IPL Laser Legislation And Equipment

The aim of this assignment is to review the current legislation applicable to clinics and management of laser/ IPL (intense pulse light) practise within the UK and to review and evaluate a range of equipment and products for hair removal and remedial skin therapy treatments. Over the years areas have changed within the laser industry, such as, machines, treatments and legislations, and this will be discussed throughout this assignment. Over time plenty of research has been conducted resulting in more background knowledge, new research, new treatments and new machines that are able to treat a wide variety of different conditions from, hair removal to skin rejuvenation.

Methodology

This section provides a general idea of the methodological approaches taken during this assignment. The main sources of research carried out were collected from secondary sources via journals, websites, articles and books. Moreover, research strategies used were grounded theory and looking at how the research and theories developed as the data was collected.

Data was also collected by the use of emailing different companies to find out more about the subject matter. Emails were sent to the Care Quality Commission, Legislation Government, Lynton Lasers and Cynosure UK Ltd, only a few companies replied; however the information they sent was very useful.

Over time, plenty of journals and books have been published that incorporate lasers and IPL’s, for example, the Journal of Cosmetic and Laser Therapy, by Amin, S and Goldberg, D.

As already mentioned the internet will be another main source of research, and so will Beauty magazines and journals, such as The Guild. There is a great deal of information surrounding laser and IPL treatments via these sources. The information was collected to find out more about the topic of lasers and to help complete the assignment.

Task 1

Care Quality Commission

The Care Quality Commission (CQC) is the independent regulator of all health and adult social care in England. They ensure that all standards are met by visiting the clinics regularly and holding interviews with the operators, they will only take action if they believe it is unsafe and people’s rights are at risk. Clinics offering laser (type 3B and 4), IPL and tattoo removal treatments must be registered with the CQC.

The CQC was formerly known as the National Care Standards Commission (NCSC), who were recognised by the government to maintain standards, excellence and consistency of services in healthcare and social care throughout the UK. They had the power to decline or withdraw a clinics registration or to prosecute anyone breaking regulations.

The NCSC were established under the Care Standards Act 2000 (CSA) who made it illegal to use IPL/ laser systems without previous registration with the CQC. Failure to register was considered a breach of section 11 of the CSA 2000. In November 2009, CQC were successful in five separate cases against a company who were fined a total of £13,000 for using lasers illegally. (Care Quality Commission, Nd)

However, since the 1st October 2010, clinics registered under the CSA 2000 that offer laser and IPL treatments were no longer required to register under the Health and Social Care Act 2008; therefore they were no longer needed to be regulated by the CQC.

One of the main concerns that arises from this change is clinics may introduce laser and IPL treatments without training, qualifications or experience. Therefore, anyone offering treatments will be putting their clients and themselves at risk. Also, due to this change clinics may be able to purchase cheaper machines from Chinese manufacturers which are unsafe, dangerous and do not comply with safety standards.

Nevertheless, many local authorities supported by the Laser Protection Advisors (LPA) and Expert Medical Practitioners (EMP) can issue special treatment licenses. This covers laser practitioners and helps to maintain high standards of safety and quality. The EMP is above all responsible for producing suitable medical procedures for laser and IPL treatments.

Key Policies

When carrying out laser and IPL treatments there are many key policies that should be in place to ensure the treatment is performed to a safe, high standard, such as, risk assessments, staff training, record cards, clinical controls, client protocols and complain and feedback procedures.

Risk Assessment of the Laser Controlled Area Risk assessments are a legal requirement and should without exception be carried out when using type 3b and 4 lasers. ‘The employer should undertake a suitable and sufficient risk assessment in order to comply with regulation 3 of the Management of Health and Safety at Work Regulations 1999.’ (King, M. 2008, p18)

A risk assessment is an examination of what accidents could occur during a treatment, it weighs up whether enough precaution has been taken to prevent it from happening. A risk assessment should identify the hazards, consider who could be harmed and how, evaluate the risks and decide on precautions. The findings should be recorded, implemented and reviewed regularly.

