Health

One of the principle aims of standardisation in healthcare is to ensure safe and high quality conditions both for the patient and for the health care provider. SMEs are active throughout this sector, often with very sophisticated equipment and materials.

In order to promote SME interests in the health sector, NORMAPME takes part in the main standardisation activities with the active member association FEPPD 'the European and International Organisation of Independent Dental Technicians and Laboratory Owners'. With our sister organisation UEAPME, we operate a Health Forum with around 20 members who meet several times per year to debate the situation and the needed actions.

Our actions are two fold:

• To discuss with the various European Commission Directorates and CEN on strategic level on the important issues impacting small enterprises in the sector:
• Together with our sister organisation UEAPME we prepare positions for future standards and related legislation at different levels:
• at the Advisory Board for Health Standards (ABHS) which aims at coordinating and steering the standardisation in the health sector.
• in follow up of the CEN eHealth Focus Group we are member of the eHealth Stakeholders Group operated by DG-Information Society.
• on the revision of the medical device directive with DG-Sanco.
• in various EU Committees that deal with standards and new mandates.
• At CEN we are represented in the :
• CEN TC 55 – Dentistry materials, in addition,
• we are prepared for any eHealth activities in CEN and ETSI that come up in the future.

Furthermore, NORMAPME is partner in the vocational training project with FEPPD: 'Development of generic occupational standards and the promotion of mobility for dental technicians'.

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CEN TC 55 - DENTISTRY

The European and International Federation of Dental Technicians (FEPPD), member of NORMAPME, represents European wide the majority of this profession. Their offices are in the NORMAPME/UEAPME building and therefore contact is at ease. They have provided the NORMAPME expert for CEN TC 55, Mr Jürgen Schwichtenberg, who is at the same time, FEPPD President and NORMAPME Vice-President.

Thus, NORMAPME is represented in CEN TC 55, the Advisory Board for Health Standards (ABHS) and the newly created Task Force on denture base risk assessment ( CEN TC 55/WG 8). The work of this TC WG had been requested for several years and was finally created after the decision of the CEN TC plenary meeting in February 2007. The work will include the topic occupational health and safety questions. The reason for the creation of this TF was the recognition of the fact that denture base polymer materials may be a risk material for dental personnel including dental technicians as well as for patients because of the monomer content. NORMAPME expert has been pointing out these risks for years. It is to note with satisfaction that the work can now start.

In the past years, NORMAPME already succeeded by leading ISO to adopt a decision on limited use of beryllium containing alloys that are poisonous for patients and dental technicians.

Furthermore, NORMAPME supports good manufacturing procedures for custom-made medical devices and favours European legislation and standardisation versus national legislation and standardisation. Most custom made devices are manufactured by micro and small enterprises which account for 2.75 % of all SMEs to the prescription of a qualified professional. This complicates the 'putting into service' and the use by 'final user'.

Other issues at stake:

• Checklist to comply with the provisions of the medical device directive (MDD)

Medical devices have become an increasingly important health care area in relation to their impact on health and health care expenditure. The sector covers some 8000 types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment.

NORMAPME/UEAPME Health Care Forum proposed a position on non compulsory quality systems included in the Medical Devices Directive (MDD).

• Generic occupational standards: Why occupational standards? A common level of competency for increased mobility working across borders and experiences in manufacturing is needed. This could help to avoid any confusion of generic terms. Occupational standards describe the skills and knowledge of the profession. This is useful for comparing educational systems, developing vocational training systems, life-long learning, career pathways, etc.It would encourage mobility, improve the level of education and ultimately influence the labour market. It increases transparency and mutual recognition of the profession and the competences. This can be used for the development of guidelines for best practices. The results might be common European occupational standards for dental technicians. They should be made available in 7 languages (E/F/D/NL/I/RO/SK). In order to demonstrate benefits of an occupational standard and to facilitate harmonisation of the education and vocational training FEPPD is coordinating a Leonardo da Vinci Project (called DOSAM, under the contract with DELACO) together with 11 other partner associations. The project uses the UK standards as a starting point. After the kick-off meeting in Amsterdam (14/01/06), in the summer and early autumn, discussions took place at national levels to find out to what extent the UK level could be accepted in the various Member States. At the end of October 2006 the national results were analysed at EU level. The first trans-national meeting with all the Leonardo da Vinci project partners was held in Brussels on 27-28th October 2006. A second trans-national meeting was held in Brussels on 12-13 January 2007.
  Specific aim of the project is to help the development of generic occupational standards and particularly overall promoting mobility for dental technicians.

The Dutch Federation of Dental Technicians pointed out that insurance companies should be discouraged from offering financial incentives to dentists to use low cost products and services from overseas, especially without the knowledge and prior consent of the patient. NORMAPME and FEPPD are in agreement on the need to adopt and maintain high standards throughout the industry.

CEN is interested in standardisation where Cad-Cam is concerned. NORMAPME is following this issue as dental technicians are working with such systems. NORMAPME demand precise user information and clear indications to health and environmental hazards stemming of components such as nickel and monomer.

The Medical Devices Expert group was informed that the Commission, ENTR F3 has drafted a mandate requesting the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (S CENIHR) established according to COM 2004/206/EC on the safety/potential toxicity of dental amalgam and alternative fillings to the patients and to the users (dental professionals). Also, an evaluation of the contribution of dental amalgam and alternatives to dental health will be requested.

Evaluation & Future actions

In June 2007 the CEN Technical Board accepted mandate M/403 in the field of information and communication technologies applied to the domain of eHealth. The work is allocated to CEN/TC 251 Health Informatics, which will work in close cooperation with the relevant CENELEC and ETSI technical bodies. In order to fill the position of a medical devices consultant to this TC, the CEN Management Centre has launched a call for a consultant.

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