The EU Blood Directives:

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The EU Blood Directives An overview of
developments at European level
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Two Directives completed The Core Directive
EC/2002/98 The Technical Specifications
EC/2004/33 Donors, Products Two in
Process Quality system, (doesnt apply to
hospital blood banks) Haemovigilance,
Traceability
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The main Directive (2002/98/EC) 34
Articles 4 Annexes
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Additional text (recitals).. The
Commission should be empowered to establish
technical requirements and adopt any necessary
changes thereto and to the Annexes in order to
take into account scientific and technical
progress.
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ARTICLES General provisions for Blood
establishments Autologous (predeposit)
transfusion Hospital blood banks Quality
systems, personnel Inspection and
licensing Adverse event reporting
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Blood establishments Any facility engaged in
any aspect of collection, testing,
processing, storage, transport,
distribution of blood or blood components when
intended for transfusion (.or as a starting
material for manufacture of blood products.)
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Hospital Blood banks Member states shall take
all necessary measures to ensure that (each
hospital blood bank) maintains a
quality system maintains documentation ensures
that traceability is adequate notifies serious
adverse events Stores and distributes in
accordance with Article 28(e) Personnel.shall
be qualified
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Blood banks will be required to be registered in
some way, that will be determined by each Member
State Member States will have to develop
methods to ensure conformance.
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Accreditation Inspection of Blood
Establishments activities must be
specified Substantial changes only with
agreement of Competent Authority pathogen
inactivation, leucodepletion, apheresis red
cells, introduce new test, drop an old one.
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Competent Authority An agency empowered by the
Government to accredit or licence blood
establisnments
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Inspection at least every two years in the
event of a serious adverse event or
reaction or suspicion thereof
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Responsible Person Ensures compliance with the
provisions of the Directive Must have formal
qualification in the medical or biological
sciences PLUS two years experience in an
authorised Blood Establishment
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Responsible Person this person must be
officially notified to the competent
authority and the competent authority must be
informed when she or he is replaced, even
temporarily
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Quality system for Blood Establishments standar
ds and specifications will be decided in the
near future
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Serious Adverse Events and Reactions any
serious adverse event (errors or
accidents) which may have an influence on
quality and safety any serious reaction
observed during transfusion which may be
attributed to the quality and safety of the
component.. are notified to the competent
authority
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Technical Articles information to
donors information from donors eligibility of
donors Storage, transport, release product
specifications (quality and safety
requirements) testing ANNEX IV
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Essentially The Commission draws up the
technical specifications for more or less
everything (a huge task). It then presents
these to a regulatory committee, composed of
the representatives of the member States. And
chaired by the Commission.
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Article 24 The Commission shall meet regularly
with delegations of experts from blood
establishments.
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Further Directives Quality system, adverse
event reporting, haemovigilance (2005) Tissues
Cells (2005/6)
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Technical Specifications Directive
EU/2004/33 Accepted in November 2004 into
force February 2005 (November 2005)
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The Technical Specifications Directive language
designed to allow regulators to define
standards and manufacturers to achieve
compliance without compromising innovation
attempted not to enshrine current limitations
into law
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1. Red cell preparations The components listed in
points 1.1 to 1.8 may be further processed within
blood establishments and must be
labelled accordingly. 1.1 Red cells 1.2 Red
cells, buffy coat removed 1.3 Red cells,
leucocyte-depleted 1.4 Red cells, in additive
solution 1.5 Red cells, buffy coat removed, in
additive solution 1.6 Red cells,
leucocyte-depleted, in additive solution
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5. New components Quality and safety
requirements for new blood components must be
regulated by the competent national authority.
Such new components must be notified to the
European Commission with a view to Community
action.
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Component Quality Measurements Required The
required frequency of sampling for all
measurements shall be determined using
statistical process control. Statistical
process control means a method of quality
control of a product or a process that relies on
a system of analysis of an adequate sample size
without the need to measure every product of the
process.
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Introductory Note All testing and processes
referred to in these Annexes must be subjected to
validation.
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2. TRANSPORT AND DISTRIBUTION Transport and
distribution of blood and blood components at all
stages of the transfusion chain must be under
conditions that maintain the integrity of the
product.
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Next phase. How will the involvement of the EU
in Blood Transfusion evolve ? How will
sanctions operate ?
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Conclusion. IBTS, Crumlin, Cappagh, Galway, VRL
will be inspected licenced by the IMB.
Hospitals performing predeposit
autologous transfusions, and irradiation
will be inspected licenced by the IMB.
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Conclusion. All other hospital blood banks will
be accreditied to ensure they maintain a
quality system (but not specified by
EU) maintain documentation ensure that
traceability is adequate notify serious adverse
events Store and distribute in accordance with
Article 28(e) that Personnel.are
qualified