SIST EN 16844:2017
(Main)Aesthetic medicine services - Non-surgical medical treatments
Aesthetic medicine services - Non-surgical medical treatments
This European Standard addresses the requirements for aesthetic medicine services to patients.
This European Standard provides recommendations for non-surgical medical procedures for clinical treatment, including the ethical framework and general principles according to which clinical services are provided by all aesthetic practitioners. These recommendations apply before, during and after the procedure.
Dentistry ) procedures and aesthetic surgical procedures covered by EN 16372 are excluded from the scope of this European Standard.
Aesthetic non-medical procedures (tattooing and any procedure not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.
Dienstleistungen in der ästhetischen Medizin - Nicht-chirurgische, medizinische Behandlungen
Diese Europäische Norm legt Anforderungen an bestimmte ästhetische nicht-chirurgische, medizinische Behandlungen fest:
- Behandlungen mit resorbierbaren Injektionsmitteln, Botulinumtoxin und Micro-Needling;
- Behandlungen mit nicht-ablativer fraktionierter Hauterneuerungsbehandlung (Resurfacing) und Oberflächenpeelings, Behandlungen mit Laser und vergleichbaren energiebasierten Geräten;
- Behandlungen mit fraktionierter ablativer Behandlung mit Laser und vergleichbaren energiebasierten Geräten und mitteltiefe Peelings; und
- andere Behandlungen, wie tiefe chemische Peelings, vollständig ablative Laserbehandlungen und Fadenliftings.
Diese Europäische Norm gibt Empfehlungen in Bezug auf ästhetische nicht-chirurgische, medizinische Behandlungen, einschließlich des ethischen Rahmens und allgemeiner Grundsätze, nach denen ästhetische medizinische Dienstleistungen durch alle Ärzte und Interessengruppen im Bereich der ästhetischen Medizin erbracht werden. Diese Empfehlungen gelten vor, während und nach der Behandlung.
Jede ästhetische medizinische Behandlung, die das Gewebe unterhalb der Hornschicht der Haut (Stratum corneum) betrifft, oder die einen biologischen Effekt auf das Gewebe unterhalb der Hornschicht der Haut besitzt (mit oder ohne Instrumente(n) oder Geräte(n)), fällt in den Anwendungsbereich dieser Europäischen Norm.
Ästhetische chirurgische Eingriffe nach EN 16372 und Verfahren der Zahnheilkunde sind aus dem Anwendungsbereich dieser Europäischen Norm ausgeschlossen.
Ästhetische nicht-medizinische Behandlungen (Tätowieren und sämtliche Behandlungen, die nicht das Gewebe unterhalb der Hornschicht der Haut betreffen), die von anderen nichtärztlichen Fachgruppen (z. B. von Tätowierern, Kosmetikern) auf gesetzlich zulässige Weise durchgeführt werden können, sind aus dem Anwendungsbereich dieser Europäischen Norm ausgeschlossen.
Services en médecine esthétique - Traitements médicaux, non chirurgicaux
La présente Norme européenne traite des exigences relatives aux prestations de services en médecine esthétique proposées aux patients (traitements médicaux non chirurgicaux).
La présente Norme européenne donne des recommandations en matière de traitements de médecine esthétique non chirurgicaux, y compris un cadre éthique et des principes généraux d’exécution des prestations de services en médecine esthétique par tous les praticiens et parties prenantes de ce domaine. Ces recommandations sont applicables avant, pendant et après le traitement.
Tous les traitements de médecine esthétique qui vont au-delà de la couche cornée ou qui ont ou prétendent avoir un effet biologique au-delà de la couche cornée (avec ou sans instruments ou appareils) sont inclus dans le domaine d'application de la présente Norme européenne. Les traitements de médecine esthétique suivants sont explicitement inclus dans le domaine d'application de la présente Norme européenne :
- traitements de médecine esthétique avec produits d'injection résorbables, toxine botulique et micro-needling ;
- traitements de médecine esthétique avec resurfaçage fractionnel non ablatif, peelings superficiels, lasers et dispositifs médicaux comparables fondés sur l’énergie ;
- traitements de médecine esthétique avec lasers fractionnés ablatifs et dispositifs médicaux comparables fondés sur l’énergie, ainsi que peelings moyens ; et
- autres traitements de médecine esthétique tels que les peelings chimiques profonds, les lasers ablatifs continus, la greffe de cheveux (greffe d’unité folliculaire et extraction d’unité folliculaire) et les fils tenseurs sous-cutanés.
Les actes de chirurgie esthétique traités dans l'EN 16372 et les actes de médecine bucco-dentaire ) sont exclus du domaine d'application de la présente Norme européenne.
Les traitements esthétiques non médicaux (tatouage et traitements dont l'application ne touche pas les tissus au-delà de la couche cornée) qui peuvent être réalisés en toute légalité par des personnes qui ne sont pas médecins (par exemple, tatoueurs, esthéticiens) ne relèvent pas du domaine d'application de la présente Norme européenne.
