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I) Skin irritations in medical personnel on the rise

Surgical gloves have to meet high requirements in the operating room including for tear resistance, tightness, grip, comfort and virus-resistance. Therefore, it is all the more important that the materials used as well as the manufacturing and quality processes contribute to the safety of and ultimately the confi dence in the glove.

According to a Europe-wide study published in 2015, up to 31 % of occupational illnesses in Europe are due to skin diseases. For the most part, they are cases of irritant or allergic contact dermatitis. Employees in the healthcare sector (around 35 %) and in the service sector (hairdressers, cleaners, see fi g. 1) are affected particular-ly often.2)

Irritant hand eczema is a local skin irritation caused by detergents, frequent hand washing, lack of hand drying, aggressive hand sanitising techniques, glove powders, and the occlusive effect of wearing liquid-tight gloves. In the healthcare sector, hand eczema has a prevalence of 23 – 44 %, especially in surgical and medical settings.3)4)

For nurses the prevalence is 17 – 30%.5) The transition of many European clinics from latex to synthetics has led to a signifi cant increase in type IV allergies in recent years, especially among surgeons, nurses and anesthesiolo-gists.6) The prevalence of contact dermatitis in medical personnel in particular has risen 4½-fold between 1996 and 2012.7)

informOccupational skin diseases and allergies in the healthcare sectorSkin diseases are on the rise worldwide. However, preventative measures, such as skin-friendly gloves can help.Skin diseases are now second among all occupational diseases in Europe and cost the healthcare system more than fi ve billion euros a year.1)Especially common is contact der-matitis, which manifests in the form of itchy eczema. One possible cause are the accelera-tors used in the vulcanisation process while the gloves are being manufactured. While the transition to powder-free latex gloves and synthetic gloves has led to a dramatic decline in latex allergies (type I allergy) since the turn of the millennium, type IV allergies such as contact dermatitis have increased signifi cantly. Below, Sempermed provides information on the causes and symptoms of contact dermatitis as well as preventive measures and the latest glove solutions.

Fig. 1: Frequency of contact dermatitis by occupation-al group in % of persons examined, irritant or allergic

40

30

20

10

0

24,0%

30,5% 31,3%

34,3% 35,0%

Total working population

Food/ Catering

Professional cleaning/ Hygiene

Beauty/Hairdresser

Medicine

2 3

Symptoms of contact dermatitis

Contact dermatitis can appear as irritant contact derma-titis – a non-immunological infl ammatory reaction of the skin, or as allergic contact dermatitis, a so-called late-type allergy. In both cases, hands are affected 80 % of the time, followed by the wrists and forearms.8) While allergic reactions to the chemicals in gloves typically ap-pear on the back of the hand, other reactions are more noticeable on the palms of the hands.9)

Irritant contact dermatitis

This common skin disease (80 % of contact dermatitis cases) is an intolerance response of the skin to damage of the epidermis by mostly external, non-infectious irritants.

In addition to itching, pain and a burning sensation are the main symptoms of this skin disease, which manifests as subacute or chronic eczema.8) Irritant contact dermati-tis typically develops minutes to hours after contact with the irritant and remains localised.10) Irritant reactions to glove accelerators can mimic the clinical symptoms of allergic reactions and must be differentiated from them

by differential diagnosis. In principle anyone who is in frequent contact with these chemicals are susceptible to the development of irritant contact dermatitis. However, it occurs especially in patients with an atopic skin diathe-sis or with a pre-existing impairment of the physiological skin barrier.11)

Allergic contact dermatitis (type IV allergy)

A cellular immune response is responsible for 20 % of occupational contact dermatitis cases. The symptoms come to light in a two-phase process: Phase I, the sensi-taisation phase and Phase II, the triggering phase. In the sensitisation phase, the allergens that have entered the skin are bound by the Langerhans cells of the epidermis. Through this contact, the Langerhans cells are activated and stimulated to antigen presentation to T cells. The sensitised T lymphocytes can then release infl ammatory mediators in the triggering phase – with renewed anti-gen contact. The triggering phase takes 8 to 48 hours, after which the clinical symptoms manifest in the form of eczema.8) Typical symptoms of allergic contact dermatitis include itching erythema, papules, scaling and scatter-ing phenomena, i.e. skin symptoms extending from the contact area of the allergen.11)

