result of voting (formal vote) on fpren 16372 … · votes by national members country member...

TC403_N0188

EUROPEAN COMMITTEE FOR STANDARDISATION

COMITÉ EUROPEÉN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Austrian Standards Institute – Österreichisches Normungsinstitut

Sitz: Wien, ZVR-Zahl: 627457584, Gerichtsstand: Wien, DVR: 0000477, UID: ATU16358000

Member of CEN and ISO | ÖNORM EN ISO 9001:2008 zertifiziert durch

Austrian Standards Institute Heinestraße 38 | 1020 Wien | Austria

Dr. Karl Grün

Secretary

T: +43 1 213 00-714

F: +43 1 213 00-722

E: [email protected]

www.austrian-standards.at

Vienna, 13. Juni 2014

To the members and observers of CEN/TC 403

Result of Voting (Formal Vote) on FprEN 16372 Aesthetic Surgery Services (approved)

Dear Madam/Sir,

Please find attached the result of the Formal Vote on European Final Draft FprEN 16372:2014 “Aesthetic Surgery Services”.

With 11 national CEN Members approving, 2 national CEN Members disapproving and with 78.19 % weighted percentage approving (requirement ≥ 71%) FprEN 16372 is approved.

Best regards,

Karl Grün

Ballot Information:

Ballot reference: FprEN 16372

Ballot type: FV (Formal Vote)

English title:Aesthetic surgery services

French title:Services en chirurgie esthétique

German title:Ästhetische Chirurgie und ästhetische nicht-chirurgischeärztliche Dienstleistungen

Work Item Number: 00403001

Procedure Iteration: 1

Vienna Agreement Status: None

Opening date: 2014-04-10

Initial closing date: 2014-06-10

Closing date: 2014-06-10

Note:

Result of voting(National Members having abstained are not counted in this vote.)

Approved by National MembersNational Members approving: 11

National Members disapproving: 2Weighted percentage approving: 78.19 % (requirement >= 71%)

Votes by National MembersCountry Member Participation Approval Disapproval Abstention Vote on

