Laser safety management (medical and cosmetic applications)
'Core of knowledge' course notes
Health and Safety Regulation
(The following section applies to UK regulation. For Republic of Ireland, Click Here.)
Sensible consideration of health and safety in the workplace of paramount importance for the following reasons:
a) Moral duty of care
b) Legal duty of care
c) Potential financial loss due to litigation and loss of reputation etc.
Changes in working practices due to health and safety considerations may also result in more efficient or effective ways or working. Ideally, health and safety should be an asset to an organisation.
Health and safety, a 'damaged brand'
In recent years the term 'health and safety' has arguably become a negative phrase in the eyes of many. The following factors have been identified as possible causes of this;
1) Poor understanding and over-the-top approaches by councils and other bodies
2) Inaccurate reporting in the press
3) 'Rogue' health and safety advisers
Unfortunately all these things undermine health and safety and make the promotion of a good health and safety culture in the workplace more difficult.
Summary of the main legal requirements (Great Britain)
All businesses and public sector services (e.g. NHS) must comply with the health and safety statues such as the Health and Safety at Work Act 1974. There are a fair amount of regulations governing the workplace but the main specific requirements for lasers and intense light are:
Suitable and sufficient risk assessment / management
and
Provision of adequate training and information
The requirement for the above is specifically reinforced in The Control of Artificial Optical Radiation at Work Regulations 2010
Policy and Procedures
Under the Health and Safety at Work Act 1974, suitable health and safety policy and instruction should be in place.
In optical radiation safety (lasers/IPL) the following policies and procedures are usually put into place,
- Health and Safety Policy (covers everything)
- Laser/IPL safety policy (usually suitable for larger organisations)
- General laser/IPL safety procedures for each facility (often termed 'local rules' or 'safe working practices')
- Specific instructions (how to carry out the work, e.g. 'Standard Operating Procedures (SOP)' or 'treatment protocol'
See also: Written procedures for laser safety
For sole operator/owners, policies and procedures have very little benefit. For businesses employing 5 or more people, all the above must be documented in writing. They can be useful for a number of reasons, such as,
- Help provide suitable training and information for staff (a legal requirement)
- Consistency of service
- Quality assurance
Risk Assessment
Under the Management Health and Safety at Work Regulations 1999, a suitable and sufficient risk assessment should be undertaken. This is reinforced in The Control of Artificial Optical Radiation at Work Regulations 2010 which also states that the following must be included where applicable:
- measurements or calculations of the levels of optical radiation, if necessary
- consideration of the level, wavelength and duration of foreseeable exposure
- the exposure limit values
- effects of exposure on 'at risk' groups
- consideration of photosensitising chemical substances
- risk of temporary blinding, explosion or fire
- assessment of the availability of alternative equipment to reduce exposure
- appropriate health surveillance information
- manufacturers information
The 'paper' summary is only part of the risk management process. Any actions should be addressed with appropriate controls.
Risk assessment review
The assessment must be reviewed,
- If there are any significant changes in the facility, equipment or activity.
- If there is any reason to suspect that the controls are not adequate, for example, if there has been an incident.
- If there are any changes in the law that impact on the activity
See also: Medical and cosmetic laser risk assessment templates and guidance
Laser Safety Training
The Control of Artificial Optical Radiation at Work Regulations 2010 emphasises the requirement for optical radiation safety training and instruction and states that the following should be included where applicable:
- the measures taken to minimise risk
- exposure limit values
- an explanation of the findings of the risk assessment
- detecting and reporting adverse health effects
- health surveillance
- safe working practices
- proper use of personal protective equipment.
From the list above it is clear that much of the training and instruction is specific to the site and activity. Sending staff on a generic external course will not usually fulfill these requirements.
Other regulations (e.g. The Provision and Use of Work Equipment Regulations, 'PUWER')
reinforce the requirement for adequate training in the safe use of the equipment. For medical and cosmetic applications, training in the use of the machine and how to perform treatments is often referred to as 'applications training'. This type of training is typically carried out initially by the equipment supplier or specialist independent training companies. Further training (new staff etc.) is typically cascaded down in-house.
A popular term to describe laser safety training is 'core of knowledge'. This is not a legally recognised term and there's no set syllabus or content. However, insurance companies and the 'low-end' regulators (councils) may ask for 'core of knowledge certificates'. All training should ideally be tailored to the laser, applications and role of the learner, but as a rough guide, the MHRA have listed an example course content in their guidance publication (DB 2008(03) Guidance on the safe use of lasers, IPL systems and LEDs).
Industry specific legislation
Surgical Lasers in England
Under The Health and Social Care Health and Social Care Act (Regulated Activities) Regulations 2010, providers of healthcare services must register with the Care Quality Commission (CQC) if they use lasers for:
- Treatment of disease, disorder or injury. Exactly what treatments fall into this category will actually be decided by the provider themselves.
- Surgery
Technically, lasers are not specifically regulated, but the activities above, are.
