• AUSTRALIAN & NEW ZEALAND SOCIETY OF BLOOD TRANSFUSION INC.

• AUSTRALIAN RED CROSS BLOOD SERVICE

• NEW ZEALAND BLOOD SERVICE

Guidelines for Gamma

Irradiation of Blood Components

Revised 2003

ANZSBT
Australian & New Zealand
Society of Blood Transfusion Inc
Copyright© by The Australian & New Zealand Society of Blood Transfusion Inc.
Australian Red Cross Blood Service
New Zealand Blood Service

Apart from any fair dealing for the use of private study, research, criticism, or review as permitted under the
Copyright Act, no part of this book may be transmitted or reproduced in any form, electronic or mechanical, or by
any information storage and retrieval system, without the written permission of the Publishers.

Published in Australia by:

Australian & New Zealand Society of Blood Transfusion Inc.

145 Macquarie Street
Sydney NSW 2000
AUSTRALIA

ISBN No: 0 9577262 4 4

1st ASBT Edition 1996

Australian & New Zealand Society of Blood Transfusion
Australian Red Cross Blood Service
New Zealand Blood Service

Guidelines for Gamma Irradiation of Blood Components

RATIONALE

Transfusion-associated graft-versus-host disease (TA-GVHD) is a rare, but usually fatal, complication

of transfusion. The risk associated with an individual transfusion depends on the number and viability
of contaminating lymphocytes, the susceptibility of the patient's immune system to their engraftment
and the degree of immunological disparity between donor and patient. The mainstay of prevention is
gamma irradiation, which inactivates T lymphocytes whilst preserving the function of other blood cells.
Leucodepletion by current filtration technology is inadequate [unproven] for this purpose.

SCOPE

These guidelines cover the procedural aspects, equipment dosimetry and maintenance, and clinical
indications for gamma-irradiated blood components.

1. PROCEDURAL ASPECTS

1.1 Dose of gamma radiation

Experience has revealed the importance of the selection of an effective dose of gamma radiation.
The minimum dose achieved in the irradiation field should be 25 Gy, with no part receiving
greater than 50 Gy.

1.2 Effect of irradiation on blood components

Red cells / Whole Blood

There is evidence that gamma irradiation results in reduced post-transfusion red cell recovery, but
only after prolonged storage. Irradiation has no clinically significant effect on red cell pH,
glucose consumption, ATP and 2,3 DPG levels. However gamma irradiation of red cells does
increase the rate of efflux of intracellular potassium. In considering the clinical significance of
this, both the speed and volume of the transfusion, as well as the age of the blood, must be taken
into account.

Platelets
Gamma irradiation below 50 Gy has not been shown to produce significant clinical changes in
platelet function.

Granulocytes
The evidence for irradiation damage to granulocyte function is conflicting, but in any case
granulocyte products must be transfused as soon as possible after preparation.
1.3 Blood component shelf life

Red cells
Red cells may be irradiated at any time up to 14 days after collection, and thereafter stored for a
further 14 days from irradiation. Where the patient is at particular risk from hyperkalaemia, it is
recommended that red cells be transfused within 24 hours of irradiation.

[Red cells can re-enter the inventory as long as the altered shelf is observed].

Platelets
Platelets can be irradiated at any stage in their five-day storage and can thereafter be stored up to
their normal shelf life of five days after collection.

Granulocytes
Granulocytes for all recipients must be irradiated as soon as possible after production, and
thereafter transfused with minimal delay.

1.4 Labelling and documentation requirements

All irradiated components must be identified [and labelled immediately] with an approved label.
The label should be permanent and include the date and dose of irradiation and any reduction in
shelf life. Each batch of one or more units should be monitored using a radiation-sensitive label
or device to indicate adequate exposure to gamma rays. As a minimum, a label should be
included with every batch. However, it is not necessary to attach a label to every pack in a batch
provided that the irradiation procedure follows a validated, documented and well-controlled
system of work practice. There must be a permanent record of all units irradiated.

