UK Regulations regarding Laser Use
Laser use in general dental practice has grown considerably over the past 30 plus years, both in numbers of machines and the scope of usage. In many instances, the employment of laser photonic energy is in the form of low power delivery, to aid alignment and scanning when using adjunctive dental equipment.
To help to understand those instances where a given laser may pose a risk to operator or patient, reference to an accepted classification defines those lasers that demand associated risk assessment and precautions during use. In general, those lasers that emit photonic energy above a threshold value – classified as IIIB and IV, carry implicit registration and regulation. Certainly, all lasers that are capable of direct target (oral and perioral) tissue manipulation fall within these two classes.
CQC Registration
There are several statutory Acts of Parliament that, although not directly addressing the use of Class IIIB and IV lasers in dentistry, nonetheless amount to a demand on the clinician and/or Practice owner to register such use.
Although a significant source of statutory requirement is the Control of Artificial Optical Radiation at Work Regulations (2010), in each of the four nations of the UK there is an over-riding requirement to register laser use. All dental practices in the UK must register with the Care Quality Commission (CQC), having responsibility for a given devolved nation of the UK:
- The CQC regulates all health and social care services in England. CQC regulate against the Health and Social Care Act (2008), Regulated Activities Regulations (2010), and the CQC (Registration) Regulations (2009).
- The Health and Social Care Act 2008. CQC (2010) / HSCA (Regulated Activities) Regulations 2014, are subordinated in Scotland, Wales and Northern Ireland.
- Scotland, as Healthcare Improvement Scotland (2016)
- Wales as Independent Health Care Services (2011).
- Northern Ireland: an establishment that uses lasers or intense pulsed light treatment, you must be registered with the Health and Social Care Regulation and Quality Improvement Authority (RQIA).
The CQC will draw upon the safety advice and guidelines from the MHRA publication “Lasers, Intense Light Sources and LEDs in medical, surgical, dental and aesthetic practices”. This covers manufacturing requirements, PPE (personal protective equipment), laser safety training, and the need for safety advice from a certificated laser protection advisers.
Laser Protection Adviser & Laser Safety Supervisor (Officer)
The CQC website (www.cqc.org.uk/guidance-providers/dentists/dental-mythbuster-26-safe-use-lasers) provides overall guidance on Class IIIB and IV laser registration and regulation. Central to such compliance is the appointment of a Laser Protection Advisor (LPA), to provide assessment and advice on all aspects of hazard, risk and safety in the clinical use of these classes of lasers. Subordinate to the central role of the LPA, the Laser Protection Supervisor (also referred to as Laser Safety Officer, is a suitably-trained and appointed member of the clinical staff with authority to oversee laser use on the daily and by-treatment basis of a dental practice.
Examples of some of the CQC requirements of Class IIIB and IV laser users:
- Submission of an updated (modified) Statement of Purpose to the CQC, to identify the use of a laser.
- Appoint a certificated LPA to provide an audit of premises, equipment and services relating to the safe use of lasers in a clinical setting.
- A Risk Assessment provided by an LPA on the laser treatment room (otherwise known as the laser treatment controlled area), relative to the laser(s) being used.
- Appropriate warning signs.
- Risk assessment relating to laser-assisted treatments being provided.
- Laser-assisted treatment protocols relating to the clinician’s scope of practice
- Local Rules as may apply to the use of Class IIIB and IV lasers, written by an LPA
- A log of each time the laser is used
- A person on-site in charge of laser safety on a day to day basis (known as a Laser Protection Supervisor or Laser Safety Officer).
DeLTA Laser Safety Support
All dental practices registered with the CQC in the UK that use Class IIIB and IV lasers are required to employ the services of a LPA and to receive a detailed report as to compliance with safety regulations.
DeLTA has developed a comprehensive range of support measures to meet the requirements of the MHRA guidelines and provide evidence to show compliance with (essentially) Regulations #11, #12, #15, #16 of the Health and Social Care Act.
DeLTA is proud to be a unique resource in relation to these requirements, through the following:
- On-line laser safety course – through four years of availability, it has provided a platform for dental staff in addressing laser safety standards consistent with current regulations.
- A modular course delivery that recognises competency but also quantitative accreditation through a MCQ examination.
- Core of knowledge in the use of lasers in dentistry.
- Full LPA support services package.
- Templates to cover risk assessments, treatment protocols and modified Statement of Purpose.
- Local Rules template.
- On-going LPA support, including yearly updates on Practice compliance
Steven Parker is now registered as a certificated Laser Protection Adviser, as a member of the Association of Laser Safety Professionals (registration no. 0112024):
For more information, please contact Steven directly at thewholetooth@mail.com, with reference “DeLTA LPA Services”.