• Appendix 1 - Primary legislation considerations for cosmetic piercing activities
• Appendix 2 - Pre-consultation with client
• Appendix 3 - Infection control
• Appendix 4 - Cleaning and disinfection
• Appendix 5 - Aftercare advice
• Appendix 6 - Safe waste disposal
• Appendix 7 - Anaesthetics
• Appendix 8 - Additional areas of the legislation & guidance
• Appendix 9 - Enforcement
• Appendix 10 - Website links and relevant publications
• Appendix 11 - Glossary of body adornment terms
• Table 1 - Selected enforcement approaches
• Table 2 - Disinfectant usage & supporting notes

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Appendix 1 - Primary legislation considerations for cosmetic piercing activities

14. Facilities, conditions and activities within premises must comply with the requirements of the legislation below. At present any enforcement is limited to the following legislation, some of which is applicable to a variety of special treatments, including cosmetic piercing, (ear piercing and body piercing), semi-permanent skin-colouring (e.g. micropigmentation, semi-permanent make-up and temporary tattooing), acupuncture, electrolysis and tattooing:

15. The Local Government (Miscellaneous Provisions) Act 1982

If an LA has previously adopted the Local Government Miscellaneous Provisions Act (1982), this allows it to make bylaws on electrolysis, acupuncture, ear piercing and tattooing. The person(s) carrying on the business and the premises are required to register with the LA that enforces the provisions of the byelaws. These cover the cleanliness of the premises, fittings, equipment and persons carrying on the business. These businesses are inspected to ensure that they comply with the bylaws.

The Local Government Act 2003 (section 120 and Schedule 6) has amended the 1982 Act to give local authorities powers to regulate businesses providing cosmetic body piercing, micropigmentation and similar activities. The 2003 Act introduces new terminology for simplicity and clarity:

• Ear piercing and cosmetic body piercing are encompassed in the single term cosmetic piercing (which is the term also used in the legislation affecting London LAs);
• Micropigmentation, semi-permanent make-up and temporary tattooing are covered by the umbrella term semi-permanent skin-colouring. This approach allows for other similar activities to be covered in future.

This change in the law came into force from 1st April 2004.

16. Greater London Council (General Powers) Act, 1981

The 1981 Act provides that no person may carry out acupuncture, tattooing or cosmetic piercing in their area unless he and any business premises are registered. The Borough Council may make byelaws for the purpose of securing the cleanliness of premises, instruments, equipment and persons. Books, cards or forms must also be kept by persons registered under this section, recording their activities in connection with the practice of business in respect of which they are so registered and that appropriate entries are made in such books, cards or forms. In some cases certain treatments are expressly forbidden under local licensing under this Act.

17. London Local Authorities Act, 1991

This Act states that no person shall carry on an establishment for special treatments without first obtaining a licence from a participating council.

An ‘establishment for special treatment’ is defined in the Act as any premises used or represented as being, or intended to be used for the reception or treatment of persons requiring massage, manicure, acupuncture, tattooing, cosmetic piercing, chiropody, light, electric or other special treatments of a like kind or vapour, sauna or other baths.

Conditions can be attached to licences that may cover items such as safety of equipment, hygiene practices, age limits, hours of operation etc.

Premises are exempt from the need to license if the premises are not used for gain or reward, or, e.g. if the special treatment is carried out by or under the supervision of a medical practitioner registered with the GMC or persons who are bona fide members of a body of health practitioners. This list is not exhaustive and there are other exemptions.

Health practitioner is defined as ‘a person who uses his skills with a view to the curing or alleviating of bodily diseases or ailments but does not include a person whose skills are employed mainly for cosmetic alteration or decorative purposes’.

A list of bodies of health practitioners currently granted exemption is provided to all London authorities that have adopted the Act. This list is commonly held by the Licensing Section of the borough council, e.g. as for Walthamstow.

18. Health and Safety at Work etc Act, 1974

This Act regulates the health and safety of persons at work, including the self-employed, and persons affected by a work activity.

Section 2 of the Act places a duty upon every employer to ensure the health, safety and welfare of their employees.

Section 3(1) of the Act is particularly applicable to business premises where the public is affected by business activity, and states that: ‘It shall be the duty of every employer to conduct his undertaking in such a way as to ensure, so far as is reasonably practicable, that persons not in his employment who may be affected are not exposed to risk to their health and safety.’

Section 3(2) of the Act places a similar duty on every self-employed person. Ultimately, whether LAs register the business or not, the HSWA, 1974 applies to all employers, employees and self-employed people. It also protects people not at work such as members of the public, who may be affected by a work activity. As with any business, Sections 2 and 3 of the HSWA, 1974 would be applied at any cosmetic piercing premises to ensure the suitability of the premises, safety of staff employed and to ensure a safe treatment environment for the public affected by the business.

19. Training of cosmetic piercers and the Management of Health and Safety at Work Regulations, 1999

The HSW Regulations, 1999 also requires employers to provide whatever information, instruction, training and supervision that is necessary to ensure, so far as is reasonable practicable, the health and safety of their employees.

An employer is therefore required to provide adequate employee training to ensure that they can carry out their work safely. However, there is no recommended period of study for cosmetic piercing training, and LA enforcement officers may have to rely on discussion with newly trained people to establish their competence during work activities.

At this time there are no nationally approved training courses available for UK body piercers, although a number of commercially run courses are available. It is recommended that basic first aid training and infection control guidance be provided as part of any cosmetic piercing training course. The latter is available within this document and via other authoritative sources. HABIA, part of the Consumer Services Industry Authority (CSIA), is the Standards Setting Body with responsibility for both body piercing and tattooing at the time of writing. HABIA is developing occupational standards for skin piercing activities and these may lead to the implementation of qualifications in the future. For more information visit www.habia.org.

20. Tattooing of Minors Act 1969

This Act prohibits the permanent tattooing of anyone in the Great Britain under the age of 18 yrs. Standard tattoos are a well-known form of body adornment but are also a form of body modification because they are permanent skin alteration unless removed by laser treatment. Removal treatment may itself result in incomplete removal and / or scarring. The implications for this Act in the context of micropigmentation are covered in greater detail in LAC 14/1. Briefly,

• Micropigments are made from suspended particulates in a liquid base, unlike traditional tattooing dyes or inks, which comprise soluble colours;
• Concerns remain over the degree of permanence of temporary or semi-permanent tattoos, i.e. products that reputedly fade within 5 - 10 years. Since most UK treatments have been administered well within this time frame the semi-permanency of the many available products is not yet clear; and
• Descriptions of micropigment content as ‘natural plant extracts’ or ‘natural minerals’ is no guarantee that the pigment will fade within 5 - 10 years, or that it will be chemically and biologically appropriate for intradermal administration.
• Following any first consultation related to facial tattooing of any kind, a period of reflection is recommended in view of the potential impact that such treatments may have on the client.

21. Age and consent issues

Declaration and proof of age should be a fundamental part of the client consultation process (Appendix 2). There is no statutory age limit for ear piercing or cosmetic body piercing within England and Wales. However, London Boroughs have used licensing powers to impose licence conditions relating to the age of the client.

• In parallel with tattooing, some London Boroughs allow no body piercing (except ears, nose and navel) below the age of 18 years;
• Some impose no age restrictions;
• Others allow only ‘above the belt’ piercing at age 16 – 18 years or require either proof of ID or an adult’s consent for this age range;
• Others stipulate under 16 year piercing only with a parent or guardian present;
• Most piercers should be advised to request that the client sign a consent form prior to any piercing; and
• Body piercers should be advised to adopt reasonable age restrictions. An operator with a successful business would then avoid parental conflict and legal complications, while enhancing his or her reputation for high standards. Advice to the enforcement officer on this subject is given Appendix 8.

