THE EUROPEAN
DIRECTORATE FOR THE
QUALITY OF MEDICINES
& HEALTHCARE
(EDQM)
2022 SARE exercise (2021 data)
SARE Reporting for
Blood and Blood
Components
SoHO Standard Section, Department of Biological Standardization, OMCL
Network & HealthCare (DBO)
EDQM, Council of Europe
2 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
SARE Annual
Summary
Report
3 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
DATA COLLECTED from 30 Countries:
AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, FR, HR, HU, IS, IE, IT, LV, LI, LT, LU, MT, NL, NO, PL, PT, RO, SI, SK,
SE and UK (Northern Island).
• 2021 SARE exercise: 30 reporting countries
• 2022 SARE exercise: 30 reporting countries
- 1 less country: Greece
- 1 new reporting country compared to exercise 2021 : Malta
4 ©2023 EDQM, Council of Europe. All rights reserved.
Data completeness 2022 SARE exercise (2021 data)
Data completeness: 100% of the data provided by 23 out of 30 reporting countries,
75%-99% of the data provided by 6 countries, 1 country was not able to provide info on reporting
completeness.
Number of units issued: 21 countries provided 100% of the data, 3 countries provided 90%-99% of the
data, 1 country provided 0% of the data. 5 countries were not able to provide info on data completeness.
Number of recipients: 12 countries provided 100% of the data, 5 countries provided 70%- 95% of the
data, 3 countries provided 0%-50% of the data. 10 countries were not able to provide info on data
completeness.
Number of units transfused: 17 countries provided 100% of the data, 5 countries provided 94% - 99%
of the data, 1 country provided 66% of the data. 7 countries were not able to provide info on data
completeness.
Number of establishments: 3307 (3617 in 2020, 261 BE withdrawn from the exercise due to Brexit)
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Denominators 2022 SARE exercise (2021 data)
Units issued : 13.5 million, 20.6 million after cross-checking with number of units transfused
Units transfused : 17.8 million
UNITS TRANSFUSED PER BLOOD COMPONENT
UNITS ISSUED PER BLOOD COMPONENT*
Plasma Whole blood
Plasma Whole blood
2,272,341 2,999
2,657,259 3,265
13% 0%
13% 0%
Platelets
Platelets 2,158,095
2,422,663 12%
12%
RBC RBC
15,608,682 13,375,434
75% 75%
Countries
Total (x106 units)
Countries reporting
Total (x106 units)
reporting
17.8 26
20.6 30
NB: When possible, Covid Convalescent Plasma (CCP) data (issued /
* Including data on transfused units from DE, NO and ES transfused) have been removed from regular plasma figures
6 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Incidence (number of units issued per million population*)
Austria (AT) 36,221
Belgium (BE) 44,874
Bulgaria (BG) 34,494
Croatia (HR) 63,639
Cyprus (CY) 97,619
Czechia (CZ) 54,277
Denmark (DK) 43,597
Estonia (EE) 48,019
Finland (FI) 38,242
France (FR) 44,419
Germany (DE) 59,933 3 categories
Hungary (HU) 55,033
Iceland (IS) 39,459 More than 70.000 : Cyprus
Ireland (IE)
Italy (IT)
29,063
50,040 40 000 - 70 000 : 16 countries
Latvia (LV)
Liechtenstein (LI) 5,659
48,614
Less then 40 000 : 13 countries
Lithuania (LT) 45,472
Luxembourg (LU) 38,185
Malta (MT) 44,679
Netherlands (NL) 26,169
Norway (NO) 39,496
Poland (PL) 41,146
Portugal (PT) 36,137
Romania (RO) 35,135
Slovakia (SK) 62,500
Slovenia (SI) 48,316
Spain (ES) 39,742
Sweden (SE) 52,333
United Kingdom (UK)* 25,755
0.0 10000.0 20000.0 30000.0 40000.0 50000.0 60000.0 70000.0 80000.0 90000.0 100000.0 110000.0
*population on January 1st 2021, https://ec.europa.eu/eurostat/web/population-demography/demography-population-stock-balance/database
7 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Incidence (number of units transfused per million population*)
Austria (AT) 35,110
Belgium (BE) 44,356
Bulgaria (BG) 28,512
Croatia (HR) 60,754
Cyprus (CY) 93,805
Czechia (CZ) 54,071
Denmark (DK) 43,702
Estonia (EE) 46,877
Finland (FI) 0
France (FR) 41,641
Germany (DE)
3 categories
59,933
Hungary (HU) 22,025
