ARPANSA Drafting ‘National advice for light-based treatments’

ARPANSA has been engaging in public consultation on ‘draft advice’ for cosmetic treatments and beauty therapy using lasers, intense pulsed light (ipl) devices and high-powered light-emitting diodes (leds). The deadline for public comments and submissions closed on 23 September. 

The Australian Radiation Protection and Nuclear Safety Agency (a body operating under the Australian Department of Health) in August published four formal answers to the question: “Why do we need national advice for light-based cosmetic treatments in Australia?”

They were:

• The use of lasers, intense pulsed light (IPL) devices and light-emitting diode (LED) phototherapy (collectively referred to as light-based techniques) is common in the cosmetic and beauty therapy industry.
• The application of these treatments may present a hazard to the skin and eyes of the person undergoing the treatment and the provider applying the procedure.
• Currently, there is no nationally-available approach to managing these hazards in Australia.
• Regulatory frameworks are currently in place in Queensland, Tasmania and Western Australia only.

ARPANSA explained its ‘advisory note’ regarding the use of lasers, IPL sources and LED phototherapy “in the cosmetic and beauty therapy industry” aims to provide the “necessary information to assist in the safe delivery of light-based cosmetic treatments and communicate risk awareness about their use”.

However it also noted:

• “there is no expectation that the publication of this advice will make any significant changes to regulations currently in place in Queensland, Tasmania and Western Australia”;
• “the advice will not necessarily a ect the implementation of regulation in other jurisdictions within Australia”;
• “regulation of private businesses o ering these services is a matter for the state or territory where the business practises”.

Importantly, ARPANSA’s latest August update did describe three key issues currently facing regulators:

• Reports of injuries, increased media coverage and industry calls for regulation of non-surgical cosmetic treatments “have led radiation regulators to consider the potential problems within the cosmetic and beauty therapy industry”.
• Regulatory oversight of treatment providers “varies throughout Australia”. These services include using lasers and IPL devices for procedures such as hair removal, skin resurfacing, acne and scar reduction and tattoo removal.
• There is “no oversight and very little information available” for providers or consumers regarding LED phototherapy.

Previous industry consultation

Back in 2015, ARPANSA released a consultation Regulatory Impact Statement (RIS) for the use of lasers and IPL devices in the cosmetic and beauty therapy industry. The public consultation received a large number of submissions from the public and industry stakeholders.

The majority of submissions indicated the industry “would benefit from some system of oversight in the use of lasers and IPLs for cosmetic treatments”. However there was “insu cient information provided by submissions to support the introduction of a national regulatory framework”.

Based on the support for oversight and the safety concerns raised in the consultation process, the Radiation Health Committee (RHC) agreed there was “a need to develop nationally-available advice for the cosmetic and beauty therapy industry, in order to promote a uniform approach to managing key issues around the use of optical radiation for non-surgical cosmetic treatments”.

To that end, ARPANSA’s new ‘advisory note’ will focus on the safe delivery of cosmetic treatments in two key areas: consumer education and treatment provider competency.

Potential health consequences

Lasers, IPLs and LED phototherapy used in cosmetic treatments emit either visible or infrared light; or in the case of IPLs, a combination of both. This light is known as non-ionising radiation (NIR).

The International Commission on Non-ionizing Radiation Protection (ICNIRP) is the peak world body for providing scientific advice and guidelines to protect people and the environment from detrimental exposure to NIR.

ARPANSA notes that, in ICNIRP’s advice about visible and infrared optical radiation exposure, they have stated: • “Visible radiation (light) is not thought to play a role in initiating skin cancer. However, some medications can result in the skin becoming photosensitized so that exposure to visible radiation (light) can cause toxic photochemical reactions in the skin.”

• “With regard to shorter-wavelength (blue light) visible radiation, there are some ongoing discussions that this might accelerate retinal aging.”
• “Blue light also suppresses the secretion of melatonin, which contributes to the regulation of sleep and wake cycles. The health implications of deregulation of the day and night (circadian) rhythm remain unclear and continue to be the subject of research.”
• “Exposure to extremely bright sources such as high power ash-lamps at close distances, or laser radiation (light) with intermediate or higher power levels, can also result in high local temperature rises inducing retinal thermal injury (eye damage) within milliseconds (i.e. much too fast for the natural aversion response to prevent injury). This retinal burn leads to a localised loss in the visual eld (a dark spot). Other absorbing (sensitive) tissues, particularly the iris and the skin, are also at risk from burning.”
• “IR (infrared light) penetrates the human skin and the eye to various depths ranging from several millimeters to superficial absorption. Harmful health effects of IR (infrared light) are due to thermal injury of tissues mediated largely through water molecules but also through changes to protein structure.”

