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Epidemiologic Notes and Reports
Update: Creutzfeldt-Jakob Disease in a Second Patient
Who Received a Cadaveric Dura Mater Graft
In late May 1988, a 25-year-old man from New Zealand developed a
rapidly progressive dementia 31 months after neurosurgery for head
injuries sustained from a fall. During surgery, extensive,
bilateral
dura mater tears were repaired with imported, commercially prepared
cadaveric human dura mater grafts. The patient died July 31, 1988,
and
Creutzfeldt-Jakob disease (CJD) was confirmed by brain necropsy,
which
demonstrated spongiform encephalopathy. He had no family history of
degenerative neurologic disease, nor had he received cadaveric,
pituitary-derived human growth hormone. Previous major surgery
included
an appendectomy at age 10. An ongoing investigation by the New
Zealand
Department of Health determined that the dural grafts used in this
patient were LYODURA, processed by B. Braun Melsungen AG of the
Federal
Republic of Germany; the lot numbers are unknown.
Reported by: TJ Nisbet, PhD, Office for Inquiries, New Zealand Dept
of
Health; I MacG Donaldson, MD, FRACP, FRCP, Christchurch Hospital,
Christchurch, New Zealand; SN Bishara, MCh, FRCS, FRACS, Dunedin
Hospital, Dunedin, New Zealand. Food and Drug Administration.
Hospital
Infections Program and Div of Viral Diseases, Center for Infectious
Diseases, CDC.
Editoral Note: This is the second patient reported to CDC who
developed CJD after receiving a lyophilized, irradiated, human
cadaveric dura mater graft, LYODURA. The first patient was a
28-year-old woman from Connecticut who had received her graft,
LYODURA
(lot 2105), during a surgical resection of a cholesteatoma 19
months
before onset of CJD (1,2). The young age of the patient from New
Zealand and his recent surgery using the same brand of dura mater
graft
that was implicated as the source of the CJD agent in the U.S.
patient
strongly suggest that his dural grafts were the vehicle of
transmission
of the CJD agent. The surgeries during which LYODURA grafts were
used
in the two patients were performed within a 6-month period in 1985.
Lot
2105 was not distributed to New Zealand. Whether these grafts were
produced around the same time is unknown.
This second case of LYODURA-associated CJD supports a published
conclusion of the joint CDC/Food and Drug Administration (FDA)
investigation of the first patient that "LYODURA may carry a higher
risk of transmitting CJD than other dura mater products used in the
United States" (2). In June 1987, representatives of B. Braun
Melsungen
AG reported that their procedures for collection and processing of
dura
after May 1, 1987, were revised to reduce the risk of CJD
transmission.
On April 28, 1987, FDA had issued a safety alert recommending
disposal
of all LYODURA from packages bearing a four-digit lot number
beginning
with the digit "2" (code for material packaged in 1982), as well as
all
unmarked LYODURA (3). Because the lot numbers of the LYODURA used
in
the New Zealand patient cannot be determined, however, it now may
be
prudent to avoid using LYODURA produced before the manufacturer's
reported changes in procedures were instituted.
The methods of producing and distributing human tissue products,
including dura mater grafts, are not routinely subjected to FDA
inspection and approval. Health-care providers are urged to use
human
tissue products that have been handled according to strict
guidelines,
such as those established by the American Association of Tissue
Banks
(4,5). In addition, hospitals should maintain records so that
infections associated with human tissue products can be linked with
specific lot numbers of the specific products.
Previous and current patients who have rapidly progressive
dementing
illnesses consistent with CJD and who have received a dural graft
during an operative procedure should be reported through their
appropriate state health department to L. Schonberger, M.D.,
Division
of Viral Diseases, Center for Infectious Diseases, CDC, Building 6,
Room 127, Mailstop A32, Atlanta, Georgia 30333; telephone (404)
639-3091.
References
CDC. Rapidly progressive dementia in a patient who received a
cadaveric dura mater graft. MMWR 1987;36:49-50,55.
2.CDC. Update: Creutzfeldt-Jakob disease in a patient receiving a
cadaveric dura mater graft. MMWR 1987;36:324-5.
3.Food and Drug Administration. FDA safety alert: possibly
contaminated dura mater transplant material. Rockville, Maryland:
US
Department of Health and Human Services, Public Health Service,
April
28, 1987.
4.American Association of Tissue Banks. Standards for tissue
banking.
Arlington, Virginia: American Association of Tissue Banks, 1984.
5.American Association of Tissue Banks. Technical manual for tissue
banking: section II--Musculoskeletal Council. Arlington, Virginia:
American Association of Tissue Banks, 1987;M-1 to M-25.
Disclaimer
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