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Medical Laser and Laser Clinic Regulation in the UK
See also:
Laser Protection Adviser
Laser Protection Adviser for Laser Clinics
Laser Safety for Laser Clinics
Registration with the Healthcare Commission
Under current legislation - the Care Standards Act 2000 - all premises operating a Class 3b or Class 4 Laser or an Intense Pulse Light (IPL) source for the purposes of treating humans must register with the Healthcare Commission (www.healthcarecommission.org.uk). This includes all hospitals, dental surgeries, cosmetic clinics, health centres etc. There are some exceptions, particularly where a Class 3b laser is operated by a Health Care Professional, but the regulations must be studied in some detail to claim such exemption, and in any case where Class 4 lasers are used registration is always required.
Requirement for a Laser Protection Advisor
The National Minimum Standards and Regulations for Independent Health Care 2002 define both Core Standards (Standards C1 to C32), which apply to all independent health care facilities, and specific standards for Lasers and IPLs (Standards P1 to P3). The latter standards will require the owners of those premises seeking registration, to use a laser or an IPL, to appoint a Laser Protection Adviser (LPA) for the oversight of the installation and ensure that Local Rules are drawn up to guide all users in the safe operation of the equipment. Good practice as promulgated by the MDA publication "Guidance on the Safe Use of Lasers in Medical and Dental Practice" requires the appointment of a Laser Protection Supervisor (LPS). This individual is in day to day charge of the equipment and acts as the link between the users and the LPA.
Local Rules for use of the Laser
The Local Rules must define, at a minimum,
- The possible hazards from the equipment
- How these are controlled, including the specification for Personal Protective Equipment (PPE)
- Where the Laser or IPL can be used. The Laser Controlled Area.
- The personnel allowed to use the equipment.
- Action to be taken in the event of an accident or incident.
Other Requirements for Medical and Cosmetic Lasers etc.
In addition to these rules the operators will have to have in place
- Patients' Guide informing patients of the treatment benefits and risks. (C1)
- Statement of Treatment Policy (C2 to C7)
- Management and Personnel (C8 to C13)
- A Complaints procedure (C14 to C16)
- Premises, facilities and equipment management (C17 to C19)
- Risk Management Procedures (C20 to C28)
- Research Strategy (C32)
The Healthcare Commission will carry out annual inspections and the results are published on the Healthcare Commission website.
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