ARPANSA also warns that “in current cosmetic and beauty therapy industry practice the risk of inappropriate or incorrectly performed treatments is not well understood”.

ARPANSA specifically advises: “There have been several reported instances of injuries received by consumers. The consequences of these incorrect treatments can range from minor burns to severe injuries requiring follow-up medical treatments leading to permanent scarring in the affected areas.

“Treatments conducted near the eyes could also lead to eye injuries and vision impairment.

“Of particular concern have been cases where cosmetic treatments have been performed inappropriately to treat the symptoms of malignant skin conditions including melanoma, effectively masking or removing these symptoms. This has led to several instances of late or missed diagnosis of serious underlying health problems.”

Why is ARPANSA ‘advice’ necessary?

The applications of light-based cosmetic treatments provide a range of bene ts to consumers but, ARPANSA warns, the delivery of these services “comes with varying degrees of risk depending on the procedure performed”.

Currently, regulatory oversight of the use of lasers and IPLs in cosmetic light-based treatments varies considerably throughout Australia. Tasmania, Queensland and Western Australia each have regulatory frameworks in place to promote the safe delivery of services using lasers in cosmetic treatments.

However each of these states has a different set of requirements for licensing.

Regulations for the safe use of IPLs to perform cosmetic procedures are only in place in Tasmania. In the remaining states and territories there are no licensing requirements at all.

ARPANSA comments: “Aside from causing confusion for treatment providers wanting to set up a business in the industry, there is no single national standard in place to promote the safe delivery of these services to consumers wishing to bene t from the range of treatments available.”

And ARPANSA warns: “There are currently a wide range of operators providing services with lasers, IPLs and LED phototherapy devices. While many are quali ed professionals trained in the use of lasers and IPLs for cosmetic purposes, operators with limited or possibly no training can also provide services.

“Furthermore, the devices used for cosmetic treatments are not necessarily approved by the Therapeutic Goods Administration (TGA). This is because their application for cosmetic purposes is not considered medical.

“These devices are also easily available for purchase on the internet, sometimes at low cost; this relative ease of accessibility has resulted in a situation where consumers can receive cosmetic treatments using IPLs and lasers from operators who do not have a proper understanding of the risks involved in applying the treatment, and who are using equipment that may be sub-standard or poorly maintained.”

ARPANSA’s latest August update concluded: “The current status quo – different approaches to oversight of the industry, depending on state or territory of practice – does not promote a uniform approach to safety. It has also led to gaps in the stakeholder knowledge about their obligations as treatment providers.

“Treatment providers seeking to gain qualifications or training for service provision, whether required by local law or not, do not have a clear understanding of the types of courses available.”

Importance of uniform service provision

ARPANSA research has found there is “a common public perception that cosmetic medicine using laser and IPL techniques is quick, easy, painless and low risk”. This low-risk perception is “not supported as evidenced by the repeated calls for regulation of the industry and the inconsistent approach to oversight in Australia.

“Many procedures are complex and require a high level of skill and experience, regarding treatment application, aesthetic appreciation of the desired appearance outcome, after-treatment care and understanding of risks.”

Hence ARPANSA has determined that “promoting a uniform approach to delivering light-based cosmetic treatments creates an opportunity for treatment providers across Australia to better understand and manage the risks involved with the procedures they perform.”

Importantly, information about common standards and risk management strategies “can improve the safety of not only clients seeking these treatments but also treatment providers exposed to hazards from the equipment they use.”

From a consumer perspective, ARPANSA says, providing nationally available advice around the delivery of services “based on good safety practice can increase confidence in the safe delivery of the desired cosmetic outcome.”

And educating consumers provides individuals seeking cosmetic treatments with the ability to make informed decisions.

ARPANSA notes: “The decisions consumers make should relate to both the choice of treatment provider and the procedure itself. The communication of the risks associated with light-based cosmetic treatments can assist consumers in deciding whether a treatment is necessary or advisable in their particular circumstance.”

