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From: TSS ()
Subject: Re: Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens
Date: December 27, 2005 at 6:21 pm PST
In Reply to: Biomedical Tissue Services (BTS) THE BODY SNATCHERS and mad cow disease i.e. CJD and other dangerous pathogens posted by TSS on December 20, 2005 at 2:05 pm:
CJD WATCH MESSAGE BOARD
Anonymous
Re: Possible body parts theft ring uncovered (spreading TSEs
Tue Dec 27, 2005 20:34
70.110.84.167
Update on Donor Screening
for TSEs
Melissa A. Greenwald, MD
Division of Human Tissues
Office of Cellular, Tissue and Gene Therapies
AATB 29th Annual Meeting
Hollywood, Florida
Council of Accredited Tissue Banks
Tuesday 20 September 2005
Today’s talk will focus on:
• What are Transmissible Spongiform
Encephalopathies (TSEs)?
• Background on CJD/vCJD Draft
Guidance
• Specific recommended deferral criteria
• Allow time for discussion and
questions
What are TSEs?
• Human Transmissible Spongiform
Encephalopathies (TSEs) include
Creutzfeldt Jakob Disease (CJD) and
variant Creutzfeldt Jakob Disease
(vCJD)
• CJD has been a known agent, but
vCJD has only been identified in the
recent past—is a human form of
Bovine Spongiform Encephalopathy
(BSE), known as “mad cow disease”
What are TSEs? (cont.)
• The TSE agent is a prion–a poorly
understood agent; is an abnormal
protein that causes a degenerative
disease of the central nervous
system (CNS) that is not curable and
invariably leads to the death of the
person with the disease
• The agent is very difficult to destroy
and would not be inactivated by
current tissue processing technology
What are TSEs? (cont.)
• Blood from some animals
experimentally infected with TSE
agents, including the BSE agent,
contains low levels of infectivity
• Several TSE agents, including BSE,
have been experimentally
transmitted by transfusion
• Agent for vCJD is ingested, so it is
likely that the agent has a bloodborne
phase in humans (the
specifics of the pathology in humans
is poorly understood)
What are TSEs? (cont.)
• There are no published studies
showing transmission of the BSE
agent via HCT/Ps; however
• vCJD agent is present in lymph
nodes and tonsils of infected
patients
• vCJD has been transmitted via blood
transfusion in the UK
• Transmission of CJD via cornea and
dura mater has already been
demonstrated in humans
What are TSEs? (cont.)
• Because of studies showing blood
infectivity of TSE agents, it is a
theoretical risk that HCT/Ps have the
potential to transmit TSEs
• Because of this theoretical risk, FDA
is concerned about the potential for
transmission of TSEs via HCT/Ps
and therefore considers TSEs a
RCDAD and requires donor
screening for these agents
CJD/vCJD draft guidance
• Deferral of tissue donors for risk
factors for “classic” (sporadic)
CJD—already recommended in the
1997 guidance for industry
• The draft guidance for CJD/vCJD
incorporated those deferrals, and in
addition recommends deferrals for
risk factors for variant CJD—travel or
residence in BSE-affected countries
• The draft guidance published June
2002
• There was a 6 month comment
CJD/vCJD draft guidance
• Draft guidance was modeled after the
guidance for industry for blood
donors, issued August 2001
• Recommends the same countries,
dates, and lengths of
travel/residence as does the
guidance for blood donors
• Permits an exception for the
collection and storage of
hematopoietic stem cells from
donors who live in or travel to a BSEaffected
country (for urgent medical
CJD/vCJD draft guidance
• Comments reviewed at CBER
• Final recommendations for
CJD/vCJD screening will be
incorporated into the final Donor
Eligibility guidance when published
• As of May 25, 2005 Transmissible
Spongiform Encephalopathy (CJD
and vCJD) is a relevant
communicable disease agent or
disease (RCDAD) and establishments
must screen for CJD/vCJD
CJD/vCJD draft guidance
• Specific deferral criteria in the draft
guidance are an indication of FDA’s
current thinking about how to
adequately and appropriately reduce
the risk of infectious disease
transmission by this agent
• Until a final guidance is issued,
establishments would not
necessarily have to “adopt” the
recommended deferral criteria but
the regulations do require some
screening for TSEs (including CJD
and vCJD)
CJD/vCJD draft guidance
• May use alternate screening criteria as long
as the screening criteria are at least as strict
as those recommended by FDA (i.e., are as
effective to adequately and appropriately
reduce the risk of infectious disease
transmission)
• No testing recommendations made—there
are no FDA approved tests for humans
CJD/vCJD Risks for Donor
Screening
• Persons who have been diagnosed
with vCJD or any other form of CJD
• Persons who have been diagnosed
with dementia or any degenerative or
demyelinating disease of the CNS or
other neurological disease of
unknown etiology [Possible that
FDA may make a distinction between
dementia and acute delirium (e.g.,
delirium caused by toxic/metabolic
disease or recent head trauma)]
Donor Screening (cont.)