Staff Training Anyone carrying out laser or IPL treatments should undergo training to ensure the treatment is performed correctly and to a safe, high standard, ensuring effective results. It also allows the practitioner to gain further knowledge on the subject and to understand the hazards from device malfunction and the safety management, including local rules, legislations and controlled areas. All staff should regularly update their training and only use the equipment for which they have been trained. As long as the correct training is undergone then no further qualifications are essential, as Ellipse IPL training centre states ‘Anyone can qualify to operate the UK’s leading IPL System’. (Ellipse, 2011)

Record Cards It is vital to fill out and keep a record for every time IPL is carried out on a client; this makes it easier and quicker to access their data, such as, the date, shots used, fluence, pulse delay and initial reaction. It can also be used as a backup in case a client has a reaction and wants to take legal action. All records should be kept on file in case any inspection is carried out within the future.

Clinical Controls

When using laser and IPL machines, there are different clinical controls, for example, engineering controls, personal control measures and administrative controls. Firstly, engineering control measures should be carried out. Located on the machine is a red button and a lock and key, this enables the practitioner to turn the machine on or off. Before treating a client the machine should run through a set of questions to make certain it is safe to proceed, for example, the machine may double check everyone in the room is wearing the correct eyewear. Furthermore, before the treatment begins, the practitioner enters the client’s skin type, hair colour and fluence level, this ensures that the treatment is safe and is set at the right level for that particular client.

Secondly, personal control measures should be carried out, such as, wearing the correct eyewear, no jewellery worn by either the client or practitioner, skin cooling is carried out before, throughout and after the treatment, sun protection or aftercare lotion is applied after the treatment and the door to the treatment room is locked and warning signs are placed on all entryways to notify people not to enter.

Finally, administrative controls should be in place, such as, education of staff, program monitoring, standard operating procedures, documentation of training, documentation of services, annual laser/ IPL safety audits conducted and establishment of credentialing standard.

Client Protocols It is essential when carrying out laser and IPL treatments that a code of correct conduct is followed for each client. All clients receiving treatments should undergo a patch test and a consultation to ensure the treatment is safe to proceed. The consultation should be completed every time the client returns in case any information has changed. During the treatments clients should be given protective equipment to wear, such as, goggles and the correct products should be used, like ice packs and cooling gel. After the treatment the correct aftercare product must be applied and aftercare advice should be given.

The correct gap should be left between each treatment. The length of the gap depends on what treatment the client has received, for example, usually with hair removal a four week gap is advised. Having a treatment gap during hair removal allows some of the hair to re-grow and hairs that were resting during the previous treatment to grow.

Client Complaints and Feedback Systems If the correct training has been completed and the treatments are to a safe, high standard, then complaints should be minimal; however, this is not always the case. If a client does complain, listen sympathetically, record the details, offer rectification and have an appropriate follow up or action plan.

Feedback systems such as comment cards or before and after photos are good ways to find out how effective the treatments were. Feedback is always good whether it is positive or negative as it can be used to improve matters if negative or if positive it will give the practitioner a good reputation.

Task 2 Part A

Classifications of Lasers

There are different classifications of lasers which are based on output power and wavelengths. Lasers are categorised according to the more harm they can cause, the higher the number, the greater the harm. The current classes are 1, 1M, 2, 2M, 3R, 3B and 4. Laser and IPL machines are classified as class 3B and 4, which are safe to use on the skin but can damage the eyes if protection was not used.

Research was carried out on the following laser machines, ND: YAG, Ruby, Pulsed Dye, Alexandrite and also IPL systems. These machines were reviewed to observe what they treat, advantages and disadvantages, features, skin types the laser can be used on and its specifications. As well as this research, clinical trials were also studied to evaluate the effectiveness of different laser systems (refer to appendix 1).

Nd: YAG Laser (Neodymium: Yttrium-Aluminum-Garnet)

Some of the popular Nd: YAG laser devices in the market are as follows. CoolGlide, Athos, Medlite IV, Varia, Lyra, and Image.

What it treats

Advantages

Disadvantages/ side effects

Features

skin types

Specifications

Hair removal

Tattoo removal

ND: YAG shows a significant delay before hair grows again in the treated areas

One study found 15 clients had 59% reduction at 3 months (E Medicine, 2011)

Large areas of the skin can be treated quickly and efficiently

This laser is effective on all tattoos of all colours but most effective on black, red and orange

Fast repetition rates allow large areas of the body to be treated quickly

There may be risk of  burns, scars, redness, skin discoloration and swelling

This laser has not been proven to be effective in achieving long-term results

If the carbon used is exploded it could produce a tattoo-like mark on the skin

This laser has the capability of delivering two different wave lengths of light. One is an invisible infrared light used for deeper penetration. The other wavelength, which is a green light, is used for treating hair follicles closer to the surface.

