- The scope of the EU Medical Devices Directive should be extended to include all cosmetic implants including dermal fillers, UK legislation should be introduced to enact the changes sooner. Legislation should be introduced to classify fillers as a prescription-only medical device.
- All those performing cosmetic interventions must be registered.
- The Health Education England’s (HEE’s) mandate should include the development of appropriate accredited qualifications for providers of non-surgical interventions and it should determine accreditation requirements for the various professional groups. This work should be completed in 2013.
- Surgical providers should provide both the person undergoing a procedure and their GP with proper records.
- A breast implant registry should be established within the next 12 months and extended to other cosmetic devices as soon as possible, to provide better monitoring of patient outcomes and device safety.
Thursday, 9 May 2013
The time has come for better and effective regulation of non surgical cosmetic treatments such as Botox and dermal fillers. This follows the publication of a report published on 24 April by the Department of Health in England. The report is entitled the "Review of the Regulation of Cosmetic Interventions". The Department of Health reporting group was asked to review regulation in the cosmetic interventions sector following the PIP breast implant scandal which revealed serious lapses in product quality, after care and record keeping. I was astounded to read that the report also draws attention to widespread use of misleading advertising, inappropriate marketing and unsafe practices right across the sector. The report points highlights that cosmetic interventions are a booming business in the UK, worth £2.3 billion in 2010, and estimated to rise to £3.6 billion by 2015. They can either be surgical – such as face-lifts, tummy tucks and breast implants – or non-surgical – typically dermal fillers, Botox or the use of laser or intense pulsed light (IPL). These latter account for nine out of ten procedures and 75% of the market value.
The report authors were surprised to discover that non-surgical interventions, which can have major and irreversible adverse impacts on health and wellbeing, are almost entirely unregulated. The report highlights that a person having a non-surgical cosmetic intervention has no more protection and redress than someone buying a ballpoint pen or a toothbrush. This type of finding points to an industry that is out of control with no regulatory input where everybody and anybody with minimal training can set themselves up to provide services. The industry is glamourised by the media who fail to discriminate between legitimately trained and ethical practitioners with a scientific background and operators who are just cashing in.
As a concerned, responsible and ethical practitioner I support the key recommendations of the report namely:
Regrettably for some people nonsurgical cosmetic treatment is not seen as a medical procedure. This has led to events such as Botox parties where non-qualified non-trained members of the public can inject other members of the public with a drug and a chemical with no regulation, license or inspection. This is a situation that has to be stopped and cannot continue for safety of the public. This is not about cost and any arguments that are put forward to advance that are missing the point. This is simply about public safety.
We have looked at the regulation of these procedures. If you are working in an unregulated environment where you do not have to worry about hygiene, safety, inspections and regulations you will be able to provide this procedure at a cheap cost. There are no issues of training or continuing professional development or education involved. In this way you are putting your health at risk and those people who administer these treatments they are a danger to the public and must be stopped. I am not saying that doctors and dentists provide these treatments cheaper. However at least you know that you will be treated in a safe, clean, hygienic environment to the highest standards by a professional whose job is to put your safety above all else. I continue to support the position that only trained doctors, dentists and nurses should provide nonsurgical cosmetic treatments.
I and my team at Langley Dental Practice, Middleton, Manchester have been offering treatments such wrinkle smoothing and dermal fillers for almost 10 years with excellent results. We also offer tooth whitening administered by UK trained and qualified dentists from only £199. Currently non-surgical procedures such as laser treatments or injectables can be administered by people with no healthcare qualifications whatsoever. I was quite astounded when I read that you do not need to be medically trained to administer these types of procedure. Regulation of these procedures is important and I hope that the government will act swiftly and decisively.
Monday, 6 May 2013
I recently gave my full backing to an e-petition on the HM Government website launched to guarantee funding or places for all new graduate foundation dentists. The details of the petition which already has over 3000 signatures can be seen here. http://epetitions.direct.gov.uk/petitions/40302
All new dental graduates are supposed to be given a training place in a practice in the first year after graduation. In fact a few years ago in response to a shortage of NHS dentists, the government created an additional 77 new dental places by opening two new dental schools, UCLAN and Peninsula. However last year 35 new graduate dentists ended up without a training place job. I cannot imagine how desperately demoralising and shattering this experience must have been for these new graduate dentists.
In 2005 the Chief Dental Officer giving evidence to the Public Accounts Committee of the House of Commons stated that it cost the taxpayer around £250,000 to train each student dentist. That was seven years ago. Last year we had 35 dentists unfunded. If you add that all up in today's money, that makes a figure of £9 million wasted last year with 35 unemployed dental graduates - a frightening sum. On top of that these students are leaving universities with levels of debt approaching £50,000. If last year's state of affairs is duplicated it will be heartbreaking for new graduate dentists and a waste of time and money for the taxpayer. Because completion of Dental Foundation Training is a prerequisite for newly-qualified dentists wishing to provide NHS care, these individuals will be disqualified from caring for NHS patients.That surely cannot make sense.