Storitve estetske medicine - Nekirurški medicinski posegi
Ta evropski standard obravnava zahteve za storitve estetske medicine za bolnike.
Ta evropski standard določa priporočila za nekirurške medicinske postopke za klinično zdravljenje, vključno z etičnim okvirjem in splošnimi načeli, v skladu s katerimi vsi izvajalci na področju estetske medicine zagotavljajo klinične storitve. Ta priporočila se uporabljajo pred in med postopkom ter po njem.
Zobozdravstveni postopki in estetski kirurški postopki, ki so zajeti v standardu EN 16372, ne sodijo na področje uporabe tega evropskega standarda.
Estetski nemedicinski postopki (tetoviranje in kateri koli postopki, ki ne vplivajo na tkivo globlje od rožene plasti), ki jih lahko zakonito izvajajo osebe, ki niso zdravniki (npr. Osebe, ki tetovirajo, lepotni terapevti), so izvzeti iz področja uporabe tega evropskega standarda.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Storitve estetske medicine - Nekirurški medicinski posegiDienstleistungen in der ästhetischen Medizin - Nicht-chirurgische, medizinische BehandlungenServices en médecine esthétique - Traitements médicaux, non chirurgicauxAesthetic medicine services - Non-surgical medical treatments11.020.10Zdravstvene storitve na splošnoHealth care services in generalICS:Ta slovenski standard je istoveten z:EN 16844:2017SIST EN 16844:2017en,fr,de01-oktober-2017SIST EN 16844:2017SLOVENSKI
STANDARD
SIST EN 16844:2017
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16844
June
t r s y ICS
r uä r z rä { {â
s sä r t rä s r English Version
Aesthetic medicine services æ Nonæsurgical medical treatments Services en médecine esthétique æ Traitements médicauxá non chirurgicaux
Dienstleistungen in der ästhetischen Medizin æ Nichtæchirurgischeá medizinische Behandlungen This European Standard was approved by CEN on
t y February
t r s yä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
9
t r s y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s x z v vã t r s y ESIST EN 16844:2017
EN 16844:2017 (E) 2 Contents Page European foreword . 4 Introduction . 5 1 Scope . 6 2 Terms and definitions . 6 3 Competencies . 8 3.1 General . 8 3.2 Training . 8 3.3 Continuous professional development (CPD) and continuous medical education (CME) . 9 4 Management and communication with patients . 9 4.1 Office staff/Booking arrangements . 9 4.2 Patient consultation and assessment . 10 4.3 Consent . 11 4.4 Documentation . 12 4.5 Post-treatment follow up and patient satisfaction . 13 4.6 Advertising . 13 4.7 Medical tourism and travelling long distance for treatment . 14 4.8 Medical indemnity and insurance . 14 4.9 Fees . 15 4.10 Arrangements for out of hours and emergency cover . 15 4.11 Complaints . 15 4.12 Confidentiality . 15 4.13 Safe timing of treatments . 16 4.14 Registration . 16 5 Facilities . 16 5.1 Evaluation of compliance and risk management . 16 5.2 Personnel . 16 5.3 Documentation of medical records . 17 5.4 Facility . 17 5.5 Administrative and waiting area . 17 5.6 General requirements and recommendations for treatment rooms and procedure rooms . 17 5.7 Patient safety and security . 18 5.8 Hygiene standards for treatment rooms and procedure rooms . 19 5.9 Medicines Management . 20 5.10 Treatment room (TR) . 21 5.11 Procedure room (PR) . 21 6 Treatments . 22 6.1 General . 22 6.2 Aesthetic medical treatment categories . 22 6.3 Identifying factors . 23 6.3.1 General . 23 6.3.2 Practitioner . 23 6.3.3 Facility . 23 6.3.4 Anaesthesia level . 24 SIST EN 16844:2017
EN 16844:2017 (E) 3 6.3.5 Risk level of treatment . 24 6.3.6 Patient physical status and age . 24 6.3.7 Mental status and patient expectations . 25 6.4 Treatment identification . 25 6.5 Cooling off period . 25 6.6 Aesthetic medical treatments . 25 Annex A (normative)
Code of Ethics for marketing and advertising . 28 Annex B (informative)
A–deviations . 30 Bibliography . 45
SIST EN 16844:2017
EN 16844:2017 (E) 4 European foreword This document (EN 16844:2017) has been prepared by Technical Committee CEN/TC 403 “Aesthetic surgery and aesthetic non-surgical medical services”, the secretariat of which is held by ASI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2017, and conflicting national standards shall be withdrawn at the latest by December 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 16844:2017
EN 16844:2017 (E) 5 Introduction This European Standard provides a set of requirements, which are deemed to be essential for the provision of aesthetic medicine services (non-surgical medical treatments). However, attention is drawn to the fact that in certain countries specific national regulations apply and take precedence over this European Standard. Users of this European Standard are advised to inform themselves of the applicability or non-applicability for this European Standard by their national responsible authorities. Furthermore, recommendations for other aspects of good practice are provided. The Bibliography provides a list of European and International Standards and other documents of general interest for aesthetic medicine services. This list is not intended to be exhaustive. Emphasis is placed on defining requirements for the quality of the aesthetic medicine services offered in order to ensure patient safety. Other factors which influence the overall quality of service include: qualifications and professional competencies, staff behaviour, facility design and choice of products and suppliers. This European Standard is designed to bring the following advantages to those that adopt it: — improvement in aesthetic medicine services which can enhance patient safety and reduce the risk of complications; — to promote consistently high standards for aesthetic medicine service providers across Europe; — enhance patient satisfaction. Requirements for a quality management system based on EN ISO 9001 for health care services are provided in EN 15224. Requirements concerning the occupational health and safety of service providers and their staff at work are provided in relevant EU-Directives and national occupational health and safety legislation. SIST EN 16844:2017
