AT523982A2 - Coated gloves with dispenser box to prevent nosocomial infections - Google Patents

Abstract

The invention relates to single-use medical gloves together with a dispenser box, the gloves according to the invention having disinfecting coatings and the gloves being able to be removed from the dispenser box in a hygienically correct manner. The gloves packed in the dispenser box are equipped with disinfecting surfaces on the inside and/or outside so that pathogenic germs cannot multiply on their surfaces.

Description

The invention relates to single-use medical gloves together with a dispenser box, the gloves according to the invention having disinfecting coatings and the gloves from the dispenser box according to the invention being hygienically flawless

can be removed.

The gloves packed in the dispenser box are equipped with disinfecting surfaces on the inside and/or outside so that pathogenic germs cannot multiply on their surfaces. The dispenser box according to the invention has one, but preferably two, removal openings that are positioned so that the gloves can only be picked up specifically at the cuff edge and external contamination of the unused gloves in the palm and finger area in the dispenser box by dirty hands of the user is avoided.

In the United States, one in ten hospital patients is currently infected with a hospital-acquired infection, commonly referred to as a nosocomial infection. The 2 million patients affected each year cause additional costs in the US healthcare system of between US$ 4.5 billion and US$ 11 billion. Around 90,000 deaths are caused by these "hospital germs" in the USA every year and at least 35% of these infections are estimated to be easily avoidable. The situation in Europe is similar: in Germany there are more than 500,000 nosocomial cases of infection every year, with many thousands of deaths and additional costs of well over 2.5 billion euros.

The need for protection of nursing staff has led to a more than hundredfold increase in the consumption of examination gloves worldwide in the last 3 decades. At the same time and contrary to all expectations, nosocomial infections, which often also affect the hospital staff themselves, multiplied. This is due to the fact that the use of examination gloves leads to increased growth of germs on the one hand due to the occlusive inclusion of the human skin under the glove, and on the other hand it can be assumed that the nursing staff usually wears gloves when they come into contact with infected patients and contaminated waste, gloved hands themselves are washed and disinfected less often.

A significant proportion of nosocomial infections are spread through contaminated hands of hospital and nursing staff. This is improper on and

As soon as examination gloves are removed, there is almost always a critical contamination of the freshly put on gloves or of gloves lying unused in the pack. Subsequent infections of patients, e.g. when catheters or infusions are placed, are inevitable, especially due to the fact that germs and pathogens that mainly grow on human tissue are transmitted.

The situation is aggravated by the fact that in recent years the gloves, which are mainly made of natural or synthetic rubber latex, tend to have fewer chemical residues for reasons of skin compatibility, and there are hardly any bactericidal rubber chemicals, such as dithiocarbamate accelerators, in the rubber film, which reduces the survival rate of Germination on the rubber surface increased drastically. Due to the fact that the proportion of powder-free examination gloves is increasing, there are no powder residues left on the hands of the nursing staff after the gloves are removed and the subjective false impression of "clean,

"germ-free" hands, which leads to a further reduction in hand washing.

It is therefore an object of the present invention to reduce the chains of contamination caused by the use of disposable medical gloves

to prevent pathogenic germs.

The object is achieved in such a way that the use of disposable gloves that are equipped with disinfecting surfaces on the inside and/or outside is proposed. This prevents the transmission or multiplication of pathogenic germs on the glove surfaces. The disposable gloves according to the invention should preferably be used in combination with dispenser boxes where the gloves are not contaminated in the shaft area when they are removed. The surface properties of the gloves according to the invention are appropriate for this, as described below

to adjust.

When using the gloves according to the invention (preferably in combination with optimized dispenser boxes), there is a significant reduction in nosocomial

Infection rates to be expected in hospitals and care facilities.

The non-sterile gloves used in health care are usually delivered in non-sterile form in so-called dispenser box packs with a capacity of typically 100 to 200 gloves that can be used on both hands. Due to fully automatic production systems and GMP-compliant manufacturing and packaging methods, there is usually hardly any pre-contamination of the gloves.

The usual way of interrupting the chain of contamination described is ongoing cleaning and disinfection of the hands of the nursing staff, combined with frequent changing of gloves. This is essentially a purely organizational measure, but it is not unproblematic from the point of view of skin compatibility due to the use of disinfectants that usually contain alcohol and long-lasting occlusive wearing conditions.

As mentioned in the introduction, it can be assumed that gloved hands are often not washed and disinfected sufficiently often, even in hospital and care settings. When using examination gloves, the occlusive inclusion of the human skin under the glove leads to increased perspiration and germ growth, and finally to unwanted germ transmission.

It is therefore proposed in the present invention that disposable gloves used in the health and food sectors have disinfecting surfaces which contain germ-killing or germ-inhibiting substances.

