Abstract
Introduction
While the demand for aesthetic procedures is rising, complications are rising alongside. Infection is a frequent complication, there is therefore an increased need for strict aseptic technique, particularly in procedures breaching the skin. The level of training of practitioners carrying out these procedures varies and there are no comprehensive guidelines on aseptic aesthetic practice in the Benelux region.
Objective
Developing a step‐by‐step procedure for achieving and maintaining a high standard of aseptic conditions in a standard aesthetic practice in the Benelux region.
Methods
A consensus group of 10 aesthetic medical practitioners (dermatologists, plastic surgeons, and cosmetic physicians) representing the Benelux region convened to discuss best practice for aseptic techniques in medical aesthetics. Step‐by‐step procedures were recommended to achieve optimal aseptic practice in private facilities and define important considerations for reducing infection risk. Recommendations were based on current evidence and extensive clinical experience.
Results
Recommendations were made to achieve and maintain a high standard of asepsis and infection control. Guidance included maintaining high standard aseptic conditions of the injecting room, the injecting area on the patient, the injection procedure, the materials, and procedures commonly used to achieve aseptic conditions.
Conclusions
This expert consensus summary publication recommends aseptic procedures, setting a standard with the goal of minimizing rates of complications in aesthetic clinical practice in the Benelux region.
Keywords: aesthetic, Aseptic, clinic, injection, standards
1. INTRODUCTION
Aesthetic clinical practitioners face challenges in maintaining infection control; however, due to variation in local guidelineswithan extensive catalogue of techniques practiced, the minimum and optimal standards required for asepsis are sometimes unclear.
With a rising demand for aesthetic procedures and a broad range of specialities able to perform procedures, injection complication rates have risen in recent years.1, 2
European Standard EN 16844, published in 2017 and updated in 20193 was designed to enhance patient safety and reduce the risk of complications in aesthetic medicine across Europe. It covers:
Treatments with resorbable injectables, botulinum toxin, and micro needling
Treatments with non‐ablative fractional resurfacing and superficial peels, lasers (and comparable devices)
Treatments with fractional ablative lasers (and comparable devices) and medium depth peels
Other treatments such as deep chemical peels, full ablative lasers, and thread lifts
The Standard provides recommendations for aesthetic non‐surgical medical treatments, including hygiene standards for treatment rooms and procedure rooms as well as recommendations on training and continuous professional development, and guidance on patient consultation and assessment. However, aesthetic non‐medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) that can be performed by non‐physicians (e.g., tattooist, beauty therapists) are excluded. Additionally, in certain countries, specific national regulations apply and take precedence over this European Standard. The document also notes that “Other factors which influence the overall quality of service include: qualifications and professional competencies, staff behaviour, facility design and choice of products and suppliers.”
1.1. Types of treatments
Injectables for facial aesthetics include a range of products, both pharmaceutical and non‐pharmaceutical including:
Botulinum toxin. A prescription only medicine, which may only bedispensed and used by medically qualified professionals4, 5, 6, 7
Dermal fillers, including hyaluronic acid‐based products for:
Superficial treatment of skin lines and wrinkles
Deeper and higher volume treatments8
Currently, in the EU, regulatory authorities class dermal fillers as medical devices, which do not undergo the same level of clinical scrutiny as medicinal products and require only the Conformité Européene (CE) mark to receive a product license.9
1.2. Specialties
Aesthetic procedures are carried out by a range of practitioners in Belgium, Netherlands, and Luxembourg including Dermatologists, Plastic surgeons, Aesthetic doctors, beauty therapists, and even hairdressers (sometimes despite official recommendations to the contrary) etc. with accompanying variation in the setting the procedure takes place in. Evolving legislation differs across the countries resulting in a lack of clarity on permitted procedures per specialty. Table1 offers an insight based on existing legislation and the group's experiences.
TABLE 1.
