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Laser and IPL Physics and Safety ‘Core of Knowledge’ – Relevant legislation and safety standards UK & N.I (Unit 4)

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Student Resource

Course Workbook 4

Relevant legislation and safety standards(United Kingdom & Northern Ireland)

Author:Dr Godfrey Town Ph.D.

Co-Author:Patti Owens RN, BSN, MHA, CMLSO, CNOR



Dear Colleague,

Lasers and Intense Pulsed Light (IPL) Physics and Safety ‘Core of Knowledge’ – Unit 4:Relevant legislation and safety standards

The course is intended for aestheticians, beauty therapists, nurses, nurse practitioners,doctors, dentists and other personnel intending to use powerful lasers and IPL systems toperform energy-based treatments in cosmetic skin therapy. It is also suitable for healthcareprofessionals wishing to understand the safety controls and compliance necessary for theuse of these devices for the treatment of disease, disorder or injury in all specialitiesincluding OBGYN, ENT, orthopaedics, dental, etc.

This learning programme provides you with the necessary basic knowledge about light-based therapy and shares with you over 20 years of experience in light-based technologysafety and skin therapy science. It will help you to offer “best practice” to your patients orclients and extend your ability to use light-based technology more effectively.

Upon completion, you will receive a professional Certificate of Achievement under theauthority of Dr Godfrey Town an RPA 2000 certified Laser Protection Adviser (Certificate No:L00159 dated 1st May 2018) that you can provide to your employer, insurer, CQC or localauthority responsible for regulating / licensing users of lasers and IPL devices confirming thatyou have successfully completed a recognised Laser and IPL Physics and Safety “Core ofKnowledge” course.

In addition, the course is worth 30 CPD learning credits (which is equivalent to a notional 30hours of learning) accredited by The CPD Accreditation Group and is approved by the BritishMedical Laser Association in the United Kingdom, The Royal Australasian College of GeneralPractitioners and Radiation Health, Queensland, Australia.

I hope that you will enjoy the course,

Dr Godfrey Town PhDInternational Course Director

Patti Owens RN, BSN, MHA, CMLSO, CNORCo-Author



TABLE OF CONTENTS

ABOUT THE AUTHORS................................................................................................................................... 5

INTRODUCTION................................................................................................................................................ 7

COURSE OVERVIEW ................................................................................................................................................................7LASER & IPL SAFETY TRAINING ..........................................................................................................................................7BENEFITS ACHIEVEMENTS & FEEDBACK ...........................................................................................................................7TRAINING FACULTY................................................................................................................................................................8DISCLAIMER.............................................................................................................................................................................8COURSE OBJECTIVES: ..................................................................................................................................... 9

RELEVANT NATIONAL LASER & IPL SAFETY LEGISLATION............................................................10

UK REGIONAL GOVERNANCE IN INDEPENDENT HEALTHCARE .........................................................................10ENGLAND: CARE QUALITY COMMISSION (CQC)............................................................................................................ 10Independent cosmetic clinics using laser/IPL ........................................................................................................... 11Adverse incident reporting............................................................................................................................................. 12HEALTH IMPROVEMENT SCOTLAND (HIS)..................................................................................................................... 12HEALTH INSPECTORATE WALES (HIW)......................................................................................................................... 13Standard 7, Regulation 15 & 45-1: Treatment protocol....................................................................................... 14Standard 16, Regulation 15, 23 and Schedule 3: Procedures for the use of devices ................................... 14Standard 16, Regulation 15, 23, 45-(2): Treatment register............................................................................... 14Regulation 45-2 and Schedule 3 Part 11 3.A: Register of servicing .................................................................. 14Regulation 45-3 User training....................................................................................................................................... 14Adverse incident reporting to HIW .............................................................................................................................. 14REGULATION AND QUALITY IMPROVEMENT NORTHERN IRELAND N.I. (RQIA) ..................................................... 1548.2 Register of authorised users ................................................................................................................................ 1648.3 Treatment protocol................................................................................................................................................. 1648.4 / 48.14-48.21 Procedures for the use of devices (“Local Rules”) ............................................................. 1648.6 Certificated Laser Protection Adviser................................................................................................................ 1648.7 Person with overall on-site responsibility........................................................................................................ 1648.9 / 48.10 Records of the use of the equipment (‘Treatment Register’) ..................................................... 1648.11 Risk Assessments................................................................................................................................................... 1748.12 User training........................................................................................................................................................... 1748.13 Update training ..................................................................................................................................................... 17Adverse incident reporting to RQIA and HSENI ....................................................................................................... 17WHAT IS REGULATED IN THE USE OF LASERS AND INTENSE LIGHT SOURCES?.......................................................... 18UK LEGISLATION ................................................................................................................................................................. 19Health & Safety at Work Act ......................................................................................................................................... 20Duty of the Employer:...................................................................................................................................................... 20Duties of Employees:........................................................................................................................................................ 20Duties of Manufacturers / Suppliers:.......................................................................................................................... 20REGULATIONS UNDER THE HEALTH AND SAFETY AT WORK ACT RELATING TO LASERS ........................................ 20MEDICAL DEVICE DIRECTIVES & CE MARKING ................................................................................................21THE MEDICAL DEVICE REGULATION (MDR)...................................................................................................22THE U.S. FOOD & DRUG ADMINISTRATION (FDA).........................................................................................23

ADMINISTRATIVE CONTROLS...................................................................................................................24



AUTHORISED USERS, LASER/IPL SAFETY SUPERVISOR AND THEIR ROLE ......................................................24AUTHORISED USER.............................................................................................................................................................. 24LASER/IPL PROTECTION SUPERVISOR (LPS/IPLPS)................................................................................................. 24Who should be the LPS / IPLPS? ................................................................................................................................... 24General Duties of the LPS ............................................................................................................................................... 24Ensuring suitable Local Rules are drawn up ............................................................................................................. 25LASER PROTECTION ADVISER (LPA) .............................................................................................................................. 26SAFETY POLICIES AND PROCEDURES ................................................................................................................................ 26Advising the employer on choice of a new laser or IPL......................................................................................... 26Hazards and risk assessment before laser use ........................................................................................................ 26Approval of a Suitable Person to act as a Laser / IPL Protection Supervisor ................................................. 27Installation Testing (Commissioning) ......................................................................................................................... 27Identifying the extent of the laser / IPL controlled areas (LCA) ......................................................................... 27Maintaining a register of every laser / IPL and its location................................................................................. 27Monitoring all safety aspects of lasers / IPLs operated on the employer’s premises (regular safetyaudit)..................................................................................................................................................................................... 27Investigating and reporting adverse incidents to the employer and outside agencies .............................. 27Annual Laser Safety Surveys.......................................................................................................................................... 28RELEVANT NATIONAL AND INTERNATIONAL LASER AND INTENSE LIGHT SAFETYSTANDARDS AND GUIDELINES .................................................................................................................29

STANDARDS & GUIDANCE DOCUMENTS ............................................................................................................29EDUCATION AND TRAINING OF LASER AND IPL USERS.....................................................................................30CORE OF KNOWLEDGE TRAINING...................................................................................................................................... 31THE IMPACT OF NHS HEE VOLUNTARY EDUCATIONAL STANDARDS ....................................................................... 32‘BENCHMARKING’ COMPETENCE IN AESTHETIC LASER AND ILS PROCEDURES....................................................... 33THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) .......................................34ROLE OF THE MHRA (FORMERLY MEDICAL DEVICES AGENCY)................................................................................ 34What Is a Medical Device?............................................................................................................................................. 34Device Technology and Safety Section ....................................................................................................................... 34Medical device standards enforcement..................................................................................................................... 35EMERGENCY ACTION, ACCIDENT PROCEDURE AND REPORTING.......................................................................36INCIDENT REPORTING ........................................................................................................................................................ 36



About the authorsCourse Director Dr Godfrey Town Ph.D.Dr Town Ph.D. is a UK registered clinical technologist and scientist specialising in the comparativemeasurement of IPL and laser devices. He is a regular invited speaker at international aesthetic lasermeetings and has published scientific and clinical papers in international peer-reviewed journals on the useof laser and intense pulsed light (IPL) devices.

For five years, he was an owner-manager of a successful UK private laser & IPL clinic in the UK. As an RPA2000Certificated Laser Protection Adviser (LPA), his LPA consultancy has supported over 300 private medical anddental practices, clinics, salons and spas using more than 350 laser and IPL devices for whom he has alsoprovided applications and accredited ‘Core of Knowledge’ training, clinical protocol, regulatory and safetyprocedure support.

He has authored over twenty-five peer-reviewed studies and journal articles on laser and IPL use and writtencomprehensive laser hair removal and skin rejuvenation training manuals and book chapters and has directlyassisted in the staff training and commissioning of numerous laser skin care clinics.

He is engaged with national and international agencies in order to identify, design and formulate necessaryregulations and standards for lasers and light-based devices. His area of work as an Expert Witness embracescosmetic laser injuries, negligence in laser surgery and laser accidents.