Iceland (IS)
Ireland (IE) 28,801
36,305
More than 70.000 : Cyprus
Italy (IT)
Latvia (LV)
48,716
48,127
40.000-70000 : 11 countries
Liechtenstein (LI)
Lithuania (LT) 0
5,659 Less then 40 000 : 14 countries
Luxembourg (LU) 37,473
Malta (MT) 34,668
Netherlands (NL) 25,223
Norway (NO) 39,496
Poland (PL) 0
Portugal (PT) 34,188
Romania (RO) 34,148
Slovakia (SK) 62,500
Slovenia (SI) 0
Spain (ES) 39,742
Sweden (SE) 43,158
United Kingdom (UK)* 23,711
0.0 10000.0 20000.0 30000.0 40000.0 50000.0 60000.0 70000.0 80000.0 90000.0 100000.0
*population on January 1st 2021, https://ec.europa.eu/eurostat/web/population-demography/demography-population-stock-balance/database
8 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Incidence (number of units transfused pmp by country and by blood component)
Red blood cells Platelets Plasma Whole blood
Number of Units Number of Units Number of Units Transfd Number of Units Transfd
Country Transfd pmp Transfd pmp pmp pmp
Austria (AT) 0.28 0.03 0.00
Belgium (BE) 0.40 0.06 0.04 0.00
Bulgaria (BG) 0.10 0.02 0.69 0.00
Croatia (HR) 0.17 0.03 0.04 0.00
Cyprus (CY) 0.06 0.00 0.01 0.00
Czechia (CZ) 0.42 0.05 0.10 0.00
Denmark (DK) 0.18 0.03 0.04 0.00
Estonia (EE) 0.04 0.00 0.01 0.00
France (FR) 2.26 0.33 0.22 0.00
Germany (DE) 3.51 0.59 0.87 0.00
Hungary (HU) 0.16 0.05 0.00
Ireland (IE) 0.12 0.02 0.00
Italy (IT) 2.41 0.24 0.23 0.00
Latvia (LV) 0.05 0.03 0.00
Luxembourg (LU) 0.02 0.00
Malta (MT) 0.01 0.00
Netherlands (NL) 0.39 0.05 0.00
Norway (NO) 0.15 0.02 0.04 0.00
Portugal (PT) 0.29 0.05 0.01 0.00
Romania (RO) 0.35 0.10 0.20 0.00
Slovakia (SK) 0.20 0.02 0.11 0.00
Spain (ES) 1.51 0.23 0.14 0.00
Sweden (SE) 0.36 0.05 0.04 0.00
United Kingdom (UK) 0.03 0.00
9 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Incidence (number of units transfused pmp by country and by blood component)
Sweden (SE) 0.4 0.1
Spain (ES) 1.5 0.2 0.1
Slovakia (SK) 0.2 0.1
Romania (RO) 0.4 0.1 0.2
Portugal (PT) 0.3 0.1
Norway (NO) 0.2
Netherlands (NL) 0.4 0.1
Latvia (LV) 0.1
Italy (IT) 2.4 0.2 0.2
Ireland (IE) 0.1
Hungary (HU) 0.2 0.1
Germany (DE) 3.5 0.6 0.9
France (FR) 2.3 0.3 0.2
Denmark (DK) 0.2
Czechia (CZ) 0.4 0.10.1
Cyprus (CY) 0.1
Croatia (HR) 0.2
Bulgaria (BG) 0.1 0.7
Belgium (BE) 0.4 0.1
Austria (AT) 0.3
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0
Red blood cells Number of Units Transfd pmp Platelets Number of Units Transfd pmp Plasma Number of Units Transfd pmp
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Units issued and transfused 2022 SARE exercise (2021 data)
Total number = total of RBC, platelets, plasma and whole blood (separately reported)
Countries Number of Units Issued Number of Units Transfd
Issued and transfused (in mio) Austria (AT) 323 548 313 628
Belgium (BE) 518 514 512 521
6.00
Bulgaria (BG) 238 582 197 206
Croatia (HR) 256 870 245 223
* Cyprus (CY) 87 467 84 050
5.00 Czechia (CZ) 569 628 567 467
Denmark (DK) 254 611 255 219
Estonia (EE) 63 869 62 349
4.00 Finland (FI) 211 621 0
France (FR) 3 005 234 2 817 261
Germany (DE) 4 983 716 4 983 716
Hungary (HU) 535 512 214 322
3.00 Iceland (IS) 14 552 13 389
Ireland (IE) 145 501 144 185
* Italy (IT) 2 964 204 2 885 769
2.00 Latvia (LV) 92 038 91 115
Liechtenstein (LI) 221 221
Lithuania (LT) 127 126 0
Luxembourg (LU) 24 237 23 785
1.00
Malta (MT) 23 059 17 892
* Netherlands (NL) 457 317 440 791
Norway (NO) 212 938 212 938
0.00 Poland (PL) 1 615 651 0
Portugal (PT) 372 143 352 078
Romania (RO) 674 654 655 704
Slovakia (SK) 341 234 341 234
Slovenia (SI) 101 897 0
Spain (ES) 1 883 734 1 883 734
Sweden (SE) 543 175 447 945
Units issued (mio) Units transfused (mio) United Kingdom (UK) 49 016 45 127
* Including data of transfused units in units issued from DE, NO and ES Total 20 691 869 17 808 869
11 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Number of recipients transfused per type of blood component
19 countries: AT, BE, BG, HR, CY, CZ, DK, FR, IS, IE, IT, LI, LU, MT, NL, NO, ES, SE and UK.