Fig. 3: Allergic contact dermatitis

PROTECTION AGAINST TYPE IV ALLERGIES

• Accelerator-free gloves• Use of accelerator with low allergy potential

Sempercare® Green Glove

EXAMINATION GLOVESSURGICAL GLOVES

Sempermed® Syntegra IR

Fig. 2: Irritant contact dermatitis

Sempermed® Syntegra UV

CONTACT allergy(type IV)

In the US, allergic contact dermatitis costs the healthcare system about $ 1 billion a year.1)

1BILLION$

of healthcare sector employees suffer from allergic contact eczema.1) 13)

Up to 31%

Gloves are just one source: If gloves are the trigger, allergic reactions are caused in 80 % of cases by vulcanisation accelerators.13)

80%

of substances are contact allergens.12)

(including creams and disinfectants)

More than 2.800

LA-

TEX-FREELATEX AND AC-

CELERATOR-FREE

LATEX AND AC-

CELERATOR-FREE

More than 2,800 substances are known to be contact sensitisers, including soaps, cleaners and disinfect-ants.14) Often there is polysensitisation against a variety of chemicals. Glove-related contact allergies are mainly caused by chemical residues from the production pro-cess, about 80 % of them by traditional vulcanisation accelerators (e.g. thiurams, benzothiazoles, thioureas, carbamates, guanidines), antioxidants (e.g. aromatic amines, phenols), dye additives and anti-ageing agents (e.g. p-phenylenediamines).15) 16) The allergy potential of a chemical depends on the substance and the concen-tration on the glove surface. Examinations of chemical

residues in glove samples showed 10-fold differences between different manufacturers (values of 2 – 15 μmol/g glove material), and powdered gloves contained signifi -cantly more chemical residues.15) 17) 18)

Accelerators in the vulcanisation process

The analysis of the chemicals used in glove production in epicutane tests with the most common allergens from the European standard series (EBS) revealed that, in addition to the known problematic thiuram mix, the vulcanisation accelerator diphenylguanidine, some accelerators made from dithiocarbamate and mercaptobenzothiazole, and the lubricant cetylpyridinium chloride play a signifi cant role in the emergence of contact dermatitis. Most of the patients tested in the study had worked in surgery for decades, but contact dermatitis had mostly devel-oped in recent months. Switching from latex to synthetic gloves is an immediate catalyst for the increase in con-tact dermatitis here as well.19)

II) Chemicals often a trigger

A cellular immune response is responsible for 20 % of

after which the clinical symptoms manifest in the form of

SURGICAL GLOVES

Sempermed®

Syntegra IR

LA-

TEX-FREETEX-FREE

LATEX AND AC-LATEX AND AC-

CELERATOR-FREE

CELERATOR-FREE

Sempermed®

TEX-FREETEX-FREE

SURGICAL GLOVES

Sempermed®

Syntegra UV

LATEX AND AC-LATEX AND AC-

CELERATOR-FREE

CELERATOR-FREELATEX AND AC-LATEX AND AC-

CELERATOR-FREE

CELERATOR-FREE

Sempermed®

CELERATOR-FREE

CELERATOR-FREE

SURGICAL GLOVES

Sempercare®

Green Glove

EXAMINATION GLOVES

LATEX AND AC-LATEX AND AC-

CELERATOR-FREE

CELERATOR-FREE

4 5

Proper glove selection plays an important role in avoid-ing occupational contact dermatitis. It is recommended to select gloves that maintain the health of the skin and have low allergenic or irritating potential.

Therefore, it is therefore important to be informed of which vulcanisation accelerators are used by the manu-facturer and how high their allergenic or irritating poten-tial is. Quality suppliers do without thiuram in the vulcan-isation process and always use accelerator combinations with better compatibility.9) Another important measure are multiple, thorough washings of the gloves to mini-mise residual chemicals. The manufacturer can provide information about their processes as well.

