Bioptica Laser Aesthetics
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EUROPEAN AESTHETICS STANDARDS
November 2018: At the Leaders in Healthcare 2018 Conference, held in Birmingham from 14-16 November, a Poster was displayed on the subject of “Learning to Reach Consensus”, in the context of the development, agreement, and subsequent publication of two major European Standards on Aesthetics. The Standards cover both surgical and non-surgical treatments. To view the Poster click here.
AESTHETIC MEDICINE NORTH
October 2018: Laser Safety Advisory - Mike Regan - has again been invited to talk at Aesthetic Medicine North, Manchester. https://aestheticmed.co.uk/e/amnorth/site/home/
Mike's contribution this year is to give an update on the new Medical Device Regulation, MDR. To read more click here.
COMPANY RENAMED LASER SAFETY ADVISORY LTD
July 2018: Bioptica Laser Aesthetics has been renamed Laser Safety Advisory (www.lasersafetyadvisory.co.uk) to reflect more accurately the range of services we offer and to differentiate us from Bioptica Laser Safety (www.bioptica.co.uk), an associated but separate company.
JCCP & CPSA OFFICIAL LAUNCH
February 2018: The Joint Council for Cosmetic Practitioners (JCCP) has made the following announcement:
- JCCP and CPSA official launch at the House of Lords – 22nd February, 2018.
- JCCP opens Practitioner Register and Register of Approved Training Providers on 1st March 2018.
- Governance Arrangements now approved and operational
- New CPSA practice standards for the non-surgical cosmetic and hair restoration surgery sector to be published and endorsed by the JCCP in February, 2018.
For further detail click here.
LASER EYEWEAR SURVEY
October 2017: Work is underway within ISO (the International Standards Organisation) to develop a future laser eye protection standard.
Your input on this would be greatly appreciated.
Future markings under the ISO standard will almost certainly need to include some way of describing the resistance of the eyewear to laser damage (currently not needed under EN 207 because that property is automatically defined when the user specifies an OD).
There is an online survey at the link below. The survey asks you to choose between three broad areas of laser use, where you feel comfortable responding, but you can fill in multiple surveys if you want to cover more than one. The marking options given are the same for all – only the scenario descriptions are different.
The survey takes the form of two examples within each area of laser use – one simple, and one complicated – that you might come across in real life.
There are free text fields where you can note down any aspects that are not captured by the marking options.
All responses will be treated in confidence – and you do not need to give a name if you don’t want to. It would however be helpful if you could indicate that you are from the UK (if you are), to help with analysing national trends in the responses.
Please respond by 17:00 (UK time) on Monday 30th October 2017. Thanks in advance for your help.
Member ISO/TC 94/SC 6/JWG 1
Joint ISO/TC 94/SC 6 - IEC/TC 76 WG Requirements for eye and face protection against laser radiation www.iso.org/committee/50612.html
NEW EUROPEAN AESTHETIC NON-SURGICAL STANDARD - HAS NOW BEEN PUBLISHED
August 2017: A new European Standard on non-surgical aesthetics has now been published.
The Standard covers a vast range of treatments, including:
- Chemical peels
- Botulinum toxin injections
- Micro needling
- Laser & IPL
- … and many more
The full title of the Standard is: Aesthetic medicine services - Non‑surgical medical treatments EN 16844.
The topics covered are:
- Management and communication with patients
- Code of Ethics for marketing and advertising
To obtain a copy of the Standard go to http://shop.bsigroup.com/ and search on the Document Number i.e. 16844
Chair, BSI Committee CH/403
IEC TC76 LASER SAFETY CONFERENCE - BEIJING
October 2016: The annual IEC TC76 Laser Safety Conference took place this year in Beijing from 23rd to 28th October. The IEC is the International Electrotechnical Commission. Bioptica Laser Aesthetics Consultant Mike Regan had the privilege of being a Member of the UK Delegation to the Conference. The very full week long programme included discussions on updating the IEC 60601-2-22 medical / aesthetic laser product standard, as well as the IEC 60825-8 safe use guide. Patient eyewear was also discussed, as well as a new draft International Standard on clinician eyewear. It is anticipated that these standards, if and when agreed, will as far as Europe is concerned supersede the EN 207 and EN 208 eyewear standards. Outside the medical / aesthetic sectors, work on a new Edition of the IEC 60825-2 fibre optics comms product standard was initiated. In addition emerging technologies such as UAS (Unmanned Aerial Systems) - effectively high altitude drones - were also considered for future work on the IEC 60825-12 free space comms product standard.
