Cosmetic
IPL Regulation: Where are we now?

Google the words ‘IPL NZ’ and you get pages and pages of salons offering IPL treatment for skin rejuvenation and hair removal. In what has been a challenging couple of years for our industry it is no surprise that salons are turning to higher profit services such as IPL and Laser, but the potential for client dissatisfaction, not to mention painful burns, permanent scarring and even the mistreatment of potentially fatal melanomas, is huge when these devices are misused.
Although there are currently no New Zealand regulations in place for the use of IPL and Laser machines, section 33 of the NZARH Code of Ethics states:
The New Zealand Association of Registered Beauty Therapists Inc. does not recommend the use of unregulated IPL machines which have not been certified. We recommend that members only purchase machines from reputable suppliers who provide post graduate training, hold a current Safety Certificate and have comprehensive insurance coverage. Clients must give an ‘informed consent’ which must be signed prior to the commencement of any treatment.
Section 17 of the NZARH Code of Practise also states:
Health and safety policy for ip light
The management and distributor of any IPL will have an active consultative commitment to continuous improvement in all areas of health and safety management in the workplace.

1. Comply with all of the following relevant legislation, standards, codes of practices and safe operating procedures, including:
    a. Health and Safety in Employment Act 1992, including amendments.
    b. Health and Safety in Employment Regulations 1995.
    c. Injury Prevention, Rehabilitation, and Compensation Act 2001.
2. Provide and maintain a procedure of accurate reporting and recording of accidents, incidents and near misses, notably including processes to bring about improvement. Following a critical event or incident – an investigation will be carried out and the corrective actions will be carried out.
3. Implement a system for continuously improving health and safety management in the business, through regular reviews by management of health and safety-related policies, and system procedures to ensure their ongoing effectiveness.
4. Realise the busines’s commitment to the issue of effective health and safety management by designating specific health and safety coordination roles at a senior management level.
5. To educate all staff, students, visitors and contractors as far as reasonably practicable as to the potential dangers and hazards that exist within the business and the appropriate steps to take in order to ensure the safety and health of all staff and visitors.
6. Support staff participation in building decisions on health and safety issues through regular contact.
7. Provide, where necessary and practicable, training.
8. In order to implement this policy staff, contractors and their employees have a responsibility to co-operate by:
    a. Working safely and with efficiency.
    b. Using protective clothing and equipment whenever necessary.
    c. Complying with all legal requirements and work standards.
    d. Reporting all accidents and incidents regardless of whether or not injury or damage has resulted.
    e. An employee is to be elected to the role of Safety Representative and is expected to partake in a consultative role with management.
9. Training certificates must be displayed in a prominent position so clients can read them, and must be in the name of the therapists performing the treatment.

Health and safety regulations
Under the health and safety and employment act, along with the electricity act, it is necessary, annually, to have all electrical cabling, appliances and machines certified as electrically safe.
In June 2009 the NZARH also sent letters to all IPL and Laser machine suppliers who advertise in BeautyNZ magazine advising them of a change of policy. The pertinent points were as follows:
“The Association has decided to implement a policy not to accept any advertising for IPL (Intense Pulsed Light) whether by another name or combining any other form of energy from any supplier unless that supplier can produce evidence of the manufacturer’s compliance for that product with either or both of the following certifications:
• CE (European Conformity)
• FDA (American Food and Drug Administration)

The letter also requested that the product be registered with WAND (Web Assisted Notification of Devices) Medsafe NZ but after discussing the matter more fully with industry experts, it was decided that WAND certification was no longer a requirement.
In 2010, NZARH members were given the opportunity to participate in a survey of IPL and laser devices for the treatment of pigmented skin lesions, due to concerns that they may be used inadvertently for the treatment of malignant skin lesions such as melanoma by personnel who do not have formal training in the recognition of skin cancers.
A standardised 16 part questionnaire was formulated by Dr Paul Jarett, Dermatology Department of Middlemore Hospital and Judy West, President NZARBTH and was distributed to all 700 members via BeautyNZ magazine.
The anonymous questionnaire contained 16 questions including four unlabelled photographs of pigmented lesions. The four photographs were of a “classic” superficial spreading malignant melanoma, a subtle melanoma in situ, a lentigo and a naevus. The superficial spreading melanoma and the melanoma in situ were histologically confirmed. Ethics Committee approval was obtained for this study.
79 questionnaires were returned. 39 percent of respondents did not receive any formal training in the identification of skin cancer. 51 percent of those who had formal instruction spent less than a day on this aspect of training. Most respondents were taught about skin cancer identification by other beauty therapists (53 percent) while 28 percent received teaching from doctors or nurses. 12.5 percent were self-taught from sources ranging from magazines to the internet.
When asked what they would do if a client was concerned about a skin pigmentation from ultraviolet exposure on the skin, the majority (90 percent) would refer to a doctor. Most therapists also reported that they would not treat a blemish if they themselves had concerns about it (87 percent).
The questionnaire asked the therapists if they would treat the “classic” superficial spreading malignant melanoma and the more subtle melanoma in situ. For the “classic” melanoma, 97 percent would not and three percent were unsure. By comparison, when shown the “subtle” melanoma, 29 percent would have treated the lesion, 49 percent would not and 22 percent were unsure.
The therapists were asked if they knew the meaning of the ABCD guide to melanoma and 60 percent replied “no”. The majority of them (94 percent) were keen to receive formal training in the identification of skin cancer. More than half the respondents (64 percent) did not have access to a registered medical practitioner or registered nurse in their practice.
This survey demonstrated that a large number of the respondents received no training in skin cancer recognition, and there was even greater concern about unregulated and untrained IPL operators who practise outside of the Association.
As a result, the NZARH proposed that all users of IPL and lasers undergo appropriate standardised and mandatory training in the recognition of skin cancer to limit the potential risk of an adverse outcome to patients.
Although there is a slow movement worldwide towards tighter controls of IPL and laser use, the industry remains largely self-regulated.

