Transfus Clin Biol 2001 ; 8 : 285-90

2001 ditions scientifiques et mdicales Elsevier SAS. Tous droits rservs

S1246782001001161/SSU

COMMUNICATION

Haemovigilance in Europe:
the European haemovigilance network
J.C. Faber*
Blood Transfusion Service, Luxembourg Red Cross, 4244, Bd Joseph II, L-1840, Luxembourg

Nowadays haemovigilance is considered to be a crucial

part of the safety concept in blood transfusion. The
approach to haemovigilance in Europe is as diverse as
the organisation of European blood transfusion services
[1, 9].
The aim of haemovigilance should be to collect data
on (serious) sequelae of blood component transfusion
and to contribute to:
improving the safety of the transfusion process;
informing policy;
improving standards;
aiding in the drawing up of guidelines.
The complexity of the European situation starts with
the definition of haemovigilance in the different European countries: one definition is the following, which is
used in several countries:
Haemovigilance is a surveillance system based on an
ongoing and standardised collection and analysis of
data:
monitoring the prevalence and incidence of infectious markers in blood donors;
compiling a list of adverse events that are suspected
or have been confirmed to be associated with blood
collection or transfusion of labile components,
including transfusion errors and product-related sideeffects;

*Correspondence and reprints.

E-mail address: transfusion@croix-rouge.lu (J.C. Faber).

registering confirmed transfusion of blood components to patients; and

incorporating rapid alert/warning procedures.
THE EUROPEAN LEVEL
Before developing the situation in Europe one has to
define what is meant by Europe. In the context of blood
transfusion, one generally refers either to the European
Union (EU) or to the Council of Europe (European
Council): this simple approach already shows significant differences.
The European Union (EU)
The EU, with 15 Member States (MS), is organised in
the following way: the C of E acts in a co-decision
process with the European Parliament on advice from
the Social and Economic Committee and the Committee of the Regions. The European Commission is
the executive tool, the guardian of the Treaties and has
the right of legislative initiative.
In the context of blood transfusion, Directive
89/381/EEC relating to proprietary medicinal products and laying down special provisions for medicinal
products derived from human blood or human plasma
is a milestone in the sense that it establishes legal
provision for plasma derivatives: it rules that they are
considered medicinal products and as such come under

286

J.C. Faber

Community legislation on medicines; this is true also

from the vigilance standpoint, and as such they are
covered by pharmacovigilance (as required by Directive
75/319/EEC, under article 29a). Blood products were
excluded expressis verbis from these provisions and do
not fall under pharmacovigilance procedures.
The C of E, in its Resolution of 2 June 1995 on blood
safety and self-sufficiency in the Community, invited
the Commission to submit appropriate proposals in the
framework of the development of a blood strategy: it
proposed to include the establishment of a haemovigilance system based on existing networks for the collection of epidemiological data in relation to the blood
transfusion chain.
A Colloquium was organised in Adare (Ireland) in
September 1996 on Blood Safety and Self-Sufficiency:
an Agenda for the European Community. Six areas of
action for the European Community were identified:
one of them was haemovigilance. This was to be
addressed by the European Community, upon a proposal from the European Commission.
Concerning haemovigilance specifically, the European Commission at the end of 1995 launched a call
for tender for a feasibility study on a haemovigilance
network within the European Community: the
HAEMAN Consortium was constituted in 1997, the
MS met in 1998 and a report on the feasibility of a
haemovigilance network was published in 1999 by the
European Commission [10] (at the time DGV/F/4 was
in charge of blood issues within Employment, Industrial Relations and Social Affairs Public Health and
Safety at Work: communicable, rare and emerging
diseases). Up to the present date no further action has
been taken on this subject.
In order to complete the list of legal provisions in the
field of blood transfusion, Council Recommendation
98/463/EEC on the suitability of blood and plasma
donors and the screening of donated blood in the
European Community should be mentioned.
The Treaty of Amsterdam (1999) lays down in Article
152, 4(a) and (5) that measures should be adopted
setting high standards of quality and safety of organs
and substances of human origin, blood and blood
derivatives.
Based on this article, a proposal for a European
Blood Directive was elaborated by the European Commission and is now discussed: the Directive of the
European Parliament and of the Council setting standards of quality and safety for the collection, testing,
processing, storage, and distribution of human blood

