If your organisation is a clinic offering laser or intense pulsed light (IPL) treatments or therapy, then you will need to have the services of a suitable Laser Protection Advisor (LPA) and an Expert Medical Practitioner (EMP). This rule applies to any clinic offering private treatments using class 3B lasers or IPL devices in England and Wales. At Lucid we offer a Nationwide Laser Protection Advisor service to clinics, providing the expert laser and IPL advice and associated procedures in a flexible and cost-effective way, and include the services of an EMP as part of the total package.
Our aim in acting as your specialist medical Laser Safety Advisor (or adviser) is primarily to ensure the safety of both staff and clients/patients undergoing light based treatments or therapy from either lasers or intense pulsed light systems. This clearly must be our main priority for medical, dental and cosmetic clinics, but additionally we aim to provide valuable assistance in gaining and maintaining Care Quality Commission (CQC) (previously Healthcare Commission, HCC or HC) registration for the laser and IPL treatments offered by your clinic. The EMP is primarily responsible for producing suitable medical protocols for the laser and IPL treatments, whilst our LPA will work with the EMP to ensure the full suite of documents is complete, consistent and fit for purpose.
At Lucid we provide a friendly service with well-qualified staff and expert Laser and IPL Safety specialists who are happy to ensure that your experience of working with us is both enjoyable and efficient. The services we offer include suitable training for your staff in all the relevant laser and IPL safety issues, the basic training course being known as the 'Core of Knowledge' (as required by the CQC), and this can be conducted on your site or at our training centre. There is more information on these topics, the services offered and how we help you below:
The current clinic registration requirements are in a state of flux. Please click here for our latest advice. The text below relates to the previous situation.
The process of registration with the Healthcare Commission is something that most clinics find onerous and off-putting. At Lucid we have experience of compiling the paperwork required such that the process is efficient and the workload for clinic staff is drastically reduced ensuring that your normal work need not be significantly affected, thus allowing you to focus on your core busines onjectives - we will look after the rest.
The Healthcare Commission is a powerful body, and demands high standards from clinics seeking to register with them - as all using lasers and IPL devices must. They exercise their power in situations where clinics have failed to start the registration process promptly, or do not achieve the required standards. It is clearly in the interests of clinics to work with them to ensure the safety of clients and hence ease the registration process.
Our role with Healthcare Commission registration is to support the clinic by producing the specialist documentation required, such as the 'local rules' protocol and procedures. In addition there is a lot of paperwork relating to more general activities of the organisation, health and safety and so on, which we can produce where required. There is inevitably some work for the clinic to do for themselves, and clearly procedures that are submitted for registration must be fully adopted and followed by the clinic, but by doing the time-consuming work of developing adn documenting the procedures on your behalf we help to significantly reduce the impact on the day-to-day running of your clinic - whilst at the same time providing you with high quality procedures that will meet the standards the Healthcare Commission requires. The accuracy and quality of the paperwork describing these procedures is important not just from the point of view of achieving registration with the Healthcare Commission for the laser and IPL treatments, but also in ensuring that all the treatment procedures (as well as general health and safety procedures) followed by your clinic are both safe and efficient. The cost of poor procedures can result in inefficiencies, possible delays in registration and (if an accident were to occur) potential legal action, including litigation and tribunals - the negative impact of which on the clinics standing in the sector should not be underestimated.
On-going LPA Support & Services for Clinics
Once a clinic has achieved full registration with the Healthcare Commission, we can provide on-going LPA and EMP support - as required by the Healthcare Commission. The registration requires that the clinic have an appointed LPA and EMP. The on-going roles of the LPA and EMP are to provide support and advise for any unforseen circumstances that may occur, and to be available should there be an incident, as well as on-going annual re-inspections and / or support in respect of self-assessments.
Should the range of treatments offered by the clinic expand, then this will have to be reflected in the procedures and medical protocols. It is useful to the clinic to know that expert help is close by and any new paperwork can be quickly devised by experts familiar with your staff, premises and procedures.
Similarly if the organisation obtains new premises or new treatment rooms are allocated as business needs dictate, then it is important that the services offered by the LPA are prompt and do not cause unnecessary delays in making new or additional laser and IPL treatments available.