Nd Yag Laser can be used on skin types 1-6 but is known to be more effective on darker or tanned skin.

This laser is not as effective on white/ light or fine hair.

Wavelength: 1064 nm

Repetition rate: Up to 10 Hz

Pulse width: 10-50 ms

Spot size: 3-5 mm

Fluence: 20-100Ruby Laser

What it treats

Advantages

Disadvantages/ side effects

Features

skin types

Specifications

Hair removal

Tattoo removal

Long term hair removal can be achieved and it is moderately pain-free when compared to other lasers

If hair grows back, it tends to be sparser and finer

Outstanding results are observed, especially with black and dark blue tattoos

A large short-term study observed two-thirds of clients had over 50% reduction at 3 months (Hair Facts, 2011)

Penetration is not as deep, as the laser looses up to 50% of energy when it penetrates through the first 1mm of skin (Goldberg, D. 2008)

The laser has a slow repetition rate which could increase the treatment time

There is risk of edema, scaring, hypo-pigmentation, hyper-pigmentation, erythema and blistering

This is the oldest type of laser used for hair removal purposes. The melanin inside the hair shafts are targeted by the red coloured laser, it also targets nearby hair follicles.

This laser is suitable for skin types 1 and 2. It is ideal for people with fair skin and dark hairs.

Ruby laser cannot be used on tanned or dark skin and on white or light hair

Wavelength: 694 nm

Repetition rate: 0.5 – 1.2 Hz

Spot size: 3-10 mm

Pulse width: 0.85-3 ms

Fluence: 5-40

Pulsed dye

What it treats

Advantages

Disadvantages/ side effects

Features

skin types

Various vascular lesions

Port wine stains

Haemangioma

Rosacea

Spider naevus

Warts

Acne and acne scaring

The procedure is non-invasive and quick, it usually requires 10 minutes per session

In a study conducted in the United Kingdom, of 41 patients with acne who received the treatment, 53 percent noticed a decrease in overall lesions (E How, 2011)

May produce redness which could last three to four months

There is a small risk of lightening or darkening of the skin. This is rare but more likely to happen if the skin is dark or tanned

Sometimes a scab may form on the treated area

The pulsed dye laser carry’s a wavelength and duration that has been optimised for the treatment of vascular lesions. This laser can be used as an alternative to carbon dioxide lasers or surgical removal procedures.

Studies have shown the success rate with Pulsed-Dye laser can be up to 93%. (Advanced Foot and Ankles Centre, 2009)

Should not be used on skin type 6, or patients with a suntan. Can be used on skin types 1-5, but caution should be took when using on skin type 5.

IPL Systems

The popular IPL laser devices in the market are as follows, Aculight, Epilight, PhotoDerm, Quantum and Vasculight

What it treats

Advantages

Disadvantages/ side effects

Features

skin types

Specifications

Hair removal

Skin rejuvenation

Thread vein removal

Acne

Vascular and pigmented lesions

Sun damage and uneven skin colouring

When using IPL, the surrounding skin does not have the potential to get as injured compared to laser

This system is fast and can cover large areas of skin and pigmentation changes have less chance of occurring

IPL has proven to be a very effective long-term hair removal technique. Statistics show that 60-95% of targeted hair is permanently gone after the recommended course of treatments (Harley Medical, 2008)

May not be effective on red, blonde and white hair

The IPL system cannot be used on sun exposed/ tanned skin

IPL is not effective on all hair and skin types; therefore it is not as adaptable as the ND: Yag Lasers

IPL therapy works by focusing a high frequency beam of light directly onto the hair shaft. The light reduces the moisture levels in the hair follicle, causing it to burn and die.

IPL can also be customised based on hair colour, skin type, and hair depth.

IPL can work on skin types 1-5 but is recommended not to be used on skin type 6.

IPL produces better results in persons with light skin colour with darker hair.

Most IPLs use many different wavelengths of approximately 550-1100nm and produce a white light.

Alexandrite Laser

What it treats

Advantages

Disadvantages/ side effects

Features

skin types

Specifications

Hair removal

Tattoo removal

Removal of visible leg veins

This laser has a very good skin penetration rate and is more effective on finer, thinner hairs

It is good for treating larger body areas, an entire back can be treated in less than thirty minutes. (Alexandrite, Nd)

Tattoos are lightened or removed with this laser, particularly green and black inks

Up to 50% of patients experience textural changes in their skin (Skincare Guide, 2010)

This laser may cause pigment changes, either darkening or lightening of the skin

Hair removal is short term and usually more painful (refer to appendix 1)

Occurrence of side effects on dark coloured clients is 2% (El-Rouby Clinic, Nd)

The alexandrite is the fastest most widely used laser for hair removal.