NEW EUROPEAN NON-SURGICAL STANDARD – FORMAL VOTING PERIOD
January 2016: For several years now UK clinical experts and patient representatives have been working on a draft Non-Surgical Standard for the European aesthetics sector. They have been meeting and debating under the auspices of the BSI (British Standards Institution), together with partners throughout Europe. The non-surgical draft has now reached its final voting stage within CEN, the European Committee for Standardisation. If the vote is successful the Non-Surgical Standard should be published by Q3 2016. The full title is as follows: FprEN 16844 - Aesthetic medicine services - Non-surgical medical procedures. For more information on the BSI Committee (CH403) responsible for this work click here.
BSI LEADERSHIP AWARD
December 2015: Bioptica Laser Aesthetics Consultant - Mike Regan - has been awarded a BSI Leadership Award for his chairmanship of the CH 403 “Aesthetic surgery and aesthetic non-surgical medical services committee”. (BSI is the British Standards Institution). The BSI Leadership Award is given to recognize chairmen of BSI committees who have demonstrated outstanding leadership.
Citation: “Mike Regan was appointed Chair of CH 403 (Aesthetic surgery and aesthetic non-surgical medical services, mirror to CEN/TC 403) with a formidable challenge ahead of him. The remit, to produce a standard on aesthetic surgical services, was an enormous challenge in the United Kingdom. Shortly after the work item began, the PIP breast implant scandal broke and the need for the standard was shown in stark relief against the behaviour of businesses involved in the sector. Mike was a consummate chair of a disparate group with many conflicting agendas. He was the perfect choice for Chair. He allowed delegates to vent their feelings but always stressed the need to gain consensus. His chairing was inclusive, sensitive and productive. Without his leadership it is likely that the mirror group would have been split but it was cohesive and was able to carry the argument in plenary sessions for the need for the standard, in the face of significant opposition from other countries who did not see the need for it. He fully deserves the Leadership Award for the work he has done with CEN TC/403 in his characteristically quiet, diplomatic way.”
For more detail and video click here.
CORE OF KNOWLEDGE - ADDITIONAL NEW TRAINING VENUE IN THE NORTH WEST - WARRINGTON
From September 2015: we will be offering an additional new training venue in the North West (Warrington) for our Core of Knowledge Courses, at the premises of SkinFirst Ltd. Conveniently situated near Warrington town centre this bespoke training venue is short taxi ride, or fifteen minute walk, from Warrington Bank Quay Railway Station. There is also excellent car access from the M6, M56 and M62 motorways.
NEW EUROPEAN AESTHETIC NON-SURGICAL STANDARD – PUBLIC CONSULTATION COMMENCES
February 2015: A Public Consultation has now started on a new draft European Standard dealing with non-surgical aesthetic treatments. The title of the Standard is: "Aesthetic medicine services – Non-surgical medical procedures (EN 16844)". The scope of the Standard includes treatments such as injectables (botulinum toxin and fillers), chemical peels, laser skin resurfacing, skin rejuvenation / hair reduction and so on. The Public Consultation is being carried out throughout Europe, including in the UK where it is being managed by BSI, the British Standards Institution. Comments are invited from interested professional organisations as well as from the general public. To make comments go to http://drafts.bsigroup.com/Home/Details/54413 and follow the registration instructions. The Consultation will run from 27th February to 4th May 2015.
NEW EUROPEAN AESTHETIC SURGERY STANDARD - HAS NOW BEEN PUBLISHED
January 2015: The new European "Aesthetic Surgery Services Standard" EN 16372 has now been published. The UK committee that helped develop this Standard, in collaboration with colleagues throughout Europe, agrees that this the document provides a framework to work by for those working in the aesthetics sector, and also a guideline for those seeking treatment. It will act as a benchmark for aesthetic surgery services in the United Kingdom and across Europe. To obtain a copy go to http://shop.bsigroup.com/ and search on the Document Number i.e. 16372.
