Client and practitioner safety in microneedling treatments depends largely on strict compliance with hygiene and sterilisation protocols. As this technique compromises the integrity of the skin barrier, failure to follow these measures can have serious consequences, including bacterial, viral or fungal infections, and transmission of blood-borne pathogens.
Applicable regulatory framework in Spain
In Spain, aesthetic centres performing microneedling must comply with:
- Royal Decree 1420/2013, on sanitary conditions for tattooing, micropigmentation and analogous establishments
- Royal Decree 65/2006, on requirements for pressure equipment
- Specific regional regulations (each autonomous community may establish additional requirements)
- EU Regulation 2017/852 on mercury and other related European regulations
Personal protective equipment (PPE)
The practitioner must wear the following PPE throughout the entire microneedling procedure:
- Disposable nitrile gloves: not latex (allergy risk for clients). Change if punctured or in contact with contaminated surfaces.
- Surgical or FFP2 mask: especially where there is a risk of aerosols (though in standard microneedling the risk is low).
- Protective eyewear: recommended to prevent accidental fluid splashes.
- Clean work gown or apron: changed between clients or if contaminated.
Work area preparation
Surface cleaning and disinfection
Before each treatment:
- Clean all work surfaces (treatment bed, instrument tray, auxiliary table) with hospital-grade detergent.
- Apply high-level disinfectant (2% glutaraldehyde, sodium hypochlorite at 1000 ppm, or broad-spectrum disinfectant with virucidal and fungicidal activity).
- Cover the treatment bed with disposable paper (change between each client).
- Prepare materials on a sterile instrument tray covered until use.
Single-use materials
The following items must be single-use and disposed of in the appropriate container after each client:
- Dermapen needle cartridge
- Gauze and cotton swabs
- Gloves
- Treatment bed paper
- Active ampoules (do not reuse leftovers)
Dermapen device maintenance
Device body
The dermapen body (the motorised part that holds the cartridge) does not come into direct contact with the skin but may become contaminated by splashes. After each session:
- Remove the needle cartridge wearing gloves without touching the needles directly.
- Clean the device body with a cloth soaked in alcohol disinfectant (70% ethanol or isopropanol) or as directed by the manufacturer.
- Do not submerge in liquids or autoclave sterilise (electronic components cannot withstand this).
- Store in its protective case in a clean, dry location.
Needle cartridges
Needle cartridges are single-use. They must never be reused on the same client between sessions, nor between different clients. Using worn or deformed needles reduces treatment efficacy and may cause skin tears.
Waste management
Waste generated during a microneedling treatment is Class II sanitary waste (non-special bio-sanitary). Its management must comply with:
- Needle cartridges (sharps waste) must be deposited in rigid puncture-resistant containers approved for sharps waste.
- Gauze contaminated with blood or bodily fluids is managed as Class II sanitary waste.
- The centre must hold a contract with an authorised sanitary waste management company.
Specific infection prevention
Cold sore prevention
In clients with a history of recurrent oral herpes (HSV-1), microneedling in the perioral area may trigger an outbreak. Prophylaxis with oral aciclovir (prescribed by a doctor) 24–48 hours before treatment is recommended for at-risk clients. If there is an active outbreak, postpone the treatment.
Cross-contamination
Take extreme precautions to avoid cross-contamination between clients. Cosmetic products (BCN actives) must not be shared between clients: each ampoule is used in full or the remainder discarded. Do not reinsert the applicator into the ampoule after contact with the client's skin.
Pre-session checklist
Before starting each session, verify:
- ☐ Full PPE in place
- ☐ Surfaces disinfected
- ☐ Treatment bed covered with disposable paper
- ☐ New cartridge in the dermapen
- ☐ Actives at room temperature
- ☐ Sharps container accessible
- ☐ Medical history and consent form signed