WRITTEN QUESTION E-3057/01 by María Sornosa Martínez (PSE) to the Commission. Controls on the manufacture and importation of medical equipment.
Date: 2001-11-05
Institutions: European Parliament, Provisional data
Subjects: Croatia, EC conformity marking, Spain, death, kidney disease, marketing, medical device, multinational enterprise, product safety, technical standard

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16.5.2002

Nonetheless, any citizen of the EU is free to use his or her mother tongue when submitting such
proposals.

the Commission not consider

Does
strongly recommending the use of English constitutes
discrimination against the large number of citizens of the Union who do not have a good command of
that language?

that

Will the Commission ensure that all applications are treated in exactly the same way, irrespective of the
language of the Union in which they are drafted?

Answer given by Mrs Wallström on behalf of the Commission

(6 December 2001)

The Commission does not insist that the technical description of Life-Environment proposals is submitted
solely or also in English. It simply recommends to present the technical part of the proposals (and only
this) also or only in English, because various internal Commission and external experts participate in the
evaluation of the proposals.

Each applicant has the right to present a proposal in any of the official Community languages. For this
purpose the complete application form has been published in all official
languages. The Commission
assures that all applications in whatever Community language are dealt with in the same manner and that
no discrimination occurs during the evaluation of each file (for example a large coverage of Community
languages is assured in expert panels).

(2002/C 115 E/233)

WRITTEN QUESTION E-3045/01

by Glenys Kinnock (PSE) to the Commission

(5 November 2001)

Subject: Provision of lifeguards

Is the Commission aware of a recent UK study into the number of children who drown in pools and in the
sea in Member States of the EU every year?

In the light of this study, would the Commission consider initiating a systematic recording of figures in all
Member States in the EU?

What plans does the Commission have to introduce a Regulation on the provision of lifeguards at public
pools and beaches?

Answer given by Mr Byrne on behalf of the Commission

(3 December 2001)

The Commission is not aware of the study referred to by the Honourable Member but is collecting the
information it needs to answer the question. It will communicate its findings as soon as possible.

(2002/C 115 E/234)

WRITTEN QUESTION E-3057/01

by María Sornosa Martínez (PSE) to the Commission

(5 November 2001)

Subject: Controls on the manufacture and importation of medical equipment

In August this year 12 deaths in Spain (in Valencia, Madrid and Barcelona) were apparently caused by use
of the dialysis machines which the multinational company Baxter markets all over Europe. A few days ago

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the European press also reported the deaths of 23 more kidney patients who had been treated with the
same type and make of dialysis machine in Croatia. Baxter itself denies that the cause of death is linked to
its filters (Althane A-15, A-18 and A-15), although it has withdrawn them from the European market as a
preventive measure.

In view of all this, does the Commission consider that the Spanish authorities, both national and regional,
may have been guilty of negligence in this case, with reference to Directive 93/42/EEC (1) concerning
medical devices, in particular:

@ Article 2, which obliges the Member States to take steps to ensure the safety of devices installed;

@ Annex 1, which lays down the requirements which the Member States must make manufacturers or
distributors meet as regards the design and use of products (in particular point 12.7 @ protection
against mechanical and thermal risks)?

Has the Commission been duly informed by the Spanish Government about the case of the Baxter dialysis
machines,
in accordance with Article 8 (Safeguard clause) and Article 10 (Information on incidents
occurring following placing of devices on the market) of the same directive?

Can the Commission confirm that the Spanish authorities ascertained, before authorising their use, that the
Baxter machines had the required EC marking and an EC certificate of conformity?

Does the Commission not consider that better and broader legislation is needed on the correct
manufacture of medical devices, applicable to both equipment manufactured in the Community and that
imported from third countries, and laying down stricter standards in order to ensure the safety of potential
users?

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

Answer given by Mr Liikanen on behalf of the Commission

(19 December 2001)

In accordance with article 10 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices,
the Spanish authorities officially informed the Commission and Member States, on September 2001, about
the problems that it had encountered with the product referred to. This allowed Member States to
immediately take action with regard to products on their market. Further information was given by the
Spanish authorities on 18 October 2001.

According to the information received from the Spanish authorities, this product had been subject to the
required conformity assessment procedures and CE marked accordingly.

The Spanish authorities also confirmed that as yet it has not been possible to establish a link between the
Spanish and Croatian cases.

They are still actively investigating the problems encountered with the dialyzers and will communicate
their conclusions to the Member States as soon as they are available.

Provisional conclusions of a review process currently being carried out with national authorities and other
stakeholders indicate that present regulatory framework offers overall a high level of safety. Various
conformity assessment procedures are foreseen, based on the type of products and their potential risks.
Furthermore, the Directive foresees various mechanisms allowing authorities to intervene, even where
products have been regularly placed on the market, where safety concerns arise. However, in the course of
this review process, Commission and Member States also accepted that on some aspects, implementation
of the directive can be improved. Commission and Member States have already taken various initiatives in
this respect.