Cornet – Project „Health Safety in Connection with the Use of Tattoo and Permanent Make-up Dyes“ WP3 Definition of a Common Standard for Tattooing Definite Version Table of contents 1. Introduction ...................................................... ...Error! Bookmark not defined. 1.1. 1.2. 1.3. 1.4. Definitions................................................................. Error! Health considerations and risks .................................... Error! Existing regulations .................................................... Error! Target group of the code of good practice ..................... Error! 2. Code of good practice .......................................... Error! Bookmark not defined. 2.1. 2.2. 2.3. 2.4. 2.5. 2.6. 2.7. Professional code of ethics .......................................... Error! Facilities and hygiene in the reception and work areas .... Error! Handling of materials and instruments .......................... Error! Procedures ................................................................ Error! Post-tattooing care ..................................................... Error! Collection and treatment of waste ................................ Error! General recommendations ........................................... Error! Bookmark Bookmark Bookmark Bookmark Bookmark Bookmark Bookmark Bookmark Bookmark Bookmark Bookmark not not not not not not not not not not not defined. defined. defined. defined. defined. defined. defined. defined. defined. defined. defined. 1. Introduction 1.1. Definitions By "tattooing", we mean the whole procedure by which pigment/ink is introduced under the skin using one or more needles. Tattooing is a technique for decorating the body. A motif/drawing is created that is meant to look decorative. Permanent make-up is a cosmetic tattooing technique by which pigments are introduced under the skin to embellish the eyes, the arch of the eyebrows and the lips. Permanent make-up is not ornamental; it accentuates the natural features of the face, mainly for practical purposes. Micro pigmentation or dermography includes permanent make-up and reconstructive treatments, especially enlargement of the upper/lower lip, complete colouring of the lips, correction of a labial fissure (commonly known as harelip), camouflaging of burn, operation and accident scars, reconstruction of the areola or the nipple. The main differences between tattooing and permanent make-up/micro pigmentation lie in the type of pigment/ink used, the depth and angle of the needle, the equipment used as well as and primarily the purpose of the operation. The purpose of tattooing, permanent make-up and micro-pigmentation is to obtain a permanent change of colour. After a certain time, the results can fade, depending on the way in which the pigment/ink was introduced, the type of pigment/ink, the equipment used, the effects of the sun/of medicines and changes and reactions in the body. All the terms mentioned above are tattooing techniques. They are used without differentiation. The aesthetic purpose is paramount and the safety and well being of the customer are the main concern. In this text, the term tattooing is used for both tattooing and permanent make-up, micro-pigmentation and dermography. 1.2. Health considerations and risks Technically, these treatments are no different from the perforation of the skin performed to insert a drip or that done to the gums during dental treatment. The aim of tattooing, however, is not to improve health. The treatment actually only aims to make an aesthetic change. Tattooing is an operation that can have health repercussions: formation of scars, bacterial infection, viral infection (hepatitis, HIV). To guard against any of these outcomes it is therefore necessary to observe the same hygiene rules at those which apply during normal medical treatments. 1.3. Existing regulations See adjoining table (Appendix 1). 1.4. Target group of the code of good practice Professional tattooists are the target group of the code of good practice. It is also aimed at: beauticians and other professionals whose secondary activity is micro pigmentation. 2. Code of good practice The present code of good practice is set out under the following headings: Definite version 1 - Professional code of ethics; - Facilities and hygiene in the reception and work areas; - Handling of equipment and instruments; - Procedures o to be followed for tattooing; o to be followed for washing hands; o to be followed in case of an accidental pricking; - Post-tattooing care; - Collection and handling of waste. 2.1. Professional code of ethics Age – offer 2.1.1. Tattooing can only be practised on persons aged at least 18, adult and legally responsible. People over 18 without legal responsibility cannot be tattooed. 