COUNCIL OF EUROPE CONSEIL DE L’EUROPE INTERNATIONAL FIGURES ON ORGAN DONATION AND TRANSPLANTATION - 2004 2005 FUNDACION RENAL IÑIGO ALVAREZ DE TOLEDO NEWSLETTER TRANSPLANT SEPTEMBER 2005 Vol. 10. Nº 1
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COUNCILOF EUROPE
CONSEILDE L’EUROPE
INTERNATIONAL FIGURES ON
ORGAN DONATION AND TRANSPLANTATION - 2004
2005
FUNDACION RENALI Ñ I G O A L V A R E Z D E T O L E D O
NEWSLETTER
TRANSPLANTSEPTEMBER 2005
Vol. 10. Nº 1
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– AUSTRALIALee Excell
– AUSTRIAGuido Persijn (ET)
– BELGIUMGuido Persijn (ET)
– BULGARIAYanko Nachkov
– CANADAKim Badovinac
– CROATIAMirela Busic
– CYPRUSGeorge Kyriakides
– CZECH REPUBLICEva Pokorna
– DENMARKFrank Pedersen (SKT)
– ESTONIAPeeter Dmitriev
– EUROTRANSPLANT (ET)Germany, The Netherlands,Austria, Belgium, Slovenia,LuxemburgGuido Persijn (ET)Marjan Slot
– FINLANDFrank Pedersen (SKT)
– FRANCEYlana ChalemPhilippe Tuppin
– GEORGIAGia Tomadze
– GERMANYGuido Persijn (ET)
– GREECEGeorgia MenoudakouMarianthi Katsani
– HUNGARYPeter Borka
– ICELANDFrank Pedersen (SKT)
– IRELANDPhil Pocock
– ISRAELSharona Bem Ami
– ITALYPaola di Ciaccio
– LATVIASergej Trushkov
– LITHUANIAJulija Shirokova
– LUXEMBURGGuido Persijn (ET)
– MALTATony Bugeja
– NEW ZEALANDLee Excell
– NORWAYFrank Pedersen (SKT)
– POLANDJaroslaw Czerwinski
– PORTUGALLuisa Taveira
– ROMANIAVictor Gheorgue Zota
– SCANDIATRANSPLANT (SKT)Denmark, Sweden, Norway, Finland, Iceland Frank Pedersen
– SLOVAK REPUBLICLudovit Laca
– SLOVENIALea LamjnetGuido Persijn (ET)
– SPAINCarmen MartinMª Jose LopezCarmen Cobo
– SWEDENFrank Pedersen (SKT)
– SWITZERLANDDiane Moretti
– THE NETHERLANDSArnoud SloofGuido Persijn (ET)
– TURKEYAltay Köken
– UNITED KINGDOM Phil Pocock
– UNOS: USAwww.unos.org
– ARGENTINACarlos Alberto Soratti
– BOLIVIAwww.gpuntacana.org
– BRASILRoberto Soares
– CHILENelly de Lourdes AlvaradoJose Luis Rojas
– COLOMBIARafael Romero
– CUBAAlexander Marmol
– DOMINICANAwww.gpuntacana.org
– ECUADORIgnacio Ramirez
– EL SALVADORwww.gpuntacana.org
– GRUPO PUNTA CANAArgentina, Brasil, Bolivia, Chile, Colombia, Costa Rica,Cuba, Ecuador, El Salvador,Guatemala, Honduras, México, Panamá, Paraguay,Perú, Puerto Rico, Dominicana R., Uruguay,Venezuelawww.gpuntacana.org
– GUATEMALARudolf A. García-Gallont
– MEXICOJosé Salvador Aburto
– PANAMAwww.gpuntacana.org
– PARAGUAYEduardo Wilson Martínez
– PERUCarmen Fajardo
– PUERTO RICOE. Santiago-Delpín
– URUGUAYRaul José Mizraji
– VENEZUELACarmen Luisa Lattuf de Milanés
INTERNATIONAL FIGURES ON ORGAN, TISSUE & HEMATOPOIETIC STEM CELL DONATION &
TRANSPLANTATION ACTIVITIES. DOCUMENTS PRODUCED BY THE COMMITTEE OF EXPERTS ON THE
ORGANISATIONAL ASPECTS OF CO-OPERATION IN ORGAN TRANSPLANTATION (2004)
Editors: Rafael Matesanz & Blanca Miranda
NATIONAL DATA PROVIDED BY:
Data recorded & prepared by Organización Nacional de Trasplantes (ONT) – SpainDr. Rafael MatesanzDra. Blanca MirandaAna GarcíaMarina Alvarez
Foot Note: For the purposes of this Newsletter the following definitions were used:Organ donor: Every potential donor transferred to the operating theatre from whom, at least, one solid organ has been retrievedMultiorgan donor: Every donor from whom, at least, two different solid organs have been retrievedAbsolute number: Include all figures corresponding to all donors/patients adults and children Paediatric: Includes only paediatric activity (patients under 15 years old)
AULA MÉDICA EDICIONES. Paseo Pintor Rosales, 26. 28008 Madrid (España)Tel. 91 542 09 55. Fax 91 559 51 72. Depósito legal: M-
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The outstanding work of the Transplant Committee of the Council of Europe in the field oforgan, tissue and cells donation and transplantation for many years is now serving as a mo-del for other International bodies in other parts of the world for setting standards, obtainingaccurate data of activity, and implementing new forms of organization.
UE has widely used the documents elaborated by this Committee for the tissue and cell di-rective. WHO is now in the phase of development of the 57th World Health Assembly Re-solution about Human Organ and Tissue Transplantation and certainly our experience willserve as a basis for the future work in Latin America or Asia.
TRANSPLANT NEWSLETTER is now the only official publication which provides data of or-gan donation and transplantation of everyday more and more countries all over the world.A wonderful example has been Latino America. Thanks to the cooperation of professionalsand authorities of these countries and the coordinators of the GRUPO PUNTACANA, we
NEWSLETTER TRANSPLANT 2005
INTRODUCTION
FROM EUROPE TO OTHER PARTS OF THE WORLD
• INTRODUCTION: FROM EUROPE TO OTHER PARTS OF THE WORLD 3
• INTERNATIONAL FIGURES ON ORGAN DONATION AND TRANSPLANTATION. YEAR 2004
• INTERNATIONAL DATA ON ORGAN DONATION, TRANSPLANTATION, WAITING LIST AND FAMILY REFUSALS. YEAR 2004
• INTERNATIONAL DATA ON TISSUES AND HEMATOPOIETIC STEM CELL TRANSPLANT ACTIVITY. YEAR 2004
• DOCUMENTS AND RECOMMENDATION PRODUCED BY THE TRANSPLANT COMMITTEE OF THE COUNCIL
OF EUROPE. YEAR 2004
– LINK TO: GUIDE TO SAFETY AND QUALITY ASSURANCE FOR ORGANS, TISSUES AND CELLS
– RECOMMENDATION REC (2004) 19 OF THE COMMITTEE OF MINISTERS TO MEMBER STATES ON CRITERIA FOR
THE AUTHORISATION OF ORGAN TRANSPLANTATION FACILITIES
– RECOMMENDATION REC (2005) 11OF THE COMMITTEE OF MINISTERS TO MEMBER STATES ON THE ROLE AND
TRAINING OF PROFESSIONALS RESPONSIBLE FOR ORGAN DONATION (TRANSPLANT «DONOR CO-ORDINATORS»)
CONTENTS
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started to publish their data and now we are the more accurate source of data for this con-tinent. The recent approval of the project of IBEROAMERICAN COUNCIL OF ORGAN DO-NATION AND TRANSPLANTATION which will serve to harmonize these activities in Spanishand Portuguese speaking countries can be considered as a reflex of this Committee at theother side of Atlantic ocean.