and blood components and amending Council Directive 89/381/EEC. Article 14. on the Notification of
adverse reactions and events proposes to lay down that
1. Member States shall ensure that there is a system in
place to collect, collate, and transmit information about
adverse reactions and events related to the collection,
testing, processing, storage and distribution of blood
and blood components to the competent authority.
Although the term haemovigilance is not used, this is
what it means.
The Council of Europe (C of E)
The Council of Europe (C of E) is a intergovernmental
organisation founded in 1949, which is headquartered
in Strasbourg and at the moment includes 43 member
states.
In the context of blood transfusion, the C of E has a
long tradition going back to the 1960s, when a special
group was set up to deal with blood transfusion and
technical details associated with blood grouping and
transfusion practices. This group was later on formalised and named SP-HM (Sant PubliqueHmatologie), working under the CDSP (Comit
Directeur Sant Publique). SPHM meets regularly,
has itself a select committee (SPRGS; Sant Publique Restreint Groupes Sanguins), updating annually Recommendation Rec. No. R (95) 15 to the
preparation, use and quality assurance of blood components, better known as the Guide [11]). The C of E has
issued a great number of documents, guidelines, recommendations and agreements in the field of blood
transfusion. Concerning haemovigilance, no specific
targeted work has been undertaken by the C of E, but in
several documents the importance of haemovigilance
has been underlined.
THE NATIONAL LEVEL
The situation in relation to blood transfusion is, as
already mentioned and shown below, quite heterogeneous and in constant evolution (tables I and II).
Particularities
It should be noted that for Germany (and also partially
for Austria) there exists a particular situation in relation
to the administration of blood products: in Germany,
the labile blood products are considered medicinal products and come under the German Drug Law; according
Transfus Clin Biol 2001 ; 8 : 28590

287

The European haemovigilance network

Table I. Situation as in 1999 [9].
Country

Population (in mio.)

Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
Sweden
UK

7.8
9.9
5.1
4.9
56.6
79.7
10.2
3.5
56.4
0.4
14.8
10.4
38.4
8.6
55.5

Blood Transfusion
Oorganisation

Operational
Responsibility

No. of BB

Regional
Regional
Hospital
Central
Central
Mixed
Hospital
Regional
Hospital
Central
Regional
Mixed
Mixed
Hospital
Regional

Red Cross
Red Cross
Public health
Red Cross
Public health
Mixed
Public health
Public health
Public health
Red Cross
Public
Public health
Public health
Public health
Public health

7
37
88
5
14
116
88
2
387
1
9
70
142
90
20

Law on tx

Haemovig.
established

Yes
Yes
No?
Yes
Yes
Yes
Yes
No?
Yes
Yes
Yes
Yes
Yes
Yes
No?

Yes*
No
No
No
Yes
Yes*
Yes
Yes
No
Yes
Yes
No
No
Yes
Yes

Organisation: central = centralised; regional = according to regions; hospital = blood banks are hospital based; BB = blood banks; *= blood
products are classified as medicinal products (drugs), covered by pharmacovigilance; haemovigilance established = in place and functioning,
not necessarily required by law. A similar situation exists with haemovigilance, as shown in table II.
Table II. Situation as in 1999 [9].
Country

Traceability Mandatory/ voluntary

Types of reaction Standardised report/form Epidemiologies of donors

Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
Sweden
UK

Shared
Shared
Central
Shared
Central
Shared
Shared
Shared
Central
Shared
Shared
No
Shared
Central
Shared

All
No
Infections
No
All
All
No
Severe
All
All
All
No
No
All
Severe

M
V
V
V
M
M*
V
V
M
V
M
V
V
M
V

Simple
No
No
No
Detailed
Simple
No
Detailed
No
Simple
No
No
No
No
Detailed

Red-Cross
Red-Cross
National
Red-Cross
National
National
National
National
National
Red-Cross
National
National
National
National
National

