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Medical Devices Made With Tainted Heparin Recalled
By
Medtronic
Medtronic Inc. is recalling some medical devices because they may be coated with
tainted heparin, a drug linked to 81 deaths in the US. The disposable medical
devices, used during cardiac bypass surgery, are made with Medtronic's Carmeda
BioActive surface, which includes heparin. No injuries have been reported in
relation to the Medtronic devices, but the recall underscores the enormous scope
of the problems involving contaminated heparin.
Tainted heparin first garnered attention earlier this year, when Baxter
International recalled nearly all its heparin injections in the US after some
patients experienced extreme - and in some cases fatal - allergic reactions,
including difficulty breathing, nausea, vomiting, excessive sweating, and
rapidly falling blood pressure that was life threatening after being
administered the products. There have been similar recalls by other
manufacturers of Chinese-sourced heparin in 11 other countries, including
Denmark, Italy, France Germany and Japan. In the US, heparin has been associated
with the deaths of more than 100 people since early 2007, according to the Food
& Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were
associated with contaminated batches of heparin.
In March, the FDA confirmed that it had found chondroitin sulfate in samples of
the active ingredient used in Baxter heparin. The FDA said the chondroitin
sulfate was molecularly changed to mimic heparin’s blood-clotting properties.
That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant
partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Since
then, researchers have been able to show that chondroitin sulfate can cause
reactions like those seen among patients treated with tainted heparin.
In speaking with reporters after a Senate hearing last month, FDA Commissioner
Andrew von Eschenbach said that while the agency has no specific evidence that
the chondroitin sulfate contamination was intentional, “the concern is that it
had to be by design.” It costs a fraction of the ingredient usually used in
heparin, and producers may have used it in an attempt to cut costs.
Medtronic says the Carmeda BioActive surface is used on blood oxygenators,
reservoirs, pumps and other disposable products that are used during the bypass
surgery. According to Reuters, Medtronic initiated the recall because of an
April 8 recommendation by the FDA that medical devices employing heparin be
checked with newly-developed tests to make sure the heparin is not tainted.
Chondroitin sulfate cannot be identified with the tests normally used to inspect
batches of heparin.
A separate Medtronic line of disposable bypass-surgery products covered with a
different biosurface called Trillium will remain on the market because they
incorporate far smaller amounts of heparin.
Reference :
http://www.yourlawyer.com/articles/read/14358
Italy-India Forum Focuses
On Technology
Co-operation
Italian Trade Commission (ICE), in
association with Federation of Indian Chambers of Commerce and Industry (FICCI),
recently organised Italy-India fora at
New Delhi
and Bangalore. The focus was on co-operation in the form of technology transfer
between enterprises, research centres, realisation of joint training projects,
and exchange between universities through scholarships. The enlisted speakers
discussed exchange of intellectual property with particular reference to the
emerging high technology sectors. ICE also came out with special reports on
biotechnology and nanotechnology sectors in India.
Paolo
Trichilo, Charge 'd'Affaires a.i., Embassy of Italy, said, "This forum is an
important step in promoting trade relations between the two countries and I am
thankful to FICCI for helping us organize the same. India is gradually making a
mark in the biotechnology sector and by 2010, the Indian biotech industry is
expected to achieve revenue of $5 million and create one million jobs. The forum
was to encourage Italian representatives to develop a better understanding of
Indian biotechnology and nanotechnology, improve economic co-operation between
the two countries in form of technology transfers."
Professor
Leonardo Santi, President, National Committee for Biosafety, Biotechnology and
Life Sciences,
Italy,
while addressing the gathering said, "Italy in agreement with EU believes that
biotechnology and life sciences are to be considered priority for any country's
economy. With India experiencing a moment of great economic growth, thanks to
organisational and social instruments with specific features, can ensure
harmonic collaborations in the field of bio economy." |
