TYCT Newsletter October 2016

World-class help for resolving disputes

cedr logo 100 yearsWe all know how important it is to our business that we resolve complaints quickly. When that gets difficult, call on the Treatments You Can Trust (TYCT) service to get help from the Centre for Effective Dispute Resolution (CEDR), which is the largest conflict management and resolution consultancy in the world and is provided as part of your TYCT membership. Don’t worry, it helps the smallest of clinics too.

Sometimes it is not possible quickly to achieve an outcome that both complainant and clinic can accept. Your business doesn’t need a disaffected patient, or a law suite. TYCT will signpost you to an acceptable outcome quickly and effectively at modest cost.

Ensure that you add this to your Clinic’s Complaints Policy

If you find yourself in need of this service, email TYCT for assistance at This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Dermal Fillers and their legal classification

Very recently, Sally Taber, our Director, discussed the classification of Dermal Fillers with the Department of Health. The MHRA is now working towards registering all Dermal Fillers as Medical Devices.

mhra logoThe draft EU Medical Devices Regulation includes within its scope products without an intended medical purpose, one category of which includes dermal fillers. The Regulations have not yet been formally adopted but we expect them to enter into force in Spring of next year.  The requirements for products without an intended medical purpose however do not apply until the development of ‘common specifications’ for this group of products, a work item which is already underway between the Commission and Member States. The deadline for such common specifications is set for three years after the Regulation enters into force, which based on current timetables would be Spring 2020.

A key tenet of the new Regulations is that devices placed on the EU market should have improved traceability. Under the new Regulations, a centralised European database (EUDAMED) will store information such as which devices are on the EU market, which economic operators have been involved in the supply chain, and longer term, the unique device identification (UDI) of individual devices (including barcode information) will be uploaded onto the database.

Still, unfortunately for patients, a bit of a free for all at the moment and risk remains too high for comfort.

 

Standards for Lasers

laser on skinEssential Standards regarding Class 3B and Class 4 Lasers and Intense Light Sources in Non-surgical Applications

Since de-regulation in 2010, there have been no nationally applicable standards to apply to users of Class 3B and Class 4 Lasers and Intense Light Sources. Revised and updated Essential Standards regarding Class 3B and Class 4 Lasers and Intense Light Sources in Non-surgical Applications will shortly be launched for use across the UK.

The Standards have been agreed by the British Medical Laser Association, Treatments You Can Trust, the Association of Laser Protection and Healthcare Advisers and the Hair and Beauty Industry Authority.

The Standards include

  • Requirement for a clinic to have a treatment protocol produced by an Expert Registered Healthcare Professional (ERHP). BMLA intends to list ERHPs.
  • Requirement for a description of the Local Rules under the advice and approval of a certificated Laser Protection Advisor who will need to do a site visit and produce a risk assessment.

A description of the training and CPD requirement. References include:

  1. BMLA/IPEM/SRP approved Core Of Knowledge syllabus and
  2. MHRA September 2015 Guidance and
  3. the Health Education England work on the types of treatments that can be delivered at Level 4, 5, 6 and 7
    Found at treatmentsyoucantrust.org.uk/tyct-standards-for-cosmetic-injectables
  4. Standards for the treatment environment and
  5. the current standards for Lasers BS EN 60601-2-22 for medical lasers and BS 60601 -2-57 for IPL.
  6. Details of the Registration Schemes namely
    1. LPA Registration
    2. Clinic Registration
    3. EHRP Registration
    4. and a comprehensive Bibliography

 

What’s happening with the European Standard for Non–surgical Treatments re Claim of defective standard EN 16708

The UK mirror committees to CEN/TC 403 and CEN/TC 409 have jointly agreed the following briefing statement concerning the way ahead following a dispute caused by a complaint lodged against CEN/TC 403;-

  • First of all it has to be recognised that both committees have concerns that require further clarification. It is acknowledged that the CEN TC 409 is seeking to achieve a similar overarching aim as CEN TC 403, i.e. patient safety.

In discussion between the two UK mirror committees it has become very clear that a major factor underlying the current debate is that the two CEN TCs have developed their two standards (EN 16708 and EN 16844) from rather different perspectives. Perhaps a lack of clarity in some sections of the two standards, together with some possible misunderstanding by TC 403 of the detailed workings of the beauty therapy sector, and in particular its qualifications framework, has compounded the situation.

The UK 403 mirror committee (Aesthetic surgery & aesthetic non-surgical medical services) raised concerns regarding the advanced treatments within EN 16708 (chemical peels, radiofrequency and laser), which would require further terminology/definition clarification to ensure the boundaries are clearly defined between beauty treatments and medical treatments using similar equipment but with outcomes within their qualifications.