Information is an absolute need for taking decisions. It is a simple question of justice thankto all the people who provides these data every year from more and more countries. We allare contributing to provide these therapies everyday to more and more people all over theworld.
Rafael Matesanz
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International Figures onorgan donation and
transplantation activityyear 2004
COUNCILOF EUROPE
CONSEILDE L’EUROPE
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CA
DA
VE
RIC
DO
NO
RS
Ann
ual
Rat
e p.
m.p
. 200
4
16,7
19,6
13,7
20,9 13
,6
10,2
14,7
1311,9
10,2
16
20,5
22,6
18 13,4
0,5 0,
9
62
11,4
8,8
21,1
34,6
2112
,6
22,1
13,8
15,5
21,8
2
22,2
17,8
7
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CA
DA
VE
RIC
KID
NE
YT
RA
NSP
LA
NT
Ann
ual
Rat
e p.
m.p
. 200
4
37
25,5
36,8 25
16,5
27,3
24,125
18,4
28,4
39,3
42,4
27,5 24
0,9 1,
8
10,5
3,6
21,4
11,9
30,6
47,8
36,7
22,6
36,7
24,4
25,9
33,9
20
39,2
30,9
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LIV
ING
KID
NE
YT
RA
NSP
LA
NT
Ann
ual
Rat
e p.
m.p
. 200
4
10,2
20,7
15,8
1 3,6
1,2
1,6
0,6
5,99,6
0,4
1,1
3,7
4,6
27,5 1,
6
8
1,3
6,9
7,8
41,4
10
2,4
1,4
2,7
11,3
0,8
7,8
15,3
1,8
20
2,9
0,4
9
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LIV
ING
KID
NE
YT
RA
NSP
LA
NT
/ T
OT
AL
KID
NE
Y T
RA
NSP
LA
NT
%100
35,8
38,1
2,5 12
,5
6,55
100
219
,7
27,8
0 3,7
8,6
9,8
0 6,1
88,8 41
,6
39,5
68,2
65,9
85,1
7,1
2,8
6,7
31,6
2
24,3
37,1
5,1
0
6,6
1,3
10
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LIV
ER
TR
AN
SPL
AN
TA
nnua
l R
ate
p.m
.p. 2
004
9,8
14,8
9,6
5,2
10,77,8
4,3
8,1
16,1
7,5 9,
7
0,8 0,
1
2,6
6,7
6,6
18,2
24,1
15,1
14,8
11,5
3,6
11,7
22
20,5
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HE
AR
T T
RA
NSP
LA
NT
Hea
rt -
Lun
g T
rans
p. I
nclu
ded
Ann
ual
Rat
e p.
m.p
. 200
4
7,4
3,4
4 0,4
2,7
54,5
2 1
4,7
7,8
1,5 1,
8
0,2 0,
1
0,5
0,4
2,5
6,2
6,8
5,2
4
3,1
27,
4
4,5
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LU
NG
TR
AN
SPL
AN
TSi
ngle
+ D
oubl
e L
ung
Hea
rt -
Lun
g T
rans
p. I
nclu
ded
Ann
ual
Rat
e p.
m.p
. 200
4
2,4
2,9
1,9
0,03
2,95,2
0,4
0,7
9,5
0,02
4,3
1,5
3,3
2,8
5
2,3
3,3
6,1
0,1
13
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PAN
CR
EA
S T
RA
NSP
LA
NT
–inc
lude
d al
l th
e co
mbi
nati
ons–
Ann
ual
Rat
e p.
m.p
. 200
4
2,2
0,9
0,4
2,3
1,2
2,4
5
0,1 2,
5
0,5
1,3
1,6
1,7
1,7
1,5
1
1,3
1,3
4
1,2
14
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KID
NE
Y-P
AN
CR
EA
ST
RA
NSP
LA
NT
Ann
ual
Rat
e p.
m.p
. 200
4
1,7
0,6
0,4
1,9
1,2
1,6
3,6
0,1 2,
5
0,3
1,3
11,
4
1,4
1,4
1
1,2
1,1
1,7
1,2
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CANADÁ
USA
AUSTRALIA
NEW ZEALAND
POPULATION: 31,9 millions (pmp)Cadaveric donors 414 (13),0Cadaveric Kidney Transplant 603 (18,9)Living Kidney Transplant 413 (12,9)Liver Transplant 420 (13,2)Heart Transplant 146 0(4,6)Heart - Lung Transplant 3 0(0,1)S. Lung + D. Lung Transp. 135 0(4,2)Pancreas Transplant 61 0(1,9)
POPULATION: 297 millions (pmp)Cadaveric donors 7.150 (24,1)Cadaveric Kidney Transplant 9.354 (31,5)Living Kidney Transplant 6.647 (22,4)Liver Transplant 6.168 (20,8)Heart Transplant 2.055 0(6,9)Heart - Lung Transplant 39 0(0,1)S. Lung + D. Lung Transp. 1.173 0(3,9)Pancreas Transplant 1.484 0(5),0
POPULATION: 20,1/4,1 millions Australia N. ZealandCadaveric donors (pmp) 218 (10,8) 40 0(9,8)Cadaveric Kidney Transplant 405 (20,1) 58 (14,2)Living Kidney Transplant 246 (12,2) 48 (11,8)Liver Transplant 177 0(8,8) 36 0(8,8)Heart Transplant 78 0(3,8) 6 0(1,4)Heart - Lung Transplant 6 0(0,2) –0000–0S. Lung + D. Lung Transp. 98 0(4,8) 12 0(2,9)Pancreas Transplant 31 0(1,5) 2 0(0,4)
CANADÁ
USA
AUSTRALIA
NEW ZEALAND
Kidney Liver Heart Lung PancreasPatients awaitingfor a transplant by2004, 31st Dec. 2.975 667 129 181 154Patients deadwhile on the WLduring 2004 0.058 096 026 043 003
Kidney Liver Heart Lung PancreasPatients awaitingfor a transplant by2004, 31st Dec. 1.399 104 45 87 30Patients deadwhile on the WLduring 2004 – – – – –
Kidney Liver Heart Lung PancreasPatients awaitingfor a transplant by2004, 31st Dec. 301 12 10 7 4
Kidney Liver Heart Lung PancreasPatients admittedto the waiting listduring 2004 27.298 10.180 2.908 1.964 2.788Patients awaitingfor a transplant by2004, 31st Dec. 61.924 17.336 3.309 3.659 4.159Patients deadwhile on the WLduring 2004 21.548 09.537 3.150 1.882 2.604
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CADAVERIC DONORSAnnual Rate p.m.p. 2004
14,1
21,8
3,1
0,3
6,81,9
7,7
6
1
0,3
0,2
10,8 19,2
8,9
3,2
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CADAVERIC KIDNEYTRANSPLANT & / LIVING
KIDNEY TRANSPLANTAnnual Rate p.m.p. 2004
1,51,4
02,8
166,1
16,5
0,55,5
102,1
3,64,21
10,27,3
8,91,9
1,60,9
01,2
15,35 26,3
15,62,2
3,22,6
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LIVING KIDNEY TRANSPLANTS /TOTAL KIDNEY TRANSPLANTS
%
8,6
10027,9
0
92
17,953,4
41,7
17,5
36,1
100
2,7 0
12,3
44,4
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LIVER TRANSPLANTAnnual Rate p.m.p. 2004
2,3
17,9
1
2
5,3
3
0,2
0,4
6,6
4,7
1,5
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HEART TRANSPLANTHeart - Lung Transp. Included
Annual Rate p.m.p. 2004
0,3
4,6
0,2
1,1
0,2
1,9 3,1
1,4
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LUNG TRANSPLANTSingle + Double Lung
Heart - Lung Transp. IncludedAnnual Rate p.m.p. 2004
1,8
0,3
0,2
0,1
0,8 0,3
0,4
22
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PANCREAS TRANSPLANT–included all the combinations–
Annual Rate p.m.p. 2004
2,8
0,4
0,2 1,6
0,1
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International data on organ anddonation transplantation activity,waiting list and family refusals
Year 2004
COUNCILOF EUROPE
CONSEILDE L’EUROPE
24
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NTR
IES
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GER
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GR
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EP
opul
atio
n (m
illio
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habi
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40.