22. Control of Substances Hazardous to Health 2002 – including biological agents (COSHH)

The COSHH regulations require employers and self-employed to prevent or control the exposure of employers and others such as members of the public to hazardous substances. This includes exposure to biological agents such as bacteria, fungi and viruses as well as to chemical agents such as disinfectants. The Regulations specifically requires the operator to assess the hazardous substances that their employees and the clients would be exposed to. This process is similar to a risk assessment, but a COSHH assessment has to be recorded. The publication ‘A step by step guide to COSHH assessments’ HS (G) 97, HSE Books 2004, ISBN 0 7176 2785 3 gives details on how to carry out a COSHH assessment. COSHH sets out basic measures that employers must take to

• Assess the risks associated with hazardous substances, e.g. liquids, aerosols, volatile fumes
• Establish who may be at risk
• Implement any measures needed to prevent or control exposure, and
• Establish good working practices to support this.

Assessments should include:

• The use and correct storage of bulk cleaning products and disinfectants required to effectively clean equipment; and
• Any contact with body fluids, hazardous waste or sharps.

COSHH also requires that sufficient information, instruction and training be provided to employees. This should include

• The names of substances they work with;
• The main findings of the risk assessment, including handling of materials which may be contaminated with blood products;
• The precautions they should take to protect themselves and other employees, including disposal of materials containing blood products;
• How to use personal protective equipment and clothing;
• Emergency procedures to be followed.
• A COSHH Essentials information document is now available for cosmetic skin piercers at: http://www.coshh-essentials.org.uk/assets/live/SR12.pdf [135KB]

23. Anaesthetics

Detailed legislation exists governing the appropriate use of anaesthetics during cosmetic piercing activities, and this subject is dealt with in Appendix 7, along with other, non-legal considerations related to anaesthetic use.

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Appendix 2 - Pre-consultation with the client and record keeping

24. Record keeping protects the interests of both operator and client. The client, because technical details of their treatment are noted, so the treatment and any follow-up care can then be tailored in the knowledge of all relevant details. For the operator, the identification of any allergies or health problems that may affect treatment is essential to avoid complications during or after the procedure. A consultation should therefore be undertaken with the client before any treatment is carried out. Records should be kept of this consultation. Many traditional tattooists photographically record their work for use as in-house advertisements or for reference if further ‘touching up’ of artwork is required. However, if this were done it would require customer agreement, and a guarantee of security for image(s) storage. Declaration and proof of age should be a fundamental part of the consultation process. Records should preferably be kept for a period of two years (one year minimum), and should include the following items:

• Date of procedure;
• The client’s name and contact address,
• Treatment plan, including actual treatment to be carried out and area to be treated;
• A record of the type of body jewellery used, if applicable. If the operator did not supply jewellery, then accurate details of chain of supply should be established;
• Medical history, to consider:
  • Chronic skin conditions such as eczema & psoriasis
  • Haemophilia
  • Heart disease**
  • High/low blood pressure
  • Medication
  • Epilepsy
  • Diabetes
  • Allergies*
  • Nursing mothers; pregnancy & breast feeding
• Other contra indications, e.g. skin infections close to area to be treated;
• After care advice (written and verbal);
• Photographic evidence
• Associated hazards and risks

*It may be appropriate to patch test skin products if indicated. Some operators will recommend this routinely.

**Recent advice from the British Society for Antimicrobial Chemotherapy states that anyone who had previous heart surgery, or been diagnosed with a heart condition, should consult their doctor before having a piercing involving a mucous membrane (nose, lip, tongue or genitals), as there may be a risk of potentially serious infection

If there is a history of any relevant medical conditions, the client should be advised to consult their GP for advice on their suitability for treatment.

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Appendix 3 - Infection control

25. When carrying out cosmetic skin piercing infection control considerations are paramount and essential. As with all skin piercing activities the skin is punctured and there is a risk of blood borne virus transmission, including hepatitis B, hepatitis C and HIV, if hygienic procedures are not followed. Some blood borne viruses, for example hepatitis B, can be transmitted by very small volumes of blood; too small to be visible. There have been outbreaks of hepatitis B infection associated with tattooing and acupuncture in the past, but by implementing sensible precautions these can be avoided.

26. Immunisation

It is recommended that the person carrying out cosmetic piercing (the operator) be immunised against hepatitis B to protect themselves and their client. Because of the occupational nature of the requirement, an operator may be charged by his / her GP for this course of injections. Skin piercers should keep copies of their antibody results following immunisation for inspection. Repeat immunisation and/or antibody level checks should be made as directed by a GP. Nevertheless, immunisation should not be a replacement for good hygiene standards, because most infections are transmitted between clients via the skin piercer rather than from the piercer to the client. There is still no vaccine available against HIV or hepatitis C, so any potential contact with blood and other body fluids should be approached with all necessary precautions – see below. Anyone handling sharps is also advised to be up to date with their tetanus immunisation. All such immunisations can be arranged through a GP and advice on these issues is given in, Immunisation Against Infectious Disease 1996 HMSO, ISBN 0 11 321815 X. See also,

• The Advisory Committee on Dangerous Pathogens (ACDP); Protection against blood-borne infections in the work place: HIV and hepatitis, HMSO 1996, ISBN 0 11321953 9.
• The NHS also provides comprehensive information regarding currently available immunisation. http://www.immunisation.nhs.uk/

27. Work surfaces

Whenever blood products are being handled certain work surface precautions are necessary. Contact with blood-borne viruses such as HIV, hepatitis B and C can occur whenever operators are exposed to the blood of their clients, or vice-versa. These viruses are classified as Hazard Group 3 (on a scale 1 – 4 of increasing risk), by The Health and Safety Commission, and can cause serious disease.

All work surfaces, couches, seats etc. should be designed so that they are smooth, impervious and can be effectively cleaned by wiping with a suitable disinfectant between clients, to reduce the risk of cross infection. Soft furnishings are generally inappropriate for such work areas. Where any soft furnishings are present, e.g. seat covers, they should be replaced or covered by appropriate easy wipe surfaces. Any cleaning products used should be chosen with care to avoid causing chemical damage to such work surfaces. Advice on the cleaning of work surfaces and equipment is now available through COSHH Essentials at: http://www.coshh-essentials.org.uk/assets/live/SR04.pdf [129KB]

28. Personal hygiene

A good standard of operator personal hygiene must be encouraged to maintain a safe working environment whenever skin piercing is performed. Hand washing is an important procedure for preventing the spread of infection. It has been shown repeatedly in the hospital environment that hand washing is best performed using liquid soap and running water in a purpose-designed basin, with effective drainage. Water should preferably be supplied hot and cold via a lever-operated mixer tap, and hands dried with disposable towels, not multi-use cloth towels. Hand washing is particularly important:

• Before and after tattooing or skin piercing procedures;
• Whenever hands become accidentally contaminated with blood, body fluids or secretions;
• Before applying and after removing protective gloves;
• After visiting the toilet;
• Before handling food and drinks;
• After smoking; and
• After handling money. Operators should also note that:
• Smoking should not be allowed during skin piercing procedures or treatment, as there is the risk of transferring bacteria from the operator’s mouth via fingers to the client. Staff should wash their hands after smoking.
• The operator should cover any cuts or grazes they have prior to starting treatment. Their nails should be clean and short and eating and drinking should be avoided in the clean treatment area.
• Alcoholic hand rub (cleanser) should only be used on hands that are already physically clean.

29. Personal protective equipment (PPE) and appropriate clothing

In order to protect the operator from body fluids and protect the client from infection it is essential that gloves and the following PPE be worn:

30. Gloves

Examination style gloves should be worn during the treatment to protect the operator during contact with bodily fluids and tissues. This barrier also protects the client from any microorganisms harboured on the operator’s hands, but should NOT be regarded by an operator as a substitute for good hand washing. Importantly, gloves, if contaminated, can transfer infection in the same way as dirty hands. Other activities, e.g. answering the telephone, should therefore be avoided while gloves are worn as this may result in cross contamination.