Rapid alert
+
+
+
+
+
+
+
+
?
+
+
+
?
?
+

Traceability: central = under the responsibility of a single type of institution; shared = under the responsibility of more than one type of
institution; severity of transfusion reactions: for example, grade 14 (1 = absence of vital threat; 2 = vital threat in the long term; 3 = immediate
vital threat; 4 = death of the patient); epidemiologies of donors: means mainly data on infectious markers; rapid alert: + = exists; ? = no reliable
data or no information at all.

to the national legal provisions covering medicines, side

effects observed have to be reported according to the
rules of pharmacovigilance.
Some results from existing surveillance systems
The following results illustrate once again the diversities and differences existing in the Member States of the
EU.
Transfus Clin Biol 2001 ; 8 : 28590

In France, where the haemovigilance system is nationwide, with a legal obligation to notify in written form
every side-effect in relation to a blood transfusion (grade
1 to 4), the number of notifications is important, e.g.
2,3 incident reports generated per 1 000 allogeneic
blood components transfused [3]. In 1997 there were 7
604 reports, in 1998 7 725 reports and in 1999 7 089
reports, with an estimated 2.7 million blood components transfused every year [2, 4].

288

J.C. Faber

In the UK (SHOT, Serious Hazards of Transfusion)

where haemovigilance is a scheme between professionals
and set up on a voluntary basis, covering transfusion
reactions of grades 2 to 4, the number of notifications is
much lower than in France. In 1996/97 there were 169
reports, in 1997/98 197 reports and in 1998/99 252
reports, with an estimated 3 million blood components
transfused every year. Fifty-five percent of the reports
fell into the category wrong blood to patient (independent of the presence or absence of clinical signs). It was
concluded that only a minority of cases were reported
[5-8].

web-site is structured in a public domain and a protected (private) domain, the last housing the rapid alert:
this section can only be accessed by authorised persons,
using a password. The address of the site is: www.ehnorg.net. It is protected by a certificate system (figure
1-4).
The home page of the web-site gives access to information on the EHN, contact addresses, the rapid alert
(protected by password) and the national menus of the
participating countries.
The general section of the national menu contains
information on the organisation of the transfusion

THE EUROPEAN HAEMOVIGILANCE NETWORK: EHN

In 1998, five countries took the initiative to work
together in the field of haemovigilance: Belgium,
France, Luxembourg, Portugal, and The Netherlands.
The first meeting was organised in Paris on February
10, 1998. Later on, Denmark joined and Switzerland
was adopted as an associate member. Several member
states of the EU have now shown interest in cooperating with the above-mentioned countries.
The EHN
The aims of the European Haemovigilance Network
(EHN) are:
facilitating close contacts in the field of haemovigilance between countries in Europe;
allowing rapid and efficient exchange of reliable information and experience;
maintaining a rapid alert system;
developing joint activities (such as organising European Seminars on Haemovigilance).

Figure 1.

European Haemovigilance Seminars

The first European Seminar on Haemovigilance was
organised by France and took place in Bordeaux in
November 1997; this was followed by the seminars in
Lyon in November 1998, in Lille in September 1999
and in Montpellier in September 2000.
Internet site of the EHN: www.ehn-org.net
At the same time, an Internet site was developed and
put in place: the web-site contains a rapid alert module.
It allows efficient and quick exchange of information on
different matters in relation to haemovigilance. The

Figure 2.
Transfus Clin Biol 2001 ; 8 : 28590

The European haemovigilance network

289

The Rapid Alert System (RAS)

Figure 3.

