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 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 Baxter itself denies that the cause of death is linked to its filters (Althane A-15, A-18 and A-15), although it has withdrawn them from the European market as a preventive measure.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.