Risk assessment

Thread Lift Procedures Risk Assessment

Polydioxanone (PDO) and absorbable suspension thread lifting - identification, evaluation and control of clinical, infection prevention and patient safety risks for an aesthetic clinic

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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 - Regulations 9, 10, 11, 12, 13, 17, 18 and 19
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20 (Duty of Candour)
  • Care Quality Commission (Registration) Regulations 2009
  • Health and Safety at Work etc. Act 1974 and the Management of Health and Safety at Work Regulations 1999
  • Control of Substances Hazardous to Health Regulations 2002 (COSHH)
  • Human Medicines Regulations 2012 and Medicines and Healthcare products Regulatory Agency (MHRA) requirements
  • Medical Devices Regulations 2002 (as amended) and UKCA / CE marking requirements
  • Health and Safety (Sharps Instruments in Healthcare) Regulations 2013
  • Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR)
  • Health and Care Act 2022, section 180 (licensing scheme for non-surgical cosmetic procedures in England)

Who it applies to

All registered managers, prescribers, aesthetic practitioners (medical and non-medical), clinical assistants, reception and decontamination staff involved in the consultation, prescribing, undertaking or aftercare of thread lift procedures at [Organisation Name]

Glossary

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

Adrenaline (epinephrine)
An emergency medicine given by injection to treat a severe allergic reaction, and also added to local anaesthetic to reduce bleeding.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Aseptic non-touch technique (ANTT)
A standard method of carrying out a procedure so that the parts that must stay sterile are never touched, to prevent infection.
Aspiration
Drawing back on a syringe before injecting to check the needle is not in a blood vessel.
Best interests
A decision made for someone who cannot decide for themselves, choosing the option that is best for them.
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 is excessively preoccupied with a perceived flaw in their appearance.
Cannula
A thin tube, sometimes with a blunt tip, inserted under the skin to place threads or other material with less risk of injuring 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 standards and may lawfully be placed on the market.
Chlorhexidine
An antiseptic used to clean the skin before a procedure to reduce infection risk.
Clinical governance
The system through which a service monitors and improves the quality and safety of the care it provides.
Cold chain
Keeping vaccines and certain medicines within a safe temperature range from delivery to use.
Continuing professional development (CPD)
Ongoing learning and training that keeps a practitioner's knowledge and skills up to date.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
The law for safely managing chemicals and other hazardous substances at work.
Cosmetic Practice Standards Authority (CPSA)
A body that sets clinical standards for non-surgical cosmetic treatments in the UK.
Decontamination
The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
Disclosure and Barring Service (DBS) check
A criminal-records check showing whether a person is suitable to work with patients or vulnerable people.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
Embolic event
A blockage of a blood vessel by material that has travelled through the bloodstream, which can cause serious harm.
Extrusion
Where an inserted thread works its way back out through the skin.
Freedom to speak up
Arrangements that allow staff to raise concerns about wrongdoing, risk or poor care without fear of being penalised.
Fundamental standards
The minimum standards of safety and quality below which care must never fall.
General Dental Council (GDC)
The body that registers and regulates dental professionals in the UK.
General Medical Council (GMC)
The body that registers and regulates doctors in the UK.
General Pharmaceutical Council (GPhC)
The body that registers and regulates pharmacists and pharmacy technicians in the UK.
Granuloma
A small lump of inflamed tissue that can form as the body reacts to a foreign material such as a thread.
Health and Care Act 2022
An Act of Parliament that, among other things, provides for a licensing scheme for non-surgical cosmetic procedures in England.
Health and Safety at Work etc. Act 1974
The main law placing duties on employers to protect the health and safety of staff and others.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that providers of regulated care must meet.
Hepatitis B immunisation
A vaccination that protects against the hepatitis B virus, recommended for staff at risk of blood exposure.
Human Medicines Regulations 2012
The main law governing the licensing, supply, prescribing and administration of medicines in the UK.
Hyaluronidase
An enzyme injected to dissolve hyaluronic-acid dermal filler, used to treat certain filler complications.
Immediate life support (ILS)
Training in the initial steps of treating a person whose heart or breathing has stopped, until further help arrives.
Indemnity (medical indemnity)
Insurance or cover that protects a practitioner against the cost of claims arising from their clinical work.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Inoculation injury
An injury, such as a needlestick or splash, that could expose a person to infection from blood or body fluids.
Instructions for use (IFU)
The manufacturer's written guidance on how to store and use a device or product safely.
Intralipid (lipid emulsion)
A fatty emulsion given into a vein as an emergency treatment for severe local anaesthetic poisoning.
Joint Council for Cosmetic Practitioners (JCCP)
A register and standards body for practitioners who provide non-surgical cosmetic treatments in the UK.
Local anaesthetic
A medicine that numbs a specific area of the body so a procedure can be carried out without pain.
Local anaesthetic systemic toxicity (LAST)
A dangerous reaction caused by too much local anaesthetic reaching the bloodstream, affecting the heart and nervous system.
Management of Health and Safety at Work Regulations 1999
The law requiring employers to assess and manage risks to health and safety at work.
Medical Devices Regulations 2002
The law governing the safety, marking and supply of medical devices in the UK.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK body that regulates medicines, medical devices and blood components for safety and quality.
Mental capacity
Whether a person can understand and make a particular decision for themselves at the time it needs to be made.
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, for example skin, often caused by a loss of blood supply.
Nominated Individual
The senior person responsible to the regulator for supervising how a service is provided.
Notifiable safety incident
An incident during care that results in, or could result in, significant harm and which the provider must be open about under the duty of candour.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses and midwives in the UK.
Percutaneous
Carried out through the skin, for example by passing a needle or thread through it.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Poly-L-lactic acid (PLLA)
An absorbable synthetic material used in some lifting threads that also stimulates the body to produce collagen.
Polycaprolactone (PCL)
A slowly absorbable synthetic material used to make some lifting threads.
Polydioxanone (PDO)
A common absorbable synthetic material used to make lifting threads, which the body breaks down over several months.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Prophylactic antibiotic
An antibiotic given to prevent infection rather than to treat an existing one.
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.
Resuscitation Council UK
A UK body that produces the recommended guidelines for treating cardiac arrest and other medical emergencies.
Revalidation
The periodic process by which registered professionals demonstrate they remain fit to practise.
Rhytidectomy
The medical term for a surgical face-lift.
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).
Standard operating procedure (SOP)
A written, step-by-step instruction for carrying out a routine task consistently and safely.
Subcutaneous
Relating to the layer of tissue just beneath the skin.
Subdermal plane
The level just below the skin where lifting threads are usually placed.
Suspension suture
A thread inserted under the skin to lift and hold soft tissue in a new position.
UKCA marking
The UK mark showing a product meets the relevant Great Britain safety standards and may lawfully be placed on the market.
Vascular occlusion
A blockage of a blood vessel, which can cut off the blood supply to tissue and cause serious harm.
Vector
The direction along which a thread is placed to lift tissue.

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