After
substandard breast implants went unnoticed for more than a decade, the EU's
health commissioner has announced plans for tighter controls on a wide variety
of medical devices.
Health and
Consumer Policy Commissioner John Dalli said Brussels would tighten the rules
on medical devices, from life support machines to sticking plasters, as well as
broadening the definition so that more products were subject to checks.
The changes
are a reaction to a breast implant scandal affecting thousands of women, with breast
implants using industrial-grade silicon remaining on the market for over a
decade unchecked.
"We
must do our best never to let this happen again," Dalli said in a
statement on Wednesday, adding that the new EU proposals were "better
adapted to scientific and technological developments."
The Maltese
politician said "everybody was shocked" by the widespread use of
substandard breast implants made by the now-defunct French company Poly Implant
Prothese (PIP), "which affected tens of thousands of women in Europe and
around the world."
The
European Commission said that the new rules took the PIP mistakes into account
and would subject medical devices to far more stringent tests before they could
be put on the market. The definition of medical devices would also be expanded
to include items like breast implants.
Wolves
guarding chickens
Independent
and national assessment agencies - most of the health industry's regulators are
currently private companies - would be given greater powers, and patients would
be provided with more data on medical devices they might consider purchasing.
"If
this was happening in the market, the PIP scandal would have been detected many
years before and eliminated," Dalli told a news conference.
The
statement said that the medical device market in the 27 EU states plus Norway
and Switzerland was worth 95 billion euros ($122 billion) in 2009.
The
proposals will now be submitted to the European Council and the European
Parliament for approval.
msh/jr (AFP, dpa, Reuters)
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