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’35’
41’
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261
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HB
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(R
ate
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185
(22’
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227
(21’
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7 (0
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59 (1
3.4)
8 (1
1.4)
211
(20’
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(11’
9)19
(13’
6)10
9 (2
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1291
(21)
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(13’
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66 (6
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HB
Don
ors
(pm
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(0,3
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(0’4
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Mul
tiorg
an d
onor
s76
’883
’757
8354
65’6
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9676
’7
TRA
NSP
LAN
TATI
ON
KID
NEY
TX –
incl
uded
all
the
com
bina
tions
- (p
mp)
38
6 (4
7’07
)37
2 (3
5’77
)24
(3)
113
(25.
7)44
(62.
8)44
2 (4
3)18
7 (3
4’6)
40 (2
8’6)
197
(37’
4)24
23 (3
9’4)
8 (1
’6)
2478
(30’
07)
192
(17’
4)%
(Liv
ing
TX/
Tota
l TX)
9.8
5.1
41.6
6.1
65.9
8.6
27.8
12.5
2.5
6.7
100
19.7
39.5
Pae
diat
ric <
15 y
ears
1416
21
810
868
78C
adav
eric
TX
(pm
p)34
8 (4
2’44
)35
3 (3
3’94
)14
(1.8
)10
6 (2
4)15
(21.
4)40
4 (3
9’3)
135
(25)
35 (2
5)19
2 (3
6’8)
2259
(36’
7)19
89 (2
4’14
)11
6 (1
0’5)
-Sin
gle
TX (p
mp)
95 (2
1.59
)1
(1.4
)40
4 (3
9’3)
35 (2
5)22
26 (3
6’2)
114
(10’
4)-D
oubl
e TX
(pm
p)7
(10)
33 (0
’5)
2 (0
’18)
Livi
ng T
X (p
mp)
38 (4
’6)
19 (1
’8)
10 (1
.3)
7 (1
.59)
29 (4
1.4)
38 (3
’7)
52 (9
’6)
5 (3
’6)
5 (1
)16
4 (2
’7)
8 (1
’6)
489
(5’9
)76
(6’9
)N
HB
kid
ney
TX (p
mp)
13 (1
’59)
7 (0
’67)
2 (0
’2)
LIVE
RTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)13
2 (1
6’10
)22
9 (2
2’02
)1
(0.1
3)43
(9.7
)83
(8’1
)42
(7’8
)50
(9’6
)93
1 (1
5’1)
881
(10’
69)
29 (2
’6)
Pae
diat
ric <
15 y
ears
831
1 (0
.13)
311
451
91-S
plit
Live
r TX
(pm
p)8
(0’9
8)20
(1’9
2)56
(0’9
)11
7 (1
’42)
-Dom
ino
Live
r TX
(pm
p)1
(0’1
0)12
(0’2
)7
(0’0
8)Li
ving
Liv
er T
X (p
mp)
6 (0
’73)
25 (2
’40)
1 (0
.13)
1 (0
’1)
1 (0
’2)
48 (0
’8)
64 (0
’78)
NH
B L
iver
TX
(pm
p)5
(0’4
8)
HEA
RT
TX-in
clud
ed H
eart
-lung
tra
nspl
ant-
(pm
p)64
(7’8
)77
(7’4
)1
(0.1
3)8
(1.8
)48
(4’7
)24
(4’5
)21
(4)
339
(5’6
)41
2 (5
)6
(0’5
4)P
aedi
atric
<15
yea
rs2
38
31
HEA
RT-
LUN
GTr
ansp
lant
s (p
mp)
1 (0
’12)
3 (0
’29)
1 (0
’2)
2 (0
’4)
22 (0
’4)
14 (0
’17)
Pae
diat
ric <
15 y
ears
1
LUN
GTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)78
(9’5
1)63
(6’0
6)7
(0’7
)28
(5’2
)10
(1’9
)16
7 (2
’8)
240
(2’9
1)P
aedi
atric
<15
yea
rs1
23
-Sin
gle
(pm
p)20
(2’4
)28
(2’7
)3
(0’3
)22
(4’1
)3
(0’6
)47
(0’7
)44
(0’5
)-D
oubl
e -
incl
uded
Hea
rt/
Lung
TX
- (p
mp)
58 (7
’1)
35 (3
’4)
4 (0
’4)
6 (1
’1)
7 (1
’3)
120
(2)
196
(2’4
)N
HB
– d
oubl
e +
sing
le -
Lun
g TX
(pm
p)
PAN
CR
E1A
STX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)41
(5)
42 (4
’04)
11 (2
.5)
25 (2
’4)
103
(1’7
)19
2 (2
’33)
Pae
diat
ric <
15 y
ears
-Kid
ney
- P
ancr
eas
TX (p
mp)
30 (3
’66)
18 (1
’73)
11 (2
.5)
17 (1
’6)
86 (1
’4)
163b
(1’9
8)-P
ancr
eas
TX A
lone
(pm
p)5
(0’6
1)5
(0’4
8)8
(0’8
)17
(0’3
)20
(0’2
4)
SMA
LL B
OW
ELTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)7
(0’1
)P
aedi
atric
<15
yea
rs7
-Liv
er +
Sm
all B
owel
(pm
p)1
(0’0
2)-S
. B. T
X A
lone
(pm
p)6
(0’1
)
MU
LTIV
ISC
ERA
L(p
mp)
49 (0
’8)
25
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RGO
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PO
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GA
LR
OM
AN
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opul
atio
n (m
illio
n in
habi
tant
s)10
0’3
3’9
6’8
56.9
2’3
3.4
0’5
0.4
4’6
38’2
1021
DO
NAT
ION
Cad
aver
ic D
. - in
clud
ed N
HB
D -
(R
ate
- pm
p -)
160
(16)
5 8
(16’
7)
86 (2
2’1)
60 (8
’82)
1203
(21’
1)41
(17’
83)
35 (1
0.2)
1 (2
)4
(10)
90 (1
9’6)
562
(14’
7)22
2 (2
2’2)
10 (0
’48)
NH
B D
onor
s (p
mp)
1 (0
’14)
15 (6
’53)
% M
ultio
rgan
don
ors
4580
7583
’72’
4417
.110
010
090
3979
’780
TRA
NSP
LAN
TATI
ON
KID
NEY
TX –
incl
uded
all
the
com
bina
tions
- (p
mp)
29
5 (2
9’5)
3 (1
0’2)
146
(37’
4)81
(11’
9)18
81 (3
3)72
(31’
31)
61 (1
7.7)
10 (2
0)11
(27.