RECIPIENTS TRANSFUSED
Plasma Whole blood
246,949 1,080 Recipients transfused
9% 0% Blood component
Platelets (mio)
278,050
10%
Red blood cells 2.226
RBC
Platelets 0.278
2,226,386
81% Plasma 0.247
Whole Blood 0.001
TOTAL 2.752*
*Total blood regardless of component type: 159 842 (RO)
17,809 mil units transfused to 2,912 mil recipients
NB: A patient who received more than one blood component will be shown more than once in these figures
to be interpreted with caution!
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SARE REPORTED 2022 SARE exercise (2021 data)
Serious Adverse Events 2. 734 (3 018 in 2020)
Serious Adverse Reaction (recipient) 2. 814 (2 967 in 2020)
- imputability level 1-3 2 814 SAR
- imputability level 2-3 1 379 SAR (1 756 in 2020) 25 deaths (24 in 2020)
Serious Adverse Reaction (donors) 2. 946 (4 025 in 2020)
13 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
30 Countries:
AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, HU, IS, IE, IT, LV, LI, LT, LU, MT, NL, NO, PL, PT, RO, SK, SI, ES,
SE and UK.
Serious Adverse Reactions (in recipients)
14 ©2023 EDQM, Council of Europe. All rights reserved.
SAR per type of blood component 2022 SARE exercise (2021 data)
Total = 17 808 869 Total = 1 379 Total = 25 Total = 1732 Total = 2 814
100%
45 43 78
2
2,272,341
0 238
90% 149 149
4
80% 2,158,095
571
70% 356 352
60%
More than one blood component transfused
Whole blood
50%
Plasma
40% Platelets
13,375,434 17
Red blood cells
1600
30%
697 680
20%
10%
0%
Units transfused Total SAR (level 2+3) Death (level 2+3) No Death (level 2+3) Total SAR
(level 1-3)
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Incidence of SAR (2-3) (per 100 000 units transfused)
2022 SARE exercise (2021 data)
SAR (2+3)
Deaths
incidence Death Percentage of
Units Total SAR Total SAR incidence (per
Component type (per 100 000 (level deaths among
transfused (level 1-3) (level 2+3) 100 000 units
units 2+3) SAR 2-3
transfused)
transfused)
Red blood cells 13 375 434 1 718 724 5,4 17 2,3% 0,13
Platelets 2 158 095 623 374 17,3 4 1,1% 0,18
Plasma 2 272 341 298 164 7,2 0 0% 0
Whole blood 2 999 2 2 66,7 0 0% 0
More than one
blood component 76 43 NA 2 4,6% NA
transfused
Total 17 808 869 2 717 1 307 7,3 23 1,7% 0,13
* SAR from countries that did not report the number of units transfused have not been included in this table (FI, LT, PL, SI)
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2022 SARE exercise (2021 data)
Incidence of SAR (2-3) (per 100 000 units transfused)
Austria (AT) 22.0
Belgium (BE) 2.5
Bulgaria (BG) 0.5
Croatia (HR) 5.3
Cyprus (CY) 0.0
Czechia (CZ) 2.6
Denmark (DK) 2.4
Estonia (EE) 12.8
France (FR) 2.5
Germany (DE) 3.6
Hungary (HU) 7.5
Iceland (IS) 0.0
Ireland (IE) 38.8
Italy (IT) 20.1
Latvia (LV) 3.3
Liechtenstein (LI) 0.0
Luxembourg (LU) 0.0
Malta (MT) 0.0
Netherlands (NL) 11.8
Norway (NO) 16.4
Portugal (PT) 5.7
Romania (RO) 1.4
Slovakia (SK) 18.2
Spain (ES) 3.8
Sweden (SE) 4.5
United Kingdom (UK)* 13.3
0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0 45.0
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2022 SARE exercise (2021 data)
SAR distribution per blood component type (levels 1-3) = 2 814
100% 0
1 0 0 0 0 0 0 0 8 0 0 0 0 0 0 0
32 2 1 4
1 1 1 1
15 144 12
17 3 20 2
90% 0 3
5 0 1 61 9
10 4 8 16 6
24
4 8 89 7
80% 1
6 21
7
0 34 328 1
70% 2
2 4
2 3 2 9 21
0 53
60% 8
0
2 6
50% 1 1
8 10
102
40%
1 398 23
14 54 71 9
23 15 23 3
30% 9 66 17 702 35
8 7 127 38
5
20%
6 1
5
10%
0% 0 0 0
Red Blood Cells Platelets Plasma Whole blood More than one blood component transfused
18 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
SAR distribution per blood component type (levels 2-3) = 1 379
100% 0 0 0 0 0 0 0 3 0 0 0 0 0 0
15 1 4
1 6 1
1 11 99 1
90% 14 3 5 3 0
3 3 0 0 15 9
0 5 16 6
29 20 5
80%
0 7
