by Ruth Nicholson
NZ Laser Training Limited encourages beauty and appearance medicine professionals with an interest in lasers and pulsed light (IPL); to get involved with what is happening in New Zealand regarding laser regulations.
On all fronts, things are now moving along and it seems like governing bodies such as The Minister of Health (Hon Jonathan Coleman), Health & Hygiene bylaw instigators, Auckland Council and advocates for safer practice; Medical Aesthetic Laser Technology Council of NZ (MALT NZ); along with our own lobbying on these issues is making an impact.
There is a need for leadership towards self-regulation before pursuing formal government regulation. Caroline Dafoe from MALT NZ would like to improve training parameters, educate the public on what to look for in a trained and qualified technician and to educate on purchasing quality laser platforms with proper education and technical support and why this is important. The New Zealand Government is currently working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981 and its Regulations.
It would be reassuring to think that ‘medical lasers’ that can remove the epidermis, remodel deep collagen through heat induced trauma, laser probes that are used internally, such as in vaginal rejuvenation and or stress incontinence laser procedures, would be deemed medical devices through Medsafe; however, in New Zealand right now this is not the case. This might change now with notice of a long overdue revision of Medsafe’s classification of medical devices for therapeutic purpose. The issue is that as an industry if we do not get involved in this process early enough there could be a knee jerk reaction and over regulation which will impact existing laser and IPL businesses throughout the country.
Lasers that might be deemed medical use only by some practitioners should indeed only be offered through physician lead practice due to the higher risks they pose. However a thoroughly educated laser technician with appropriate training and working under the supervision of a physician (such as a dermatologist, plastic surgeon or other laser physician) can do these treatments safely. Internationally this is more common, such as in Canada where medical aestheticians can perform anti-snoring laser treatments with mentorship and oversight from their medical lead practices.
Moving forward, industry will not want to restrict development of professional avenues for those seeking to specialise in aesthetic laser procedures and for those serious about gaining correct education in this area.
For a ‘product’ to be categorised as a medical device it must have a therapeutic purpose, as defined in section 4 of the Medicines Act 1981. The current definition of therapeutic purpose (amended with effect from
1 July 2014) is:
In this Act, unless the context otherwise requires, therapeutic purpose means any of the following purposes, or a purpose in connection with, any of the following purposes:
- Preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury
- Influencing, inhibiting, or modifying a physiological process
- Testing the susceptibility of persons to a disease or ailment
- Influencing, controlling, or preventing conception; or (e) testing for pregnancy
- Investigating, replacing, or modifying parts of the human anatomy
Currently the removal of hair or tattoos does not meet the definition of therapeutic purpose, and therefore, products promoted for these applications are not medical devices. However, NZ Laser Training Limited, backed by Dr Ken MacDonald (Dermatologist, CHC) and Caroline Dafoe of MALT NZ, do agree that ablative and invasive lasers should be reclassified as medical devices, therefore restricting their use to medical practitioners. It is open for debate right now as to which lasers fit into each category and how risks associated with operating these devices can be mitigated through regulation.
This new legislation is planned to provide a more robust and controlled regulatory environment for medical devices. While Medsafe has no regulatory oversight of these products there are avenues available to consumers unhappy with the service provided by current Laser & IPL treatment providers. These include complaints to the Health and Disability Commissioner (HDC), Consumer Affairs, or the Commerce Commission under the Fair Trading Act.
The New Zealand Association of Registered Beauty Professionals Code of ethics outlines requirements for members around the use of IPL treatment, but not Lasers specifically; this includes the requirement of clients being asked to give written informed consent and qualification / certification requirements on association members who offer IPL treatment. Unfortunately, Laser and IPL technologies have grown at a much quicker pace than what the industry has been able to keep up with MALT NZ and NZ Laser Training Limited will be hosting an industry forum in late June in Auckland with the view that other events will be hosted around the country – the goal is to get more Laser & IPL professionals involved in discussion groups and create a proactive movement towards better industry practice and onwards to a self-regulated but better controlled industry.
Auckland Council has also recently stated that they are actively investigating breaches of Part 7 (IPL & Laser) of the Health & Hygiene Bylaw 2013, in Auckland clinics and have agreed that the existing documents provide only a minimum standard. Greater collaboration between industry experts and advisors and governing bodies is required to bring everything up to date to meet best practice for a better industry. Work continues on advancements in this area as parties involved in seeing action and changes implemented, move forward.