5)26
5 (5
7’6)
1067
(27’
9)43
6 (4
3’6)
189
(9)
% (L
ivin
g TX
/ To
tal T
X)3.
710
02
85.1
7.1
1.3
6.55
035
.82
6.6
88.8
Pae
diat
ric <
15 y
ears
1310
1440
11
931
107
Cad
aver
ic T
X (p
mp)
284
(28’
4)14
3 (3
6’7)
81 (1
1’9)
1746
(30’
6)71
(30’
87)
57 (1
6.5)
10 (2
0)8
(20)
170
(37)
1045
(27’
3)39
2 (3
9’2)
19 (0
’9)
-Sin
gle
TX (p
mp)
284
(28’
4)13
8 (3
5’4)
70 (1
0’29
)15
64 (2
7’4)
71 (3
0’87
)57
(16.
5)8
(20)
1045
(27’
3)39
1 (3
9’1)
-Dou
ble
TX (p
mp)
5 (1
’3)
101
(1’8
)1
(0’1
)Li
ving
TX
(pm
p)11
(1’1
)3
(10’
2)3
(0’8
)69
(10)
135
(2’4
)1
(0’4
4)4
(1.2
)4
(10)
95 (2
0’7)
22 (0
’6)
29 (2
’9)
168
(8)
NH
B k
idne
y TX
(pm
p)2
(0’2
9)24
(10’
44)
LIVE
RTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)43
(4’3
)45
(11’
5)45
(6’6
1)10
35 (1
8’2)
45 (9
’8)
199
(5’2
)20
5 (2
0’5)
16 (0
’76)
Pae
diat
ric <
15 y
ears
66
615
3311
2-S
plit
Live
r TX
(pm
p)2
(0’2
9)94
(1’6
)1
(0’2
)3
(0’3
)-D
omin
o Li
ver
TX(p
mp)
46 (4
’6)
Livi
ng L
iver
TX
(pm
p)6
(0’8
8)19
(0’3
)18
(0’5
)5
(0’5
)9
(0’4
3)N
HB
Liv
er T
X (p
mp)
HEA
RT
TX-in
clud
ed H
eart
-lung
tra
nspl
ant-
(pm
p)10
(1’0
)17
(2’5
)35
3 (6
’2)
1 (0
’44)
34 (7
’4)
105
(2’7
)45
(4’5
)4
(0’1
9)P
aedi
atric
<15
yea
rs2
141
21
HEA
RT-
LUN
GTr
ansp
lant
s (p
mp)
3 (0
’1)
1 (0
’03)
Pae
diat
ric <
15 y
ears
1
LUN
GTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)4
(0’4
)29
(4’2
6)85
(1’5
)11
(2’4
)1
(0’0
3)10
(0’1
)P
aedi
atric
<15
yea
rs1
4-S
ingl
e (p
mp)
23 (3
’38)
40 (0
’7)
1 (0
’03)
10 (0
’1)
-Dou
ble
- in
clud
ed H
eart
/ Lu
ng T
X -
(pm
p)4
(0’4
)6
(0’8
8)45
(0’8
)11
(2’4
)N
HB
– d
oubl
e +
sing
le -
Lun
g TX
(pm
p)
PAN
CR
EAS
TX –
incl
uded
all
the
com
bina
tions
- (p
mp)
12 (1
’2)
4 (1
)9
(1’3
2)94
(1’6
)10
(2’2
)16
(0’4
)12
(1’2
)2
(0’1
)P
aedi
atric
<15
yea
rs1
-Kid
ney
- P
ancr
eas
TX (p
mp)
12 (1
’2)
4 (1
)9
(1’3
2)55
(1)
8 (1
’7)
15 (0
’4)
12 (1
’2)
2 (0
’1)
-Pan
crea
s TX
Alo
ne (p
mp)
39 (0
’6)
2 (0
’4)
1 (0
’03)
SMA
LL B
OW
ELTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)7
(0’1
)P
aedi
atric
<15
yea
rs-L
iver
+ S
mal
l Bow
el (p
mp)
-S. B
. TX
Alo
ne (p
mp)
6 (0
’1)
MU
LTIV
ISC
ERA
L(p
mp)
1 (0
’02)
26
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Pop
ulat
ion
(mill
ion
inha
bita
nts)
5’4
243
’29
7’2
16’3
67’8
5920
’131
’94’
129
7
DO
NAT
ION
Cad
aver
ic D
. - in
clud
ed N
HB
D -
(R
ate
- pm
p -)
55 (1
0’22
)36
(18)
1495
(34’
6)12
3 (1
3’7)
91 (1
2’6)
247
(15’
5)13
6 (2
)81
3 (1
3’8)
218
(10’
8)41
4 (1
3)40
(9’8
)71
50 (2
4’1)
NH
B D
onor
s (p
mp)
716
(0’8
)11
1 (6
’81)
1 (0
’01)
87 (1
’5)
4 (0
’2)
% M
ultio
rgan
don
ors
32’7
364
83.5
88’6
8053
1784
8485
80
TRA
NSP
LAN
TATI
ON
KID
NEY
TX –
incl
uded
all
the
com
bina
tions
- (p
mp)
99 (1
8’4)
55 (2
7’50
)21
25 (4
9’2)
372
(41’
3)25
6 (3
5’5)
673
(41’
29)
775
(11’
4)19
05 (3
2’3)
651
(32’
3)10
61 (3
3’2)
106
(26’
1)16
001
(54)
% (L
ivin
g TX
/ To
tal T
X)0
02.