EN 16844:2017 (E) 6 1 Scope This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments: — treatments with resorbable injectables, botulinum toxin and micro needling; — treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices; — treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and — other treatments such as deep chemical peels, full ablative lasers and thread lifts. This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment. Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard. Aesthetic surgical procedures covered by EN 16372 and dentistry1) procedures are excluded from the scope of this European Standard. Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 aesthetic medicine services services related to non-surgical medical treatments where the primary aim is the aesthetic change, restoration or improvement of the appearance, the function and/or well-being at the request of an individual with medical treatments, including the prevention and treatment of all kind of aesthetic concern, aging process, as well as the promotion of health 2.2 adverse event unfavourable, unexpected or unintended temporary or permanent medical outcome to the patient Note 1 to entry: “Adverse event” is defined in ISO/TS 19218-1:2011, 2.1 as an event associated with a medical device that led to death or serious injury of a patient, user or other person, or that might lead to death or serious injury of a patient, user or other person if the event recurs. This definition is consistent with the guidance in GHTF/SG2/N54/R8:2006 and definition includes malfunction or deterioration of a device which has not yet caused death or serious injury, but which could lead to death or serious injury.
1) As defined in EN ISO 1942. SIST EN 16844:2017
EN 16844:2017 (E) 7 Note 2 to entry: “Adverse event” is defined in 2001/20/EC, Article 2 (m) as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. 2.3 competence demonstrated and qualified ability to apply established scientific knowledge and skills according with the law and regulations of the country where is practiced 2.4 complaint expression of dissatisfaction made to an organization or a practitioner, related to its services and/or results, or the complaints-handling process itself, where a response or resolution is explicitly or implicitly expected 2.5 “cooling off” period time between the end of the consultation where the treatment is proposed, its risks are explained and the detailed fee estimation is given, and the decision to proceed with this treatment 2.6 facility medical establishment where aesthetic medical treatments and procedures are performed 2.7 health state of complete physical, mental and social well-being and not merely the absence of disease or infirmity Note 1 to entry: This definition is from the preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19–22 June 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948. 2.8 patient satisfaction patient's perception of the degree to which the patient's requirements have been fulfilled Note 1 to entry: Patient complaints are a common indicator of low patient satisfaction but their absence does not necessarily imply high patient satisfaction. Note 2 to entry: Even when patient requirements have been agreed with the patient and fulfilled, this does not necessarily ensure high patient satisfaction. Note 3 to entry: This definition was adapted from EN ISO 9000:2015, 3.9.2. 2.9 practitioner medical doctor authorized by national competent authority to practice medicine autonomously 2.10 reporting notification of an adverse event, defective health care product or negligent service delivery to the relevant competent authorities SIST EN 16844:2017
EN 16844:2017 (E) 8 3 Competencies 3.1 General 3.1.1 During care activity, the practitioner shall control the competencies and capacities of person(s) doing work under his/her control. In addition, the medical establishment or the practitioner when he/she is the employer shall: — determine the necessary competence of person(s) doing work under its control, — ensure these persons are competent on the basis of training, skills and experience, — where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken, — retain documented information as evidence of competence, — check the professional credentials and certified training of any professional applying to provide services under its responsibility. 3.1.2 If the aesthetic medicine services are delivered in a facility placed under supervision of a managing director, tasks described in 3.1.1 are under responsibility of both practitioner and managing director. 3.1.3 A registration for all practitioners performing aesthetic medical treatments is highly recommended within two years after publication of this European Standard. This register shall be national, certified, updated regularly and freely accessible to public in particular via the internet. 3.1.4 Directive 2005/36/EC demands formal basic medical training or specialist medical training to be recognized by a national competent authority. 3.1.5 The practitioner shall be a medical doctor authorized by national competent authority to practice medicine autonomously. Medical doctors authorized by the national competent authority are entitled to perform aesthetic medical treatments provided they are trained to these treatments. Assistants shall be medical doctors, who are in a recognized post-graduate training scheme, or authorized healthcare professionals who shall be working under the practitioner’s direct supervision (direct supervision means to be physically present in the facility and able to respond and act according to the level of risk of the procedure). 3.1.6 Authorized healthcare professionals who are allowed to work under the practitioner's direct supervision shall have a professional training of at least 3 years. 3.1.7 Treatments with the use of lasers (class 2 and higher), light- (IPL and LED) and other energy based devices shall only be applied by qualified medical practitioners or by authorized healthcare professionals under practitioner's direct supervision. 3.1.8 Delegation of aesthetic medical treatments to practitioners who do not meet the national required competency shall not be allowed. 3.2 Training 3.2.1 A practitioner undertaking aesthetic medical treatments shall be trained in the respective treatment and this training shall be in compliance with the national competent authority's rule with a minimum of 3 years. SIST EN 16844:2017