• Single use examination-style gloves should be worn during micropigmentation procedures and must be disposed of between clients. Fresh gloves must be used at commencement of every new procedure. Latex allergies are becoming common with prolonged use of latex gloves, and the use of vinyl or nitryl-based glove materials will avoid sensitisation. These should be CE marked as suitable for biohazard use (see also Relevant Publications section);
• Gloves should always be changed if punctured at any time during a procedure or when otherwise contaminated during procedures, e.g. if there is a possibility of contamination from the previous client and / or if areas are touched other than sterile instruments or client treatment area;
• Hands should always be washed prior to donning gloves and after glove removal;
• Used, single-use gloves should be disposed of to clinical waste receptacles and should never be re-used, or washed for re-use.
• Domestic style gloves should only be used for equipment cleaning and should be stored correctly so as to avoid possible misuse;

31. Clothing

• Clean, washable clothes are suitable for use by the operator and a single-use plastic apron should be worn over these and should be disposed of between clients.
• Re-usable cotton towels should NOT be used as clothing protection. They may harbour and transmit blood-borne infection even after hot machine washing.

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Appendix 4 - Cleaning and disinfection

32. Important note

Any re-usable equipment used during cosmetic piercing procedures will require steam sterilization before re-use, and it is essential that thorough cleaning and drying of any re-usable equipment is undertaken prior to the steam sterilization process.

Definitions:

33. Cleaning - a process that physically removes contamination but does not necessarily destroy microorganisms. The reduction of microbial contamination cannot be defined and will depend on many factors including the efficiency of the cleaning process and the initial bio-burden. Cleaning of equipment and work surfaces is best achieved using detergents compatible with the materials from which the equipment and work surfaces are made.

34. Ultrasonication – Ultrasonication is an efficient cleaning method and operates using a process known as cavitation. This cleaning effect attacks every surface, including apertures and recesses that may otherwise be inaccessible. Cleaning agents are added to the bath and these are usually supplied with the equipment, or else recommended by the equipment supplier. A cleaning effect occurs wherever equipment is in contact with the liquid; therefore it is an effective way of cleaning the smallest crevasses in objects. NB. Ultrasonic cleaning is not a disinfection process and items cleaned by ultrasonication must be subjected to a subsequent sterilization process. Therefore items removed from the ultrasonication bath should be handled with care.

35. Disinfection - reduces the number of viable microorganisms but it may not necessarily inactivate some bacteria, fungi, viruses and spores. Disinfection does not achieve the same reduction in microbial contamination levels as sterilization and it lacks the treatment quality assurance of steam sterilization.

36. Sterilization - renders an object completely free from viable microorganisms, including bacterial and fungal spores.

37. Cleaning of equipment – general principles:

The Medicines & Healthcare products Regulatory Agency (MHRA; now incorporating Medical Devices Agency [MDA] and Medicines Control Agency [MCA]) has issued guidance on reprocessing instruments and decontamination of other equipment, ( Appendix 10). The guidance relates the choice of decontamination method to the infection risk associated with the intended use of the equipment. High risk is associated with items that are in “close contact with a break in the skin” and for these, sterilization is essential. The MHRA-MDA recommends steam sterilization at the highest temperature compatible with the equipment being processed. Wherever possible it should be carried out by a hospital sterile services department or non-hospital, commercial Sterile Services provider that has the equipment and expertise to ensure that items are cleaned thoroughly and sterilized consistently. In the absence of hospital sterilization facilities a properly functioning bench top steam sterilizer (autoclave) may be used – but it must be suitable for the equipment that the user intends to process. MHRA-MDA has provided guidance for the purchase, operation and maintenance of steam sterilizers, ( Appendix 10).

38. Single use equipment

It is strongly recommended that single use equipment is used wherever feasible. When re-useable equipment must be used, it should be capable of being steam sterilized.

39. Single use equipment must never be reused and should be disposed of appropriately. (See Appendix 6). Body piercing needles are generally hollow and are designed for single use; these must be disposed of after each client. For additional advice see also MHRA-MDA document DB2000(04), Single-use Medical Devices: Implications and Consequence of Re-use ( Appendix 10). When it is not possible to use single use instruments, reusable instruments must be reprocessed properly – see 38 above.

40. Although gross contamination during individual cosmetic piercing procedures is unlikely, visible soiling such as blood and grease should always be rinsed off instruments using warm (not hot) soapy water prior to immersion in the ultrasonic tank.

41. Ultrasonic cleaners should be operated in accordance with manufacturers instructions and used with the lid / cover in place to prevent aerosol formation. Instruments should ideally be placed in the basket supplied with the machine; this should be an appropriate size for the equipment being cleaned. The efficiency of ultrasonic cleaning is improved by the use of a low foaming surfactant or detergent. The choice of detergent and control of the in-use concentration of detergent have a significant effect on cleaning performance. Advice should be sought from both the instrument and detergent manufacturers.

42. The tank of the ultrasonic cleaner should be cleaned with a suitable non-corrosive detergent and soft brush at least weekly. The tank should be emptied and refilled with clean solution when the solution has become visibly soiled, or every four hours during the working day, whichever is the sooner. De-gassing is necessary after each fill, before instruments are processed. Periodic functional testing of ultrasonic cleaners should be performed as recommended in the manufacturer’s instructions. These tests should be based on relevant tests described in the NHS HTM 2030 document - Washer-disinfectors and ultrasonic cleaners, Validation and Verification.

43. Cleaning. Thorough cleaning is a prerequisite to all other decontamination processes. If an item is not clean this may inhibit disinfection/sterilization. Used instruments should be cleaned thoroughly to remove all debris and body fluids, first in cool water (below 35 oC to minimise steam and droplet generation) and then in warm water to enhance the cleaning effect. Detergents assist cleaning and should be used according to manufacturers’ instructions (i.e. at the correct dilution, etc.), but disinfectants should not be used, as unlike detergents, disinfectants alone do not assist the removal of organic residues. Scrubbing above the water surface can create aerosols, which can spread infectious agents from contaminated equipment. All scrubbing should therefore be performed below the surface of the water. Ultrasonic cleaning can be more consistent than manual cleaning. Only instruments that can tolerate ultrasonication should be processed in this way. Washing up type gloves, a non-absorbent apron and eye protection should be worn when manually washing instruments. Additional advice on cleaning can be found in Section 83, ref. 14.

44. Disinfection. Viable microorganisms may remain on work surfaces and instruments despite apparently thorough disinfection. Adequate disinfection may be achieved using fresh bleach containing minimum 1000ppm available chlorine or purpose-designed disinfection products. Many bleach products do not state their contained chlorine activity, and this may undermine effective disinfection. Hypochlorite, as tablets of sodium dichlorisiocyanurate (NaDCC) - containing pre-measured amounts of NaDCC – can help in this respect. Numerous brand suppliers exist, but once dissolved, this product is as unstable as other liquid hypochlorites. It should be noted that a product might be suitable for some areas but not others. In particular, many products may be designed for either skin or environmental application, but not both. E.g. bleach solution (1000ppm) can be used effectively on hard work surfaces but can damage skin and metal instruments. Some common disinfectants, and their appropriate uses, are given in Table 2

45. Sterilization

Steam sterilization is the preferred method of sterilizing equipment. Hot air ovens, water boilers, UV light boxes and glass bead sterilizers are not reliable methods of sterilization and must not be used. Specifically, the MHRA reports that hot air ovens are often poorly maintained and do not have interlocks; items can therefore be removed before full sterilization is complete. With glass bead sterilizers there is a fundamental problem with their reliability to sterilize that part of the device/item in contact with the beads. As with the use of hot ovens, there are no safe guards to prevent access to the device and no method of recording, calibration or routine testing. There are also issues with toxin and general contamination build-up amongst the beads over time and also the inconsistency of decontaminating the beads themselves. By contrast, steam sterilization is rapid, automated, easy to use, reliable, non-toxic, non-polluting and effective when used correctly. It is also cheap to run. A standard bench-top steam sterilizer will sterilize items that are not hollow, not tubular, not porous (i.e. fabrics) and not packaged. If the use of such unpackaged items is not immediate, they must be stored dry, in a clean, disinfected, covered container that avoids dust settling on clean items. Although they have been cleaned and sterilized, these items cannot be regarded as having a high quality assurance of sterility at point of use because they are not being used in a controlled clinical environment, e.g. an operating theatre. It is therefore likely that the microbiological condition of appropriately stored items will, at worst, be comparable with that of the environment in which they are used. Such items should be used within three hours of removal from the steam sterilizer.