Such surfaces have already been described, for example, in WO 2009/073907 for the inner and outer surfaces of the gloves.

The Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the German Robert Koch Institute (RKI) regularly publishes recommendations for effective chemicals for hand hygiene in healthcare facilities (see e.g. Bundesgesundheitsbl. 2016 - 59:1189-1220 DOI 10.1007/s00103-016-2416 -6 © Springer-Verlag Berlin-Heidelberg 2016).

The following compounds are therefore suggested here as examples of disinfectants that can be used to produce the disinfecting glove surfaces:

- Chlorhexidine (not water soluble)

- mecetronium ethyl sulfate (water soluble)

- Triclosan (not water soluble)

- Triclocarban (not water soluble)

- Octenidine (not water soluble)

- Chloramine T (water soluble)

- Thymol (not water soluble)

- Chloroxylenol (not water soluble)

- Chitosan (polymer, not water soluble)

- Polyhexanide (polymer, water soluble)

- zinc, copper, silver salts (preferably not water-soluble) - iodine compounds (e.g. polyvinylpyrrolidone-iodine)

- Quarternary ammonium compounds (e.g. didecyldimethylammonium chloride, alkylamidopropyl betaine)

- 2-phenylphenol (not water soluble)

- phenoxyethanol

- ethacridine salts

and many more.

The disinfectants mentioned here are often used in healthcare facilities in the form of alcoholic or aqueous solutions to disinfect hands, skin and medical devices.

However, when disinfectants are used for the surface treatment of examination gloves, the slipperiness of the outer and inner glove surfaces is often impaired, resulting in problems of peeling off the molds in the manufacturing process and sticking of the gloves in the dispenser box packaging, and finally poor donning of the gloves at the user leads. In particular, in the case of packaging in dispenser boxes, where the gloves are stacked and should only be grasped by the glove shaft when they are removed for hygiene reasons, there must be a sufficient number

It is therefore the object of the present invention to define surfaces of thin-walled disposable gloves together with the associated products and processes in such a way that the following properties are guaranteed:

Inner and/or outer surfaces of the gloves must have germ-killing or germ-inhibiting properties.

The inner and outer surfaces of the gloves must have sufficient surface slipperiness to ensure that the gloves can be easily demoulded during the manufacturing process and that the gloves can be easily put on by the user.

The outer surfaces of the gloves must be such that the adhesion between two gloves pressed together is so low that easy removal from small dispenser box packaging with stacked gloves is guaranteed at all times, even in the case of dispenser box packaging where, for reasons of hygiene, the gloves are only gripped by the shaft can become.

In an embodiment variant according to the invention, the disinfectants are applied to the glove surfaces together with silicone oil when they are applied to the disposable gloves. According to the present invention, mixtures of siloxanes in the form of silicone oil, silicone oil solutions or silicone oil emulsions are produced with the disinfectant to be applied or a solution or emulsion thereof. These mixtures according to the invention are then sprayed onto the gloves or applied by dipping. The spraying is preferably carried out using rotating drying drums analogous to tumble dryers, or for example as part of the extraction process on the glove manufacturing machines. The application in the dipping process takes place, for example, in dipping baths on the glove manufacturing machines.

Examples of silicones according to the invention are:

- Rhodorsil Oils 47 V 20 to V 1000, as well as associated emulsions and solutions

- Dow Corning (R) 1664 Emulsion

- Silbione Emulsion 70001 SP

- etc.

- Dow Corning (R) 1664 Emulsion : alcoholic solution of mecetronium ethyl sulfate 0.2% (Sterillium) in a 1:1 mixing ratio

- Silbione Emulsion 70001 SP : 0.1% alcoholic solution of triclosan in a 1:1 mixing ratio

- etc.

In a variation according to the invention, when applied to the medical gloves, the disinfectants are applied to the glove surfaces together with, for example, fatty acid salts, chlorinated polyolefins, polyolefin, paraffin oil or wax suspensions or hydrogel mixtures. The substances mentioned act as lubricants and a mixture, solution or emulsion is used that contains both the lubricant and the disinfectant to be applied. In particular, it can be provided that a slippery coating is produced from a liquid or disperse mixture which contains at least one lubricant and one or more germ-killing or germ-growth-inhibiting substances. The mixtures according to the invention are applied here, for example, as part of the production process using a dipping or spraying process, or are applied to the gloves in a subsequent process step, for example by spraying.

In principle, any mixture and combination of disinfectant and lubricant that is used for the coating of thin-walled medical gloves is used

is claimed as according to the invention.