838
.131
.637
.168
.224
.337
.838
.945
.241
.5P
aedi
atric
<15
yea
rs1
6814
638
868
764
Cad
aver
ic T
X (p
mp)
99 (1
8’4)
55 (2
7’50
)20
64 (4
7’8)
230
(25’
5)16
3 (2
2’6)
423
(25’
95)
246
(3’6
)14
42 (2
4’4)
405
(20’
1)60
3 (1
8’9)
58 (1
4’2)
9354
(31’
5)-S
ingl
e TX
(pm
p)55
(27’
50)
2025
(46’
9)16
0 (2
2’2)
243
(3’5
)13
58 (2
3)40
2 (1
9’9)
589
(18’
4)54
(13’
2)-D
oubl
e TX
(pm
p)39
(0’9
)3
(0’4
)3
(0’0
4)8
(0’1
)3
(0’1
)14
(0’4
)4
(0’9
)Li
ving
TX
(pm
p)61
(1’4
)14
2 (1
5’8)
81 (1
1’3)
250
(15’
3)52
9 (7
’8)
463
(7’8
)24
6 (1
2’2)
413
(12’
9)48
(11’
8)66
47 (2
2’4)
NH
B k
idne
y TX
(pm
p)92
(2’1
)12
(1’6
)17
1 (1
0’49
)1
(0’0
1)14
7 (2
’5)
8 (0
’4)
LIVE
RTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)15
(7’5
0)10
40 (2
4’1)
133
(14’
8)84
(11’
7)10
9 (6
’69)
245
(3’6
)73
1 (1
2’4)
177
(8’8
)42
0 (1
3’2)
36 (8
’8)
6168
(20’
8)P
aedi
atric
<15
yea
rs58
135
1183
610
158
0-S
plit
Live
r TX
(pm
p)14
(0’3
)2
(0’3
)6
(0’3
7)2
(0’0
2)60
(1)
28 (1
’3)
10 (0
’3)
2 (0
’4)
-Dom
ino
Live
r TX
(pm
p)7
(0’2
)6
(0’7
)2
(0’3
)2
(0’0
3)Li
ving
Liv
er T
X (p
mp)
2 (0
’4)
18 (0
’4)
9 (1
)4
(0’6
)3
(0’1
8)13
3 (1
’9)
10 (0
’2)
1 (0
’04)
53 (1
’7)
323
(1’1
)N
HB
Liv
er T
X (p
mp)
5 (0
’1)
8 (0
’49)
28 (0
’5)
HEA
RT
TX-in
clud
ed H
eart
-lung
tra
nspl
ant-
(pm
p)11
(2’0
4)3
(1’5
0)29
4 (6
’8)
31 (3
’4)
29 (4
)32
(1’9
6)33
(0’4
)18
0 (3
’1)
78 (3
’8)
146
(4’6
)6
(1’4
)20
55 (6
’9)
Pae
diat
ric <
15 y
ears
202
124
132
297
HEA
RT-
LUN
GTr
ansp
lant
s (p
mp)
7 (0
’2)
15 (0
’3)
6 (0
’2)
3 (0
’09)
39 (0
’1)
Pae
diat
ric <
15 y
ears
46
LUN
GTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)14
3 (3
’3)
26 (2
’9)
36 (5
)54
(3’3
1)2
(0’0
2)13
4 (2
’3)
98 (4
’8)
135
(4’2
)12
(2’9
)11
73 (3
’9)
Pae
diat
ric <
15 y
ears
71
15
46
54-S
ingl
e (p
mp)
41 (0
’9)
19 (2
’1)
2 (0
’3)
7 (0
’4)
2 (0
’02)
37 (0
’6)
11 (0
’5)
29 (0
’9)
2 (0
’4)
-Dou
ble
- in
clud
ed H
eart
/ Lu
ng T
X -
(pm
p)10
2 (2
’4)
7 (0
’8)
34 (4
’7)
47 (2
’9)
97 (1
’6)
87 (4
’3)
106
(3’3
)10
(2’4
)N
HB
– d
oubl
e +
sing
le -
Lun
g TX
(pm
p)7
(0’2
)2
(0’0
3)
PAN
CR
EAS
TX –
incl
uded
all
the
com
bina
tions
- (p
mp)
74 (1
’7)
8 (0
’9)
11 (1
’5)
22 (1
’35)
37 (0
’5)
79 (1
’3)
31 (1
’5)
61 (1
’9)
2 (0
’4)
1484
(5)
Pae
diat
ric <
15 y
ears
1-K
idne
y -
Pan
crea
s TX
(pm
p)61
(1’4
)5
(0’6
)10
(1’4
)18
(1’1
0)21
(0’3
)69
(1’2
)23
(1’1
)45
(1’4
)2
(0’4
)88
0 (3
)-P
ancr
eas
TX A
lone
(pm
p)12
80’
3)3
(0’3
)1
(0’1
)4
(0’2
5)16
(0’2
)10
(80’
2)5
(0’2
)16
(0’5
)60
4 (2
)
SMA
LL B
OW
ELTX
– in
clud
ed a
ll th
e co
mbi
natio
ns -
(pm
p)7
(0’2
)1
(0’0
1)7
80’1
)1
(0’0
3)15
2 (0
’5)
Pae
diat
ric <
15 y
ears
57
92-L
iver
+ S
mal
l Bow
el (p
mp)
4 (0
’1)
6 (0
’1)
-S. B
. TX
Alo
ne (p
mp)
3 (0
’1)
1 (0
’01)
1 (0
’02)
152
(0’5
)
MU
LTIV
ISC
ERA
L(p
mp)
2 (0
’2)
1 (0
’03)
27
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Pop
ulat
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ion
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8.2
10.4
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90.
75.
41.
45.
261
.53
582
.411
4
WA
ITIN
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IST
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NEY
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ENTR
ES:
71
41
145
24
4P
atie
nts
adm
itted
to
the
WL
durin
g 20
04
402
452
440
2025
740
224
3032
2833
371
Pat
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s aw
aitin
g fo
r a
TX b
y 20
04, 3
1stD
ec80
593
660
810
040
323
244
5626
9270
847
1021
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
0444
3144
53
35
115
482
43ES
RD
on
dial
ysis
tre
atm
ent
durin
g 20
0445
0424
040
846
00
LIVE
RN
ºTX
CEN
TRES
:2
11
241
1P
atie
nts
adm
itted
to
the
WL
durin
g 20
0418
330
893
5250
1160
1427
81P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
108
243
4616
247
415
2547
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
0452
267
210
328
815
HEA
RT
NºT
X C
ENTR
ES:
22
126
11
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
9593
7533
2342
975
69
21P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
75
3474
184
277
613
1822
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
0419
1216
24
8717
22
13
HEA
RT-
LUN
GN
ºTX
CEN
TRES
:9
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
29P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
39
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
0418
LUN
GN
ºTX
CEN
TRES
:1
11
121
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
100
6616
459
176
405
9P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
57
4622
414
144
457
24
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
0413
113
81
4410
8
PAN
CR
EAS
NºT
X C
ENTR
ES:
18
2P
atie
nts
adm
itted
to
the
WL
durin
g 20
0438
375
511
121
313
Pat
ient
s aw
aitin
g fo
r a
TX b
y 20
04, 3
1stD
ec36
536
1318
115
814
Pat
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TRES
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Pat
ient
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mitt
ed t
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ring
2004
3P
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nts
awai
ting
for
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by
2004
, 31st
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4
Pat
ient
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04
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Pop
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44.
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1021
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ITIN
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NEY
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ENTR
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11
639
12
11
185
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
22
026
0452
613
2519
211
9043
2P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
171
497
6561
375
434
1485
169
1201
1626
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
04
2918
812
413
3873
ESR
D o
n di
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is t
reat
men
t du
ring
2004
19
015
340
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RN
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TRES
:1
320
16
1P
atie
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adm
itted
to
the
WL
durin
g 20
04
118
1359
5329
023
4P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
21
130
1457
410
529
0P
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
27
137
525
36
HEA
RT
NºT
X C
ENTR
ES:
318
61
42
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
68
498
635
213
35P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
12
164
06
417
872
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
04
2493
11
428
HEA
RT-
LUN
GN
ºTX
CEN
TRES
:2
Pat
ient
s ad
mitt
ed t
o th
e W
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ring
2004
18
Pat
ient
s aw
aitin
g fo
r a
TX b
y 20
04, 3
1stD
ec
14P
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
7
LUN
GN
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CEN
TRES
:2
141
1P
atie
nts
adm
itted
to
the
WL
durin
g 20
04
4118
632
7P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
44
238
458
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
04
1066
9
PAN
CR
EAS
NºT
X C
ENTR
ES:
13
171
41
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
12
614
30P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
720
514
25P
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
72
SMA
LL B
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ELN
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CEN
TRES
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Pat
ient
s ad
mitt
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2004
8
Pat
ient
s aw
aitin
g fo
r a
TX b
y 20
04, 3
1stD
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22P
atie
nts
dead
whi
le o
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e W
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ring
2004
29
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Pop
ulat
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5.38
243
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7.2
16.3
67.8
5920
.11
31.9
44.