This is an information channel for very rapid diffusion

of important information in relation to emerging
threats, of whatever kind they may be. It works via fax,
e-mail and web-site (protected domain). The contact
person in one member country of the EHN is informed
that in the given country a problem has emerged, for
example through the national haemovigilance system
or by other means. This key person analyses the information and decides whether this information is diffused to the contact persons in the other countries,
members of the EHN. It is the responsibility of the
contact persons in the other countries to take up the
information, evaluate them and decide upon the action
in the respective country.
In the past the RAS has been used on several occasions, e.g.:
the appearance of clusters of clinical signs after transfusion;
hidden or apparent defects of disposable material
used in transfusion (such as leakages of filter housings,
holes in collection bags, defects in apheresis material,
etc);
problems with equipment;
other instances.
Exchange of information

Figure 4.

system as well as detailed data on donors, donations,

blood components, etc.
The section on haemovigilance contains specific information and data in relation to the haemovigilance
system in the selected country.
The last section of the national menu is designed in
such a way to permit presentation of news, developments and possible problems.
Transfus Clin Biol 2001 ; 8 : 28590

Another objective of the EHN has been the sharing of

data between the member countries concerning:
organisation of the blood transfusion system with
emphasis on haemovigilance collection, preparation,
usage of blood products;
epidemiologies of donors and recipients;
incidents in the context of transfusion.
It became apparent that in order to exchange information and compare results (for example in relation to
haemovigilance) standardisation was important. Therefore it was crucial to find consensus definitions for some
of the key parameters. Finally, it should be noted that
the EHN is in close contact and cooperation with the
EBA.
The European Blood Alliance (EBA)
The European Blood Alliance (EBA) was founded in
1998 and for the moment has 11 members and 2
associate members, all of them being national blood
services in a member country of the European Union.

290

J.C. Faber

The aim of the EBA is to develop and maintain an

organisational framework of European national blood
services within the European Union.
CONCLUSION
The field of haemovigilance is an extremely important
one when it comes to the safety and quality of blood
transfusion. Significant differences exist for the moment
in the countries in Europe in terms of definition, organisational schemes, state of development, impact and
efficiency, cooperation, etc. in relation to haemovigilance. The EHN is a European initiative to bring this
important item forward and to develop it into an
efficient tool intended to increase the safety and quality
of European blood transfusion.
REFERENCES
1 Engelfriet CP, Reesink HW. Haemovigilance systems. Vox
Sang 1999 ; 77 : 110-20.
2 Rouger P, Le Pennec PY, Noizat-Pirenne F. Analyse des risques

3
4
5
6
7

8
9
10
11

immunologiques en transfusion sanguine priode 19911998.

Transfus Clin Biol 2000 ; 7 : 9-14.
Debeir J, Noel L, Aullen JP, Frette C, Sari F, Vo Mai M, et al.
The French haemovigilance system. Vox Sang 1999 ; 77 :
77-81.
AFSSAPS/Agence Franaise de Scurit Sanitaire des Produits
de Sant. Bulletin priodique. Hmovigilance 2000 ; 2 : 1-6.
Williamson LM, Lowe S, Love E, et al. Serious hazards of
transfusion: annual report 1996/97. ISBN 0 9532 789 0 5: 18
March 1998.
Williamson LM, Lowe S, Love E, et al. Serious hazards of
transfusion: annual report 1997/98. ISBN 0 9532 789 1 3: 9
March 1999.
Williamson LM, Lowe S, Love E, Cohen H, Soldan K, McClelland DBL, et al. The serious hazards of transfusion (SHOT)
initiative analysis of the first two annual reports. Br Med J
1999 ; 319 : 16-9.
Love E, Williamson LM, Cohen H, et al. Serious hazards of
transfusion: annual report 1998/99, ISBN 0 9532 789 2 1: 7
April 2000.
Faber JC. Lhmovigilance en Europe. Transfus Clin Biol
2000 ; 7 : 5-8.
European Commission. The establishment of a haemovigilance
network in the European Community: a feasibility project
carried out by HAEMAN Consortium, December 1998.
Council of Europe. Recommendation No. R (95) 15: guide to
the preparation, use and quality assurance of blood components. 7th edition. ISBN 92-871-4548-2: 2001.

Transfus Clin Biol 2001 ; 8 : 28590