Journal of Aesthetic Nursing - Aesthetics in Ireland: the publication of IS EN 16844

Abstract

IS EN 16844 aesthetic medicine services: non-surgical medical procedures has now been published in Ireland. Two years on, what does this mean for Irish nurses and what has changed in Irish aesthetics?

Two years ago, I wrote a guest editorial about the panic experienced by Irish nurses at the prospect of the publication of the European Standard CEN (European Committee for Standardisation) IS EN 16844 Aesthetic medicine services – non-surgical medical procedures (McGloin, 2017). The final draft of this standard was put to the vote at the committee in January 2017 and took effect in July 2017. The standard addresses the specific requirements for non-surgical medical aesthetic treatments such as dermal fillers, botulinum toxin, chemical skin peels and medical skin needling. It also provides recommendations for the provision of these treatments, including the ethical framework and general principles according to which these medical aesthetic procedures are provided by medical practitioners and stakeholders within this sector.

Over the last 2 years, more and more unqualified practitioners in Ireland are claiming to be medically qualified

Unfortunately, there were no Irish nurse representatives on the CEN, and Irish nurses were informed about the vote on the final draft with only a few days' notice, leaving very little time for nurses to provide their comments to the National Standards Authority of Ireland (NSAI). The National Standards Authority of Ireland (NSAI) abstained from voting but the CEN standard was passed. This standard will come up for review again in roughly 2–3 years' time and hopefully Irish nurses will then have a say.

At the time, the main worry for Irish nurses was that ‘nurse’ was not specified in the term ‘practitioner’, meaning that Irish nurses would have to work under supervision by doctors rather than working autonomously, as had been the case. This was a huge concern as the majority of medical aesthetic nurses in Ireland are independent practitioners, who work without support from colleagues.

Fast forward to today and IS EN 16844 has been adopted and implemented in Ireland, but there have been no changes to the way nurses practise, or indeed, to the industry as a whole. The standard remains voluntary. In fact, I would say that many doctors, dentists and nurses working in aesthetics are not aware of it. In my opinion, despite my previous concerns, the CEN European standards may be a way to regulate aesthetic medicine and should be mandatory in order to protect the public from unskilled and untrained persons conducting medical aesthetics.

In Ireland, the main change noted over the last 2 years is the dramatic increase in the number of lay groups offering medical aesthetics procedures. These unqualified practitioners have been presenting themselves as medically qualified persons to access courses provided for nurses and doctors, to buy prescription-only products and also to give training to other equally unqualified persons. These groups and individuals offer treatments, for example botulinum toxin, that Irish nurses cannot prescribe or administer without facing fines, imprisonment or the risk of being struck off the Nursing and Midwifery Board of Ireland (NMBI) register. They also illegally import and administer prescription-only medications such as lidocaine at high strengths and use cheap dermal fillers. When procedures go wrong, they are unable to fix the problem and clients have no recourse.

Both Ireland and the UK need to improve patient safety in medical aesthetics and there are some existing measures in place and further measures are in development. The Irish minister for health, Simon Harris, announced in June 2019, that a ban on botulinum toxin and filler treatments for those under 18 is being considered. This is a huge step forward in acknowledging the medical aesthetics crisis in Ireland and it was especially heartening to hear as, a few weeks prior, he replied to a letter where I outlined my concerns for the medical aesthetics sector (Box 1).

Box 1.

Question to Simon Harris and his reply regarding the dangers of botched procedures and untrained practitioners

The question posed to him was:

To ask the Minister for Health his plans to ensure that the lack of regulations within the medical aesthetic and cosmetic surgery sector here is addressed in order to protect public health; if his attention has been drawn to the dangers posed by botched procedures and unskilled and untrained persons conducting medical aesthetics here; his further plans to combat this growing trend; and if he will make a statement on the matter.

His reply:

Cosmetic surgery is currently controlled through the regulation of cosmetic surgeons in accordance with the Medical Practitioners Act 2007. Under that Act, medical practitioners, including cosmetic surgeons, who practise medicine in Ireland must be registered with the Medical Council, which has responsibility for the registration of medical practitioners and the regulation of their activities.

Certain medical devices used in cosmetic and aesthetic treatments are captured under medicines legislation and must have a product authorisation from the Health Products Regulatory Authority (HPRA) or the European Medicines Agency (EMA) before being placed on the market. There are also restrictions on who can prescribe and administer such devices as some such products are subject to prescription requirements and may only be administered by registered medical doctors or registered dentists.

Under legislation, medical devices must also be CE marked before being placed on the market. The CE mark follows assessment of conformity to the relevant legislative requirements relating to benefit, risk, composition, safety and labelling and also of the manufacturer's production standards. It does not regulate who can use the medical device or practice relating to the use of the device. The new EU Medical Devices Regulation (EU 2017/745), due to be commenced in May 2020, formally includes dermal fillers in Annex XVI within the scope of medical device regulation as devices without a medical purpose (cosmetic).

The HPRA's regulatory role involves monitoring the safety of medical devices in Ireland after they are placed on the market. The HPRA also operates a national reporting system for medical devices where users of devices are encouraged to report incidents or problems associated with their use to the HPRA.

Where a significant safety or quality concern is identified with the actual device, there are a range of regulatory actions the HPRA can take to protect public health. These include changes to labelling, information and safety notices to users and recalling the product from the market. They can also request changes or modifications to the device itself.

Further regulation in this area will be seen following the introduction of the Patient Safety Licensing Bill. The General Scheme of the Bill was approved by Government on 12 December 2017, has completed pre legislative scrutiny, and is currently with the Attorney General's Office for drafting. The aim of this Bill is to improve patient safety by ensuring that providers of health services do not operate below core standards, which are applied in a consistent and systematic way. Public and private hospitals and providers of high risk healthcare activities taking place outside a hospital setting will require a license to operate. HIQA will be the licensing authority. The non-hospital high risk designated activities will be prescribed by the Minister and the Department is currently working to identify those activities which should be so designated.

The Department of Health has previously recommended that anyone seeking to have a cosmetic surgery procedure should seek advice from their General Practitioner (GP) to ensure that they are a suitable candidate for the procedure in question. GPs can then recommend a reputable specialist practitioner in this area.

The Department further recommended a consultation with an appropriately registered plastic surgeon. In Ireland, such surgeons can be found by examining the online register of medical practitioners found at the website of the Medical Council. A patient can also establish whether a surgeon is a full member of the Irish Association of Plastic Surgeons at the website of that organisation; all of its members have had full specialist training and are on the Specialist Register in Plastic and Reconstructive Surgery of the Medical Council. Specific advice, which has been prepared by the Chief Medical Officer and the Irish Association of Plastic Surgeons, is also available on the website of my Department.

After campaigning for regulations and public safety for the past 8 years in Ireland, I feel that the government is finally listening and, following discussions with others, we may see some form of regulation when the Patient Safety Licensing bill comes in. After seeing the draft, my concern is that it will be the already-regulated who will be penalised while the unregulated will be free to carry on. The harsh reality is that while there is a strong demand for these procedures, there will be unscrupulous and untrained practitioners offering procedures such as botulinum toxin and fillers without regulation.

On a personal note, the Campaign for Safer Medical Aesthetics Procedures was set up to educate the public and to highlight the dangers of cheap products and treatments by non-medics. We do need regulations in place to prevent fatalities. We can only keep applying pressure on our government and the minister for health to change the laws and introduce regulations, and hope that between a ban on botulinum toxin and filler treatments for those under 18 and the introduction of the Licensing bill, we will see a safer medical aesthetic sector in Ireland.