Dr Town’s Professional Affiliations include: Senior Research Fellow, Ph.D., Department of Dermatology, Aalborg University

Hospital, Aalborg, Denmarksince 2019

ANSI SSC-3 Laser safety standards sub-committee since 2014 Cardiff University Bond Solon Expert Witness Certificate holder since 2013 Committee Member: EPL/076 Optical radiation safety and laser equipment;

IEC TC/76 WG4 Safety of medical laser equipment; CPL/61/1 ‘Liaison Expert EPL/76’Safety of household and similar electrical appliances; and IEC TC61 WG30 Beautytherapy appliances for household and commercial use

since 2010

Fellow of American Society for Laser Medicine and Surgery (ASLMS) since 2003 Member of British Medical Laser Association (BMLA) since 2002 Registered Clinical Technologist (RCT-IPEM) since 2002 Member of European Society for Laser Dermatology (ESLD) since 2001

A full C.V. and comprehensive bibliography is available at: www.godfreytown.com

Patricia Owens RN, BSN, MHA, CMLSO, CNOR, Course Co-Author

Patti Owens provides consultation services in aesthetic and medical safety programs and in-officemanagement services for a variety of laser companies and professional organizations. Patti is anactive member on the ANSI Z136.3 committee where she has been appointed as the acting secretaryfor the past 3 years.

Patti has published numerous articles in the field of laser surgery and aesthetics. Her co-authoredbook with Pamela Hill, Milady’s Aesthetician Series, Laser and Light Therapy, was published in 2009 byCengage Learning.

A full C.V. and comprehensive biography is available at www.aestheticmedconsulting.com



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IntroductionCourse Overview

Laser and IPL Physics and Safety ‘Core of Knowledge’ is a collaboration of the current evidencebased and consensus based practices listed in the CENELEC Technical Report CLC/TR 50448:2005: ‘Guide to levels of competence required in laser safety’ [1], International ElectricalTechnical Commission Technical Report IEC/TR 60825-8:2006 Edition 2: ‘Safety of laserproducts: Guidelines for the safe use of laser beams on humans’ [2], MHRA document ‘Lasers,intense light source systems and LEDs - Guidance for Safe Use in medical, surgical, dental andaesthetic practices’ September 2015 [3], Essential Standards Regarding Class 3B and Class 4Lasers and Intense Light Sources in Non-surgical Applications October 2016 – published by theBritish Medical Laser Association [4] and the recommended practices published in the‘American National Standard for Safe Use of Lasers in Health Care Z136.3 2011 edition’ [5]

This e-learning course is designed to provide approximately 30 hours of training at Level 4 fortherapists and healthcare professionals intending to provide laser and/or intense pulsed lightservices in registered establishments. It is worth 30 CPD credits (awarded by The CPD Group)for completion of the course. In addition, it is designed to provide Laser Safety Supervisors /Laser Safety Officers and IPL Safety Supervisors with the necessary laser and IPL physics andsafety training to enable them to carry out the duties required of them under currentlegislation.

The Core of Knowledge contained in this course includes that recommended in the MHRAdocument Lasers, intense light source systems and LEDs - Guidance for Safe Use in medical,surgical, dental and aesthetic practices September 2015[3].

Participants are also encouraged to read the Reference Guide to Consent for Examination orTreatment (second edition) and Information to Assist in Amending Consent Forms publishedby the UK Department of Health at:http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_103643

Laser & IPL Safety Training

With the rapidly increasing popularity of intense pulsed light sources and the inclusion ofthese devices in current legislation covering licensed establishments, this course has beenexpanded beyond the content of the UK MHRA document to provide appropriate, relevantand necessary information to support users in the safe operation of these non-laser intenselight systems.

Benefits Achievements & Feedback

The attendee will benefit from the course by being better informed about the safe use oflasers and intense pulsed light devices in their delivery of patient/client-centred care.Participants completing this course will meet the requirements of the recommended BMLA



Essential Standards in respect of adequate training as a Laser Protection Supervisor (LPS) [6].

The achievements of the learner will be assessed through completion of Multiple-ChoiceQuestionnaires (MCQs) at the end of each Unit of learning to qualify for nationallyrecognised CPD credits.

Feedback on the content, quality of presentation, level of course fees and suggestions forimprovements will be recorded on the Feedback Form at the end of the course and analysedfor reference in improving subsequent courses.

Financial Interest: This course is run on a ‘for-profit’ basis.

Correspondence please contact: Dr Godfrey Town: [email protected]

Training Faculty

Dr Godfrey Town PhD, RPA2000 Certificated Laser Protection Adviser

Patti Owens RN, BSN, MHA, CMLSO, CNOR, Co-Author

Anita Clarkson, Beauty Therapist Trainer

Basics Physics and Safety Core of Knowledge Training includes the following topics:

Unit 1: Laser/intense light generation and characteristicsUnit 2: Hazards and risks from equipment and laser/IPL beamsUnit 3: Laser & Intense Light Source radiation - tissue InteractionUnit 4: Relevant legislation and safety standards

Disclaimer

Online Laser Training Ltd provides information for educational purposes only; it is not intended toprovide medical or legal advice or for any of its’ users. The information provided in this e-learning isnot a guarantee of compliance with regional or national regulations and non-regulatory controls.

Aesthetic practice and regulatory information may change quickly, and information contained shouldnot be relied on as the benchmark document pertaining to all laser and IPL devices and all aestheticprocedures. It is mandatory that the Laser Safety Officer and Laser User review the manufacturer’sprocedure manual concerning each laser device along with receiving the appropriate education andhands-on training before attempting to treat an aesthetic patient. Policies and procedures willconcurrently need to be established along with a viable laser and IPL safety programme. You agreethat by using this resource that the limitations of liability set out in this disclaimer are reasonable andwill protect and indemnify Online Laser Training Ltd and its officers, employees, agents, successorsand assigns.



COURSE OBJECTIVES:UNIT 4 TITLE: Understand relevant safety standards and legislation

At the end of this Section, the learner should be able to:

1. Understand the registration/licensing requirements for lasers and IPL devices under various UKjurisdictions.

1.1 Explain under what circumstances establishments must register under various nationaljurisdictions, including The Care Quality Commission (CQC), The Health Inspectorate Wales(HIW), The Regulation and Quality Improvement Authority N.I. (RQIA), HealthcareImprovement Scotland (HIS), the London Local Authority Act 1991, the Essex Act 1987 andthe Nottinghamshire County Council Act 1985

1.2 Identify example treatments which do NOT require registration under the variousjurisdictions.

2. Understand the roles of Authorised Users, Laser Safety Supervisor / LSO and Laser ProtectionAdviser (LPA).

2.1 Identify who appoints an Authorised User, a Laser/IPL Protection Supervisor and a LaserProtection Adviser (LPA)

2.2 Explain the role of the laser/IPL Protection Supervisor (LSO)2.3 Identify three services provided by the Laser Protection Adviser2.4 Evaluate how often ‘Core of Knowledge’ Certificate training should be repeated.

3. Understand Local Rules, safety policies and procedures, routine tests.

3.1 Identify who must read and sign-off on the Local Rules3.2 Describe three important points contained in the Local Rules3.3 List three key policies and procedures to be used in a laser/IPL establishment3.4 Explain one daily routine test or check related to laser/IPL use.

4. Have a working knowledge of relevant national and international laser and intense light safetystandards, regulations and guidelines.

4.1 Describe one specific laser or IPL safety standard that is applicable to laser/IPLestablishments

4.2 Identify at least one source of guidelines for professional use of lasers and/or IPLs4.3 Explain the difference between standards and regulations.

5. Understand emergency action, accident procedure and reporting.

5.1 Describe three procedures necessary in the event of an adverse event or accident5.2 Describe two examples of a serious adverse event (SAE)5.3 Identify to whom you should report a Serious Adverse or sentinel event.

6. Understand non-laser/IPL regulations that apply to establishments providing cosmetictechnology services.

6.1 Identify at least one set of non-laser/IPL safety regulations that are applicable to laser/IPLestablishments employing staff

6.2 Explain who implements these regulations.

7. Be familiar with educational standards for laser and ILS applications.

7.1 Describe options for laser/IPL training including HEE standards framework and independenttraining providers including online alternatives.



RELEVANT NATIONAL LASER & IPL SAFETY LEGISLATION

UK regional governance in independent healthcareRegulations are rules that derive their authority from legislation and provide specificdirection in the way in which laws are interpreted and applied. Regulations are enforced by aregulatory agency mandated to carry out the provisions of legislation. Regulations are notlaws but have the same legal effect as laws and are obligatory.

Since the UK Government deregulated users of lasers and intense pulsed light devices inEngland in 2010 with the repeal of the Care Standards Act 2000, there has been a generalphilosophy of avoiding regulatory controls. As a consequence, the medical and beautymarkets in England and Scotland have been largely free from any registration requirementsfor premises or technologies. Thus, anyone in England and Scotland has been able topurchase intense light sources (ILS), such as intense pulsed lights (IPLs), cosmetic laserequipment or light emitting diodes (LEDs) and set up shop without restriction and with littleor no training.