Specialty of practitioners permitted to perform aesthetic procedure across the Benelux region
| BOTOX | Dermal fillers | Deep peels | Medium peels | Microdermabrasion/Superficial peels | Needling/ Mesotherapy | Ablative lasers | Non‐ablative lasers | Thread Lift | PRP | |
|---|---|---|---|---|---|---|---|---|---|---|
| Belgium | MD | MD | MD | Medical professionals | Any | Medical professionals | MD | Any (BVEG) | MD | MD |
| Netherlands | MD | MD | MD | Skin therapist | Any | Medical professionals | MD | Skin therapist | MD | MD |
| Luxembourg | MD | MD | Any |
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1.3. Complications
Infections are the most frequent serious complication (self‐limiting temporary complications such as redness and bruising excluded).10 The frequency of serious infections is generally accepted to be underreported after aesthetic procedures. Infection risks to consider before injecting a patient include viral, bacterial, and fungal (usually Candida) species.11, 12 Other complications reported following the application of soft tissue fillers, include delayed inflammatory nodule formation,13 granulomatous reactions, pigmentary changes, hypersensitivity reactions, vascular occlusion,14, 15 and rarely blindness.16 These can all be further complicated by secondary infection.17, 18 One report in 2017 recorded 934 complaints regarding unregistered practitioners, and 616 related to use of dermal fillers; mainly associated with lip procedures.19
An improved understanding and practice of aseptic technique minimizes the potential for cross‐contamination and infection, ensuring that only uncontaminated equipment and products come into contact with susceptible treatment areas.20
2. METHODS
A consensus group of 10 expert aesthetic medical practitioners representing the Benelux region convened to discuss best practice for aseptic techniques in medical aesthetics. Experts were virtually gathered for the discussion in July 2020. Specialities present included dermatologists, aesthetic physicians, and a plastic surgeon.
The virtual meeting was led by a chairperson and notes were recorded by a medical writer. Prepared questions designed in conjunction with a member of the advisory board were introduced to structure the meeting and answers were sought from the group (Supplemental material: Appendix Table 1).
The main objective was developing a step‐by‐step procedure for achieving and maintaining a high standard of aseptic conditions in a standard aesthetic clinic in the Benelux region. Also, other important considerations for reducing infection risk were defined.
Recommendations were based on current evidence and extensive clinical experience and consensus was reached via group discussion and agreement, with any objections noted.
Discussion centered on:
Achieving and maintaining high standard aseptic conditions of:
an injecting room
an injecting area on the patient
the injection procedure
The materials and procedures commonly used to achieve aseptic conditions
The procedural challenges
3. RESULTS
Via discussion, consensus was reached by the group on recommendations for achieving and maintaining a high standard of aseptic conditions in a standard aesthetic clinic by the group and are presented below.
3.1. Patient selection
Selecting appropriate patients and not treating inappropriate patients is one of the most important considerations in aesthetic medicine.21 Obtaining a thorough patient history of skin conditions, as well as allergies, systemic disease, current medication, and previous procedures is mandatory clinical practice12 since skin conditions and infections can be exacerbated, causing complications following aesthetic procedures.21
Pre‐treatment of underlying conditions such as rosacea, dermatitis, or Herpes simplex, may be important to enable adequate healing time to restore the skin's barrier function.22 Practitioners may wish to consider pre‐treating patients with a history of cold sores or fever blisters with antivirals, such as acyclovir, to reduce the risk of cutaneous herpes infections.21
Contraindications include patients with remote infections,12 and caution should be applied when considering dermal fillers in patients with compromised immune systems, such as with HIV, cancer treatment, immunotherapy, or poorly controlled diabetes.11
In cases of active inflammatory dermatitis, including atopic dermatitis, allergic contact dermatitis, and seborrheic dermatitis, the clinician must make their best judgment for treatment based on the severity of the condition and its proximity to the treatment area.21
3.2. Recommendations for achieving and maintaining aseptic conditions
3.2.1. Treatment room preparation
A summary of recommendations for treatment room preparation are shown in Figure1.
FIGURE 1.
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3.2.2. Patient preparation
Before any procedure, patients should be advised to attend clinics with a clean face and without cosmetics. If they do attend with make‐up, this should be removed with a make‐up remover for sensitive skin (See also section 4. Board recommendations: Patient considerations, for further information)
Practitioners should then disinfect the skin of the entire face, repeating this with any change in injection zone when a cannula is used
For skin disinfecting, use chlorhexidine (2%) or isopropyl alcohol (70%)
Hair should be secured away from the treatment area (use plastic hairbands for ease of disinfection and reuse, or a disposable hair cap)
Patients do not need to shave their beard to receive an injection because:
Disinfection of the treatment area of the skin will also cover the hairs in the area
Shaving can cause microwounds
In certain circumstances, beards do not cover the treatment area
If the patient is involved with holding or applying pressure, their hands should be cleansed with alcohol as a minimum, but preferably gloved
Cyclodextrin‐based mouthwash is preferred over chlorhexidine, used when procedures involve the lips. A 1% hydrogen peroxide solution may also be used
Spectacles are not considered an infection risk though are usually removed due to inconvenience of access to the treatment area
Treating patients with pre‐existing diseases or skin conditions is possible but considering the criteria as mentioned in section 1. Patient selection
3.2.3. Practitioner preparation
A summary of recommendations for practitioner preparation are shown in Figure2.