46. Items that are packaged, hollow, porous or tubular should be sterilized in a sterilizer that has forced air removal (e.g. pre-sterilization vacuum stage) and which has been validated for the intended items. For packaged items, the sterilizer must have an effective post-sterilization drying stage. The packaging material must be purpose-made for steam sterilization and able to resist ingress of contamination when dry: BS EN 868-4:1999 is the relevant standard. Wet (or damp) packages cannot be regarded as sterile because microorganisms can penetrate wet packaging. Vacuum steam sterilizers are relatively complex pieces of equipment and must be well maintained to ensure effective performance. Their performance in air removal varies considerably, so the suitability of a particular sterilizer for a particular load needs to be verified prior to purchase to ensure sterilization efficiency. (See MHRA-MDA guidance, Relevant Publications section).

47. The MHRA-MDA has also issued guidance on reprocessing instruments and decontamination of other equipment. The guidance relates the choice of decontamination method to the infection risk associated with the intended use of the equipment. High risk is associated with items that are in “close contact with a break in the skin” and for these, sterilization is essential. The MHRA-MDA recommends steam sterilization at the highest temperature compatible with the equipment being processed.

48. In summary, the following are recommended:

• Sterile, single use needles, tubes, grips and/or tips for all piercing procedures should be used wherever possible. These should be supplied pre-sterilized and seal-wrapped by the manufacturer;
• The use of a hospital sterile services department for sterilization may be appropriate if a commercial service is available nearby the operator. This might avoid the need for purchase of an expensive vacuum steam sterilizer (autoclave), though some form of steam sterilization must be available at the cosmetic piercing premises;
• Where vacuum steam sterilizers are used, ensure prior cleaning of equipment by ultrasonic cleaner, cleaning crevices and lumens with narrow brushes and flushing through with water.

Steam Sterilizers of all kinds are pressure vessels, and as such are subject to safety checks under the Pressure Systems Safety Regulations, 2000. All steam sterilizers must have a pressure cycle to be effective for the uses described above.

49. Sterilization indicators - Sterilization indicators change colour when the specified time and temperature have been achieved for sterilization. Autoclave tape, or the indicators printed on the outside of a sterilization bag or pouch, are only intended to show exposure to steam i.e. to distinguish items that have been processed from those that have not been processed. They do not show that sterilizing conditions have been met within a packaged, porous or lumened item. The use of an inappropriate indicator can give dangerously misleading results.

50. Emulating indicators conforming to ISO 11140 part 1 - Sterilization of health care products – Chemical indicators (Class 6 – Emulating indicators), are designed to react to all critical parameters (e.g. time, temperature and saturated steam) of a specified sterilization cycle. Only that type of indicator will show, when placed in the load, whether sterilizing conditions have been attained at that point. Sterilization indicators (both chemical and biological (e.g. spore strips) are a quality control measure and are not a substitute for routine periodic testing, validation and correct maintenance of a sterilizer.

51. Specific advice on prevention of infection can be obtained from the Consultant in Communicable Disease Control or the local community infection control team. Advice on sterilizers and sterilization can be obtained from a Registered Authorised Person (sterilizers) [AP(s)]; a list of their names and contact details can be obtained from The Institute of Healthcare Engineers and Estates Management 12 Abingdon House, Cumberland Business Park, Northumberland Road, Portsmouth PO5 1DS Tel 01705 823186, or on the IHEEM website at: http://www.iheem.org.uk/authorising/documents/APSList.doc [2MB]

52. Additional hygiene considerations for cosmetic piercing

• There is a clear need for sterility of inserted jewellery and implants used in piercing practices, as well as for the instruments used. Cleaned jewellery or implant items should be sterilized as described above. The period between the opening of the steam sterilizer and insertion of the jewellery should be minimal, and if jewellery has cooled while enclosed in the sterilizer a skilled operator can insert it soon after retrieval. Despite an absence of clean air conditions, this can help to minimise infection risks.
• Many piercers use small bags for steam sterilizing of re-usable tools and jewellery. Bags intended only for steam sterilization should be used only if the sterilizer has a vacuum stage air removal can its effectiveness be validated for this type of packaging and content.
• In most cases the client will choose an item of jewellery with care and retain it after insertion. However, if a jewellery item is subsequently rejected and removed in the studio, best practice would be to destroy the item and not to re-use it. This is because any scratch damage to the jewellery either by the operator or client can harbour infection, and it may be impossible to detect hairline scratches on jewellery surfaces.

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Appendix 5 - Aftercare advice

53. Operators should be trained to give comprehensive aftercare advice. Interviews with operators have suggested that verbal aftercare advice provided after treatment is rarely heeded. Excitement or discomfort can limit attention following treatment. It is therefore prudent for the operator to offer advice before the procedure is carried out and while they have the client’s full attention; but then reinforce this during and after the procedure. This can logically be done immediately after the questionnaire is completed. The provision of written aftercare advice to reinforce verbal advice given at the time of the treatment is considered best practice. These need to be basic instructions to minimise healing times and reduce the risk of acquiring infection at the treatment site.

54. The LA enforcement officer should ensure that the operator provides the following basic advice, which is largely based on sensible hygiene precautions:

• A good standard of personal hygiene will generally assist in reducing the risk of wound infection. Medically trained staff consulted on this issue indicate that leaving the pierced area completely dry is preferable. In view of this, personal hygiene should avoid submersion or direct handling of the newly pierced site for at least 4 days after the initial treatment. This will allow drying of the wound and will greatly reduce the chance of wound infection;
• Cleaning, and the use of skin disinfectant chemicals can result in damage to delicate scar tissue and extended healing time and should therefore be avoided; and
• For body piercing, expected (complete) healing times are difficult to predict because individuals’ healing abilities vary, but a client should be told what to expect. The healing time is the time required for the jewellery ‘tunnel’ to become dry and healed after the initial tissue damage. Guidelines are scarce in this area, but those provided by the US Association of Professional Piercers are:

Ear lobe, eyebrow and nasal septum: 6 – 8 weeks
Ear (cartilaginous region) and nostril: 2 months to 1 year
Tongue: 4 to 8 weeks
Lips and cheeks: 6 to 12 weeks
Genital (female and male) including inner labia, clitoral hood: 4 to 12 weeks
Nipple, scrotum, outer labia: 2 to 6 months
Navel and ampallang (a transverse penile piercing): 4 months to 1 year

55. NB. Both operator and client should take seriously any excessive bleeding after body piercing. In the first instance, firm pressure should be applied to the area with clean dressings, e.g. sterile gauze. Ice on a pierced tongue may also reduce swelling and bleeding. If bleeding persists in any area, but in particular after tongue piercing, medical help should be sought from the nearest accident and emergency department. Clients should be encouraged to return to their local cosmetic piercer as a matter of routine for follow up care within two weeks, to check for anything abnormal around the pierced site.

56. Possible complications resulting from cosmetic skin piercing

LA officers and cosmetic skin piercing operators should be aware of the possible complications that may arise as a result of such treatments. While it is acknowledged that problems may arise from improper aftercare, the responsibility of the enforcement officer is to ensure, wherever possible, that the premises is suitable for the activities undertaken and that appropriate aftercare advice is given by the special treatments practitioner. An appreciation of post treatment complications is required, as these may be responsible for initially bringing a problem to the attention of the LA officer.