1 8 2
1 1 16
70%
24 2 4 21
205
2 8 18
60%
7 6
50% 1 0
7
40% 5
55
131 14
9 9 0 4 36 23 3
30% 30
9 29
35 2 38
7 274 4 29
20%
5 1
5
10%
0% 0 0 0 0 0 0
Red Blood Cells Platelets Plasma Whole blood More than one blood component transfused
19 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
SAR by type of reaction Imputability levels 2-3 N =1 379
Other (404) 29,3%
Febrile non-haemolytic transfusion (334) 24,2%
Anaphylaxis/hypersensitivity (217) 15,7%
TACO (185) 13,4%
Immunological Haemolysis (124) 9%
TAD (41) 3%
TRALI (38) 2,7% 1 121 SAR level 2
Hypotensive transfusion reaction (14) 1% 258 SAR level 3
Transfusion-transmitted viral infection (4) 0,3%
Post-transfusion purpura (3) 0,2%
Non-immunological Haemolysis (3) 0,2%
Transfusion associated graft versus host disease (1) 0,07%
Transfusion-transmitted bacterial infection (11) 0,07%
Transfussion-transmitted prion infection (0) 0%
Transfusion-transmitted fungal infection (0) 0%
Transfusion-transmitted parasitical infection (0) 0%
0 5 10 15 20 25 30 35
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“others” category of SAR : 2022 SARE exercise (2021 data)
Allergic reaction 318
Other without specifications 53
Delayed haemolytic transfusion reaction (DHTR) 11
Fever + other symptoms 5
Respiratory disorders (other than TRALI) 2
Hypertension 2
404 SARS in recipients classified as “others” in 2021 (487 in 2020)
Fever 2 accuracy in classification ?
Dyspnea + other symptoms 2
Cannot conclude 2
Urticarial rash 1
Mild allergic reactions 1
Low grade pyrexia, hypotension, chills,GI symptoms, dizziness 1
Increased respiratory rate, bilateral crepitations, signs of congestive cardiac failure 1
Hypertension + other symptoms 1
Hemosiderosis 1
Auto immune haemolytic anemia aggrevated by transfusion 1
0 50 100 150 200 250 300 350
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Number of deaths per SAR type of reactions 2022 SARE exercise (2021 data)
N= 23 N= 24
Death level 1 Death level 2-3
TACO 12 TACO 8
Anaphylaxis/hypersensitivity 3 Immunological Haemolysis due to ABO incompability 8
Other 2* Transfusion-transmitted bacterial infection 3 (no details on type of bacteria)
Transfusion related acute lung injury (TRALI) 2 Immunological Haemolysis due to other allo-antibody 3
Immunological Haemolysis due to ABO incompability 2 Transfusion related acute lung injury (TRALI) 2
TAD 1 Other 1**
Immunological Haemolysis due to other allo-antibody 1 Hypotensive transfussion reaction 0
Hypotensive transfussion reaction 0 TAD 0
Febrile non-haemolytic transfusion 0 Febrile non-haemolytic transfusion 0
Graft versus host disease 0 Graft versus host disease 0
Transfusion-transmitted viral infection 0 Transfusion-transmitted viral infection 0
Transfusion-transmitted fungal infection 0 Transfusion-transmitted fungal infection 0
Transfusion-transmitted parasitical infection 0 Transfusion-transmitted parasitical infection 0
Transfusion-transmitted bacterial infection 0 Post-transfusion purpura 0
Post-transfusion purpura 0 Non-immunological Haemolysis 0
Non-immunological Haemolysis 0 Anaphylaxis/hypersensitivity 0
0 2 4 6 8 10 12 14 0 1 2 3 4 5 6 7 8 9
13 Countries: BE, FI, FR, DE, HU, LU, NL, NO, PL, PT, RO, ES, UK
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2022 SARE exercise (2021 data)
Number of SAR (Imputability levels 2-3) per type/blood component
More than one blood
Red blood cells Plasma Platelets Whole blood component
transfused All
No Death Death No death Death No Death Death No Death Death No Death Death
SAR Type (Level 2+3) No Death Death Total
Anaphylaxis/hypersensitivity 57 1 47 0 98 0 0 0 15 0 217 0 217
Immunological Haemolysis due to ABO incompability 44 8 6 0 3 0 1 0 1 0 55 8 63
Immunological Haemolysis due to other allo-antibody 49 2 0 0 1 0 0 0 0 1 50 3 53