The CQC have published a document entitled "essential standards of quality and safety". This moves away from the old prescriptive 'minimum standards' which have been scrapped. The new standards are intended to be more 'outcome based'. They are open to interpretation but suggest the following:
- Risk assessment and review of risk
- Effective risk management
- Competency to ensure laser safety
- Implement of guidance issued by laser safety experts
London Local Authorities Act 1991 and other regional bye laws (e.g. Nottinghamshire, Essex)
In a few areas of England, businesses using lasers for treatments such as hair removal may be required to purchase a "licence" from their local council. To obtain the licence, a series of conditions must be met that typically includes; training, written procedures and other prescriptive requirements. Note that the vast majority of councils do not require this.
Independent healthcare providers in Scotland
In April 2011, Healthcare Improvement Scotland (HIS) became a regulator of independent hospitals in Scotland and began a schedule of inspection. They have yet to undertake the regulation of independent clinics.
As from 2017, 'Independent Clinics' were required to register with HIS. Whilst there are technically no specific laser requirements, the regulator often asks for additional requirements such as input from a laser safety adviser in to risk assessment process.
Users of lasers and intense light sources in Wales
Under the The Care Standards Act 2000 any business using lasers or intense light sources in Wales must register with the Healthcare Inspectorate Wales (HIW). This involves compliance with the National Minimum Standards for Independent Health Care Services in Wales.
With respect to lasers and intense pulsed light sources, the standards document states that,
"As a minimum, registered persons should be able to demonstrate that service users and patients are protected from adverse incidents or effects from their use, by informing their operational policies, procedures and practices through the standards set out in the MHRA guidance. Treatment protocols must be written by an expert medical or dental practitioner and a certificated Laser Protection Adviser must provide advice on the safety of the laser installation and day to day operational use."
Independent healthcare providers in Northern Ireland
Any private establishment providing treatments using laser or IPL equipment in Northern Ireland must register with the Regulation & Quality Improvement Authority (RQIA) in Belfast.
Registration is required under the
- The Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003
And
- The Independent Health Care Regulations (Northern Ireland) 2005
Lists the prescribed technologies and overview of requirements.
The specific requirements for laser/IPL registration are detailed in the,
Minimum Care Standards for Independent Healthcare Establishments, July 2014, Standard 48, page 106
General health and safety legislation
The main health and safety legislation applicable to optical radiation is:
- The Health and Safety at Work Act 1974
- Employers must ensure the health, safety and welfare of employees as far as is reasonably practicable.
- Health and safety policy/procedures, instruction and training.
- Non-employees must not be exposed to risks (e.g. students, members of public)
- Laser/IPL equipment is safe to use.
- It is the duty of every employee while at work to take reasonable care of him or herself and of any other person who may be affected by his or her actions.
In Northern Ireland, similar provisions are made by the Health and Safety at Work (Northern Ireland) Order 1978.
- The Management of Health and Safety at Work Regulations 1999
- Make arrangements for implementing the health and safety control measures identified as necessary by risk assessments
- monitor and review those arrangements
- appoint people with sufficient knowledge, skills, experience and training to help them to implement these arrangements
- set up emergency procedures (e.g. hospital in case of eye strike)
- provide clear information, supervision and training for employees
- The Control of Artificial Optical Radiation at Work Regulations 2010
These reinforce the Management Regulations above but add more detail specific to optical radiation. Specifically, there are now specific risk assessment and training requirements.
- Make arrangements for implementing the health and safety control measures identified as necessary by risk assessments. This includes:
- measurements or calculations of the levels of optical radiation, if necessary
- consideration of the level, wavelength and duration of foreseeable exposure
- the exposure limit values
- effects of exposure on 'at risk' groups
- consideration of photosensitising chemical substances
- risk of temporary blinding, explosion or fire
- assessment of the availability of alternative equipment to reduce exposure
- appropriate health surveillance information
- manufacturer's information
- Provide clear information, supervision and training for employees, including:
- the measures taken to minimise risk
- exposure limit values
- an explanation of the findings of the risk assessment
- detecting and reporting adverse health effects
- health surveillance
- safe working practices
- proper use of personal protective equipment.
The other main regulations that will have a direct impact on business using lasers are also:
- Workplace (Health, Safety and Welfare) Regulations 1992
- Lighting
- Ventilation
- Temperature
- Cleanliness and waste materials
- Room dimensions and space
- Maintenance
- Floors and traffic routes
- Falling objects
- Personal Protective Equipment at Work Regulations 1992
- Maintained in good order
- Storage
- Provision of instruction and training (risk, correct use, maintenance)
- Where appropriate, organise demonstrations
- Report loss or defect
- Personal Protective Equipment Regulations 2002
- CE marking for laser eyewear
- The Provision and Use of Work Equipment Regulations 1998
- Take into account the working conditions and hazards in the workplace
- Ensure equipment is used only for operations for which it is suitable.
- Ensure that equipment is maintained in an efficient state, in efficient working order and in good repair.
- Give adequate information, instruction and training to operators, supervisors and managers.
