WRITTEN QUESTION No. 3764/97 by Cristiana MUSCARDINI , Gastone PARIGI , Amedeo AMADEO to the Commission. Uniform safety standards for treatment in hyperbaric chambers
Date: 1997-11-21
Institutions: AMADEO, European Parliament, MUSCARDINI, PARIGI
Subjects: EU law - national law, approximation of laws, civil defence, medical centre, medical device, pressure equipment, public safety, safety standard

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  (cid:145)medical  devices(cid:146)  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  device(cid:146)s  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 (cid:145)compatibility of medical equipment with oxygen(cid:146).

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.