Government intervention
Late in 2012, MP Dr Paul Hutchison put IPL under the spotlight with his Health (Skin Cancer and Trauma Prevention) Amendment Bill, which proposed the introduction of mandatory standards to prevent avoidable harm from ultraviolet radiation through the use of solaria and laser devices. Although the bill wasn’t drawn from the ballot, it received significant media attention due to recent IPL horror stories that highlight the gap between access to IPL technology and proper training and care.

The proposed Bill stated the following:
• Laser devices and pulsed light devices, such as IPL and VPL devices, involve the use of non-ionising radiation (high intensity pulsed light sources) on the skin. Users include medical specialists, general practitioners, beauty therapists and, more recently, members of the general public who can purchase the machines direct from the manufacturers. There are currently no regulations or standards governing the use of the treatment, or the suitability for the purposes of these devices.
There is accumulating evidence that avoidable trauma is occurring on patients where laser devices and pulsed light devices are operated by inadequately trained or even untrained operators. There is also a danger of malignant lesions being treated inappropriately, with potentially dire consequences.
There is a call by dermatologists and the New Zealand College of Appearance Medicine to ensure that this form of treatment adheres to the highest standards available, according to contemporary evidence.
Dr Garsing Wong, Educator and Censor for the NZ College of Appearance Medicine was involved in putting together the Bill, and believes that both machine (including premise) and operator need regulating to ensure that best practise is undertaken for the safety of the public.
“Once upon a time, price governed who the operators of these machines were. Now price is no longer an issue because there are countries such as China making the machines and they are of variable standards. Traditionally, operators relied on the distributor to give reliable information about the machine, including clinical papers that proved it does what it says.”
Dr Wong believes that with the drop in price, the market has opened up and we now have a situation likened to car salesmen issuing drivers licences. “Initially, only medical professionals could afford to buy IPL and laser machines and we knew that we had to calibrate machines to ensure the power output and wavelengths are correct. Now it is all about price, and there the public is no longer protected.”
Dr Wong also strongly supports regulation of the operator. “My concern is not with people who have been adequately trained, it is with the operators who have no training at all,” says Dr Wong. “At this point in time we are relying on the fact that the operator will know their limitations, and it is only a matter of time until someone removes pigment from a melanoma without knowing it. The consequences of that will only be discovered months later when someone is dying from a metastatic melanoma, and that is why both sides need to be vigilant and the industry needs to be regulated.”

Across the ditch
Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), as part of the Health and Ageing Portfolio, is a Federal Government agency charged with responsibility for protecting the health and safety of people, and the environment, from the harmful effects of ionising and non-ionising radiation.
ARPANSA states that lasers and IPLs used for cosmetic purposes are hazardous. There have been reported cases where patients/clients have received an injury following a cosmetic procedure using a laser or IPL. Reported injuries have included burns, blistering, scarring, keloids (thickened, overgrown scars), increased or decreased skin pigmentation and eye damage (damage to the retina (back) or uvea (front) of the eye).
The causes of such injuries include:
• Use of a laser/IPL by an untrained operator
• Inappropriate use of a laser/IPL eg the wrong type of device/settings for a treatment or the wrong type of device is used on a specific skin type/hair colour
• Contraindications/medications that may make skin more sensitive to light therapies not considered or not disclosed by the client/patient (including recent sun exposure)
• Safety procedures are not followed (e.g. use of protective eyewear)
• Equipment malfunction.
 