EN 16844:2017 (E) 9 3.2.2 This training shall include outcomes which require a firm understanding of the basic science principles and evidence past which underpin treatments. This includes but is not exclusive to anatomy, physiology, pharmacology, immunology, pathology and mechanistic understanding in the respective treatment. Adequate knowledge is required to minimize inappropriate treatment or missed diagnosis. Knowledge of appropriate medical treatment options is required to optimize care. Recognition, diagnosis and the ability to manage complications relating to the relevant treatment is required. 3.2.3 Training should also include issues relating to ethics, psychology, consent and indemnity. 3.2.4 Training shall have a theoretical part and a practical part. The practical part of the training shall include a period of mentorship. 3.3 Continuous professional development (CPD) and continuous medical education (CME) 3.3.1 The practitioner shall: a) maintain a valid registration by the national competent authorities of the country of practice and shall be involved in aesthetic practice on a regular basis; and b) attend at least two CME accredited scientific events per year relevant to the sphere of aesthetic practice he/she performs or accreditation by the recognized national profession society. 3.3.2 Practitioners should preferably be member of a scientific society of their profession. 3.3.3 The continuous professional development undertaken shall enhance the practitioner’s aesthetic practice and shall comply with the national educational requirements, relicensing and/or maintenance of practice agreement. 4 Management and communication with patients 4.1 Office staff/Booking arrangements 4.1.1 Hospitals, private establishments and private practices as well as all their medical or otherwise involved partners that are in a position to obtain patient's information shall have a confidentiality policy on protecting patient's privacy that is clear, understood and well known by all staff. 4.1.2 Financial inducements shall not be used towards patient, practitioners, staff, or other professionals to entice patients to consult or to have primary or combined aesthetic medical treatments. Economic considerations shall not override patient safety. 4.1.3 The consultation process is an opportunity to explore the concept of aesthetic medical treatment during which the patients shall have the implications, limitations and complications of treatment explained in language they understand, and with written information, including information presented on internet websites, for them to read later – it shall not involve any enticement to proceed. The consultation shall be done in a language both parties can understand and agree on. 4.1.4 The practitioner shall give impartial objective advice during the consultation for which a fee should be charged. 4.1.5 Cancellation policies shall be clear to the patient before any payment is made. A full refund of treatment fees shall be given if any pre-payment is made when the cancellation is within the “cooling off” period. Further arrangements are at the practitioner/clinics discretion but shall be clearly explained and set out in writing to patients. SIST EN 16844:2017
EN 16844:2017 (E) 10 4.1.6 The identification of any practitioner who performs the treatment and his/her speciality(ies) officially recognized by the national competent authority shall appear accurately and without ambiguity on letterheads and in all communications with the patient. 4.2 Patient consultation and assessment 4.2.1 The initial consultation shall be with the practitioner planning to undertake the aesthetic medical treatment. 4.2.2 Any other professional involved in the consultation process shall declare their name, expertise and qualifications and explain their role in the consultation, i.e. junior doctor in training, medical secretary or nurse. Practitioners should explain their role in screening or general health assessments. Nurses and non-medical professionals shall not be used as a shortcut for the practitioner who remains responsible for carefully assessing the patients and thoroughly undertaking the consent process (see 4.3). Practitioners should make themselves aware of regulators' guidance on remote prescribing. Practitioners should stay informed of guidelines and recommendations issued by competent authorities on telemedicine. It is good practice to wear an identification badge. 4.2.3 The practitioner shall be knowledgeable on the legislation and scientific literature on the treatments that he/she performs, the devices that he/she uses and the related safety issues. 4.2.4 The practitioner shall inform the patient on outcome indicators of the treatment that he/she performs, the devices he/she uses and be able to relate these outcome indicators with alternative treatments and devices. 4.2.5 The practitioner shall provide information that is understandable, timely, verifiable, accurate, complete, truthful and not misleading. 4.2.6 The practitioner shall provide information on the aim of the aesthetic medical treatment, benefits and harms, potential adverse consequences, including their frequency, alternative options and costs. 4.2.7 The practitioner shall provide transparency on the device or product used and possible alternatives. The rationale should include quality assurance and evidence. The practitioner shall provide background literature on the device or product and its use upon request. 4.2.8 At the end of the first consultation all patients shall be made aware of the risks and benefits of the proposed aesthetic medical treatment and shall be given the opportunity to digest the information and reflect on discussions before deciding to proceed. 4.2.9 Patients shall be made aware that further consultations are advisable and shall be encouraged for more risky/serious treatments. Patients should be informed that all consultations necessary to his/her consent are available to him/her but also duly informed of financial arrangement regarding this additional consultations. 4.2.10 Processes designed to reflect intention of outcome shall be used honestly. They shall not be used as a marketing tool. The limitations of the process shall be explained to the patient. Practitioners are advised that when example photographs are used to demonstrate outcomes, they should be accompanied by a disclaimer explaining the result cannot be guaranteed. Photographs shall not be modified to manipulate the outcome of the treatment. 4.2.11 The initial consultation(s) shall include a) verification of the patient’s condition to check medical feasibility of the planned treatment; SIST EN 16844:2017