0629
7
WA
ITIN
G L
IST
KID
NEY
NºT
X C
ENTR
ES:
41
424
625
2520
243
250
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
22
438
357
282
832
1403
2808
2729
8P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
759
108
4231
350
488
116
7904
5299
1399
2975
301
6192
4P
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
70
16
1811
127
358
2154
8ES
RD
on
dial
ysis
tre
atm
ent
durin
g 20
0412
2521
031
3426
2
LIVE
RN
ºTX
CEN
TRES
:1
124
33
177
89
111
7P
atie
nts
adm
itted
to
the
WL
durin
g 20
04
312
1460
130
115
154
631
875
1018
0P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
7
670
117
8615
573
725
310
466
712
1733
6P
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
1
116
36
1521
6296
9573
HEA
RT
NºT
X C
ENTR
ES:
21
173
412
74
121
131
Pat
ient
s ad
mitt
ed t
o th
e W
L du
ring
2004
9
939
436
4559
2420
629
08P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
3
1611
316
1845
182
111
4512
910
3309
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
04
15
362
616
1726
3150
HEA
RT-
LUN
GN
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CEN
TRES
:P
atie
nts
adm
itted
to
the
WL
durin
g 20
04
Pat
ient
s aw
aitin
g fo
r a
TX b
y 20
04, 3
1stD
ecP
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
LUN
GN
ºTX
CEN
TRES
:1
82
212
64
51
67P
atie
nts
adm
itted
to
the
WL
durin
g 20
04
120
938
4188
120
519
64P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
145
3117
861
272
8718
17
3659
Pat
ient
s de
ad w
hile
on
the
WL
durin
g 20
04
126
63
1446
4318
82
PAN
CR
EAS
NºT
X C
ENTR
ES:
110
32
259
27
114
1P
atie
nts
adm
itted
to
the
WL
durin
g 20
04
9812
395
2627
88P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
796
3435
3630
154
441
59P
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
3
12
13
2604
SMA
LL B
OW
ELN
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CEN
TRES
:2
11
33
18P
atie
nts
adm
itted
to
the
WL
durin
g 20
04
82
1424
4P
atie
nts
awai
ting
for
a TX
by
2004
, 31st
Dec
6
16
119
5P
atie
nts
dead
whi
le o
n th
e W
L du
ring
2004
2
121
9
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transplant activityYear 2004
COUNCILOF EUROPE
CONSEILDE L’EUROPE
32
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SB
ULG
AR
IAG
REE
CE
ISR
AEL
ITA
LYLI
THU
AN
IAP
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ND
PO
RTU
GA
LR
OM
AN
IASL
OVE
NIA
SPA
INSW
IZER
LAND
T. NE
THER
LAND
STU
RK
EYU
. K.
Pop
ulat
ion
(mill
ion
inha
bita
nts)
7.8
116.
856
.99
3.4
38.2
310
212
43.2
7.2
1667
.859
TISS
UE
AC
TIVI
TY IN
DIC
ATO
RS
Mus
culo
Ske
leta
l Tis
sue
Nº
Cad
aver
ic d
onor
s (p
mp)
478
1419
1 4
506
101
(61.
3)(2
.1)
(3.4
)(0
.19)
(11.
7)(6
.3)
Nº
Livi
ng D
. (pm
p)10
6 22
07
1828
2919
96
(13.
6)(3
8.7)
(0.8
5)(6
5.5)
(124
.7)
Nº
Gra
fted
Pat
ient
s (p
mp)
644
3380
1194
426
5970
1068
(82.
6)(5
9.3)
(312
.4)
(1.2
3)(1
38.2
)(6
6.7)
Nº
Ban
k P
roce
ssed
Pie
ces
7015
7513
8192
5665
(pm
p)(8
99.3
)(1
31.8
)(2
00.2
)(3
54.1
)
Per
cent
age
of D
eses
timat
ion
Type
s of
Tis
sues
Dis
trib
uted
: 69
90.2
94
Bon
e %
(fro
zen/
freez
e-dr
y/(6
1.3/
38.
7)(2
2/19
/53)
dem
iner
aliz
ated
)
Type
s of
Tis
sues
Dis
trib
uted
:
Tend
on %
1531
9.8
6
Cor
neas
Nº
Cad
aver
ic d
onor
s (p
mp)
91
46
250
6471
15
35
6 7
2268
45
1726
20
4319
03
(11.
7)(4
.2)
(37)
(113
.5)
(4.4
)(3
5.6)
(0.3
3)(5
2.5)
(6.2
5)(1
07.9
)(3
0)(3
2.3)
Nº
Gra
fted
Pat
ient
s (p
mp)
132
141
4953
28
71
6 55
673
76
29
6184
820
4324
54
(16.
9)(1
2.8)
(86.
9)(8
.2)
(18.
7)(5
5.6)
(3.4
7)(3
8)(6
8.5)
(53)
(30)
(41.
6)
Nº
Ban
k P
roce
ssed
Pie
ces
174
1195
3 12
17
843
1615
33
1666
(pm
p)(2
2.3)
(209
.7)
(3.5
)(4
.7)
(99.
9)(9
5.8)
(24.
5)
Per
cent
age
of D
eses
timat
ion
7614
33
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OM
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OVE
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SPA
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T. NE
THER
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STU
RK
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. K.
Pop
ulat
ion
(mill
ion
inha
bita
nts)
7.8
116.
856
.93.
438
.23
212
43.2
7.2
1667
.859
TISS
UE
AC
TIVI
TY IN
DIC
ATO
RS
Vasc
ular
Tis
sue
Nº
Cad
aver
ic d
onor
s (p
mp)
168
10
176
(2.9
)(2
.9)
(4.0
7)
Nº
Gra
fted
Pat
ient
s (p
mp)
166
711
99
(2.9
)(2
.1)
(0.3
)(2
.3)
Nº
Ban
k P
roce
ssed
Pie
ces
972
147
(pm
p)(1
7.1)
(3.4
)
Per
cent
age
of D
eses
timat
ion
20.9
Type
s of
Tis
sues
Dis
trib
uted
:
Arte
ry58
.95
795
.2
Type
s of
Tis
sues
Dis
trib
uted
:
Vein
41.0
54.
8
Valv
es
Nº
Cad
aver
ic D
onor
s (p
mp)
4726
5 10
175
1734
2 7
(7)
(4.6
)(2
.9)
(4.0
5)(2
.36)
(21.
4)(0
.1)
Nº
Livi
ng D
onor
s (p
mp)
12
(0.7
5)
Nº
Gra
fted
Pat
ient
s (p
mp)
119
3 17
615
4 7
(2.1
)(0
.86)
(4.6
)(3
.5)
(0.1
)
Nº
Ban
k P
roce
ssed
Pie
ces
512
287
299
(pm
p)(9
)(7
.5)
(6.9
)
Per
cent
age
of D
eses
timat
ion
29.7
Type
s of
Tis
sues
Dis
trib
uted
:
Aor
tic/
Pul
mon
ary
%41
.1/
58.9
40/
60
Type
s of
Tis
sues
Dis
trib
uted
:
Tric
uspi
d/ M
itral
%
34
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UN
TRIE
SB
ULG
AR
IAG
REE
CE
ISR
AEL
ITA
LYLI
THU
AN
IAP
OLA
ND
PO
RTU
GA
LR
OM
AN
IASL
OVE
NIA
SPA
INSW
IZER
LAND
T. NE
THER
LAND
STU
RK
EYU
. K.