As a result of devolved government in UK there are several separate bodies responsible forindependent healthcare governance in the United Kingdom:

Care Quality Commission (CQC) Health Improvement Scotland (HIS) Health Inspectorate Wales (HIW) Regulation and Quality Improvement Authority N.I. (RQIA)

England: Care Quality Commission (CQC)

Employers and establishments in private healthcare in England previously consulted the CareStandards Act 2000 which regulated premises covered by the requirements of this legislation(e.g. use of Class 3B or Class 4 lasers in private hospitals, clinics, dentists and otherhealthcare establishments defined by the Act). However, this Act was repealed and ThePrivate and Voluntary Health Care Regulations under The Social Care Act 2008, came intoforce from 1st October 2010, to ensure that establishments using lasers or intense pulsedlights for medical treatments i.e. the treatment of “disease, disorder or injury” meet certainNational Minimum Standards. CQC Inspectors will grant registration when they are satisfiedthat these standards have been met. Laser and IPL establishments in England providingtreatments for "disease, disorder or injury" are required to register with the CQC.Independent clinics offering invasive surgery (such as breast augmentation, face-lift surgery,mole removal, etc., are required to register with the CQC.

The CQC consists of a head office and several regional / area offices (the focus forregistration and inspections). The regulations require patients to have access to appropriateprocedures for dealing with complaints and there must be a system for assuring quality thatincludes seeking the views of patients. This new legislation is intended to be consistent with



the National Health Service (NHS) frameworks and proportionate to the service beingoffered.

Although the new Health and Social Care Act 2008 Regulations seek to encompass "allproviders", the Care Quality Commission (‘CQC’), as the agency of the Department of Health,has unilaterally decided to deregulate Class 3B / 4 lasers and intense light sources (ILS) inEngland where they are not used for the treatment of "disease, disorder or injury" e.g. hairreduction. From 1st October 2010, the CQC is NOT registering any independent cosmeticoperators of lasers or ILS devices in England.

Independent cosmetic clinics using laser/IPL

However, several local Authorities in England with ‘unitary’ powers, (including most LondonBorough Councils, Nottinghamshire Council, several boroughs in Essex, Birmingham andLiverpool), have recognised the particular risks of both ocular and skin injuries with Class3B/4 lasers and intense light sources and taken back the responsibility to control the use ofthese devices. ‘Unitary’ powers in local county borough councils are where the county hasacts in place, recognised by central government, that determine local laws e.g. London LocalAuthorities Act 1991, The Essex Act 1987 and the Nottinghamshire County Council Act 1985.

Establishments providing cosmetic laser or IPL procedures are regulated through the issue of‘Special Treatments’ licences under these pre-existing statutes and bylaws and usingenforcement under the Health and Safety at Work Act 1974 and the Control of ArtificialOptical Radiation at Work Regulations 2010. This initiative has already spread outsideLondon and Nottinghamshire to some other provincial Local Authorities without unitarypowers.

In addition, most London borough councils and Nottinghamshire borough councils haveadopted a version of the National Minimum Standards “Essential Standards Regarding Class3B and Class 4 Lasers and Intense Light Sources” in Non-surgical Applications now publishedby the British Medical Laser Association, as a licensing requirement, so this means that anestablishment using laser or IPL will, as a minimum, most probably be expected to abide by aCode of Practice issued by the local council and provide evidence of support and advice froma certificated Laser Protection Adviser including the issue of Local Rules and RiskAssessments.

An example of a typical Code of Practice for ‘Special Treatments Premises’ issued by theLondon Borough of Hounslow can be found in Appendix 1.

Thus, private cosmetic establishments providing non-surgical, laser/IPL cosmetic treatmentsin England are NOT required to register with the CQC but may be required to obtain a‘Special Treatments License’ from their local authority and be inspected by theEnvironmental Health Department.



Adverse incident reporting

Adverse incidents involving specified injuries including actual eye damage, serious skindamage, accidents or ill health at work must be reported under the Reporting of Injuries,Diseases and Dangerous Occurrences Regulations 2013 by internet(www.hse.gov.uk/riddor/), telephone, fax or post to:

The Incident Contact CentreCaerphilly Business ParkCaerphillyWales, CF83 3GGwww.riddor.gov.uk/info.htmlTel: 0845 3009923 Fax: 0845 3009924

Serious adverse incidents involving specified injuries including actual eye damage resulting inloss or reduction of sight, serious skin damage, accidents (e.g. electrical shock leading tounconsciousness) or ill health at work as a result of using this equipment must also bereported in writing to the Local Council (and CQC/MHRA/HSE if applicable).

Health Improvement Scotland (HIS)

The Regulation of Care (Scotland) Act 2001 established the Scottish Commission for theRegulation of Care and set out the care services that it regulates. These services includeindependent healthcare services. The first phase of implementation started on 1st April 2016and seeks to formally register independent clinics provided by medical practitioners,registered nurses, midwives, dental practitioners and dental care professionals to befollowed at a future date by qualified therapists working in registered establishments. Thekey legislation is the Public Services Reform (Scotland) Act 2010 and the Scottish StatutoryInstrument (SSI) relating to Healthcare Improvement Scotland (HIS) for IndependentHealthcare (IHC) Regulations 2011. It becomes an offence to operate an unregisteredindependent clinic in Scotland on 1 April 2017. The Care Inspectorate was set up in 2011 bythe Scottish Government as a single regulatory body required by law to apply the NationalCare Standards.

Healthcare Improvement Scotland (HIS) has also started regulating independent medicalclinics using Class 3B and Class 4 lasers or intense pulsed light (IPL) systems with ownersrequired to pre-register online by 31st March 2017.

The regulations clearly state that a provider must have appropriate systems, processes andprocedures for all aspects of care and treatment carried out by the independent health careservice, including the use of Class 3B or Class 4 laser and intense light source equipment.Moreover, the expectation is that any independent clinic in Scotland that is using laserand/or intense pulsed light equipment, must have access to the services of a certificatedLaser Protection Adviser (LPA) and work to a set of Local Rules.



The National Care Standards (NCS) are the current standards of the Scottish Government foruse by service providers to improve and maintain the quality of delivered services, asrequired by the Regulation of Care (Scotland) Act 2001.

There is a dedicated set of standards relating to independent specialist clinics in Scotlandthat provide cosmetic surgery and treatments where lasers are used (e.g. tattoo or excesshair removal) that until now have never been implemented because there has never been acommencement order from the Scottish Government to allow regulation of independentclinics to be initiated. Until now, only independent hospitals, voluntary hospices and privatepsychiatric hospitals have been subject to regulation.

Broadly, the requirements cover suitability of premises, cleanliness, hygiene and infectioncontrol procedures, safe disposal of waste, the use of personal protective equipment (PPE)and reporting of adverse events.

Health Inspectorate Wales (HIW)

As a result of devolved UK government powers to Wales and the timing of the revoking ofthe Care Standards Act 2000 in England, the provisions of ‘Prescribed Techniques andPrescribed Technology’ still apply in regulation. They are enforced by the HealthInspectorate Wales (HIS) as the responsible independent health and social care regulator.

Independent healthcare is regulated in Wales under the Care Standards Act 2000 and theHealth Inspectorate Wales (HIW) acts as the regulator of healthcare services. Establishmentsusing Class 3B or IPL (‘prescribed techniques’ or ‘prescribed technology’) for medical orcosmetic treatments are regulated under The Independent Health Care (Wales) Regulations2011 and The National Minimum Standards for Independent Health Care Services in Wales(2011 No.16). HIW Inspectors will grant registration to independent establishments(‘Independent Hospitals’) when they are satisfied that these standards and regulations havebeen met.

As a minimum, registered persons in Wales should be able to demonstrate that service usersare protected from adverse incidents or effects from their use, by informing theiroperational policies, procedures and practices through the standards set out in the UKMHRA guidance ‘Lasers, intense light source systems and LED’s – ‘Guidance for safe use inmedical, surgical, dental and aesthetic practices’, September 2015 or the IHAS EssentialStandards.

Thus, establishments providing cosmetic laser or IPL procedures in Wales are required toregister with Health Inspectorate Wales (HIW) and ensure that the following key proceduresrelating to laser and IPL devices under The Registration of Social Care and IndependentHealth Care (Wales) Regulations 2002 are met:



Standard 7, Regulation 15 & 45-1: Treatment protocol

Establishments are required under HIW regulations and National Minimum Standards tohave a written Treatment Protocol for each laser and/or IPL, produced by an expert medicalor dental practitioner, which sets out various checks, tests and procedures, how theprocedure is to be applied, variations in treatment settings and when to abort treatment, aslisted in the Standards. The Treatment Protocol should be kept available for reference in theLCA.

Standard 16, Regulation 15, 23 and Schedule 3: Procedures for the use of devices

A certificated Laser Protection Adviser must provide advice on the safety of the laserinstallation and day-to-day operational use including the issue of Local Rules and RiskAssessments, advice on safety eyewear, the management of smoke plume extraction. Thismeans that the establishment will be expected to provide evidence of support and advicefrom a certificated Laser Protection Adviser.

Standard 16, Regulation 15, 23, 45-(2): Treatment register

The establishment must keep a treatment record every time a laser or IPL system isoperated, including the name of the person treated, the date, the operator, the treatmentgiven and the name and qualifications of the person who compiled the professional protocolused. Your local RQIA inspector may wish to check your record keeping arrangements.Because the records contain medical details of your clients, you should ensure thattreatment records are kept in a lockable drawer or cabinet. A locked room also may beacceptable to your inspector.