NEW EUROPEAN AESTHETIC NON-SURGICAL STANDARD – PUBLIC CONSULTATION ANNOUNCED
December 2014: A Public Consultation will be held in early 2015 on a new draft European Standard dealing with non-surgical aesthetic treatments. The title of the Standard will be: "Aesthetic medicine services – Non-surgical medical procedures". The Standard has been in development for the past four years by CEN, the European Committee on Standardisation www.cen.eu. The scope of the Standard includes treatments such as injectables (botulinum toxin and fillers), chemical peels, laser skin resurfacing, skin rejuvenation / hair reduction and so on. The Public Consultation will be carried out throughout Europe, including in the UK where it will be managed by BSI, the British Standards Institution. Comments will be invited from interested professional organisations as well as from the general public. The web site used will be http://drafts.bsigroup.com/, but please wait for another announcement closer to the date when a more precise link will be provided, together with details on how to submit comments.
This will in fact be the third Public Consultation that has been held by CEN on aesthetic treatments over the past few years, the previous two having requested comments on aesthetic surgery as well as non-surgical treatments. However the decision was made about a year ago that the work be split on a surgical / non-surgical basis. The surgical work has now been completed and the resulting European Standard (EN 16372) will be published throughout Europe (including in the UK as BS EN 16372) in the next few months.
UPDATE ON NEW EUROPEAN AESTHETIC SURGERY STANDARD: PUBLICATION TO GO AHEAD
November 2014: The procedural issues raised by some CEN Member States subsequent to the formal vote in June 2014 were discussed by the CEN Technical Board (CEN/BT) at its meeting on 28th October. The CEN/BT decision is to go ahead and publish the “Aesthetic Surgery Services” document as a European Standard - as originally planned. The EN (European Norm / European Standard) identifier will be EN 16372. CEN is the European Committee for Standardisation.
IEC LASER SAFETY CONFERENCE, TOKYO
November 2014: The annual meeting of IEC TC76 Laser Safety Committee will be held in Tokyo from 5th – 9th November 2014. IEC is the International Electrotechnical Commission www.iec2014.org
The medical / aesthetic working group (TC76 WG4) has a busy programme, including the following:
- Home use aesthetic laser & IPL product standard IEC 60335-2-xx
- Laser & IPL protective eyewear product standards and guidelines
- Medical & aesthetic laser product standard IEC 60601-2-22
- Medical & aesthetic laser safe use guide IEC 60825-8
SAFE USE OF LASERS & IPLS: PRESENTATION AT OLYMPIA BEAUTY
September 2014. Safe use of lasers and IPLs
Thinking of buying a laser or IPL? Already offering treatments? This talk is by Bioptica Laser Aesthetics Consultant Mike Regan – who by virtue of his experience as an independent Laser Protection Adviser, will be able to give you a truly impartial view of the safe use of these devices. The talk is part of the Advanced Beauty Conference at Olympia Beauty 2014. For more detail click here.
UPDATE ON NEW EUROPEAN STANDARD: APPEAL LODGED AGAINST APPROVAL
July 2014. Subsequent to the 10-Jun-2014 announcement by CEN (the European Committee for Standardisation) regarding the positive voting result throughout Europe on the new "Aesthetic Surgery Services" Standard, one of the CEN member national committees - not the UK - has lodged an appeal against the result. This appeal will in due course be considered by the CEN Technical Board (CEN/BT). In the meantime the actual publication of the Standard will be put on hold.
NEW EUROPEAN AESTHETICS SURGERY STANDARD GAINS CEN APPROVAL
June 2014. For the past three and a half years a new pan European services standard for aesthetics surgery has been in development. This work has been coordinated at the European level by CEN, the European Committee for Standardization. Member states, including the UK, have been making considerable input into this work. Two public consultations have been held across the whole of Europe. The resulting draft of the standard was sent out for final vote to all national committees a few months ago, with the voting period ending on 10-Jun-2014. The result has now been announced. The vote was successful, and the document will be published within the next few months as European standard EN 16372. The title will be: Aesthetic surgery services. For more detail click here.