Pop
ulat
ion
(mill
ion
inha
bita
nts)
7.8
116.
856
.938
.23
212
43.2
7.2
1667
.859
TISS
UE
AC
TIVI
TY IN
DIC
ATO
RS
Skin
Nº
Cad
aver
ic d
onor
s (p
mp)
352
151
217
668
34
6
(45.
1)(2
2.5)
(3.8
)(0
.28)
(1.5
)(2
1.6)
Nº
livin
g do
nors
(pm
p)28
8
(0.5
)(0
.38)
Nº
graf
ted
patie
nts
(pm
p)29
6 11
2252
14
55
(38)
(19.
7)(1
.4)
(0.6
6)(1
.2)
Nº
Ban
k P
roce
ssed
Pie
ces
308
4139
3915
9210
(pm
p)(3
9.5)
(691
6.8)
(336
5.3)
Per
cent
age
of D
eses
timat
ion
812
Cel
l Cul
ture
s
Nº
Cad
aver
ic d
onor
s (p
mp)
29
(4.0
3)
Nº
Livi
ng D
onor
s (p
mp)
Nº
Gra
fted
Pat
ient
s (p
mp)
1483
12
(0.4
)(1
.92)
(1.6
6)
Nº
bank
Pro
cess
ed P
iece
s 99
147
(pm
p)(2
.6)
(3.4
)
Per
cent
age
of D
eses
timat
ion
58.6
Type
s of
Tis
sues
Dis
trib
uted
:
Cho
ndro
cyte
s36
Type
s of
Tis
sues
Dis
trib
uted
:
Ker
etin
ocyt
es %
64
Type
s of
Tis
sues
Dis
trib
uted
:
Oth
er %
14
35
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Documents produced by theTransplant Committee of
the Council of Europe2004
COUNCILOF EUROPE
CONSEILDE L’EUROPE
36
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This Guide includes standards for procurements, preservation,processing and distribution of organs, tissues and cells. It is thefirst international text on this topic adopted by Health Authorities.
ISBN: 92-871-5518-6Format: 16 x 24 cmNo. of pages: 95
SYNOPSIS
The purpose of this guide is to provide guidance for all those involved in the transplantation tomaximise the quality, and thereby the success rate, of transplants, and to minimise the risks to allinvolved in this complex procedure. It includes safety and quality standards for procurement, pre-servation, processing, and distribution of organs, tissues and cells of human origin (allogeneic andautologous) used for transplantation purposes.
As the European Union Directive on Tissues and Cells (2004/23/EC) was recently adopted, theEuropean Commission will build on the Council of Europe’s guide when establishing technicalstandards under the directive. This co-operation will ensure that the same standards are appliedthroughout Europe.
CONTENTS
1. Introduction.2. Quality management: principles for ensuring the quality of organs, tissues and cells.3. Selection of donors.4. Organ procurement and preservation.5. Tissue and cell procurement.6. Tissue establishments.7. Transplantation practices.Appendices.
http://www.coe.int/T/E/Social_Cohesion/Health/Activities/Organ_transplantation/
GUIDE TO SAFETY AND QUALITYASSURANCE FOR ORGANS,
TISSUES AND CELLS - 2nd Edition (2004)
37
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RECOMMENDATION REC(2004)19OF THE COMMITTEE OF MINISTERSTO MEMBER STATES ON CRITERIA
FOR THE AUTHORISATIONOF ORGAN TRANSPLANTATION FACILITIES
Adopted by the Committee of Ministers on 15 December 2004at the 909th meeting of the Ministers’ Deputies
The Committee of Ministers, under the terms of Ar-ticle 15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Euro-pe is to achieve greater unity between its mem-bers and that this aim may be pursued inter alia by the adoption of common action in the healthfield;
Taking into account Resolution No. R (78) 29 onharmonisation of legislation of member states relatingto removal, grafting and transplantation of humansubstances, the final text of the 3rd Conference of Eu-ropean Health Ministers (Paris, 16-17 November1987); Articles 19 and 20 of the Convention of HumanRights and Biomedicine, and Articles 3 and 4 of theAdditional Protocol to the Convention on HumanRights and Biomedicine, on Transplantation of Organsand Tissues of Human Origin;
Considering that:
– organ transplantation is a well-established, life-saving, and effective treatment: a successful or-gan transplantation may be the only treatmentavailable for some forms of end stage organ fai-lure and is the most clinically and cost effectivetreatment for chronic renal failure;
– organ exchange and circulation of recipientsamong member states is becoming a more fre-quent phenomenon, and that a minimum com-mon standard should be guaranteed to the citi-zens;
– member states should therefore provide high-quality transplant services for the benefit of theircitizens. Considering the limited organ supply, allnecessary steps should be taken to make sureall available organs are properly safeguarded andused so as to maximise the benefit to patients;
– the highest professional standards are to bemaintained in the area of organ transplantation,
Recommends that the governments of memberstates take all necessary measures to ensure the fo-llowing:
1. An appropriate mechanism for the authorisa-tion1 of health care facilities carrying out organtransplantations2 should be set up. In order toobtain authorisation these facilities should meetthe following criteria:
– feasibility of programme, based on clinical ne-ed assessment and a documented estimateof organ supply, to ensure that projected ac-tivity levels are sufficient to maintain clinicalexpertise and programme quality;
1 For the purpose of this Recommendation, the term «authori-sation» refers to any appropriate mechanism for designating, aut-horising, accrediting or licensing health care facilities carrying outorgan transplantations.
2 This Recommendation refers to the facilities where organs arebeing «implanted».
38
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– standards of vocational training of teammembers, and infrastructural conditions rela-ting to availability of beds, intensive care facilities, and diagnostic and therapeuticback-up services (radiology, microbiology, im-munology services, etc.), and to care provi-ded by nursing, physiotherapy, social servicesand related medical professionals.
2. Medical professionals forming part of an organtransplant team should be properly qualified andtheir previous training in the field of transplanta-tion should be documented and personalised.
3. A quality-management system should be put inplace to evaluate performance against establis-hed national and/or international standards asapplicable, and to ensure the quality of the pro-cess of organ procurement and transplantation,following the principles described in the Coun-cil of Europe’s Guide to safety and quality assu-rance for organs, tissues and cells.
4. Authorisations should be regularly reviewedagainst agreed quality criteria and standards, aswell as against audit results.
5. Outcome results for each type of transplantshould be within the margins of internatio-
nal registers, at an equivalent degree of com-plexity of patients. In order to guarantee clini-cal results and cost-effective performance, mi-nimal yearly activity standards shall beestablished in order to maintain an active pro-gramme.
6. These minimal activity standards, required to ke-ep active each kind of transplant programme,should be related to the mean number of cada-veric organs available to the transplant team inrecent years.
7. Any transplant centre which, after several war-nings, continues to fail to meet activity or out-come criteria may have its authorisation with-drawn.
8. No new transplant centre may be authorised ifthere are not enough organs available to ena-ble a new centre to reach the required stan-dards.
