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Risks to clients due to Poorly Regulated Treatments

Written by Godfrey Town PhD& Dr Daniel Fleming MB ChB FACCS on February 28th, 2018.      0 comments

Although sometimes we think that there are too many rules and regulations and that we live in a risk-averse society, prescriptive health and safety rules over the manufacture of electrical and other potentially hazardous equipment used in the workplace are necessary to protect staff and clients/patients. The purpose of this article is to clarify the role of regulation and standards and considers the importance of education and guidelines used in aesthetic practice.

Regulations are rules that derive their authority from legislation and provide specific direction in the way in which laws are interpreted and applied. Regulations are enforced by a regulatory agency mandated to carry out the provisions of legislation. Regulations are not laws but have the same legal effect as laws.
Since New Zealand Governments adopted policies of extensive deregulation, there has been a general philosophy of avoiding regulatory controls in New Zealand. As a consequence, the medical and beauty markets have been largely free from any registration requirements for premises or technologies.
More disturbing is that anyone can purchase intense light sources (ILS), such as intense pulsed lights (IPLs), cosmetic laser equipment or light emitting diodes (LEDs) and set up shop in New Zealand with little or no training.
There is no national legislation or regulations controlling the sale or use of such devices although Auckland Council published The Health and Hygiene Code of Practice 2013 (updated 2014) which established minimum standards under the Health and Hygiene Bylaw including Minimum Standard 7 “Pulsed Light and Laser Treatment”. This Minimum Standard can be enforced in Auckland City and District Council areas under the Local Government Act 2002 and Health Act 1956 with penalties including suspension of a Health Protection Licence or fine up to $20,000.

The New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) operates in a similar way to the MHRA (Medicines & Healthcare products Regulatory Agency) in UK and does not register laser or intense light source devices for medical cosmetic, professional cosmetic or consumer use (such as hair reduction or skin rejuvenation). This is because cosmetic devices do not meet the legal definition for a device with “therapeutic purpose” i.e. treating a “disease, ailment, defect, or injury”. MEDSAFE is responsible for the regulation of therapeutic products in New Zealand, so medical surgical lasers used to prevent, diagnose or treat disease, disorder or injury are subject to registration.
Auckland Council Minimum Standard 7 requires evidence of minimum training by operators; provision of comprehensive advice and obtaining of written, informed consent from the patient/client; skin patch tests; detailed record keeping including client and equipment service and calibration records; establishing of a safe controlled area; safety rules; protective eyewear stipulations; hygiene and infection control procedures.
The Health and Hygiene Code of Practice 2013 is currently undergoing a further update, which will probably lead to tighter controls.

Outside of Auckland, there is no specific national legislation or requirement for training covering the use of laser or ILS equipment and there are several hundred clinics across New Zealand offering light-based skin treatments. These vary from large chains to small independent therapists that offer a range of beauty treatments including hair reduction, tattoo and blemish removal and skin rejuvenation.

Sample guidelines document  ---- >
Sample guidelines document
Numerous types of IPL, LED and laser devices are readily available from a variety of distributors and other outlets. Some of the more reputable dealers offer online, or one- to three-day training courses that include
certification, although who evaluates the standard of some of this training is difficult to ascertain.

Laser & ILS Equipment Standards
Standards are authoritative published documents that are usually voluntary (unless specifically adopted by national legislation) and establish specifications and procedures intended to ensure quality and reliability of materials, products, processes or services. These standards provide the foundation for product development by establishing consistent design and engineering controls that can be universally understood and adopted. Standards also make it easier to comprehend and compare competing products.

Lasers and intense light sources (ILS) attract standards and regulatory controls because of the unique eye hazard associated with their use. The wavelengths and outputs available from such devices are capable of blinding careless or inexperienced users and those being treated by them. These devices usually belong in the highest risk category.