Despite this, only Tasmania is currently moving towards the regulation of IPL in the cosmetic industry.
“Without regulation and industry oversight, there is a risk that people could be treated with equipment that does not comply with safety standards, or by someone who is not trained to properly operate IPLs. There are many reported cases where incorrect treatments from IPLs have led to hypopigmentation, hyperpigmentation or even severe burning and scarring of the skin.  IPLs can also present a hazard to the eyes of operators and clients alike unless protective eyewear is used. Regulation will help give people peace of mind that they are accessing safe, professional treatment. It will also bring consistency to the way lasers and IPLs are regulated in the cosmetic industry.” Department of Human and Health Services, Tasmania.
Tasmania has regulated the use of high power lasers (Class 3B and Class 4) since 1977. Initially lasers were mostly used in medicine, science and industry. During the 1990s, lasers began to be used for cosmetic purposes, such as hair depilation and skin rejuvenation. Only appropriately qualified medical practitioners were allowed to use them for cosmetic purposes. Also during the 1990s, the beauty industry started using IPLs. New laws were introduced in Tasmania from 2005, allowing lasers and IPLs to be regulated.

What does the proposed regulation look mean?
• IPL operators will be licensed
• IPLs will only be used by a person who is authorised and licensed to do so under the Radiation Protection Act 2005. The licence specifies what equipment can be used, and how it should be used.  The annual cost of a licence to possess, store and use one IPL device is set by the Radiation Protection Regulations 2006.  The fee is currently $191 a year.

Operators will be trained and experienced
Licence applicants will need to demonstrate that they have appropriate knowledge in IPL safety and are competent in using the equipment. Applications will be considered on a case-by-case basis, as there are no nationally consistent training courses for cosmetic lasers and IPLs.

Operators will have medical backing and support
Operators must have a formal and documented relationship with a registered medical practitioner who has training and skills in the use of the types of lasers and IPLs authorised on the licence. The medical practitioner does not necessarily need to be authorised on the licence, but their name, their training and skills, must be detailed in an approved Radiation Management Plan.
 
Clients will be safer
The medical practitioner (named in the Radiation Management Plan) will be available to advise the licensed operator on treatment protocols and assess and manage any adverse outcomes that may result from laser or IPL treatments performed by the licence holder.

The equipment will be approved and safe
IPL equipment will need to have approval from the Therapeutic Goods Administration and comply with the technical standard IEC 60601-2-57- Ed 1.0 B:2011. This may change as other technical standards for IPLs become available.

Europe and beyond
In the UK, skin specialists say they are worried about the lack of regulation for laser hair removal, with unofficial figures stating that hundreds of women suffered from burns and / or permanent damage last year alone.
Consultant dermatologist Dr Nick Lowe says that many clients are treated with the wrong lasers, wrong settings and they will burn and blister and sometimes scar, usually due to inadequate, or a complete lack of training.
The Department of Health says the regulation of laser and IPL hair removal is under review, and in late 2012 a cosmetic surgery review call for evidence was published to enable the public, cosmetic interventions industry and patient groups to contribute to NHS Medical Director Sir Bruce Keogh’s review of the regulation of cosmetic interventions.
While there were a wide range of views on the future regulation of cosmetic interventions, some consistent key messages emerged from respondents:
• The current regulatory framework was inconsistent and did not reflect the many changes and innovations in such a fast-growing and dynamic sector
• Training requirements were felt by many to be disproportionately weak compared to the potential risks of a procedure and more specialised training was welcomed
• Dermal fillers and intense pulsed light and laser procedures were highlighted by many as an area where there was insufficient legislation to protect the public.

Closer to home
Last year, BeautyNZ mystery shopped three Association salons to see how in depth and accurate their IPL consultations were for the treatment of pigmentation. The results were quite varied, but showed a good knowledge and level of care.
In the heat of summer 2013 and heavily pregnant, a BeautyNZ staff member mystery-shopped six Aassociation salons and six non-association salons to ask two questions:
Can I have spot treatment done on my pigmentation today?
Are the results permanent?
Thankfully, no salon was prepared to offer IPL treatment on the spot due to her pregnancy, but many weren’t able to give the reason why.
“One of the main reasons is that you run a risk of hyper-pigmentation because you have a lot more hormones rushing around. The bottom line is, any elective beauty procedure must be postponed because the pregnancy comes first.” – Dr Garsing Wong, NZ College of Appearance Medicine.
Three non-Association salons stated that conducting the service during summer was not a problem, and half of the salons visited gave mixed or misleading advice about how permanent the results would be.
What the latest mystery-shopping visits showed was that there is still a wide variation in training when it comes to IPL and Laser and with regulation coming and customer satisfaction being a priority good clinics should be ensuring now that their training and practices are up to scratch to gain an advantage over their competitors and avoid having to rush to get things in place when regulation arrives.

 

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