Examples of mixtures of disinfectants and lubricants according to the invention are:

- MAqueous coagulation baths containing calcium stearate in the dipping process of glove production, to which a non-water-soluble disinfectant has been added in small quantities (e.g. containing 1% calcium stearate and 0.05% triclosan)

- Mixture of magnesium stearate and octenidine dihydrochloride, e.g. in the last wash immersion bath as part of the glove manufacturing process on a chain dipping machine (e.g. 0.5% magnesium stearate and 0.05% octenidine dihydrochloride)

- Mixture of e.g. paraffin oil and polyhexanide (PHMB) e.g. for use on the outer glove surfaces after removing the gloves from the dip forms in front of an automatic stacking device (autolayering device)

The preferred amount of germ-killing or germ-growth-inhibiting substances applied to the gloves is about 0.1 to 10 times the recommended value for hand disinfection or 0.01 to 5 times the recommended value for wound disinfection based on the active ingredient of the respective type of disinfectant according to the manufacturer's instructions.

The preferred amount of lubricant applied is highly dependent on the respective lubricant, the glove material and the way it is applied to the gloves, and in most cases must be determined individually for each individual case as part of the product and manufacturing process optimization.

The simultaneous use of gloves according to the invention with germicidal or germ growth-inhibiting surfaces in combination with dispenser boxes according to the invention, where stacked gloves can only be taken at their shaft edges for removal, also represents a new synergistically effective method for combating nosocomial infections Mixtures of disinfectants and lubricants cause in particular good removal from dispenser box packs where the gloves are in a stacked arrangement and preferably only for removal

can be grasped by their shaft edges.

Of course, the lubricant/disinfectant mixtures described can also be used for the surface treatment of other medical products, such as catheters, stomas, cannulas, hoses, and others, as well as for the treatment of critical

Surfaces in the care and treatment area, etc., are used.

The gloves according to the invention to be packed in the dispenser boxes are described in more detail below using a few production examples: Powder-free latex examination gloves are usually produced on a continuously operated chain dipping machine, with hand-shaped dipping forms made of ceramic material being moved through baths and hot-air dryers by means of a circulating chain. According to the prior art, the process steps listed below are essentially run through, with production steps 1 to 18 on the continuously running immersion machine, production step 19 in continuous or discontinuous washing or chlorinating drums, and production step 20 in drying drums equipped with a spray device , is carried out:

1. Immersion in mold cleaning baths.

2. Mold drying after mold cleaning.

3. Dip into a coagulant bath (coagulant dip) which preferably contains calcium salts and a mold release agent (lubricant)/disinfectant mixture according to the invention (e.g. calcium nitrate/calcium stearate/mecetronium ethyl sulfate in combination with surfactants and defoamers).

4. Hot air drying after the coagulant bath.

5. Dip into one or more natural or synthetic latex blend baths to prepare the latex backing.

6. Air drying after the latex baths.

7. Diving in one or more hot water baths (precure leaching).

8. Optional hot air drying after precure leaching.

9. Optional dipping in synthetic latex (PU/polyacrylate) for the later interior gliding layer.

10. Optional hot air drying.

11. Attaching the rolled edge.

12. Main drying with hot air (vulcanization oven, "curing").

13. Diving in water baths (postcure leaching) and optional online chlorination with chlorine water.

14. Optional further diving in water baths (postcure leaching).

15. Optional application of a lubricant/disinfectant mixture (e.g. zinc stearate/ mecetronium ethyl sulfate).

16.Hot air drying.

17. Optional: Cooling before removing the latex gloves.

18. Pull off the latex gloves while turning them inside out.

19. Optional: washing and possibly light chlorination of the gloves in washing drums, whereby in a preferred variant the gloves can be treated with a mixture of lubricant and disinfectant solution.

20. Optional: Drying in warm air and spray treatment of the gloves in a rotating dryer, the gloves being coated with a mixture of lubricant (e.g. silicone oil emulsion or calcium stearate emulsion) and disinfectant solution

be sprayed. The given description of the _manufacturing process of natural or

Synthetic latex gloves are to be considered as examples only and reflect only the typical state of the art using chain dipping machines. changes

According to the invention, through the targeted combined application of lubricants and disinfectants, disinfecting surfaces are formed (optionally) both on the outside and on the inside of the gloves.

Due to the simultaneous application of the disinfectants together with the lubricants, the disinfectants are distributed more homogeneously over the glove surfaces. The lubricant content prevents the gloves from sticking and makes it much easier to remove the gloves from the dispenser box - especially in dispenser boxes where the gloves are arranged stacked and for removal only at the shaft edges

can be taken.

The simultaneous use of gloves with germicidal or antimicrobial surfaces in combination with a dispenser box according to the invention represents a new, synergistically effective method for combating nosocomial infections.