2.1.2. In exemption to point 2.1.1., tattooing of persons under 18 years of age or without legal responsibility may be considered as long as all the following conditions are met: - the person to be tattooed is at least 16 years old; - the professional can reasonably estimate that the person to be tattooed has reached physical maturity or that their body will not undergo further significant changes during the next two years; - the professional has received in advance the written authorisation of all persons who have parental authority over the person to be tattooed; - the tattooing is carried out in the presence of at least one of the persons with legal responsibility for the minor; this condition does not apply to persons under 18 years of age who have been the subject of legal emancipation. 2.1.3. The written authorisation detailed in point 2.1.2. must contain full details of the person to be tattooed and persons with parental authority (name, first name, address, telephone number, relationship). It must also state the form, size and place on the body of the design to be tattooed. It must be retained by the professional for at least two years. 2.1.4. A tattooing carried out on medical advice is exempt from the conditions laid out in points 2.1.1. to 2.1.3. Time to consider, information, information obligation 2.1.5. All customers, both adults and minors, have the right to a professional consultation followed by time to consider their decision before undergoing a treatment, which is without obligation. 2.1.6. It must be clearly explained to the customer that having a tattoo is a permanent and final act and that the operation is by no means painless. Moreover, it is not always possible to completely erase the result, even by laser. Definite version 2 2.1.7. Publicity, brochures, the website and advice content or any other publications may not leave room for misunderstanding or contain misleading information on the subject or the tattooing operation itself. 2.1.8. Before the operation customers will be informed, orally and in writing, of the potential risks and complications of the chosen procedure; of the healing time; of what they must not do during the healing time and the care procedures to be followed. 2.1.9. The professional will make it their business to find out, before the operation, about the general health of the customer and their age. Written proof must be retained for at least one year. 2.1.10. Once the operation has been completed the customer will be given written instructions on the care procedures to follow. The professional will go over these with the customer. Anaesthesia 2.1.11. Only medical staff may carry out a sub-cutaneous Professionals without medical training may not carry it out. anaesthetic. 2.1.12. It is permitted to use anaesthetics in the form of creams, gels or sprays bought in a pharmacy by following the products’ own instructions for use. Behaviour 2.1.13. Tattooing may not be carried out on persons who are under the influence of alcohol, drugs or medicines which affect their decision-making capacity or who, more generally, are not in possession of their decision-making capacities. 2.1.14. Tattooing may not be carried out by professionals under the influence of drugs or alcohol. Equipment 2.1.15. Equipment (unipacks, disinfectant) used during the tattooing must carry a label listing the ingredients and, if such be the case, the CE symbol or the relevant EN-ISO standard. 2.1.16. Gloves must be latex, nitrile or vinyl and may be used only once. Fairs, gatherings 2.1.17. Professionals only carry out their activity in their place of work. They therefore may not perform any work in other places not suitable for tattooing such as cafés, back-of-shops, kitchens, barns, cellars, trade and erotic fairs, bikers’ meetings, music festivals, exhibitions, fairs, (flea)markets. 2.1.18. Professional meetings, specifically organised by professionals, constitute an exception to point 2.1.17. It goes without saying that all the rules in the present code also apply to such meetings. Technical quality of work 2.1.19. The professional will carry out the work demanded according to the rules of the art. 2.1.20. No unnecessary scarring will be caused to customers, who, moreover, will not be exposed to any danger as a result of the procedure or the products used. Definite version 3 2.2. Fitting out and hygiene in the reception and work areas 2.2.1. The reception area and the work area must be separated by a partition. 2.2.2. It is forbidden to smoke or to drink alcohol in the work area. Nor may animals be admitted to this area. The area shall be regularly ventilated. 