-COSHH Regulations 2002
- Hazardous substances (e.g. dye lasers, excimer lasers)
-Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR)
- Certain accidents must be reported to the regulator including;
- death of any person
- a 'major injury' to any person at work,
- hospital treatment of any person who is not at work,
- an accident resulting absence from work for more than 7 days.
-The Manual Handling Operations Regulations 1992
- Most laser equipment is bulky and can introduce manual handling risks.
-The Regulatory Reform (Fire Safety) Order 2005
- Carry out a fire-risk assessment identifying any possible dangers and risks.
- Reduce the risk from fire as far as is reasonably possible and
- Provide general fire precautions to deal with any possible risk left.
- Take other measures to make sure there is protection if flammable or explosive materials are used or stored.
- Create a plan to deal with any emergency and, in most cases, keep a record of your findings and review your findings when necessary.
Note that this applies to England and Wales. Scotland and Northern Ireland have similar regulations.
-Electricity at Work Regulations 1989
- Safety checks should be carried out and documented to ensure the equipment does not present an electrocution risk.
- Health and Safety (Display Screen Equipment) Regulations 1992 (amended in 2002)
- Applies to the displays on almost all modern equipment.
- The Health and Safety (Safety Signs and Signals) Regulations 1996
- Employees must be made aware of exactly what the signs mean and what is expected of them.
In Northern Ireland, the legislation is very similar but is often denoted by "(Northern Ireland)" and is commonly issued one year after the GB legislation. See relevant examples below.
A Health and Safety at Work (Northern Ireland) Order 1978
B The Management of Health and Safety at Work Regulations (Northern Ireland) 2000
C The Control of Artificial Optical Radiation at Work Regulations (Northern Ireland) 2010
D The Personal Protective Equipment at Work Regulations (Northern Ireland) 1993
E The Personal Protective Equipment Regulations 2002
F The Health and Safety (Safety Signs and Signals) Regulations (Northern Ireland) 1996
G The Provision and Use of Work Equipment Regulations (Northern Ireland) 1999
H The Workplace (Health, Safety and Welfare) Regulations (Northern Ireland) 1993
All of the above acts and regulations are freely available to download from government websites. The Health and Safety Executive (HSE) have also produced many guides and information leaflets to present the information in a more readable format. Their website is also a very good general resource.
See also: List of applicable UK legislation
See also: Safety and healthcare regulation in Republic of Ireland
|
Revision Questions 1. Three reasons for health and safety are? 2. List five applicable 'statutory instruments' (laws or regulations)? 3. List three applicable legal requirements |
Government regulators (English example)
There are basically two applicable Health and safety regulators;
(a) Health and Safety Executive, HSE (Hospitals and medical clinics),
(b) Local council (beauty salons and smaller, lower risk businesses).
The HSE will have laser safety specialist knowledge and experience. However, this capability is usually far beyond the resource of the local council. Recent government reports have stated that with respect to non-surgical lasers,
"EHOs [Environmental Health Officers] do not have the training or expertise to determine whether staff are adequately trained and following best practice".
More general government reports have even recommended that Health & Safety regulation be taken away from local councils in favor of direction from the HSE. However, this is unlikely to happen in the near future.
Hospitals and laser clinics may also be regulated by regional healthcare regulators (e.g. Care Quality Commission, CQC). Technically, this is for healthcare rather than health and safety, but there is some natural overlap.
Approved Code of Practice (ACOP)
The HSE have also published 'ACOPs' and guidance for a number of safety statutes. Following these should ensure an appropriate level of legal compliance. With regards to lasers, the HSE have published,
Guidance for Employers on the Control of Artificial Optical Radiation at Work Regulations (AOR) 2010
This can be freely obtained from the HSE or downloaded here: www.lasersafe.co.uk/HSEGUIDE.pdf
Enforcement notices
If a health and safety regulator inspectors a premises and it is deemed that statutory health and safety requirements are not being met, an enforcement notice may be issued.
- Improvement notice: The business is given a timescale in which to ensure compliance and may continue trading.
- Prohibition notice: The business must cease the activity until improvements are made.
Penalties
Court proceedings may result in the following penalties,
Criminal law
- Magistrates ct: organisations can be fined up to 20,000GBP per offence and individuals can be fined up to 5,000 and/or 6 months imprisonment.
- Crown ct: unlimited fines, up to 2 years prison
Civil Law
- Compensation
In 2014, the NHS Litigation Authority reported that a total of 26.1 billion pounds of taxpayer's money (nearly one quarter of the NHS annual budget) has had to be set aside to pay compensation to those harmed by poor care.
The culture in the NHS has traditionally been to cover up or deny mistakes and the problems facing those highlighting weaknesses (unhelpfully termed 'whistleblowers') is well documented. It is hoped that good examples from other industries (the airline industry is often cited) might be imported into the NHS. In the meantime, the government has plans to implement a system of financial sanctions for hospitals that fail to be honest about clinical mistakes, in an effort to reduce the 'cover up culture'.
|
Revision Questions 1. When should risk assessments be reviewed? 2. What enforcement action can a regulator take? 3. Which legal system is used to make compensation claims (civil or criminal)? |