EN 16844:2017 (E) 11 b) explore the specific aesthetic concerns; c) assessment of patient's mental health/psychological state, including past psychological/mental health history where possible; d) assessment of patient’s expectations; e) request relevant blood tests, if necessary; f) request other relevant investigations; g) request to communicate with relevant medical colleagues; If in doubt, the practitioner should consult with or refer medical specialists. h) if the patient is diagnosed with dysmorphobia no aesthetic medical treatments shall be performed; i) pre-treatment tests and investigations shall be performed where appropriate. The practitioner shall inform the patient of the financial implications. NOTE 1 The consultation is the start of the consent process, see 4.3. NOTE 2 For consultation documentation, see 4.4. 4.2.12 If the practitioner deems that the environment in which the aesthetic medical treatment shall be performed, the devices or personnel are not fit for purpose the practitioner shall cancel the treatment. 4.3 Consent 4.3.1 Consent is an ongoing process extending from the time of first contact until the day of the aesthetic medical treatment; the majority of this process should be completed prior to booking. 4.3.2 The process shall include the following: a) A clear explanation of the limitations of the aesthetic medical treatment and alternative treatments that may be available (including those not offered by the practitioner). b) A clear explanation of the implications of the aesthetic medical treatment, including a clear explanation of the recovery time, duration of recommended absence from work and follow up plans. c) The practitioner shall ensure that the patient clearly understands the risks involved with the planned treatment. The frequently occurring and the rare, but serious, complications should be fully explained and understood. A personal low rate of complication shall not be used to entice patient to undertake aesthetic medical treatment. If data are available, personal risks should be stated in natural numbers and in relation to a number of treated patients, for example 1 out of 200 patients suffer from this side effect rather than 0,5 % of all patients. d) The d
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Storitve estetske medicine - Nekirurški medicinski postopkiDienstleistungen in der ästhetischen Medizin - Nichtchirurgische, medizinische EingriffeServices en médecine esthétique - Interventions non chirurgicales médicalesAesthetic medicine services - Non-surgical medical procedures11.020.10Zdravstvene storitve na splošnoHealth care services in generalICS:Ta slovenski standard je istoveten z:FprEN 16844kSIST prEN 16844:2016en,fr,de01-april-2015kSIST prEN 16844:2016SLOVENSKI
STANDARD
kSIST prEN 16844:2016
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN 16844
January
t r s x ICS
r uä r z rä { {â
s sä r t r English Version
Aesthetic medicine services æ Nonæsurgical medical treatments Services en médecine esthétique æ Traitements médicauxá non chirurgicaux
Dienstleistungen in der ästhetischen Medizin æ Nichtæchirurgischeá medizinische Behandlungen This draft European Standard is submitted to CEN members for formal voteä It has been drawn up by the Technical Committee
If this draft becomes a European Standardá CEN members are bounwhich stipulate the conditions for giving this European Standard the status of a national standard without any alterationä
This draft European Standard was established by CEN in three ofer language made by translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey andUnited Kingdomä
Recipients of this draft are invited to submitá with their commentsá notification of any relevant patent rights of which they are aware and to provide supporting documentationä
Warning ã This document is not a European Standardä It is distributed for review and commentsä It is subject to change without notice and shall not be referred to as a European Standardä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
9
t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä FprEN
s x z v vã t r s x EkSIST prEN 16844:2016
FprEN 16844:2016 (E) 2 Contents Page European foreword . 4 Introduction . 5 1 Scope . 6 2 Terms and definitions . 6 3 Competencies. 8 3.1 General . 8 3.2 Training . 9 3.3 Continuous professional development (CPD) and continuous medical education (CME) . 9 4 Management and communication with patients . 9 4.1 Office staff/Booking arrangements . 9 4.2 Patient consultation and assessment . 10 4.3 Consent . 11 4.4 Documentation . 12 4.5 Post-treatment follow up and patient satisfaction . 13 4.6 Advertising . 13 4.7 Medical tourism and travelling long distance for treatment . 14 4.8 Medical indemnity and insurance . 15 4.9 Fees . 15 4.10 Arrangements for out of hours and emergency cover . 15 4.11 Complaints . 16 4.12 Confidentiality . 16 4.13 Safe timing of treatments . 16 4.14 Registration . 16 5 Facilities . 16 5.1 Evaluation of compliance and risk management. 16 5.2 Personnel . 17 5.3 Documentation of medical records . 17 5.4 Facility . 17 5.5 Administrative and waiting area . 17 5.6 General requirements and recommendations for treatment rooms and procedure rooms . 17 5.7 Patient safety and security . 18 5.8 Hygiene standards for treatment rooms and procedure rooms . 19 5.9 Medicines Management . 20 5.10 Treatment room (TR) . 21 5.11 Procedure room (PR) . 21 6 Treatments . 23 6.1 General . 23 6.2 Aesthetic medical treatment categories . 23 6.3 Identifying factors . 23 6.3.1 General . 23 6.3.2 Practitioner . 24 6.3.3 Facility . 24 kSIST prEN 16844:2016
