WRITTEN QUESTION E-3397/03 by Cristiana Muscardini (UEN) to the Commission. Dental instruments and risk of infections.
Date: 2003-11-17
Institutions: European Parliament, Provisional data
Subjects: health care, health control, health legislation, health risk, infectious disease, medical device, national implementing measure, public health

27.3.2004

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Official Journal of the European Union

C 78 E/279

combination with the drastic reduction in opportunities of finding employment in the EU, condemn
Kosovo to destitution on an indefinite basis. Under these circumstances, the EP resolution of 5 June 2003,
expressing Parliament’s lively concern regarding the economic and social situation in the Western Balkans,
and calling for maximum priority to be given to eliminating the visa obligations for the EU, is quite
particularly urgent in the case of Kosovo.

What are the Commission’s proposals with regard to getting rid of visa obligations for the citizens of
Kosovo, a small country devastated by war? What are the Commission’s proposals with regard to Kosovo’s
final constitutional status?

Answer given by Mr Patten on behalf of the Commission

(21 January 2004)

Since June 1999, Kosovo is under interim United Nation administration pursuant to the United Nation
Security Council Resolution 1244.

As regards (short-term) Schengen-visas nationals of all countries in the region except Croatia are subject to
the visa obligation in accordance with Council Regulation 539/2001. It should be underlined that short-
term-Schengen-visas are not issued for immigration purposes in the Schengen States. Kosovar citizens,
who hold travel documents issued by the United Nations Mission in Kosovo (which is a travel document
recognised by all Schengen states) can apply for a Schengen visa for a short stay visit. In order to obtain a
Schengen visa, they have to fulfil all the relevant conditions laid down in the ‘acquis’ (in particular in the
Common Consular Instructions part III).

As regards the possibility to move ‘to take up employment in the Member States’, this requires a work
permit. The Commission has made a proposal (directive) on the conditions of entry and residence of third-
country nationals for the purpose of paid employment and self-employed activities (cid:1) this draft is still
being discussed in the Council. At present, Member States decide alone about the conditions to grant a
work permit to third country nationals (except in specific cases: e.g. third country national is a member of
the family of an Union citizen exercising his/her right of family reunification).

As regards the ‘final constitutional status of Kosovo’, the strategy followed by the international community
is the United Nations ‘standards before status’ policy, according to which no discussion for the settlement
of the final status can start unless Kosovo has attained a number of standards (e.g.
functioning of
democratic institutions, rule of law, freedom of movement, sustainable return of displaced people and
minority rights).

Currently, the United Nations Interim Administration Mission in Kosovo (Unmik) is trying (cid:1) with the
support of the international community, including the Union (cid:1) to establish a work plan and a timetable
for the implementation and close monitoring of the standards. The Contact Group has made it clear that
final status discussions could begin by mid 2005 provided sufficient progress has been made on this work
plan by then.

(2004/C 78 E/0280)

WRITTEN QUESTION E-3397/03

by Cristiana Muscardini (UEN) to the Commission

(17 November 2003)

Subject: Dental instruments and risk of infections

Numerous studies carried out in Italy and worldwide have shown that infections, including those of a
severe nature, can be caused by dental instruments. The water and air tubes often go unchanged for years:
a biofilm forms inside them which creates a favourable breeding-ground for bacterial and viral colonies.
The tubes which hold an aspirator a few centimetres away from an open cavity are infected throughout

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27.3.2004

with incrustations left by saliva, blood, plaque, filings and remains of metal, and this can go on for days,
months or years. There are 170 million hepatitis C sufferers worldwide, and it now has to be admitted that
some of these have been infected in the course of dental treatment.

In the light of EU Directive 93/42/EEC (1), which concerns biological risks from electromedical instruments
and is based on statistical studies:

1.

Is the Commission aware of these risks?

2.

Is the Commission in possession of studies concerning the incorporation of Directive 93/42/EEC and
the results obtained in the Member States?

3. Does the Commission not consider it desirable to urge the health ministries in the Member States to

ensure that this directive is applied in full?

(1) OJ L 169, 12.7.1993, p. 1.

Answer given by Mr Liikanen on behalf of the Commission

(23 December 2003)

The Commission is aware of risks of contamination associated with the use of medical devices. In this
respect, a distinction must be made between medical devices themselves and the use which is made of
devices.

Medical devices Directives, in particular Council Directive 93/42/EEC of 14 June 1993, define the essential
requirements devices have to meet in terms of quality, safety and performance to be put on the market
and into service. The devices in question are assessed by a third party, the ‘Notified Body’, and only those
that meet the state of the art requirements are CE marked and available for health care purposes. An
essential element of the Directives concerns the instructions for use,
in particular re-sterilisation and
replacement.

The question to know to what extent health care providers properly implement instructions for use when
using medical devices, is a different one, that falls with national health policies based in Article 152 of the
EC Treaty. According to this Article, the Community action in the field of public health shall fully respect
the responsibilities of the Member States for the organisation and delivery of health services and medical
care.

The Commission would welcome every initiative that, at national level, Member States may implement to
increase the degree of safety and health protection of patients.

(2004/C 78 E/0281)

WRITTEN QUESTION E-3406/03

by Antonios Trakatellis (PPE-DE) to the Commission

(17 November 2003)

Subject: Installation and operation of mobile telephone antennae in Chortiatis

Over the last few years it has been noted that in Chortiatis in Thessaloniki and many other regions of
Greece mobile telephone antennae have been set up and are operating very close to residential areas and
even in close proximity to school buildings and hospitals.