Proper hand-care is important as well. Washing and dry-ing your hands thoroughly after working with gloves is recommended. There are also some gloves on the mar-ket made of various synthetic materials such as polyiso-prene, chloroprene or nitrile butadiene rubber, which do not use accelerators and still provide latex-like comfort.

Skin-friendly accelerator system

Many traditional accelerators from the thiuram, carba-mate, and thiazole groups have been identifi ed as po-tent contact sensitisers. Some of them are also classifi ed as harmful to health and the environment or as a trig-ger for carcinogenic nitrosamines (carcinogenic nitrogen compounds). Understanding these risks has led to the use of new accelerators that are much safer.

One of these skin-friendly accelerator systems is used in the production of Sempermed® SyntegraIR and the associated under-gloves Sempermed® Green Syntegra: The synergistic combination of the two multifunctiona-laccelerators diisopropylxanthogen polysulphide (DIXP) andzinc diisononyldithiocarbamate (ZDNC) produces a particularly skin-friendly product. The polyxanthogen-ate DIXP is split into volatile reaction products during the vulcanisation process. The special zinc dithiocar-bamate ZDNC is a virtually non-allergenic accelerator. Furthermore, ZDNC is very soluble in rubber and hard-ly extractable by aqueous systems (e.g. sweat). Thanks to this tried-and-tested system, there are virtually no traces of accelerators in the glove that can trigger type IV allergies. Type IV allergy potential is therefore mini-mal. Compared to other dithiocarbamate systems, the Sempermed® Syntegra IR accelerator system is also low-cytotoxic, highly-effective and signifi cantly im-proves the properties of the vulcanised material.24) 25) 26) 27)

The Report on Contact Dermatitis & Workforce Eco-nomics by Jacob et al. 2006 analyses the absence rate and follow-up costs due to contact dermatitis in Amer-ican hospitals. At a hospital with an average of 25-49 beds and an average of 1.4 nurses per acute bed, the report assumes that 12 to 23 nurses experience chron-ic allergic contact eczema. The average number of days lost due to contact dermatitis for a nurse is 6 days per year.22) The cost per year for an average wage rate of $ 26.46 is $ 2,858 per nurse; multiple absences per year can cost up to $ 65,734 per nurse.23) The US

Department of Health and Human Services estimates costs of around $ 1 billion a year.1) Although gloves are only a small part of the cause of allergic contact eczema, they can cause cross-reactions. Look-ing purely at cost-effectiveness it is therefore counterproductive to look only at cost when selecting suitable gloves and skin protec-tion-products for the hospital system.21)

IV) Preventive measures

III) Risks and costs

A recent European study examined the most common allergy triggers for their allergic potency. Considering only the vulcanisation accelerators, thiuram mix followed by mercapto mix pose the highest risks for the devel-opment of allergic contact dermatitis.2) Although glove manufacturers have signifi cantly reduced the use of thi-urams since the mid-1990s, they are still occasionally used in combination with carbamates and diphenylgua-

nidine.20) It is precisely this combination that sometimes leads to cross-reactions in invitro studies.9) In addition, the incidence of allergic reactions to now frequently-used carbamix (zinc diethyldithiocarbamate, zinc dibutyldithi-ocarbamate, diphenylguanidine) has increased.20)

Given the newly-developed accelerators, which are much safer, thiurams are no longer used in quality gloves today.

Allergies to carbamix

The role of accelerators in the vulcanisation process

• The vulcanisation process is the most important step in the rubber-manufacturing process, without which neither natural nor synthetic latex would be elastic.

• The rubber molecular chains are crosslinked under the infl uence of heat with the help of sulphur. The number of sulphur bridges (crosslink density) depends on the amount of sulphur and the dura-tion of vulcanisation and is crucial for high elasticity and dimensional stability of the glove material.

• Accelerators act as catalysts in the crosslinking process: They increase the speed and effi ciency of crosslink construction and increase the elasticity, resilience and durability of the gloves.