datesAustria ASI Secretariat, Inside EEA X Yes

Belgium NBN Member, Inside EEA X * NoAnswer

Bulgaria BDS Member, Inside EEA X * Yes

Croatia HZN Member, Outside EEA X * Yes

Cyprus CYS Member, Inside EEA X * Yes

Czech Republic UNMZ Member, Inside EEA X * Yes

Denmark DS Member, Inside EEA X * NoAnswer

Estonia EVS Member, Inside EEA X Yes

Finland SFS Member, Inside EEA X Yes

France AFNOR Member, Inside EEA X * NoAnswer

Germany DIN Member, Inside EEA X * Yes

Greece NQIS ELOT Member, Inside EEA X * NoAnswer

Hungary MSZT Member, Inside EEA X Yes

Iceland IST Member, Inside EEA X Yes

Ireland NSAI Member, Inside EEA X * NoAnswer

Italy UNI Member, Inside EEA X Yes

Latvia LVS Member, Inside EEA X * Yes

Lithuania LST Member, Inside EEA X Yes

Luxembourg ILNAS Member, Inside EEA X * Yes

Malta MCCAA Member, Inside EEA X * Yes

Netherlands NEN Member, Inside EEA X * NoAnswer

Norway SN Member, Inside EEA X * NoAnswer

Poland PKN Member, Inside EEA X * NoAnswer

Portugal IPQ Member, Inside EEA X * Yes

Romania ASRO Member, Inside EEA X * NoAnswer

Slovakia SUTN Member, Inside EEA X Yes

Slovenia SIST Member, Inside EEA X * NoAnswer

Spain AENOR Member, Inside EEA X * NoAnswer

Sweden SIS Member, Inside EEA X Yes

Switzerland SNV Member, Outside EEA X * NoAnswer

The FormerYugoslav Republicof Macedonia

ISRM Member, Outside EEA X * NoAnswer

Turkey TSE Member, Outside EEA X NoAnswer

United Kingdom BSI Member, Inside EEA X Yes

TOTALS 11 2 20

(*) A comment file was submitted with this vote

Comments on Implementation Dates

Country Member Participation Answer

Comments from Voters

Belgium NBN Member, Inside EEA FprEN_16372_NBN.doc

Bulgaria BDS Member, Inside EEA FprEN_16372_BDS.doc

Croatia HZN Member, Outside EEA FprEN_16372_HZN.doc

Cyprus CYS Member, Inside EEA FprEN_16372_CYS.doc

Czech Republic UNMZ Member, Inside EEA FprEN_16372_UNMZ.doc

Denmark DS Member, Inside EEA FprEN_16372_DS.doc

France AFNOR Member, Inside EEA FprEN_16372_AFNOR.doc

Germany DIN Member, Inside EEA FprEN_16372_DIN.doc

Greece NQIS ELOT Member, Inside EEA FprEN_16372_NQIS ELOT.doc

Ireland NSAI Member, Inside EEA FprEN_16372_NSAI.doc

Latvia LVS Member, Inside EEA FprEN_16372_LVS.doc

Luxembourg ILNAS Member, Inside EEA FprEN_16372_ILNAS.doc

Malta MCCAA Member, Inside EEA FprEN_16372_MCCAA.doc

Netherlands NEN Member, Inside EEA FprEN_16372_NEN.doc

Norway SN Member, Inside EEA FprEN_16372_SN.doc

Poland PKN Member, Inside EEA FprEN_16372_PKN.doc

Portugal IPQ Member, Inside EEA FprEN_16372_IPQ.doc

Romania ASRO Member, Inside EEA FprEN_16372_ASRO.doc

Slovenia SIST Member, Inside EEA FprEN_16372_SIST.doc

Spain AENOR Member, Inside EEA FprEN_16372_AENOR.doc

Switzerland SNV Member, Outside EEA FprEN_16372_SNV.doc

The FormerYugoslav Republicof Macedonia

ISRM Member, Outside EEA FprEN_16372_ISRM.doc

http://cen.iso.org/livelink/eb33/download/file.doc?attachmentId=644879&versionId=1






















Template for comments and secretariat observations Date: 2014-06-10 Document: Project: FprEN 16372

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ES All ge The Mirror Technical Committee vote negative because some of the members think that the standard is exclusionary and restrictive and others of the members think that the standard of “aesthetic surgery services” shall do refer only to the surgeon (eliminate practitioner of the standard)


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FR It was not possible to reach a consensus in the mirror committee due to the issue of frontier procedures and the major concern of authorities over an eventual application in the future of this European Standard to the domestic territory

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ASRO/RO

ge After years of meetings and negotiations, the initial aim of the project has been lost. The final version of the project is not only dealing with Aesthetic Surgery but also with Aesthetic Medicine.

The two terms are used equally while they do cover two different realities and two different fields, not unanimously accepted in European countries.

Romanian mirror committee do not accept that synonyms for aesthetic surgery are for example cosmetic surgery, beauty surgery and aesthetic medicine. This makes confusion and affects the patient safety, and in the same time dermatologists' interests were not represented in the drafting of the standard. In the final version of the project there is frequently lacks of precision, if not to say is deliberately nebulous on major issues, facilitates the official recognition of the untrained doctors/practitioners as specialists in the field defined by themselves. This confounding wording is not acceptable in the process of determining a European standard.

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BG ge BDS submits an abstention vote as we have not achieved final consensus among the Bulgarian interested parties. There was not a clear consensus position among the Bulgarian stakeholders in regard to achieve a definitively accepted approval of the draft.

1. On one hand is the position of the representatives of the Bulgarian association of plastic, reconstructive and aesthetic surgery who generally support the proposed content of the standard but have some reservations about the applicability of some requirements at national level.

2. On the other hand is the position of the Bulgarian society of aesthetic surgery and aesthetic medicine who totally reject the standard as a document revealing very serious striking inconsistencies and lack of understanding in regard to what aesthetic surgery means (comments presented below).

BG 2

2.1

te The primary aim of aesthetic surgery services is defined as: "restoration, normalization or improvement of the appearance, the function…". According to clause 1, reconstructive surgery procedures are excluded from its scope – “Dentistry1) procedures and reconstructive surgery procedures are excluded from the scope of this European Standard.” Subsequently, clause 2.1 is in direct contradiction with clause 1. "Restoration" is the other word for "Reconstruction". "The restoration of the appearance and the function…" is a definition of reconstructive interventions in cases with abnormal (impaired) appearance or abnormal (impaired) function. These are diseases/disorders/abnormalities, formulated in the definition of reconstructive surgery as cases of burns, traumas and their implications. This means that their treatment cannot be defined as "at the request of the individual" (2.1), i.e. the terms are mixed-up and open the doors for the integration of reconstructive surgery (excluded in clause 1 of this Standard) as aesthetic.