• Persons who are at increased risk for CJD
– Receipt of human dura mater transplant
– Receipt of human pituitary-derived growth
hormone
– One or more blood relatives diagnosed with
CJD
• Persons who spent three months or more
cumulatively in the U.K. from the
beginning of 1980 through the end of 1996
Donor Screening (cont.)
• Persons who are current or former
U.S. military members, civilian
military employees, or dependents of
a military member or civilian
employee who resided at U.S.
military bases in Northern Europe for
6 months or more from 1980 through
1990, or elsewhere in Europe for 6
months or more from 1980 through
1996
Donor Screening (cont.)
• Persons who lived cumulatively for 5
years or more in Europe between
1980 and the present
• Persons who received any
transfusion of blood or blood
components in the U.K. between
1980 and the present
• NOTE—If the person being
interviewed is not familiar with the
term CJD, you may take that as a
negative response
The UK
• For the guidance, the UK includes
– England
– Northern Ireland
– Scotland
– Wales
– Isle of Man
– Channel Islands
– Gibraltar
– the Falkland Islands.
Military Bases
• In Northern Europe includes
– Germany, UK, Belgium, Netherlands
– Deferral from 1980-1990
• In Southern Europe includes
– Greece, Turkey, Spain, Portugal, Italy
– Deferral from 1980-1996
Family History of CJD
• Would be ineligible UNLESS:
– the diagnosis of CJD was subsequently found
to be an incorrect diagnosis;
– the CJD was iatrogenic; or
– laboratory testing (gene sequencing) shows
that the donor does not have a mutation
associated with familial CJD
For further information
http://www.fda.gov/cber/gdlns/cjdvcjd0602
.htm
Melissa Greenwald
301-827-2002
melissa.greenwald@fda.hhs.gov
Vox Sang. 89(2) pp. 63-70.
http://www.fda.gov/cber/summaries/aatb092005mg.pdf
what does this week have in store for recipients of donor tissue;
PRODUCT
Acellular Dermal Matrix Skin Tissue, Recall # B-0276-6
CODE
Alloderm
B10084-002, B10084-007, B10084-009, B10084-012 thru 014, B10084-017 and 018, B10084-023, B10084-025 thru 029, B10085-001 and 002, B10085-007 thru 012, B10085-017, B10085-021 thru 025, B10088-001, B10088-006 thru 009, B10088-010 thru 021, B10088-025 thru 035, B10134-001 thru 004, B10134-010 and 011, B10134-017 thru 026, B10192-007 and 008, B10192-012, B10192-016 and 017, B10192-019, B10192-024 and 025, B10192-028 thru 035, B10222-001, B10222-005 and 006, B10222-014 and 015, B10222-017 thru 020, B10222-022 thru 024, B10222-026, B10222-028, B10721-009 thru 012, B10721-016 thru 024, B10819-001 and 002, B10819-005 thru 007, B10819-009 thru 014, B10819-016 thru 018, B10819-031 and 032, B10819-035, B10838-007, B10838-009, B10838-018 thru 023, B10838-026 thru 028, B10850-001 thru 004, B10850-009 thru 016, B11021-001 and 002, B11021-008 thru 011, B11022-016 and 017, B11024-011 thru 013, B11024-015 thru 019, B11025-001, B11025-011 thru 016, B11025-019 thru 021, B11026-001 thru 003, B11026-010 thru 012, B11026-015, B11026-017 thru 023, B11052-003 and 004, B11052-012 and 013, B11052-015 and 016, B11054-013, B11055-003 and 004, B11055-011 and 012, B11055-017, B11055-019 and 020, B11061-002, B11061-015 thru 017, B11064-002 thru 004, B11064-013 thru 017, B11064-020, B11064-022, B11065-001 and 