CARE QUALITY COMMISSION DEREGULATION

FEBRUARY 2010

April 2010 sees the repeal of the Care Standards Act 2000 and its replacement by The Health and Social Care Act 2008 . The Care Quality Commission (CQC), which took over from the Healthcare Commission (HCC) in April 2009, will continue to regulate the use of Class 3b & Class 4 Lasers and Intense Pulse Light devices used in "surgical" applications (i.e. applications carried out in Hospitals and certain other NHS Establishments) but will no longer regulate these devices used in any "non-surgical" applications (i.e. applications carried out in Beauty Salons, non-NHS Private Clinics and other cosmetic establishment) after October 2010.

What the CQC is saying on its web site is legally correct but easily open to misinterpretation by a provider who will NOT fall under CQC jurisdiction after October 2010. On Page 8 of the downloadable CQC document "A new system of registration - The scope of registration" (click here for a copy) you will find the following under "Other exemptions":

Use of non-surgical lasers and intense pulsed lights (used mainly in beauty salons, dental clinics and some dermatology services). However, services that use surgical lasers and intense pulsed lights (for example, those used in refractive eye surgery) must still register.

Therefore, under the current advice from the CQC, you are NOT a provider who will fall under CQC regulation after October 2010.

However, the Department of Health (which employs the CQC) is continuing its efforts to identify a suitable alternative legislative vehicle (probably the Local Authorities Act) to manage the regulation of the non-surgical use of lasers and IPLs. The Department of Health is also working with The Independent Healthcare Advisory Services (IHAS) and representatives of other specialist groups to agree suitable alternative National Minimum Standards for laser and IPL use in the shorter rather than the longer term.

It is most likely that there will be a transition period during 2010 when new legislation will take over from the Care Standards Act for non-surgical use of lasers and IPLs, and it is anticipated that Service Providers registered with the HCC or CQC will be 'carried over' to the new regulatory system. Also, because of the 8 -18 week timescale that it typically takes to get registered in the first place, there will also obviously have to be a cut off date for new applications that is well before October 2010. This is probably going to be July 1st 2010, but the CQC are still working on the exact details of the deregulation process and are promising to provide much more extensive information in the very near future.

As your Equipment Supplier we must advise you that you are still obliged by statute to remain registered and comply fully until October 2010, and that you will be liable to prosecution if you do not continue to follow the current legislation. Moreover, where insurance cover is contingent upon registration under the current regulations, it is particularly important to continue compliance with these existing regulations. See the recent successful prosecution by CQC of the Skin Health Spa chain of clinics (click_here).

Intense Pulsed Light for Skin Rejunenation

Intense Pulsed Light for Skin Rejuvenation

Telangiectasias, irregular pigmentation, and skin texture improved after treatment with intense pulsed light, but some found it too painful.

Intense pulsed light (IPL) treatments have been shown to improve telangiectasias and hyperpigmentation related to photodamage, but effects on wrinkles and skin texture have not been conclusively demonstrated. In this randomized, controlled, split-face trial from Denmark, 32 patients with relatively symmetrical facial wrinkles, abnormal skin texture, telangiectasias, and irregular pigmentation received three IPL treatments, spaced 1 month apart, to a randomly chosen half of the face. Treatment was delivered with a second-generation IPL device using a wavelength band of 530 to 750 nm and energy fluences of 7.5 to 8.5 J/cm² given in two 2.5-ms pulses, with a 10-ms interpulse delay. The results were assessed by a blinded observer, clinically and in photographs, and by patient self-assessment at 1, 3, 6, and 9 months after treatment.

Telangiectasias were significantly improved on the treated side, at all time points, in 79% to 89% of patients on clinical evaluation and 53% to 71% of patients on photographic evaluation. Irregular hyperpigmentation was significantly improved on the treated side at all time points in 59% to 77% of patients on clinical evaluation and 61% to 86% of patients on photographic evaluation. There was no significant change in overall skin pigmentation at any time point as measured by reflectance spectroscopy. In patient self-assessments, 46% reported moderate or marked improvement in their irregular pigmentation and telangiectasias. On clinical evaluation, skin texture was found to be significantly improved in 82% of patients at 1 month, in 42% of patients at 3 months, and in 56% of patients at 9 months. Significant differences in skin texture were not evident in photographic evaluations, but 58% of patients reported mild-to-moderate improvement in skin texture. No significant improvement in wrinkles was noted. One patient developed an atrophic scar on the treated side. Three patients (9%) dropped out due to the pain of treatment.