9. Any new transplant centre should be authorised,accredited or licensed on the basis of agreedcriteria and initially should be limited in time. If,within an agreed timescale, the new centre do-es not achieve the required standards, authori-sation shall be withdrawn.
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RECOMMENDATION REC(2005)11OF THE COMMITTEE OF MINISTERSTO MEMBER STATES ON THE ROLEAND TRAINING OF PROFESSIONALS
RESPONSIBLE FOR ORGAN DONATION(TRANSPLANT «DONOR CO-ORDINATORS»)
Adopted by the Committee of Ministers on 15 June 2005at the 930th meeting of the Ministers’ Deputies
The Committee of Ministers, under the terms of Ar-ticle 15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Euro-pe is to achieve greater unity between its mem-bers and that this aim may be pursued, inter alia, by the adoption of common action in the healthfield;
Taking into account Resolution (78) 29 on the har-monisation of legislation of member states relatingto removal, grafting and transplantation of humansubstances, the final text of the 3rd Conference ofEuropean Health Ministers (Paris, 16 and 17 No-vember 1987); Articles 19 and 20 of the Conventionon Human Rights and Biomedicine, and Articles 3and 4 of the Additional Protocol to the Conventionon Human Rights and Biomedicine concerningTransplantation of Organs and Tissues of HumanOrigin, and principles established in the 1998 Coun-cil of Europe consensus document entitled «Meetingthe organ shortage»;
Considering that organ transplantation is a well-es-tablished, life-saving, and effective treatment: a suc-cessful organ transplant may be the only treatmentavailable for some forms of end stage organ failureand is the most clinically effective and cost-effectivetreatment for chronic renal failure;
Considering the universal shortage of organs fortransplantation;
Considering that the transplant process is complex,involves various services and therefore requires effec-tive organisation and co-ordination of health care pro-fessionals;
Bearing in mind that in many member states thetraining and employment of health care professionalsresponsible for detecting potential deceased organdonors and organising the donation process has in-creased the efficiency of the procurement of organsand improved the functioning of local and nationaltransplant systems; and that such professionals canalso increase the rate of donation of tissues for trans-plantation,
Recommends that the governments of memberstates take the measures contained in the appendixto this recommendation as regards the role and trai-ning of professionals responsible for organ donation(transplant «donor co-ordinators»).
APPENDIX TO RECOMMENDATION REC(2005)11
1. A professional responsible for the identificationof potential deceased organ and/or tissue do-nors should be appointed in every hospital withan intensive care unit. This professional shouldhave appropriate training and experience, be in-dependent of any transplant teams, and have
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clearly defined responsibilities for the establish-ment, management and audit of a hospital-ba-sed system for potential deceased donor iden-tification and organ/tissue procurement. Theperson should also be responsible for monito-ring the donation and procurement process andfor identifying and implementing improvements.For the purposes of this recommendation, theprofessional will be termed a transplant «donorcoordinator».
2. Donor co-ordinators should be properly ac-countable to senior management of the relevanthealth institution and to any regional or national
transplant organisations. Donor co-ordinatorsmay be complemented by, or responsible to, ot-her transplant co-ordinators at regional or natio-nal level.
3. Donor co-ordinators, and any other transplantco-ordinators should have a high standard ofprofessional training consistent with internatio-nally recognised standards, to ensure the hig-hest possible professional and ethical standardsin organ donation and procurement. Memberstates should establish formal national or inter-national accreditation for donor co-ordinationactivities/donor co-ordinators.
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MEMBERS OF THE TRANSPLANT COMMITTEEOF THE COUNCIL OF EUROPE
AUSTRIAFerdinand MühlbacherBELGIUMLudo MuylleJean-Paul SquiffletBOSNIA AND HERZEGOVINAMarina BeraBULGARIAYanko NachkovCROATIAMirela BusicCYPRUSGeorge KyriakidesCZECH REPUBLICPremysl FrydaSylva Dusilova-SulkovaDENMARKJorn CarlsenESTONIAPeeter DmitrievEUROTRANSPLANTGermany, The Netherlands, Austria, Belgium, Slovenia, LuxemburgGuido PersijnBernard CohenFINLANDKaija SalmelaFRANCEBernard LotyGEORGIAGia TomadzeGERMANYGünter KirsteGREECEIoannis BoletisHUNGARYJozsef BorsiFerenc PernerIRELANDDavid P HicKeyISRAELTamar AshkenaziAlain BerrebiITALYAlessandro Nanni CostaGiuseppe PiccoloLATVIARafail Rozental
LITHUANIAJulija ShirokovaMALTAPeter CauchiNORWAYPer PfefferPOLANDJanusz WalaszewskiPOTUGALManuel M. AbecasisLuisa TaveiraRUSSIAN FEDERATIONNikolay V. TarabarKoROMANIAIrinel PopescuSCANDIATRANSPLANTSLOVENIADenmark, Sweden, Norway, Finland, IcelandPer PfefferArnt JakobsenSERBIA AND MONTENEGROSinisa GradinacSLOVAK REPUBLICLudovit LacaSLOVENIADanica Avsec- LetonjaSPAINRafael MatesanzSWEDENHakan GabelSWITZERLANDPhilippe MorelTURKEYBekir KeskinkilicTHE NETHERLANDSBernadette Haase-KromwijkUNITED KINGDOMChris RudgeStephen Powis
COUNCIL OF EUROPE (Secretariat)Alina TatarenkoSophie-Marie Le GuillouxJacqueline LostaoEUROPEAN COMMISSIONEduardo Fernandez-ZinckeWHOLuc Nöel
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14 October 2005Palexpo, Geneva, Switzerland
Council of Europe 7th European Day for Organ Donationand Transplantation
1st World Day for Organ Donation and TransplantationWith the participation of the World Health Organization
Preliminary Program
Morning: Council of Europe’s 7th European day for organ donation and transplantationwith participation of the Council of Europe Committee of Experts on Transplantation (SP-CTO)
10:00-10:55 Welcome from local, national and international representativesCouncil of Europe Role in Transplantation and Organ Donation
11:00 – 11:45 Round table I:Quality of life after organ transplantation
11:55-12:40 Round Table II: Organ Donation: Ethical and religious aspectsHanding the vase over to Turkey, which will host the 8th European Day in Istanbul
12:40-14:00 Lunch
Afternoon: 1st World day for organ donation and transplantationWith the participation of the World Health Organisation (WHO)
14:00-14:45 Resolution WHA 57.18 of the 57th World Health Assembly (organ and tissue transplantation)will be brought by a transplanted sport-person from the WHO headquarters to Palexpo. Thecontent of the resolution will be presented
14:50-15:35 Round Table III:Economical aspects of organ donation and transplantation
15:45-16:30 Round table IV:Access to organ transplantation worldwide
16:40-18:00 Closing ceremony:Launch of an international donor cardPassage of the baton to the organizers of the 2nd World day for organ donation and transplantation (Argentina)Human chain of solidarity
18:00 Onwards: Festive evening (concert, films)
A G I F T F O R L I F E
A G I F T F O R L I F E
Council of Europe
7th European Day for Organ Donationand Transplantation
1st World Day for Organ Donationand Transplantation
With the participation of the World Health Organization
14 October 2005Palexpo, Geneva, Switzerland
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COUNCILOF EUROPE
CONSEILDE L’EUROPE
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