Aesthetic laser and ILS equipment applications can range from invasive surgical interventions such as laser lipolysis (laser fat reduction), to non-invasive procedures such as light based hair reduction.
For all such credible equipment to be sold legally in New Zealand, these devices must either be tested to relevant New Zealand safety standards, meet the IEC 60601 electrical safety regulation or be legitimately CE-marked under Mutual recognition Agreements (MRAs) with the European Union which came into force in New Zealand in 1999.

Unfortunately, although we have all got accustomed to assuming that these imported devices are compliant to New Zealand standards; (of which a majority of commercially imported units are) some devices imported directly by individuals can often bypass the testing requirements of Energy Safety and just arrive with a suppler Declaration of Conformity (SDoC) from the country of manufacture.
These SDoC’s are supposed to meet the ISO/IEC 17050 standards, but as the devices are privately imported, who monitors this?
Many buyers also see the European CE-mark as an indication of safety and compliance, however there is also a “China Export” mark which bears a striking similarity to the official European marking. (See comparison graphic) What this means is that devices used in beauty therapy clinics, including professional laser and intense light source devices that have been purchased easily online from China may not comply with any of the required standards for safe use.
Comparison of CE marks-257
Comparison of CE marks

In these instances, the obligation to ensure the devices meet relevant standards is the responsibility of the individuals purchasing the device directly. In the eyes of the law, they are the importer.

Without proper compliance, users of these devices are unwittingly invalidating their insurance and opening themselves up to punitive damages in the event of any litigation brought against them.
It is a case of “buyer beware”.

‘Benchmarking’ Competence in Aesthetic Laser and ILS Procedures
In any civil litigation case the standard of proof that must be satisfied is that of the balance of probabilities, i.e. 'more likely than not'. While it is for the court to decide on the issue of negligence, expert witness testimony is usually sought to establish whether the actions of a professional, who is alleged to have caused the injury or loss, could be considered to be of a standard that would be expected of a competent practitioner and thereby establish ‘causation’ (connecting conduct with a resulting injury) and possible ‘damages’ for ‘negligence’.
In order to establish whether, on the balance of probabilities, the defendant’s actions were of a standard reasonably expected of a competent practitioner, guidelines on procedures published by a recognised expert professional body can be a very useful ‘benchmark’ in determining whether a course of action by the defendant was valid.

Guidelines are codes of conduct or statements that determine a course of action. Although not binding or legally enforceable, when issued by a professional, authoritative body, they may carry weight in litigation cases where they provide a ‘benchmark’ in establishing whether the actions of a professional could be thought competent.
Risks to clients due to Poorly Regulated Treatments
Example of practitioner incompetence

Unfortunately, only limited guidance on professional competence in laser and ILS treatments can be found in published literature, making benchmarking challenging in claims for compensation in personal injury and medical negligence cases. In the absence of specific treatment protocols issued by an expert practitioner, court decisions are often based upon expert witness testimony which may rely only on manufacturers’ user and application manuals.

The most relevant professional bodies in New Zealand include the New Zealand Dermatological Society, a professional body for dermatologists whose members are also vocationally registered by the Medical Council of New Zealand. The society has a most comprehensive and user-friendly reference web site for dermatological conditions. ( International learned societies, recognised codes of conduct or case law may also be a source of benchmarking in litigation cases.

Variations in regional Government policy have led to significant disparities in licensing and enforcement of controls over the use of lasers and ILS devices.
The distinction between “medical” and “cosmetic” blurs which agency is responsible for the enforcement of standards.

Equipment compliance standards are too easily avoided through internet purchase and weak enforcement, and aggressive Chinese export marketing creates insecurity about the legitimacy of the CE-marking on some devices.

Insurance providers offer some hope for raising standards, and new educational standards are desperately needed. These initiatives however, will have limited impact without the support of legislation.
In the meantime, adverse incidents from laser / ILS use will likely increase.

Author: Godfrey Town PhD& Dr Daniel Fleming MB ChB FACCS
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