Non-immunological Haemolysis 3 0 0 0 0 0 0 0 0 0 3 0 3
Post-transfusion purpura 1 0 1 0 0 0 0 0 1 0 3 0 3
Transfusion related acute lung injury (TRALI) 19 0 7 0 5 1 0 0 5 1 36 2 38
Transfusion-transmitted bacterial infection 1 0 0 0 6 3 0 0 1 0 8 3 11
Transfusion-transmitted parasitical infection 0 0 0 0 0 0 0 0 0 0 0 0 0
Transfusion-transmitted fungal infection 0 0 0 0 0 0 0 0 0 0 0 0 0
Transfusion-transmitted viral infection 2 0 0 0 1 0 0 0 1 0 4 0 4
Transfusion associated Graft versus host disease 0 0 0 0 0 0 0 0 1 0 1 0 1
TACO 156 8 4 0 6 0 0 0 11 0 177 8 185
Febrile non-haemolytic transfusion 240 0 8 0 81 0 0 0 5 0 334 0 334
TAD 26 0 3 0 11 0 1 0 0 0 41 0 41
Hypotensive transfusion reaction 10 0 1 0 3 0 0 0 0 0 14 0 14
Transfussion-transmitted prion infection 0 0 0 0 0 0 0 0 0 0 0 0 0
Other 135 1 103 0 171 0 0 0 2 0 411 1 412
Total 743 20 180 0 386 4 2 0 43 2 1354 25 1379
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2022 SARE exercise (2021 data)
28 Countries:
AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, IS, IE, IT, LV, LT, LU, MT, NL, NO, PL, PT, RO, SK, SI, ES, SE and
UK
(No report from LI and HU)
Serious Adverse Events
24 ©2023 EDQM, Council of Europe. All rights reserved.
Number of Serious adverse events (SAE) 2022 SARE exercise (2021 data)
N= 2 734
Austria (AT) 11
Belgium (BE) 644
Bulgaria (BG) 1
Croatia (HR) 4
Cyprus (CY) 1
Czechia (CZ) 3
Denmark (DK) 9
Estonia (EE) 47
Finland (FI) 15
France (FR) 468
Germany (DE) 259
Hungary (HU)
Iceland (IS) 3
Ireland (IE) 133
Italy (IT) 10
Latvia (LV) 2
Liechtenstein (LI)
Lithuania (LT)
Luxembourg (LU)
Malta (MT)
Netherlands (NL) 81
Norway (NO) 86
Poland (PL) 37
Portugal (PT) 34
Romania (RO) 688
Slovakia (SK)
Slovenia (SI) 6
Spain (ES) 7
Sweden (SE) 124
United Kingdom (UK) 61
0 100 200 300 400 500 600 700 800
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Incidence of SAE (per 100 000 Units processed) 2022 SARE exercise (2021 data)
SAE per
Total Number of
Country SAE 100 000 units
Units Processed
Austria (AT) 2.7 processed*
Belgium (BE) 100.8 Austria (AT) 408702 11 2,7
Bulgaria (BG) 0.4 Belgium (BE) 638796 644 100,8
Croatia (HR) 2.1 Bulgaria (BG) 280675 1 0,4
Cyprus (CY) 1.5 Croatia (HR) 189020 4 2,1
Czechia (CZ) 0.2 Cyprus (CY) 66208 1 1,5
Denmark (DK) 1.4 Czechia (CZ) 1506077 3 0,2
Estonia (EE) 91.5 Denmark (DK) 661814 9 1,4
Finland (FI) 6.9 Estonia (EE) 51348 47 91,5
France (FR) 15.6 Finland (FI) 217802 15 6,9
Germany (DE) 4.0 France (FR) 3008673 468 15,6
Hungary (HU) Germany (DE) 6496821 259 4,0
Iceland (IS) 26.6 Hungary (HU)
Ireland (IE) 106.4 Iceland (IS) 11293 3 26,6
Italy (IT) 0.3 Ireland (IE) 125026 133 106,4
Latvia (LV) 3.4 Italy (IT) 3021143 10 0,3
Liechtenstein (LI) Latvia (LV) 58603 2 3,4
Lithuania (LT) 0.0 Liechtenstein (LI)
101598 0 0,0
Luxembourg (LU)
Malta (MT)
0.0
0.0
SAE incidence 0 - 140 Lithuania (LT)
Luxembourg (LU) 44181 0 0,0
Netherlands (NL) 10.7 Malta (MT) 16157 0 0,0
Norway (NO) 46.8 Netherlands (NL) 760000 81 10,7
Poland (PL) 2.6 Norway (NO) 183592 86 46,8
Portugal (PT) 10.9 Poland (PL) 1397355 37 2,6
Romania (RO) 90.0 Portugal (PT) 310757 34 10,9
Slovakia (SK) 0.0 Romania (RO) 764037 688 90,0
Slovenia (SI) 3.5 Slovakia (SK) 195340 0 0,0
Spain (ES) 0.4 Slovenia (SI) 173768 6 3,5
Sweden (SE) 24.4 Spain (ES) 1720402 7 0,4
United Kingdom (UK) 140.4 Sweden (SE) 509025 124 24,4
0.0 20.0 40.0 60.0 80.0 100.0 120.0 140.0 160.0 United Kingdom (UK) 43435 61 140,4
Total 22 961 648 2734 11,9
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* SAE from all activity steps have been included, although denominator is only about processing
Distribution of SAE per steps 2022 SARE exercise (2021 data)
100% 4
2 8
1 1 5
2 1
90% 110
3
1 8
1 3 1 81 1 6
16 17
80%
39
1
70% 3
1 171 4 9 Other
13
3
Issue
60% 1 2 12
3