Comment: This visible-light IPL strategy is effective for the treatment of telangiectasias, irregular pigmentation, and abnormal skin texture due to photodamage. Effective treatment of wrinkles by IPL might require longer, more deeply penetrating (near-infrared) wavelengths, possibly with the addition of radiofrequency energy. The absence of skin texture improvement in the photographs may be related to the use of a ring flash, which flattens the skin surface into a two-dimensional plane. The lack of active cooling in the studied device may have contributed to the relatively high degree of pain experienced by the patients and, possibly, the one scar that developed. The impermanence of the skin-texture improvement supports the need for maintenance IPL treatments. Enhanced, longer-lasting results might have been obtained had the patients undergone a series of five treatments, as is usual in most clinical practice.

— George J. Hruza, MD

Published in Journal Watch Dermatology September 1, 2006

Citation(s):

Hedelund L et al. Skin rejuvenation using intense pulsed light: A randomized controlled split-face trial with blinded response evaluation. Arch Dermatol 2006 Aug; 142:985-90.

We will provide more information on different approaches to IPL treatments in my daily blog, should you require further assistance please visit us on www.quantavision.co.uk and leave your comments!

Best regards

Ronaldod de Moura ( director )

Quanta Vision Aesthetics

IPL Background

IPL Background
Also called IPL (intense pulsed light), ILS (intense light source), full spectrum, non-coherent, and broadband light. The primary differences between flashlamps and lasers used in hair removal are:

Kind of light
As mentioned earlier, flash lamps do not use one wavelength of light the way a laser does. Flashlamps emit every wavelength of light in the visible spectrum, and a little into the band of infrared radiation (up to about 1200 nm). Practitioners select a cutoff filter to block out lower wavelengths.

Size and shape of the spot (beam) Most flashlamps emit a beam that covers more area than a laser. Most flashlamps also have a rectangular spot, rather than the round type usually standard on lasers.

IPL History
Xenon is commonly used as a light source because of the brilliant, full spectrum illumination it provides when exposed to energy. Like laser, it can be designed to be extremely powerful and has industrial applications like paint stripping. It is also used for items such as the flashes in photographic equipment and in surgical lighting equipment.

The xenon flashlamp, first developed as an energy source for laser beams, was soon being used therapeutically with direct applications of its energy. As with lasers, flash lamps began to be used for medical purposes in the 1960's. The latter half of the 1960's saw published data on treating eye and skin disorders.

Early attempts in the 1970's to use xenon light energy delivered via fiberoptic filament have not been demonstrated to be permanent. Although these devices (see photoepilators) are still in use, they should not be confused with the devices that became available 25 years later.

By the mid-1990's, researchers were exploring the use of flashlamps for treating vascular lesions. In the year the first flashlamp was cleared by FDA for use in treating vascular lesions,one study noted hair loss as a side effect of treatment. Other papers indicated promising results for some in the treatment of leg veins, prompting one manufacturer to apply for and receive FDA clearance for hair removal in 1997. In 2000, FDA began allowing some brands to claim permanent hair reduction in most skin types.The darkest skin type was not included.

IPL Clinical data
There is limited clinical data and even less with long-term follow-up for flashlamps. Arguably the best overview is Tse. Several brief discussions suggest usefulness without detailing clinical data.

The pilot study observed 60% reduction at 3 months and 75% at 12 months. Another study observed 80% reduction at 8 months. One study with no follow-up observed 77% reduction immediately after a 6th treatment.

Two articles reporting on overlapping patient groups reported 54% to 64% reduction at 6 months. A later study by the same authors observed 76% reduction immediately after a 4th treatment. The study observed 41% of subjects had an average 83% reduction at 12 months or more.

One clinical report found “satisfactory” results at 6 months in 2 transsexuals who received 13 and 41 treatments, respectively. Another clinical report observed one patient had successful removal of transplanted scalp hair grafts with 1.5 year follow-up.

One study had findings which aligned more closely with other reported light-based results, observing an average 33% reduction at 6 months after 2 treatments.

Laser and flashlamp promoters sometimes suggest the devices are very different in terms of effectiveness or side effects, but this is not based on published comparative data.