HSE WARNS OF POTENTIAL PROBLEMS WITH "TEMPORARY TATTOO" EQUIPMENT

HSE press release: E177:03 -17 September 2003

A year-long investigation by the Health and Safety Executive (HSE) has shown that hand-held micropigmentation machines - used for semi permanent make-up and "semi-permanent" tattoos - may provide a serious risk to health.

New guidance is being put on HSE's website to encourage those thinking about having micropigmentation to ask the right questions [no longer available]. Further information will be issued in October to Local Authority Health and Safety Inspectors who inspect premises and handle complaints and investigations in health and beauty salons.

The investigation was started as a result of an Environmental Health Officer in Tunbridge Wells prohibiting the use of a system called Goldeneye Basic, which could not be adequately cleaned. This was brought to their attention by a registered Tattooist in their area who was concerned with the equipment. HSE responded to the request made by Tunbridge Wells to investigate this particular piece of equipment and its supply was subject to a Prohibition Notice by HSE. All known users were visited to ensure the machines were taken out of use.

Debbie Stock, Head of Environmental Services at Tunbridge Wells said "This investigation arose as a result of an Environmental Health Officers, Justene Lawal's concerns over the aerosol contamination of the Goldeneye Basic micropigmentation equipment and the clear inability of it to be effectively cleaned between customers.

"We prohibited the use of the equipment in our Borough, but our contact with the supplier of the equipment, led us to believe that there was limited awareness of the risks posed by this equipment and an inconsistent approach being taken by other local authorities in allowing its use for micropigmentation. We contacted the HSE to address this issue nationally. "I am extremely pleased to see that the Government will be introducing changes to the skin piercing legislation to cover this type of tattooing and through this process there will be greater control of this activity by Environmental Health Officers registering and monitoring standards."

Following this, all known suppliers of various machines in the UK, were investigated by HSE inspectors to establish if they could be cleaned effectively. Some 13 suppliers had 21 different types of equipment, varying in design. Where defects were found Improvement Notices were served. A further machine - Reza - was voluntarily taken out of use.

The Health and Safety Laboratory (HSL) is currently testing six different models of micropigmentation equipment to establish the potential for internal contamination with pigment (residual pigment implies that the machine could be contaminated with bodily fluids from a carrier of one of the viruses.)

Inspector Helen Thackray, on secondment from Bolton Metropolitan Borough Council to HSE, has been investigating the risks. She explained: "Although some parts, such as needles, are routinely replaced between clients, pigment residues may be deposited in the upper regions of the equipment, close to the motor, during use. Since pigment may mix with blood and body fluids, this leaves serious implications for cross infection between clients including HIV or hepatitis.

"This is especially worrying because young people are attracted to temporary tattoo's without very much thought about the tragic consequences which might so easily happen. A lot of women going in for semi-permanent make-up may also not be aware of the risk of cross contamination.

There is very little information available and salon owners seem unaware that when they buy equipment, they are technically responsible for any health and safety performance of the equipment. This could lead them with big bills if they are sued when things go wrong.

"It is easy to get fooled from both sides. The salon may well change the needle and think that they are doing a good job, when the contrary is true. This equipment costs a few hundred pounds and can be imported easily via the Internet without any proper understanding of the risks."

Leading expert Professor Norman Noah from the London School of Hygiene and Tropical Medicines said: "I cannot stress too strongly the importance of using equipment that is properly designed for the job.

"This means that it must be capable either of being sterilized or, if pre-sterilized disposable needles are used, it must not transmit serum from a previous piercing to the next customer. This is because the three most important risk infections are hepatitis B, hepatitis C and HIV [the AIDS virus]. All these diseases are potentially fatal, two of them can cause liver failure, and all can be transmitted to others by different routes.

"Unfortunately these viruses are so highly contagious that simple cleaning and disinfection are inadequate for parts, such as needles, which are in direct contact with the skin. Large outbreaks have occurred in the past from inadequately sterilized instruments used for cosmetic piercing. It would be tragic if someone dies or becomes seriously ill after what after all is basically a fashion procedure. 'Better safe than sorry' is a cliché, but it's true."

Many of these hand pieces have a similar design, and the degree of contamination is likely to be dependent on the equipment design, length of use and whether the instrument is maintained and cleaned properly, or inadvertedly tipped so bodily fluids contaminate parts which cannot be cleaned.

Dr Alan Beswick, who is carrying out the research at the Health and Safety Laboratory (HSL) in Sheffield explained "Some areas close to the motor are not replaceable and are difficult to clean between clients and so the opportunity for cross contamination may exist.

"In particular, I am interested to establish the degree of movement - tracking back - of dye along the internal components of each machine, or whether the opportunity exists for fine droplet spread on to internal components by aerosol generation."

In order to assess the equipment, each machine is being put through a standardised series of usage tests over 15, 30, 45 and 60 minute periods, with short periods of inactivity in between. Micropigmentation of skin is being simulated using the application of a UV-excitable pigment on to practice skin; the latter is a material used by some semi-permanent makeup artists for training purposes.

Dr Beswick added: "Each instrument is initially being used exactly as designed, and with no improper use of the hand piece. A measure of any pigment tracking back and/or deposition is then possible from high sensitivity UV visualisation of the pigment.

"Following this initial step, instruments will be held horizontally and at a 45 degree upwards angle, in order to simulate improper use. These periods of misuse will be designed to mimic momentary lapses in concentration and will be of set length. The degree of internal contamination of each of the six instruments will then be comparable over time and nature of use."

Notes to editors

1. Micropigmentation machines operate by injecting dye via a needle into the surface layers of skin but if correctly applied not as deep as conventional tattoo. By careful choice of the pigment or dye the technique can be considered as semi-permanent but dye residuals will stay in the skin permanently. Because it is considered semi-permanent it has become popular among young people wanting fashionable body adornment. The other main use is for women who want semi-permanent make-up, because the finer needles provide a more natural finish.

2. The Supply of Machinery Regulations, 1992, as amended, apply to micropigmentation equipment. This is European Directive 98/37/EC legislation brought in by Department of Trade and Industry and they are enforced by HSE in work situations. What the regulations require are that the European manufacturer or the importer (if imported from outside the EU) carries out a risk assessment and ensures the machine and its instructions are safe and that they meet essential health and safety requirements listed in the Regulations. Because this equipment is relatively new there are not yet European harmonised Standards. The equipment has to be CE marked and a declaration of conformity issued. Most equipment where there is a risk of biological cross contamination is medical and therefore is covered by the Medical Devices Directive and the enforced by the Medical Devices Agency. Because this equipment is not for medical use it is not covered.

3. Salon owners should be aware that if they purchase equipment from outside the EU, Norway or Iceland, which has not gone through the process, they will be regarded as the responsible person and must take on these duties.

4. Conventional tattoo equipment is constructed so that the parts at risk can be sterilized by autoclaving. This is pressure steaming. The design of micropigmentation equipment varies considerably and is generally constructed of plastic cases incorporating motors and other electrical circuits and therefore cannot be sterilized in this way. The safest alternative is for the parts at risk to be single use ie, disposable and the best equipment uses this approach. The machines that were prohibited presented a clear risk of contamination as the parts were not single use and could not be cleaned. Other machines had some risk of contamination but were able to be effectively cleaned by ultrasonic baths (using tiny bubbles to access crevices) and suitable cleaning fluid, followed by disinfection.

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