FprEN 16844:2016 (E) 3 6.3.4 Anaesthesia level . 24 6.3.5 Risk level of treatment . 24 6.3.6 Patient physical status and age . 25 6.3.7 Mental status and patient expectations . 25 6.4 Treatment identification . 25 6.5 Cooling off period . 26 6.6 Aesthetic medical treatments . 26 Annex A (normative)
Code of Ethics for marketing and advertising . 29 Annex B (informative)
A–deviations . 31 Bibliography . 42
kSIST prEN 16844:2016
FprEN 16844:2016 (E) 4 European foreword This document (FprEN 16844:2016) has been prepared by Technical Committee CEN/TC 403 “Project Committee - Aesthetic surgery and aesthetic non-surgical medical services”, the secretariat of which is held by ASI. This document is currently submitted to the Formal Vote. kSIST prEN 16844:2016
FprEN 16844:2016 (E) 5 Introduction This European Standard provides a set of requirements, which are deemed to be essential for the provision of aesthetic medicine services (non-surgical medical treatments). However, attention is drawn to the fact that in certain countries specific national regulations apply and take precedence over this European Standard. Users of this European Standard are advised to inform themselves of the applicability or non-applicability for this European Standard by their national responsible authorities. Furthermore, recommendations for other aspects of good practice are provided. The Bibliography provides a list of European and International Standards and other documents of general interest for aesthetic medicine services. This list is not intended to be exhaustive. Emphasis is placed on defining requirements for the quality of the aesthetic medicine services offered in order to ensure patient safety. Other factors which influence the overall quality of service include: qualifications and professional competencies, staff behaviour, facility design and choice of products and suppliers. This European Standard is designed to bring the following advantages to those that adopt it: — improvement in aesthetic medicine services which can enhance patient safety and reduce the risk of complications; — to promote consistently high standards for aesthetic medicine service providers across Europe; — enhance patient satisfaction. Requirements for a quality management system based on EN ISO 9001 for health care services are provided in EN 15224. Requirements concerning the occupational health and safety of service providers and their staff at work are provided in relevant EU-Directives and national occupational health and safety legislation. kSIST prEN 16844:2016
FprEN 16844:2016 (E) 6 1 Scope This European Standard addresses the requirements for aesthetic medicine services to patients (non-surgical medical treatments). This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment. Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard. The following aesthetic medical treatments are explicitly included in the scope of this European Standard: — aesthetic medical treatments with resorbable injectables, botulinum toxin and micro needling; — aesthetic medical treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices; — aesthetic medical treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and — other aesthetic medical treatments such as deep chemical peels, full ablative lasers, hair transplantation (strip follicular unit transplant and follicular unit extraction) and thread lifts. Aesthetic surgical procedures covered by EN 16372 and dentistry1) procedures are excluded from the scope of this European Standard. Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 aesthetic medicine services
services related to non-surgical medical treatments where the primary aim is the change, the restoration or improvement of the appearance, the function and/or well-being at the request of an individual with medical treatments, including the prevention and treatment of all kind of aesthetic concern, aging process, as well as the promotion of health 2.2 adverse event situation or event that has caused harm to a patient Note 1 to entry: "Adverse event" is defined in ISO/TS 19218-1:2011, 2.1 as an event associated with a medical device that led to death or serious injury of a patient, user or other person, or that might lead to death or serious injury of a patient, user or other person if the event recurs. This definition is consistent with the guidance in
1) As defined in EN ISO 1942. kSIST prEN 16844:2016
FprEN 16844:2016 (E) 7 GHTF/SG2/N54/R8:2006 and definition includes malfunction or deterioration of a device which has not yet caused death or serious injury, but which could lead to death or serious injury. Note 2 to entry: "Adverse event" is defined in 2001/20/EC, Article 2 (m) as any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. [SOURCE: EN 15224:2012, 3.5.2, modified – Note 1 to entry and Note 2 to entry have been added.] 2.3 competence demonstrated and qualified ability to apply established scientific knowledge and skills according with the law and regulations of the country where is practiced 2.4 complaint expression of dissatisfaction made to an organization, related to its services and/or results, or the complaints-handling process itself, where a response or resolution is explicitly or implicitly expected 2.5 "cooling off" period time between the end of the consultation where the treatment is proposed, its risks are explained and the detailed fee estimation is given, and the decision to proceed with this treatment 2.6 facility medical establishment where aesthetic medical treatments are performed 2.7 health state of complete physical, mental and social well-being and not merely the absence of disease or infirmity Note 1 to entry: This definition is from the preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19-22 June 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948. 2.8 patient satisfaction patient's perception of the degree to which the patient's requirements have been fulfilled Note 1 to entry: Patient complaints are a common indicator of low patient satisfaction but their absence does not necessarily imply high patient satisfaction. Note 2 to entry: Even when patient requirements have been agreed with the patient and fulfilled, this does not necessarily ensure high patient satisfaction. Note 3 to entry: This definition was adapted from ISO 9000:2015, 3.9.2. 2.9 practitioner, medical practitioner medical doctor authorized by national competent authority to practice medicine autonomously kSIST prEN 16844:2016