2.2.3. The walls and floor of the work area will be made of a non-porous durable material. 2.2.4. The work area must be cleaned daily with a disinfectant. The reception must be cleaned daily with a detergent. 2.2.5. The lighting must be bright and full to avoid accidents associated with poor lighting. When an adjustable lamp is used, it must be disinfected between the visits of each customer. 2.2.6. Regular cleaning of work surfaces plays a major part in the cycles of disinfection and cleaning. 2.2.7. The armchair or couch on which the customer sits during the operation must be covered in a non-porous and easy to clean material. The armchair must be disinfected between the visits of each customer even if an examining sheet is used. 2.2.8. The trays on which equipment is placed must be stable and made of a nonporous material. They must be disinfected before and after each time they are used. 2.2.9. The work surface must be made of a non-porous material that can be cleaned and disinfected before and after every time it is used. 2.2.10. The work area is made of a disposable, impermeable, use-once-only material, for example, plastic film. When a tray is used, it must also be covered in a similar impermeable disposable material. This tray must be disinfected between each client. 2.2.11. During a tattooing session, the tattooist uses a small individual waste container (perhaps a plastic rubbish bag). When the work is completed, this individual bin is disposed of: - 2.2.12. Either in a waste bin situated within the work place and made of hard plastic or metal and equipped with a lid. This must open by means of a pedal action. The waste gathered in this bin must be emptied out every day into the main dustbin that is the final place where all rubbish is put. This dustbin will conform to the specific requirements for collecting household waste imposed by the council in which the establishment is situated; Or in the main dustbin that is the final place where all rubbish is put, which conforms to the requirements cited above. The work area must be equipped with a washbasin for washing hands before and after every operation. It must be easily accessible. The wshbasin must be equipped with a tap that is operated by a pedal or with the elbow or with an infrared tap. Dispensers of liquid soap and paper towels, which must be thrown away after being used once, complete the area used for washing hands. 2.3. Handling of materials and instruments 2.3.1. A general rule: materials must be, as much as is possible, disposable. In the same way, it is recommended that inks in use-once-only packages be used. Reusable materials as well as instruments must be cleaned and, if possible, sterilised after use. All accessories that come into contact with the hands or with the customer must be encircled with adhesive tape or wrapped up before use. 2.3.2. The tattooing needles can be used only once and must be put away after Definite version 4 use, at the moment they are detached, in a closed container that contains a disinfectant. 2.3.3. 2.3.4. (1) (2) (3) (4) 2.3.5. Gloves, dressings, swabs, razors, small ink or pigment recipients, as well as any other materials can be used only once. All new materials and all materials that, during the operation, risk being contaminated must be cleaned and sterilised in situ in the sterilisation area in the following manner: soaked in cold water with a cleaning product added (soap, detergent or disinfectant); cleaned by ultrasound; disinfected in a disinfecting bath; sterilised in an autoclave. Every surface or object must be sterilised as soon as there is risk of contamination. 2.3.6. During the tattooing activity, the professional must wear specific work clothes (a smock, for example). These clothes must not leave the place of work so that they do not risk becoming contaminated by exterior germs or by objects situated outside the room. As far as possible, plastic disposable clothing will be preferred. Cleaning of reusable clothing must be done with a disinfectant product. Cleaning 2.3.7. Immediately after use, the instruments must be placed to soak in a bath specially reserved for this purpose and full of cold water with a cleaning product added. 2.3.8. The instruments must never be left to dry. 2.3.9. The cleaning bath must be replaced every day. When this is done, it must be rinsed and cleaned using suitable products. 2.3.10. After washing, materials are passed under cold running water and placed in the ultrasound cleaner. 2.3.11. As a precautionary measure, gloves will be worn during the washing phase. It is also advisable to protect oneself against splashes, for example by wearing plastic sleeves or a long-sleeved smock, a mask and protective goggles, … Cleaning by ultrasound 2.3.12. Instruments must be cleaned by ultrasound using products designed for the purpose for at least 20 minutes (according to the instructions of use of the machine). 