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EU revamps medical devices directive
Ban on substances avoided, but rules tighten on
labelling.
5 April 2007 - Uniform European Union (EU) rules on re-using and labelling
plastic medical devices have been agreed by the European Parliament, revamping
the EU medical devices directive to boost patient safety. Although the renewed
legislation avoids an outright ban on using materials deemed carcinogenic,
mutagenic or toxic to reproduction, the new law clearly instructs they should be
avoided where possible.
The key is whether there is an alternative material. A European Commission
statement said: "A total ban of these substances is not possible without banning
many medical devices which are indispensable for the protection of health." This
revised directive covers devices ranging from spectacles, joint and breast
implants, to the most sophisticated diagnostic imaging and minimally invasive
surgical equipment, including plastic stitching thread.
As regards labelling and re-usage, the new legislation clarifies rules on
reprocessing; defines the term "single use"; and insists future medical device
labelling be uniform across the EU. Devices which could possibly release
phthalates into patients’ bodies should be labeled accordingly.
Other rules within the revamped directive include a commitment for device
manufactures to attempt developing alternative substances or products with lower
health risks. They are also instructed to design devices with a "particular
emphasis on the working environment in which device is used", aiming for a
"possible reduction of potential accidents".
Given this package was negotiated with the EU Council of Ministers, formal
adoption of these new rules is anticipated shortly. They do not cover medical
devices combined with human cells and tissues, which will be covered by separate
future legislation under consideration.
Ref: http://www.prw.com/home PBP_NADetail_UP.aspx?ID_ Site= 818& ID_Article=16658&
mode=1& curpage=0
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