7 Compatibility testing/cross-matching
2
5
50% 9 1 2 1 1 43 18 1
7 7 7 4 6 Component selection
55
4
7 3 Distribution
40% 22
1
2
4
1
Storage
3 331
81
30% 78 7 Processing
2 4
1 19
6 Testing
20% 5
102 11
33 1 28 Apheresis Collection
7 2
1 1
10% 30 Whole blood collection
1 5
1
32
24 2
37 3 36 5 Donor selection
0% 1 1 1
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Number of SAE per collection type 2022 SARE exercise (2021 data)
100%
90%
80%
70%
60%
50% Apheresis collection
40% Whole blood collection
30%
20%
10%
0%
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Distribution of SAE per steps 2022 SARE exercise (2021 data)
Donor selection (324)
12%
Whole blood collection (155) N= 2 734
6%
Apheresis Collection (50)
Other (850)
2%
31%
Testing (435)
16%
Issue (216)
8%
Processing (217)
Compatibility testing/cross-
8%
matching (89)
3% Component selection (116) Storage (209)
4% 7%
Distribution (73)
3%
29 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Percentage of SAE classified as “other” per country Distribution of “other” SAE per country
120
United
Slovenia (SI)
Kingdom (UK)
1 Latvia (LV) Ireland (IE)
Poland (PL) 3
100 0% 1 35
2 0%
14 0% 4% Norway (NO)
0%
39
5%
80
50 55 55 France (FR)
60
74 212
83 25%
95 95
Belgium (BE)
557
86
40 66%
50 45 45
20
26
17
0
5 5
Latvia (LV) Slovenia Poland (PL) United Ireland (IE) Norway France (FR) Belgium
(SI) Kingdom (NO) (BE) • Other (850) : 31% of all SAE reported
(UK)
• More than 90% of all « other » SAE are
% "other" category % defined categories reported by 2 countries (BE, FR)
30 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Distribution of SAE per event specification
100% 10 6 1
22 7 1 1
3
1 2 1 6
2 104 1
90% 3
1
28
80% 157
1
281 2 122 1 157 63 31
70% 6 23
2
60% 5 89
6
3 30
50% 1 1 11 10 3 1
8 73
40 5
40%
243 50
8 1
35
30% 427
338 1
2 3 1 29
113 18
20%
1 13
1
10% 2 1 24
53 17 3 1
1 2
1 5
0% 5 1 1 1
Component defect Equipment failure System failure Human error Materials Other
31 ©2023 EDQM, Council of Europe. All rights reserved.
SAE distribution per event specification 2022 SARE exercise (2021 data)
Other (127)
Materials (21)
5%
1%
Human error (974) Component defect (1037)
35% 38%
System failure (332)
12%
Equipment failure (243)
9%
32 ©2023 EDQM, Council of Europe. All rights reserved.
Distribution and type of human error events? 2022 SARE exercise (2021 data)
Compatibility
Whole blood
testing/Cross
Testing collection Apheresis collection
matching (BE or HBB
2% 3% 1% activity step)
7% Component selection
(BE or HBB activity
step)
Storage 10%
Processing
2% 14% Distribution
5%
Donor selection
11%
Other
28% Issue (BE or HBB
activity step)
17%
33 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
23 Countries:
AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, IS, IE, IT, LU, NL, NO, PL, PT, RO, SK, SI and SE.
Serious Adverse Reactions
(in donors)
DENOMINATORS -Total number of collections :
• 16.2 million whole blood collections
• 6,0 million apheresis collections
34 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Number of SAR in donors per type of collections (voluntary reporting)
43
Sweden (SE) (43) 0
16
N=2 946
Slovenia (SI) (16) 0
Slovakia (SK) (92) 89
3
Romania (RO) (93) 93
0
Portugal (PT) (13) 13
0
Poland (PL) (50) 46
4
Norway (NO) (156) 130
26
Netherlands (NL) (15) 3
12
Italy (IT) (343) 247
96
Ireland (IE) (15) 14
1
Iceland (IS) (6) 0
6
Germany (DE) (345) 280
65
France (FR) (1402) 957
445
Finland (FI) (1) 1
0
Estonia (EE) (6) 5
1
Denmark (DK) (14) 4
10
Czechia (CZ) (6) 2
4
Cyprus (CY) (3) 3
0
Croatia (HR) (206) 205
1
Bulgaria (BG) (83) 83
0
Belgium (BE) (31) 24
7
Austria (AT) (7) 4
3
0 100 200 300 400 500 600 700 800 900 1000
SAR in Whole blood collection SAR in Apheresis collection
35 ©2023 EDQM, Council of Europe. All rights reserved.