An important aspect of the LPA's work for the clinic is to advise on suitable and appropriate safety eyewear for the staff and patients during laser and IPL treatments at the clinic. This is an area where we are concerned that others do not always know how to do the appropriate calculations, whereas we have considerable experience in this area and can also use our commercially marketed LaserBee laser safety software to perform and check calculations. The consequence of poorly specified eyewear, either from the instrument supplier or the LPA, is that laser and IPL treatments can become much more difficult as the operator struggles to see through the safety glasses, or alternatively eyewear is inappropriate or underspecified leading to potential eye injuries for the wearer.
Core of Knowledge Training and Certification
For clinic staff working with lasers and IPL instruments, it is required that they attend a training course providing the 'Core of Knowledge' deemed appropriate for safe use of these treatment devices. This training on key features and safety aspects of the use of laser and IPL treatment systems takes around half a day and can be conducted on your site if you have a few staff who all require the training, or at our training centre.
For small numbers of staff we recommend you attend a Core of Knowledge course at our training centre. This has the advantage that trainees can meet the Lucid staff members who they may speak to and get relevant laser or IPL safety advice from in the future, rather than solely to have met the LPA who audited their premises.
At times we can provide public 'Core of Knowledge' laser and IPL safety training courses at central venues. If you register your interest in our Core of Knowledge public training courses with us then this can help us to select an appropriate venue and offer you the laser and IPL training you require in a manner that is more convenient to you.
An important aspect of our Core of Knowledge course is that it has been developed to be readily delivered to a wide range of clinic staff who come into contact with laser and IPL treatment systems. The course has technical elements but is readily followed by non-technical clinicians, and similarly there are biological elements, but there no prior knowledge of the biology of the skin or eye is required. It is important to us that key safety and background laser and IPL knowledge training is delivered in a logical and lucid way, so that all concepts are understood. At Lucid we believe staff follow procedures, and take appropriate precautions, more willingly when they understand the reasons behind them.
Certificated Laser Protection Adviser (LPA)
The Healthcare Commission requires that LPAs are fully certificated by an approved independent body. These qualified, expert LPAs are known as Certificated Laser Protection Advisers (or Advisors), as they have met the stringent requirements and proven their expertise in being able to provide expert advice on laser and lamp safety issues. .
In summary, we would advise clinics to check the qualifications of any LPAs and ensure the LPA they appoint has the relevant medical LPA certification. We believe this is now an area where the Healthcare Commission are tightening up on for new laser and IPL clinic registrations.
"In questions of science, the authority of a thousand is not worth the humble reasonings of a single individual." - Galileo Galilei. We agree with Galileo where the "single individual" is an expert, and experienced, certificated Laser Protection Advisor!
Dental Laser Protection Adviser (LPA) Services
Although laser dental treatments were first developed some time ago, it is only recently that these laser treatments have become a more mature and accepted practice, if still not quite commonplace amongst dental surgeons in the UK. There is no exception made for dental surgeons, and they too must register with the Healthcare Commission and have both an LPA and an EMP. In the case of dental treatments, the EMP should be a dental surgeon familiar with and expert in laser dental treatments. By way of comparison, the medical EMP for other medical and cosmetic clinics will normally be a specialist dermatologist for skin treatments.
At Lucid we can provide Certifcated LPA services in support of medical and cosmetic clinics and dental surgeries wanting to offer patients the option of laser or IPL treatments. Having seen the advantages offered by the latest dental lasers we are convinced that this is a big step forward in dentistry and we hope more UK dentists will start to take the plunge and invest in laser devices and training. Modern laser dentistry can be safe and is almost pain-free with much better recovery times for the patient due to the lessened chance of infection and the much reduced trauma to surrounding tissue when compared with traditional scalpel and drill techniques. The prospect of pain-free dentistry is a bonus to everybody, but particularly patients who may have had a bad experience or are unable to have normal pain killing drugs.
As with our other LPA services we can help by doing laser safety risk assessments to develop a range of procedures and local rules in order to gain Healthcare Commission registration for the laser or IPL treatments being offered.