FIGURE 2.
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3.3. Recommendations for treatment room procedures
3.3.1. Layout and accessibility
The placement of consumables needed for procedures is still debated. Some practitioners prefer having the products accessible immediately and some prefer discussing the treatment plan with patient, then bringing the required products into the treatment room, see Table2 for the factors that can influence this decision.
TABLE 2.
Positive and negative considerations for keeping products out of the treatment room pre‐procedure
| Positive | Negative |
|---|---|
| Less pressure on the patient for purchasing specific products | Physicians should not access cabinets during the procedure, as this will require restarting the aseptic technique. |
| Reassurance that the purchased product is not shared between others |
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However, having products and treatment devices readily accessible, on the table, and available before the patient enters the treatment room:
Fosters trust between the patient and Injector and improves understanding of the products and procedure
Opening new products/blisters in front of the patient provides reassurance
Means less movement around the treatment room in general, which is considered increasingly important post‐COVID‐19
Post‐injection, ensure the treatment area (and chair) is thoroughly cleaned
3.3.2. Waste disposal (sharps bins, general clinical bin)
In the EU, recapping a needle before disposal into a sharps bin is (although not recommended) a common practice
Used product vials should be discarded in a medical waste bin (with deactivation of remaining product if applicable)
3.3.3. Cleaning surfaces of the treatment area
Pre‐treatment, standard aseptic cleaning techniques should be implemented
For cleaning of surfaces, isopropyl alcohol or 70% ethanol should be used—the effect of isopropyl alcohol is short lived.
Cleaning products with different mechanisms of action should not be mixed (positive vs negative)
The Board agreed that cleaning is paramount when applying dermal filler due to the risk of latent infections
There was also agreement that botulinum toxin is less complicated for Injectors compared with dermal fillers, due to the virtually non‐existent rate of infection complications
A pencil is sometimes used for marking an injection area.
If a pencil is used, ensure it is first cleaned with alcohol
The pencil is a source for contamination and should be removed before injection
Do not inject through a mark on the skin. Either remove prior to injection, or inject adjacent to the mark
3.3.4. Air Circulation (cleaning of vents and air conditioning filters)
Comfortable working environments are important for both physicians and patients.
Air conditioning systems will not infect patients, but they must have a HEPA filter and receive regular cleaning and maintenance
Open windows are generally not considered clean, as they permit contamination via pollution and insects; however, with COVID‐19 measures in place, it is commonly recommended to open windows in between patients to refresh and decontaminate the air in the room
None of the Board use ozone‐based disinfecting aerosols
3.3.5. Other cleaning considerations
Cold packs are used pre‐ or post‐procedure, but not peri‐procedure
Before use, cold packs are washed with disinfectant soap and water, then cleaned with disinfectant wipes
Products such as CoolSense® pain numbing applicator, which provides a cap with a disinfection mechanism, are available for peri‐procedure use when injecting botulinum toxin.
3.4. Recommendations: Patient considerations
3.4.1. Make‐up/skin cleansing
Prior to any procedure, patients should be advised to attend clinics with a clean face and without cosmetics. Although patients are required to attend clinic without make‐up, it was noted by the board that around half still have cosmetics applied pre‐procedure.
Post‐procedure, recommendations varied between the Board, with a general consensus favoring no make‐up for 4 to 24 hours afterwards
If absolutely necessary, the patient can be supplied with a sterile, SPF 50 cosmetic sample; or alternatively, they can purchase new make‐up—patients must not use contaminated (already opened or personal) cosmetics within this period
While injection wounds close rapidly, for simplicity patients can be advised to apply no make‐up until the following day
3.4.2. Skin disinfection
The Board recommended that once make‐up (and any residual dirt) is removed, a disinfectant should be applied
Any products used to clean the face should be gentle and hypoallergenic
Where dermal fillers are used, disinfect the whole face
Before using a needle, disinfect the treatment area once, but not every subsequent time; treatment areas should be disinfected every time before use of a cannula
Disinfect widely around area of cannula use, as several motions are used, increasing the risk of environment skin contact and cross‐contamination
Due to the risk of keratitis, chlorhexidine should not be used around the ocular area. Hypochlorous acid is a suitable substitute
The face should be cleaned again following procedure and then left alone
Application of a sterile balm following lip procedures was recommended
3.4.3. Hair and beards
Any hair in the treatment area should be cleaned thoroughly with a disinfectant
Hair should be covered or fixed with a hairband
3.4.4. Hands
The Board recommended that patients should not attend a professional masseuse or beautician for 48 hours post‐procedure.