Incidence of SAR in donors (per 100 000 collections)* 2022 SARE exercise (2021 data)
1.3
Austria (AT) 0.7
5.6
N=2 946
Belgium (BE) 3.3
Bulgaria (BG) 52.9
0.0
Croatia (HR) 110.2
20.4
Cyprus (CY) 4.5
0.0
Czechia (CZ) 0.4
0.4
Denmark (DK) 2.1
10.3
Estonia (EE) 10.3
33.3
Finland (FI) 0.5
0.0
France (FR) 40.1
128.0
Germany (DE) 7.6
2.3
Iceland (IS) 0.0
715.1
Ireland (IE) 10.9
10.6
Italy (IT) 9.6
21.1
Netherlands (NL) 0.7
3.5
Norway (NO) 78.2
149.4
Poland (PL) 3.6
3.2
Portugal (PT) 4.3
0.0
Romania (RO) 12.4
0.0
Slovakia (SK) 47.0
40.4
Sweden (SE) 11.3
-80.0 20.0 120.0 220.0 320.0 420.0 520.0 620.0 720.0
Number of SAR per 100 000 WB collection Number of SAR per 100 000 apheresis collection
36 ©2023 EDQM, Council of Europe. All rights reserved. * Only countries having reported SAR in donors have been included
Incidence of SAR in donors (per million collections)* 2022 SARE exercise (2021 data)
Austria (AT)
N=2 946
Belgium (BE)
Bulgaria (BG)
Croatia (HR)
Cyprus (CY)
Czechia (CZ)
Denmark (DK)
Estonia (EE)
Finland (FI)
France (FR)
Germany (DE)
Iceland (IS)
Ireland (IE)
Italy (IT)
Netherlands (NL)
Norway (NO)
Poland (PL)
Portugal (PT)
Romania (RO)
Slovakia (SK)
Slovenia (SI)
Sweden (SE)
-800.0 200.0 1200.0 2200.0 3200.0 4200.0 5200.0 6200.0 7200.0
Number of SAR per million apheresis collection Number of SAR per million WB collection
37 ©2023 EDQM, Council of Europe. All rights reserved. * Only countries having reported SAR in donors have been included
2022 SARE exercise (2021 data)
Incidence of SAR in donors (per 100 000 collections)*
N=2 946
Austria (AT) 0.7 1.3
Belgium (BE) 3.3 5.6
Bulgaria (BG) 0.0 52.9
Croatia (HR) 20.4 110.2
Cyprus (CY) 0.0 4.5
Czechia (CZ) 0.4 0.4
Denmark (DK) 10.3 2.1
Estonia (EE) 33.3 10.3
Finland (FI) 0.0 0.5
France (FR) 128.0 40.1
Germany (DE) 2.3 7.6
Iceland (IS) 715.1
Ireland (IE) 10.6 10.9
Italy (IT) 21.1 9.6
Netherlands (NL) 3.5 0.7
Norway (NO) 149.4 78.2
Poland (PL) 3.2 3.6
Portugal (PT) 0.0 4.3
Romania (RO) 0.0 12.4
Slovakia (SK) 40.4 47.0
Sweden (SE) 11.3
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Number of SAR per 100 000 apheresis collection Number of SAR per 100 000 WB collection
38 ©2023 EDQM, Council of Europe. All rights reserved.
* Only countries having reported SAR in donors have been included
2022 SARE exercise (2021 data)
Distribution of SAR in donors per type of reaction (Voluntary reporting)
APHERESIS COLLECTION WHOLE BLOOD COLLECTION
Major Nerve injury
General Citrate Nerve injury
cardiovascular irritation Major
1% reaction irritation
event or death Other 2% cardiovascular Other
5% 14% 7%
up to 24h after 19% event or death up
donation to 24h after
donation
1%
0,6%
Allergic Vasovagal
reaction Vasovagal
reaction
1% reaction
79%
71%
N=684 N=2 262
39 ©2023 EDQM, Council of Europe. All rights reserved.
Number of SAR in donors per type : Apheresis collection* 2022 SARE exercise (2021 data)
15 Countries: AT, BE, HR, CZ, DK, EE, FR, DE, IS, IE, IT, NL, NO, PL and SK.
100%
90%
N= 684
80% CZ, FR, DE : 4 MCE reported
no deaths in donors
70%
Other
60% Major cardiovascular event or death up to
24h after donation
50%
Allergic reaction
40%
Vasovagal reaction
30%
20% Citrate reaction
10% Nerve injury irritation
0%
40 ©2023 EDQM, Council of Europe. All rights reserved. * Only countries having reported SAR in donors have been included
Number of SAR in donors per type : Whole blood collection
2022 SARE exercise (2021 data)
21 Countries: AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, IE, IT, NL, NO, PL, PT, RO, SK, SI and SE.
100% N= 2 262
90% • FR, DE : 12 MCE reported no death in
donors
80%
• BG, SE : 2 MCE reported no further
details (death ?)