About the representations:

Legend for the drawings:

2 side surface of the dispenser box 3 top surface of the dispenser box

4 removal openings

5 Hand part of the gloves, consisting of fingers, palm or back of the hand 6 Gauntlet edge or rolled edge

9 separating film, designed here in the form of a sack

1 shows a dispenser box packaging of stacked examination gloves according to the prior art, the gloves usually not having disinfecting surfaces and being grasped by their palms for removal.

2 shows an example according to the invention of a dispenser box packaging for examination gloves arranged in a stack. Here are stacks of gloves and

to ensure single withdrawal.

3 shows microbiological tests on examination gloves whose surfaces were treated with mecetronium ethyl sulfate/calcium stearate or triclosan/silicone oil mixtures.

The disinfectants mentioned are usually used in healthcare facilities in the form of alcoholic or aqueous solutions for disinfection. Despite the fact that the gloves were well dried after application of the disinfectant mixture and did not have any low-molecular alcohol content on the surfaces, a significant growth inhibition of Staphylococcus aureus around the treated glove pieces could be detected and thus the effectiveness of the concept according to the invention could be proven.

Gloves whose surfaces were treated with the mixtures according to the invention mentioned here were always very easy to remove from the stack packs according to the invention, in contrast to gloves that were free of lubricant and treated with disinfectant.

Claims (1)

1. Flexible, preferably powder-free, object with a flexible carrier layer made of polymeric material, in particular made of natural or synthetic latex or soft PVC, preferably produced in a dipping process, which is designed with at least a partial area of the surface for contact or for contact with human skin , in particular a work, examination, surgical glove, a catheter, a condom or the like, for single use, which is provided with a slippery coating at least in a partial area of the inner or outer surface, characterized in that the lubricious coating comprises one or more contains germ-killing or germ-growth-inhibiting substances. 2, Flexible article according to claim 1, characterized, that it is a glove for single use, the glove having germicidal or germ growth-inhibiting lubricant-containing coatings on the inner surface and/or on its outer surface, with particular provision being made for the glove to be coated both on the inner surface and on its outer surface has germicidal or germ growth-inhibiting lubricant-containing coatings according to the invention. 3. A method for producing disposable gloves according to one of claims 1 or 2, characterized, that during the manufacturing process, germ-killing or germ-inhibiting mixtures are applied to the gloves, which contain lubricants from the group of polysiloxanes, fatty acid salts, polyolefins, paraffin oils, waxes or hydrogels. 4. A method for producing disposable gloves made of natural or synthetic latex according to claim 3, characterized, that the gloves are made using a dipping process, and that germ-killing or germ-growth-inhibiting substances in combination with lubricants from the group of fatty acid salts, polyolefins, paraffin oils, waxes, applied to the gloves during the manufacturing process before the first latex dip are, with the germicidal or germ growth-inhibiting substances in disperse form. 5. A method for producing disposable gloves made of natural or synthetic latex according to claim 3 or 4, characterized, that the gloves are made by dipping, and that a coagulant dip is used before the first latex dip as part of the A manufacturing process, which, in addition to water-soluble calcium salts, contains germicidal or germ-inhibiting substances in combination with lubricants, preferably from the group of fatty acid salts, polyolefins, paraffin oils, polysiloxanes, waxes, with both germicidal or germ growth-inhibiting substances and the Lubricants are not water soluble and are in disperse form. 6. Liquid or disperse mixture for the surface treatment of flexible objects according to claim 1 or 2, characterized, that these have germicidal or germ growth-inhibiting substances in combination with lubricants, in particular from the group of polysiloxanes, fatty acid salts, polyolefins, paraffin oils, waxes or hydrogels. 7. Liquid or disperse mixture for the surface treatment of flexible objects according to claim 5 or 6, characterized, that the germ-killing or germ-growth-inhibiting substances come from the group of wound or hand disinfectants, particularly preferably chlorhexidine, mecetronium etil sulfate, triclosan, triclocarbane, octenidine, chloramine T, thymol, chloroxylenol, chitosan, polyhexanide, quaternary ammonium compounds, 2phenylphenol, phenoxyethanols, zinc, Copper, silver salts, iodine compounds. 8. Use of gloves for single use according to one of claims 1 or 2, characterized, that these are used in combination with a dispenser box in which the gloves according to the invention are present in a parallel stacked arrangement. characterized, that stacks of gloves and removal openings (4) are arranged in such a way that the gloves are only gripped at the upper glove edges for their removal be able. 10. gloves, in particular according to one of claims 1 or 2, to prevent nosocomial infections in combination with a dispenser box, wherein the dispenser box contains at least one stack of gloves, the stack of gloves with an associated removal opening (4) being arranged in such a way that the gloves can only be grasped at the upper glove edges or gauntlet edges (6) for removal, characterized, that the gloves have surfaces that contain germicidal or contain antimicrobial substances in combination with lubricants.