Regulation 45-2 and Schedule 3 Part 11 3.A: Register of servicing

There should be a register of servicing including date of purchase, date of installation anddetails of maintenance and the dates on which maintenance work was performed.

Regulation 45-3 User training

All users are required to have training, which covers the correct use of the laser/IPLequipment, the risks in using a laser or IPL, its biological and environmental effects,precautions to be taken before and during use and action to be taken in the event of anaccident. Since your inspector may ask to see evidence, I recommend that you make sureyou have certificates of training and keep them available for inspection. It is not essential tohave them on display.

Adverse incident reporting to HIW

All incidents must be reported to HIW. Paperwork must be submitted using one of thefollowing methods:

(a) Electronically via e-mail to [email protected]



(b) In hard copy using Signed-for Delivery to Notifiable Events, Healthcare InspectorateWales, Welsh Government, Rhydycar Business Park, Merthyr Tydfil, CF48 1UZ

Adverse incidents involving actual eye damage, serious skin damage, accidents or ill healthat work must be reported under the Reporting of Injuries, Diseases and DangerousOccurrences Regulations 2013 by internet (www.hse.gov.uk/riddor/), telephone (Tel: 0345300 9923) or should it be essential for you to submit a report by post, it should be sent to:

RIDDOR Reports, Health & Safety ExecutiveRedgrave CourtMerton RoadBootleMerseysideL20 7HS

Regulation and Quality Improvement Northern Ireland N.I. (RQIA)

As a result of devolved UK government powers to Northern Ireland and the timing of therevoking of the Care Standards Act 2000 in England, the provisions of ‘Certain Techniquesand Technologies’ (‘P’ standards) still apply in regulation. They are enforced by theRegulation and Quality Improvement Authority N.I. (RQIA) as the responsible independenthealth and social care regulator.

Standards are based on the provisions of the HPSS (Quality, Improvement and Regulation)(Northern Ireland) Order 2003 and the Independent Health Care Health Care Regulations(Northern Ireland) 2005 and the amendments set out in the Regulation and ImprovementAuthority (Independent Health Care) (Fees and Frequency of Inspections) (Amendment)Regulations (Northern Ireland 2011 and apply to those establishments regulated under theprovisions of these regulations. They ensure that establishments in Northern Ireland usinglasers or intense pulsed lights for cosmetic treatments meet certain Minimum CareStandards for Independent Healthcare Establishments. RQIA Inspectors will grantregistration when they are satisfied that these standards have been met.

These standards describe the safe operation of “certain techniques and technologies”including lasers and intense light sources as a registration requirement so this means thatcosmetic establishments in the private sector will most probably be expected by theRegulation and Quality Improvement Authority N.I. (RQIA) to provide evidence of supportand advice from a certificated Laser Protection Adviser including the issue of Local Rules andRisk Assessments.

So, establishments providing cosmetic laser or IPL procedures in Northern Ireland arerequired to register with the Regulation and Quality Improvement Authority N.I. (RQIA) andregulations include the following key procedures relating to laser and IPL devices under thenumbered regulations:



48.2 Register of authorised users

There should be a register of persons authorised to use the laser or intense light sourceequipment and any users should sign to indicate that they have read and understood theLocal Rules and agree to follow them.48.3 Treatment protocol

Establishments are required to have a written Treatment Protocol for each laser and/or IPL,produced by an expert medical or dental practitioner, which sets out various checks, testsand procedures, as listed in the Standards. The Treatment Protocols should be kept availablefor reference in the Laser Controlled Area (LCA).

48.4 / 48.14-48.21 Procedures for the use of devices (“Local Rules”)

Establishments are also required to have a protocol, usually known as Local Rules, whichcontrol the safe use of the laser or intense light source equipment. These rules are usuallywritten for use in the LCA at the laser premises and must also be kept available for referencein the LCA.Normally, these Local Rules are written in accordance with the Medicines and Healthcareproducts Regulatory Agency’s ‘Lasers, intense light source systems and LEDs - guidance forsafe use in medical, surgical, dental and aesthetic practices’, September 2015. They shouldbe reviewed by the Laser Protection Supervisor (LPS) and Laser Protection Adviser (LPA)annually or following any required amendments to the text and reprinted with a new issuedate and revision number following any changes. The Local Rules shall be kept in the LPShandbook. If and when changes are made to the Local Rules, the master copy shall bereplaced with a revised version and staff informed. All authorised users must sign to indicatethat they accept and will follow these Local Rules.

48.6 Certificated Laser Protection Adviser

The Standards require that the establishment has access to safety advice from a certificatedLaser Protection Adviser (LPA).

48.7 Person with overall on-site responsibility

You will also need to identify a Laser Protection Supervisor (LPS) as the person with overallon-site responsibility for the safe use of the laser or intense light source equipment. Thespecific duties of the LPS are listed in the enclosed Local Rules.

48.9 / 48.10 Records of the use of the equipment (‘Treatment Register’)

The establishment must keep a treatment record every time a laser or IPL system isoperated, including the name of the person treated, the date, the operator, the treatmentgiven, the precise exposure and any accidents or adverse effects. You are also advised tomaintain a record of shots after each treatment. Your local RQIA inspector may wish tocheck your record keeping arrangements. Because the records contain medical details ofyour clients, you should ensure that treatment records are kept in a lockable drawer orcabinet. A locked room also may be acceptable to your inspector.



48.11 Risk Assessments

A separate Risk Assessment must be undertaken by the LPA which is reviewed by theprovider in agreement with the LPA at least every three years.48.12 User training

All users are required to have training, which covers the subjects listed in the Standards.Since your inspector may ask to see evidence, I recommend that you make sure you havecertificates of training and keep them available for inspection. It is not essential to havethem on display.

48.13 Update training

The standards require laser or IPL users to have regular update awareness training as well.This usually means they should attend an update/refresher course or other relevantcontinuing professional development at least every year.

Adverse incident reporting to RQIA and HSENI

Specified adverse incidents and events should be reported to The Regulation and QualityImprovement Authority (RQIA) and Health and Safety Executive Northern Ireland (HSENI). ANotable Event document should be sent to RQIA & HSENI no more than 3 days after theevent. It can be reported online or emailed to [email protected] and [email protected] with the investigation report for the incident or event.

Adverse incidents or events to be reported include:- The death of a client in the establishment during treatment or as a result of

treatment provided- Any serious injury to a client- Any theft, burglary or accident in the establishment- The outbreak of any infectious diseases- Allegations of misconduct resulting in actual or potential harm to a client by a

registered person or anyone employed in the establishment- Any event that adversely affects the wellbeing or safety of the client

RQIA Incident AdministratorThe Regulation and Quality Improvement Authority9th Floor Riverside Tower5 Lanyon PlaceBelfast, BT1 3BTTel: 028 9051 7500

The Health and Safety Executive Northern Ireland (HSENI) should also be contacted if anadverse incident occurs. The address is:



Health and Safety Executive Northern Ireland83 Ladas DriveBelfast, BT6 9FRTel: 028 90243249 Fax: 0208 9023 5383

What is regulated in the use of lasers and intense light sources?

The ‘P’ standards covering ‘Prescribed Techniques and Prescribed Technologies’ in the CareStandards Act 2000 applied in Northern Ireland and Wales and the ‘Special TreatmentLicence’ provisions implemented in London, Nottinghamshire and some other provincialareas are almost identical and include (but are not limited to):

Appointment by the laser/IPL establishment of a trained and experienced Expert MedicalPractitioner to produce a ‘Treatment Protocol’ document which must be kept on site andinclude:

Name and technical specifications of the equipment;Treatment contra-indications;Client consent prior to treatment;Treatment technique;Cleanliness and infection control;Pre-treatment tests and checks;Post-treatment care;Recognition of treatment-related problems;Procedure if anything goes wrong with treatment;Emergency procedures;Permitted variation on machine variables; andProcedure in the event of equipment failure.

Retaining the services of a certified Laser Protection Advisor who will assist in theproduction of a ‘Local Rules’ document which will include:

The potential hazards associated with lasers and intense light sources;Device description;Laser Protection Supervisor;Controlled area designation and safe access;Authorised operator’s responsibilities;Methods of safe working;Safety checks;Laser/IPL operator training;Personal protective equipment;Prevention of use by unauthorised persons;Emergency shutdown procedure; andAdverse incident procedures.

That the authorised users of any laser/IPL shall be trained to at least the ‘Core ofKnowledge’ Certificate level and records of such laser physics and safety training shall be



kept on site within the Local Rules. Any training on the specific equipment in use at thepremises shall also be recorded. Such training should be refreshed every 3-5 years.

A suitably qualified member of staff on the premises shall be identified as the LaserProtection Supervisor. The Laser Protection Supervisor will have day to day responsibilityof ensuring the Local Rules are followed.

A treatment register shall be completed every time the laser/IPL is operated, includingthe following information:

The name of the person treated;The nature of the laser/ILS treatment given;The name and signature of the laser/IPL operator;The date and time of treatment;The treatment parameters;Any accidents or adverse effects.

