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News -
September 1997
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Legislation
Europe: June 14 1998 deadline extended for medical devices
The European commission has agreed that medical devices which do not
carry the CE mark, but which are already in the distribution chain by
June 14th, 1998, may still be marketed until June 2001.
The 2001 date is provisionary, and may change.
The deadline of June 1998 for placing devices on the market which are
not CE marked has
not changed.
Product News
Japan: Arrow antiseptic coated catheters banned.
Arrow International have been banned from selling their antiseptic
coated catheters (Arrowguard)
in Japan following a series of incidents where 12
patients suffered from anaphylaxis over a 16 month period.
Although many intensive care units believe that the antiseptic coating
reduces infection rates, it appears that a few patients are sensitive
to the antiseptic coating, chlorhexadine.
One theory is that
the Japanese may be more sensitive than other races due to the use of
creams containing chlorhexadine.
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Last Modified: Thursday, 11-Sep-1997 15:20:57 BST