The hair follicles are disabled in the active growth phase due to a build-up of heat. This makes it possible to achieve effective hair removal.

This laser is suitable for light skin tones only. It is ideal for those with skin type 1.

Wavelength: 755

Pulse width: 2-20

Fluence: 10-40

Spot size: 5-10

Repetition rate: 1-5Task 2 Part B

During the last few years Laser and IPL have increasingly become more popular due to the fact more research has been conducted. One of the leading laser hair removal clinics in the UK known as the Harley Medical Group has carried out over 250,000 treatments to date. (Harley Medical 2008)

Since those original systems used a few years ago there have been many advances in the laser industry, resulting in new laser treatments. As there are numerous IPL/ laser machines available, it is important when purchasing one that all factors are taken into account to ensure the right machine is chosen the first time. If the wrong machine was chosen, it could potentially cause unsuccessful treatments with ineffective results, regular adverse reactions, a high number of refunds, complaints and a negative word of mouth.

Lynton, a laser manufacturer investigated the possible dangers faced by those practitioners considering purchasing a laser or IPL machine that are readily available from Chinese manufacturers. These Chinese machines do not provide the power which they say they do and they are also made from poor materials which lead to problems such as, contaminated water and rusty metal work. These machines do not comply with safety standards and it became clear that anybody who invested in such a piece of equipment would be putting themselves and others at risk. (Lynton lasers, 2010)

Cost of the Machine

Firstly, one of the main factors to take into account is cost of the machine, especially considering the current financial climate. There is a wide price range when it comes to laser and IPL machines, more often than not the machines with higher fluences; wavelengths and pulse durations are more expensive. Machines can start from £15,000 and reach £50,000 plus. As most machines are expensive companies like Lynton rent or lease their machines, which may be more cost effective.

Some machines will offer more than others so it is important research is carried out to ensure the clinic is getting the most for their money. Several companies supplying IPL/ laser machines also help implement the treatment by offering, training, marketing expertise, treatment advice, posters/ leaflets and maintenance service. One IPL company called Ellipse provides one year free training, CQC guidance, marketing support, sales master classes, two year warranty with extended warranty available and in house finance support, where as the company cynosure does not include any extra support.

According to Steven Mulholland, ‘the faster the system (hertz and spot size dependent), the more effectively you can compete, and the more affordable your product will be for your client. The ability to offer laser hair removal quickly and affordably for large zones (backs and legs) has been a tremendous advance.’ (Goldberg, D. 2008, p201)

Specifications of the Machine

There are different specifications to look at when purchasing machines such as, fluence, pulse duration and wavelengths. The higher the fluence the more depth penetration will occur. Goldberg, D. (2008, p137) discussed ‘higher fluences have shown to be more effective at achieving permanent hair reduction.’

Furthermore, the longer the pulse duration is the more heat is accumulated in hair follicles with large diameters containing a great deal of melanin. An IPL machine can emit a range of wavelengths from 400nm to 1200nm, the wavelength will determine the skin penetration; ‘it follows the more wavelengths produced the more treatments can be offered.’ (Magic Skin, Nd)

Some IPL machines have built in generated scanners, which help detect any areas that the therapist may have missed during the treatment; this allows the treatment to be more accurate. Other machines contain integrated cooling system and have the ability to cool the skin and reduce reactions such as redness and burns.

(Magic Skin, Nd)

This photo shows the effects of different temperatures, it is clear there is not much reaction on the ‘control’ photo due to the integrated cooling system.

A number of machines can treat more than one condition, for example, Artisan by Palomar treats wrinkles, stretch marks, scar removal, skin rejuvenation and resurfacing, where as the machine Cynergy by Cynosure only treats vascular conditions like, pigmented lesions. The more the machine treats, the wider variety of treatments the clinic can offer, however these machines tend to be more expensive.

Laser and IPL Companies

It is an advantage if the IPL Company is situated in the UK; as it makes it easier if a problem occurs. It is important that the chosen company is well known, recognised and will still be doing business in year’s to come. Purchasing from a reputable provider is the safest and most cost effective way, providers like Lynton offer the machine, training, servicing and support to ensure help and advice is at hand when necessary. The company should provide quality service in the field and offer warrantees, guarantees and insurance (parts and/or labour), it is important that when a machine is purchased these are put into place in case the machine is faulty.