Protective eyewear shall be worn by everyone within the controlled area wheneverthere is a risk of exposure to laser/IPL. All protective eyewear shall be marked with thewavelength range and protection offered as detailed in the Local Rules document. Theyshall be in a clean serviceable condition.

The Laser Protection Supervisor shall ensure that the key to any laser/IPL equipment iskept in a secure and separate area when not in use and that only authorised users haveaccess to the key.

Laser/IPLs shall be serviced annually and a record kept of servicing and repairs with thelocal rules document.

How is the regulation of premises and laser/IPL users enforced?

Regulatory authorities in Wales and Northern Ireland and those ‘unitary’ authorities issuing‘special treatment’ licences can require therapists to hold beauty qualifications, (e.g. NVQ L4or equivalent) and require premises to recruit the services of a certificated Laser ProtectionAdviser (LPA) and an Expert Medical Practitioner (EMP), evidence recent ‘Core ofKnowledge’ Certificate training and obviously comply with the Health and Safety at Worketc. Act 1974. However, in England there is regional variation of local authority requirementsfor laser and intense light source practitioners and facilities, arising primarily from theinterpretation and implementation of the guidance and/or standards by the inspectingEnvironmental Health Officers (EHOs).

Reported safety breaches and resultant adverse incidents including eye and skin injuryinvestigated by EHOs may be prosecuted under the Health and Safety at Work etc. Act 1974and EHOs have the powers to stop a laser clinic trading including the seizure of laser/ILSequipment or prohibiting their use.

UK Legislation

As opposed to the use of ionising radiation (x-rays etc.), there is not a mountain of legislationthat specifically refers to lasers or IPLs although there is much that is applicable to the area



of clinical laser and IPL use.

If any prosecution in connection with laser safety is to be brought, it would be under theterms of the Health & Safety Act. This Act states that the employer has ultimateresponsibility for the safety of staff, patients and all other persons on their premises. TheProtective Equipment regulations state that it is the responsibility of employers to providesuitable safety equipment and the employees responsibility to make correct use of it.Health & Safety at Work Act

The primary aim of the Health & Safety at Work Act 1974 is to secure the health, safety andwelfare of people at work and other people who may be affected by that work (e.g. thepatient). The Act is very general but allows for Regulations to be made that are morespecific. The Act places ‘general duties’ on the employers, employees, manufacturers,suppliers etc.Duty of the Employer:

Employees must be satisfied that organisational arrangements exist, which includes: Safe equipment Safe systems of work Safe environment Effective instruction and training Supervision Safety of visitors and patients Report accidents with and serious defects in laser products to the Department of

Health or other local responsible bodyDuties of Employees:

Take reasonable care of the health and safety of themselves and others who may beaffected by their acts and omissions at work

Not to interfere with / tamper with equipment Co-operate with their employer on health and safety matters

Duties of Manufacturers / Suppliers:

Ensure that their products are inherently safe through design features andconstruction (carry out testing to prove this).

Supply the user with comprehensive safety and operating information

Regulations under the Health and Safety at Work Act relating to lasers

(1) The Control of Artificial Optical Radiation at Work Regulations 2010 (AOR) for businessesthat use hazardous sources of AOR. The regulations specifically cover medical andcosmetic treatments including laser surgery, blue light and UV therapies and IntensePulsed Light sources (IPLs).

(2) Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995- Loss of sight from viewing the beam- Physical injuries from the mechanical aspects of the equipment- Electrical shock



- Must notify the HSE by the ‘quickest practical means’ and submit a report(3) Control of Substances Hazardous to Health Regulations 2002 (COSHH)- Some lasers contain harmful chemicals (dyes, gasses, etc.)- Supplier should provide a health risk assessment- Follow suppliers recommended procedures (e.g. dye change)(4) Electricity at Work Regulations 1989

Covers working on high voltage lasersThe installation must comply (minimise the electrical danger by appropriatewiring/fuses/isolators etc.)Regular inspection

(5) Management of Health & Safety at Work Regulations 2006- Risk assessment (overlaps with other safety legislation)(6) Provision and Use of Work Equipment Regulation 1998 (PUWER)- Employer must ensure that laser and ancillary equipment is fit for purpose (safety and

application)- Equipment maintenance by suitably trained persons only- Maintenance log book kept up to date- LPS / IPLPS must be given instructions on safe operation, hazard assessment, and

contingency plans.- Adequate guarding of dangerous parts of laser (e.g. High Voltage.- Prevention/control of exposure to specified hazards e.g. discharge of gas, vapour etc.(7) Workplace (Health, Safety and Welfare) Regulations 1992- Workplace must be clean and maintained- Sufficient lighting, space, seating, ventilation etc.(8) Manual Handling Operations Regulations 1992 (Revised 2002)- Avoid moving laser (or IPL)(9) Personal Protective Equipment at Work Regulations 1992- Employer’s responsibility to provide suitable safety equipment and the employees

responsibility to make correct use of it.

Medical Device Directives & CE markingAesthetic laser and ILS equipment applications can range from invasive surgical interventionssuch as laser lipolysis (laser fat reduction), to non-invasive procedures such as light basedhair reduction and non-ablative skin rejuvenation. For all such equipment to be sold legallyin the UK, these devices must be legitimately CE-marked, (which stands for ‘ConformitéEuropéenne’) and is the symbol applied to equipment to indicate conformity with therelevant European Directive(s) regarding health and safety.

Unfortunately, although we are accustomed to assuming that CE-marked devices arecompliant with standards (of which a majority of products are) some devices importeddirectly by individuals may bypass testing requirements and just arrive with a supplierDeclaration of Conformity (SDoC) from the country of manufacture. These SDoC’s are



supposed to meet the BS EN ISO/IEC 17050-1:2010 quality assurance and EU electrical safetystandards, but as the devices are privately imported, who monitors this?

Many buyers also see the European CE-mark as an indication of safety and compliance,however there is also a “China Export” mark which bears a striking similarity to the officialEuropean marking (see Figure 1). What this means is that devices used in beauty therapyclinics, including professional laser and intense light source devices that have beenpurchased easily online from China may not comply with any of the required standards forsafe use.

In these instances, the obligation to ensure that the devices meet relevant standards is theresponsibility of the individuals purchasing the device directly. In the eyes of the law, theyare the importer.

Figure 1: Comparison of CE marks (CE mark available from https://ec.europa.eu/growth/single-market/ce-marking_en).

Without proper compliance, users of these devices are unwittingly invalidating theirinsurance and opening themselves up to punitive damages in the event of any litigationbrought against them. It is a case of “buyer beware”.

The European Commission has now classified infra-red, visible light and UV devices includingcoherent and non-coherent sources such as lasers and intense pulsed light equipmentintended for use on the human body (which were previously regulated under the MedicalDevice Directive EU/42/EEC) under the EU medical Device Regulation EU 2017/745,irrespective of whether manufacturers claim a medical purpose.

The Medical Device Regulation (MDR)The new Medical Device Regulations (EU 2017/745) published in the Official Journal of theEU in May 2017 has been delayed by the COVID-19 pandemic and now enters fully into forceon 27th May 2021 after a 4-year implementation period. This also means that the formerMedical Device Directives will be repealed on the date of application of the MDR in May2021.



One consequence of the new MDR is that manufacturers of medical lasers need to startmedical compliance testing through an MDR registered EU Notified Body in order to sellproducts legally after May 2021.

Another consequence of the new MDR is that many laser and IPL devices currently sold as‘beauty devices’ under the Low Voltage Machinery Directive for treatments on the humanbody, will be reclassified as ‘medical’ devices and fall under the MDR.

The U.S. Food & Drug Administration (FDA)The Food and Drug Administration (FDA or USFDA) is a federal agency of the United StatesDepartment of Health and Human Services.

The FDA has the authority to regulate the design, manufacture and distribution of medicaldevices. It oversees all regulations of each device for safety and efficacy. Laser systems andother types of cosmetic devices receive clearance for marketing, once the FDA feelsconfident that it is a safe and effective device.

FDA marketing clearance is NOT a recognised requirement in the United Kingdom.



ADMINISTRATIVE CONTROLS

Authorised users, laser/IPL safety supervisor and their role

Authorised User

No person should be allowed to use the laser or IPL unless they are suitably trained and it isthe responsibility of the manager, owner or head of department to authorise persons to usethe laser. A list of authorised persons should be attached to the Local Rules. Certificates ofadequate, relevant training may be a requirement but at least may be expected in thefuture.

There should also be a register of persons authorised to use the laser and/or IPL equipment.Each authorised user must sign and date the register, to indicate that they accept andunderstand the local rules, and agree to follow them at all times. It is convenient to keep theregister at the back of the rules. Users can be added to or removed from the list by thisperson without reference to anyone, provided he/she is satisfied that new users areadequately trained and competent.

Laser/IPL Protection Supervisor (LPS/IPLPS)

The LPS/IPLPS is responsible for the supervision of all practical laser/IPL safety aspects on aday-to-day basis, including ensuring that the local rules are implemented and followed.

Who should be the LPS / IPLPS?

