Risk assessment

Dermal Filler Treatments Risk Assessment

A comprehensive risk assessment for the provision of injectable dermal filler treatments in an aesthetic clinic setting, aligned to the CQC single assessment framework and the relevant statutory and professional standards.

For Aesthetic ClinicRef BS-AES-RA-004See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

This risk assessment is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Scope and purpose
  • 2. Legal and regulatory framework
  • 3. Risk assessment methodology
  • 4. Hazards, controls and risk rating
  • 5. Action plan
  • 6. Monitoring and review
  • 7. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
  • Care Quality Commission (Registration) Regulations 2009
  • Health and Safety at Work etc. Act 1974
  • Management of Health and Safety at Work Regulations 1999
  • Control of Substances Hazardous to Health Regulations 2002
  • Health and Safety (Sharps Instruments in Healthcare) Regulations 2013
  • Human Medicines Regulations 2012
  • Medical Devices Regulations 2002 (as amended)
  • Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013
  • Data Protection Act 2018 and the UK General Data Protection Regulation
  • Local Government (Miscellaneous Provisions) Act 1982 (special treatment licensing where applicable)

Who it applies to

All clinical, registered and support staff, contractors, locum practitioners and persons who carry out, assist with, or are present during dermal filler consultations and treatments at [Organisation Name].

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

ABCDE approach
A standard emergency method for assessing and treating a seriously ill patient in order: Airway, Breathing, Circulation, Disability and Exposure.
Accident and emergency department
The hospital department that treats people with serious or life-threatening injuries and illnesses needing urgent care.
Adrenaline
An emergency medicine injected to treat a severe allergic reaction (anaphylaxis).
Adverse event
Any unexpected or unwanted occurrence linked to a treatment that harms, or could harm, a patient.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Aseptic non-touch technique
A careful method of carrying out a procedure so that the parts that must stay sterile are never touched, reducing the risk of infection.
Aspiration
Drawing back on the syringe plunger before injecting to check the needle has not entered a blood vessel.
Basic life support (BLS)
First-response emergency care, such as chest compressions and rescue breaths, given to keep someone alive until advanced help arrives.
Best interests
A decision made for someone who cannot decide for themselves, choosing the option that is best for them.
Biofilm
A thin, stubborn layer of bacteria that can form around an implant or filler and cause persistent infection.
Blood-borne virus (BBV)
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Body dysmorphic disorder (BDD)
A mental health condition in which a person worries excessively about perceived flaws in their appearance.
British Standard BS 7320
The published safety standard that sharps disposal bins must meet.
Cannula
A thin, blunt-tipped tube used instead of a sharp needle to place filler with less risk of damaging blood vessels.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
CE marking
A mark showing a product meets European safety and performance standards, still recognised for some products placed on the UK market.
Chlorhexidine
An antiseptic solution used to clean the skin before injection to reduce infection.
Cold chain
Keeping vaccines and certain medicines within a safe temperature range from delivery to use.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
The law for safely managing chemicals and other hazardous substances at work.
Cooling-off period
A set waiting time between consultation and treatment so the patient can reflect before deciding to go ahead.
Cosmetic Practice Standards Authority (CPSA)
A body that sets clinical standards for safe practice in cosmetic procedures.
Decontamination
The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
Dermal filler
A gel substance injected under the skin to smooth lines or add volume, most often made from hyaluronic acid.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
Granuloma
A small lump of inflamed tissue that the body can form as a reaction around injected filler.
Health Technical Memorandum 07-01
Official guidance on the safe and sustainable management and disposal of healthcare waste.
Hepatitis B
A virus that infects the liver and can be passed on through blood; staff can be protected by vaccination.
Hyaluronic acid
A natural substance found in the skin, used in many dermal fillers and able to be dissolved if needed.
Hyaluronidase
An enzyme injected to dissolve hyaluronic acid filler, used to correct problems or reverse a blocked blood vessel.
Immediate life support (ILS)
A level of emergency resuscitation training above basic first aid, covering the early management of a collapsing patient.
Indemnity
Insurance or professional cover that pays compensation if a patient is harmed and makes a claim.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Information governance
The framework for handling people's personal and health information legally, securely and appropriately.
Informed consent
Agreement to treatment given freely after the risks, benefits and alternatives have been clearly explained.
Inoculation injury
An injury, such as a needlestick or splash, that could pass infection from blood or body fluids into a person.
Joint Council for Cosmetic Practitioners (JCCP)
A voluntary register and standards body for practitioners who carry out cosmetic procedures.
Lidocaine
A local anaesthetic medicine used to numb the skin and reduce pain during treatment.
Medical device
A product, such as a dermal filler, used for a medical or treatment purpose rather than working like a medicine.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK body that regulates the safety of medicines and medical devices.
Mental capacity
Whether a person can understand and make a particular decision for themselves at the time it needs to be made.
Mental Capacity Act 2005
The law that protects and supports people who may be unable to make particular decisions for themselves.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Necrosis
The death of body tissue, which can follow a blocked blood vessel after filler injection.
Nominated Individual
The senior person responsible to the regulator for supervising how a service is provided.
Notifiable event
An incident a provider is legally required to report to the regulator, such as a death or serious injury.
Patient Specific Direction (PSD)
A written instruction from a prescriber to give a named medicine to a named individual patient.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Post-exposure prophylaxis (PEP)
Medicine given soon after possible exposure to an infection, such as HIV, to help prevent it taking hold.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR)
The law requiring certain workplace injuries, diseases and dangerous events to be reported to the Health and Safety Executive.
Risk assessment
A structured check identifying what could cause harm and what is being done to prevent it.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Single assessment framework
The structure the regulator uses to judge a service, built around quality statements and five key questions (safe, effective, caring, responsive, well-led).
So far as is reasonably practicable
A legal test meaning the effort and cost of a safety measure must be balanced against the risk it removes.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
UKCA marking
A mark showing a product meets the safety and performance requirements for sale in Great Britain.
Vascular occlusion
A blockage of a blood vessel, here by filler, which can cut off blood supply and cause tissue death or blindness.
Yellow Card scheme
The UK system for reporting suspected side effects of medicines or faults in medical devices to the regulator.

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  3. Complete the placeholders for your service, then have it approved before use.
  4. Add the optional updates subscription and we keep it current as guidance changes.

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