Texts of the Standard have to fully exclude reconstructive surgery, and clearly separate aesthetic surgery and aesthetic non-surgical medical services from treatment of diseases, restoration, normalization of abnormal function and appearance. The definition should be : 2.1 aesthetic surgery services services related to operative procedures, where the primary aim is the aesthetic change, the restoration, normalization or improvement of the appearance, the function and well-being at the request of an individual .


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BG 6 6.3.6

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te These two sub-clauses "patient with mild systemic disease (ASA 2)” and „patient with severe systemic disease (ASA 3)" permit ill patients to be identified as aesthetic services patients.

These sub-clauses about ill patients have to be excluded from the Standard. Treatment of diseases cannot be classified as " improvement of the appearance and well-being at the request of an individual", as per the definition given in clause 2.1. The standard should declare that patients for aesthetic services should be clinically healthy at the moment of intervention. Any chronic diseases and allergies have to be suppressed at the moment of the surgical intervention. Otherwise the patient is exposed to higher levels of risk and mortality.

BG te Each medical activity has contraindications and indications. Such are not present in the draft of the European Standard “Aesthetic surgery and aesthetic non-surgical medical services”

Include list of indications and contraindications for aesthetic surgery and aesthetic non-surgical medical services in the Standard.

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CY ge Lack of technical expertise

Template for comments and secretariat observations Date: 2014-06-04 Document: DIN EN 16372 Project:

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DE General ge DIN abstains from voting regarding the acceptance of FprEN 16372 as a European standard. Reason for German abstention: There are different opinions in Germany regarding the acceptance of FprEN 16372 as an European standard. On the on hand this standard could be helpful for consumers and providers of Aesthetic surgery services especially in an European context. On the other hand there are a lot of A-Deviations which are necessary especially due to German legislation. Because of these laws and the established system of medical self-administration providing a high-level regulatory framework as well as the responsibility of the federal states to legislate in health matters this standard is difficult to apply and may lead to insecurity among the users in Germany.

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DK GE No answer from those concerned or no interest in project

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HR No national position

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LU GENERAL / ge No available expertise in Luxembourg on Subject Matter /

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PT No comments


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MK No response from stakeholders, and national TC

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LV ge Latvia abstains from voting due to no national expertise


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MT 1 GENERAL / ge No available expertise in Malta on Subject Matter /


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NBN No consensus among the Belgian experts has been reached during the national mirror committee meeting

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NL Whole document

GE Vote ABSTAIN:

According to the Dutch BIG law (law regulating professionals in healthcare), all invasive procedures are restricted to medical doctors with appropriate competence. Competence is defined by foundational education, CME and proven expertise. FprEN 16732 however, limits aesthetic services to those professionals with a certification in plastic surgery exclusively, regardless of the competence driven nature of Dutch law, thereby excluding many competent practitioners from performing aesthetic procedures. FprEN 16372 does not define requirements that correlate to competence, such as experience, volume of performed procedures etc. FprEN 16372 is unfit to the Dutch situation. FprEN 16372 is inconsistent with the line of thinking in the Dutch law. Plastic surgeons in the Dutch mirror committee continue to support FprEN 16372 and underpin their defense as a first step towards better patient safety. All other members (6) of the mirror committee strongly reject FprEN 16372, based on the arguments mentioned above as well as claims of inadequate due diligence by CEN, and inadequate


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representation in mirror committees elsewhere. No consensus Even though 6 out of seven members of the Dutch mirror committee oppose FprEN 16372, the Dutch national mirror committee is at a stalemate based on CEN regulations. The Dutch national mirror committee has not been able to reach consensus on a YES or NO vote. Request to countries that vote abstain The Dutch mirror committee by majority assumes that a similar stalemate is to be expected in other EU countries if representation is fair and adequate. Hence the risk arises that the final vote will be determined by a minority of members, of which the procedural quality may furthermore be questioned. Hence, the Dutch mirror committee requests all countries voting ABSTAIN to FprEN 16372 to indicate if lack of consensus is the reason for the vote.


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GR ge lack of expertise

5Template for comments and secretariat observations Date: 10th June 2014

Document: FprEN 16372 Project:

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IE ge HIQA (Irish Health Information and Quality Authority) has agreed to abstain from taking a position on this standard.