The role of the LPS / IPLPS is pivotal to ensuring the safe use of lasers and/or IPLs in thedepartment. Care must be taken in the choice of the LPS / IPLPS, taking into account theirdirect involvement in laser work, their seniority, their experience and their enthusiasm. TheMHRA would expect the LPS to be the clinician or nurse who operates the laser and cantherefore control the safety of the patient and other persons present in the room. However,the LPS / IPLPS can also be, for example, a nurse with managerial responsibilities, a nurse (orO.D.A.) or a beauty therapist who is routinely involved with laser or IPL sessions. Theappointed LPS / IPLPS will need to good working relationships with clinical users of thedevices, the support of the Responsible Person in a private establishment, head ofdepartment, the co-operation of staff and good communication with the LPA.

General Duties of the LPS

To instruct other staff in the safe use of equipment and local safety procedures, and inemergency arrangements. The LPS / IPLPS acts as a focal point for training staff in workwith the laser or IPL, ensuring that they understand and follow the Local Rules.

To notify the LPA of any changes in the laser equipment, its usage and its operatingenvironment. It is essential to ensure that the LPA has an opportunity to fully assess thepotential hazards associated with new procedures.

To ensure that the Register of Authorised Users is maintained and that the correct



procedure for authorisation has been undertaken. To obtain and keep on file, written statements from each Authorised User that they have

read and understood the Local Rules and sent copies of statements to the LPA or theResponsible Person, Head of Department, etc. (depending on the arrangement).

To ensure that only the Authorised Users operate the device. To ensure that the Authorised User and all other employees and authorised visitors

receive such safety information, instruction and training as is appropriate. To inform the Registered Person as soon as possible in the event of an untoward

incident occurring. To draw to the attention of the Registered Person any problem or potential problem

with regard to IPL safety. Notify the LPA of any change in the work, or the facilities, andof new equipment or modifications to old equipment wherever these may have asignificant bearing on laser or IPL safety.

To maintain, in collaboration with the LPA a set of current Local Rules. These must detailthe principles and the working practices to ensure safe use of the laser / IPL facility andmust be kept under continuous review (at least on an annual basis). To inform theRegistered Person and the LPA is he/she considers that the existing rules requireamendment.

To ensure that the Local Rules are adhered to. To ensure that all members of staff involved in the work of the establishment have read

the Local Rules and have signed a declaration acknowledging this. To be responsible, in collaboration with the Registered Person for maintaining the

required standard of laser / IPL device safety and that the local rules are implemented inpractice.

To seek assistance from the LPA on the safety implications when a change in operatingprocedure is envisaged.

To report to the Laser Protection Adviser annually. Carry out any specific operational duties laid out in the local rules and any other duties

delegated by the Head of Department. For example:o Ensuring that the laser / IPL equipment is regularly serviced and maintained by a

suitably qualified engineer, whether employed by the laser / IPL supplier or ‘inhouse’.

o Setting up and maintaining a quality control programme as part of acomprehensive quality system.

Ensuring suitable Local Rules are drawn up

The LPS should draw up local rules after advice from the LPA on content and discussion withthe laser operators. These rules should then be agreed with the head of department orestablishment Responsible Person and then ratified by the LPA as suitable.



Laser Protection Adviser (LPA)

The MHRA Guidance document states that where there are lasers of Class 3B or above, thena Laser Protection Adviser should be consulted by the employer, to provide advice on thecontrol of laser hazards, relevant regulations and standards. The individual does not havespecific managerial responsibility for laser safety and in that sense, is analogous to theRadiation Protection Adviser defined by the Ionising Radiations Regulations 1999.

Following the deregulation in September 2010 in England of Class 3B & Class 4 lasers andintense pulsed light (IPL) devices under the Care Standards Act 2000 for cosmetic users,establishments in England may continue to be licensed and regulated under local health andsafety legislation, such as The London Local Authorities Act 1991, requiring them to appointor consult with an LPA who may need to make a site visit and prepare a site audit report.

The scope of the appointment should be set out by the employer in the establishment’slaser, IPL or LED safety policy. If relevant it would be appropriate to include laser safety andLPA ‘Core of Knowledge’ training on the agenda of the establishment’s Safety Committee.

The LPA is principally concerned with potential eye or other bodily tissue injury to staff andpatients (and the public in adjoining areas). He/she will also be assessing the risks of injury tothe skin and of fire. This will therefore necessarily require that the safety eyewear that hasbeen provided (particularly if it has been provided without the Laser Protection Adviserbeing involved in the specification) is adequate for the use of the laser or IPL. The LPA doesnot, however, provide medical governance.

Safety policies and procedures

Advising the employer on choice of a new laser or IPL

Important dialogue is required between the intended clinical user of a laser or IPL, thepotential device supplier and the LPA to determine what is needed and what is available onthe market i.e. such that an informed choice is made. Whereas the operator of the laser orIPL may be clear in their own mind as to what they need, they may not be aware of all thecompanies that produce lasers and IPLs that may be suitable. Also, they will probably not bein a position to make a full assessment of the technical features of all the availablemachines.

Hazards and risk assessment before laser use

The Laser Protection Adviser must be given as much detail as possible to be able to envisagethe hazards involved in using a particular laser in a particular location and for a particularpurpose. The LPA can then decide on advice to be given and on any necessary modificationrequired to the location/installation, or to the intended operating procedure. The LaserProtection Adviser may also be a useful interface with company so that the correct servicesfor the laser are planned for (e.g. water for cooling, 3-phase and/or high current electricity,ventilation etc.).



Approval of a Suitable Person to act as a Laser / IPL Protection Supervisor

It is a legal requirement for a Laser Protection Supervisor (LPS) to be approved by the LaserProtection Adviser. The LPA will want to reassure the employer that the person appointedhas appropriate training, has sufficient authority (both as person and in their formal role)and is suitable in any other way. If an incident occurs and the HSE / Department of Health orother local responsible body is involved and the LPS / IPLPS is deemed not to have fulfilledtheir role, the focus will be on the management decision on the appointment of the LPS.

Installation Testing (Commissioning)

Installation and testing the laser/IPL and location to ensure it is fit for use is a keyrequirement before treating any patient. The cooperation of an appropriately qualifiedengineer employed by the supplier with full understanding of the capabilities of the laser/IPLis important (see below). This testing is to ensure compliance with BS EN 60825 and otherapplicable standards.

It is essential that LPA is consulted at the planning stage of a room in which a laser or IPL isto be used (LCA). It is extremely disruptive for a room to have wires chased into the wall forlaser warning signs to be connected to the laser or highly reflective surfaces removed orredecorated after the room has been finished and the first patient is about to be treated.

Identifying the extent of the laser / IPL controlled areas (LCA)

The definition of these areas is important for indicating to staff and other persons thedistance at which the hazards from the laser or IPL cannot cause skin or eye injury. The word‘controlled’ means just that; e.g. if the main theatre scrub area or other preparation areaconnected to the laser/IPL treatment room is not controlled in access, then it will generallyhave to be included in the LCA.

Maintaining a register of every laser / IPL and its location

There should not be any laser or IPL within the facility that the Laser Protection Adviser isunaware of. A register of lasers and/or IPLs also enables the Laser Protection Adviser tocheck hazard notice for their relevance within the organisation.

Monitoring all safety aspects of lasers / IPLs operated on the employer’s premises (regular safetyaudit)Arrangements concerning lasers should be checked at regular intervals. This is an audit to‘independently’ check the laser performance and the arrangements in place.

Investigating and reporting adverse incidents to the employer and outside agencies

Any accident with the laser or IPL resulting in injury to staff, visitors or patients, should bereported, as appropriate, to the Responsible Person and the Head of Department, LPA,MHRA, RIDDOR, etc. In the case of laser/IPL eye injury or serious skin burns due to operatorerror, this should be reported to the MHRA or other local responsible body.



Annual Laser Safety Surveys

A report should be made annually to the LPA to check the laser / IPL device records andassociated records at least once per year to ensure good practice is being upheld and thatthe output of the laser or IPL is within tolerance. This will include room facilities such assafety eyewear, blinds or curtains, warning lights and door lock/security arrangements.Role of the Independent Laser Adviser (LPA):An independent LPA, not acting for the private institution, may be asked to inspect on behalfof the Care Quality Commission or local council. He/she is given the authority under thelegislation to enter premises and inspect and is concerned with safety/quality of treatmentof the patients. However, the CQC Inspector or local council Environmental Health Officerdecides finally on whether or not to accept all or part of the advice of the independent LPA.

Typical areas inspected could be:- Appointment of suitable LPA – is the LPA a certificated LPA?- Appointment of LPS / IPLPS (in writing, with duties)- Formal training of LPS / IPLPS- Existence of Local Rules, signed statements of authorised users having read Local Rules- Other laser / IPL operator training- Existence and use of appropriate protective eyewear- Adequate patient / client treatment records- Service / fault / incident log- Hazard warning signs on doors etc.- Emergency stops, key security and other safety features of lasers- Other factors relevant to patient / client safety (blinds on windows of controlled areas)

Note that the Health and Social Care Act Regulations:- Include the use of intense light sources as well as lasers- Exclude cosmetic treatments (e.g. beauty salons)- Include a degree of medical direction / governance and operator training in the

inspection process- Expect training should include mentored practical experience as well as theoretical

laser / IPL ‘Core of Knowledge’- Recognise that Continued Professional Development (CPD) is also important- Check establishments employ a certificated Laser Protection Adviser- Expect some practices may be under a registered practitioner, not necessarily a GMC-

registered medical doctor e.g. physiotherapist, can operate a Class 3B laser in aprivate establishment without the need to register the practice.