57. The client’s perception of a problem may govern whether they return to the original operator, another operator or to their own GP for follow-up care. Severe problems will usually result in direct medical intervention of some kind. Examples of recognised problems following piercing and tattooing include:

• Jewellery embedding - where part or all of the inserted item sinks beneath the skin surface after piercing. This is usually caused by infection and has been observed after inappropriate use of ear-piercing guns on other body parts, e.g. navels. It can also result from insertion of items of jewellery
• Allergies to jewellery – this is often the result of allergy to metal components, e.g. Nickel, poor gold plating or the use of 9 carat gold materials. Most operators now use either titanium, low nickel surgical grade steel or implant grade steel to avoid such problems. Eighteen carat gold is less likely to cause allergic responses than 9 carat, but is much softer than steel, may become pitted, and so is avoided by many operators. See also paragraph 70. It should also be noted that allergies might exist to aftercare products and skin cleaning agents. Clients should be consulted on this before treatment commences.
• Migration of jewellery – can happen to any pierced area, especially if inserted jewellery is too thin or is agitated before healing. This can also be a problem with implanted (subcutaneous) items used in scarification and piercing procedures, and results in jewellery migrating through or under the skin, away from the original point of insertion. The UK Association for Master Tattoo Artists and Body Piercers also indicates that migration can also occur if jewellery is incorrectly inserted in to piercing sites, e.g. if the shape of a client’s navel means there is permanent pressure navel tissue displacing on an item of jewellery after its insertion.
• Scarring – when not a planned part of the treatment, this is sometimes the result of poor jewellery insertion, jewellery migration or of infection and poor healing generally.
• Severe localised swelling – can happen anywhere following tattooing or piercing, but particularly dangerous with oral piercing (proximity to airway), e.g. the tongue may swell to at least twice its normal size after piercing and this must be accommodated by the correct choice of jewellery. However, it may also be a sign of infection – see below.
• Localised infections – usually caused by opportunistic bacteria, e.g. Staphylococcus, Streptococcus and Pseudomonas species. Can be avoided with good piercing hygiene and effective aftercare, but may become systemic (septicaemia). More common in diabetics.
• Septicaemia, or blood poisoning – a serious systemic infection, i.e. affecting the whole body. May be life threatening and requires immediate medical intervention in the form of admission to hospital. Individuals with pre-existing heart disease are especially prone to septicaemia.
• Bleeding – Must be expected following most piercing and sometimes occurs following tattooing, but may be persistent. High-risk areas include male genital piercing (Prince Albert / ampallang) and tongue piercing. Lips (labret) may also bleed profusely. These areas have rich blood supplies that may lead to haemorrhaging after piercing. Individuals taking aspirin, anticoagulant drugs or with haemophilia are especially likely to bleed.

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Appendix 6 - Safe waste disposal

Clinical waste

58. Waste from skin piercing procedures is clinical waste. Clinical waste is defined as “any waste consisting wholly or partly of human or animal tissue, blood or other bodily fluids, excretions, drugs or other pharmaceutical products, swabs or dressings, or syringes, needles or other sharp instruments, being waste which unless rendered safe may prove hazardous to any person coming in to contact with it’.

The Health Services Advisory Committee (HSAC Working Group), in agreement with the Advisory Committee on Dangerous Pathogens (ACDP), have produced a document entitled - The Safe Disposal of Clinical Waste (1999) (See Relevant Publication section for further information).

59. The disposal of clinical waste is controlled by the Environment Agency. There is a duty on those producing the clinical waste to take reasonable steps to handle and look after it safely, and to ensure others licensed to perform this task dispose of it legally. It is usually disposed of in yellow clinical waste bags. Clinical waste must be kept apart from general waste and must only be disposed/removed from the premises to a licensed clinical waste incineration site by a contractor licensed under the Waste Management Licensing Regulations, 1994, with the Environment Agency.

Sharps

60. Sharps should be disposed of in an approved sharps container, constructed to BS 7320 1990, and must be disposed of through a waste management company who will dispose of them safely as category ‘b’ waste – for incineration only. Companies engaged in waste disposal will provide approved plastic incinerator bins for the collection of dressings, sharps etc. Collection can then be arranged, whereby the used collection bin is replaced with an empty receptacle. Clinical waste must be stored where children and scavenging animals cannot access it.

61. The Environmental Protection Act (1990): Waste management: the duty of care, a code of practice (ISBN 0 11 752557 X) gives further information on this subject.

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Appendix 7 - Anaesthetics

Information relating to The Medicines Act (1968);

62. The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980

Pain thresholds vary between individuals. Therefore anaesthetics are sometimes used. The MHRA-MCA is the main enforcement body of the Medicines Act 1968, which states that only certain people are licensed to sell medicinal products, usually pharmacists. Medicines sold are divided into three main groupings:

• (a) Prescription only medicines (POM), supplied by a pharmacist following an appropriate practitioner’s prescription, e.g. Doctor, dentist, or under certain circumstances, an independent nurse prescriber or supplementary prescriber.
• (b) Pharmacy medicines (P), supplied only by pharmacists and under supervision from a pharmacist.
• (c) General Sales List medicine (GSL), available from other retail outlets
• To this end, it is important to note that in the UK any medicinal product that is injected becomes Prescription Only Medicine (POM) and as such, should only be: self administered; administered by a doctor, or subject to certain limitations, an independent nurse prescriber or supplementary prescriber; by anyone acting in accordance with patient-specific directions of a doctor or, subject to certain limitations, an independent nurse prescriber or supplementary prescriber.
• The use of POM would be inappropriate unless the client’s doctor had prescribed it. An example of such a product is Emla cream.
• Lignocaine-based cream/spray and Ametop gel are (P)-products. They can be legally used as topical anaesthetics by the Purchaser, (including tattooists or cosmetic body piercers) but they must not be administered by injection, as this will make the products POM.
• Under the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations, 1980 (P)-medicines can be bought wholesale by anyone who requires them for the purpose of administration in the course of his or her business. This is subject to the requirement that the products to be used within their licensed indications. However, the legality of administration of such drugs by the practitioner remains questionable – see section 130 (Medicines Act 1968).
• The MHRA-MCA or police should be informed if any P or POM drugs are prescribed or sold without licence or if either is used inappropriately. General referrals can be directed to the Enforcement Section of the Medicines and Healthcare products Regulatory Agency, Tel. No: 020 7273 0000 .

Potential complications of local anaesthesia

63. The legalities of anaesthetic use have been described in some detail above. However, another important issue concerns the damage of tissue by some products used for local anaesthesia. Ethyl chloride spray – a pharmacy issue (P) drug - is used in dental surgery, chiropody, ear piercing and other minor surgical procedures. The product is volatile, highly flammable and subject to a COSHH assessment prior to its appropriate use. It must be carefully stored, monitored during storage and disposed of as special waste.

• Operators should be made aware of the prolonged effects of ethyl chloride. It can cause a ‘frost-bite’ effect if left in contact with the skin for too long.
• It is recommended that operators do not use ethyl chloride. Resulting skin damage may increase the chances of infection at the treated site.