2.3.13. Detachable components must be detached and cleaned. 2.3.14. Instruments must be placed in the ultrasound machine in such a way that they do not touch the bottom of the tank. In order to do this the basket or graduated dish supplied with the ultrasonic machine must be used. 2.3.15. The level of the liquid much always reach the line marked on the machine’s vat or graduated dish, whatever the quantity of instruments to be cleaned. Disinfection 2.3.16. The instruments must be placed to soak in a bath of powerful disinfectant in a tub specially reserved for the purpose. 2.3.17. The instruments must never be left to dry. 2.3.18. The period of soaking recommended by the maker of the disinfectant product will be adhered to (usually from 15 to 30 minutes). The expiry date Definite version 5 of the product will be adhered to. 2.3.19. The cleaning bath must be replaced every day. When this is done, it must be rinsed and cleaned using suitable products. 2.3.20. A disinfectant product will be used that conforms to national regulations, or, in the absence of such regulations, that conforms to European standards. 2.3.21. It is forbidden to mix two different disinfectant products. 2.3.22. The maker’s instructions for diluting the disinfectant product must be followed. 2.3.23. After washing, materials are passed under cold running water and placed in the ultrasound cleaner. Drying 2.3.24. Once disinfected, the equipment will be rinsed under cold running water and left to dry on an absorbent surface that does not leave fluff. 2.3.25. Once they are completely dry, the instruments are wrapped in sachets for the purposes of sterilisation and placed in the autoclave. They must be perfectly dry. Only dry items may be wrapped up. Wrapping in sterilisation sachets and opening them 2.3.26. 2.3.27. Wrapping is done using sachets specially designed for steam sterilisation (one side paper and one side plastic with a temperature indicator). Wrapping is done according to the following: - only one object may be placed in each sachet, or one set of needles and holder per sachet; - close the sachet by sealing or sticking it. Sachets are closed using a sealing machine or hermetically sealed, either by being folded on themselves (self-adhesive sachets), or with an adhesive that changes colour during sterilisation (adhesive by autoclave). 2.3.28. Sterilisation sachets must be dated. A sachet only remains sterile for three months after sterilisation. After this time has elapsed, it becomes microporous. 2.3.29. All wrapping that is damaged, wet or opened, must be considered nonsterile. 2.3.30. To remove instruments and equipment wrapped and sterilised, it is best to use the technique known as «no touch»: separate the two sides of the sachet and let the equipment or instruments inside it fall onto the work surface without touching them. Sterilisation in the autoclave 2.3.31. Only items which have already been cleaned and disinfected, can be properly sterilised. 2.3.32. To sterilise wrapped items, it is obligatory to use a type B autoclave that can sterilise hollow objects and components. 2.3.33. Wrapped instruments are placed in the autoclave with the paper side facing upwards so as not to impede the circulation of steam (consequently they cannot be too tightly packed together). 2.3.34. If the autoclave is not equipped with a printer that shows the progress of the cycle, indicators of the same are placed in the machine to act as a control. 2.3.35. At the end of the cycle the control indicators must be checked and it must Definite version 6 be ensured that the packages are intact. When the door of the autoclave is opened, the contents must be completely dry. A package or instrument that is damp is not sterile. Drying cannot take place with the door open. 2.3.36. After sterilisation and drying, the sterilised instruments, still in their sterilisation sachet, are placed in a drawer, a cupboard or a closed container for a period that must not exceed one month. 2.3.37. The following instruments and equipment must be sterilised before use: - guide-needles and handles; - needle holders; - needles. 