Risk assessment

Microneedling Risk Assessment

Collagen Induction Therapy and Skin Needling - Clinical, Infection Prevention and Treatment Safety Risk Assessment for Aesthetic Practice

For Aesthetic ClinicRef BS-AES-RA-008See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
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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
  • 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
  • Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013
  • Medical Devices Regulations 2002 (as amended)
  • Health and Safety at Work etc. Act 1974
  • Local Government (Miscellaneous Provisions) Act 1982
  • London Local Authorities Act 1991
  • Health and Care Act 2022

Who it applies to

All registered managers, prescribing clinicians, aesthetic practitioners, skin therapists, healthcare assistants and reception staff involved in the consultation, delivery or aftercare of microneedling (collagen induction therapy) treatments at [Organisation Name]

Glossary

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

Adverse event
Any unexpected or unwanted occurrence linked to a treatment that harms, or could harm, a patient.
Anaesthetic (topical)
A numbing cream or gel applied to the skin to reduce pain during a procedure.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Aseptic non-touch technique
A careful method of working that avoids touching key parts and sites so that germs are not introduced during a procedure.
Basic life support (BLS)
Emergency first-aid skills, such as chest compressions and rescue breaths, used to keep someone alive until help arrives.
Blood-borne virus (BBV)
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
CE marking / UKCA marking
Marks placed on a product to show it meets the safety standards required to be sold in Europe (CE) or in Great Britain (UKCA).
Collagen induction therapy
Another name for microneedling: making tiny controlled punctures in the skin to prompt it to repair itself and produce more collagen.
Contraindication
A condition or circumstance that makes a particular treatment unsuitable or unsafe for that person.
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)
The body that sets clinical standards for non-surgical cosmetic treatments in the United Kingdom.
Decontamination
The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
Dermis
The deeper layer of the skin that lies beneath the surface and contains collagen, blood vessels and nerves.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
Epidermis
The thin outermost layer of the skin.
Fitzpatrick skin type
A scale from I to VI that classifies skin by how much pigment it has and how it reacts to sunlight, used to plan safe treatment.
Fundamental standards
The minimum standards of safety and quality below which care must never fall.
Health and Care Act 2022
A United Kingdom law that, among other things, gives the power to set up a licensing scheme for cosmetic procedures in England.
Health and Safety at Work etc. Act 1974
The main law placing a general duty on employers to protect the health and safety of staff and others affected by their work.
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 / hepatitis C
Viral infections of the liver that can be passed on through contact with infected blood.
Herpes simplex virus (HSV)
The common virus that causes cold sores around the mouth and can flare up after skin treatment.
HIV
A virus, passed on through blood and certain body fluids, that attacks the immune system.
Hyperpigmentation / hypopigmentation
Patches of skin that become darker (hyper-) or lighter (hypo-) than the surrounding skin, sometimes after treatment.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Informed consent
Agreement to treatment given freely after the risks, benefits and alternatives have been clearly explained.
Instructions for use (IFU)
The written guidance a manufacturer supplies with a device, setting out how to use it safely and correctly.
Isotretinoin
A strong oral medicine for severe acne that thins and sensitises the skin, so recent use can make some treatments unsafe.
Joint Council for Cosmetic Practitioners (JCCP)
The voluntary register and standards body for practitioners providing non-surgical cosmetic treatments in the United Kingdom.
Keloid
A raised, overgrown scar that extends beyond the original wound, more likely in people prone to it.
Lidocaine / tetracaine
Local anaesthetic medicines commonly used in numbing creams applied to the skin.
Local Government (Miscellaneous Provisions) Act 1982
A law under which local authorities outside London register premises and practitioners that carry out skin piercing.
London Local Authorities Act 1991
The equivalent law to the 1982 Act under which skin-piercing premises and practitioners are registered within London.
Management of Health and Safety at Work Regulations 1999
The law requiring employers to assess workplace risks and put suitable controls in place.
Medical Devices Regulations 2002
The United Kingdom law governing the safety, marking and monitoring of medical devices such as microneedling pens and cartridges.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom body that regulates medicines and medical devices and monitors their safety.
Methaemoglobinaemia
A blood disorder, occasionally triggered by some anaesthetics, in which the blood carries less oxygen than normal.
Microneedling
A treatment that uses fine needles to make tiny controlled punctures in the skin to prompt repair and renewal.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
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.
Occlusion
Covering a treated area, for example with a dressing or film, which can increase how much of a product the skin absorbs.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Post-exposure prophylaxis (PEP)
Medicine started soon after possible exposure to an infection, such as HIV, to reduce the chance of catching it.
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.
Residual risk
The level of risk that remains after control measures have been put in place.
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.
Safety data sheet (SDS)
A manufacturer's document describing a chemical's hazards and how to handle, store and dispose of it safely.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Sharps bin
A rigid, sealable container for the safe disposal of used needles and other sharps.
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).
Skin piercing
Any procedure that breaks the skin with a needle or similar instrument, a category that includes microneedling for registration purposes.
Sun protection factor (SPF)
A measure of how well a sunscreen protects the skin from the sun's burning ultraviolet rays.
Vasovagal syncope
A common, brief faint caused by a sudden drop in heart rate and blood pressure, often triggered by pain or anxiety.
Venous thromboembolism (VTE)
A blood clot that forms in a vein, which can be serious if it travels to the lungs.
Yellow Card scheme
The United Kingdom system for reporting suspected problems with medicines or medical devices to the Medicines and Healthcare products Regulatory Agency.

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