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Appendix 8 - Additional areas of the legislation or guidance relevant to cosmetic skin piercing

Age of consent and assault

64. Licences under the 1991 Act may stipulate specific conditions related to age in the London Boroughs where piercing and other special treatments are performed. In the absence of these there are some legal principles that may assist the enforcement officer to advise piercers in their area:

• Under the Sexual Offences Act (1956), Girls and boys under the age of 16 cannot legally give consent to intimate sexual contact under any circumstances, so piercing of nipples and genitalia (for girls) or genitalia (for boys) can be regarded as an assault offence. However, only proof that such contact was for sexual gratification would likely constitute an indecent assault. Indecent assault is a serious sexual offence that attracts a prison sentence and a subsequent requirement to register with the police as a serious offender under the Sexual Offender Act, 1997.
• Unless byelaws or local licensing prohibits, the law allows children under the age of 18 to consent to cosmetic body piercing provided they are sufficiently mature to understand the nature of the request. This kind of assessment is clearly a subjective matter for the operator involved. The client should be provided with sufficient information to allow them to proceed in an informed way and without pressure. Sometimes, the greatest pressure to be pierced may come from friends or relatives;
• If operators are willing to treat minors, the visiting EHO should recommend the presence of a parent or guardian during any such procedure, and
• Where age permits, the law recognises that certain activities that give rise to ‘Harm’ are lawful. This includes surgery, tattooing, ear piercing and violent sports.

Assault – legal provisions dealing with violent behaviour or harassment

65. The criminal law contains a wide range of powers to deal with violent behaviour or harassment, but it is accepted that there are certain activities – e.g. contact sport – where injury may occur but where the participant accepts this risk. Although some skin piercing methods may result in lasting marks to the body, the practice of scarification is undertaken with the sole intention of causing permanent scarring and the informed client accepts this as an end point to the treatment. The way that this type of activity is treated in law would be much like any other, and any scarification activity would have to be viewed in the light of the existing offence definitions if a prosecution was under consideration. Current law describes assault and its penalties as the following:

• Assault which attracts a maximum penalty of 6 months’ imprisonment and / or a fine of £500;
• Assault occasioning actual bodily harm (section 47 of the Offences Against the Persons Act, 1861) and malicious wounding (section 20 of the 1861 Act), with a maximum 5 years’ imprisonment; and
• Wounding with intent to cause grievous bodily harm under section 18 of the 1861 Act, which attracts a maximum sentence of life imprisonment. Where an attack results in death, the offender may be charged with murder or manslaughter, where the maximum sentence is also life imprisonment.

66. The Home Office interprets the law to mean that a person cannot give their consent to a serious assault. If such an assault were believed to have taken place, then it would be a police matter to take any prosecution forward. As there is no specific legislation attached to the practise of scarification or skin piercing, the law would develop on a case-by-case basis. A court would have to consider - on this basis - whether the action performed constituted an offence as described in the assault categories above. Courts have held in the past that body piercing for decoration is lawful. For any charges to be made under these circumstances it would be usual for the ‘victim’ to make a complaint to the police authorities. If a person has previously asked for piercing or scarification to be performed, it is unlikely that they would then wish to prosecute the person who had performed the act. Circumstances such as these would make any kind of prosecution difficult, even if permanent body modification resulted. This makes it all the more important for the piercer to obtain a consent form and to keep records.

The Prohibition of Female Circumcision Act (1985)

67. This Act makes it a criminal offence to ‘excise, infibulate or otherwise mutilate the whole or any part of the labia majora, labia minora or clitoris of another person’. Any decision as to whether a genital piercing constituted such an act could be decided only in a court of law. It is important to note that the Act does not allow females to consent to any procedure that could be defined as female circumcision. The Police enforce this area of law.

Jewellery material and the Nickel Directive

68. The style of body piercing jewellery is distinct from traditional jewellery worn in the ear lobe such as studs and butterfly designs. Variations on the barbell and ball closure (captive-bead) ring design are those most commonly seen in cosmetic piercing because these substantial shapes minimise the risk of embedding, tearing and migration. High quality jewellery is made with smooth surfaces and joins in order to reduce the risk of irritation or of harbouring infection.

69. Allergies to some forms of jewellery are mentioned in the terminology glossary of this document. Regulations on implantable jewellery have recently been amended as indicated below:

Statutory Instrument 2000 No 1668 [which implements the latest revision of EU Directive 94/27/EC (The Nickel Directive)] are available in its entirety on-line (see Appendix 10). It states: ‘Prohibitions on the supply of products containing nickel and its compounds - (1), no person shall supply any post assembly intended to be inserted into a pierced ear or other pierced part of the human body during epithelization of the wound caused by such piercing (whether or not it is a post assembly which is intended subsequently to be removed) if that post assembly contains nickel or a nickel compound, unless the post assembly is homogeneous and the concentration of nickel which it contains is less than 0.05% (expressed as mass of nickel to total mass). (2), no person shall supply any products intended to come into direct and prolonged contact with the skin, which contains nickel or a nickel compound if the rate of nickel release from the parts of the product coming into direct and prolonged contact with the skin is greater than 0.5µg/cm2/week, including any of the following products –

1. Earrings;
2. Necklaces, bracelets, chains, anklets and finger rings;
3. Wrist-watch cases, watch straps and tighteners;
4. Rivet buttons, tighteners, rivets, zippers and metal marks, contained in or intended to be used in garments;

(3) Paragraph (2) above shall not apply to any product that contains nickel and has a non-nickel coating to which paragraph (4) below applies.

(4) Subject to paragraphs (5) and (6) below, no person shall supply any product listed in paragraph (2)(a) to (d) above or any other product intended to come into direct and prolonged contact with the skin which –

1. Contains nickel or a nickel compound; and
2. Has a non-nickel coating, unless the non-nickel coating is sufficient to ensure that the rate of nickel release from the parts of the product coming into direct and prolonged contact with the skin will not exceed 0.5µg/cm2/week for a period of at least two years of normal use of the product.’

Additional information regarding jewellery materials

70. The use of gold, although desirable for other forms of adornment, is avoided by many cosmetic piercers. Only solid 14 carat and 18 carat material is said to be pure enough for body piercing applications. The use of gold below 14 carat increases the chance of metal impurities that may cause allergic reactions. Jewellery that is much more than 18 carat is generally too soft and becomes easily pitted and scratched. This may, in turn, encourage infection to develop. Other metals and non-metal materials have been used safely in cosmetic piercing work providing they are free of nickel or other toxic metals. These include titanium, platinum, niobium (metals) and PTFE (also known as Teflon TM); the last being an inert non-metal sometimes used for subcutaneous implants. Silver is not suitable for body piercing because it damages easily and may increase the chances of infection.

Legislation related to sterilization

71. There is no specific legislation that is applicable to the sterilization process but there is legislation that is applicable to anyone who places medical devices on the market (whether or not the devices are sterile - Note that ‘placing on the market’ means selling, leasing, lending or giving the product to another legal entity). However, legal opinion is that devices used for cosmetic skin piercing and tattooing do not meet the definition of a medical device provided in the Medical Devices Regulations 1994 (S.I 1994 No.3017), which transposes the European Union Medical Devices Directive (Council Directive 93/42 EEC) into UK law. So even if a cosmetic piercer or tattooist uses a medical device for body piercing, it would not be regulated as a medical device.

72. The procedures for the prevention of cross infection are well established. The MHRA-MDA has published ‘Guidance on decontamination from the Microbiology Advisory Committee’ (1996) which categorises infection risk to the patient according to the nature and degree of contact between the patient and an item of equipment. It reiterates the guidance in the text book Control of hospital infection: a practical handbook, Eds, G A J Ayliffe et al., (2000), that ‘Items in close contact with a break in the skin or mucous membranes, or introduced in to a sterile body area, e.g. surgical instruments, dressings, implants-should be sterilized.’

73. Decontamination includes cleaning together with either, or both, disinfection and sterilization. The document ‘Guidance on decontamination’ covers the principles and practice of cleaning and sterilization while the purchase, operation and maintenance of bench top steam sterilizers is covered in the Medical Devices Agency’s device bulletins, DB9605 and DB 2002(06) – see also the MHRA – MDA Web pages. These are listed with a contact address in Appendix 10 of this LAC, and further advice on practical sterilization requirements is provided within Appendix 4.