RELEVANT NATIONAL AND INTERNATIONAL LASER AND INTENSELIGHT SAFETY STANDARDS AND GUIDELINES

Standards & Guidance DocumentsStandards are authoritative published documents that are usually voluntary (unlessspecifically adopted by national legislation) and establish specifications and proceduresintended to ensure quality and reliability of materials, products, processes or services. Thesestandards provide the foundation for product development by establishing consistent designand engineering controls that can be universally understood and adopted. Standards alsomake it easier to comprehend and compare competing products. Manufacturers shouldalways follow standards if they apply to their device and application.

Lasers and intense light sources attract standards and regulatory controls because of theunique eye hazard associated with their use. The wavelengths and outputs available fromsuch devices are capable of blinding careless or inexperienced users and those being treatedby them. These devices usually in the highest risk category.

Laser Safety Standards contain advice to users as well as to manufacturers. Although theBritish Standards are not legally enforced in the UK, the wording of the Health and Safety atWork Act enables any of these standards or parts of them to be adopted as a basis for adviceand enforcement i.e. to define good practice in the workplace. Therefore, although‘compliance with a British Standard does not itself confer legal obligations’, laserinstallations should still comply with the specifications of the following:

Lasers, intense light source systems and LEDs - Guidance for Safe Use in medical, surgical,dental and aesthetic practices September 2015: The relevant guidance document adopted asthe basis for an Approved Code of Practice and for clinical laser / IPL use, issued by theMedicines & Healthcare products Regulatory Agency (MHRA) of the Department of Health.(An HSE inspector has stated that failing to follow this guidance would be interpreted asfailure to protect others and prosecution under the Health and Safety at Work Act couldresult).

PD IEC TR 60825-8:2006: Edition 2 Safety of laser products - A user's guide. Lasers, Safetymeasures, Light hazards, Hazards, Occupational safety, Training, Instructions for use, riskassessment.

BS EN 207:2009: Personal eye-protection equipment. Filters and eye protectors against laserradiation (laser eye-protectors). Protective eyewear for lasers is subject in the UK to ThePersonal Protective Equipment at Work Regulations (1992) and its associated GuidanceNotes from the HSE. The relevant European Standards with which laser eyewear mustcomply are BS EN 207 for full beam protection and BS EN 208 for protection against beamsduring alignment. Specification for filters and equipment used for personal eye-protectionagainst laser radiation.



BS EN 208:2009: Personal eye-protection equipment. Filters and eye protectors against laserradiation (laser eye-protectors). Specification for personal eye-protectors used foradjustment work on lasers and laser systems.

BS EN 60601-2-22:2013: Medical Electrical Equipment: Particular requirements for basicsafety and essential performance of surgical, cosmetic, therapeutic and diagnostic laserequipment.

BS ISO 12609-1:2013: Eyewear for protection against intense light sources used on humansand animals for cosmetic and medical applications – Part 1: Specification for products.

BS ISO 12609-2:2013: Eyewear for protection against intense light sources used on humansand animals for cosmetic and medical applications – Part 2: Guidance on use. The standardsare based on Exposure Levels to the eye (retina, cornea and lens) and the skin, below whichthe laser exposure is considered to be safe. They do not apply to patient exposure in themedical use of lasers for treatment purposes.

BS EN 60601-2-57:2011: Medical electrical equipment: Particular requirements for the basicsafety and essential performance of non-laser light source equipment intended fortherapeutic, diagnostic, monitoring and cosmetic/aesthetic use.

It should be borne in mind that laser safety standards change in response to research e.g.laser damage thresholds of tissue (in particular there is an inadequate amount ofexperimental data on the effects of pulsed lasers) and to the development of new lasers ofdifferent wavelengths and pulse lengths.

Education and training of laser and IPL usersThe use of laser and intense light sources (ILS) in UK is firmly established in both the privateand public sectors, e.g. both hospital departments and private aesthetic clinics and beautysalons. Their use has been underpinned by numerous British and international standards(IEC, CIE, ISO, etc.) and guidance documents since the 1980’s including safety and trainingrelated standards. The current most authoritative UK foundation document is the Medicinesand Healthcare products Regulatory Agency (MHRA) Guidance document containing the‘Core of Knowledge’ syllabus in Appendix C. Elements of this guidance can be traced back tothe repealed Registered Homes Act, 1984 and the Healthcare Commission Care StandardsAct 2000 ‘Prescribed Techniques and Prescribed Technologies’ - ‘P’ Standards and the BritishStandard BS EN 60825-8:2006 Guidelines for the safe use of laser beams on humans. The ‘P’standards also provided the basis for the ‘IHAS Essential Standards’ which were updatedduring 2015/16 and published by the British Medical Laser Association (BMLA) in October2016. They reflect essential arrangements for safety and quality and provide a usefultemplate for facility audit.



BS EN 60825 states only that persons who have been trained to an appropriate level shouldbe placed in control of Classes 3A/3B/4 lasers. For the use of medical lasers, training mustcover the following: Instructions on how to operate the laser system Training in laser safety Training in clinical application

Instruction on the operating procedure of the laser would normally be given by themanufacturer or supplier in the first instance (i.e. on delivery), but thereafter it may be theresponsibility of the LPS / IPLPS or the most experienced operator (with reference to theoperator’s manual) to train new users.

Clinical training should be covered initially by the Clinical Use Specialist provided by themanufacturer and supported by an approved training course (check with the relevant RoyalCollege or professional body where appropriate to see if it meets their requirements). In-house training by a senior operator would also be expected.

NOTE: Where the Care Standards Act 2000 no longer applies in England, establishmentsshould check with local borough council licensing department for ‘Special Treatments’Licenses or the Environmental Health Department.

Core of Knowledge training

In the UK, the ‘Core of Knowledge’ Certificate syllabus remains a fundamental component oflaser and light knowledge-related education and training in both the private and publicsector. All lasers and IPL operators should have a minimum level of knowledge about lasersand IPLs BEFORE they start using them and ‘Core of Knowledge’ training is usually arequirement of obtaining insurance cover and local council licensing.

To comply with the MHRA Guidance Notes, laser users (including the LPS / IPLPS) mustundertake a course that covers a specified syllabus referred to as the ‘Core of Knowledge asto the Protection of the Patient and all Persons Present During the Use of a Class 3A/3B/4Laser in Medical Practice’. This also covers the training requirements in Section 6 in PDIEC/TR 60825-8:2006 Edition 2.

Core of Knowledge training should be repeated at least once every 3 years and include: Fundamentals of optical radiation devices and their interaction with tissue How lasers and IPLs are made, what types of active media are used, emission modes

and delivery systems Characteristics and uses of optical radiation Hazards and how to control them Safety management Effects of optical radiation on eyes, skin and other tissues. Emergency action and accident procedure



The Impact of NHS HEE Voluntary Educational Standards

Health Education England (HEE) published the standards framework ‘Qualificationrequirements for delivery of cosmetic procedures. Non-surgical cosmetic interventions andhair restoration surgery' which attempts to set minimum levels of competence for aestheticpractitioners. HEE in conjunction with the Joint Council of Cosmetic Practitioners (JCCP) setup in 2017 aims to commence a register of approved providers of cosmetic services inNovember 2017 and implement voluntary standards fully by 2018 including the approval oftraining providers.

The cosmetic sector is well served by a significant number of credible, robust, academicprogrammes of study ranging from Quality and Credits Framework (QCF) Level 3 to Level 7including all applications listed in the HEE knowledge set, namely: hair reduction, skinrejuvenation, tattoo removal, treatment of vascular and pigmented lesions, non-ablative andablative therapies (QCF Level 6, MATA, QCF Level 7 UCLan). Review of current trainingprovisions also indicate that the core HEE principles of patient assessment, informedconsent, information governance and record keeping, and ensuring that practitioners have aclear understanding of the requirement to operate from safe premises, with patient safetytraining in topics such as infection control, treatment room safety and adverse incidentreporting, are included within the programme specifications.

However, this new UK educational standard for non-invasive cosmetic procedures is notmandatory and the Government’s response in 2014 to the recommendations of theindependent Review of the Regulation of Cosmetic Interventions published by Sir BruceKeogh in 2013, was only to encourage industry self-regulation through establishing voluntarystandards of competence and education.

A recent private ‘straw poll’ of UK insurance providers gives no indication that the medicalmalpractice insurers or cosmetic industry underwriters are embracing this new educationalstandard before providing cover.

If the proposed new education standards eventually gain ‘traction’ in the market, forexample through adoption by local authorities with unitary powers (four or five Londonboroughs have already adopted them for new ‘Special Treatments’ license therapistapplications), then standards of basic education and training may slowly improve in theaesthetic therapy sector.

If these proposed standards are adopted in England, users of lasers or IPL will requireeducational certification to the following nationally-recognised competency levels:- Level 4: Laser/IPL hair reduction and the treatment of sun-induced benign vascular and

pigmented dyschromia. Non-ablative laser/IPL & LED for photo-rejuvenation and acne- Level 5: Laser tattoo removal and the treatment of benign vascular lesions- Level 6: Laser/IPL treatment of generalised and discreet pigmented lesions. Ablative

fractional laser treatments



- Level 7: Fully ablative laser skin treatments i.e. non-fractional resurfacing.