002, B11065-004, B11065-006 and 007, B11065-009, B11065-012 thru 018, B11079-004, B11079-013 and 014, B11079-016, B11079-019, B11079-021 thru 024, B11079-029 thru 031, B11080-002, B11080-009 thru 011, B11080-016, B11080-021, B11083-019 thru 022, B11083-024 thru 027, B11087-003 thru 005, B11087-007 thru 013, B11099-012 and 013, B11099-016 thru 026, B11103-003, B11103-008, B11103-011 thru 015, B11104-002 thru 005, B11104-009, B11107-002 thru 004, B11107-011, B11107-014 thru 020, B11107-025, B11115-003 and 004, B11115-012 and 013, B11115-018 thru 021, B11115-025 and 026, B11120-019, B11120-021, B11127-008 thru 010, B11127-013 and 014, B11129-001, B11129-009 and 010, B11129-013 and 014, B11131-011 thru 013, B11131-015 thru 017, B11148-012, B11148-016 thru 023, B11156-009, B11156-013 thru 017, B11163-002, B11163-015, B11163-017 thru 021, B11180-001, B11180-004, B11180-009 thru 012, B11180-014 and 015, B11180-017, B11181-001, B11181-003, B11181-009, B11181-011 thru 015, B11202-001 thru 004, B11202-014 thru 016, B11202-021 and 022, B11213-001, B11213-003 and 004, B11213-007, B11213-010 thru 014, B11213-022, B11217-010 thru 013, B11217-015, B11239-003, B11239-006, B11239-015, B11239-023 and 024, B11239-026, B11239-030, B11244-014, B11244-017, B11244-020, B11244-022, B11247-001, B11247-016, B11247-018, B11247-021, B11262-016, B11266-014, B11266-016, B11266-018 and 019, B11266-023, B11281-021, B11281-023, B11282-015, B11282-019, B11286-013 and 014, B11296-010 thru 013, B11296-015, B11324-027, B11324-030, B11327-014 and 015, B11349-009, B11350-012, B11350-017, B11350-019, B11363-012, B11363-015, B11367-018 thru 020, B11367-030 and 031, B11410-012 and 013, B11432-012, B11432-014, B11468-013 and 014, B7406-001 thru 031, B7406-034 thru 037, B7406-045 thru 047, B7406-050 thru 061, B7406-065 thru 067, B7406-069 thru 077, B7417-001 thru 013, B7417-015 , B7417-019 thru 023, B7417-037 thru 042, B7417-044 thru 046, B7417-048, B7417-050, B7417-054 thru 058, B7430-001 thru 014, B7430-018, B7430-020, B7430-026 and 027, B7430-035 thru 037, B7430-039 thru 079, B8410-012 thru 037, B8410-039 thru 052, B8411-002 and 003, B8411-007, B8411-014 and 015, B8411-017 thru 056, B8414-001 thru 008, B8414-015 thru 029, B8421-001, B8421-003, B8421-005 and 006, B8421-009, B8421-024 thru 048, B8421-051 thru 058, B8422-001 thru 006, B8422-008, B8422-012, B8422-018 thru 028, B8422-030 thru 032, B8422-035 thru 039, B8422-043, B8422-045 thru 047, B8422-050 and 052, B8422-054, B8424-001 thru 004, B8424-008, B8424-010, B8424-014 thru 016, B8424-022 thru 032, B8424-034 and 035, B8424-037 thru 044, B8425-010 thru 019, B8425-021 and 022, B8425-025 thru 027, B8684-001 thru 005, B8684-007 and 008, B8684-010, B8684-016 thru 030, B8684-032, B8684-034 and 035, B8684-037 thru 050, B8685-001 thru 003, B8685-011 thru 042, B8695-002 and 003, B8695-005 thru 013, B8695-023 thru 061, B8697-001, B8697-006, B8697-014, B8697-017 and 018, B8697-020 and 021, B8697-037 thru 039, B8697-041, B8697-043 thru 058, B8706-001 and 002, B8706-006 thru 009, B8706-013, B8706-019 thru 023, B8706-025 thru 048, B8707-007 thru 014, B8707-016 thru 019, B8708-008 thru 025, B8720-001, B8720-003 thru 005, B8720-009, B8720-012, B8720-021 thru 025, B8720-027 thru 033, B8720-035 and 036, B8720-038 and 039, B8720-040 , B8720-042 thru 062, B8722-002, B8722-010 and 011, B8722-017 thru 025, B8722-027 thru 042, B8723-001, B8723-004 thru 007, B8723-016, B8723-025 and 026, B8723-028 and 029, B8723-031 thru 33, B8731-013 and 014, B8731-017, B8731-021 and 022, B8731-026 thru 045, B8732-001, B8732-004 and 005, B8732-005, B8732-016 thru 024, B8732-026 thru 045, B8734-021 thru 023, B8734-027, B8734-029 thru 031, B8734-033, B8734-037 and 038, B8734-041, B8734-043 thru 053, B8734-055 thru 057, B9132-002 thru 005, B9132-010, B9132-014 thru 029, B9228-007 thru 018, B9232-004, B9232-010 and 011, B9232-016 thru 023, B9243-001, B9243-003, B9243-005, B9243-011, B9243-014, B9243-016, B9243-018 thru 027, B9245-001, B9245-009, B9245-013 and 014, B9245-014, B9245-017, B9245-019 thru 028, B9284-001 thru 005, B9284-007, B9284-011 thru 020, B9284-023 thru 026, B9284-029 thru 042, B9285-001 and 002, B9285-004, B9285-012 and 013, B9285-016, B9285-019 thru 027, B9285-029, B9322-002 thru 004, B9322-007, B9322-013 thru 022, B9322-024 thru 026, B9323-001, B9323-006 and 007, B9323-017, B9323-019 thru 030, B9331-001, B9331-004 thru 007, B9331-017, B9331-020 thru 028, B9331-031 thru 042, B9333-001 thru 003, B9333-005 and 006, B9333-012, B9333-015 thru 020, B9340-002 and 003, B9340-006 and 007, B9340-010 thru 012, B9340-014 thru 022, B9491-001 thru 003, B9491-006, B9491-011 thru 013, B9491-017 thru 023, B9509-001, B9509-012, B9509-018 thru 022, B9693-002, B9693-008 thru 015, B9725-001, B9725-005 and 006, B9725-012 thru 031, B9725-033 thru 037, B9765-002 and 003, B9765-005 thru 007, B9765-015, B9765-018 thru 022, B9927-001 thru 004, B9927-007, B9927-009 thru 011, B9927-013 thru 029, B9927-031 thru 033, C10602-016 thru 021
Repliform
B10084-019 and 020, B10084-022, B10084-024, B10134-016, B10192-013, B10192-015, B10192-018, B10192-020 thru 023, B10819-027, B11120-008 thru 11, B7406-044, B7406-048, B7406-064, B7406-078 thru 83, B7417-031 and 32, B7430-038, B8414-014, B8421-020, B8421-022 and 23, B8422-042, B8424-036, B8684-015, B8685-005 thru 8, B8697-040, B8697-042, B8706-024, B8723-019, B8723-024, B8734-042, B9232-014 and 015, B9243-015, B9245-018, B9284-027 and 028, B9285-015, B9285-017 and 018, B9333-007 and 08, B9333-010 and 011, B9509-015, B9725-007, B9765-008, C10602015
Graft Jacket
B10084-016, B10084-021, B10085-014 thru 016, B10088-023 and 024, B10134-013, B10838-015, B11021-006, B11052-010, B11065-011, B11079-009, B11087-006, B11131-008, B11148-009, B11163-016, B11163-008 and 009, B11181-010, B11266-012, B7406-062, B7417-051 thru 053, B8421-049 and 050, B8422-041, B8684-036, B8695-019, B8697-032, B8706-014, B8720-016, B8720-019, B8720-020, B8720-034, B8720-037, B8732-025, B8732-013, B9243-013, B9245-015, B9245-016, B9284-022, B9331-029 and 030, B9340-009, B9491-014, B9765-013, B9765-016
RECALLING FIRM/MANUFACTURER
LifeCell Corporation, Branchburg, NJ, by telephone and facsimile transmission beginning September 30, 2005, and by follow-up letter dated October 12, 2005. Firm initiated recall is ongoing.
REASON
Human Tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,652 allografts from 102 lots
DISTRIBUTION
Nationwide, Australia and Korea
http://www.fda.gov/bbs/topics/enforce/2005/ENF00932.html
TSS
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