FprEN 16844:2016 (E) 8 2.10 reporting notification of an adverse event, defective health care product or negligent service delivery to the relevant competent authorities 3 Competencies 3.1 General 3.1.1
During care activity, the practitioner shall control the competencies and capacities of person(s) doing work under his/her control. In addition, the medical establishment or the practitioner when he/she is the employer shall: — determine the necessary competence of person(s) doing work under its control, — ensure these persons are competent on the basis of training, skills and experience, — where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken, — retain documented information as evidence of competence, — check the professional credentials and certified training of any professional applying to provide services under its responsibility. 3.1.2
If the aesthetic medicine services are delivered in a facility placed under supervision of a managing director, tasks described in 3.1.1 are under responsibility of both practitioner and managing director. 3.1.3
A registration for all practitioners performing aesthetic medical treatments is highly recommended within two years after publication of this European Standard. This register shall be national, certified, updated regularly and freely accessible to public in particular via the internet. 3.1.4
Directive 2005/36/EC demands formal basic medical training or specialist medical training to be recognized by a national competent authority. 3.1.5
The practitioner shall be a medical doctor authorized by national competent authority to practice medicine autonomously. Medical doctors authorized by the national competent authority are entitled to perform aesthetic medical treatments provided they are trained to these treatments. Assistants shall be medical doctors, who are in a recognized post-graduate training scheme, or authorized healthcare professionals who shall be working under the practitioner’s direct supervision (direct supervision means to be physically present in the facility). 3.1.6
Treatments with the use of lasers (class 2 and higher), light- (IPL and LED) and other energy based devices shall only be applied by qualified medical practitioners or by authorized healthcare professionals under practitioner's direct supervision. 3.1.7
A trained practitioner shall perform all the steps in a hair transplant treatment that involve incisions in the skin. These would include making Follicular Unit Extraction incisions (or directing those made by a robotic device), harvesting Strip Follicular Unit Transplant donor hair, and making hair transplantation recipient site incisions (whether done using a blade, needle, implanter, other instrument or robotic device). kSIST prEN 16844:2016
FprEN 16844:2016 (E) 9 3.1.8
Delegation of aesthetic medical treatments to practitioners who do not meet the national required competency shall not be allowed. 3.2 Training 3.2.1
A practitioner undertaking aesthetic medical treatments shall be trained in the respective treatment and this training shall be in compliance with the national competent authority's rule. 3.2.2
The training shall include outcomes which require a firm understanding of the basic science principles and evidence past which underpin treatments. This includes but is not exclusive to anatomy, physiology, pharmacology, immunology, pathology and mechanistic understanding in the respective treatment. Adequate knowledge is required to minimise inappropriate treatment or missed diagnosis. Knowledge of appropriate medical treatment options is required to optimize care. Recognition, diagnosis and the ability to manage complications relating to the relevant treatment is required.
3.2.3
Training should also include issues relating to ethics, psychology, consent and indemnity.
3.2.4
Training shall have a theoretical part and a practical part. The practical part of the training shall include a period of mentorship. 3.3 Continuous professional development (CPD) and continuous medical education (CME) 3.3.1
The practitioner shall a) maintain a valid registration by the national competent authorities of the country of practice and shall be involved in aesthetic practice on a regular basis; and b) attend at least two CME accredited scientific events per year relevant to the sphere of aesthetic practice he/she performs or accreditation by the recognized national profession society. 3.3.2
Practitioners should preferably be member of a scientific society of their profession. 3.3.3
The continuous professional development undertaken shall enhance the practitioner’s aesthetic practice and shall comply with the national educational requirements, relicensing and/or maintenance of practice agreement. 4 Management and communication with patients 4.1 Office staff/Booking arrangements 4.1.1
Hospitals, private establishments and private practices as well as all their medical or otherwise involved partners that are in a position to obtain patient's information shall have a confidentiality policy on protecting patient's privacy that is clear, understood and well known by all staff. 4.1.2
Financial inducements shall not be used towards patient, practitioners, staff, or other professionals to entice patients to consult or to have primary or combined aesthetic medical treatments. Economic considerations shall not override patient safety. 4.1.3
The consultation process is an opportunity to explore the concept of aesthetic medical treatment during which the patients shall have the implications, limitations and complications of treatment explained in language they understand, and with written information, including information presented on internet websites, for them to read later – it shall not involve any enticement to proceed. The consultation shall be done in a language both parties can understand and agree on. kSIST prEN 16844:2016
FprEN 16844:2016 (E) 10 4.1.4
The practitioner shall give impartial objective advice during the consultation for which a fee should be charged.
