UKITL © All Rights Reserved.
UK Regulatory Changes
England's new Health Care Act applicable from October 2010 has resulted in a change to the regulation of Class 3B lasers and Class 4 lasers (such as hair and tattoo removal equipment). We hope the following will offer a useful summary of the current position for those practising in England.
Care Quality Commission
Up until October last year the CQC directly regulated the
use of all these lasers with the exception of 3B lasers which were exempted from
registration where used by specified healthcare professionals (members of GMC or
HPC) or where the user is working under supervision of such professionals. Any 3B
users outside this definition were required to register their premises with the CQC
with the associated compliance and registration costs.
This has now changed as the new Act redefines the scope of CQC regulation to focus more closely on the provision of health and social care with most equipment being incidental. The CQC now only directly regulates core medical professionals such as doctors and nurses in Primary Care, and use of 3B lasers only falls within this scope where it is used for the treatment of "disease, disorder and injury". See the CQC website for the precise list of included professions and applications.
Other users including other HPC-regulated healthcare professionals, acupuncturists, general therapists and those using cosmetic lasers are not included in the CQC scope unless they are working under the direct supervision of a CQC-regulated individual.
A guidance document is being prepared by the CQC on what it will require of the laser
users included within its scope. It is hoped from discussions Omega has had to date
that there will not be an additional fee or costly set of requirements imposed for
the 3B laser users over and above their registration and compliance with Health and
Safety standards which must be clearly maintained and documented as always.
Local Authorities
With so many higher powered laser users dropping out of CQC regulation and with the
only other regulation being the policing of Health and Safety compliance and premises
Licensing by Local Authorities, there was some concern in the industry that the use
of particularly the cosmetic Class 4 lasers might be under-regulated and potentially
hazardous or overly regulated and constrained. A working group originally chaired
by the IHAS and including representatives from the laser protection community, user
groups, government departments and latterly local authorities was set-up to address
this.
A standards document was prepared by this group for the Local Authorities as
guidance on appropriate licence conditions for premises with lasers in use. The
advisory group has explicitly exempted HPC-regulated Class 3B laser users from these standards
because they are deemed not necessary for these users. Under these recommendations
other therapists (including Acupuncturists) would however, be subject to the conditions.
Whether the councils take up the recommendations of the advisory body is up to each individual LA, but many are seeking a consensus and a group of London boroughs has initiated a pilot, trialling the recommended standards on a voluntary basis to help identify any problems or gaps. It should be noted that in the normal course of events both Health and Safety requirements and Licence conditions (where they exist) are mandatory, not voluntary.
Certainly it is generally agreed that disproportionate regulation for 3B lasers designed to address much more potentially hazardous equipment is inappropriate. It might also be noted that LAs can choose to widen the range of 3B laser users to be exempted or conversely to reject the expert advice altogether if they so wish.
The good news is that in general the various authorities do now seem open to representation on behalf of 3B laser users and appear keen to get proportionate workable regulation in place.
As things develop, we will keep you in touch.
This information was kindly provided to UKITL by Omega Lasers