GOVERNMENT PUBLISHES RESPONSE TO KEOGH REVIEW
February 2014. The Parliamentary Under Secretary of State (Dr Dan Poulter) has published his response to the Keogh Review on the Regulation of Cosmetic Interventions. To read the response in full click here.
RESPONSE TO HEALTH EDUCATION ENGLAND REVIEW OF COSMETIC QUALIFICATIONS
February 2014. The Association of Laser Safety Professionals (ALSP) has submitted a response to the call for evidence by Health Education England Review. To read the response in full click here.
Following the publication last year of recommendations by Professor Sir Bruce Keogh, a call for evidence has recently been made by Health Education England. The objective is to review the qualifications required for non-surgical cosmetic procedures. ALSP has commented on the laser and IPL training aspects of this project.
VTCT COURSE PROSPECTUS
December 2013. Our Core of Knowledge Laser / IPL Safety Courses have been listed in the VTCT Training Academy Prospectus for 2013 - 2014. VTCT is a specialist awarding organisation for the beauty sector.
For further information go to the VTCT website and click on “Core of Knowledge for lasers and IPLs in healthcare”.
CLINICAL COSMETIC & RECONSTRUCTIVE EXPO
October 2013 Clinical Cosmetic & Reconstructive (CCR) Expo is a ground-breaking business to business event that will bring the international surgical and non-surgical community together at one major-scale event.
Being held at London Olympia on 11-12 October 2013, this event will bring together an audience from across the globe to debate and share best practice. Experts from all disciplines will have the opportunity to meet in one arena to help define the future of aesthetics. It’s a chance to explore, question, discuss, learn and contribute. Bioptica Laser Aesthetics Consultant Mike Regan has been invited to be on an expert panel at this event, during a 'Great Live Debate' which will discuss how new EU standards will affect the medical and aesthetic sectors in the UK. For further information click here.
UPDATE ON NEW EUROPEAN AESTHETICS STANDARD
July 2013 Update on new European Draft Standard: Aesthetic surgery and aesthetic non-surgical medical services.
For the past three years a new pan European standard for the aesthetics sector has been in development. This work has been coordinated at the European level by CEN, the European Committee for Standardization. Member states, including the UK, have been making considerable input into this work, and it had been hoped to publish the standard (as EN 16372) by Q2 / Q3 2014.
The current working title for the EN 16372 standard, reflecting its wide scope is: 'Aesthetic surgery and aesthetic non-surgical medical services'. However CEN has announced that, for procedural reasons, the decision has now been made to split EN 16372 into two separate standards. One will deal solely with 'aesthetic surgery services', and the other with 'aesthetic non-surgical medical services'. It is anticipated that the content of the two separate standards will be similar to the recent public consultation draft - but simply split into two documents. The target publication dates for the two standards are Q2 and Q4 2014 respectively.
Chair, BSI Committee CH/403
Aesthetic Surgery Services
June 2013 Bioptica Laser Aesthetics Consultant Mike Regan has again been invited to talk at the
FACE Conference, London.
Being held in at the QEII Conference Centre in London from 21st to 23rd June, FACE is a premier scientific event that has significantly grown in size and popularity over the past decade. Mike's contribution this year is to give an update on the new European Aesthetics Standard, prEN 16372. To read more click here.
NHS PUBLISHES KEOGH RECOMMENDATIONS ON COSMETIC INTERVENTIONS
April 2013 Recommendations from the independent NHS review into cosmetic interventions was published on 24 April 2013. The review, led by Professor Sir Bruce, looked into how the sector can be better regulated, practitioners better trained and people having proper redress if things go wrong.
The key elements the Keogh review group felt would contribute to a successful and safe industry include:
- making all dermal fillers prescription only;
- ensuring all practitioners are properly qualified for all the procedures they offer;
- an ombudsman to oversee all private health care including cosmetic procedures to assist those who have been treated poorly.
To read more click here.