Risk factorsfor the development of contact dermatitis21)

• Continuing contact with irritants such as water and detergents

• Intense hand scrubbing and poor drying• Occlusion effect• Glove powder• High concentration of chemicals on the glove

surface

21)

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Sempermed® Syntegra IR protects medical staff and patients: It is powder-free, nat-ural-latex-free and free of allergenic proteins. So the risk of sensitisation is minimal – especially for people with atopic skin. The glove can be put on easily and quickly in any situation thanks to its soft, elastic material. It is the ideal choice if you are concerned about skin health.

Sempermed® Syntegra UV is the fi rst ANTI-ALLERGEN POLYISOPRENE ORGANIC GLOVE that is not only produced without natural latex but also without vulcanisation accelerators. This guarantees high safety, skin compatibility and comfort comparable with natural latex.The benefi ts? Latex-like comfort with 100 % protection against latex and accelerator allergies.

Thanks to the new and innovative production process, you can now rest with a good conscience with Sempercare® Green. That is because you are actively contributing to the reduction of your ecological footprint with this skin-friendly glove solution. The la-tex-free examination glove is also made without any vulcanisation accelerators, there-by reducing the risk of delayed type IV hypersensitivity, primarily caused by residues from vulcanisation accelerators, such as thiurams, carbamates and thiazoles, which are commonly known as triggers for skin irritation. The soft, green nitrile material adapts optimally to the skin and is particularly suitable for people with sensitive skin. The innovative, pure formula is also chlorine-free and offers great comfort when wearing.

Conclusion

Studies show that the annual costs of absences, loss of work and the spread of infections exceed the annual costs for skin-friendly accelerator-free gloves many times over. In addition to the selection of quality products, an important key is also prevention so skin irritation in medical personnel does not even occur.

UV light instead of vulcanisation accelerator

Sempermed has developed a completely new produc-tion process together with the Polymer Expertise Center Leoben for the surgical gloves Sempermed® Syntegra UV. With this process, the molecules do not crosslink due to accelerators and sulphur, but due to UV light. After years of research, Sempermed has succeeded in produc-ing the world’s fi rst surgical glove that gives you more freedom to work – not only because it is free of latex proteins, but also completely free of vulcanisation accel-erators. Thanks to its natural latex-like material polyiso-prene, it offers the natural comfort popular with latex. This makes it especially suitable for allergy sufferers and those with sensitive skin.

Skin-friendly accelerator systemSEMPERMED® SYNTEGRA IR

Latex and accelerator-freeSEMPERMED® SYNTEGRA UV

Latex and accelerator-free nitrileSEMPERCARE® GREEN

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Skin-friendly solutionsfrom Sempermed

In order to reduce the risk of allergic and irri-tant reactions, Sempermed relies on the use of a skin-friendly accelerator system as well as addition-al glove washing. Sempermed has also succeeded in developing a completely new, innovative pro-duction process that makes it possible to launch a completely accelerator-free glove.

Thanks to the new and innovative production process, you can now rest with a good Thanks to the new and innovative production process, you can now rest with a good Thanks to the new and innovative production process, you can now rest with a good Green. That is because you are actively contributing to Green. That is because you are actively contributing to Green. That is because you are actively contributing to

the reduction of your ecological footprint with this skin-friendly glove solution. The la-the reduction of your ecological footprint with this skin-friendly glove solution. The la-the reduction of your ecological footprint with this skin-friendly glove solution. The la-tex-free examination glove is also made without any vulcanisation accelerators, there-tex-free examination glove is also made without any vulcanisation accelerators, there-tex-free examination glove is also made without any vulcanisation accelerators, there-by reducing the risk of delayed type IV hypersensitivity, primarily caused by residues by reducing the risk of delayed type IV hypersensitivity, primarily caused by residues by reducing the risk of delayed type IV hypersensitivity, primarily caused by residues