2.4. Procedures Procedure to be followed when tattooing 2.4.1. Generally, it is very important that at any moment there is a risk of crosscontamination; gloves must be thrown away, the hands washed and a new pair of clean gloves used. 2.4.2. In order to check if the customer is sensitive to certain pigments, a test can be carried out a few days before the treatment. To do this, a small quantity of pigments is deposited in a discreet place (for example, behind the ear or between the toes). The customer will check if he or she has reacted to the test over the following days. To carry out tattooing, it is advisable to follow, in order, the following steps: (1) wash and disinfect the hands; (2) put on a new pair of clean gloves; (3) all equipment that is touched during a tattooing session must be enveloped in plastic film or wrapped in plastic bags intended for that purpose. (in other words: wrap the tattooing machine’s motor and the power cable in a plastic bag intended for that purpose; wrap the control panel of the transformer in plastic; cover in plastic the armchair and armrests or the couch, the sprays and any other objects likely to be touched during a tattooing session); (4) take off the gloves, wash and disinfect the hands; (5) put on a new pair of clean gloves; (6) create a new work area following the so-called "no touch" technique; (7) set up the tattooing machine; take the needle sets and handles out of the sterile sachets (preferably using the « no touch » technique); (8) fill new small ink recipients with ink. The ink bottle must not touch the ink recipients; (9) the part of the body to be tattooed must be shaved with a disposable razor and then disinfected; (10) apply the tracing of the tattoo to the skin with the aid of a disinfectant or draw the outline with felt-tip pens intended for the purpose; (11) affix the tattoo; (12) at the end of the session, rinse and disinfect the tattoo, put on a new pair of gloves, then apply a cream to the tattoo and cover it with plastic film; (13) take the needles out of the reusable needle holders and throw them in the needle container; (14) place the handles, the needle guides and the needle holders in a decontamination bath to be washed later by hand and by ultrasound. The needle holders will subsequently be sterilised; (15) throw away all the waste material, dirty objects, plastic film and plastic bags in the rubbish bag of the individual rubbish bin. Close this rubbish bag and throw it in the rubbish bin with a closing lid or in the main large rubbish bin (see point 2.2.11); 2.4.3. Definite version 7 (16) disinfect the work table and the armchair; (17) take off gloves and wash hands; 2.4.4. For permanent make-up, micro-pigmentation and dermography, the following procedure must be adhered to, in the order as is stated: (1) wash and disinfect the hands; (2) put on a new pair of clean gloves; (3) all equipment that is touched during a permanent make-up, micropigmentation or dermography session must be enveloped in plastic film or wrapped in plastic bags intended for that purpose. (in other words: wrap the tattooing machine’s motor and the power cable in a plastic bag intended for that purpose; wrap the control panel of the transformer in plastic; cover in plastic the armchair and armrests or the couch, the sprays and any other objects likely to be touched during a session); (4) remove all make-up the customer is wearing, disinfect the part of the body to be treated and dry it by dabbing it with Kleenex; (5) sketch out the drawing with the felt-tip pens intended for the purpose; (6) take off the gloves, wash and disinfect the hands; (7) put on a new pair of clean gloves; (8) create a new work area following the so-called "no touch" technique; (9) set up the pigmentation apparatus; attach the sterile needle and the hood (if available, depending on the type of apparatus); (10) fill new small pigment recipients with pigment. The pigment bottle must not touch the pigment recipients; (11) apply the treatment; (12) after the treatment, clean and disinfect the part of the body treated and apply a healing cream with a cotton bud; (13) Detach and throw away the needles and the hoods in the needle container; (14) throw away all the waste material, dirty objects, plastic film and plastic bags in the rubbish bag of the individual rubbish bin. Close this rubbish bag and throw it in the rubbish bin with a closing lid or in the main large rubbish bin (see point 2.2.11); (15) disinfect the worktable and the armchair; (16) take off gloves and wash hands. 2.4.5. Tattooing and pigmenting machines can only be set up during the session in the presence of the customer: power cable, handles and needle sets. 2.4.6. When during the session the ink must be added, if the ink bottles are not plastified, the following procedure must be adhered to: (1) throw away the dirty gloves in the individual waste bin; (2) put on a new pair of clean gloves; (3) fill the small recipient with ink or pigments, The ink/pigments bottle must never come into contact with the small recipient. 