Laser & IPL Clinic Registration Requirements in the UK
It is interesting to note that the rules for different areas of the UK are currently a little different, with a particular difference being that Scotland is currently unregulated. This is a situation that appears unlikely to be seen as acceptable for long as accidents and burns do happen with laser and IPL treatments, and these are far more commonplace when fewer or no formal checks, procedures and medical protocols are in place. Although there is the possibility that treatments in an unregulated environment may be marginally cheaper as the clinic overheads will be a little lower, it is a brave patient who will submit to a treatment with an unregulated clinic, when the consequence of incorrect laser or IPL use could be burning and scarring.
In England all clinics conducting laser and IPL treatments, including dental surgeries, must be registered with the Healthcare Commission (HCC), whereas the equivalent body for Wales is the Care Standards Inspectorate for Wales (CSIW). For England and Wales, any clinics not registered with these bodies and operating laser and IPL treatments for medical or cosmetic purposes on people, are operating illegally.
At Lucid we can provide the expert medical practitioner (EMP) services you require for skin rejuvination, hair removal, tattoo treatment, smart lipo and so on. The EMP is retained by the clinic in a similar way to the LPA. The role of the EMP is to produce and maintain expert medical protocols in support of the treatments being offered. The Healthcare Commission guidance states:
"A written treatment protocol must be produced and signed by an expert medical or dental practitioner. The author of the protocol must produce written evidence acknowledging the use of the protocol and that he/she is available for advice as required."
The expert medical or dental protocol must include:
- pre-treatment tests
- post treatment tests
- recognition of treatment related problems
- procedure if anything goes wrong with treatment
- permitted variation on the machine variables
- procedure in the event of equipment failure
The Healthcare Commission further requires that expert medical practitioners and expert dental practitioners demonstrate and provide evidence that they have received appropriate and relevant training and have experience in this field.
The treatment protocol must be appropriate and reflect the current practice at the clinic/establishment, and must also be dated and signed by the author (EMP).
Personal Views on Laser & IPL Clinic Registration
In our experience the Healthcare Commission are sometimes prepared to turn a blind eye to clinics operating whilst waiting for their registration to come through. This is an unofficial situation that we cannot endorse, but whilst there are clinics operating who have not taken any steps to gain registration for their laser and IPL treatments these will likely bear the brunt of any legal action and enforcement by the appropriate bodies. In contrast, clinics who have applied for registration are clearly more concerned with following appropriate procedures and ensuring the safety and well-being of their clients. Please be aware that this is an individual view based on experience and hearsay, and not an official company view or endorsement of any clinics operating lasers or IPLs for treatment without Healthcare Commission (or the CSIW for Wales) approval.
Outside of the UK the situation in other countries is fragmented in that some have similar schemes of regulation, whilst others are unregulated. In the unregulated countries debates rage over the extent of regulation and qualification required in order to safely operate laser and IPL devices for medical or cosmetic treatments. Some believe that this should be a medical preserve, with only medically qualified staff operating even IPL hair removal devices as these have the potential to burn and scar people if used incorrectly, whilst others argue that schemes such as the regulation levels in England and Wales are too severe. For our part we do not want to see regulation become unnecessarily onerous, but we know from what we have seen that if we went to have any treatments we would ensure we went to a properly regulated clinic - we would rather pay more of our own hard-earned cash than risk suffering painful burns and scarring.
Veterinary Laser Treatments
Laser treatments on animals are now becoming available, and are currently unregulated in the UK. This is an anomaly that exists for a variety of reasons, but vets using laser and IPL treatments should none-the-less be aware that they have a duty of care towards their colleagues, clients and the public. This duty of care under the Health and Safety at Work act, means that they should do risk assessments and ensure suitable procedures are followed and precautions taken whenever they use laser or IPL treatment devices. In order to adequately do this, veterinary surgeons would need to have some Laser Safety or IPL safety training and the veterinary practice might well require an appointed Laser Safety Officer (LSO) with access to the services of a Certificated LPA. To operate a hazardous laser or IPL device without producing appropriate procedures and appointing competent laser safety people could potentially be seen as operating in a negligent manner.
Of course our views in this field may be considered biased, and many surgeons, whether medical, dental or veterinary, consider other things they do to be more hazardous than operating a laser or IPL treatment system. The difference is that most surgeons have had very little to no laser safety training as part of their qualification as a surgeon, and some laser or IPL devices have a long range capability to cause harm, or a cumulative effect where harm is only apparent after a long time period. With these situations it is not always readily apparent who might be at risk.