NB. All excluding treatments within the periorbital rim.

‘Benchmarking’ Competence in Aesthetic Laser and ILS Procedures

In any civil litigation case the standard of proof that must be satisfied is that of the balanceof probabilities, i.e. 'more likely than not'. While it is for the court to decide on the issue ofnegligence, expert witness testimony is usually sought to establish whether the actions of aprofessional, who is alleged to have caused the injury or loss, could be considered to be of astandard that would be expected of a competent practitioner and thereby establish‘causation’ (connecting conduct with a resulting injury) and possible ‘damages’ for‘negligence’.

In order to establish whether, on the balance of probabilities, the defendant’s actions wereof a standard reasonably expected of a competent practitioner, guidelines on proceduresincluding treatment protocols published by a recognised expert professional body can be avery useful ‘benchmark’ in determining whether a course of action by the defendant wasvalid.

Guidelines are codes of conduct or statements that determine a course of action. Althoughnot binding or legally enforceable, when issued by a professional, authoritative body, theymay carry weight in litigation cases where they provide a ‘benchmark’ in establishingwhether the actions of a professional could be thought competent.

Unfortunately, only limited guidance on professional competence in laser and ILS treatmentscan be found in published literature, making benchmarking challenging in claims forcompensation in personal injury and medical negligence cases. In the absence of directmedical supervision or at least specific treatment protocols issued by an expert practitioner,court decisions are often based upon expert witness testimony which may rely only onmanufacturers’ user and application manuals.

Examples of UK national laser and IPL guidelines include:- Essential Standards Regarding Class 3B and Class 4 Lasers and Intense Light Sources in

Non-surgical Applications. Issued May 2017.- Drugs and lasers/IPLs – Guidance provided by the British Medical Laser Association.

Issued November 2017.- Resumption of Laser/ IPL skin services post COVID-19 lockdown- British Medical Laser

Association (BMLA) guidance document, Issued 27th May 2020.

Examples of international laser and IPL guidelines include:- Photo-Epilation: Guidelines for care from the European Society for Laser Dermatology

(ESLD). Drosner M, Adatto M. J. Cosmet Laser Ther 2005; 7:33-38.



- Vascular lasers and IPLS: guidelines for care from the European Society for LaserDermatology (ESLD) Adamic M, Troilius A, Adatto M, Dahmane R. J Cosmet Laser Ther.2007; 9(2):113-124.

The Medicines and Healthcare Products Regulatory Agency (MHRA)

Role of the MHRA (Formerly Medical Devices Agency)

An Executive Agency of the Department of Health (since 27th September 1994) Our aim is to:“take all reasonable steps to protect the public health and safeguard the interests of patientsand users by ensuring that medical devices and equipment meet appropriate standards ofsafety, quality and performance and that they comply with the relevant Directives of theEuropean Union.”What Is a Medical Device?

All products, other than medicines, used for patients in healthcare or in thealleviation of injury or handicap.

e.g. x-ray machine, pacemaker, bandage, walking aid, heart valve.Activities: As UK Competent Authority, negotiate European Directives and implement and

enforce UK regulations for medical devices; Investigate adverse incidents involving medical devices and issue warnings and

advice to users and manufacturers; Manage an independent programme of device evaluation and publish reports and

surveys; Contribute to safety and performance standards for medical devices; Provide advice to Government, the Department of Health, the NHS and other

healthcare providers, professional bodies and manufacturers.Organisation: European and Regulatory Affairs; Device Technology and Safety; Device Evaluation and Publication; Clinical; Corporate and Financial Services.

Device Technology and Safety Section

Incident Handling: Adverse Incident Centre DTS1 – Sterile, Surgical and In-Vitro Diagnostic Devices DTS2 – Rehabilitation and Transfer Equipment DTS3 – Wheeled Mobility

Adverse Incidents: Equipment failure causing death or injury to patients or staff; Failure in diagnosis or therapy;



Poor or deteriorating performance; Non-compliance (if claimed) with safety standards; Unsafe design or poor user instructions; The possibility to cause any of the above.

The Adverse Incident Centre: Receives adverse incident reports from users, manufacturers and other sources; Logs reports on our Adverse Incident Database; Passes reports to the appropriate Product Group;

When the Product Group has chosen the level of investigation (in-Depth, Mid-Tier orProforma), raises files to hold documentation: Handles correspondence for all Proforma and some Mid-Tier investigations; Following investigation, records incident summaries and causes the database; Closes files and arranges for document storage.

Medical device standards enforcement

However, the Medicines & Healthcare products Regulatory Agency (MHRA) does not registerlaser or intense light source devices for cosmetic, professional cosmetic or consumer use(such as hair reduction or skin rejuvenation). This is because cosmetic devices do notcurrently meet the legal definition for a device with “therapeutic purpose” i.e. treating a“disease, disorder or injury”.

It is therefore left to Trading Standards Institute officers, supported by Public Health England(formerly the Health Protection Agency – HPA) to take joint responsibility for enforcement ofstandards of laser and ILS devices sold as non-medical, professional cosmetic treatmentdevices. However, shortage of manpower exacerbated by departmental budget cuts and thedifficulty in actually making a complaint via a local Citizens Advice Bureau (as no nationaltrade or professional body monitors the cosmetic device industry) means that complaints golargely ignored and never reach influential managers in either the Trading StandardsInstitute or Government. For example, there is almost nothing to stop the widespread sale,usually via the internet, of falsely CE-marked or inadequately tested laser/IPL devices whichmay not have any suitable EU electrical safety compliance, let alone medical device safetycompliance. Individual internet purchases in UK may simply bypass EU conformityrequirements.



Emergency action, accident procedure and reportingHopefully, the safety precautions, which you have in place, will prevent any serious incidentsfrom occurring. The risk assessments should have identified all possible hazards and reducedeither the outcome or the frequency. However, if in an emergency or incident does occur:

1.Switch off the laser / IPL using the emergency button (if provided)2.Switch off using the key3.Unplug the laser / IPL at the mains4.Check for any casualties and arrange First Aid5.Fix a notice to the laser / IPL, warning other people not to use it6.Contact the LPS / IPLPS and the LPA – IMMEDIATELY7.If a person has received an over exposure to the eye – A full ophthalmic examination

must be carried out as soon as possible and in any case, within 24 hours

In the event of a fire, steps 1 – 3 must be observed. A Carbon Dioxide (CO2) extinguisher forelectrical equipment should be used. Sound the fire alarm. Make sure that you have a CO2

extinguisher within easy reach of the Laser Controlled Area.

Incident Reporting

Any incident involving inadvertent exposure of laser / IPL radiation should be immediatelyreported to the employer and the LPA. The procedure for dealing with and reporting anadverse incident should be stated in the Local Rules.

Local requirements for incident reporting are detailed in the relevant national safetystandards section of this workbook.

An investigation should be carried out by the LPS / IPLPS, with the assistance of the LPA, ofthe circumstances of the incident. A report should be sent to the employer following theguidelines in the Health and Safety document ‘Reporting of Injuries, Diseases and DangerousOccurrences Regulations: 1995’.

Laser / IPL accidents and serious defects in laser / IPL equipment should be reported to theMHRA. Details of reporting adverse incidents are given in the MHRA’s first Device Bulletin ofthe year (for example DB 2008(01) ‘Reporting adverse incidents and disseminating medicaldevice alerts’), available on the MHRA website www.mhra.gov.uk.

It is recommended that reports of laser / IPL accidents and the results of ophthalmicexaminations should be collated by a central agency such as The Professional Unit,Moorfields Eye Hospital, City Road, London EC1V 2PD.

This is the end of Unit 4 Relevant Legislation and Safety Standards(United Kingdom)



[1] CLC/TR 50448:2005 Guide to levels of competence required in laser safety. Available at:https://shop.bsigroup.com/ProductDetail?pid=000000000030138690[2] IEC TR 60825-8:2006 Safety of laser products – Part 8: Guidelines for the safe use of laserbeams on humans. Available at: https://webstore.iec.ch/preview/info_iec60825-8%7Bed2.0%7Den.pdf[3] MHRA: Lasers, intense light source systems and LEDs - Guidance for Safe Use in medical,surgical, dental and aesthetic practices. September 2015 Available at:https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/474136/Laser_guidance_Oct_2015.pdf[4] Essential Standards Regarding Class 3B and Class 4 Lasers and Intense Light Sources inNon-surgical Applications. October 2016 – published by the British Medical LaserAssociation. Available at: https://www.bmla.co.uk/bmla-essential-standards/[5] Z136.3 2011 American National Standard for Safe Use of Lasers in Health Care. Availableat: https://webstore.ansi.org/standards/lia/ansiz1362011#:~:text=in%20Health%20Care-,ANSI%20Z136.,altered%20or%20symptoms%20are%20relieved.[6] Essential Standards Regarding Class 3B and Class 4 Lasers and Intense Light Sources inNon-surgical Applications October 2016 – published by the British Medical Laser Association.

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