2.4.7. For each customer, an individual waste bin is used with a plastic bag in which are thrown all the waste materials (except the needles). At the end of the session, the bag is then thrown in the waste bin with a lid on the premises or in the main rubbish bin (see point 2.2.10). As for the needles, they are placed in the required needle container. Procedure to be followed for washing hands 2.4.8. To wash the hands, the following procedure must be adhered to: (1) wet the hands (without jewellery, short unvarnished nails) under tepid running water; (2) take some little liquid anti-bacterial soap and rub it into the hands and wrists until it froths for 45 to 60 seconds. Pay particular attention to the nails and between the fingers. The nails should be cleaned with a brush. Don't forget the forearms; Definite version 8 (3) rinse thoroughly under running water and let the water continue to run to wash away all the suds from the basin; turn the tap on and off without touching it directly with the hands; (4) dry the hands with a disposable absorbent paper towel; (5) throw away the paper towel; (6) after washing the hands, it is possible to use a little alcoholised gel or hydro-alcoholic solution to ensure that they are well disinfected. 2.4.9. If, contrary to the recommendations in point 2.2.11, the wash basin is not equipped with an infra-red operated tap, or a foot- or elbow-operated tap, the tap must be turned on and off using a disposable absorbent paper towel. 2.4.10. The hands must be washed before and after each action involving physical contact with the customer, as well as after each action in which the hands could be contaminated (for example, after working in the sterilisation area). 2.4.11. Wearing gloves is not a substitute for washing the hands. 2.4.12. When the hands are washed frequently and come into contact with the talc inside the gloves, it is advisable to apply gentle hand cream to them to prevent the skin from drying and cracking. Procedure to be followed in case of accidental pricking 2.4.13. In case of an accidental pricking it is advisable to follow this procedure: (1) dispose of the needle in an approved needle container; (2) take off the gloves immediately and wash the part of the body which has been pricked with hot water and anti-bacterial soap for at least one minute; (3) dry the area that was pricked and put a dressing on the wound; (4) tell the person in charge of the establishment about the incident and make a note of the occurrence; (5) Visit a GP within 24 hours or consult the medical service at work; (6) evaluate the incident to work out what went wrong in order to prevent it happening again in the future. 2.4.14. In any case, it is strongly recommended to have a hepatitis B vaccination as a precautionary measure. 2.5. Post-tattooing care 2.5.1. After the tattoo has been finished, written instructions must be given to the customer explaining how to make the tattoo heal quickly and easily. 2.5.2. The instructions in point 2.5.1. may under no circumstances recommend the use of any the following products: - povidone-iodine; - alcohol, isopropanol, ethanol, perfume; - oxygenated water; - any aggressive product (those which are not recommended for prolonged usage). 2.5.3. Customers must be able to freely consult the professional who carried out their tattooing to receive advice and follow-up to the operation. 2.6. Collection and handling of waste 2.6.1. Needles are dangerous medical waste and should be thrown away in approved needle containers. 2.6.2. These containers must be collected from the establishment by a body recognised by the public authorities as qualified to remove this type of Definite version 9 waste. The needles must be destroyed by this body. The tattooing establishment must retain the most recent document attesting to the destruction of the needles. 2.6.3. All other waste products are specific refuse of the business and their disposal must be in accordance with local authority regulations. 2.7. General recommendations 2.7.1. The professional will undergo regular training, especially in the following areas: 2.7.2. - basic principles on risks of infection and haemorrhage; - basic principles of toxicology, pigments; - transmissible diseases, preventing their transmission; - first aid; - universal principles of hygiene, disinfection of skin and hands and wearing of gloves; - basic concepts of disinfection and asepsis; - sterilisation of reusable thermo-resistant equipment and disinfection of reusable thermo-sensitive equipment; - upkeep of premises and furniture; - dealing with laundry; - dealing with waste. In the reception area of the establishment the following notices will be prominently displayed: no smoking, animals not allowed, age limits. Definite version 10