Recommendations for Practice have been developed and agreed jointly by medical and beauty stakeholders. *

  • There are existing National Qualifications within the beauty sector for advanced treatments that are regulated by OfQual and listed on the Qualifications and Credit Framework, QCF.
  • The QCF can be mapped to the European Qualifications Framework EQF, so national qualifications can be compared with other European countries.
  • de facto situation in the UK where beauty therapists are legally able to offer these services and have been doing so for many years. **

* Taking into consideration the concerns of the UK 403 and 409 mirror committees, they are able to agree on suggesting to the CEN/BT the following pragmatic way forward.

** Further clarification is added to EN 16708 as requested regarding treatment ranges. In addition an explanation of the EQF and Cosmetics Regulation, supplied as an annex, will provide further guidance on the national qualifications and how cosmetic preparations are controlled within the EU.

The Way Forward

Work towards the publication of both EN 16708 and EN 16844 be paused while a formal group is set up between CEN TC 409 and CEN TC 403 to work only on terminology clarification/annex mapping to the beauty therapy qualifications.

It is intended that this group is chaired by a neutral standards body representative rather than a CEN TC 403/409 representative.

The standard will remain on hold while CEN pulls together a couple of delegates from the CEN 409 committee and the individuals that raised the complaint. There will be a meeting 7 December.

 

Cosmetic Surgery (Standards of Practice) Bill Launched in Commons

kevan jonesThe Labour MP for North Durham, Mr Kevan Jones, has again brought the issues of the cosmetic surgery sector direct into the heart of Government by launching a Bill in the House of Commons last week.

Mr Jones wants to see the law changed to make cosmetic surgery firms more accountable, with less ability to aggressively market procedures, to ensure the people carrying out cosmetic surgery are properly trained, in line with the licensing and accreditation plans from the Royal College of Surgeons (RCS), and to establish a code to ensure that patients are properly informed about cosmetic procedures and associated risk.

Mr Jones stated that he wished to "...bring in a bill to make provision about the training, qualifications and certification of medical practitioners conducting cosmetic surgical procedures; to establish a code of practice for the provision of information to patients on the options and risks in relation to such procedures; to make provision about permissible treatments and the advertising of such treatments; and for connected purposes."

To see Mr Kevan Jones, MP introduce his 10-min rule motion for the Cosmetic Surgery (Standards of Practice) Bill in the House of Commons on Wednesday 19th October, you will need to do the following. Visit the link below on Parliament TV and then using the timed schedule menu look for the entry at 13:13, labelled Ten Minute Rule Motion: Cosmetic Surgery (Standards of Practice) - Mr Kevan Jones MP (North Durham, Labour).

Alternatively you can read the Hansard transcribed speech. The second reading of the Cosmetic Surgery (Standards of Practice) Bill will not take place until Friday 24th March 2017. The wheels of Government are sadly as slow as ever, but we feel this is a positive step to again highlight the regulation discrepancies within the sector!

 

 

For Registered Nurses

mnc logoNursing Revalidation Update

There are now 690,000 nurses and midwives on the NMC register. 75,513 registrants have revalidated between July to September 2016 with 60,095 of these taking place in England.

Ipsos Mori will be shortly undertaking an independent evaluation of revalidation over the next three years.

The Medicines Management Standards are on the NMC list to be reviewed.

 

 

In the Media

Raconteur on Cosmetic Procedures

15 September 2016 - The Times, Raconteur 12-page insert

TYCT, as part of its programme for advertising its mission of safety for the public, supported and advised on this publication.

The insert promotes the activity of performing cosmetic procedures, articles include:

  • gunning for the cosmetic cowboys
  • staying safe despite the cosmetic hype
  • what women want
  • after all these years, is beauty in the ‘phi’ of the beholder
  • establishing guidelines to protect public.

Much more is to be found at

 

 

Useful Social Media tags and links

Treatments You Can Trust

Royal College of Surgeons – Cosmetic Surgery

Find useful information and advice here about cosmetic surgery, procedures, choosing a surgeon and questions to ask.

MHRA

 

 

For your Action

Change in TYCT Register Terms and Conditions

Upon our accreditation by the Professional Standards Authority, we were advised to clarify our terms and conditions in certain particulars, including our expectations in terms of registrants meeting the TYCT Standards; and the sanctions we might impose in case of non-conformities by registrants.

 

 

New Declaration

When you renew your registration, we ask you to declare your intentions to meet TYCT Standards. We draw upon the recently revised GMC standards for this.

