Post on 31-Aug-2019
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3/26/2012 11:53:35 AM
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20011123
(I)
Clostridium Sordellii
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(II)
(CDC)
Clostridium Infections Associated with M l k l t l Ti All ftMusculoskeletal-Tissue Allografts
N Engl J Med 2004; 350:2564-2571
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FDA 2002/3
FDA+CDC
CDC 2002/7 54
2002/8 7913
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3
CDC
CDC findings
+
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1980dura mater (C t f ld J k b Di CJD)
(I)
(Creutzfeld-Jakob DiseaseCJD)
19927 1990
CJD
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4
1999
(II)
2002 C 6
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Take home message (I)
CDC2002 3Morbidity and Mortality Weekly Report (MMWP)(aseptic)(sterile) (sterile)
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42 USC 264 - Regulations to control i bl di
(I)
communicable diseasesSection 361 (Sec. 361) of the Public Health Service Act (PHS Act) [42 USC 264].FDA 1993/12
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12/14/1993 provisions of the interim l fi l l 21 CFR 1270
(II)
rule final rule 21 CFR 1270 (1998/1/26 )FDA PHS Act Section 36121 CFR 1270, F d l F d D dFederal Food, Drug, and Cosmetic Act (FD&C Act)
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1997 FDA:
(III)
;
(cGTP)
21 CFR 1271 (2004/1/21 )14
21 CFR part 1270: human tissue intended for transplantation
(IV)
transplantation
FDAFDAFDA
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Subpart A--General Provisions
(IV-1) 21 CFR 1270
Subpart B--Donor Screening and TestingSubpart C--Procedures and RecordsSubpart D--Inspection of Tissue Establishments
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21 CFR part 1271: current good tissue ti f f t f h
(V)
practice for manufacturers of human cellular and tissue-based products cGTPHCT/Ps
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Subpart A--General ProvisionsS b t B P d f R i t ti d
(V-1) 21 CFR 1271
Subpart B--Procedures for Registration and Listing Subpart C--Donor Eligibility Subpart D--Current Good Tissue Practice Subpart E Additional Requirements forSubpart E--Additional Requirements for Establishments Described in 1271.10 Subpart F--Inspection and Enforcement of Establishments Described in 1271.10
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AATB
1976
19861993 6th Standards1996 7thS
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Standards 21 108200 510th Standards 142200812th Standards 113()+ guidance2012/213th
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21 CFR 1270 & 1271
Regulations vs. Standards (I)
AATB standardsfunctional components of a tissue bank director, medical director, technical t ff lit staff, quality assurance program
qualifications & responsibilities
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Sec. 1271.260 Storage. ( )C t l f t Y t
Regulations vs. Standards (II)
(a)Control of storage areas. You must control your storage areas and stock rooms to prevent:(1) Mix-ups, contamination, and cross-contamination of HCT/Ps, supplies, and reagents, and (2) An HCT/P from being improperly made available for distribution.(b)Temperature. You must store HCT/Ps at an appropriate temperature.21
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Sec. 1271.260 Storage.
Regulations vs. Standards (III)
(c)Expiration date . Where appropriate, you must assign an expiration date to each HCT/P based on the following factors: (1) HCT/P type; (2) Processing, including the method of preservation; (3) Storage conditions; and (4) Packaging.(d)Corrective action(e)Acceptable temperature limits .
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AATB standards
Regulations vs. Standards (IV)
E 4.100 storage temperature (
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E4.300 Expiration Date/Storage period
Regulations vs. Standards (IV-1)
E4.320 :5: 5
: 5
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EU
1994(R d ti N R(94)1)(Recommendation No. R(94)1)2004(Directive)2004/23/EC 2005(European
i i H lth & C
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commission Health & Consumer Protection Directorate-General)
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Derivative 2006/86/EC
Unless otherwise specified in point 4, where tissues or cells are exposed to thetissues or cells are exposed to the environment during processing, without a subsequent microbial inactivation process, an air quality with particle counts and microbial colony counts equivalent to those f G f
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of Grade A as defined in the current European Guide to Good Manufacturing Practice (GMP)
Grade Aclass 100 ISO 5
Remark(I)
Derivative 2006/86/EC2003/94/ECGMPD(Class 10ISO 8)
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2006/86/EC(microbial inactivation)
Remark(II)
(microbial inactivation)A A AAA
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EATB (I)
The first European Conference on Ti B ki i 1991 ETissue Banking in 1991 European Association of Tissue Banks (EATB)The Association shall promote cooperation, research and d l t i th f Ti
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developments in the area of Tissue Banking and related sciences in Europe.
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EATB(II)
The aims of the EATB are:- international coordination;- international standardization;- exchange of experience;- cooperation
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cooperationCommon Standards for Tissues and Cells Banking, version 2003
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2
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198810(Asia Pacific Association of(Asia Pacific Association of Surgical Tissue BanksAPASTBwww.apastb.net )APASTB standards for tissue banking
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(I)
GMPGMP4
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200(cornea)20(sclera)10
(II)
(www.eplanetventures.com/en/news/releases/pr_031408_1.html)Korea Bone Bank Inc.(1997)www kbbcom co kr
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)www.kbbcom.co.kr
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Korea Bone Bank
(III)
Dr. Nather 1988
NUS 1992960(deep-frozen long bones)(lyophilized)
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1994NUS9
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(III-1)
National University Hospital Tissue Bank protocol follows guidelinesBank protocol follows guidelines recommended by the American Association of Tissue Banks and the European Association of Tissue Banks using donor selection criteria
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using donor selection criteria Femoral Head Banking: NUH Tissue Bank Experience ORTHOPEDICS April 2007;30(4):308.
(III-1)
http://www.nhcs.com.sg/patientcare/clinicalspecialtiesservices/cardiothoracicsurgery/NCHB/Pages/Home.aspx
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Take home message (II)
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TW &
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20
14
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18-1
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21
98.02.02
2
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www.fda.gov.tw/people_laws_list.aspx?classifysn=88 ?
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76
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1st 120K NT 2nd 80K NT
1st 120K NT, 2nd 80K NT
1st 80K NT, 2nd 50K NT 5K NT 50K NT: ,,
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Remark:
120K NT 150K 80K 80K
20~100 200~1000
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TFDA
or
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GTP(I)
()
AATB standards: training, competency, continuing education, training records
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GTP(II)
However, class 100 l 10Kclass 10K
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EXP:
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USA EU APASTB TW
PHS directives
21 CFR 1270,1271
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AATB standards
EATB standards
APASTB standards
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199711 26
() ()
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199711 26
84
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Take home message (I)
CDC2002 3Morbidity and Mortality Weekly Report (MMWP)(aseptic)(sterile) (sterile)
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Take home message (II)
86
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tissue bank or cell bank
Take home message (III)
:3:
2 2:
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