IA#84-03 --- 6/27/87
BACKGROUND
A recent reported case of Creutzfeldt-Jakob Disease (CJD) in a 28 year-old
patient who had received a human dura mater graft indicates that the graft may
have been the source of this always fatal disease. The woman died 22 months
after receiving the lyophilized, irradiated human cadaveric dura mater graft.
The dura mater used in the graft was packaged in October 1982 under lot #2105
by B. Braun Melsungen AG of West Germany, shipped to Tri Hawk International,
Inc., Montreal, Quebec, Canada and sold to Saint Francis Hospital, Hartford,
Connecticut, on April 4, 1985.
This is the first known case of CJD transmission associated with a dura mater
graft. Present methods of sterilizing the dura mater do not completely
inactivate the CJD agent.
The dura mater is manufactured by the West German firm under the trade name
Lyodura. Although the material is primarily used in neurosurgery, it is also
used in orthopedic, otologic, dental, urologic, gynecologic, and cardiac
surgical procedures.
We have been unable to determine the total number of packages of Lyodura that
were imported into the United States because the Canadian distributor failed
to maintain adequate records of distribution for all lots which may have been
distributed by mail to hospitals in the United States and Canada.
As stated in the FDA Safety Alert which issued April 28, 1987, we strongly
recommend that users of dura mater choose only products from known sources
which retrieve, process and handle the material according to guidelines such
as those of the American Association of Tissue Banks.
To report cases or for further information, please contact:
Gordon C. Johnson, M.D.
Center for Devices and Radiological Health
Food and Drug Administration
8757 Georgia Ave,
Silver Spring, Maryland 20910
GUIDANCE
Alert your local Customs office to be aware of this import alert and to
monitor mail shipments for this product.
Detain all shipments of Lyodura (dura mater) received from Tri Hawk
International, Inc., Montreal, Quebec, Canada or from B. Braun Melsungen AG of
West Germany. Charge: "The article is subject to refusal of admission
pursuant to section 801(a)(1) in that it appears to be adulterated under
section 501(h), because the methods and controls used for the storage and
distribution of Lyodura (dura mater) are not in conformance with current good
manufacturing practice requirements under section 520(f)(1)."
|