LASER SAFETY EDUCATION AWARD
March 2013 At this year’s ILSC (International Laser Safety Conference) held in Orlando Florida, Bioptica Consultant Roy Henderson was awarded the prestigious Rockwell Award. To read more click here.
The objective of the Rockwell Award, which is administered by the LIA (Laser Institute of America), is "to recognize outstanding contributions in laser safety education".
BSI UPDATE ON NEW EUROPEAN AESTHETICS STANDARD
February 2013. The British Standards Institution (BSI) has issued a Press Release on the new European Aesthetics Standard prEN 16372. To view the full text click here.
The public consultation process held last year for the European standard for Aesthetics Surgery Services, EN 16372, received a large number of comments from European countries, including the UK. The comments have now been reviewed by the European committee and as a result the draft has undergone significant changes. The revised draft is now going out for a second public consultation before moving on to the final stage in its development process.
NHS PUBLISHES SUMMARY OF RESPONSES RECEIVED
December 2012. Following its recent Call for Evidence, the Department of Health has published a summary of the responses it has received, to view this click here.
The Call for Evidence was issued in August 2012 to enable the public, cosmetic interventions industry and patient groups to contribute to NHS Medical Director Sir Bruce Keogh’s review of the regulation of cosmetic interventions. While there were a wide range of views on the future regulation of cosmetic interventions, some consistent key messages emerged from respondents.
RESPONSE TO NHS REVIEW OF COSMETIC PROCEDURES
October 2012. The Association of Laser Safety Professionals (ALSP) has submitted a robust response to the NHS Review. To read the response in full click here.
The review, led by NHS Medical Director Professor Sir Bruce Keogh, requested people and organisations to give their views on and share their experiences of the cosmetic surgery industry and cosmetic procedures.
COMPETENCE IN LASER SAFETY
September 2012. Bioptica Laser Aesthetics Consultant Mike Regan gave a presentation to the Laser Safety Forum in Loughborough on “Competence in Laser Safety”. For more detail on the Forum, which is organised jointly by Loughborough University and the Health Protection Agency, see www.hpa.org.uk/laser
Held annually the Laser Safety Forum brings together laser safety professionals from across the UK, Europe and worldwide. Mike’s talk was titled “LPA Certification - an ALSP Perspective”, and addressed the issue of defining suitable criteria for the certification of LPAs (Laser Protection Advisers). The criteria were discussed around the following headings:
NEW EUROPEAN AESTHETICS STANDARD: AN UPDATE
June 2012. Bioptica Laser Aesthetics Consultant Mike Regan gave a presentation to the FACE Conference, Royal College of Physicians in London: www.faceconference.com
The public consultation process for the European standard for Aesthetic Surgery Services, EN 16372 ran for a four-month period, ending on 22-May-2012.
The British Standards Institution (BSI) led the consultation process in the UK, and interested parties from the sector were invited to register their comments online. In the UK alone over 600 comments were submitted, from organisations and individuals.
A set of articles about the EN 16372 Standard appeared in the May 2011 issue of the (UK) Cosmetic News magazine, pages 25/26. The articles may be accessed by clicking on the "Magazine" tab at www.cosmeticnewsuk.com
INTERNATIONAL LASER SAFETY CONFERENCE
May 2012. Bioptica Consultant Roy Henderson has again been invited to be a Member of the International Advisory Board for the International Laser Safety Conference (ILSC) being held in Orlando, Florida, from 18 to 21 March 2013: https://www.lia.org/conferences/ilsc/conference
Held every two years, ILSC is the world's leading conference on laser safety and covers all sectors of laser use and application.
AN UPDATE ON LASER / IPL EYEWEAR
May 2012. Bioptica Consultant Roy Henderson gave a presentation to the British Medical Laser Association at Laser Europe 2012 in London: www.lasereurope2012.co.uk
Two initiatives are currently under development in ISO (the International Organization for Standardization) with the aim of establishing international standards for eye protection in the fields of lasers and intense light sources (ILS).
When published as ISO documents, it is hoped that these will become adopted as European (EN) standards. In the case of lasers, this would replace the existing EN 207 and EN 208, whilst the ILS standard will establish new requirements for eye protection for use with IPLs (which are not currently covered by any international or European standard).