2. EQUIPMENT DOSIMETRY AND MAINTENANCE

2.1 Choice of blood irradiators

Irradiation of blood components will normally be undertaken using dedicated Blood irradiators.
Such instruments will contain a long half-life, gamma-emitting source. The source must be
double encapsulated. All specifications should be available. Adequate shielding must be
provided to ensure that all dose rates are as low as is reasonably achievable at all accessible
points. Radiation safety, dosimetry and personnel safety issues should be under the responsibility
of a suitability qualified person in accordance with legislation.

In some circumstances linear accelerators or similar equipment may be used to irradiate blood
components. These guidelines are applicable to such situations and systems should be put in
place to ensure that dosimetry requirements contained within these guidelines are met.

2.2 Commissioning
The manufacturer, or their agent, should commission the irradiator and provide a calibration
certificate for a dose rate at a specified point in the canister.

2.3 Dosimetry and Operation

Following calibration/recalibration, a table must be produced which gives irradiation times for
specified doses for a set period. Both the dose rate and the dose distribution must be checked
upon installation, at least annually, and after any source change or mechanical alterations,
particular to the rotating turntable.
2.4 Quality control of procedures
All operators must have been adequately trained in the use of the equipment.

2.5 Maintenance
Wipe tests must be carried out at regular intervals, preferably six monthly, to check for leakage of
radioactive contamination.

2.6 Legislation
Ensure compliance with local legislation.

3. CLINICAL INDICATIONS FOR GAMMA IRRADIATED BLOOD COMPONENTS

These Guidelines outline the minimum clinical criteria for the use of irradiated blood
components based on currently available evidence. It is recognised that individual centres may
utilise wider criteria. This is acceptable if the criteria are clearly documented and in all instances
meet or exceed the requirements identified below.

Blood components that must be gamma irradiated

Lymphocyte viability is retained in stored red cells for at least three weeks, and TA-GVHD has
developed following transfusion of whole blood, red cells, platelet and granulocytes. For at-risk
patients, all red cell, platelet and granulocyte transfusions must be irradiated, except
cryopreserved red cells after deglycerolization. It is not necessary to irradiate fresh frozen
plasma, cryoprecipitate or fractionated plasma products. Blood stem cells for the purposes of
transplantation must not be irradiated.

3.1 Donations from family members and HLA-selected donors

Because of the possibility of shared HLA haplotypes within families, donations from family
members pose a particular risk of TA-GVHD, especially when the recipient is a neonate. All
transfusions from blood relatives must be irradiated, even if the patient is immunocompetent.
Likewise, all HLA-selected platelets must be irradiated, even if the patient is immunocompetent.

3.2 Paediatric practice

The newborn may be at particular risk of TA-GVHD either because of possible physiological
immune incompetence or because of an underlying congenital T-cell immunodeficiency. The
majority of cases of TA-GVHD reported in apparently immune competent infants have occurred
in the setting of intrauterine transfusion followed by exchange transfusion.

Intrauterine and exchange transfusion

All blood for intrauterine transfusion must be irradiated. It is essential to irradiate blood
for exchange transfusion if there has been a previous intrauterine transfusion, or if the
donation comes from a relative. For other exchange transfusion cases, irradiation is
recommended provided this does not unduly delay transfusion. Blood less than 5 days of
age should be used for intrauterine and exchange transfusion, and must be transfused
within 24 hours of irradiation.

Top-up transfusion
There is no necessity to irradiate blood for routine ‘top-up’ transfusions of premature or
term infants unless either there has been a previous intrauterine transfusion or the blood
has come from a blood relative, in which case the blood must be irradiated.
 Platelet transfusions
Irradiation must be performed on platelets transfused in utero to treat alloimmune
thrombocytopenia, and on platelet transfusions given after birth to infants who have
received either red cells or platelets in utero. However, there is no requirement to
irradiate platelets for pre-term or term infants, unless they are derived from blood
relatives.

Granulocyte transfusions
As stated previously all granulocyte transfusions must be irradiated for babies of any age
and transfused as soon as possible after irradiation.