There are obviously some serious obstacles to imposing a registration process on lasers and IPL treatments in veterinary surgeries, in that the vet might need to take the treatment to the animal, and hence the treatment room could be a barn or stable. This makes it difficult to equip the treatment area with suitable signs and laser safety interlocks, but this makes the issue of appropriate procedure and training all the more important.
Anomalies in Regulation of Laser and IPL Devices
There are clearly a number of anomalies in the UK regulation of laser and IPL devices, for example the following do not require registration:
- cosmetic clinics performing laser and IPL treatments in Scotland
- veterinary use of laser and IPL treatments on animals
- physiotherapists using laser and IPL devices for sports injuries
These are anomalies that may be with us for a little while, but may be addressed by the European Physical Agents (Artificial Optical radiation) Directive that EU countries have until the 27th April 2010 to implement via Regulation. This will effectively define minimum acceptable levels of health and safety provision for any light sources that are man-made, such as lasers, IPLs and bright LEDs. The directive goes beyond risk assessment and control to define health surveillance, suitable instruction and training.
It might be that what is finally decided as being appropriate for some specialist areas will be unique to those areas for whatever reasons, but it will be much harder for anybody to ignore the hazards posed by some of the laser, IPL and possibly LED light sources. We believe it is likely that any court would expect even specialist industries or categories of laser and IPL user to have health and safety procedures, including specialist rules ('local rules' or equivalent) and possibly medical protocols that are as thorough in conception as those required in a cosmetic or medical clinic using lasers and IPL systems. Effectively all laser and IPL system users would be required to show equivalent levels of health and safety provision in their use of such devices regardless of industry sector.
An analogy can be drawn with road safety where all UK motor vehicle drivers are required to have a driving license, insurance, display vehicle excise duty, ensure the vehicle in their use is roadworthy and follow the highway code. There are no exceptions to this rule for talented racing drivers or police officers, on non-emergency journeys. These rules, and possibly also the requirement of 3-year old cars to have an annual Ministry of Transport (MOT) test, are a nuisance and additional expense for some of us, but many of us will also acknowledge that these compulsory requirements have saved lives and injuries. Few would wish to return to a totally unregulated road and motor vehicle system or to allow exemptions from the rules for people with certain qualifications or working in certain industries.
Laser and IPL Treatments
The list of treatments possible with optical radiation produced by lasers or intense pulse light (IPL) sources is increasing steadily. Many such as hair removal / reduction and skin rejuvination are now very popular, whilst neweer trearments like Smart Lipo and cellulite reduction are not so well known but growing in popularity very quickly. Some of the more common treatments, listed by their common names, are:
- hair removal & hair reduction
- skin rejuvenation
- thread vein treatment
- skin re-surfacing
- tattoo removal
- port wine stain treatment
- skin tightening / wrinkle reduction
- acne treatment
- damaged skin - sun damaged or dark spots
- smart lipo - reduction of small fat deposits around areas like the face
- cellulite reduction / body sculpting
- eye treatment - detached retina or cornea resculpting for eyesight correction
- physiotherapy treatments for muscle strains
- tooth whitening
- tooth health assessment
- tooth drilling & filling
- tooth sterilisation
The treatments work extremely well for many people, especially with the latest equipment, and the results are quite obvious with before and after comparisons. The treatments are not normally regarded as being significantly painful, with most patients reporting some quite tolerable feeling sometimes compared to being flicked with a rubber band. Indeed most clinics will negotiate with the patuient to find the level of treatment they can offer in a session that the patient finds comfortable rather than just tollerable. Following the treatment there may be some continued sensation as skin can be a little inflamed for a short time, but this is very dependent on the particular laser or IPL treatment applied.
The range of treatments is large and growing with some less hazardous specialist medical optical diagnostic applications being researched and a promise of sophisticated and low-cost devices in the future. In some cases the optical element of the treatment is combined with other, non-optical, treatments such as localised radio-frequency (RF), but the addition of laser or IPL in a combined treatment can significantly aid the effectiveness and sometimes the safety of such treatments.