ARPANSA ‘Advice’ follows public consultation ARPANSA’s draft formal ‘advice’ – following the period of public consultation – will be in the form of questions and answers (Q&As) related to the safe delivery of cosmetic treatments. It has two main focuses: to promote a nationally available resource for service providers in the industry to measure their own safety performance; to assist consumers in making informed decisions as to which service providers they choose for their treatments. The advice consists of two parts: advice for consumers seeking cosmetic treatments; and advice for treatment providers delivering these services. Advice for consumers The information focuses on what a light-based cosmetic procedure is and what a consumer should expect from a cosmetic treatment service provider. Additionally, the advice discusses some of the important responsibilities of the consumer seeking treatment. The underlying message “aims to promote risk awareness and provides simple strategies for minimising the potential for harm when undergoing treatments with either lasers, IPLs or LED phototherapy”. Important highlights include: how laser, IPL and LED phototherapy treatments result in cosmetic outcomes; circumstances and conditions which may a ect treatment outcomes or increase the risk of treatment to a point where undergoing a light-based procedure is inadvisable; strategies for assessing whether treatment providers are reputable; • common general side effect from treatment along with more serious adverse reactions needing medical follow-up. Advice for treatment providers The advice for treatment providers contains detailed information about aspects that contribute to safety when providing light-based cosmetic treatments. The scope of the advice includes discussion of equipment, appropriate training, safety strategies, client assessments and injury reporting related specifically to radiation hazards and protection. The safety information contained in the advice discusses equipment requirements, training, relevant competencies, definitions of various treatments from a risk perspective, and risk mitigation strategies. There is also information on service provision discussing consultations with clients and relevant considerations before treatment commences. Important highlights include: licensing awareness for states that have a regulatory framework in place; possible negative effects (contra-indications) to light-based treatments and how to assess the risk of providing services to clients based on their circumstances, health conditions or personal physical traits; appropriate types of training courses for gaining competencies in performing various procedures; relevant standards for equipment and personal protective equipment.

Current state laser regulations

NSW, VIC, ACT, NT: ‘Buyer Beware’

Licensing the ownership and use of energy-based devices (such as radio-frequency, laser and intense-pulsed light) is effectively ‘non- existent’ in NSW, Victoria, the ACT and Northern Territory.

Anyone can purchase this type of equipment and, with minimal training and virtually no medical knowledge, set themselves up to perform ‘treatments’ on a patient’s skin.

As long as the device is being used for what are described as purely ‘cosmetic’ or ‘beauty’ procedures, there is no requirement to be registered under the Therapeutic Goods Administration; qualification as a ‘medical device’ (requiring TGA approval) only occurs if ‘therapeutic’ bene ts are being offered or claimed.

As Dr Michael Molton, President of the Cosmetic Physicians College of Australasia, bluntly warned the NSW Parliamentary Committee’s Inquiry into Cosmetic Health Service Complaints in August: “The use of energy-based devices such as lasers et cetera can and has caused serious burns, disfigurement and scarring in untrained and inexperienced operators. They are ending up in the wrong hands, and this is happening at a staggering rate in NSW. On the way here I passed seven clinics between Double Bay and (NSW Parliament House). I doubt whether they have the expertise to use them .

. . . Despite years of stakeholder consultations, no regulations govern their use in NSW.”

Western Australia: New rules from 15 August

The Radiological Council – an independent statutory authority appointed under the Radiation Safety Act in WA to assist the Minister for Health to “protect public health and to maintain safe practices in the use of radiation” – published new regulations for the “cosmetic use of lasers” on 15 August.

The Radiation Safety Act regulates the keeping and use of radioactive substances, irradiating apparatus (eg x-ray equipment) and certain electronic products (eg lasers, sun-tanning units and UV trans-illuminators).

For those using high-powered lasers in the course of their business, the term ‘laser’ in this instance “refers to high-powered lasers prescribed under the Radiation Safety Act as Class 3B (greater than 5mW in power output) and Class 4 lasers, as classified by AS2211.1 Safety of laser products”.

Cosmetic use of Lasers:

Non-medical practitioners may be able to use lasers for cosmetic procedures with a current ‘exemption from licence’. An exemption from licence requires an application to the Radiological Council and an exemption certificate to be issued.