Some well known IPL company’s have won awards, for instance; Lynton in 2008 received the Aesthetic Medicine’s inaugural equipment Brand of the Year award. Lynton have also been awarded Investors in People and Quality Management which ensures they look after their staff offering the best service and product knowledge.

Before purchasing a machine it is best to check it has been tested and approved for safety and performance by accredited, independent testing facilities, such as, the European Union Medical Devices Directive (EU), as well as the FDA (Food and Drug Administration)

Portable Machines

Most machines are quite heavy so make certain it is easily moveable and portable. If the machine is portable it can treat more customers in different locations, this could increase the market and therefore the revenue. However, if the machine was smaller, the treatment would take longer and depending on the machine it may slow down in longer treatments. Laser and IPL machines vary in size, so when purchasing make certain there is enough space for the machine to fit.

Clinical Trials

Many clinical trials have been conducted to examine the safety, effectiveness and quality of laser and IPL machines. These clinical trials show which machine produces the best results, in how long and on what type of clients (refer to appendix 1).

Conclusion

In conclusion, after all the research that has been conducted through out this assignment it shows there are many different laser and IPL machines that are able to treat a wide variety of conditions and skin types. However, before purchasing a machine it is clear that research must be carried out as there are a lot of different aspects that need to be considered to ensure the right machine is purchased for the clinic. After researching the different areas when acquiring a laser or IPL machine, it is understandable why it is best to buy from a reputable clinic in the UK even if the machine is more expensive, it is better off in the long run.

Due to the legislation change in October 2010, clinics offering laser or IPL treatments no longer need to be registered with the Care Quality Commission. This could cause problems as clinics may introduce Laser and IPL treatments without training, qualifications or experience, which if these treatments were carried out, it would be putting the clients and the practitioners at risk. However, to ensure the clinic is meeting high standards of safety and quality they can be issued special treatment licenses by the local authorities, this gives the clinic a good reputation and allows clients to make certain that where they are having their laser or IPL treatments is safe.

References

Advanced Foot & Ankle Centre (2009) Pulsed Dye Laser Therapy [on-line] Available at: www.advancedfootankleswfl.com, date accessed: 17th December 2010

Alexandrite (Nd) The Alexandrite Laser [on-line] Available at: www.alexandrite.net, date accessed: 17th December 2010

Amin, S and Goldberg, D. (2006) Journal of Cosmetic and Laser Therapy. Taylor & Francis. USA

Care Quality Commissions (Nd) CQC Prosecutes Owner of Beautician Chain [on-line] Available at: www.cqc.org.uk, date accessed: 16th December 2010

Dr. Mohamed, A. (Nd) El-Rouby Clinic [on-line] Available at: www.elroubyegypt.com, date accessed: 17th December 2010

E Medicine (2011) Laser Hair Removal [on-line] Available at: http://emedicine.medscape.com, date accessed: 17th December 2010

E How (2011) Pulsed Dye Laser Therapy for Acne [on-line] Available at: www.ehow.com, date accessed: 4th January 2011

Ellipse (2011) Ellipse IPL Training Centre [on-line] Available at: http://trainingcentre.ellipseipl.co.uk, date accessed: 7th January 2011

Goldberg, D. (2008) Laser Hair Removal. United Kingdom: Martin Dunitz London

Hair Facts (2011) Ruby Laser Medical Data [on-line] Available at: www.hairfacts.com, date accessed: 20th December 2010

King, M. (2008) Safeguarding Public Health: Guidance on the safe use of

Lasers, intense light source systems and LEDs in medical, surgical, dental and aesthetic Practices. London: Medicines and Healthcare products Regulatory Agency

Lynton Lasers (2010) Cheap Laser Imports [on-line] Available at: www.lynton.co.uk, date accessed: 29th December 2010

Magic Skin (Nd) Critical Factors in Choosing an IPL System [on-line] Available at: www.magicskin.com, date accessed: 15th December 2010

Skin care (2010) Skin Care Guide [on-line] Available at: www.skincareguide.com, date accessed: 17th December 2010

The Harley Medical Group (2008) Laser Hair Removal [on-line] Available at: www.harleymedical.co.uk, date accessed: 17th December 2010