WRITTEN QUESTION No. 3764/97 by Cristiana MUSCARDINI , Gastone PARIGI , Amedeo AMADEO to the Commission. Uniform safety standards for treatment in hyperbaric chambers
C 187/52 EN Official Journal of the European Communities 16. 6. 98 (98/C 187/83) WRITTEN QUESTION E-3764/97 by Cristiana Muscardini (NI), Gastone Parigi (NI) and Amedeo Amadeo (NI) to the Commission (21 November 1997) Subject: Uniform safety standards for treatment in hyperbaric chambers Eleven people died in a tragic incident in the hyperbaric chamber at the Galeazzi Institute in Milan. Although health matters are the responsibility of the Member States, the Maastricht Treaty has afforded some possibility for the Union to wield influence. Will the Commission therefore draw up a Directive stipulating that no patients may be admitted to any hyperbaric chamber in the Union unless they have first taken off their own clothes and put on overalls or some other garment appropriate for the treatment to be administered? Will it likewise make provision in the Directive to lay down uniform Community-wide safety standards for all hyperbaric medicine centres? Answer given by Mr Bangemann on behalf of the Commission (21 January 1998) The hyperbaric chambers used in hospitals in order to treat certain pathologies in atmospheres at high pressure and, in general, heavily enriched with oxygen are ámedical devicesí within the meaning of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (1), and are therefore covered by that Directive. The Directive contains technical requirements that are to be met if the products concerned are to be placed on the market and in service. They are classified as being for high-risk use and in this case the Directive provides for mandatory certification by an independent third party (notified body) in respect of the deviceís design and manufacture. The health and safety protection requirements to be met cover the familiar relevant aspects of the safe use of hyperbaric chambers and, in particular, the risk of fire or explosion during normal use, the hazards associated with compatibility with other medical devices under an oxygen-rich atmosphere, together with the need to provide users with information on their use, and the precautions to be taken. Moreover, hyperbaric chambers are subject to protection requirements relating to the hazard arising from pressure. These are covered by a Parliament and Council harmonising directive (97/23/EEC) of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment (2). That Directive will take effect in November 1999. In the meantime the hazard arising from pressure will be covered by the provisions of national law. Finally, the Commission has asked the European Standardisation Committee (CEN) to prepare a standard dealing with the ácompatibility of medical equipment with oxygení. Beyond the safety aspects linked with the design and manufacture of hyperbaric chambers, including the instructions for their use, the Member States should ensure that the competent authorities take the necessary practical action in order to ensure that there are proper conditions of use and that precautions are taken by the persons exposed to the risks, including those concerning clothing and any objects introduced by such persons. (1) OJ L 169, 12. 7. 1993. (2) OJ L 181, 9. 7. 1997