned with a cleaning agent of the prior art (enzymatic cleaner) and 97 duoendoscopes with the cleaning agent to be used according to the invention and then disinfected; Thereafter, the microbiological status of the devices was checked. The results were as follows: eR ¹ Example 3 ² tested duoendoscopes 129 97 microbiologically perfect 94 91 microbiologically not perfect 35 6 ¹ enzymatic cleaner
² detergent according to example recipe 3

Claims (10)

1. Use of liquid cleaners that contain at least one nonionic surfactant and pyrrolidone carboxylic acid, for the cleaning of medical instruments, flexible endoscopes and surfaces in medical use, by removing X-ray contrast enhancing agents.
2. Use in accordance with Claim 1, characterised in that the nonionic surfactant or surfactants is, or are chosen from a group of alkyl ethoxylates with an alkyl group that is a saturated or unsaturated, straight or branched chain alkyl group with 10 to 18, preferably 12 carbon atoms.
3. Use in accordance with one of claims 1 or 2, characterised in that the cleaner contains isotridecanol ethoxylate and/or fatty alcohol polyglycol ether.
4. Use in accordance with one of claims 1 or 3, characterised in that the cleaner contains at least one ampho-surfactant(s) as (a) further contituent(s).
5. Use in accordance with Claim 4, characterised in that the nonionic surfactant or surfactants is, or are chosen from the group of ampho-surfactants with an alkyl group that is a saturated or unsaturated, straight or branched chain alkyl group with 10 to 18, preferably 12 carbon atoms.
6. Use in accordance with one of claims 4 or 5, characterised in that it contains cocoamido betain ampho-proprionate as the ampho-surfactant
7. Use in accordance with one of claims 4 to 6, characterised in that the quantity of ampho-surfactant (one or several compounds) is chosen from the range of 1.0 to 10.0 % w/w, preferably 2.0 to 5% w/w, in each case relative to the total weight of the preparations.
8. Use in accordance with one of claims 1 to 7, characterised in that the cleaner contains one or several nonionic surfactants in a quantity of 1.0 to 20.0 % w/w, preferably 10.0 to 15% w/w, in each case relative to the total weight of the preparations.
9. Use in accordance with one of claims 1 to 8, characterised in that the cleaner contains pyrrolidone carboxylic acid in a quantity of 0.1 to 10.0 % w/w, in each case relative to the total weight of the preparations.
10. Use in accordance with one of claims 1 to 9, characterised in that the cleaner is provided in the form of a concentrate which is diluted with water before use as a working solution.