Legal exemptions affecting special treatments

74. The enactments cited above contain various exceptions in favour of registered practitioners, dentists, those in supplementary professions (e.g. physiotherapists), their activities and premises. Recourse must be had to each of them for the detail.

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Appendix 9 - Enforcement

75. Cosmetic skin piercing,where carried out at non-domestic premises, falls within Schedule 1, paragraph 8 of the Health and Safety (Enforcing Authority) Regulations 1998.

76. Where an operator works from their own home or visits clients in their homes, Regulation 5 transfers from HSE might be appropriate. Sections 2 and 3 of HSW Act 1974, allow the enforcement officer to visit and inspect any business premises. Acceptable levels of hygiene, good working practice and training can be verified, as appropriate for the type of work being undertaken. A checklist for skin piercing activities is provided below.

77. The key legal bases for enforcement have been dealt with in some detail in the legislative sections of this document. Initial access to a skin piercing studio would be gained using the HSWA, or; the use of the newly amended Local Government (Miscellaneous Provisions) Act (1982) using any relevant byelaws. Registration of new businesses then allows for subsequent visits to ensure that standards are being maintained.

78. The Female Circumcision Act (1985), The Medicines Act (1968) and The Tattooing of Minors Act (1969) are issues that can be addressed – as appropriate - once access to premises has been achieved, or if specific complaints have been made. Other legal issues relating to age and consent can be addressed with the business operator once the LA enforcement officer has had an opportunity to get to know the business, the employees and the work being undertaken.

Where appropriate, information can be passed to the HSE via your Environmental Liaison Officer (ELO).

79. Discussion with local authority enforcement officers has highlighted a number of commonly encountered areas where appropriate enforcement action must be taken. These are summarised in Table 1

80. Skin piercing inspection checklist:

• Registration
• Records available
• Consent forms
• COSHH Assessments
• Aftercare guidance
• Training of operators
• First aid training
• Operator hepatitis B immunisation
• Public liability insurance
• Hygiene
• Designated wash hand basin for operators only
• Liquid dispense soap
• Paper towels
• Procedures for cleaning work surfaces
• Procedures for cleansing client’s skin
• Personal Protective Equipment
• Disposable nitryl/vinyl gloves with Microbiological Hazard Group 2 CE marking (latex gloves should be avoided as they are associated with latex allergy)
• Disposable plastic apron
• Disposable paper sheets for treatment couch
• No smoking sign
• Needles
• Pre-sterilized disposable needles
• Sharp box
• Sharps box disposal
• Clinical waste disposal
• Blood (body fluids) spill kit
• Equipment
• Work surface
• Ultrasonic cleaner
• Frequency of ultrasonic solution changes
• Autoclave sterilization procedures
• Autoclave performance test certificate
• Emulating indicators conform to ISO 11140 part1

Jewellery

Conforms to Nickel Regulations

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Appendix 10 - Website links and relevant publications

• www.hse.gov.uk - The Health and Safety Executive Home page
• www.doh.gov.uk - The Department of Health Home page
• www.nhs.uk - The National Health Services Home page
• Local Government Act 2003: Regulation of cosmetic piercing and skin-colouring businesses – guidance on section 120 and schedule 6, provided by the DH web site and published in February 2004.
• www.habia.org - HABIA, the Standards Setting Body for tattooing and piercing, also with general information about skill issues.

81. Relevant MHRA-MDA Publications covering instrument cleaning, instrument re-use and sterilization, and other relevant Government publications:

1. Controls assurance in infection control: decontamination of medical devices HSC1999/179 NHS Executive August 1999
2. Single-use Medical Devices: Implications and Consequences of Reuse DB2000 (04), MDA August 2000
3. Sterilization, disinfection and cleaning of medical equipment: guidance on decontamination from the Microbiology Advisory Committee, MDA 1999-2005 revised sections (sometimes referred to as ‘the MAC manual’).
4. The validation and periodic testing of bench top vacuum bench top steam sterilizers. DB9804 MDA June 1998
5. DB 2002(06). Bench top Steam Sterilizers - Guidance on Purchase, Operation and Maintenance
6. The Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000
   

   MHRA-MDA publications can be obtained from: The Medical Devices Agency, Business Services, Level 9, Hannibal House, Elephant and Castle, London, SE1 6TQ

   Copies of HSC 1999/179 can be obtained from Department of Health, PO Box 777, London SE1 6XH, Fax 01623 724524 and from the DOH website

82. COSHH publications - Approved Codes of Practice and guidance:

1. General COSHH code of Practice: Control of Substances Hazardous to Health regulations 2002 and guidance L5 (Fourth Edition), HSE Books 2002, ISBN 0 7176 2534 6
2. A step-by-step guide to COSHH assessments HS (G) 97, HSE Books 2004, ISBN 0 7176 2785 3
3. Monitoring strategies for toxic substances HSG173, HSE Books 1997, ISBN 0 7176 1411 5
4. Health surveillance at work (2 nd Edition), HSE Books 1999, ISBN 0 7176 1705 X
   Also see the HSE Web site for more information.
5. About latex allergies.

83. Other useful sources of Infection control information consulted during the preparation of this document:

1. A Guide to Hygienic Skin Piercing; tattoos, acupuncture, ear piercing, electrolysis. (Copyright 1983). Professor Norman Noah, MB, MRCP, MFCM. Published by PHLS, Colindale Avenue, London. ISBN 0 901144 10 X. [Now available with other supplements electronically only from norman.noah@lshtm.ac.uk]
2. Advisory Committee on Dangerous Pathogens; Categorisation of biological agents according to hazard and categories of containment. Fourth edition, 1995. HSE Books, ISBN 0 7176 1038 1
3. Advisory Committee on Dangerous Pathogens; Categorisation of biological agents according to hazard and categories of containment. Supplement to Fourth (1995) edition, 1998. HSE Books, MISC118
4. Health Services Advisory Committee (HSC); Safe disposal of clinical waste. 1999. HSE Books, ISBN 0 7176 2492 7
5. Guidelines for Control of Infection in Special Treatments (Tattooing, Body piercing and Acupuncture) - Working Party of London Consultants in Communicable Disease Control and Community Infection Control Nurses.
6. Advisory Committee on Dangerous Pathogens- Protection against blood-borne viruses in the workplace: HIV and hepatitis, HMSO 1996, ISBN 0 11321953 9.
7. Blood-borne viruses in the workplace: guidance for employers and employees
8. The Chartered Institute of Environmental Health, ‘Body art, cosmetic therapies and other special treatments’, Tel.020 7928 6006, E-Mail : cieh@cieh.org
9. UK Health Departments’ publication, Immunisation against infectious disease 1996 HMSO, ISBN 0 11 321815 X.
10. The intelligence Section, Medicines Control Agency, Room 18 – 155, Market Towers, 1 Nine Elms lane, London, SW8 5NQ. Tel. 020 7273 0178
11. The Medical Devices Agency (MHRA), Department of Health, Hannibal House, Elephant and Castle, London, SE1 6TQ. Tel. 020 7972 8000
12. The Association of Professional Piercers (APP – US and Europe). US, APP, 519 Castro, Box 120, San Francisco, CA 94114, USA. Europe, APP Europe, PO Box 16044, London, NW1 8ZD
13. Return of the Tribal; a celebration of body adornment. (Copyright 1997). Rufus C. Camphausen. Park Street Press, Rochester, Vermont. ISBN 0 89281 610 4
14. Guidance on manual cleaning can be found on the Community Practitioners and Health Visitors Association web site.

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Appendix 11 - Alphabetical glossary of body adornment and modification terms

Body adornment, a general term describing the adorning or decorating of the body more or less temporarily, e.g. body painting, make-up, henna designs, wearing of earrings with or without piercing.

Body modification, a variety of techniques that result in the conscious changing of the body in to a desired form. Enlarged piercings fall in to this category, and some of these ancient techniques are now being revived by modern society.