Here at Langley Dental Practice we have been a training practice for seven of the past eight years. It is one of the most rewarding experiences that we get in dentistry to watch and train a new graduate and see them mature over a 12 month period of training and mentoring into a competent caring associate able to practice independently. I feel that by signing this petition I am showing that what has happened this year is unacceptable because the government has squandered taxpayers’ money and betrayed those who have strived hard to pursue a career providing NHS dental care.
I was a nominated finalist in the Dental Defence Union "Trainer of the Year" award in 2007 for my efforts in training and mentoring newly qualified dentists. Trying to find your first job in the run up to your final dental examinations must be an extremely stressful experience. To go through a difficult complicated application procedure and rigorous interview process, only not to be allocated a place must be extremely demoralising and distressing. To make matters worse we now have a large influx of new European Union graduates where the economy has hit a downturn who do not even have to do foundation training yet some of them have actually got places on the foundation training scheme.
We know that the government has to make cutbacks and that we live in an era where difficult choices have to be made. However it is a crazy state of affairs that the NHS invests £250,000 in training a new dentist only for that dentist not to be able to find a job within the NHS. I support this e-petition for full funding for foundation dental places and I urge the government to make sufficient funds available for all dental foundation training places as a matter of priority.
Wednesday, 1 May 2013
A revised HTM0105 document on cross infection was released at the end of March. The revised document was released by the English Department of Health with very little fanfare and publicity. The very low-key launch of this document is in stark contrast to the original launch of HTM 0105 which was launched in a blaze of publicity in 2008.
There are very many dentists out there at the frontline who are not actually even aware that this document has been released. I emailed five of my colleagues forwarding them the link and none of them had even got the slightest idea that these major changes were coming through. When the original document was released in 2008 there was a massive amount of publicity given to it and it was supposed to be the new way forward for dentists in promoting the highest standards of cross infection control and decontamination. However the profession as a whole was very concerned about the very weak and poor evidence base that supported some of the recommendations. Many of the recommendations were put forward in response to concerns about CJD and many of these concerns have now been demonstrated to be perhaps a little unrealistic. It is pleasing to see that both ministers and civil servants have actually listened to and taken on board the serious and justified concerns of the dental profession and amended the document.
Our job as responsible professional dentists is to ensure the highest standards of care for our patients. This is in all aspects of treatment including decontamination and infection-control. However these needs have to be balanced with the requirements of running a frontline busy primary-care dental practice within in many cases a high street setting. We are not able to send our instruments to a central reprocessing centre for them to be sterilised like hospitals do. The original HTM 0105 document was found to be extremely difficult to work with and had a poor evidence-base and was criticised from many quarters of the profession for its poor evidence base. From the outset many dentists were of the opinion that it was technically flawed and over cumbersome and placed far too much burden on process rather than outcome. The British Dental Association was at the forefront of lobbying for change and I am pleased to say that it has been successful in reversing many of the somewhat burdensome items of the original document.
The most important and significant change to the document is the extension to the shelf life of wrapped instruments from either 21 or 60 days to a maximum of one year. As things stood we were going through cycles where we were repeatedly sterilising and autoclaving instruments that were not being used on a regular basis purely because of either 21 or 60 day deadline. Interestingly enough, prior to the revision there were different deadlines for England Scotland Wales and Northern Ireland. The twelve-month deadline is a very sensible and logical proposal and helps in the efficient running of dental practices without compromising patient safety. Another very important change is the fact that unwrapped instruments in a clinical area can now be stored for one day and if they are in a nonclinical area they can be stored for one week unwrapped. A non clinical area has been defined as either a clean area of the practice decontamination room or a clinical area not in current use. Another important change is the removal of the obligatory requirement to have two separate sinks in a decontamination area in order to wash and rinse instruments. Manual washing scrubbing and rinsing can be done with one sink with a removable bowl that is contained within the sink just for the purpose of holding instruments for watching and rinsing.
When I first took over Langley Dental Practice in 1998 it was a very rundown building in a poor state that I knew in a few years would not be fit for purpose. Therefore when I redesigned Langley Dental Practice back in 2005 I knew that further and tighter and more stringent cross infection rules and regulations would be coming. Therefore from the outset I incorporated dedicated built-in cross infection areas into the design of the building. We have always been praised when the practice has been inspection expected whether by the local health trust or by the North West deanery or by the Care Quality Commission (CQC). We regularly audit our cross infection procedures and policies and the latest guidance from Department of Health has now amended the requirements from 3 monthly audits to 6 monthly audits.
The government and the dental profession need to work together to ensure progress and ways forward for the best treatment for our patients. Logic and common sense need to prevail over rigid fixed and intransigent positions. I am really pleased that the government has demonstrated that it is able to listen to the genuine concerns of the dental profession and take them on board in order to promote the highest standards of care and also the efficient running of dental practices.