4.1.5
Cancellation policies shall be clear to the patient before any payment is made. A full refund of treatment fees shall be given if any pre-payment is made when the cancellation is within the "cooling off" period. Further arrangements are at the practitioner/clinics discretion but shall be clearly explained and set out in writing to patients. 4.1.6
The identification of any practitioner who performs the intervention and his/her speciality(ies) officially recognized by the national competent authority shall appear accurately and without ambiguity on letterheads and in all communications with the patient. 4.2 Patient consultation and assessment 4.2.1
The initial consultation shall be with the practitioner planning to undertake the aesthetic medical treatment. 4.2.2
Any other professional involved in the consultation process shall declare their name, expertise and qualifications and explain their role in the consultation, i.e. junior doctor in training, medical secretary or nurse. Practitioners should explain their role in screening or general health assessments. Nurses and non-medical professionals shall not be used as a shortcut for the practitioner who remains responsible for carefully assessing the patients and thoroughly undertaking the consent process (see 4.3). Practitioners should make themselves aware of regulators' guidance on remote prescribing. It is good practice to wear an identification badge. 4.2.3
The practitioner shall be knowledgeable on the legislation and scientific literature on the treatments that he/she performs, the devices that he/she uses and the related safety issues. 4.2.4
The practitioner shall inform the patient on outcome indicators of the treatment that he/she performs, the devices he/she uses and be able to relate these outcome indicators with alternative treatments and devices. 4.2.5
The practitioner shall provide information that is understandable, timely, verifiable, accurate, complete, truthful and not misleading. 4.2.6
The practitioner shall provide information on the aim of the aesthetic medical treatment, benefits and harms, potential adverse consequences, including their frequency, alternative options and costs. 4.2.7
The practitioner shall provide transparency on the device or product used and possible alternatives. The rationale should include quality assurance and evidence. The practitioner shall provide background literature on the device or product and its use upon request. 4.2.8
At the end of the first consultation all patients shall be made aware of the risks and benefits of the proposed aesthetic medical treatment and shall be given the opportunity to digest the information and reflect on discussions before deciding to proceed. 4.2.9
Patients shall be made aware that further consultations are advisable and are to be encouraged for more risky/serious treatments. Patients should be informed that all consultations necessary to his/her consent are available to him/her but also duly informed of financial arrangement regarding this additional consultations. 4.2.10
Processes designed to reflect intention of outcome shall be used honestly. They shall not be used as a marketing tool. The limitations of the process shall be explained to the patient. Practitioners kSIST prEN 16844:2016
FprEN 16844:2016 (E) 11 are advised that when example photographs are used to demonstrate outcomes, they should be accompanied by a disclaimer explaining the result cannot be guaranteed. Photographs shall not be modified to manipulate the outcome of the treatment. 4.2.11
The initial consultation(s) shall include a) assessment of the patient’s general health (relevant examination); b) explore the specific aesthetic concerns; c) assessment of patient's mental health/psychological state, including past psychological/mental health history where possible; d) assessment of patient’s expectations; e) request relevant blood tests, if necessary; f) request other relevant investigations; g) the condition of the patient shall be assessed to check medical feasibility of the planned treatment; h) request to communicate with relevant medical colleagues; If in doubt, the practitioner should consult with or refer medical specialists. i) if the patient is diagnosed with dysmorphobia no aesthetic medical treatments shall be performed; j) pre-treatment tests and investigations shall be performed where appropriate. The practitioner shall inform the patient of the financial implications. NOTE 1 The consultation is the start of the consent process, see 4.3. NOTE 2 For consultation documentation, see 4.4. 4.2.12
If the practitioner deems that the environment in which the aesthetic medical treatment shall be performed, the devices or personnel are not fit for purpose the practitioner shall cancel the treatment. 4.3 Consent 4.3.1
Consent is an ongoing process extending from the time of first contact until the day of the aesthetic medical treatment; the majority of this process should be completed prior to booking. 4.3.2
The process shall include the following:
a) A clear explanation of the limitations of the aesthetic medical treatment and alternative treatments that may be available (including those not offered by the practitioner). b) A clear explanation of the implications of the aesthetic medical treatment, including a clear explanation of the recovery time, duration of recommended absence from work and follow up plans. c) The practitioner shall e
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