There are three types of ‘exemptions from licence’ issued for cosmetic use of lasers: these are for hair removal, superficial cosmetic procedures (pigment and vascular treatments only) and tattoo removal. To be eligible for an ‘exemption from licence’ to
use lasers:

• for hair removal, you will need to be an Enrolled Nurse, Registered Nurse or hold a Diploma or Certificate IV in beauty therapy (or equivalent), have attended a recognised laser safety course and have undertaken a minimum of 25 hours practical training under the immediate personal supervision of a person licensed in WA for the use of lasers for hair removal.
• for superficial cosmetic procedures (pigment and vascular treatments only), you will need to be an Enrolled Nurse, Registered Nurse or hold a Diploma or Certificate IV in beauty therapy (or equivalent), have attended a recognised laser safety course and have undertaken a minimum of 100 hours practical training (50 hours training in pigment treatments and a minimum of 50 hours training in vascular treatments) under the immediate personal supervision of a person licensed in WA for use of lasers for superficial cosmetic procedures. The use of lasers for superficial cosmetic procedures does not include treating issues such as varicose veins and raised spots.
• for tattoo removal procedures, you will need to be a Division 1 Registered Nurse, have attended a recognised laser safety course and a tattoo removal course, have a minimum of 5 years nursing experience, and provide confirmation that a registered medical practitioner is available and willing to provide medical support to the nurse undertaking laser tattoo removal procedures.

Note: Enrolled Nurses and Registered Nurses “means registered as such with the Australian Health Practitioner Regulation Agency. Immediate personal supervision requires the licensee to be present and maintain direct and continuous supervision of any person under the licensee’s direction”.

To demonstrate practical experience in accordance with the above requirements, “evidence of the minimum total practical hours must be provided (eg. logbook of treatments).

In addition, the supervising licensee must provide written advice that the trainee has undertaken practical training in both consultation and beam-on aspects of the specified treatments and is competent in each aspect. Licensees supervising practical training will be held responsible for ensuring that the competence of trainees is accurately reported to the Council.”

Licensing for Medical Practitioners

Medical practitioners who hold a relevant licence under the Radiation Safety Act, or medical practitioners working under the direction and personal supervision of a licensee, may operate lasers up to and including Class 4. Personal supervision requires
the licensee to be present on the registered premises.

To be eligible for a licence, you will need to be registered as a medical practitioner with AHPRA and attend a recognised laser safety course.

Registration

The premises and all Class 3B or Class 4 lasers in use or storage must be registered.

Should you only need to bring a Class 3B or Class 4 laser into WA for a one-off event, then you will still need to register the laser; however, you may choose to obtain a temporary permit for registration which is issued for a period of three months.

For use of lasers by non-medical practitioners for hair removal, superficial cosmetic and tattoo removal procedures, a medical practitioner will be required to be involved with setting up the protocols and procedures relating to cosmetic laser treatments. In addition, prior to using lasers for these procedures written correspondence must be provided from a medical practitioner confirming the patient has undergone a skin check in person with the medical practitioner prior to each course of new treatment.

Queensland: User & device licences

Queensland Health warns “the personal appearance services (body art and beauty therapy) industry is rapidly changing. There are a number of new, emerging or popular services and procedures that may be offered by beauty therapists, dermal technicians or tattooists.”

Queensland legislation requires:

• “Any business that uses Class 4 lasers to deliver their service
  must be licensed. The person operating the equipment is also required to have a licence.
• “Class 3 lasers, which are not as powerful, do not currently need to be licensed.
• “Some higher risk personal appearance services businesses (for example tattoo artists and other people who provide treatments which are expected to cause bleeding) also require a specific licence to operate. This is managed by local government agencies. Ask to see the business’s licence.”

Radiation Health administers Queensland’s Radiation Safety Act 1999 and the Radiation Safety Regulation 2010. To demonstrate that their radiation sources and premises comply with the applicable radiation safety standard, possession licensees must obtain a ‘Certificate of Compliance’ from an appropriately accredited person.

Tasmania: Registered & ‘documented relationship’

Tasmania has regulated the use of lasers since 1977. This regulation continues under the Radiation Protection Act 2005 and addresses areas such as hair removal and skin rejuvenation.

Additionally, in 2012, Tasmania became the first state or territory to regulate the use of Intense Pulsed Lights (IPLs) for cosmetic purposes. IPLs are similar to lasers but are not authorised for use to remove tattoos.

To be authorised to use a laser or IPL for cosmetic procedures, medical and non-medical practitioners must show they have knowledge of relevant skin biology, laser or IPL safety, and have had training on the equipment they wish to use.

Also, non-medical operators of lasers and IPLs must have a ‘documented relationship’ with a registered medical practitioner who can assess skin lesions with malignant potential, and manage adverse outcomes.

Regulation also means the rooms where lasers and IPLs are used must be registered (and have a ‘certificate of compliance’), with conditions designed to ensure the client, the operator and the public are protected from the potential optical hazards caused by lasers and IPLs.