The Aesthetic Surgery Services Legislation: All You Need To Know About EN 16372

Earlier this year, the new European Aesthetics Surgery regulatory standards finally gained CEN approval. This means their publication is imminent, with the final drafts being put into practice in the coming few months – but what does their implementation mean for the aesthetics surgery industry? Much of the legislation will crack down on the inconsistency of procedural standards, training requirements and the condition of both surgical and non-surgical aesthetic treatment centres.

With our expertise here at Cosmetica Training including a number of courses that cover a majority of the procedures covered by the new legislation, we’ve compiled a comprehensive ‘all you need to know’ – ensuring you can get the correct training to give great customer care and protect your business.

What Will The New Regulations Dictate?

On the whole, the Aesthetics Surgery Services bill is designed to provide an overall set of minimum standards and quality guidelines for any practice carrying out cosmetic and aesthetic surgery – and it will apply to any EU member states governed by CEN (European Committee for Standardization). This includes the United Kingdom, as well as other European countries from Poland to Portugal and Finland to France – in total there are 31 member states whose aesthetic surgery industries will be covered by the legislation.

However, the UK has been allowed what’s known as an ‘A-deviation’ to the legislative standards – and this has been approved by the CEN in exceptional circumstances.

What will likely happen upon the legislation’s publication is that there will be two separate drafts – one which applies to surgical procedures (such as face-lifts or breast augmentations), and another which applies more specifically to non-surgical procedures (like Botox injections).

However, they’ll all fall under the same European Standard – this is due to be published before the end of the year as European Standard EN 16372: “Aesthetic Surgery Services”, according to IHAS (Independent Healthcare Advisory Services).

Useful Resources
Aesthetic Surgery Services European Standard (https://www.sfai.se/files/pren_16372_41_e_stf.pdf)
European Committee for Standardization (https://www.cen.eu/Pages/default.aspx)
Aesthetics Journal (https://www.aestheticsjournal.com/news/item/cen-aesthetic-standards-update)
IHAS (Independent Healthcare Advisory Services) (https://www.independenthealthcare.org.uk/independent-healthcare-advisory-services/what-is-ihas/menu-id-741)

Expert Views on Changing Regulations

Broadly speaking, the consensus on the new changes is incredibly positive – for those already working within the industry to high standards, such as ensuring all staff are sufficiently trained, the changes will cause little disruption. However, in the cases of surgeries that might be working with staff who have minimal or poor quality training the regulations will ensure a much better minimum standard of care, professionalism and medical practice – something which many agree is positive.

In fact, there have been calls for more controlled and more universal regulatory standards for a number of years, and British regulators welcome the changes.

The Vice President at BAPRAS (British Association of Plastic Reconstructive and Aesthetic Surgeons) Nigel Mercer said that the regulations will be a positive turn for those who ‘have suffered complications or faced unnecessary risks’ due to poorly qualified practitioners.

He told the Aesthetics Journal: “The impending European standard for Aesthetic Surgery Services means that patients can have the peace of mind that they are being treated by an appropriately qualified practitioner, in an appropriate facility, in accordance to set guidelines, which include standards on advertising.”

The Health Minister for England, Dr Dan Poulter, said that the new rules will be one of the biggest shake-ups the aesthetic surgery industry has seen. In an interview with the BBC he said: “This package is the biggest reform the industry has seen.

“Patients will meet the surgeon operating on them to discuss treatment and they will now have to sign the consent form in the presence of a doctor, not a sales person as has been the case in the past.”

Useful Resources
Aesthetics Journal (https://www.aestheticsjournal.com/)
BBC News (https://www.bbc.co.uk/news/health-26151061)
British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) (https://www.bapras.org.uk/)
British Association of Aesthetic Plastic Surgeons (BAAPS) (https://baaps.org.uk/)

What Training Do I Need?

It’s Clause 3, Sub-Clause 2 of the new Aesthetic Surgery Services regulations which specifically dictates the level of training a practice needs to ensure its staff has – and this is seen as one of the most important changes in the industry’s rules. This covers primarily the more involved and significant procedures – and all of these are split down into three categories, as follows:

Category 1: Office based procedures reasonably undertaken with/without anaesthesia (including botulinium toxins, fillers, and non-ablative laser treatments)

Category 2: Intermediate/minor minimally invasive procedures reasonably undertaken under local an-aesthetic in clinic/ minor ops environment (including blepharoplasty, brachioplasty, liposuction face)

Category 3: Major surgical procedures undertaken under local/general anaesthesia in hospital/ clinic facility (including most aesthetic facial/ eyelid/ nasal surgery, most aesthetic breast and body con-touring)

Those aesthetic practitioners carrying out the ‘lower level’ Category 1 procedures will require:

• A minimum of two years’ general clinical experience
• A minimum of three years’ specific training in office-based procedures
• Compliance with national training requirements

Any practitioner carrying out Category 2 and Category 3 must have:

• All of the above requirements for training and clinical experience
• Specific aesthetic surgical training as part of the course’s syllabus.

According to a draft of the Aesthetic Surgery Services, training requirements include:

“[At] least anatomy, physiology, pharmacology, immunology, pathology, goals of particular aesthetic medical procedures, techniques and handling complications of aesthetic medical procedures.”

The legislation doesn’t end after someone has achieved the relevant amount of training or experience, however – continuous education and assessment is a requirement. The legislation dictates that a practitioner must maintain valid national regulatory registration, work to improve knowledge and skillsets (ie. through additional training) and attend at least two CME (Continuous Medical Education) accredited events each year relevant to their field.

Useful Resources
Aesthetic Surgery Services European Standard (https://www.sfai.se/files/pren_16372_41_e_stf.pdf)
British Association of Cosmetic Nurses (BACN) (https://www.cosmeticnurses.org/)

What Are The Consequences For Non-Compliance?

Ultimately, the consequences for an aesthetic surgery practice, whether carrying out surgical or non-surgical procedures is the same – civil medical negligence lawsuits (ie. compensation claims), as well as the potential for more serious medical malpractice cases. Since the new regulations will require a specific amount of minimum training to carry out even office-based procedures, it’s not unrealistic to expect criminal cases if this is not adhered to.

The Aesthetic Surgery Services standard itself doesn’t dictate specific consequences for not complying with the regulations relating to training and practice requirements – all it lays down is a complaints procedure, which must be clear and something patients are made aware of.

4.14 Complaints
a) All practices/ companies offering aesthetic services shall have a clear complaints procedure and process.
b) Patients should be aware of the practice/ companies complaints procedure.

However the need to comply can’t be overstated at all – from a quality point of view it ensures you’re giving your patients the very best treatments and the best possible care. This protects patients from potential malpractice – whether that’s through ignorance or apathy.

From a legal point of view, it’s important to protect your practice, or yourself if you’re self-employed. Compensation lawsuits can potentially run into the thousands whether you make a mistake due to improper training or you’re simply found to not comply with legislation – it can even result in the removal of practice licenses.

Since the surge in medical negligence scandals over the last few years (e.g Stafford Hospital), there has been a 20% rise in in medical negligence claims from patients. Protecting yourself by ensuring proper practices and compliance with legislation is vital in ensuring you operate ethically.

Useful Resources
Telegraph Online (https://www.telegraph.co.uk/health/healthnews/10189204/Jaw-dropping-rise-in-NHS-claims-after-scandals.html)
MHRA (https://bit.ly/Zddqgv)