Massaging following dermal fillers is not recommended as manipulation can relocate the position of the implant
Gentle self‐massage of nodules was considered acceptable if the patient's hands are cleaned appropriately or gloved
3.4.5. PPE (patient)
Pre‐COVID‐19, PPE was not recommended for patients by any of the Board
Up‐to‐date local guidelines for aesthetic clinical practice should be followed during the COVID‐19 pandemic
3.4.6. Injection site specific precautions
Earrings were considered acceptable if small (studs) and not within the treatment area
Large or drop earrings should be removed pre‐procedure
3.5. Recommendations: Physician considerations
3.5.1. PPE
Latex‐free, powder‐free gloves are the recommended standard
Powdered gloves should not be used, as they can create an aerosol
Post‐COVID‐19, masks are recommended during application of dermal fillers (but not botulinum toxin), during insertion of threads, and with certain laser treatments
Aesthetic treatment areas should be considered as a surgical field; FFP2 face masks should be worn
Up‐to‐date local guidelines for aesthetic clinical practice should be followed during the COVID‐19 pandemic
3.5.2. Hands (sterilization and gloves)
One pair of gloves should be used per procedure (unless contaminated); hands should be washed with soap and water, then cleaned with alcohol
The Board recommended that a glove needs changing immediately following contact with the patient's mucosa
3.6. General recommendations for injectors' practice
The patient should be informed about the procedure and any potential safety issues that may occur—informed consent is vital
The Board recommended that everybody helping, assisting, or involved in the treatment of patients should receive adequate support and training to minimize the risk of error
Pre‐procedure, a welcoming, reassuring, and courteous attitude of the injector is important to engender trust
Providing a good ambiance helps ensure the patient is relaxed and comfortable
Injectable products from different manufacturers or with different mechanisms of action should not be mixed, as this can cause a change in physicochemical properties and a potential breach of sterility23
Clinics should have a resuscitation protocol, especially if there is a risk of anaphylaxis
The Board recommended that post‐injection advice should be provided to the patient both verbally and in writing
Contact lenses only need removing if procedures require the use of a CO2 laser (and with other warming devices like TIXEL®)
For many patients, music (jazz/lounge) during a procedure can contribute to a more pleasant experience
4. DISCUSSION
These Advisory board consensus recommendations intend to provide useful advice to aesthetic practitioners in the Benelux region for patient selection; achieving and maintaining aseptic conditions (in the treatment room, when preparing the patient, and when preparing the practitioner); recommendations for treatment room procedures; patient considerations; and physician considerations, with the aim of standardizing practice and reducing the risk of infections.
Educational material for both practitioners and patients is useful; however, such materials need to be tailored to the country, practitioner, and type of procedure, to be of use. Laws and regulations may vary from country to country, European Standards however apply to the EU.
Limitations include those inherent with consensus‐based recommendations being a result of personal opinion in part, albeit those of highly experienced aesthetic medical practitioners. Efforts were made to minimize error or bias and included literature searches and taking into consideration existing guidelines.
5. CONCLUSION
This document provides recommended procedural steps for aesthetic practitioners in the Benelux region, with the aim of minimizing the risk of infections/complications in their patients.
CONFLICT OF INTEREST
All authors received honoraria from Allergan for attending the advisory board meeting.
AUTHOR CONTRIBUTIONS
S.B., K.D.B., I.H., I.C., and P.T. attended the consensus meeting and contributed to the recommendations for best practice. S.B. wrote the manuscript with assistance from a medical writer. All authors have read and approved the final manuscript.
FUNDING INFORMATION
Allergan, This work was funded by Allergan UK (now Abbvie Ltd.) as part of an Educational Grant. All authors met the journal authorship criteria. Neither honoraria nor payments were made for authorship. The funder has not had input into the content of this manuscript.
ETHICS STATEMENT
The authors confirm that the ethical policies of the journal, as noted on the journal's author guidelines page, have been adhered to. No ethical approval was required as no original research data were included.
Supporting information
Appendix S1
Click here for additional data file. (48.9KB, docx)
ACKNOWLEDGMENTS
Writing and editorial assistance was provided to the authors by Sarah Webster of Jango Communications Limited, Bracknell, Berkshire, UK.
Baharlou S, De Boulle K, van Heijningen I, Cervini I, Termohlen P. Standards for aseptic techniques in medical aesthetic practices in the Benelux: Consensus recommendations. J Cosmet Dermatol. 2023;22:289‐295. doi: 10.1111/jocd.15077
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Appendix S1
Click here for additional data file. (48.9KB, docx)
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