Body painting, artificial colouring of the body, including all types of common make-up as well as multicoloured tribal style painting of the nude or semi-nude form.

Branding, this is actually a form of scarification usually achieved by burning the skin with a hot metal implement. Although skin trauma does occur, the procedure itself is reputed to carry a lower risk of wound infection than piercing and cutting due to the cauterising effect of the heat.

Cosmetic surgery, surgical procedures unrelated to the treatment of disease, but resulting from a person’s desire to alter their appearance. Face-lifts, breast augmentation, liposuction, ‘tummy tucks’ and thigh and buttock reductions all fall in to this category. Medically qualified surgeons usually perform these procedures.

Cosmetic tattooing, this technique may also be referred to as temporary tattooing, semi-permanent make-up, micropigmentation or a fading tattoo. Tattoo artists and product manufacturers claim that the dyes used are only inserted in to the outermost skin layer, resulting in a tattoo that will last between 5-8 years. Many of the popular dyes used are based on plant extracts. Different colours may also fade at different rates during this period.

Cutting, a particular form of scarification that involves cutting of the skin with a sharp instrument. Delayed healing may be induced by maintaining an open wound or by repeatedly re-cutting in order to develop a more pronounced scarring effect.

Dental modification, includes filing or chipping of teeth, in-laying of enamel with gems or gold.

Digit amputation, of toes and fingers, known to be used as a membership symbol within certain cult groups. UK newspapers have reported this activity at UK piercing premises.

Henna designs , tattoo-like, intricate patterns created using henna paste and usually applied to the hands and feet. The designs stay visible for 2-4 weeks.

Piercing, perforation of the skin and underlying tissue in order to create a tunnel in the skin through which jewellery is inserted. Usually, a protruding portion of the body is used, such as the earlobe, nasal septum, eyebrows, nipples and genitalia. If heavy jewellery or other stretching methods do not enlarge the region, this technique can usually be regarded as a temporary body modification. Removal of the jewellery item may eventually results in reduction or complete closure of the aperture. Metal rings, metal studs, sticks and tubes are all used in the range of techniques employed.

Scarification, the creation of permanent scarring of the skin by conscious decision. Methods used may be cutting or branding. In modern studios, inks or ashes are often introduced in to the open wound to enhance the scarring effect. When the wound heals it usually leaves a pronounced scar.

Tattooing, widely used for body decoration and/or body modification. The outer layers of the skin are punctured with a dye-loaded needle and colour is inserted in to the dermal (lower) layer to achieve a permanent design. In modern tattooing salons an electrically driven needle or needle cluster is invariably used, and larger tattoos may take several treatment sessions to complete. In the UK, persons must be 18 years of age or over to have a permanent tattoo performed. The action of inserting the dye causes local inflammation and bleeding, so precautions are necessary to prevent the possible spread of blood-borne infection.

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Table 1. Examples of enforcement approaches for commonly raised cosmetic piercing issues

Problem area	Appropriate action
Training – Operator has attended a training course that appears deficient in key areas of importance, e.g. infection control advice. Such courses may lie outside the LA where the trainee operator is based	Currently there are no approved training courses to recommend, but the LA where the training organisation is based should be informed of the course’s existence and can then offer appropriate advice, e.g. via their local health authority
Training – a particular aspect of the operator’s practise seems unsafe, e.g. prolonged clamping of the tongue to the point of discoloration prior to tongue piercing	Need to seek professional medical opinion. An initial prohibition notice on the specific activity may be required until the safety of the procedure has been professionally evaluated
Infection control – no steam autoclave present in the cosmetic piercing operator’s studio	Prohibition notice. No safe piercing can be performed unless effective sterilization can be offered by the operator
Infection control - no evidence that the sterilizer is maintained and tested periodically to ensure it is achieving sterilizing conditions	Prohibition notice. No safe piercing can be performed unless effective sterilization can be offered by the operator
No warm water for hand washing and other basic hygiene needs	Prohibition order – warm water, along with suitable soaps, provide the most basic hygiene requirements and are always necessary
Inappropriate use of sterilizing equipment – e.g. using contained pouches in a non-vacuum autoclave	Prohibition notice to prohibit the use of pouches in a non-vacuum autoclave. As described within this document, MHRA-MDA states that there is no guarantee of sterilization of pouch-contained items unless vacuum autoclaving is used.
Misuse of piercing equipment – e.g. the inappropriate use of an ear piercing gun for piercing other parts of the body, e.g. the navel	Prohibition notice on this activity and a recommendation to move to alternative, suitable equipment.
Operator is providing home made aftercare products to the client	Refer to Trading Standards
Incorrect jewellery in use, e.g. high nickel products likely to cause allergic skin response in the client	Refer to Trading Standards. For available information see Appendix 10of this document
The operator has no insurance cover. HABIA indicate this may be difficult to obtain.	Recommend specific public liability insurance in view of potential risks. No legal enforcement possible though.

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Table 2. Disinfectant usage. Some common disinfectants and their appropriate uses

Type of use	Instruments	Skin	Work surfaces, equipment and jewellery
Chemical / product name IMPORTANT - See NOTE (below)
Bleach	No	No	Yes (hard, man-made work surfaces). Not for jewellery.
70% alcohol	No	Yes	Yes
Dettol TM or Dettox TM	No	No	Yes (work surfaces only)
Chlorhexidine	No	Yes	No
Povidone-iodine preparations	No	Yes	No
Halogenated Tertiary Amines (e.g. Trigene)	Yes	No	Yes
Glutaraldehyde-based (e.g. Omnicide TM)	This substance is both an irritant and a potent allergen. Exposure to it is strictly controlled under COSHH. Its use cannot be recommended unless appropriate exposure control measures are in place .

Supportive information for Table 2:

Disinfectants are often unstable and are generally inactivated by organic contaminants (e.g. blood, tissue and other body fluids). Disinfectants should therefore be freshly prepared and used according to the manufacturer’s instructions. It is essential to use the correct concentration and contact time. COSSH Regulations apply.

Bleach – sodium hypochlorite solution or other source of chlorine e.g. sodium dichloroisocyanurate [NaDCC], (Presept, Haz-Tab, Sanichlor etc). NaDCC is stable under storage in its dried form and as such is preferable to liquid forms. On application bleach products must contain minimum 1000ppm available chlorine (10% dilution of proprietary disinfectant e.g. Milton or Domestos, containing 2% available chlorine. Or make a solution from sodium dichloroisocyanurate). Solutions are unstable. They must be freshly prepared and must not be stored.

70% alcohol (ethyl alcohol, ethanol, industrial methylated spirit, isopropyl alcohol or isopropanol). Highly flammable. It has a limited effect. Alcohol is less effective in the presence of proteinaceous organic matter. Higher or lower concentrations than 70% are less effective.

Chlorhexidine. Suitable only for skin disinfection, often as chlorhexidine in alcohol, chlorhexidine wipes should be packed in individual sachets.Bulk packs should not be used as they become contaminated after opening.

Dettol TM or Dettox TM preparations are inactivated by soaps and organic debris. If used on surfaces, the surface must be clean, free from detergent, and dry before applying these products.

Povidone-Iodine products, eg Betadine , used for skin disinfection, but may cause cell damage to sensitive tissues. Some iodine (non-povidone) products, e.g. the iodine in potassium iodide or alcohol may cause allergic and other responses, but povidone-iodine preparations are less likely to cause this. Might stain equipment and work surfaces.

Halogenated Tertiary Amines (e.g. Trigene): Inhalation of mist or spray should be avoided. Accidental skin contact carries low risk, though may degrease skin leading to dryness if excessive contact. The manufacturer of Trigene (Midichem International) claims effectiveness against bacteria, viruses and fungi, and this product is now widely used across special treatments. For hard surface or equipment cleaning, the manufacturer’s instructions should always be checked to ensure compatibility with materials treated.

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