The new declaration follows:


Declaration by practitioner of cosmetic injectable treatments

Strike out that which does not apply:

  • I confirm that I am registered with my professional regulator as a Doctor, Dentist or Registered Nurse;

OR

  • I am qualified to practice cosmetic injectable treatments at Level 6 or Level 7 as defined by Health Education England Qualification Requirements for delivery of cosmetic procedures July 2015 Ch 2 Table 1

I understand that Treatments you can Trust registration is accorded to those who:

  • are appropriately trained and experienced to practise safely
  • work with each individual patient to make sure their expectations about the outcomes that can be achieved for them are realistic
  • follow current guidelines or protocols for safe, effective provision of cosmetic interventions
  • consider the psychological needs of their patients
  • do not allow any financial or commercial interests in a particular intervention, or an organisation providing cosmetic interventions, to adversely affect standards of good patient care.

I will practice cosmetic injectable treatments accordingly during the whole period of my registration.

I am aware of the Treatments you can Trust Standards For Cosmetic Injectables Treatment published at treatmentsyoucantrust.org.uk/tyct-standards-for-cosmetic-injectables.

I have read and agree to the Terms and Conditions published at the same website on the date of this application.

By typing my name below I confirm that the information provided in this application is true to the best of my knowledge and belief.

Signed, Practitioner

 

Declaration by Clinic Responsible Person (Clinic Manager)

I have read the Treatments you can Trust Standards For Cosmetic Injectables Treatment published at www.treatmentsyoucantrust.org.uk and confirm that the organisation I manage will comply with these Standards at all locations from which we provide cosmetic injectable services during the period of our registration.

I will immediately inform The Registrar, Treatments you can Trust of changes that happen to the details of my clinic and the practitioners practicing at it which are displayed on the Public Register published at www.treatmentsyoucantrust.org.uk during the period of registration. 

I have read and agree to the Terms and Conditions published at the same website on the date of this application.

By typing my name below I confirm that the information provided in this application is true to the best of my knowledge and belief.

Signed, Clinic manager.


 

Your entry on the Treatments You Can Trust Register

Have you checked your entry on the Treatments You Can Trust Public Register recently? The Public Register displays details of Practitioners and their related clinics (some practise in several clinics). We look to Clinic Managers to ensure that we have the entry correct, and to tell us of any changes to registered details.

 

Change at the TYCT Registrar

The Treatments You Can Trust Registrar is the well-known and respected Northgate Public Services at Hemel Hempstead, who operate a number of registers including the National Joint Register. The team there has recently changed and is now:

The Treatments You Can Trust Registrar

northgate logo

northgate logoContacts

  • Ian Mulcahy – Team Supervisor
  • Emma Whiddett - Registrar
  • Chris Sparks – Assistant Registrar
  • Telephone – 0845 213 0310
  • Email – This email address is being protected from spambots. You need JavaScript enabled to view it. – goes to all three contacts.

 

Postal Address

  • Treatments You Can Trust
    Health Service Desk
    Northgate Public Services
    Maylands Avenue
    Hemel Hempstead
    HP24 5NW

The Registrar is responsible for helping you register or re-new your registration. Membership advice before applying, or for detailed questions on clinical governance, can be obtained from this email address:

  • This email address is being protected from spambots. You need JavaScript enabled to view it.

 

New Treatments You Can Trust Quality Assurance Mark

To mark the new status given to everyone on the Treatments You Can Trust Public Register by accreditation by the Professional Standards Authority, we have produced a new Quality Assurance Mark, as seen top right of this newsletter. Retaining the existing iconic green circle and arrow, the new Quality Assurance Mark emphasises the status of the holder still more.

The new Quality Assurance Mark is now available to all who are listed on the Register to use in your marketing material. There are multiple versions including designer artwork files for:

  • Quality Assurance Mark
    • full colour (green and black)
    • black only
    • white only.
  • Combined Quality Assurance Mark and PSA accreditation mark
    • full colour (green and black), vertical and horizontal
    • black only, vertical and horizontal
    • white only, vertical and horizontal.
  • Note: You are NOT permitted to use the PSA accreditation mark without the TYCT Quality Assurance Mark.

The best way of making best use of your investment in joining the TYCT Register is to advertise that you are a trustworthy provider of injectable cosmetics and the best advertisement is to put the new TYCT Quality Assurance Mark on your website, on your printed material, and on your patient advice sheets. Make a note today to tell your webmaster and your marketing company.

 

TYCT Cosmetic Injectables QAM 2016 green TYCT Cosmetic Injectables QAM 2016 black TYCT Cosmetic Injectables QAM 2016 white
 
TYCT PSA combined logos 2016 green vertical TYCT PSA combined logos 2016 black vertical TYCT PSA combined logos 2016 white vertical
 
TYCT PSA combined logos 2016 green horizontal
TYCT PSA combined logos 2016 black horizontal
TYCT PSA combined logos 2016 white horizontal on black
 

 

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tyct newsletter thumb

This newsletter is also available in PDF format.

 

Quality Assurance

Become a registered provider to display the Quality Assurance Mark in your promotional literature.

“The sign of safer
cosmetic injectable treatments”

Treatments You Can Trust accredited Quality Assurance Mark