Irish Medical Organisation, (National member of COPE) The concerns of the European and International Medical Professional Bodies have largely been ignored by the European Committee for Standardisation (CEN). Again we repeat that the Irish Medical Organisation (IMO) is opposed to the developments of healthcare standards at CEN. The IMO maintain that standards for healthcare services should be developed, implemented and monitored by the relevant competent authorities in consultation with the medical profession so as to ensure the highest standards of care. European and International medical professional bodies including the Standing Committee of European Doctors, (CPME), the European Union of Medical Specialists and the World Medical Association (WMA) are opposed to the development of healthcare standards at CEN. The IMO recognises the urgent need to regulate for the provision of aesthetic surgery and non-surgery services at National level in many EU member states including Ireland. However the IMO and all European Medical Organisations believe that the development of standards by CEN, the European industrial standards body, is a poor substitution for adequate national regulation. There is a general concern from the medical profession in regarding the introduction of such specific standards to medical procedures. Not only is education and training far from being harmonized throughout the EU medical training,



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resources, equipment and even specialties themselves differ significantly around the EU. Currently, the disparities between Member State’s medical education and training, along with resources and facilities are too great to provide such universal standards that have been developed by CEN and not by the profession itself. There is a risk that European Standards are set at the lowest common denominator undermining the efforts of national bodies to ensure the highest quality of care. Healthcare standards must be developed by national competent authorities in consultation with the medical profession and take into account medical training, resources and the organisation of health care services in each member state. There is support at EU level for the development of European Standards for Healthcare as stated in the Council of the European Union issued Recommendation 2009/C151/01 on Patient Safety. However a more appropriate forum, for the development of health care standards must be found at European level, such as the European Union Network of Patient Safety and Quality of Care, to promote high quality care and patient safety across Europe and ensures that standards are developed by competent authorities in consultation with the medical profession.

IE ge Irish Association of Cosmetic Doctors: The standard assumes competence in certain procedures based on monospecialty qualifications. There is a lack of emphasis on the promotion or development of aesthetic procedure-specific training. This should be a priority given that aesthetic procedures



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(nonsurgical, minimally invasive, invasive) are performed by doctors and surgeons of various backgrounds with varied experience. The standard doesn’t take in consideration competence appropriate for various cosmetic procedures is gained by various speciality training and not just based on monospecialty qualifications. There is a lack of emphasis on the promotion or development of aesthetic procedure-specific training while the focus of the standard is monopolising services. Training and future patient safety should be a priority given that aesthetic procedures (nonsurgical, minimally invasive, invasive) are performed by doctors and surgeons of various backgrounds with varied experience.

IE ge The Royal College of Surgeons in Ireland has discussed and considered this document and supports the standards and recommendations contained therein.

IE ge Association of Oral & Maxillofacial Surgeons in Ireland supports this document

IE ge Irish Medical Board supports this document

IE ge The Irish College of Ophthalmologists wishes to support the European Standards for Aesthetic Surgery Services. We approve FprEn 16273 on Aesthetic Surgery Services.

IE ge Dept. of Health Supports this document

IE ge Irish Association of Dermatologists is happy to support the European Standard on Aesthetic Surgery . IAD received queries on whether this standard will this prevent dermatology surgeons



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doing procedures such as Blepharoplasty and will the regulation be mandatory as it stands . IAD understands, following discussion, that it is a guideline which provides a voluntary code of conduct and that if our own training body supports the bleph like surgical proceedures that we are ok . IAD support publication of the final draft surgical standard.

IE ge The European Standard for Aesthetic Surgery Services was discussed at the recent meeting of the Irish Association of Plastic Surgeons, who give it their full support. President, Irish Association of Plastic Surgeons

IE ge NMBI, the Irish Nursing Board, having read through the documents sent, NMBI has previously given its comments on the previous drafts of standards circulated. While it is appreciated that these standards are voluntary and have now been divided between aesthetic surgery and medicine the Board again highlights the issue of both standards not adequately acknowledging the role of the nurse who is appropriately educated, is competent and authorised to perform services related to aesthetic practice within the context of supervised or delegated practice and the associated issues of nurses working collaboratively with medical practitioners or autonomously. NMBI are in the process of revising our scope of practice framework document and our medication management guidance for the professions, two guidance documents from the regulator that will direct the professions’ practice and standards. NMBI hold the view that the document provides a voluntary standard for application in Europe in promoting patient safety, our previous comments stand in relation to the role and scope of the nurse.



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PL ge Abstention due to lack of sufficient national interest.

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SIST We do not have interest.

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CH Abstains due to no reply from national experts

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Template for comments and secretariat observations Date: 2014-06-09 Document: FprEN 16372 Project: 00403001

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CZ ge The standpoints of various relevant medical associations differ considerably

result of voting (formal vote) on fpren 16372 … · votes by national members country member...

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