70%
60%
Other
50%
40% Major cardiovascular event or death up to 24h
after donation
30%
Vasovagal reaction
20%
Nerve injury irritation
10%
0%
41 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Annual comparison (Years of exercises 2011-2022)
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Units issued 22 817 166 24 821 809 25 129 344 24 043 766 25 717 028 25 324 888 24 827 516 24 827 516 22 922 191 22 863 135 22 104 136 20 633 199
Units
16 718 258 12 311 691 13 351 948 16 564 817 21 425 047 21 443 125 20 910 579 20 674 603 19 267 785 19 322 367 18 881 223 17 808 869
transfused
Recipients
2 298 304 2 964 839 3 595 155 3 216 938 4 190 835 4 246 978 3 123 147 3 089 746 2 913 325 2 967012 2 912 173 2 752 465
transfused
SAR (1-3) 2 449 3 133 3 519 2 831 2 441 2 587 2 950 3 114 2 451/2 512 2 625 2967 2 814
SAR ( 2-3) 1 259 1 574 1 831 1 739 1 410 1 349 1 737 1 871 1 636 1 674 1756 1 379
SAR death (2-
20 14 22 22 27 25 16 28 20 26 24 25
3)
SAE 16 360 4 113 2 953 2 972 4 460 2 338 2 599 2 920 2 770 2604 3018 2 734
SAR in donors NA NA 2 494 2 470 3 723 7 769 7 658 4 635 6 239 3 821 4025 2 946
42 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Annual comparison (Years of exercises 2013-2022) : number of units issued/transfused/recipients
30,000,000
25,129,344 25,717,028 25,324,888
25,000,000 24,827,516 24,827,516
24,043,766
22,922,191 22,863,135
22,104,136
21,425,047 21,443,125 20,910,579 20,674,603 20,633,199
20,000,000
19,267,785 19,322,367 18,881,223
17,808,869
16,564,817
15,000,000
13,351,948
10,000,000
5,000,000
4,190,835 4,246,978
3,595,155 3,216,938 3,123,147 3,089,746 2,913,325 2,967,012 2,912,173 2,752,465
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Units issued Units transfused Recipients transfused
43 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Annual comparison (Years of exercises 2013-2022): SAR (1-3), SAR (2-3), SAE, SAR in donors
9,000
8,000
7,769 7,658
7,000
6,239
6,000
5,000
4,460
4,635
4,000 4025
3,723 3,821
3,519
3,000 3,114 3018
2,953 2,972
2,831 2,950 2,920
2,770
2967 2,946
2,814
2,625 2,734
2,587 2,599 2604
2,494 2,470 2,441 2,338
2512
2,000
1,831 1,871 1756
1,739 1,737 1,636 1,674
1,410 1,349 1,379
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
SAR (1-3) SAR ( 2-3) SAE SAR in donors
44 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Annual comparison (Years of exercises 2013-2022) : number of deaths (2-3)
30
28
27
26
25 25 25
24
22 22
20 20
16
15
10
5
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
45 ©2023 EDQM, Council of Europe. All rights reserved.
General conclusions 2022 SARE exercise (2021 data)
Still some denominators missing
Inconsistency/heterogeneity in the reporting, problem of "other"
categorizations that generate discrepancies and misclassification
Gradual improvement of the data collection
46 ©2023 EDQM, Council of Europe. All rights reserved.
2022 SARE exercise (2021 data)
Next steps
• 2022 SARE exercise (data 2021) FINAL REPORT
• 2023 SARE exercise (data 2022) : deadline for
submission : July 15th 2023
[email protected]
47 ©2023 EDQM, Council of Europe. All rights reserved.
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Saatja: <
[email protected]>
Saadetud: 14.07.2023 15:18
Adressaat: <
[email protected]>; <
[email protected]>
Koopia: <
[email protected]>
Teema: Preliminary results on SARE blood 2022 (2021 data) exercise
Dear competent authorities for blood and blood components,
Please find attached the preliminary results of the SARE exercise on
blood 2022 (data 2021).
We would appreciate if you could take a look and provide us your feedback
on the data accuracy and the way of its interpretation until 15th August
2023.
Please do not hesitate to contact us or directly EDQM (in copy) for any
question or doubt.
Many thanks and kind regards,
The SoHO team.
European Commission DG SANTE (Health and Food Safety)
Unit D2 Medical Products: quality, safety, innovationOffice address: Rue
Breydel 2, 06/004, B-1049 Brussels/Belgium