Congenital immunodeficiencies in infants and children

Irradiation of cellular blood products is recommended for all infants/children with
suspected or diagnosed T-cell immune deficiency states.

Acquired immunodeficiency states in childhood

There is no indication for the irradiation of cellular blood components for children who
are HIV antibody positive, or who have AIDS.

3.3 Acute leukaemia and bone marrow / blood stem cell transplantation

Acute leukaemia
It is not necessary to irradiate red cells or platelets for adults or children with acute
leukaemia, except for HLA-matched platelets or donations from blood relatives.

Allogeneic bone marrow / peripheral blood stem cell transplantation

All recipients of allogeneic bone marrow / peripheral blood stem cell transplants must
receive gamma-irradiated blood products from the time of initiation of conditioning
chemo/radiotherapy.

This should be continued while the patient remains on GVHD prophylaxis, usually for a
minimum of six months or until lymphocytes are >1 X 109/L.

Autologous bone marrow /peripheral blood stem cell recipients

Patients undergoing bone marrow or peripheral blood stem cell harvesting for future
autologous reinfusion should only receive gamma irradiated allogeneic cellular blood
products during and for seven days before the bone marrow/stem cell harvest to prevent
the collection of viable allogeneic T lymphocytes. All patients undergoing bone marrow
transplantation must then receive gamma irradiated cellular blood products from the
initiation of conditioning chemo/radiotherapy until at least three months post autograft.
[or six months if Total Body Irradiation used].

4. OTHER PATIENT GROUPS

Other indications for gamma irradiated blood products include Hodgkin's disease and patients on
purine analogue drugs [such as fludarabine, cladribine]. There is currently no data to support a
stated period of time to use irradiated products for patients following treatment with purine
analogues.
5. TABULATED INDICATIONS

CLINICAL INDICATIONS FOR IRRADIATED CELLULAR PRODUCTS

A Definite indications

These are indications where there is strong evidence to support the requirement for use of
irradiated blood components or where there is clear consensus on the requirement within
published guidelines
Allogeneic and Autologous Bone Marrow/PBSC Transplant recipients
Congenital Cellular Immunodeficiency Disorders
Intrauterine and all subsequent transfusion and neonatal exchange transfusions
Aplastic anaemia patients receiving immunosuppressive therapy
Hodgkin's Disease
Patients receiving purine analogues with associated immunosuppression
Dedicated [directed] donations (from blood relatives)
HLA matched single donor platelets
Granulocyte transfusions

B Possible indications

This includes settings where case reports have been published but where no controlled studies
are available. Irradiation is not required in published international guidelines.
T Cell malignancies
Patients with B cell malignancy who receive chemotherapy and/or radiotherapy leading
to lymphopenia <0.5 x 109/L
Therapeutic antibodies against T cells
Acute Leukaemia
Chronic Myeloid Leukaemia
Any patient who receives high doses of chemotherapy and/or irradiation sufficient to
cause lymphopenia <0.5 x 109/L
Patients receiving long term or high dose steroids as therapy for their malignancies
Premature infants weighing less than 1200g

C No indication

No cases have been reported

AIDS (where none of the above apply)
Congenital humoral deficiency disorder
Term infants (where none of the above apply)
Thalassaemias
Haemophilia
REFERENCES

These guidelines are based on and are consistent with the references cited below:

1. Guidelines on gamma irradiation of blood components for the prevention of transfusion-

associated graft-vs-host disease prepared by British Committee for Standards in
Haematology. Transfusion Medicine 1996; 6:261-271.

2. Guidelines for irradiated blood products. Australasian Society of Blood Transfusion, 1996.

3. Transfusion-Associated Graft-Versus-Host Disease [Review]. British Journal of

Haematology, 2002,117, 275-287.

Disclaimer
Institutions using these guidelines need to formulate their own policies according to their patient
population and availability of irradiated products. By necessity these policies may need to be
much broader to cover all possible eventualities.