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Bibliography

1) CDC, NIOSH, (2011) Effects of Skin Contact with Chemicals; DHHS (NIOSH) Publication No. 2011-200.2) M. Pesonen et al., 2015: Patch test results of the European baseline series among patients with occupational contact dermatitis across Europe –

analyses of the European Surveillance System on Contact Allergy network, 2002–2010.3) Flyvholm MA et al., Contact Dermatitis 57 (2007): Handekzeme in einer Krankenhauspopulation.4) Nettis E et al., Clin Exp Allergy 32(3)2002: Type I allergy to natural rubber latex and type IV allergy to rubber chemicals in health care workers

with gloverelated symptoms. 5) Kampf G et Löffl er H, Industrial Health 45(2007): Prevention of irritant contact dermatitis among healthcare workers.6) M. Baeck et al., 2013, Allergic contact dermatitis caused by latex (natural rubber)-free gloves in healthcare workers.7) University of Michigan, 2015: The impact of national level interventions to improve hygiene on the incidence of irritant contact dermatitis in healthcare workers:

changes in incidence from 1996 – 2012 and interrupted times series analysis, published in the British Journal of Dermatology.8) D. Sasseville, 2008, Occupational Contact Dermatitis.9) R. Rose et al., 2009, A review of the materials and allergens in protective gloves.10) D. Hepner, 2003, Latex Allergy, Departments of Anesthesiology, Perioperative, and Pain Medicine and Medicine, Brigham and Women’s Hospital,

Harvard Medical School, Boston, Massachusetts.11) Heese, 1995, Allergien gegen Latexhandschuhe.12) Baeck et.al. (2012) Allergy contact dermatitis caused by latex (natural rubber)-free gloves in healthcare workers,

Article fi rst published online: 11 DEC 2012 DOI: 10.HH/j.1600-0536.2012.02054.x, 2012 John Wiley & Sons A/S. 13) Heese, A. (1989-1992) University Erlangen.14) Drake LA et al, J Am Acad Dermatol. 32(1)1995: Guidelines of care for contact dermatitis. 15) Depree GJ et al., Contact Dermatitis 53(2)2005: Survey of sulfur-containing rubber accelerator levels in latex and nitrile exam gloves.16) Rimmele-Schick E., 3/2004: Die Latexallergie als berufsbedingte Erkrankung. 17) De Jong WH et al., Toxocol Sci 66(2002): Ranking of Allergenic Potency of Rubber Chemicals in a Modifi ed Local Lymph Node Assay. 18) SHIELD Scientifi c B.V., 2014, Vulkanisationsbeschleunigerfreie Handschuhe – Fakt oder Wunschtraum?19) A. Pontén et al., 2010, Occupational allergic contact dermatitis caused by sterile non-latex protective gloves: clinical investigation and chemical analyses.20) L. Cao et al., 2010: Allergic Contact Dermatitis to Synthetic Rubber Gloves.21) D. Davis, 2003, Gloving and Skin Wellness.22) Jacob, Sharon E., et al. (2006): Contact Dermatitis & Workforce Economics; Seminars in Cutaneous Medicine & Surgery 25: 105-109. 23) Call, Brian Pet et al.(2005) cidence Rates, Costs, Severity, and Work Related Factors of Occupational Dermatitis. Arch Dermatology. 2005; 141: 713-718. 24) Presseaussendung Robac Chemicals, 11/2006: Arbestab Z and Robac AS100.25) Chakraborty KB et Couchman R (Robinson Brothers Ltd., UK): Sustainable and Safer Accelerators for the Latex Industry.26) Produktmonografi e Robac, 07/2002: Use of nitrogen free Robac AS100 and Safer Accelerator Arbestab Z as a synergistic combination –

Minimisation of N-nitrosamines and Type IV Allergic concerns in NR Latex products.27) Produktmonografi e Arbestab Z (ZDNC), 07/2002: A Safer Accelerator for Natural Rubber Latex.

ImprintPublisher and Editor: Semperit Technische Produkte Gesellschaft m. b. H., Division Sempermed, Modecenterstrasse 22, A-1030 Vienna,

Tel. +43 1 79 777-0, Fax: +43 1 79 777-630, E-Mail: sempermed@semperitgroup.com, www.sempermed.comFN 36912h, Commercial Court Vienna Ve

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