# CE2004078EN.01027901.xml

| 27.3.2004 | EN | Official Journal of the European Union | CE 78/279 |
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27.3.2004

EN

Official Journal of the European Union

CE 78/279

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(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

Subject:

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 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:

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| 1. | Is the Commission aware of these risks? |
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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? |
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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? |
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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?

Answer given by Mr Liikanen on behalf of the Commission

(23 December 2003)

(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.

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

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